6TH International Meeting of Pharmaceutical and Food Sciences (Ecfa 2022)

@2022 Journal of Pharmacy & Pharmacognosy Research, 10(Supplement 1), December, 2022
DOI: https://doi.org/10.56499/jppres.10.suppl.1
6to ENCUENTRO INTERNACIONAL DE CIENCIAS FARMACÉUTICAS

Y ALIMENTARIAS
6TH INTERNATIONAL MEETING OF PHARMACEUTICAL

AND FOOD SCIENCES
COMUNICACIONES CORTAS Y LIBRO DE RESÚMENES
SHORT COMMUNICATION AND ABSTRACT BOOK
Hotel Nacional de Cuba

La Habana, 23-25 de Noviembre, 2022
Cuban National Hotel

Havana, November 23-25, 2022
Sitio web: http://eventos.uh.cu/eventos/ifal/

Editing, design and realization:

Gabino Garrido
Marisela Valdés-González
Xavier Garrido-Valdés
Gilberto Pardo-Andreu
Editorial Scientific Council:

Javier Marín Prida
Roberto Fernández-Acosta
© Instituto de Farmacia y Alimentos, Universidad de La Habana, Cuba.

© Journal of Pharmacy & Pharmacognosy Research
© About this edition: Journal of Pharmacy & Pharmacognosy Research, December 2022.
eISSN 0719-4250
Digital printing:
Journal of Pharmacy & Pharmacognosy Research (JPPRes)
https://jppres.com/
E-mails: editor@jppres.com; jppres12@gmail.com
Editor's Note: JPPRes is an open access journal distributed under the terms of a Creative Commons Attribution License 4.0
(http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any
medium, provided the original work is properly cited. Authors may not use JPPRes information for commercial
purposes. Authors may not alter, transform, or build upon this work. Any of these conditions can be waived if you
get permission from the copyright holder. Nothing in this license impairs or restricts the author’s moral rights.
Abstracts that were not delivered on date or had more than 20% similarity with articles already published, could not
be included in this work.
The information in all parts of the book has been reproduced as provided by their respective authors.
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sii

PRESIDENTES DE HONOR | HONORIFIC PRESIDENTS
José Ramón Saborido Loidi, PhD. Ministro de Educación Superior | Ministre Higher Education
Miriam Nicado García, PhD. Rectora Universidad de La Habana | Rector University of Havana
PRESIDENTE DEL EVENTO | PRESIDENT OF THE MEETING
Liliana Mateu López, PhD. Directora-Decana del Instituto de Farmacia y Alimentos | Director (Dean),
Institute of Pharmacy and Food of University of Havana, Cuba
COMITÉ ORGANIZADOR | ORGANIZING COMITÉ CIENTÍFICO | SCIENTIFIC

COMMITTEE COMMITTEE
COORDINADOR GENERAL | GENERAL PRESIDENTE | PRESIDENT

COORDINATOR
Gilberto L. Pardo-Andreu, PhD
Gledys Reynaldo Fernández, PhD
MIEMBROS | MEMBERS
MIEMBROS | MEMBERS
Alicia Casariego Año, PhD
Raisa Mangas Marín, PhD Danae Pérez Santana, PhD
Grisel del Toro García, PhD Irela Pérez Sánchez, PhD
Yudenis Reyes González, PhD Milena Díaz Molina, PhD
Joe Doyharzabal Jiménez, BSc María Isabel Lantero Abreu, PhD
Luis Michel Rodríguez Gómez, BSc Niurys de Castro Suárez, PhD
Gilberto Suárez Balseiro, BSc Yania Suárez Pérez, PhD
Olga Sonia León, PhD
Patricia Pérez Ramos, PhD
René Tejedor Arias, PhD
Yamilet Irene Gutiérrez Gaitén, PhD
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Organizado por | Organized by
Instituto de Farmacia y Alimentos, Universidad de La Habana, Cuba | Institute of Pharmacy and

Food, University of Havana, Cuba
Co-Auspiciado por | Co-Sponsored by
Organización Superior de Dirección Empresarial, Grupo de las Industrias Biotecnológica y Farmacéutica

BioCubaFarma, Cuba | Higher Organization for Business Direction, Group of Biotechnological and Pharmaceutical
Industries, BioCubaFarma, Cuba
Ministerio de Educación Superior (MES), Cuba | Cuban Ministry of Higher Education
Ministerio de Ciencia, Tecnología y Medio Ambiente (CITMA), Cuba | Cuban Ministry for Science, Technology and
the Environment
Ministerio de la Industria Alimenticia (MINAL), Cuba | Cuban Ministry of Food Industry
Programa de Naciones Unidas para el Desarrollo (PNUD) | United Nations Program for Development
Centro de Inmunología Molecular (CIM), Cuba | Center of Molecular Immunology, Cuba
Centro de Ingeniería Genética y Biotecnología (CIGB) | Center for Genetic Engineering and Biotechnology, Cuba
Instituto “Finlay” de Vacunas, Cuba | “Finlay” Institute for Vaccines, Cuba
Empresa Laboratorios Farmacéuticos “AICA”, Cuba | Pharmaceutical Laboratories “AICA”, Cuba
Centro de Gestión del Conocimiento del Ministerio de Comercio Interior (MINCIN) | Center for Knowledge
Management of the Ministry of Internal Trade
Empresa Apícola Cubana (APICUBA) | Cuban Apiarian Company
Proyecto “Creación de capacidades para la investigación pre-clínica de compuestos cubanos con acciones sobre la
muerte celular y la inflamación” | “Capacity building of a preclinical compound screening facility for Cuban-developed
bioactive compounds targeting cell death and inflammation”. VLIR-UOS (Modalidad TEAM), código
CU2018TEA457A103
Proyecto “Mecanismos moleculares de la muerte y sobrevivencia celular en la inflamación, degeneración e

infección”. | “Molecular mechanisms of cell death and survival in inflammation, degeneration and infection”. Programa
Nacional de Ciencias Básicas y Naturales (PNCBN), código PN223LH010-035
Proyecto Adelante. Contribución al desarrollo de la medicina herbaria | Contribution to herbal medicine development
Journal of Pharmacy & Pharmacognosy Research
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STATEMENT OF PEER REVIEW
6th International Meeting of Pharmaceutical and Food Sciences
(ECFA 2022)
Havana, Cuba
November 23-25, 2022.
In submitting Conference Proceedings to this special issue of Journal of Pharmacy & Pharmacognosy
Research (JPPRes), we certify to the Publisher that we adhere to the Editorial Policy of JPPRes in order to
safeguard a good scientific practice in publishing.
Moreover, we manifest that all articles have been subject to peer review administered by the proceeding’s
editors. Also, reviewers have been conducted by expert referees, who have been requested to provide
unbiased and constructive comments aimed, whenever possible, at improving the work. Proceeding’s
editors have taken all reasonable steps to ensure the quality of the materials they publish and their
decision to accept or reject a paper for publication has been based only on the merits of the work and the
relevance to the journal.
Proceeding’s editors:
Conference representative
6th International Meeting of Pharmaceutical and Food Sciences
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MENSAJE DE BIENVENIDA
Estimados Delegados e Invitados:
El Instituto de Farmacia y Alimentos de la Universidad de La Habana, Cuba, con el auspicio de

organizaciones nacionales e internacionales vinculadas con las Ciencias Farmacéuticas y Alimentarias,
celebra el 6to Encuentro Internacional de Ciencias Farmacéuticas y Alimentarias “ECFA 2022”, en
el Hotel Nacional de Cuba, en La Habana, Cuba, del 23 al 25 de noviembre del 2022.
Es nuestro deber propiciar intercambios científicos de alto nivel que, guiados por las instituciones
académicas, contribuyan a la formación integral de los profesionales de estas disciplinas. De esta
manera, nos proponemos ejercer un impacto positivo en el logro de nuevas metas personales, así como
fortalecer el compromiso cotidiano de estos profesionales con la sociedad. Todo esto en función del
desarrollo científico-técnico del país y enfrentando los crecientes desafíos de la actual realidad
doméstica e internacional.
Este encuentro propone favorecer el intercambio de experiencias entre profesionales de las ciencias
farmacéuticas y alimentarias, ya que el desarrollo acelerado de la ciencia y la tecnología exige la
actualización continua de los expertos, técnicos, investigadores, profesores y estudiantes.
Les damos una calurosa bienvenida a este 6to Encuentro Internacional de Ciencias Farmacéuticas y
Alimentarias, en el que no sólo se compartirán días de ciencia, tecnología e innovación, sino que también
se podrá disfrutar de las bellezas naturales y la riqueza cultural y social de nuestro país para quienes nos
visiten. Les aseguramos una experiencia inolvidable, en la que podrá disfrutar de la Habana y sus
entornos, ciudad declarada por la UNESCO como Patrimonio Cultural de la Humanidad, en una época de
agradable clima tropical y en constante labor de restauración de los valores arquitectónicos e históricos
de la ciudad.
Atentamente.
Liliana Mateu López, PhD

Directora-Decana del Instituto de Farmacia y Alimentos de la Universidad de La Habana
Presidenta del ECFA 2022
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WELCOME MESSAGE
Dear Delegates and Guests:
The Institute of Pharmacy and Food of the University of Havana, Cuba, under the auspices of national
and international organizations linked to the Pharmaceutical and Food Sciences, celebrates the 6th
International Meeting of Pharmaceutical and Food Sciences “ECFA 2022”, at the Cuban National
Hotel, Havana, Cuba, November 23-25, 2022.
As part of our mission, we propitiate high level scientific exchanges, which under the guidance of
academic institutions, may contribute to the integral formation of professionals from these disciplines. By
this way, we aim to have a positive impact in the achievement of new personal goals, and also, to
strengthen the everyday commitment of these professionals with the society. All of this, in function of the
technical and scientific development of the country, and facing the increasing challenges of the current
domestic and international context.
This event is intended to favor the exchange of experiences among professionals of the pharmaceutical
and food sciences, since the rapid advance of the science and the technology demands the continuous
upgrading of the experts, technicians, investigators, professors and students.
Thus, we give you a warm welcome to this 6th International Meeting of Pharmaceutical and Food
Sciences, which is not only to share days of science, technology and innovation, but also to enjoy the
natural beauties and the cultural and social wealth of our country. We assure you an unforgettable
experience, during which you may enjoy the amazing Havana and near places, a city declared as an
UNESCO World Heritage, in a time of a pleasant tropical climate and of constant work of rescue of the
architectural and historical values of the city in the 500 anniversaries of its foundation.
Kind Regards,
Liliana Mateu López, PhD
Director (Dean), Institute of Pharmacy and Food of University of Havana, Cuba
President of ECFA 2022
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Cuotas de inscripción | Registration Fees
PARTICIPANTES CUBANOS | PARTICIPANTS FROM CUBA

Ponente Presencial | Presential Speaker 3000.00 CUP
Estudiante Presencial | Presential Student 1500.00 CUP
Ponente Virtual | Virtual Speaker 1500.00 CUP
Estudiante Virtual | Virtual Student 750.00 CUP
Off-Line 500.00 CUP
PARTICIPANTES EXTRANJEROS | FOREIGN PARTICIPANTS

Presential Speaker 270.00 USD
Companion 150.00 USD
Presential Student 150.00 USD
Virtual Speaker 70.00 USD
Virtual Student 50.00 USD
Off-Line 50.00 USD
CURSOS PRE-CONGRESOS | PRE-CONGRESS COURSES: 70.00 / 50.00 USD (Profesionales / Estudiantes

extranjeros | Foreign Profesional / Students), 300.00 / 150.00 CUP (delegados nacionales | national delegates)
Pago por transferencia bancaria en USD | Information for payment by bank transfer in USD
http://ecfa.cubagrouplanner.com/
Pago por cheque o transferencia bancaria en moneda nacional CUP | Information for payment by check or
bank transfer in national currency CUP
Nombre de la cuenta en CUP | Name of the account in CUP: UPR Inst. de Farm. y Alim. Act Autofinanciada
Número de la cuenta en CUP | Account number in CUP: 0532040014240911
Nombre del banco | Bank name: Banco Metropolitano, Agencia 320
Dirección de la sucursal | Branch address: Agencia 320, Arroyo Arenas, La Lisa, La Habana, Cuba
Pago en efectivo a su llegada a la sede del evento | Information for payment in cash at your arrival to the
event venue
Realice el pago directamente con el Departamento Económico del Evento en la Oficina del Comité Organizador en el
Hotel Nacional de Cuba. Evite pagar en Dólares de Estados Unidos de América. | Pay directly to the Economic
Department of the Event in the Office of the Organizing Committee at Hotel Nacional de Cuba. Remember that in
Cuba the American Dollar suffers a penalty of 10% on each payment. Avoid paying in United States Dollars.
PUBLICACIÓN DEL LIBRO DE RESÚMENES DEL CONGRESO | PUBLICATION OF THE PROGRAM AND THE
ABSTRACTS BOOK OF THE CONGRESS
El Libro de Resúmenes será publicado en la Revista Journal of Pharmacy and Pharmacognosy Research (JPPRes),
disponible en: https://jppres.com/jppres | The Abstracts Book will be published in the Journal of Pharmacy and
Pharmacognosy Research (JPPRes), available online at: https://jppres.com/jppres
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PROGRAMA CIENTÍFICO | SCIENTIFIC PROGRAM
CURSOS PRECONGRESO | PRECONGRESS COURSES
CPC-01
MARTES 22 NOVIEMBRE | TUESDAY, NOVEMBER 22
“El papel de la Farmacometría en el desarrollo de fármacos y en la práctica clínica”. | “The Role of
Pharmacometrics in Drug Development and Clinical Practice”.
Lugar | Place: Centro de Convenciones “Enrique José Varona”, Universidad de La Habana
Profesor | Professor: Dr. Helena Colom. Profesora Titular de la Unidad de Biofarmacia y Farmacocinética de la Universidad
de Barcelona. Línea de investigación principal: Estudios farmacocinéticos-farmacodinámicos poblacionales: preclínica y
clínica.
Orcid 0000-0002-7259-0199
Research Gate https://www.researchgate.net/profile/Helena-Colom
Objetivo general: Proporcionar los conocimientos teórico-prácticos necesarios para describir, evaluar e interpretar el
comportamiento farmacocinético de un fármaco en el organismo. Aplicar los principios farmacocinéticos para la optimización
del régimen de dosificación en la práctica clínica.
08:30-09:00 Acreditación y bienvenida | Registration and welcome

• Cómo diseñar el estudio en función del objetivo planteado.
• Métodos de análisis de datos en farmacocinética
09:00-11:00
• Concepto, método de cálculo e interpretación
• Concepto de linealidad cinética
11:00-12:30 Tiempo libre para almorzar| Free lunch time interlude
• Taller teórico-práctico diseñado a partir de un caso real en el cual los
12:30-14:30 participantes - en la aplicación de los principios farmacocinéticos para
diseñar regímenes de dosificación de fármacos en la práctica clínica.
Discusión general, conclusiones y entrega de certificados | General
14:30-15:00
discussion, Conclusions and delivery of certificates
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CPC-02
MARTES 22 NOVIEMBRE | TUESDAY, NOVEMBER 22
“Curso de Biofarmacia: Estudios de liberación de fármacos según vías de administración.” | “Course on
Biopharmaceuticals: Drug delivery and routes of administration”.
Lugar | Place: Centro de Convenciones “Enrique José Varona”, Universidad de La Habana
Profesor | Professor:
Dr. Ana C. Calpena. Profesora Titular de la Unidad de Biofarmacia y Farmacocinética de la Universidad de Barcelona.
Líneas de investigación principal: Evaluación biofarmacéutica de fármacos por la vía transdérmica y transmucosa.
Orcid 0000-0002-4989-4821
Research Gate https://www.researchgate.net/profile/Ana-Calpena
Dr. Mireia Mallandrich

Investigadora post-doctoral de la Unidad de Biofarmacia y Farmacocinética de la Universidad de Barcelona. Líneas de
investigación principal: Evaluación biofarmacéutica de fármacos por la vía transdérmica y transmucosa.
Orcid 0000-0001-9316-8459
Research Gate https://www.researchgate.net/profile/Mireia-Mallandrich-2
MC. Adriel Brito Llera

Dirección de Ciencias, Tecnología e Innovación. Universidad La Habana. Líneas de investigación principal: Administración
intranasal de fármacos, en particular, la vía “nose-to-brain”.
Orcid 0000-0001-5431-5444
Research Gate https://www.researchgate.net/profile/Adriel-Brito-Llera
1- Objetivo general: Exponer diferentes formas farmacéuticas clásicas y novedosas. Estudiar las diferentes cinéticas,
modelos y parámetros que rigen la liberación y permeación de fármacos. Practicar los ajustados cinéticos mediante un
software adecuado.
08:30-09:00 Acreditación y bienvenida | Registration and welcome

• Sistemas de administración de medicamentos
09:00-11:00 • Enfoques seleccionados para la administración de medicamentos
• Materiales y Sistemas
11:00-12:30 Tiempo libre para almorzar | Free lunch time interlude
• El futuro de la liberación in vitro ex vivo e in vivo de medicamentos
• Estudios de disolución | liberación de diferentes formas farmacéuticas.
12:30-14:30 • Celdas de difusión de Franz y de Guyot
• Tratamiento de datos en los estudios de liberación y permeación. Dosis
finitas versus dosis infinitas.
Discusión general, conclusiones y entrega de certificados | General
14:30-15:00
discussion, Conclusions and delivery of certificates
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MIÉRCOLES 23 NOVIEMBRE | WEDNESDAY, NOVEMBER 23

CÓDIGO | CODE HORA | TIME
Bienvenida y acreditación de delegados | Welcome and registration of delegates. SALA 1930
7:00-9:00
| ROOM 1930
SALA 1930 | ROOM 1930
CONFERENCIAS PLENARIAS | PLENARY LECTURES
9:00-9:30 CEREMONIA INAUGURAL | OPENING CEREMONY

ATAXIAS ESPINOCEREBELOSAS: DESDE SUS ESTADOS PRE-SINTOMÁTICOS A LOS
ENSAYOS CLÍNICOS Y BIOMARCADORES TEMPRANOS SPINOCEREBELLAR ATAXIAS:
CP-01 9:30-10:00
FROM PREMANIFEST STAGE TO EARLY CLINICAL TRIALS AND BIOMARKERS
Luis Velázquez. PhD, Presidente Academia de Ciencias de Cuba
LA FERROPTOSIS COMO BLANCO FARMACOLÓGICO EN LA ENFERMEDAD |
FERROPTOSIS TARGETING IN DISEASE
CP-02 10:00-10:30
Tom Vanden Berghe, Assistant Professor University of Antwerp, Guest-Professor University of
Ghent, Belgium
10:30-11:00 RECESO | COFFEE BREAK
11:00-14:00 SIMPOSIOS (S) Y PRESENTACIONES ORALES (PO) | SYMPOSIA (S), AND ORAL
PRESENTATIONS (PO)
14:00-15:00 ALMUERZO | LUNCH
CARTELES (P) Y PRESENTACIONES OFF-LINE (POL) | POSTERS (P) AND OFF LINE
15:00-17:00
PRESENTATIONS (POL)
SALA TAGANANA | ROOM TAGANANA
S1_2do SIMPOSIO SOBRE MUERTE CELULAR REGULADA E INFLAMACIÓN | 2nd SIMPOSIUM ON REGULATED CELL DEATH AND
INFLAMMATION
COORDINADORES | COORDINATORS: Gilberto L Pardo-Andreu, PhD, IFAL-UH, Cuba | Roberto Fernández-Acosta, MSc, IFAL-UH,
Cuba | Tom Vanden Berghe, PhD, University of Antwerp, Belgium
¿CÓMO INDUCIR UNA OLA IMPARABLE DE MUERTE EN EL NEUROBLASTOMA
RESISTENTE A LA TERAPIA? | HOW TO INDUCE AN UNSTOPPABLE WAVE OF DEATH IN
CO-01 11:00-11:10 THERAPY-RESISTANT NEUROBLASTOMA?
Tom Vanden Berghe, Assistant Professor University of Antwerp, Guest-Professor University of
Ghent, Belgium
LOS FITOMEDICAMENTOS POLIFARMACOLÓGICO TENDRÁN UN FUTURO EN LA
ONCOLOGÍA DE PRECISIÓN PERSONALIZADA: UNA PERSPECTIVA KINO2OMIC | DO
POLYPHARMACOLOGICAL PHYTOMEDICINAL COMPOUNDS HAVE A FUTURE IN
CO-02 11:10- 11:20
PERSONALIZED PRECISION ONCOLOGY: A KINO2OMIC PERSPECTIVE
Wim Vanden Berghe, PhD. PPES-IPPON, Department Biomedical Sciences, University of
Antwerpen, Belgium
MECANISMOS MOLECULARES DE LA INDUCCIÓN DE FERROPTOSIS POR LA
NEMOROSONA EN CÉLULAS CANCERÍGENEAS | MOLECULAR MECHANISMS OF
CO-03 11:20-11:30 NEMOROSONE-INDUCED FERROPTOSIS IN CANCER CELLS
Roberto Fernández-Acosta, MSc, Department of Pharmacy, Institute of Pharmacy and Food,
University of Havana, Cuba
LA PROTEÍNA FORMADORA DE PORO STICHOLISINA II INDUCE MUERTE CELLULAR
REGULADA | THE PORE-FORMING PROTEIN STICHOLYSIN II TRIGGERS REGULATED
CO-04 11:30-11:40 CELL DEATH
Carmen Soto, PhD, Center for Protein Studies, Faculty of Biology, University of Havana and
NaNoCancer-Lab-UH- Center of Molecular Immunology, Havana, Cuba
EL TRATAMIENTO CON JM-20 REDUJO LA MUERTE NEURONAL Y LA REACTIVIDAD DE
LOS ASTROCITOS INDUCIDAS POR LA ISQUEMIA-REPERFUSIÓN: PARTICIPACIÓN DE LA
CO-05 11:40-11:50
VÍA DE SEÑALIZACIÓN Akt/GSK-3β | JM-20 TREATMENT REDUCED NEURONAL DEATH
AND ASTROCYTE REACTIVITY INDUCED BY THE ISCHEMIA/REPERFUSION:
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INVOLVEMENT OF THE Akt/GSK-3β SIGNALING PATHWAY

Jeney Ramírez Sánchez, MSc, CIDEM, La Habana, Cuba
ANDROGRAFOLIDA, UN FÁRMACO MULTIFUNCIONAL QUE MODULA LA INFLAMACIÓN Y
EL METABOLISMO EN EL CÁNCER DE PRÓSTATA | ANDROGRAPHOLIDE, A
MULTITARGET DRUG THAT MODULATES INFLAMMATION AND METABOLISM IN
CO-06 11:50-12:00 PROSTATE CANCER
Magaly Martínez-Ferrer, PhD, Department of Pharmaceutical Sciences, School of Pharmacy,
University of Puerto Rico, and Division of Cancer Biology, University of Puerto Rico
Comprehensive Cancer Center, San Juan, Puerto Rico
EL PÉPTIDO CIGB-552 TIENE UN EFECTO ANTITUMORAL EN MODELOS DE CANCER
COLORECTAL | THE PEPTIDE CIGB-552 HAS AN ANTITUMORAL EFFECT ON
CO-07 12:00-12:10
COLORECTAL CANCER MODELS
Brizaida Oliva Arguelles, CIGB, La Habana, Cuba
EFFECTO DE LA IL-2 Y UNA VARIANTE MUTANTE DE IL-2 SOBRE CÉLULAS
MONONUCLEARES PERIFÉRICAS SANGUÍNEAS: EXPANSIÓN. CARACTERIZACIÓN Y
ACTIVIDAD FUNCIONAL | EFFECT OF IL-2 AND MUTANT VARIANT OF IL-2 ON
CO-08 12:10-12:20
PERIPHERAL BLOOD MONONUCLEAR CELLS: EXPANSION, CHARACTERIZATION AND
FUNCTIONAL ACTIVITY
Anabel Lavastida-Linare, CIM, La Habana, Cuba
POTENCIALIDADES ANTIPROLIFERATIVAS DE ACEITES ESENCIALES EN PLANTAS
CUBANAS RICOS EN CARVACROL BASADAS EN LA FLUIDEZ DE MEMBRANA CELULAR |
CO-09 12:20-12:30 ANTIPROLIFERATIVE POTENTIALITIES OF CARVACROL RICH ESSENTIAL OILS FROM
CUBAN PLANTS BASED ON CELL MEMBRANE FLUIDITY
Lianet Monzote Fidalgo, IPK, La Habana, Cuba
HISTORIA Y FUTURO DE LOS 18F’-RADIOFARMACÉUTICOS PARA LOS ESTUDIOS DE
TOMOGRAFÍA DE EMISIÓN DE POSITRONES (TEP) | THE HISTORY AND FUTURE OF 18F'-
CO-10 12:30-12:40
RADIOPHARMACEUTICALS FOR POSITRON EMISSION TOMOGRAPHY (PET) STUDIES
Dr Tatsuo Ido, PhD, Emeritus Professor Tohoku University, Japan
CONTRIBUCIÓN MITOCONDRIAL A LA FERROPTOSIS. | MITOCHONDRIAL CONTRIBUTION
TO FERROPTOSIS)
CO-11 12:40-12:50
Gilberto L Pardo-Andreu, PhD, Center for Research and Biological Evaluation. IFAL-UH, La
Habana, Cuba
12:50-13:00 DISCUSIÓN | DISCUSSION
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SESIÓN DE CARTELES ELECTRÓNICOS DE S1 | DIGITAL POSTERS FROM S1
COORDINADORES | COORDINATORS: Roberto Fernández-Acosta, MSc, IFAL-UH, Cuba / Daniel Álvarez Almiñaque, MSc, IFAL-UH,
Cuba
ÍNDICE DE INFLAMACIÓN COMO FACTOR PREDICTIVO Y DE PRONÓSTICO EN
PACIENTES CON CÁNCER DE PULMÓN | INFLAMMATION INDEX AS PROGNOSTIC AND
P-01 15:05-15:10
PREDICTIVE FACTORS IN PATIENTS WITH LUNG CANCER
Carmen Viada, MSc, CIM, La Habana, Cuba
LA GOSSYPITRINA, FLAVONOIDE DE ORIGEN NATURAL, ATENÚA EL DAÑO NEURONAL Y
MITOCONDRIAL INDUCIDO POR HIERRO | GOSSYPITRIN, A NATURALLY OCCURRING
P-02 15:10-15:15 FLAVONOID, ATTENUATES IRON-INDUCED NEURONAL AND MITOCHONDRIAL DAMAGE
María A. Bécquer-Viart, MSc, Center for Research and Biological Evaluation. IFAL-UH, La
Habana, Cuba
NOVEDOSAS NANOPARTÍCULAS DE ÓXIDO DE HIERRO INDUCEN FERROPTOSIS EN UN
PANEL DE LÍNEAS CELULARES CANCERÍGENAS | NOVEL IRON OXIDE NANOPARTICLES
P-03 15:15-15:20
INDUCE FERROPTOSIS IN A PANEL OF CANCER CELL LINES
Roberto Fernández-Acosta, MSc, IFAL-UH, La Habana, Cuba
EVALUACIÓN DE LOS EFECTOS TÓXICOS DE DOS FORMULACIONES DE
NANOPARTÍCULAS DE MAGNETITA SOBRE LA LOMBRIZ DE TIERRA Eisenia andrei |
P-04 15:20-15:25 EVALUATION OF THE TOXIC EFFECTS OF TWO FORMULATIONS OF MAGNETITE
NANOPARTICLES ON THE EARTHWORM Eisenia andrei
Yordanka Domínguez Linares, CENATOX, La Habana, Cuba
EL EXTRACTO DE ALGAS MARINAS DE Thalassia testudinum SUPRIME EL CRECIMIENTO
TUMORAL, LA MOTILIDAD Y LA ANGIOGÉNESIS MEDIANTE EL ESTRÉS AUTOFÁGICO Y
LAS VÍAS INMUNOGÉNICAS DE MUERTE CELULAR | MARINE SEAGRASS EXTRACT OF
P-05 15:25-15:30
Thalassia testudinum SUPPRESSES TUMOR GROWTH, MOTILITY AND ANGIOGENESIS BY
AUTOPHAGIC STRESS AND IMMUNOGENIC CELL DEATH PATHWAYS
Ivones Hernándes Balmaseda, ICIMAR, La Habana, Cuba
UN NUEVO PÉPTIDO SELECTIVO DIRIGIDO A LA CASCADA JNK INHIBE LA
FERROPTOSIS NEURONAL Y PROTEGE CONTRA LA ISQUEMIA CEREBRAL EN RATAS | A
NOVEL SELECTIVE PEPTIDE TARGETING THE JNK CASCADE INHIBITS NEURONAL
P-06 (Off-line) 15:30-15:35
FERROPTOSIS AND PROTECTS AGAINST CEREBRAL ISCHEMIA IN RATS
Javier Marín Prida, PhD, Center for Research and Biological Evaluation. IFAL-UH, La Habana,
Cuba
POTENCIAL NEUROPROTECTOR DEL JM-20, UNA NUEVA MOLÉCULA HÍBRIDA
MULTIFUNCIONAL EN MODELOS IN VITRO E IN VIVO DE LA ENFERMEDAD DE
P-07 (Off-Line) 15:35-15:40 PARKINSON | NEUROPROTECTIVE POTENTIAL OF A NEW MULTITARGET HYBRID
MOLECULE, JM-20, ON IN VIVO AND IN VITRO MODELS OF PARKINSON’S DISEASE
Luis Arturo Fonseca Fonseca, MSc, CIDEM, La Habana, Cuba
EVALUACIÓN HISTOQUÍMICA DEL EFECTO ANTI-INFLAMATORIO Y NEUROPROTECTOR
DE LA FICOCIANOBILINA EN RATONES C57BL/6 CON ENCEFALOMIELITIS AUTOINMUNE
EXPERIMENTAL | HISTOCHEMICAL EVALUATION OF THE ANTI-INFLAMMATORY AND
P-08 (Off-line) 15:40-15:45 NEUROPROTECTIVE EFFECT OF PHYCOCYANOBILIN IN C57BL/6 MICE WITH
EXPERIMENTAL AUTOIMMUNE ENCEPHALOMYELITIS
Rocío Sarduy-Chávez, BSc, Center for Research and Biological Evaluation. IFAL-UH, La
Habana, Cuba
LA EXCITOXICIDAD DEL GLUTAMATO ES CONTRARRESTADA POR LA MODULACIÓN DE
LA PCB SOBRE LOS GENES DE LA VÍA REDOX | GLUTAMATE EXCITOXICITY IS
P-09 15:45-15:50
COUNTERACTED BY PCB MODULATION OF REDOX PATHWAY GENES
Majel Cervantes-Llanos, CIGB, La Habana, Cuba
EL AZUL DE METILENO REDUCE LA CARDIOTOXICIDAD INDUCIDA POR
P-10 (Off-Line) 15:50-15:55 DOXORRUBICINA EN RATAS, PERO POTENCIA SU DETERIORO CLÍNICO | METHYLENE
BLUE REDUCES DOXORUBICIN-INDUCED CARDIOTOXICITY IN RATS, BUT POTENTIATES
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxiii

THEIR CLINICAL DETERIORATION

Sofía Diego Díaz, BSc, Center for Research and Biological Evaluation. IFAL-UH, La Habana,
Cuba
OPTIMIZACIÓN DE UN MODELO MURINO NO INFECCIOSO QUE REPRODUCE LOS
SÍNTOMAS CAUSADOS POR LA COVID-19 | OPTIMIZATION OF A NON-INFECTIOUS
P-11 (Off-Line) 15:55-16:00 MOUSE MODEL THAT REPRODUCES THE SYMPTOMS CAUSED BY COVID-19
Llilian Gómez Pérez, MSc, Center for Research and Biological Evaluation. IFAL-UH, La
Habana, Cuba
MODELO EXPERIMENTAL DE INFARTO CEREBRAL HEMORRÁGICO POR LA
ADMINISTRACIÓN INTRACEREBRAL DE SANGRE AUTÓLOGA: RESULTADOS
P-12 (Off-Line) 16:00-16:05 PRELIMINARES | EXPERIMENTAL MODEL OF HEMORRHAGIC STROKE BY
INTRACEREBRAL ADMINISTRATION OF AUTOLOGOUS BLOOD: PRELIMINARY RESULTS
Claudia M Vázquez Cunil, CIGB, Mariel, Cuba
DERIVADO BENZODIAZEPÍNICO PROTEGE LAS NEURONAS HIPOCAMPALES HT-22 DE
LA MUERTE PROVOCADA POR INDUCTORES DE FERROPTOSIS | BENZODIAZEPINE
DERIVATIVE PROTECTS HT-22 HIPPOCAMPAL NEURONS FROM DEATH CAUSED BY
P-13 (Off-Line) 16:05-16:10
FERROPTOSIS INDUCERS
Daniel Álvarez Almiñaque, MSc, Center for Research and Biological Evaluation. IFAL-UH, La
Habana, Cuba
NUEVA EVIDENCIA DE LA INTERACCIÓN ENTRE LA PROTEÍNA COMMD1 Y EL PÉPTIDO
ANTITUMORAL CIGB-552 | NEW EVIDENCE OF THE INTERACTION BETWEEN THE
P-14 (Off-Line) 16:10-16:15
COMMD1 PROTEIN AND THE ANTITUMOR PEPTIDE CIGB-552
Nivaldo G. Hernández, CIGB, La Habana, Cuba
ESTUDIO DE CITOTOXICIDAD DE NANOPARTÍCULAS POLIMÉRICAS CARGADAS DE
CARPROFENO EN LÍNEA CELULAR DE RETINOBLASTOMA | CYTOTOXICITY STUDY OF
POLYMERIC NANOPARTICLES LOADING CARPROFEN IN RETINOBLASTOMA CELL LINE
P-15 (Off-line) 16:15-16:20 Alexander Parra-Coca. Department of Veterinary Medicine and Zootechnic, Faculty of
Agriculture Sciences, University of Applied and Environmental Sciences, Bogota, Colombia.
Department of Biology and Environment, University of Trás-os-Montes e Alto Douro, Vila Real,
Portugal
EVALUACIÓN CINÉTICA DE LA REDUCCIÓN DEL ESTADO DE OXIDACIÓN PLASMÁTICA Y
EN ÓRGANOS EN INFECCIONES EXPERIMENTALES CAUSADAS POR Leishmania
amazonensis EN RATONES BALB/C | KINETIC EVALUATION OF THE PLASMATIC AND
P-16 (Off-line) 16:20-16:25
ORGANS REDUCTION OXIDATION STATE IN EXPERIMENTAL INFECTION CAUSED BY
Leishmania amazonensis IN BALB/C MICE
Lillyam Betancourt Peraza, IPK, La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxiv


SALA 1930 | ROOM 1930
S2 – TECNOLOGÍA FARMACÉUTICA, COSMÉTICA Y PRODUCTOS DE LA COLMENA | PHARMACEUTICAL TECHNOLOGY,
COSMETIC AND BEES PRODUCTS
COORDINADORES | COORDINATORS: Antonio Iraizoz Colarte, PhD / Irela Pérez Sánchez, PhD / Patricia Pérez Ramos, PhD, IFAL-UH,
La Habana, Cuba
DESARROLLO, OPTIMIZACIÓN Y EVALUACIÓN DE NANOPARTÍCULAS CARGADAS CON
FLURBIPROFENO: PERMEABILIDAD CUTÁNEA EX VIVO EN TRES ESPECIES
DIFERENTES | DEVELOPMENT, OPTIMIZATION AND EVALUATION OF NANOPARTICLES
CO-12 11:00-11:10 LOADING FLURBIPROFEN: “EX VIVO” SKIN PERMEATION IN THREE DIFFERENT SPECIES
Ana C Calpena, PhD, Departamento de Farmacia y Tecnología Farmacéutica y Fisicoquímica,
Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, Barcelona,
España
MICROEMULSIONES CARGADAS CON BARICITINIB PARA LAS ENFERMEDADES
AUTOINMUNES DE LA PIEL | MICROEMULSIONS LOADING BARICITINIB FOR
AUTOIMMUNE SKIN DISEASES
CO-13 11:10- 11:20
Mireia Mallandrich, PhD, Departamento de Farmacia y Tecnología Farmacéutica y
Fisicoquímica, Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona,
Barcelona, España
DESARROLLO, INTRODUCCIÓN Y GENERALIZACIÓN DE UNA FORMULACIÓN DE
MOXIFLOXACINO 400 MG TABLETAS REVESTIDAS | DEVELOPMENT, INTRODUCTION
CO-14 11:20-11:30 AND GENERALIZATION OF A FORMULATION OF MOXIFLOXACIN 400 MG COATED
TABLETS
Adalberto Izquierdo Castro, UEB NOVATEC, Empresa MEDSOL, La Habana, Cuba
MEJORAS APLICADAS AL CONTROL DE LAS MERMAS EN EL MATERIAL DE ENVASEEN
EL LABORATORIO FARMACÉUTICO LÍQUIDOS ORALES MEDILIP | IMPROVEMENTS
CO-15 11:30-11:40 APPLIED TO THE CONTROL OF LOSSES IN THE PACKAGING MATERIAL IN THE MEDILIP
ORAL LIQUID PHARMACEUTICAL LABORATORY
Antonio Iraizoz Colarte, PhD, IFAL-UH, La Habana, Cuba
VALIDACIÓN DEL SISTEMA DE AIRE COMPRIMIDO DE LA EMPRESA DE SUEROS Y
PRODUCTOS HEMODERIVADOS ADALBERTO PESANT DE BIOCUBAFARMA | VALIDATION
CO-16 11:40-11:50 OF THE COMPRESSED AIR SYSTEM OF THE ADALBERTO PESANT SERUM AND BLOOD
PRODUCTS COMPANY OF BIOCUBAFARMA
María Aurora Barrios, PhD, IFAL-UH, La Habana, Cuba
ESTUDIO DE ESTABILIDAD DE LA PROTEÍNA RECOMBINANTE DEL DOMINIO DE UNIÓN
AL RECEPTOR DEL VIRUS SARS-COV-2 | STABILITY STUDY OF THE RECOMBINANT
CO-17 11:50-12:00
PROTEIN OF THE RECEPTOR BINDING DOMAIN OF THE SARS-COV-2 VIRUS
Ángela Fidalgo Maceo, CIGB, La Habana, Cuba
LOS COSMÉTICOS EN CUBA: OPORTUNIDADES Y DESAFÍOS | COSMETICS IN CUBA:
CO-18 12:00-12:10 OPPORTUNITIES AND CHALLENGES
Patricia Pérez Ramos, PhD, IFAL-UH, La Habana, Cuba
LAS CIENCIAS COSMÉTICAS EN EL INSTITUTO DE FARMACIA Y ALIMENTOS.
DESARROLLO Y POTENCIALIDADES | COSMETIC SCIENCES AT THE INSTITUTE OF
CO-19 12:10-12:20
PHARMACY AND FOOD. DEVELOPMENT AND POTENTIALITIES
Irela Pérez Sánchez, PhD, IFAL-UH, La Habana, Cuba
COSMÉTICOS NATURALES ARTESANALES EN CUBA | NATURAL HANDMADE
CO-20 12:20-12:30 COSMETICS IN CUBA
Milena Díaz, PhD, IFAL-UH, La Habana, Cuba
DESARROLLO DE UN JABÓN DERMOCOSMÉTICO A BASE DE PROPÓLEOS Y MIEL |
CO-21 12-30-12:40 DEVELOPMENT OF A DERMOCOSMETIC SOAP WITH PROPOLIS AND HONEY
Diego Arnaldo Guamán Anilema, Prophar SA, Ecuador
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxv


SALA 1930 | ROOM 1930
COORDINADORES | COORDINATORS: Antonio Iraizoz Colarte, PhD / Irela Pérez Sánchez, PhD, IFAL-UH, La Habana, Cuba / Patricia
Pérez Ramos, PhD, IFAL-UH, La Habana, Cuba
DISEÑO DE UN SERUM FACIAL CON PRODUCTOS DE LA COLMENA Y ALOE VERA |
P-17 12:50-12:55 DESIGN OF A FACIAL SERUM WITH BEE PRODUCTS AND ALOE VERA
Laura C Amado, IFAL-UH, La Habana, Cuba
FORMULACIÓN Y ESTABILIDAD DE CUATRO CREMAS ELABORADAS CON PRODUCTOS
DE LA COLMENA | FORMULATION AND STABILITY STUDY OF FOUR CREAMS MADE WITH
P-18 12:55-13:00
BEE PRODUCTS
Dámarys Suárez Gómez, MSc, Centro de Investigaciones Apícolas (CIAPI), Cuba
DESARROLLO DE SHAMPOOS LIBRE DE SAL PARA CABELLOS TRATADOS Y DAÑADOS |
P-19 13:00-13:05 DEVELOPMENT OF SALT-FREE SHAMPOOS FOR TREATED AND DAMAGED HAIR
Marietta Navarro Gómez, Suchel Camacho, La Habana, Cuba
NUEVA MATERIA PRIMA BENTONITA-ÁCIDO L-ASCÓRBICO: CARACTERIZACIÓN Y
APLICACIONES DERMOCOSMÉTICAS | NEW RAW MATERIAL BENTONITE L-ASCORBIC
P-20 13:05-13:10
ACID: CHARACTERIZATION AND DERMOCOSMETIC APPLICATIONS
Anaela Montalvo León, IFAL-UH, La Habana, Cuba
DESARROLLO TECNOLÓGICO Y ESTUDIO DE ESTABILIDAD DE TABLETAS REVESTIDAS
DE RITONAVIR 100 MG | TECHNOLOGICAL DEVELOPMENT AND STABILITY STUDY OF
P-21 13:10-13:15
RITONAVIR 100 MG COATED TABLETS
Antonio Iraizoz Barrio, CIDEM, La Habana, Cuba
VERIFICACIÓN DEL MÉTODO DE CONTEO MICROBIANO UTILIZADO EN EL ENSAYO DE
EFECTIVIDAD DE PRESERVOS DE ABDALA: CANDIDATO VACUNAL CONTRA EL VIRUS
SARS-COV-2 POR VÍA INTRAMUSCULAR MULTIDOSIS | VERIFICATION OF THE
P-22 13:15-13:20 MICROBIAL COUNTING METHOD USED IN THE EFFECTIVENESS TRIAL OF ABDALA
PRESERVES: VACCINE CANDIDATE AGAINST SARS-COV-2 VIRUS BY INTRAMUSCULAR
ROUTE MULTIDOSE
Dayana Rodríguez Benítez, CIGB, La Habana, Cuba
DESARROLLO TECNOLÓGICO DE GOTAS OFTÁLMICAS DE MOXIFLOXACINA AL 0.5% |
P-23 13:20-13:25 TECHNOLOGICAL DEVELOPMENT OF MOXIFLOXACIN EYE DROPS AT 0.5%
Ania González Cortezón, CIDEM, La Habana, Cuba
DESARROLLO DEL INYECTABLE BICLOFEN | DEVELOPMENT OF BICLOFEN® INJECTION
P-24 13:25-13:30
Manuel Alejandro Rivas, AICA, La Habana, Cuba
DISEÑO Y OPTIMIZACIÓN DE UN GEL DE DICLOFENACO AL 1% COMO UN ANALGÉSICO
Y ANTINFLAMATORIO DE USO TÓPICO | DESIGN AND OPTIMIZATION OF DICLOFENAC
P-25 13:30-13:35
GEL 1 %, AS AN ANALGESIC AND ANTI-INFLAMMATORY FOR TOPICAL USE
Nilia de la Paz Martín-Viaña, PhD, CIDEM, La Habana, Cuba
ESTABILIDAD EN USO DE LA PRESENTACIÓN MULTIDOSIS DE LA VACUNA ABDALA | IN
P-26 13:35-13:40 USE STABILITY OF THE MULTIDOSE PRESENTATION OF THE ABDALA VACCINE
Gerardo García Illera, CIGB, La Habana, Cuba
INYECTABLES LIOFILIZADOS OMEPRAZOL Y VANCOMICINA: EVALUACIÓN DE LA
HOMOGENEIDAD DEL SECADO | LYOPHILIZED INJECTABLE OMEPRAZOLE AND
P-27 13:40-13:45
VANCOMYCIN: EVALUATION OF THE HOMOGENEITY OF DRYING
Laura Martínez Torres, AICA, La Habana, Cuba
DESARROLLO TECNOLÓGICO DEL CROMOLÍN SÓDICO 4%, GOTAS NASALES |
P-28 13:45-13:50 TECHNOLOGICAL DEVELOPMENT OF CROMOLYN SODIUM 4%, NASAL DROPS
Gisela Ramírez Torres, AICA, La Habana, Cuba
DESARROLLO DE LA INYECCIÓN DE CLORHIDRATO DE IRINOTECÁN | DEVELOPMENT
P-29 15:00-15:05 OF IRINOTECAN HYDROCHLORIDE INJECTION
Yusimi Izquierdo Roque, AICA, La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxvi

DESARROLLO FARMACÉUTICO DE LA FORMULACIÓN BIOCEN-128 EN GOTAS NASALES

MULTIDOSIS PARA EL TRATAMIENTO DE LA ENFERMEDAD DE ALZHEIMER |
P-30 15:05-15:10 PHARMACEUTICAL DEVELOPMENT OF THE BIOCEN-128 FORMULATION IN MULTIDOSE
NASAL DROPS FOR THE ALZHEIMER'S DISEASE TREATMENT
Sachy Rodríguez, BioCen, Mayabeque, Cuba
ESTUDIO DE ESTABILIDAD DE UN NUEVO PRODUCTO CITOSTÁTICO DE PRODUCCIÓN
NACIONAL, GEMCITABINA | STABILITY STUDY OF A NEW CYTOSTATIC PRODUCT OF
P-31 15:10-15:15
NATIONAL PRODUCTION, GEMCITABINE
Yusimí Tusell, AICA, La Habana, Cuba
DESARROLLO DE UN NUEVO PRODUCTO CITOSTÁTICO DE PRODUCCIÓN NACIONAL,
GEMCITABINA | DEVELOPMENT OF A NEW CYTOSTATIC OF NATIONAL PRODUCTION,
P-32 15:15-15:20
GEMCITABINE
Yenilen Troche, AICA, La Habana, Cuba
NUEVA FORMULACIÓN DE SALBUTAMOL 0.5 % SOLUCIÓN PARA NEBULIZACIÓN | NEW
P-33 15:20-15:25 FORMULATION OF SALBUTAMOL SOLUTION AT 0.5% FOR NEBULIZATION
Carlos Rafael Romeu Carballo, AICA, La Habana, Cuba
INCORPORATION OF L-ASCORBIC ACID INTO A NATURAL BENTONITE: AN ALTERNATIVE
P-34 (Off-line) 15:25-15:30 TO PRESERVE ITS ANTIOXIDANT EFFECTS
Dayaris Hernández, IMRE-UH, La Habana, Cuba
ELABORACIÓN DE UN BIOFORTALECEDOR DEL CABELLO CON TEJIDO RESIDUAL DE
PLACENTA HUMANA | DEVELOPMENT OF A HAIR GROWTH STIMULATING LOTION WITH
P-35 (Off-line) 15:30-15:35
RESIDUAL TISSUE FROM THE HUMAN PLACENTA
Yadira González, Centro de Histoterapia Placentaria (HISPLACEN), Cuba
EXPERIENCIAS EN EL CONTROL DE CALIDAD DE LA FORMACIÓN DE PELÍCULAS DE
CLORURO DE POLIVINILO DEL MATERIAL DE ENVASE PARA LA PROTECCIÓN DE LA LUZ
EN BLISTERS DE TABLETAS | EXPERIENCES IN THE QUALITY CONTROL OF FORMING
P-36 (Off-line) 15:35-15:40
FILMS OF POLYVINYL CHLORIDE PACKAGING MATERIAL FOR LIGHT PROTECTION IN
BLISTER PACK TABLETS
Ofelia Fariñas Suárez, SolMed, Empresa Laboratorios MedSol, La Habana, Cuba
INFLUENCIA DE CONDICIONES DE ESTRÉS SOBRE LA ESTABILIDAD DE TABLETAS DE
METFORMINA 500 MG | INFLUENCE OF STRESS CONDITIONS ON METFORMIN-500 MG
P-37 (Off-line) 15:40-15:45
TABLETS STABILITY
Taymí Díaz Rodríguez, SolMed, Empresa Laboratorios MedSol, La Habana, Cub
DESARROLLO FARMACÉUTICO DE LAS NUEVAS VACUNAS ANTIALÉRGICAS DIVALER-SL
Y TRIVALER-SL PARA LA INMUNOTERAPIA SUBLINGUAL | PHARMACEUTICAL
P-38 (Off-Line) 15:45:15:50 DEVELOPMENT OF NEW DIVALENT AND TRIVALENT ANTI-ALLERGY VACCINES FOR
SUBLINGUAL IMMUNOTHERAPY
Wendy Ramírez, BioCen, Mayabeque, Cuba
LAMOTRIGINA-100 MG, SU INTRODUCCIÓN EN UNA ESCALA INDUSTRIAL |
P-39 (Off-Line) 15:50-15:55 LAMOTRIGINE-100 MG, ITS INTRODUCTION ON AN INDUSTRIAL SCALE
Beatriz Colomina Bécquer, SolMed, Empresa Laboratorios MedSol, La Habana, Cuba
DETERMINACIÓN DEL HLBN EN EL EXTRACTO LIPÍDICO DE LAS SEMILLAS DE
CURCUBITA PEPO | DETERMINATION OF HLBN OF THE LIPID EXTRACT OF CUCURBITA
P-40 (Off-Line) 16:55-16:00
PEPO SEEDS
José Raúl Pérez-Mora, CIDEM, La Habana, Cuba
DESARROLLO FARMACÉUTICO DE UNA VACUNA DE SEGUNDA GENERACIÓN CONTRA
LA ALERGIA, PROLINEM-BT | PHARMACEUTICAL DEVELOPMENT OF A SECOND
P-41 (Off-Line) 16:00-16:05
GENERATION ANTI-ALERGIC VACCINE, PROLINEM-BT
Mayteé Mateo, BioCen, Mayabeque, Cuba
NANOPARTÍCULAS DE PLGA PARA CARGAR DERIVADO DE FLAVANONA PARA ESTUDIO
DE PERMEABILIDAD TRANSDÉRMICA EN PIEL HUMANA | PLGA NANOPARTICLES
LOADING DERIVATIVE FLAVANONE FOR TRANSDERMAL HUMAN SKIN PERMEATION
P-42 (Off-Line) 16:05-16:10
STUDY
Paola Bustos-Salgado, Departamento de Farmacia y Tecnología Farmacéutica y
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxvii

Barcelona, España
LIPOSOMAS DE BARICITINIB COMO NUEVO ENFOQUE PARA EL TRATAMIENTO DEL
SÍNDROME DE SJÖRGEN | BARICITINIB LIPOSOMES AS A NEW APPROACH FOR THE
P-43 (Off-Line) 16:10-16:15 TREATMENT OF SJÖRGEN’S SYNDROME
Núria Garrós, Departamento de Farmacia y Tecnología Farmacéutica y Fisicoquímica, Facultad
de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, Barcelona, España
EFFECTO DE MICROAGUJAS EN LA PERMEABILIDAD DEL BARICITINIB EN LA PIEL
HUMANA | EFFECT OF MICRONEEDLES IN THE PERMEATION OF BARICITINIB IN HUMAN
SKIN
P-44 (Off-Line) 16:15-16:20
Roya Mohammadi Meyabadi, Departamento de Farmacia y Tecnología Farmacéutica y
Barcelona, España
ACTIVIDAD ANTIBACTERIANA DE CREMI-GEL DE CLINDAMICINA Y METRONIDASOL
PARA EL TRATAMIENTO DE LA ROSACEA | BACTERIAL INHIBITORY ACTION OF
CLINDAMYCIN AND METRONIDAZOLE CREMI-GEL FOR THE TREATMENT OF ROSACEA
P-45 (Off-Line) 16:20-16:25
Guillermo de Grau, Departamento de Farmacia y Tecnología Farmacéutica y Fisicoquímica,
España
DESARROLLO DE MICROEMULSIONES PARA LA CARGA DE UN INMUNOMODULADOR
PARA EL TRATAMIENTO DE ENFERMEDADES INFLAMATORIAS DE LA PIEL |
DEVELOPMENT OF MICROEMULSIONS LOADING AN IMMUNOMODULATOR FOR THE
P-46 (Off-Line) 16:25-16:30 TREATMENT OF SKIN INFLAMMATORY DISEASES
Marc Soriano-Ramírez, Departamento de Farmacia y Tecnología Farmacéutica y
Barcelona, España
EVALUACIÓN DE LA ABSORCIÓN TRANSDÉRMICA DE SOLUCIONES DE BARICITINIB
ENRIQUECIDAS CON POTENCIADORES DE LA PERMEABILIDAD | EVALUATION OF THE
TRANSDERMAL ABSORPTION OF BARICITINIB SOLUTIONS ENRICHED WITH
P-47 (Off-Line) 16:30-16:35 PERMEATION ENHANCERS
Negar Beirampour, Departamento de Farmacia y Tecnología Farmacéutica y Fisicoquímica,
España
TRANSPORTADORES LIPÍDICOS NANOESTRUCTURADOS CARGADOS CON ÁCIDO
PROPANOICO 2-(5H-CHROMENO[2,3-B] PYRIDIN-7-YL) Y SUS EVALUACIONES EX-VIVO
EN DIFERENTES MUCOSAS | 2-(5H-CHROMENO[2,3-B] PYRIDIN-7-YL) PROPANOIC ACID
LOADED NANOSTRUCTURED LIPID CARRIERS AND THEIR EX VIVO EVALUATION IN
P-48 (Off-Line) 16:35-16:40
DIFFERENT MUCOSAE
Negar Ahmadi, Departamento de Farmacia y Tecnología Farmacéutica y Fisicoquímica,
España
CARACTERIZACIÓN Y LIBERACIÓN DE UN GEL DE ALGINATO RETICULADO CON
PROPIEDADES ANTIINFLAMATORIAS | CHARACTERIZATION AND RELEASE OF A CROSS-
LINKED ALGINATE GEL WITH ANTI-INFLAMMATORY PROPERTIES
P-49 (Off-Line) 16:40-16:45
Cristina Silva Baladrón, Departamento de Farmacia y Tecnología Farmacéutica y
Barcelona, España
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxviii

MIÉRCOLES 23 NOVEMBER | WEDNESDAY, NOVEMBER 23

SALA PARISIEN | ROOM PARISIEN
S3 - CONTROL Y ASEGURAMIENTO DE LA CALIDAD | QUALITY CONTROL AND ASSURANCE
COORDINADORES | COORDINATORS: Yania Suárez Pérez, PhD / Mirna Fernández-Cervera, PhD / Amelié González Atá, MSc /
Yolexis Tamayo García, MSc, IFAL-UH, La Habana, Cuba
IMPACTO DE ICH Q14 SOBRE LA VALIDACIÓN DE LOS MÉTODOS ANALÍTICOS | IMPACT
CO-22 11:00-11:10 OF ICH Q14 ON ANALYTICAL METHODS VALIDATION
Yania Suárez Pérez, PhD, IFAL-UH, La Habana, Cuba
CALIDAD BIOFARMACÉUTICA DE TABLETAS DE ATENOLOL 100 mg |
CO-23 11:10- 11:20 BIOPHARMACEUTICAL QUALITY OF ATENOLOL TABLETS 100 mg
Mirna Fernández-Cervera, PhD, IFAL-UH, La Habana, Cuba
DESARROLLO DE UN MÉTODO CROMATOGRÁFICO PRUEBA LÍMITE PARA PRODUCTOS
DE DEGRADACIÓN EN TABLETAS DE NITRAZEPAM | DEVELOPMENT OF A LIMIT TEST
CO-24 11:20-11:30 CHROMATOGRAPHIC METHOD FOR DEGRADATION PRODUCTS IN NITRAZEPAM
TABLETS
Yenisé Elledíaz, SolMed, Empresa Laboratorios MedSol, La Habana, Cuba
DESARROLLO DE UN MÉTODO ANALITICO PARA LA CUANTIFICACIÓN DE DICLOFENACO
DE SODIO, METIL Y PROPILPARABENOS POR CROMATOGRAFÍA LÍQUIDA DE ALTA
RESOLUCIÓN | DEVELOPMENT OF THE ANALYTICAL METHODS FOR THE
CO-25 11:30-11:40
QUANTIFICATION OF DICLOFENAC SODIUM, METHYL AND PROPYL-PARABENS BY HIGH
PERFORMANCE LIQUID CHROMATOGRAPHY
Caridad M García-Peña, PhD, CIDEM, La Habana, Cuba
VALIDACIÓN DE LOS PROCESOS DE TRANSFERENCIA DE TECNOLOGÍAS. APLICACIÓN
A LA FABRICACIÓN DE JUSVINZA | VALIDATION OF THE TECHNOLOGY TRANSFER
CO-26 11:40-11:50
PROCESSES: APPLICATION TO THE MANUFACTURE OF JUSVINZA
Alicia M. Terry García, BioCen, Mayabeque, Cuba
DISEÑO, DESARROLLO Y GENERALIZACION EN CUBA DEL PRIMER MEDIO DE
TRANSPORTE PARA VIRUS EN LA CONFIRMACIÓN DEL DIAGNÓ\STICO DE COVID-19 |
CO-27 11:50-12:00 DESIGN, DEVELOPMENT AND GENERALIZATION IN CUBA OF THE FIRST TRANSPORT
MEDIUM FOR VIRUSES ON THE CONFIRMATORY DIAGNOSIS OF COVID-19
Marilyn Díaz Pérez, BioCen, Mayabeque, Cuba
GESTIÓN DE LA BIOSEGURIDAD EN PROYECTOS BIOTECNOLÓGICOS EN EL CONTEXTO
DE LA COVID-19 | BIOSAFETY MANAGEMENT IN BIOTECHNOLOGICAL PROJECTS IN THE
CO-28 12:00-12:10
CONTEXT OF COVID-19
María del Rosario Alemán, CIGB, La Habana, Cuba
DISEÑO DE UN MODELO DE GESTIÓN “A MEDIDA” PARA LA CADENA DE FRÍO DE
EMCOMED | DESIGN OF A "CUSTOMIZED" MANAGEMENT MODEL FOR EMCOMED'S
CO-29 12:10-12:20
COLD CHAIN
Diana G. García, EMCOMED, La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxix

MIÉRCOLES 23 NOVEMBER | WEDNESDAY, NOVEMBER 23

COORDINADORES | COORDINATORS: Yania Suárez Pérez, PhD / Mirna Fernández-Cervera, PhD / Amelié González Atá, MSc /
Yolexis Tamayo García, MSc, IFAL-UH, La Habana, Cuba
EXCURSIONES DE TEMPERATURA EN LA IMPORTACIÓN DE PRODUCTOS
TERMOSENSIBLES POR AIRE | TEMPERATURE EXCURSIONS IN THE IMPORTATION OF
P-50 12:30-12:35
THERMOSENSIBLE PRODUCTS BY AIR
Tania Calderón Villacampa, EMCOMED, La Habana, Cuba
ESTUDIO DE ESTABILIDAD DE LA SOLUCIÓN DE COOMASSIE BASADA EN LA
APLICACIÓN DE HERRAMIENTAS ESTADÍSTICAS | STABILITY STUDY OF THE
P-51 12:35-12:40
COOMASSIE SOLUTION BASED ON THE APPLICATION OF STATISTICAL TOOLS
Inalvis Herrera. CIGB, La Habana, Cuba
EVALUACIÓN DE LA ESTABILIDAD DEL INGREDIENTE FARMACÉUTICO ACTIVO DE LA
FORMULACIÓN BIO-CEN-128 | ESTABILITY EVALUATION OF THE ACTIVE
P-52 12:40-12:45
PHARMACEUTICAL INGREDIENT FROMF THE BIOCEN-128 FORMULATION
Nashelly Esquivel Crespo, BioCen, Mayabeque, Cuba
MEJORAS EN LA PURIFICACIÓN DE ANTICUERPOS POLICLONALES ANTI DER S1 |
P-53 12:45-12:50 IMPROVEMENTS IN THE ANTI DER S1 POLICLONAL ANTIBODIES PURIFICATION
Yarelis Martínez, BioCen, Mayabeque, Cuba
CALIDAD DE LA DOCUMENTACIÓN DE ENSAYOS CLÍNICOS AUDITADOS POR EL
CENCEC DURANTE LA COVID-19 | QUALITY OF CLINICAL TRIALS DOCUMENTATION
P-54 12:50-12:55
AUDITED BY CENCEC DURING COVID-19
Rosabel Mollineda Alvaré, CENCEC, La Habana, Cuba
GESTION DE RIESGOS RELACIONADOS A LA INTRODUCCIÓN DEL PROCESO DE
MANUFACTURA DEL INGREDIENTE FARMACÉUTICO ACTIVO DE PROTEINAS
INMUNOGÉNICAS AL SISTEMA PRODUCTIVO | RISK- MANAGEMENT RELATED TO THE
P-55 12:55-13:00
INTRODUCTION OF THE MANUFACTURING PROCESS OF ACTIVE PHARMACEUTICAL
INGREDIENT OF IMMUNOGENIC PROTEIN AT THE PRODUCTION SYSTEM
Isabel Apezteguía, CIGB, La Habana, Cuba
ANÁLISIS DE FALLAS DE PROBLEMAS ENCONTRADOS EN BIOPROCESOS | FAILURE
P-56 13:00-13:05 ANALYSIS OF PROBLEMS FOUND IN BIOPROCESSES
Lázaro Cervetto de Armas, CIGB, La Habana, Cuba
BRECHAS Y OPORTUNIDADES DE MEJORA EN LA REVISIÓN DE LA CALIDAD DEL
PRODUCTO EN NOVATEC | GAPS AND OPPORTUNITIES FOR IMPROVEMENT IN THE
P-57 13:05-13:10
PRODUCT QUALITY REVIEW AT NOVATEC
Helen González Abreu, NOVATEC, La Habana, Cuba
DESARROLLO DE METODOLOGÍAS ANALÍTICAS PARA LA CUANTIFICACIÓN DE
TABLETAS AMBROXOL-30 | DEVELOPMENT OF ANALYTICAL METHODOLOGIES FOR THE
P-58 13:10-13:15
QUANTIFICATION OF AMBROXOL-30 TABLETS
Renny Small Laza, SolMed, Empresa Laboratorios MedSol, La Habana, Cuba
DESARROLLO DE LA TÉCNICA ANALÍTICA PARA LA DETERMINACIÓN DE LA RELACIÓN
SULFATO/CARBOXILATO EN MATERIAS PRIMAS DE ENOXAPARINA SÓDICA |
P-59 13:15-13:20 DEVELOPMENT OF THE ANALYTICAL TECHNIQUE FOR DETERMINATION OF THE
SULFATE/CARBOXYLATE RATIO IN RAW MATERIALS OF SODIUM ENOXAPARIN
Jorge Luis Santana Tolosa, AICA, La Habana, Cuba
VALIDACIÓN DE UN MÉTODO ANALÍTICO PARA DETERMINAR LA ESTABILIDAD EN USO
DEL INYECTABLE DOCETAXEL-10 mg/mL | VALIDATION OF AN ANALYTICAL METHOD TO
P-60 13:20-13:25
DETERMINE THE STABILITY IN USE OF THE INJECTABLE DOCETAXEL-10 mg/mL
Thais Valdés Parra, AICA, La Habana, Cuba
VALIDACIÓN DE DOS MÉTODOS ANALITICOS PARA EL REGISTRO DE UN NUEVO
P-61 15:05-15:10
CITOSTÁTICO DE PRODUCCIÓN NACIONAL, GEMCITABINA | VALIDATION OF TWO
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxx

ANALYTICAL METHODS FOR THE REGISTRATION OF A NEW CYTOSTATIC PRODUCT OF

NATIONAL PRODUCTION, GEMCITABINE
Ada Esperanza Inguanzo, AICA, La Habana, Cuba
VALIDACIÓN DEL MÉTODO ANALÍTICO PARA CONTROL DE LA CALIDAD DE LA
ENROFLOXACINA EN SOLUCIÓN INYECTABLE | VALIDATION OF AN ANALYTICAL
P-62 15:10-15:15
METHOD FOR THE QUALITY CONTROL OF ENROFLOXACIN IN INJECTABLE SOLUTION
Maybel González Mirabal. IFAL-UH, La Habana, Cuba
VALIDACIÓN DE LA TÉCNICA SDS-PAGE PARA LA DETERMINACIÓN DEL CONTENIDO DE
PROTEÍNAS EN LAS MPAS DESGRASADAS E IFAS CONCENTRADOS DE LAS VACUNAS
DIVALER-SL Y TRIVALER-SL | VALIDATION OF SDS-PAGE TECHNIQUE FOR PROTEINS
P-63 15:15-15:20
CONCENTRATION DETERMINATION IN MPAS AND IFAS FROM DIVALER AND TRIVALER
VACCINES
Anette García, BioCen, Mayabeque, Cuba
ESTABLECIMIENTO Y VALIDACIÓN DE LA TECNICA ANALITICA MICROLOWRY PARA LA
CUANTIFICACION DE PROTEINAS TOTALES | ESTABLISHMENT AND VALIDATION OF THE
P-64 15:20-15:25 MICROLOWRY ANALYTICAL TECHNIQUE FOR THE QUANTIFICATION OF TOTAL
PROTEINS
Sheila Padrón Morales, CIGB, La Habana, Cuba
VALIDACIÓN DE DOS MÉTODOS ANALÍTICOS PARA LA DETERMINACIÓN DE LA PUREZA
del Heberprot-P | VALIDATION OF TWO ANALYTICAL METHODS FOR THE
P-65 15:25-15:30
DETERMINATION OF Heberprot-P PURITY
Maylin La O, CIGB, La Habana, Cuba
VENTAJAS DEL ESTABLECIMIENTO Y VALIDACIÓN DE UN ENSAYO ALTERNATIVO DE
INMUNOMODULACIÓN PARA LA DETERMINACIÓN DE LA POTENCIA IN VITRO DEL
HeberFERON® | ADVANTAGES OF ESTABLISHING AND VALIDATING AN ALTERNATIVE
P-66 15:30-15:35
IMMUNOMODULATORY ASSAY FOR THE DETERMINATION OF THE IN VITRO POTENCY
OF HeberFERON®
Luisa G. Silega-Coma, CIGB, La Habana, Cuba
VALIDACIÓN DE LA TÉCNICA DE ELECTROFORESIS EN GEL DE POLIACRILAMIDA PARA
LA SEPARACIÓN Y CONTROL DEL INGREDIENTE FARMACÉUTICO ACTIVO RBD |
P-67 15:35-15:40 VALIDATION OF THE POLYACRYLAMIDE GEL ELECTROPHORESIS TECHNIQUE FOR THE
SEPARATION AND CONTROL OF THE RBD ACTIVE PHARMACEUTICAL INGREDIENT
Osniel Cabrera Díaz, CIGB, La Habana, Cuba
VALIDACIÓN TOTAL DE UN ELISA PARA LA CUANTIFICACIÓN DEL DOMINIO DE UNIÓN AL
RECEPTOR EN LOTES DE INGREDIENTE FARMACÉUTICO ACTIVO Y EL PRODUCTO
TERMINADO ABDALA | TOTAL VALIDATION OF AN ELISA FOR THE QUANTIFICATION OF
P-68 15:40-15:45
THE RECEPTOR BINDING DOMAIN IN BATCHES OF ACTIVE PHARMACEUTICAL
INGREDIENT AND ABDALA FINISHED PRODUCT
Yurisleydis Aldama Casas, CIGB, La Habana, Cuba
ESTABLECIMIENTO Y DEMOSTRACIÓN DE LA ADECUABILIDAD Y DESEMPEÑO DE LA
TECNICA ANALÍTICA MICROBIURET EN PLACAS DE 96 POCILLOS PARA DCUANTIFICAR
PROTEINAS TOTALES | ESTABLISHMENT AND DEMONSTRATION OF THE SUITABILITY
P-69 15:45-15:50
AND PERFORMANCE OF THE MICROBIURET ANALYTICAL TECHNIQUE IN 96-WELL
PLATES FOR THE QUANTIFICATION OF TOTAL PROTEINS
Danaydis Fonseca, CIGB, La Habana, Cuba
VALIDACIÓN DE UNA TÉCNICA DE ACTIVIDAD BIOLÓGICA PARA EL PRODUCTO
TERMINADO NASALFERON | VALIDATION OF A BIOLOGICAL ACTIVITY TECHNIQUE FOR
P-70 15:50-15:55
THE FINISHED PRODUCT NASALFERON
Yusnielis Bustamante Pérez, CIGB, La Habana, Cuba
VALIDACIÓN DE LA TECNICA POR CROMATOGRAFÍA EN FASE REVERSA PARA LA
IDENTIFICACIÓN DEL PEPTIDO GHRP-6 EN LA FORMULACION DE ACUABIO V |
P-71 15:55-16:00 VALIDATION OF THE REVERSE PHASE CHROMATOGRAPHY TECHNIQUE FOR THE
IDENTIFICATION OF THE GHRP-6 PEPTIDE IN THE FORMULATION OF ACUABIO V
Maelys Miyares Estrada, CIGB, La Habana, Cuba
P-72 16:00-16:05 VALIDACIÓN DE LAS ETAPAS DE RENATURALIZACIÓN E INTERCAMBIO IÓNICO EN LA
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxi

PURIFICACIÓN DEL INTERFERÓN GAMMA HUMANO RECOMBINANTE | VALIDATION OF

THE RENATURALIZATION AND ION EXCHANGE STEPS IN THE PURIFICATION OF
RECOMBINANT HUMAN GAMMA INTERFERON
Yanara García Martínez, CIGB, La Habana, Cuba
CARACTERIZACIÓN Y CERTIFICACIÓN DE UN MATERIAL DE REFERENCIA PARA EL
PÉPTIDO CIGB 814 USADO EN LA LIBERACIÓN DE JUSVINZA | CHARACTERIZATION AND
P-73 16:05-16:10 CERTIFICATION OF THE REFERENCE MATERIAL FOR THE CIGB 814 PEPTIDE USED IN
THE RELEASE OF THE JUSVINZA
Cristina Rodríguez, CIGB, La Habana, Cuba
DETERMINACIÓN DEL PUNTO ISOELÉCTRICO DEL MATERIAL DE REFERENCIA RBD
PARA LA LIBERACIÓN DE LAS MUESTRAS DE IFA DE LOS CANDIDATOS VACUNALES
CONTRA LA COVID-19 | DETERMINATION OF THE ISOELECTRIC POINT OF THE RBD
P-74 16:10-16:15
REFERENCE MATERIAL FOR THE RELEASE OF THE IFA SAMPLES OF THE VACCINE
CANDIDATE AGAINST COVID-19
Raydan Lemus Galvez, CIGB, La Habana, Cuba
DETERMINACIÓN DE LA PROTEÍNA LIBRE DE TOXOIDE TETÁNICO PRESENTE EN EL IFA
DE LA VACUNA HAEMOPHILUS INFLUENZAE TIPO B (HIB), MEDIANTE SDS-PAGE CON
GRADIENTE DE ACRILAMIDA | DETERMINATION OF THE FREE TETANUS TOXOID
P-75 16:15-16:20
PROTEIN, PRESENT IN THE IFA OF THE HAEMOPHILUS INFLUENZAE TYPE B (HIB)
VACCINE, BY SDS-PAGE WITH ACRYLAMIDE GRADIENT
Mareysis Ruiz Pérez, CIGB, La Habana, Cuba
COMPARABILIDAD FISICO QUIMICA DE P3R99 MAB PRODUCIDO EN TRES LINEAS
CELULARES DIFERENTES | PHYSICOCHEMICAL COMPARABILITY OF P3R99 MAB
P-76 16:20-16:25
PRODUCED IN THREE DIFFERENT CELL LINES
Yoandra M. Montano, CIM, La Habana, Cuba
EVALUACIÓN FÍSICO QUÍMICA DEL POOL DE ACEITE DE HIGADO DE TIBURON |
P-77 (Off-line) 16:25-16:30 PHYSICAL-CHEMICAL EVALUATION OF THE SHARK LIVER POOL OIL
Juan A. Pérez Carrasco, Centro de Inmunoensayos (CIE), La Habana, Cuba
DESARROLLO DE UN NUEVO MEDIO ALTERNATIVO DE TRANSPORTE VIRAL PARA EL
DIAGNÓSTICO DEL SARS-COV-2 | DEVELOPMENT OF A NEW ALTERNATIVE VIRAL
P-78 (Off-line) 16:30-16:35
TRANSPORT MEDIUM FOR THE DIAGNOSIS OF SARS-COV-2
Diana Rosa Viera Oramas, BioCen, Mayabeque, Cuba
GESTIÓN DE LA DOCUMENTACIÓN DE PRODUCTOS NASALES DERIVADOS DE
PROTEINAS RECOMBINANTES | DOCUMENTATION MANAGEMENT FOR NASAL
P-79 (Off-Line) 16:35-16:40
PRODUCTS DERIVED TO RECOMBINANT PROTEINS
Nubia González, CIGB, La Habana, Cuba
P-80 (Off-Line) PROPUESTA DE MEJORAS AL SERVICIO DE MUESTREO DE MATERIAS PRIMAS
FARMACÉUTICAS EN LA UEB SUMINISTROS FARMACÉUTICOS | IMPROVEMENT TO THE
16:40-16:45 STARTING MATERIAL´S SAMPLING SERVICE AT THE PHARMACEUTICAL SUPPLY
DISTRIBUTION CENTER
Agnieska Almeida Hernández, EMCOMED, La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxii

JUEVES 24 NOVIEMBRE | THURSDAY, NOVEMBER 24

7:00-8:55 Acreditación de delegados | Registration of delegates. SALA 1930 | ROOM 1930
SALA 1930 | ROOM 1930
DISEÑO MOLECULAR Y EVALUACIÓN DE LAS VACUNAS SOBERANA 02 Y SOBERANA
PLUS | MOLECULAR DESIGN AND EVALUATION OF SOBERANA 02 AND SOBERANA PLUS
CP-03 9:00-9:30
VACCINES
Sonsire Fernández Castillo, PhD, Instituto Finlay de Vacunas, La Habana, Cuba
SEGURIDAD ALIMENTARIA Y NUTRICIONAL. MARCO DE REFERENCIA Y APLICACIÓN |
CP-04 9:30-10:00 FOOD AND NUTRITIONAL SECURITY. REFERENTIAL FRAMEWORK AND APPLICATION
María Isabel Lantero, PhD, IFAL-UH, La Habana, Cuba
10:00-10:30 TRANSMISIÓN DE RESISTENCIA A LOS ANTIMICROBIANOS A TRAVÉS DE LOS
CP-05 ALIMENTOS | TRANSMISSION OF ANTIMICROBIAL RESISTANCE THROUGH FOOD
Yamila Puig, PhD, INHEM, La Habana, Cuba
10:30-11:00 RECESO | COFFEE BREAK
PRESENTATIONS (PO)
15:00-17:00
PRESENTATIONS (POL)
S4 - PLANTAS MEDICINALES - PRODUCTOS NATURALES-QUÍMICA MEDICINAL | MEDICINAL PLANTS - NATURAL PRODUCTS-
MEDICINAL CHEMISTRY
COORDINADORES | COORDINATORS: Yamilet Irene Gutiérrez Gaitén, PhD, IFAL-UH / Raiza Mangas Marín, PhD, IFAL-UH / Yoanna M
Álvarez-Ginarte, PhD, FQ-UH, La Habana, Cuba
PRODUCTOS BIOACTIVOS DE ALGAS MARINAS NATURALES Y PSEUDONATURALES
PARA EL DESCUBRIMIENTO DE FÁRMACOS | BIOACTIVE MARINE ALGAE NATURAL AND
CO-30 11:00-11:10
PSEUDO-NATURAL PRODUCTS FOR DRUG DISCOVERY
Eduardo J.E. Caro-Diaz, PhD, University of Puerto Rico, San Juan, Puerto Rico
INFLUENCIA DE LAS ETAPAS FENOLÓGICAS EN LOS PARÁMETROS
FARMACOGNOSTICOS Y ACTIVIDAD DIURÉTICA DE Xiphidium caeruleum | INFLUENCE OF
CO-31 11:10- 11:20 THE PHENOLOGICAL STAGES IN THE PHARMACOGNOSTIC PARAMETERS AND
DIURETIC ACTIVITY OF Xiphidium caeruleum
Carlos Rafael Núñez Cairo, ICBP Girón, La Habana, Cuba
ESTANDARIZACIÓN DEL EXTRACTO HIDROALCOHÓLICO DE LAS HOJAS DE Lippia alba
Mill | STANDARDIZATION OF THE HYDROALCOHOLIC EXTRACT OF THE LEAVES OF
CO-32 11:20-11:30
Lippia alba Mill
Alejandro Felipe González, PhD, IFAL-UH, La Habana, Cuba
ACTIVIDAD ANTICANDIDIÁSICA IN VITRO DE LOS ACEITES ESENCIALES CUBANOS DE
Citrus limon Y Plectranthus amboinicus | IN VITRO ANTICANDIDAL ACTIVITY OF CUBAN
CO-33 11:30-11:40
ESSENTIAL OILS FROM Citrus limon AND Plectranthus amboinicus
Rosario E. Velar Martínez, IPK, LA Habana, Cuba
LA DIMERIZACIÓN Y LAS SUSTITUCIONES DE D-AMINOÁCIDOS, PERO NO LA
ACETILACIÓN, AUMENTAN EL EFECTO INHIBIDOR DE UN PÉPTIDO ANTAGONISTA DE LA
INTERLEUCINA-15 | DIMERIZATION AND D-AMINO ACID SUBSTITUTIONS, BUT NOT
CO-34 11:40-11:50
ACETYLATION, INCREASE THE INHIBITORY EFFECT OF AN INTERLEUKIN-15
ANTAGONIST PEPTIDE
Yunier Rodríguez Álvarez, CIGB, La Habana, Cuba
OBTENCIÓN DE UNA MATERIA PRIMA DE Hibiscus sabdariffa L. (FLOR DE JAMAICA) DE
CO-35 11:50-12:00 PRODUCCIÓN NACIONAL PARA LA ELABORACIÓN DE PRODUCTOS NATURALES |
OBTAINING A RAW MATERIAL OF Hibiscus sabdariffa L. (FLOWER OF JAMAICA) OF
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxiii

NATIONAL PRODUCTION FOR THE ELABORATION OF NATURAL PRODUCTS

Sirley González Laime, Sierra Maestra, La Habana, Cuba
MODELOS QSAR PARA LA IDENTIFICACIÓN DE INHIBIDORES SELECTIVOS DE BACE
1/BACE 2 EN LA ENFERMEDAD DE ALZHEIMER | QSAR MODELS FOR IDENTIFICATION OF
CO-36 12:00-12:10
SELECTIVE BACE 1/BACE 2 INHIBITORS IN ALZHEIMER’S DISEASE
Yoanna María Álvarez-Ginarte, Facultad de Química, Universidad de La Habana, Cuba
MODIFICACIONES COVALENTES DE CM-P5, UN PÉPTIDO DERIVADO DE MOLUSCOS
MARINOS, UN CAMINO HACIA EL DESARROLLO DE NUEVOS AMP
FARMACOLÓGICAMENTE VIABLES | COVALENT MODIFICATIONS OF CM-P5, A PEPTIDE
CO-37 12:10-12:20
DERIVED FROM MARINE MOLLUSK, A PATH TOWARDS THE DEVELOPMENT OF NEW
PHARMACOLOGICALLY VIABLE AMPS
Fidel E. Morales Vicente, CIGB, La Habana, Cuba
MARCO REGULATORIO DE LA MEDICINA TRADICIONAL Y COMPLEMENTARIA. FOCO EN
CUBA | REGULATORY FRAMEWORK OF TRADITIONAL AND COMPLEMENTARY
CO-38 12:20-12:30
MEDICINE. FOCUS ON CUBA
Diadelis Remírez, PhD, CECMED, La Habana, Cuba
Thalassia testudinum, LA ANGIOSPERMA MÁS ABUNDANTE EN EL MAR CARIBE, UNA
MIRADA A SUS PROPIEDADES ANTICANCERÍGENAS BAJO BASES SUSTENTABLES |
CO-39 12:30-12:40 Thalassia testudinum, THE MOST ABUNDANT ANGIOSPERM IN THE CARIBBEAN SEA, A
LOOK AT ITS ANTI-CANCER PROPERTIES UNDER SUSTAINABLE BASES
Idania Rodeiro Guerra, PhD, ICIMAR, La Habana, Cuba
EFECTOS DE LA SUSPENSIÓN-ABEXOL, LA TABLETA-ABEXOL Y EL INGREDIENTE
ACTIVO-ABEXOL EN LA ÚLCERA GÁSTRICA INDUCIDA POR ETANOL EN RATAS |
CO-40 12:40-12:50 EFFECTS OF SUSPENSION-ABEXOL, TABLET-ABEXOL AND ACTIVE INGREDIENT-
ABEXOL ON ETHANOL INDUCED-GASTRIC ULCER IN RATS
Giselle Breña, CNIC, La Habana, Cuba
APLICACIONES CLÍNICAS DEL PRODUCTO NATURAL CURMERIC DURANTE LA
PANDEMIA DE COVID-19 EN CUBA | CLINICAL APPLICATIONS OF NATURAL PRODUCT
CO-41 12:50-13:00 CURMERIC DURING COVID-19 PANDEMIC IN CUBA
Tania Valdés González, PhD, Theragnostic Laboratory, University Hospital General Calixto
García-Center for Technological Application and Nuclear Development
DESARROLLO DE UN MÉTODO ANALÍTICO POR HPLC PARA DETERMINACIÓN DE LA
COMPOSICIÓN DE APITOXINA Y PRODUCTOS AFINES | DEVELOPMENT OF AN
CO-42 13:00-13:10 ANALYTICAL METHOD BY HPLC TO DETERMINE THE COMPOSITION OF APITOXIN AND
RELATED PRODUCTS
Catherine Fagúndez, PhD, Facultad de Veterinaria, UdelaR, Montevideo, Uruguay
DISEÑO IN SILICO Y SÍNTESIS DE LIGANDOS DUALES DIRIGIDOS A GPER Y C-SRC CON
POSIBLE ACTIVIDAD ANTICANCERÍGENA | IN SILICO DESIGN AND SYNTHESIS OF DUAL
CO-43 (Virtual) 13:10-13:20
LIGANDS TARGETING GPER AND C-SRC WITH POSSIBLE ANTICANCER ACTIVITY
Loreley A. Morelos Garnica, Instituto Politécnico Nacional, Ciudad de México, México
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxiv


S4-SESIÓN DE CARTELES ELECTRÓNICOS DE S4 | DIGITAL POSTERS FROM S4
COORDINADORES | COORDINATORS: Yamilet Irene Gutiérrez Gaitén, PhD / Raisa Mangas Marín, PhD, IFAL-UH, La Habana, Cuba /
Yoanna M Álvarez-Ginarte, PhD, FQ-UH, La Habana, Cuba
CO-POLÍMERO ENTRECRUZADO BASADO EN EL MACRÓMERO TRILA + PEG-MA CON
POTENCIALES APLICACIONES EN LA REGENERACIÓN DE TEJIDO ÓSEO | CROSS-
P-81 15:00-15:05 LINKED CO-POLYMER BASED ON THE TRILA + PEG-MA MACROMER WITH POTENTIAL
APPLICATIONS IN BONE TISSUE REGENERATION
Maelia Zaldívar Cuesta, IFAL-UH, La Habana, Cuba
PROPIEDADES QSAR DE FÁRMACOS ANTIPARASITARIOS CONVENCIONALES BASADOS
EN LA REGLA DE CINCO DE LIPINSKI | QSAR PROPERTIES OF CONVENTIONAL
P-82 15:05-15:10
ANTIPARASITE DRUGS BASED ON LIPINSKI’S RULE OF FIVE
Adiel González, IPK, La Habana, Cuba
COMPARACIÓN DE LA COMPOSICIÓN QUÍMICA DE LOS EXTRACTOS DE HOJAS DE
Clusia minor L | COMPARISON OF CHEMICAL COMPOSITION OF THE EXTRACTS OF
P-83 15:10-15:15
LEAVES FROM Clusia minor L
Raisa Mangas Marín, PhD, IFAL-UH, La Habana, Cuba
SÍNTESIS ALTERNATIVA DE UN DONANTE DE FUCOSA 3,4-DIBENZOILADO |
P-84 15:15-15:20 ALTERNATIVE SYNTHESIS OF A 3,4-DIBENZOYL FUCOSE DONOR
Hilda María Alarcón Ríos, Instituto Finlay de Vacuna, La Habana, Cuba
EVALUACIÓN BIOLÓGICA DE EXTRACTOS ACUOSOS DE PRÓPOLIS OBTENIDOS POR
DIFERENTES MÉTODOS DE EXTRACCIÓN | BIOLOGICAL EVALUATION OF AQUEOUS
P-85 15:20-15:25
PROPOLIS EXTRACTS OBTAINED BY DIFFERENT EXTRACTION METHODS
Dailen Guanche Gallardo, Centro de Investigaciones Apícolas (CIAPI), Cuba
EVALUACIÓN DE LA CALIDAD DE LA APITOXINA DE Apis mellifera EN APIARIOS
UBICADOS EN EL OCCIDENTE, CENTRO Y ORIENTE DE CUBA | EVALUATION OF THE
P-86 15:25-15:30 QUALITY OF THE APITOXIN OF Apis mellifera IN APIARIES LOCATED IN THE WEST,
CENTER AND EAST OF CUBA
Zonia Martínez Benitez IFAL-UH, La Habana, Cuba
ESTUDIO FARMACOGNÓSTICO, ACTIVIDAD ANTIOXIDANTE Y CICATRIZANTE DEL
EXTRACTO HIDROALCOHÓLICO DE Guarea guidonia | PHARMACOGNOSTIC STUDY,
P-87 15:30-15:35 ANTIOXIDANT AND WOUND HEALING ACTIVITY OF THE HYDROALCOHOLIC EXTRACT OF
Guarea guidonia
Ramón Scull Lizama, IFAL-UH, La Habana, Cuba
ESTUDIO FARMACOGNOSTICO Y ACTIVIDAD HEMOSTÁTICA DEL EXTRACTO
HIDROALCOHÓLICO DE Trasdescantia spathacea | PHARMACOGNOSTIC STUDY AND
P-88 15:35-15:40 HEMOSTATIC ACTIVITY OF THE HYDROALCOHOLIC EXTRACT OF Trasdescantia
spathacea
Yamilet Gutiérrez Gayten, PhD, IFAL-UH, La Habana, Cuba
ESTUDIO FITOQUÍMICO Y ACTIVIDAD ANTILITIÁSICA DEL EXTRACTO ACUOSO DE LAS
HOJAS DE Urera baccifera | PHYTOCHEMICAL STUDY AND ANTILITHIATIC ACTIVITY OF
P-89 15:40-15:45
THE AQUEOUS EXTRACT OF THE LEAVES OF Urera baccifera
Ana Cristina Noa Rodríguez, CENATOX, LA Habana, Cuba
ELABORACIÓN DE UNGÜENTO ANTIPSORIÁTICO AL 15% CON EXTRACTO BLANDO DE
Alternanthera sessilis L. R. BR | ELABORATION OF ANTIPSORIATIC OINTMENT AT 15%
P-90 15:45-15:50
WITH SOFT EXTRACT OF Alternanthera sessilis L. R. BR
Eva Salas Olivet, IFAL-UH, La Habana, Cuba
PREDICCIÓN DE LA ACTIVIDAD ANTIHISTAMÍNICA UTILIZANDO MÉTODOS QSAR |
P-91 (Off-line) 15:50-15:55 PREDICTION OF ANTIHISTAMINE ACTIVITY USING QSAR METHODS
Melissa Gil Delgado, IFAL-UH, La Habana, Cuba
SÍNTESIS MULTICOMPONENTE DE ANÁLOGOS DEL INHIBIDOR CETO-ACE |
P-92 (Off-line) 15:55-16:00 MULTICOMPONENT SYNTHESIS OF ANALOGUES OF THE INHIBITOR KETO-ACE
Gerardo M. Ojeda-Carralero, Facultad de Química, Universidad de La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxv

LEWIS Y: EFICIENCIA DE LA GLICOSILACIÓN A PARTIR DE 2 DONANTES DE FUCOSA |

P-93 16:00-16:05 LEWIS Y: GLYCOSYLATION EFFICIENCY FROM 2 FUCOSE DONORS
Yaneisy Yú Pérez, Instituto Finlay de Vacuna, La Habana, Cuba
NUEVOS RETOS EN LA EVALUACIÓN DE LA CALIDAD, SEGURIDAD Y EFICACIA DE LOS
MEDICAMENTOS HOMEOPÁTICOS | NEW CHALLENGES IN THE EVALUATION OF
P-94 (Off-line) 16:05-16:10
QUALITY, SAFETY AND EFFICACY OF HOMEOPATHIC DRUGS
Fabien Pelaez Cuesta, CECMED, La Habana, Cuba
PRESENCIA DE ANTOCIANINAS EN LA FLOR DE JAMAICA Y SU USO EN LA COSMÉTICA
CUBANA | ANTHOCYANINS OCCURRENCE IN FLOR DE JAMAICA AND ITS USE IN CUBAN
P-95 (Off-line) 16:10-16:15
COSMETICS
Migdalia García Barea, LABIOFAM, Cuba
NUEVA MATERIA PRIMA DE MORUS ALBA L. PARA LAS INDUSTRIAS BIOFARMACÉUTICA
Y ALIMENTARIA CUBANA | NEW MORUS ALBA L. RAW MATERIAL FOR THE CUBAN
P-96 (Off-line) 16:15-16:20
BIOPHARMACEUTICAL AND FOOD INDUSTRIES
Eleanis Cabrera Torrado, Sierra Maestra, La Habana, Cuba
ACTUALIZACIÓN DE LA NORMATIVA “TEXTOS IMPRESOS DE INFORMACIÓN DE
MEDICAMENTOS HERBOLARIOS DE USO HUMANO” | UPDATE OF THE REGULATION
P-97 (Off-line) 16:20-16:25
“PRINTED TEXTS FOR INFORMATION OF HERBAL MEDICINES FOR HUMAN USING”
Rosahivis Romero Sosa, CECMED, La Habana, Cuba
COMPOSICIÓN QUÍMICA Y ACTIVIDAD NEFROPROTECTORA DE HOJAS Y RIZOMAS DE
Smilax purhampuy Ruiz | CHEMICAL COMPOSITION AND NEPHROPROTECTIVE ACTIVITY
P-98 (Off-line) 16:25-16:30 OF LEAVES AND RHIZOMES OF Smilax purhampuy Ruiz
Pilar A. Soledispa Cañarte, Facultad de Ciencias Químicas “Salvador Allende”. Universidad de
Guayaquil, Guayaquil, Ecuador
PERFIL FITOQUÍMICO Y ACTIVIDAD ANTIINFLAMATORIA TÓPICA DEL EXTRACTO
ACUOSO DE Malva pseudolavatera Webb & Berthel | PHYTOCHEMICAL PROFILE AND
TOPICAL ANTI-INFLAMMATORY ACTIVITY OF THE AQUEOUS EXTRACT OF Malva
P-99 (Off-line) 16:30-16:35
pseudolavatera Webb & Berthel
Glenda M. Sarmiento Tomalá, Facultad de Ciencias Químicas “Salvador Allende”. Universidad
de Guayaquil, Guayaquil, Ecuador
COMPOSICIÓN FENÓLICA Y ACTIVIDAD INHIBIDORA IN VITRO DE LA XANTINA OXIDASA
DE Mimusops coriacea (A.DC) Miq | PHENOLIC COMPOSITION AND IN VITRO INHIBITORY
P-100 (Off-line) 16:35-16:40 ACTIVITY OF XANTHINE OXIDASE FROM Mimusops coriacea (A.DC) Miq
Katherine Elizabeth Bustamante Pesantes, Facultad de Ciencias Químicas “Salvador
Allende”. Universidad de Guayaquil, Guayaquil, Ecuador
CARACTERIZACIÓN FITOQUÍMICA Y POTENCIALIDADES ANTIINFLAMATORIAS DE LAS
HOJAS DE Nephelium lappaceum L. DE ECUADOR | PHYTOCHEMICAL
CHARACTERIZATION AND ANTI-INFLAMMATORY POTENTIALITIES OF THE LEAVES OF
P-101 (Off-line) 16:40-16:45
Nephelium lappaceum L. FROM ECUADOR
Laura Leonor Valdez López, Facultad de Ciencias Químicas “Salvador Allende”. Universidad
de Guayaquil, Guayaquil, Ecuador
CARACTERIZACIÓN FISICOQUÍMICA Y FITOQUÍMICA DE EXTRACTOS ACUOSOS DE
Corynaea crassa Hook. F | PHYSICOCHEMICAL AND PHYTOCHEMICAL
P-102 (Off-line) 16:45-16:50 CHARACTERIZATION OF AQUEOUS EXTRACTS OF Corynaea crassa Hook. F
Alexandra Jenny López Barrera, PhD, Facultad de Ciencias Químicas “Salvador Allende”.
Universidad de Guayaquil, Guayaquil, Ecuador
INVENTARIO ETNOBOTÁNICO DE LAS DOS SUBSPECIES DE Piper aduncum L. EN CUBA |
P-103 (Off-line) 16:50-16:55 ETHNOBOTANICAL INVENTORY OF THE TWO SUBSPECIES OF Piper aduncum L. IN CUBA
Orlando Abreu Guirado, Universidad de Camagüey, Camagüey, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxvi


S5 –FARMACOLOGÍA, TOXICOLOGÍA Y BIOTECNOLOGÍA | PHARMACOLOGY, TOXICOLOGY AND BIOTECHNOLOGY
COORDINADORES | COORDINATORS: Olga Sonia León, PhD, IFAL-UH, Cuba / Yoagne Trapero, PhD, IFAL-UH, Cuba / Laura Machín,
MSc, IFAL-UH, Cuba
MODELACIÓN FARMACOCINÉTICA POBLACIONAL DEL FIBRINÓGENO EN PACIENTES
CON HIPOFIBRINOGENEMIA CONGÉNITA O ADQUIRIDA-CRÓNICA O AGUDA |
POPULATION PHARMACOKINETIC MODELING OF FIBRINOGEN IN PATIENTS WITH
CO-44 11:00-11:10
CONGENITAL OR ACQUIRED -CHRONIC OR ACUTE- HYPOFIBRINOGENEMIA
Helena Colom, PhD, Facultad de Farmacia y Ciencias de la Alimentación. Universidad de
Barcelona, Barcelona, España
APROVECHAMIENTO DE MODELOS FARMACOCINÉTICOS DE BASE FISIOLÓGICA PARA
INFORMAR LA TOMA DE DECISIONES EN DIFERENTES ESCENARIOS | LEVERAGING OF
PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELLING TO INFORM DECISION-
CO-45 (Virtual) 11:10- 11:20
MAKING IN DIFFERENT SCENARIOS. PART I: EVALUATION OF CNS DRUG DELIVERY
Valvanera Vozmediano, PhD, Center for Pharmacometrics and System Pharmacology (CPSP),
Department of Pharmaceutics. College of Pharmacy. University of Florida, FL, USA
OZONO MÉDICO: MECANISMOS FARMACOLÓGICOS COMO BASE DE SU EFICACIA
SOBRE LA RESPUESTA INMUNE, DISFUNCIONES VASCULARES, CIRUGÍA Y COVID-
19/SARS-COV-2 | MEDICAL OZONE: PHARMACOLOGICAL MECHANISMS AS THE BASIS
CO-46 11:20-11:30
OF ITS EFFECTIVENESS ON THE IMMUNE RESPONSE, VASCULAR DYSFUNCTIONS,
SURGERY, AND COVID-19/SARS-COV-2
Olga Sonia León Fernández, PhD, IFAL-UH, La Habana, Cuba
EVALUACIÓN DE LOS EFECTOS DE COMPVIT - B® SOBRE LOS TRASTORNOS DE
CONDUCTA EN UN MODELO DE RATA CON SÍNDROME DE ABSTINENCIA ALCOHÓLICA |
CO-47 11:30-11:40 EVALUATION OF THE EFFECTS OF COMPVIT - B® ON BEHAVIORAL DISORDERS IN A RAT
MODEL OF ALCOHOL WITHDRAWAL SYNDROME
Viagna Valiña, CNEURO, La Habana, Cuba
Application of the Biopharmaceutical Classification System to the Basic Table of Medicines of
CO-48 11:40-11:50 Cuba: bioequivalence in vivo or dissolution in vitro?
Claudia Miranda, Centro de Bioactivos Químicos, UCLV, Villa Clara, Cuba
REPOSICIONAMIENTO TERAPÉUTICO DEL ANTICUERPO MONOCLONAL HUMANIZADO
ITOLIZUMAB EN COVID-19 | THERAPEUTIC REPOSITIONING OF THE HUMANIZED
CO-49 11:50-12:00
MONOCLONAL ANTIBODY ITOLIZUMAB IN COVID-19
Mayra Ramos Suzarte, PhD, CIM, La Habana, Cuba
APROVECHAMIENTO DE MODELOS FARMACOCINÉTICOS DE BASE FISIOLÓGICA PARA
INFORMAR LA TOMA DE DECISIONES EN DIFERENTES ESCENARIOS. PARTE II:
INTERACCIONES FÁRMACO-FÁRMACO EN POBLACIONES ESPECIALES | LEVERAGING
OF PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELING TO INFORM DECISION-
CO-50 (Virtual) 12:00-12:10
MAKING IN DIFFERENT SCENARIOS. PART II: DRUG-DRUG INTERACTIONS IN SPECIAL
POPULATIONS
Leyanis Rodríguez-Vera, PhD, Center for Pharmacometrics and System Pharmacology
(CPSP), Department of Pharmaceutics. College of Pharmacy. University of Florida, FL, USA
DIFERENTES PATRONES DE ESTRÉS OXIDATIVO SEGÚN DIVERSAS CONDICIONES
CLÍNICAS DE PACIENTES CUBANOS HOSPITALIZADOS POR SARS-COV-2 | DIFFERENT
CO-51 12:10-12:20 PATTERNS OF OXIDATIVE STRESS ACCORDING TO DIVERSE CLINICAL CONDITIONS OF
SARS-COV-2 HOSPITALIZED CUBAN PATIENTS
Lizette Gil del Valle, IPK, La Habana, Cuba
UN NUEVO CANDIDATO A FÁRMACO DIRIGIDO A LAS PROTEÍNAS VIRALES Y LAS DEL
HUÉSPED PARA INHIBIR LAS INFECCIONES VIRALES | A NOVEL DRUG CANDIDATE
CO-52 12:20-12:30
TARGETING HOST AND VIRAL PROTEINS TO INHIBIT VIRAL INFECTIONS
Celia Fernández-Ortega, CIGB, La Habana, Cuba
PRÁCTICAS DE SEGURIDAD Y SALUD EN EL MANEJO DE SUSTANCIAS CANCERÍGENAS
CO-53 12:30-12:40
EN LOS LABORATORIOS DEL INSTITUTO DE CIENCIA Y TECNOLOGÍA DE MATERIALES
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxvii

IMRE | SAFETY AND HEALTH PRACTICES IN THE HANDLING OF CARCINOGENIC

SUBSTANCES IN LABORATORIES OF THE IMRE MATERIALS SCIENCE AND
TECHNOLOGY INSTITUTE
Yoagne Trapero, PhD, IFAL-UH, La Habana, Cuba
NEUROEPO EN EL SÍNDROME CLÍNICO DE ALZHEIMER LEVE A MODERADO. ENSAYO
CLÍNICO CONTROLADO DE FASE 2-3 | NEUROEPO IN MILD-TO-MODERATE ALZHEIMER’S
CO-54 12:40-12:50
CLINICAL SYNDROME. PHASE 2-3 CONTROLLED CLINICAL TRIAL
Leslie Pérez Ruiz, CIM, La Habana, Cuba
PROPIEDADES ANTILEISHMANIA MÁS ALLÁ DE LA ENTIDAD ENDOPERÓXIDO |
CO-55 12:50-13:00 ANTILEISHMANIAL PROPERTIES BEYOND THE ENDOPEROXIDE ENTITY
Laura Machín, IFAL-UH, La Habana, Cuba
PAQUETE PRECLÍNICO TOXICOLÓGICO DE LA VACUNA ABDALA EN UN CONTEXTO DE
PANDEMIA GLOBAL | PRECLINICAL TOXICOLOGICAL PACKAGE OF THE ABDALA
CO-56 13:00-13:10
VACCINE IN A CONTEXT OF A GLOBAL PANDEMIC
Lizet Aldana Velazco, CIGB, La Habana, Cuba
COORDINADORES | COORDINATORS: Olga Sonia León, PhD, IFAL-UH, Cuba / Yoagne Trapero, PhD, IFAL-UH, Cuba / Laura Machín,
MSc, IFAL-UH, Cuba
ESTUDIO FARMACOMÉTRICO DE LA NEUROEPO EN PRIMATES NO-HUMANOS MACACA
FASCICULARIS | PHARMACOMETRIC STUDY OF NEUROEPO IN A NON-HUMAN PRIMATE
P-104 15:05-15:10
MODEL MACACA FASCICULARIS
Adriel Brito Llera, Dirección de Ciencia y Técnica, Universidad de La Habana, Cuba
DESARROLLO DE NANOPARTÍCULAS MAGNÉTICAS IMPRESAS MOLECULARMENTE
PARA LA EXTRACCIÓN EFICIENTE DEL FÁRMACO ANTIARRÍTMICO AMIODARONA A
PARTIR DE MUESTRAS BIOLÓGICAS | DEVELOPMENT OF MOLECULARLY IMPRINTED
P-105 15:10-15:15 MAGNETIC NANOPARTICLES FOR THE EFFICIENT EXTRACTION OF ANTIARRHYTHMIC
DRUG AMIODARONE FROM BIOLOGICAL SAMPLES
Rüstem Keçili. PhD, Department of Medical Services and Techniques, Yunus Emre Vocational
School of Health Services, Anadolu University, Eskişehir, Turkey
MODELACIÓN DE PARÁMETROS DE CRECIMIENTO EN RATAS SPRAGUE-DAWLEY
COMO UNA ALTERNATIVA EN TOXICOLOGÍA PRECLÍNICA | MODELING OF GROWTH
P-106 15:15-15:20 PARAMETERS IN SPRAGUE-DAWLEY RATS AS AN ALTERNATIVE IN PRECLINICAL
TOXICOLOGY
Juan Carlos Polo Vega, CIGB, La Habana, Cuba
CARACTERIZACIÓN DE LAS REACCIONES ADVERSAS A MEDICAMENTOS EN EL
TRATAMIENTO DE PACIENTES CUBANOS HOSPITALIZADOS CON COVID-19: ANÁLISIS
MEDIANTE ENCUESTA, CUBA 2021 | CHARACTERIZATION OF ADVERSE DRUG
P-107 (Off-line) 15:20-15:25
REACTIONS IN THE TREATMENT OF CUBAN HOSPITALIZED COVID-19 PATIENTS:
ANALYSIS USING A SURVEY, CUBA 2021
Rosario Gravier Hernández, IPK, La Habana, Cuba
INCORPORACIÓN DE VALOR AGREGADO EN ESTUDIOS PRECLÍNICOS Y PRUEBAS DE
SEGURIDAD DE BIOMOLÉCULAS CON FUNCIÓN NEUROPROTECTORA |
P-108 15:25-15:30 INCORPORATION OF ADDED VALUE IN PRECLINICAL STUDIES AND SAFETY TESTS OF
BIOMOLECULES WITH NEUROPROTECTIVE FUNCTION
Teresa Diez, CNEURO, La Habana, Cuba
EVALUACIÓN BASADA EN MODELOS EXTERNOS DE MODELOS FARMACOCINÉTICOS
POBLACIONALES PARA CARACTERIZAR EL EFECTO DEL GENOTIPO EN LA EXPOSICIÓN
A LA WARFARINA | EXTERNAL MODEL-BASED EVALUATION OF POPULATION
P-109 15:30-15:35
PHARMACOKINETIC MODELS FOR CHARACTERIZING THE GENOTYPE-EFFECT ON
WARFARIN EXPOSURE
Gledys Reynaldo Fernández, PhD, IFAL-UH, La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxviii

MODELO FARMACOCINÉTICO POBLACIONAL PARA GUIAR LA SELECCIÓN DE DOSIS

DEL NIMOTUZUMAB EN PACIENTES CON LA ENFERMEDAD RENAL POLIQUÍSTICA
AUTOSÓMICA DOMINANTE (ERPAD) | POPULATION PHARMACOKINETIC MODEL TO
P-110 15:35-15:40
GUIDE THE DOSE SELECTION OF NIMOTUZUMAB IN PATIENTS WITH AUTOSOMAL
DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
Niurys de Castro Suárez, PhD, IFA-UH, La Habana, Cuba
PROPUESTA DE MECANISMOS DE ACCIÓN ANTITUMORAL DE LOS PROPÓLEOS
P-111 15:40-15:45 CUBANOS | PROPOSAL OF ANTITUMOR MECHANISMS ACTION OF CUBAN PROPOLIS
Amanda Troya Pérez, IFAL-UH, La Habana, Cuba
RELACIÓN ENTRE EL ESTRÉS OXIDATIVO Y EL GRADO DE LIPOATROFIA FACIAL EN
PACIENTES CUBANOS CON VIH TRATADOS CON ANTIRRETROVIRALES | RELATIONSHIP
P-112 15:45-15:50 BETWEEN OXIDATIVE STRESS AND THE DEGREE OF FACIAL LIPOATROPHY IN CUBAN
PATIENTS WITH HIV TREATED WITH ANTIRETROVIRALS
Lillyam Betancourt Peraza, IPK, La Habana, Cuba
EFECTOS DE AMYLOVIS-201 SOBRE EL DÉFICIT CRÓNICO DE MEMORIA INDUCIDO POR
ESCOPOLAMINA EN RATONES | EFFECTS OF AMYLOVIS-201 ON CHRONIC
P-113 15:50-15:55
SCOPOLAMINE INDUCED MEMORY DEFICIT IN MICE
Karla M. Freyre, CNEURO, La Habana, Cuba
EVIDENCIAS PRECLÍNICAS DE INMUNOSEGURIDAD DEL CIGB-210, UN NUEVO
CANDIDATO A FÁRMACO CONTRA EL VIH | PRECLINICAL IMMUNO-SAFETY EVIDENCES
P-114 15:55-16:00
OF CIGB-210, A NOVEL ANTI-HIV DRUG CANDIDATE
Dionne Casillas Casanova, CIGB, La Habana, Cuba
ESTABLECIMIENTO DE UN MEDIO QUÍMICAMENTE DEFINIDO PARA LA EXPRESIÓN DE
P64KR EN ESCHERICHIA COLI | ESTABLISHMENT OF A CHEMICALLY DEFINED MEDIUM
P-115 16:00-16:05
FOR THE EXPRESSION OF P64KR IN ESCHERICHIA COLI
Laura Varas Sarzo, CIGB, La Habana, Cuba
INFLUENCIA DE LOS INMUNOCOMPLEJOS CIRCULANTES DEL COMPLEMENTO EN
MODELOS PREDICTIVOS DE EVOLUCIÓN CLÍNICA EN ARTRITIS REUMATOIDE |
P-116 (Off-Line) 16:05-16:10 INFLUENCE OF CIRCULATING COMPLEMENT IMMUNE COMPLEXES IN PREDICTIVE
MODELS OF CLINICAL EVOLUTION IN RHEUMATOID ARTHRITIS
Maité Martiatu Hendrich, Genética Médica, La Habana, Cuba
DETECCIÓN DEL POLIMORFISMO RS11125908 POR PCR ALELO-ESPECÍFICO APLICADA
A LA ARTRITIS REUMATOIDE | DETECTION OF POLYMORPHISM RS11125908 BY ALLELE-
P-117 (Off-Line) 16:10-16:15
SPECIFIC PCR APPLIED TO RHEUMATOID ARTHRITIS
Maidel Carpio Álvarez, CIGB, La Habana, Cuba
ACTIVIDAD CICATRIZANTE DE LA POMADA DE QUITOSANA AL 1% EN MODELO DE DAÑO
POR QUEMADURAS EN PIEL EN RATAS CENP: WISTAR | HEALING ACTIVITY OF
P-118 (Off-Line) 16:15-16:20
CHITOSAN OINTMENT 1% ON SKIN BURN DAMAGE MODEL IN RATS CENP: WISTAR
Addis Bellma Menéndez, MSc, CIDEM, La Habana, Cuba
EVALUACIÓN DE LA ACTIVIDAD ANTILEISHMANIAL IN VITRO DE COMPUESTOS
ANTICANCERÍGENOS: FÁRMACOS CONVENCIONALES Y DERIVADOS DE LA
P-119 (Off-Line) 16:20-16:25 QUINOXALINA | IN VITRO ANTILEISHMANIAL ACTIVITY OF ANTICANCER COMPOUNDS:
CONVENTIONAL DRUGS AND QUINOXALINE DERIVATIVES
Yesli Estrella García Vega, IPK, La Habana, Cuba
EVALUACIÓN DE ELEMENTOS DE SEGURIDAD Y DE BIENESTAR EN PRIMATES NO
HUMANOS (CHLOROCEBU AETHIOPS SABAEUS) DE LA VACUNACIÓN CON LA
PROTEÍNA PKPD-L1 EN FORMULACIONES CON FOSFATO DE ALUMINIO | EVALUATION
P-120 (Off-Line) 16:25-16:30 OF SAFETY AND WELFARE ELEMENTS IN NON-HUMAN PRIMATES (CHLOROCEBU
AETHIOPS SABAEUS) OF VACCINATION WITH THE PKPD-L1 PROTEIN IN FORMULATIONS
WITH ALUMINUM PHOSPHATE
José Rafael Martínez Castillo, CIGB, La Habana, Cuba
EVALUACIÓN DE TERAPIA CON GEMCITABINA EN PACIENTES TRATADOS EN EL
INSTITUTO DE ONCOLOGÍA Y RADIOBIOLOGÍA 2021 | EVALUATION OF GEMCITABINE
P-121 (Off-Line) 16:30-16:35
THERAPY IN PATIENTS TREATED AT THE 2021 INSTITUTE OF ONCOLOGY AND
RADIOBIOLOGY
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxix

Mayleen M. Álvarez, INOR, La Habana, Cuba

DESARROLLO DE ALGORITMOS RECURSIVOS DE BOSQUE ALEATORIO PARA LA
PREDICCIÓN DE LA SOLUBILIDAD ACUOSA DE NUEVOS FÁRMACOS | DEVELOPMENT
P-122 (Off-Line) 16:35-16:40 OF RECURSIVE RANDOM FOREST ALGORITHMS FOR THE PREDICTION OF AQUEOUS
SOLUBILITY OF NEW DRUGS
Gabriela Falcón-Cano, UCLV, Cuba
EFECTO DEL RITMO CIRCADIANO SOBRE LA FARMACOCINÉTICA DEL TACROLIMUS
DOS VECES AL DÍA EN RECEPTORES DE TRASPLANTE RENAL | EFFECT OF CIRCADIAN
RHYTHM ON THE PHARMACOKINETICS OF TWICE-DAILY TACROLIMUS IN RENAL
P-123 (Off-Line) 16:40-16:45
TRANSPLANT RECIPIENTS
Beatriz Fernández, Facultad de Farmacia y Ciencias de la Alimentación. Universidad de
Barcelona, España
CONGLOMERADOS DE CYP3A5*3 Y CYP3A4*22 QUE INFLUYEN EN LA CONCENTRACIÓN
BLANCO DE LA NUEVA FORMULACIÓN DE TACROLIMUS MELTDOSE®: UN ENFOQUE
POBLACIONAL | CYP3A5*3 AND CYP3A4*22 CLUSTER INFLUENCING THE NEW
P-124 (Off-Line) 16:45-16:50 TACROLIMUS MELTDOSE® FORMULATION TARGET CONCENTRATION: A POPULATION
APPROACH
Zeyar Mohammed Ali, Facultad de Farmacia y Ciencias de la Alimentación. Universidad de
Barcelona, España
ESTUDIOS DE BIOEQUIVALENCIA IN VITRO: PRINCIPALES DESAFÍOS EN LA INDUSTRIA
FARMACÉUTICA CUBANA | IN VITRO BIOEQUIVALENCE STUDIES: MAIN CHALLENGES IN
P-125 (Off-Line) 16:50-16:55
THE CUBAN PHARMACEUTICAL INDUSTRY
Martha Luisa Cossio Romeu, IFAL-UH, La Habana, Cuba
JUEVES 24 DE NOVIEMBRE | THURSDAY, NOVEMBER 24
SALA 1930 | ROOM 1930
S6-CIENCIAS ALIMENTARIAS | FOOD SCIENCES
- TECNOLOGÍA DE LOS ALIMENTOS | FOOD TECHNOLOGY
– ALIMENTACIÓN Y SALUD | DIET AND HEALTH
– EVALUACIÓN Y CONTROL DE ALIMENTOS | EVALUATION AND CONTROL OF FOOD
- CIENCIA Y GASTRONOMÍA | SCIENCE AND GASTRONOMY
COORDINADORES | COORDINATORS: Danae PhD / Alicia Casariego Año PhD / Dairon I Guevara
IFAL-UH, La Habana, Cuba
VIABILIDAD DE MICROORGANISMOS PROBIÓTICOS EN PRODUCTOS LÁCTEOS
SIMBIÓTICOS DURANTE EL ALMACENAMIENTO | VIABILITY OF PROBIOTIC
CO-57 11:00-11:10
MICROORGANISMS IN SYMBIOTIC DAIRY PRODUCTS DURING STORAGE
René Tejedor Arias, PhD, IFAL-UH, La Habana, Cuba
SUPERVIVENCIA DE CEPAS PROBIÓTICAS MICROENCAPSULADAS FRENTE A
CONDICIONES GÁSTRICAS, INTESTINALES Y PREBIÓTICAS SIMULADAS | SURVIVAL OF
MICROENCAPSULATED PROBIOTIC STRAINS AGAINST SIMULATED GASTRIC,
CO-58 11:10- 11:20
INTESTINAL AND PREBIOTIC CONDITIONS
Luz Alba Caballero Pérez, MSc., Faculty of Engineering and Architecture, Food Engineering
Program, University of Pamplona. University Campus, Barrio el Buque. Pamplona, Colombia
FERMENTACIÓN DE CACAO (THEOBROMA CACAO L.) CON ADICIÓN DE LEVADURA
(SACCHAROMYCES CEREVISIAE) Y ENZIMA (PPO'S) EN LA DISMINUCIÓN DE METALES
PESADOS | FERMENTATION OF CACAO (THEOBROMA CACAO L.) WITH ADDITION OF
CO-59 (Virtual) 11:20-11:30
YEAST (SACCHAROMYCES CEREVISIAE) AND ENZYME (PPO'S) IN THE DECREASE OF
HEAVY METALS
Luis Humberto Vásquez Cortez, Universidad Estatal de Quevedo, Ecuador
INDUCCIÓN EXÓGENA DE RHIZOBIUM JAPONICUM EN LA MASA FERMENTATIVA DE
DOS VARIEDADES DE CACAO (THEOBROMA CACAO L.) COMO ESTRATEGIA PARA LA
DISMINUCIÓN DEL CADMIO | EXOGENOUS INDUCTION OF RHIZOBIUM JAPONICUM IN
CO-60 (Virtual) 11:30-11:40
THE FERMENTATIVE MASS OF TWO VARIETIES OF CACAO (THEOBROMA CACAO L.) AS
A STRATEGY FOR THE DECREASE OF CADMIUM
Kerly Estefania Alvarado Vásquez, Universidad Estatal de Quevedo, Ecuador
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxx

ANÁLISIS DE RIESGO CUANTITATIVO DE ENTEROTOXINAS DE STAPHYLOCOCCUS

AUREUS EN QUESO FRESCO ARTESANAL | QUANTITATIVE RISK ANALYSIS OF
CO-61 11:40-11:50
STAPHYLOCOCCUS AUREUS ENTEROTOXINS IN FRESH ARTISAN CHEESE
Ailin Martínez,, CENSA, San José de las Lajas, Mayabeque, Cuba
AISLAMIENTO Y CARACTERIZACIÓN DE CEPAS MICROBIANAS A PARTIR DE LECHE
MATERNA HUMANA | ISOLATION AND CHARACTERIZATION OF MICROBIAL STRAINS
CO-62 11:50-12:00
FROM HUMAN BREAST MILK
Taimy Hernández, Universidad de Camagüey, Camagüey, Cuba
MEJORAS EN EL CONTROL DE CALIDAD DE LOS SUPLEMENTOS NUTRICIONALES
PRODUCIDOS POR EL BIOCEN PARA PREVENIR LA ANEMIA | IMPROVEMENTS IN THE
CO-63 12:25-12:35 QUALITY CONTROL OF NUTRITIONAL SUPPLEMENTS PRODUCED BY BIOCEN TO
PREVENT ANEMIA
Yenela García, PhD, BioCen, Mayabeque, Cuba
SISTEMA DE GESTIÓN DE LA SEGURIDAD (HACCP) CON ENFOQUE DE ECONOMÍA
CIRCULAR EN MINIINDUSTRIAS EN CUBA | SAFETY MANAGEMENT SYSTEM (HACCP)
CO-64 12:35-12:45
WITH A FOCUS ON THE CIRCULAR ECONOMY IN MINI-INDUSTRIES IN CUBA
Jenny Correa Soto, Universidad de Cienfuegos, Cienfuegos, Cuba
BUENAS PRÁCTICAS DE MANUFACTURA EN LA MINIINDUSTRIA “RANCHO VEGA” | GOOD
CO-65 12:45-12:55 MANUFACTURING PRACTICES IN THE “RANCHO VEGA” MINI-INDUSTRY
Anaiza Pérez, IFAL-UH, La Habana, Cuba
DISEÑO DE UN SISTEMA HACCP EN UNA MINI-INDUSTRIA PROCESADORA DE FRUTAS Y
HORTALIZAS | DESIGN OF A HACCP SYSTEM IN A FRUIT AND VEGETABLE PROCESSING
CO-66 12:55-13:05
MINI-INDUSTRY
Rocio Cartaya Quintero, IFAL-UH, La Habana, Cuba
DIAGNÓSTICO DE LOS REQUISITOS DE LA NC ISO/ IEC 17025: 2017 EN EL
LABORATORIO DE CONTROL DE CALIDAD DE LA UEB FÁBRICA DE YOGUR PROBIÓTICO
PARAÍSO DE LA EMPRESA DE PRODUCTOS INYECTABLES LABIOFAM | DIAGNOSIS OF
CO-67 13:05-13:15 THE REQUIREMENTS OF THE NC ISO/IEC 17025: 2017 IN THE QUALITY CONTROL
LABORATORY OF THE UEB PARAÍSO PROBIOTIC YOGURT FACTORY OF THE LABIOFAM
INJECTABLE PRODUCTS COMPANY
Claudia A Valdés, IFAL-UH, La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxxi

SESIÓN DE CARTELES ELECTRÓNICOS CIENCIAS ALIMENTARIAS S6 | DIGITAL POSTERS FROM FOOD SCIENCES S6
COORDINADORES | COORDINATORS: María Isabel Lantero PhD / René Tejedor Arias, PhD
DETERMINACIÓN DEL CONTENIDO DE AZÚCAR DE ALGUNAS FRUTAS SEGÚN EL
GRADO DE MADURACIÓN POR HPLC-ELSD | DETERMINATION OF SUGAR CONTENTS OF
P-126 15:05-15:10 SOME FRUITS ACCORDING TO THE DEGREE OF RIPENING BY HPLC-ELSD
Göksel Arli, PhD, Department of Medical Services and Techniques, YunusEmre Vocational
School of Health Services, Anadolu University, Eskişehir, Turkey
INVESTIGACIÓN DE PATÓGENOS UTILIZANDO SISTEMAS DE DETECCIÓN MOLECULAR
Y MEDIOS DE NUTRIENTES SELECTIVOS EN ÁREAS DE SERVICIO LISTAS PARA COMER
| PATHOGEN INVESTIGATION USING MOLECULAR DETECTION SYSTEM AND SELECTIVE
P-127 15:10-15:15
NUTRIENT MEDIA IN READY TO EAT SERVICE AREAS
Ümit Yılmaz YILDIZ, PhD, Medical Laboratory Techniques Program, Anadolu University,
Eskişehir/Tepebaşı, Türkiye
IMPLEMENTACIÓN DE UN SISTEMA HACCP EN UNA MINIINDUSTRIA PRODUCTORA DE
TOSTONES PRECOCINADOS | IMPLEMENTATION OF A HACCP SYSTEM IN A MINI-
P-128 15:15-15:20
INDUSTRY THAT PRODUCES PRE-PREPARED TOSTONES
Yanelis Chongo Quiñones, Empresa Integral Agropecuaria Cienfuegos, Cienfuegos, Cuba
DETERMINACIÓN DE CADMIO Y PLOMO EN HORTALIZAS FRESCAS | DETERMINATION
P-129 15:20-15:25 OF CADMIUM AND LEAD IN FRESH VEGETABLES
Lyi Wong Trujillo, INHEM, La Habana, Cuba
EVALUACIÓN DE UN NUEVO MÉTODO CROMOGÉNICO Y FLUOROGÉNICO PARA LA
DETECCIÓN DE SALMONELA EN HUEVOS | EVALUATION OF A NEW CHROMOGENIC AND
P-130 15:25-15:30
FLUOROGENIC METHOD FOR THE DETECTION OF SALMONELLA IN EGGS
Chavely Galvez Encinosa, BioCen, Mayabeque, Cuba
DESARROLLO Y EVALUACIÓN FUNCIONAL DE UN NUEVO MÉTODO CROMOGÉNICO Y
FLUOROGÉNICO PARA LA DETECCIÓN DE SALMONELLA EN HUEVOS | DEVELOPMENT
P-131 (Off-Line) 15:30-15:35 AND FUNCTIONAL EVALUATION OF A CHROMOGENIC AND FLUOROGENIC METHOD
FOR THE DETECTION OF SALMONELLA IN FOOD
Ivonne Alfonso, BioCen, Mayabeque, Cuba
EVALUACIÓN DIETÉTICA DE LAS OFERTAS ALIMENTARIAS DIRIGIDAS A ANCIANOS
P-132 15:35-15:40 CUBANOS | DIETETIC EVALUATION OF FOOD OFFERED TO THE CUBAN ELDERLY
Sandra del Castillo Ochoa, IFAL-UH, La Habana, Cuba
EVALUACIÓN DE LA GESTIÓN DE LA CARTA MENÚ DEL RESTAURANTE “EL CARIBE” DE
HOTEL ROYALTON HICACOS RESORT & SPA | EVALUATION OF THE MENU CARD
P-133 (Off-Line) 15:40-15:45 MANAGEMENT OF THE RESTAURANT "EL CARIBE" OF THE ROYALTON HICACOS
RESORT & SPA HOTEL
Olga Lidia Sosa, UEB Catering Trade and Gastronomy Airport Varadero, Matanzas, Cuba
PROYECTO DE DISEÑO Y EJECUCIÓN DE UN RESTAURANTE ESCUELA DE COCINA
CIENTÍFICA EN VARADERO | PROJECT FOR THE DESIGN AND EXECUTION OF A
P-134 15:45-15:50
SCIENTIFIC COOKING SCHOOL RESTAURANT IN VARADERO
Alexis Manuel Pascual Aguirre, Hotel Los Delfines, Islazul, MINTUR, Cuba
CALIDAD DIETÉTICO-NUTRICIONAL DEL SUMINISTRO DE ALIMENTOS PARA
TRABAJADORES DE UNA EMPRESA MATANCERA | DIETETIC-NUTRITIONAL QUALITY OF
P-135 15:55-16:00
THE FOOD SUPPLY FOR WORKERS OF A COMPANY IN MATANZAS
Yudenis Reyes, IFAL-UH, La Habana, Cuba
PERCEPCIÓN Y CONSUMO DE FRITURAS POR ESTUDIANTES DEL INSTITUTO DE
FARMACIA Y ALIMENTOS DE LA UNIVERSIDAD DE LA HABANA | PERCEPTION AND
P-136 16:00-16:05 CONSUMPTION OF FRIED FOODS BY STUDENTS OF THE INSTITUTE OF PHARMACY AND
FOOD OF THE UNIVERSITY OF HAVANA
Rosamelys Ramos, IFAL-UH, La Habana, Cuba
ESTIMATION OF CARDIOVASCULAR RISK AND EVALUATION OF THE DIET OF WORKERS
P-137 16:05-16:10 OF THE TWISTED TOBACCO COMPANY "CARLOS BALIÑO" | ESTIMATION OF
CARDIOVASCULAR RISK AND EVALUATION OF THE DIET OF WORKERS OF THE
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxxii

TWISTED TOBACCO COMPANY "CARLOS BALIÑO"

Rocio Cartaya Quintero, IFAL-UH, La Habana, Cuba
CALIDAD DIETÉTICO-NUTRICIONAL DE LA OFERTA ALIMENTARIA PARA TRABAJADORES
DE UNA EMPRESA DE MATANZAS | DIETETIC-NUTRITIONAL QUALITY OF THE FOOD
P-138 (Off-Line) 16:10-16:15
SUPPLY FOR WORKERS OF A COMPANY IN MATANZAS
Roberto León, Empresa de productos lácteos, UEB Cárdenas. Matanzas, Cuba
USO DEL ÁCIDO ACÉTICO EN LA PREVENCIÓN DE LA COLIBACILOSIS EN LA
GANADERÍA | USE OF ACETIC ACID IN THE PREVENTION OF COLIBACILLOSIS IN
P-139 (Off-Line) 16:15-16:20
FARMING
Lourdes León Puerto, Empresa Integral Agropecuaria Cienfuegos, Cienfuegos, Cuba
APLICACIÓN DE YOGUR DE YUCA EN LA CATEGORÍA DE PRECEBA Y ENGORDE EN UNA
FINCA DEL MUNICIPIO DE CIENFUEGOS | APPLICATION OF CASSAVA YOGURT IN THE
P-140 (Off-Line) 16:20-16:25 CATEGORY OF PRE-FATTENING AND FATTENING IN A FARM IN THE MUNICIPALITY OF
CIENFUEGOS
Yamary García Guerra, Empresa Integral Agropecuaria Cienfuegos, Cienfuegos, Cuba
INDUCCIÓN ANAERÓBICA DE BRADYZOBIUM JAPONICUM EN LA POSTCOSECHA DE
HÍBRIDOS EXPERIMENTALES DE CACAO (THEOBROMA CACAO L.) Y SU MEJORA EN LA
CALIDAD FERMENTATIVA (PROCESADO) Y SENSORIAL | ANAEROBIC INDUCTION OF
BRADYZOBIUMJAPONICUM IN THE POST-HARVEST OF EXPERIMENTAL HYBRIDS OF
P-141 (Off-Line) 16:25-16:30
COCOA (THEOBROMA CACAO L.) AND ITS IMPROVEMENT IN FERMENTATIVE
(PROCESSED) AND SENSORY QUALITY
Jaime Vera Chang, PhD, Universidad Técnica Estatal de Quevedo, Facultad de Ciencias
Industria y Producción, Ecuador
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxxiii

VIERNES 25 NOVIEMBRE | FRIDAY, NOVEMBER 25

7:00-8:55 Acreditación de delegados | Registration of delegates. SALA 1930 | ROOM 1930
SALA 1930 | ROOM 1930
VACUNAS INNOVADORAS Y PROYECTOS FARMACÉUTICOS COMO CENTRO DE LA
CARTERA BIOMÉDICA DEL CIGB | INNOVATIVE VACCINES AND PHARMACEUTICAL
CP-06 9:00-9:30
PROJECTS AS A FOCUS OF THE BIOMEDICAL PIPELINE OF CIGB
Gerardo Guillén, PhD, CIGB, La Habana, Cuba
VACUNA ABDALA ANTI-COVID-19: EXPERIENCIA CLÍNICA | ABDALA VACCINE ANTI-
CP-07 9:30-10:00 COVID-19: CLINICAL EXPERIENCE
Verena Muzio, PhD, La Habana, Cuba
EL RON CUBANO, PATRIMONIO INMATERIAL DE LA HUMANIDAD | THE CUBAN RUM,
CP-08 10:00-10:30 INTANGIBLE HERITAGE OF HUMANKIND
Salomé Alemán Carriazo, Ing, Maestra del Ron Cubano, Corporación Cuba Ron S.A.
PRESENTATIONS (PO)
13:30-14:00 MERIENDA | SNACK
14:00-16:00
PRESENTATIONS (POL)
17:00-20:00 CEREMONIA DE CLAUSURA | CLOSING CEREMONY
S7 - ENSEÑANZA DE LAS CIENCIAS FARMACÉUTICAS Y ALIMENTARIAS-SERVICIOS FARMACÉUTICOS-FARMACOECONOMÍA |
TEACHING OF PHARMACEUTICAL AND FOOD SCIENCES-PHARMACEUTICAL SERVICES-PHARMACOECONOMY
COORDINADORES | COORDINATORS: Olga María Nieto Acosta, PhD / Caridad Sedeño Argilagos, PhD / Milena Díaz, PhD, IFAL-UH,
La Habana, Cuba
RESULTADOS OBTENIDOS POR LA INTRODUCCIÓN Y GENERALIZACIÓN DE LOS
PRODUCTOS DE LA INDUSTRIA BIO-FARMACÉUTICA EN CUBA | RESULTS OBTAINED BY
CO-68 10:30-10:40 THE INTRODUCTION AND GENERALIZATION OF THE PRODUCTS FROM BIO-
PHARMACEUTICAL INDUSTRY IN CUBA
Manuel M Collazo Herrera, PhD, INHEM, La Habana, Cuba
EVALUACIÓN ECONÓMICA DE LA INMUNIZACIÓN INFANTIL POR VACUNAS CUBA 1962-
2019 | ECONOMIC EVALUATION OF CHILDHOOD IMMUNIZATION BY VACCINES CUBA
CO-69 10:40- 10:50
1962-2019
Manuel M Collazo Herrera, PhD, INHEM, La Habana, Cuba
UN PROYECTO PILOTO SOBRE EL USO DE UNA GUÍA DE RECOMENDACIONES DE
DOSIFICACIÓN DE CANNABIS MEDICINAL CON BASE CIENTÍFICA POR PARTE DE LOS
MÉDICOS EN PUERTO RICO | A PILOT PROJECT ON PHYSICIANS’ USE OF A SCIENTIFIC
CO-70 10:50-11:00
BASED MEDICAL CANNABIS DOSING RECOMMENDATIONS GUIDE IN PUERTO RICO
Juan A. Bernier Piñeiro, School of Pharmacy, University of Puerto Rico Medical Sciences
Campus, San Juan, Puerto Rico
PROGRAMA DOCTORAL EN CIENCIAS FARMACÉUTICAS: 30 AÑOS DE EXPERIENCIAS
EN LA FORMACIÓN DE RECURSOS HUMANOS | DOCTORAL PROGRAM IN
CO-71 11:00-11:10 PHARMACEUTICAL SCIENCES: 30 YEARS OF EXPERIENCE IN HUMAN RESOURCE
TRAINING
Caridad Sedeño Argilagos, PhD, IFAL-UH-, La Habana, Cuba
NUEVOS ENFOQUES EN EL PROGRAMA DE DOCTORADO EN CIENCIAS
FARMACÉUTICAS DE LA UNIVERSIDAD DE LA HABANA | NEW APPROACHES IN THE
CO-72 11:10-11:20
DOCTORAL PROGRAM IN PHARMACEUTICAL SCIENCES AT UNIVERSITY OF HAVANA
Olga María Nieto, PhD, IFAL-UH, La Habana, Cuba
ENFOQUE ISO 29993/29994 PARA EVALUAR EL APRENDIZAJE A DISTANCIA. ANÁLISIS
CO-73 11:20-11:30
DE UN ESTUDIO DE CASO EN LA ETAPA DE PANDEMIA | ISO 29993/29994 APPROACH TO
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxxiv

EVALUATE DISTANCE LEARNING. ANALYSIS OF A CASE STUDY IN THE PANDEMIC

STAGE
Yania Suárez, PhD, IFAL-UH, La Habana, Cuba
LA “DIDÁCTICA UNIVERSITARIA” EN LA LICENCIATURA DE ALIMENTOS DEL INSTITUTO
DE FARMACIA Y ALIMENTOS DE LA UNIVERSIDAD DE LA HABANA | THE "UNIVERSITY
CO-74 11:30-11:40 DIDACTIC" IN THE DEGREE OF FOOD SCIENCE OF THE INSTITUTE OF PHARMACY AND
FOOD OF THE UNIVERSITY OF HAVANA
Genoveva Marivel del Valle García, PhD, IFAL-UH, La Habana, Cuba
PRESCRIPCIONES POTENCIALMENTE INADECUADAS EN ADULTOS MAYORES DEL
MUNICIPIO SAN MIGUEL DEL PADRÓN, LA HABANA, CUBA | POTENTIALLY INADEQUATE
CO-75 11:40-11:50 PRESCRIPTIONS IN OLDER ADULTS IN SAN MIGUEL DEL PADRÓN MUNICIPALITY,
HAVANA, CUBA
Yoanna Herrera Preval, IFAL-UH, La Habana, Cuba
IMPACTO DE LA COMUNICACIÓN DE RIESGOS EN LA INDUSTRIA BIOTECNOLÓGICA Y
FARMACÉUTICA EN EL CONTEXTO DEL COVID-19 | IMPACT OF RISK COMMUNICATION
CO-76 11:50-12:00 IN THE BIOTECHNOLOGICAL AND PHARMACEUTICAL INDUSTRY IN THE CONTEXT OF
COVID-19
Ángela E. Sosa, PhD, CIGB, La Habana, Cuba
ACCIONES DE EDUCACIÓN AMBIENTAL PARA ENFRENTAR EL CAMBIO CLIMÁTICO
DESDE LA FORMACIÓN DEL PROFESIONAL EN CIENCIAS FARMACÉUTICAS Y
CO-77 12:00-12:10 ALIMENTARIAS | ENVIRONMENTAL EDUCATION ACTIONS TO FACE CLIMATE CHANGE
FROM PROFESSIONAL TRAINING IN PHARMACEUTICAL AND FOOD SCIENCES
Damaris García, PhD, IFAL-UH, La Habana, Cuba
MAESTRÍA EN TECNOLOGÍA Y CONTROL DE MEDICAMENTOS. UN PROGRAMA DE
EXCELENCIA PARA LA SUPERACIÓN PROFESIONAL DEL PERSONAL FARMACÉUTICO |
MASTER'S DEGREE IN PHARMACEUTICAL TECHNOLOGY AND CONTROL. A PROGRAM
CO-78 12:10-12:20
OF EXCELLENCE FOR THE PROFESSIONAL IMPROVEMENT OF PHARMACEUTICAL
PERSONNEL
MAESTRÏA EN FARMACIA CLÍNICA DEL IFAL: RESULTADOS Y PERSPECTIVAS |
CO-79 12:20-12:30 MASTER'S DEGREE IN CLINICAL PHARMACY AT IFAL: RESULTS AND PERSPECTIVES
Milena Díaz Molina, PhD, IFAL-UH, La Habana, Cuba
DIAGNÓSTICO INICIAL DEL DESEMPEÑO PROFESIONAL DE LOS PROFESORES
NOVELES DE CIENCIAS ALIMENTARIAS DEL IFAL | INITIAL DIAGNOSIS OF THE
CO-80 12:30-12:40 PROFESSIONAL PERFORMANCE OF THE NOVICE TEACHERS OF FOOD SCIENCES OF
IFAL
Whilmer Armas, PhD, IFAL-UH, La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxxv


COORDINADORES | COORDINATORS: Olga María Nieto Acosta, PhD / Caridad Sedeño Argilagos, PhD / Milena Díaz, PhD, IFAL-UH,
La Habana, Cuba
EXPERIENCIA DEL USO DE WHATSAPP COMO RECURSO EDUCATIVO Y TECNOLÓGICO EN LA
EDUCACIÓN DE POSGRADO | EXPERIENCE OF USING WHATSAPP AS AN EDUCATIONAL AND
P-142 12:50-12:55
TECHNOLOGICAL RESOURCE IN GRADUATE EDUCATION
Caridad Sedeño Argilagos, PhD, IFAL-UH, La Habana, Cuba
COMPETENCIAS DE LOS FARMACÉUTICOS DE IFAL Y SU DESEMPEÑO LABORAL EN
BIOCUBAFARMA | COMPETENCES OF IFAL PHARMACISTS AND THEIR WORK PERFORMANCE IN
P-143 12:55-13:00
BIOCUBAFARMA
Hermes Ulises Guerra González, CESFARMA, BIOCUBAFARMA, La Habana, Cuba
PRIMERAS EXPERIENCIAS EN LA IMPARTICIÓN DE METROLOGÍA EN LAS CIENCIAS
FARMACÉUTICAS CURSO DIURNO | FIRST EXPERIENCES IN TEACHING METROLOGY IN
P-144 13:00-13:05
PHARMACEUTICAL SCIENCES DAY COURSE
Armando Perdomo Morales, IFAL-UH, La Habana, Cuba
CARACTERIZACIÓN DE LA LISTA DE MEDICAMENTOS DEL HOSPITAL NACIONAL DE
OBSTETRICIA Y GINECOLOGÍA EN VIETNAM | CHARACTERIZATION OF THE DRUG LIST OF THE
P-145 13:05-13:10
NATIONAL HOSPITAL FOR OBSTETRICS AND GYNECOLOGY IN VIETNAM
Anai García Fariñas, IFAL-UH, La Habana, Cuba
GESTIÓN INTEGRAL DE LA FARMACOTERAPIA A PACIENTES CON ENFERMEDADES
CARDIOVASCULARES HOSPITALIZADOS | COMPREHENSIVE MANAGEMENT OF
P-146 13:10-13:15
PHARMACOTHERAPY FOR HOSPITALIZED PATIENTS WITH CARDIOVASCULAR DISEASES
Maraelys Morales González, Universidad de Oriente, Santiago de Cuba, Cuba
USO DEL NIFEDIPINO EN LA AMENAZA DE PARTO PREMATURO | USE OF NIFEDIPINE IN
THREATENED PRETERM LABOR
P-147 13:15-13:20
Olga María Osa Echenique, Hospital Ginecobstétrico José Ramón López Tabranes, Departamento de
Farmacia, Matanzas, Cuba
INTERACCIONES FARMACOLÓGICAS Y RIESGO ANTICOLINÉRGICO EN ADULTOS MAYORES
DEL MUNICIPIO SAN MIGUEL DEL PADRÓN, LA HABANA, CUBA | DRUG INTERACTIONS AND
P-148 14:00-14:05 ANTICHOLINERGIC RISK IN OLDER ADULTS IN THE SAN MIGUEL DEL PADRÓN MUNICIPALITY,
HAVANA, CUBA
Yoanna Herrera Preval, IFAL-UH, La Habana, Cuba
PROYECTO INDIVIDUAL DE MEJORAMIENTO PROFESIONAL Y HUMANO DE LOS DOCENTES DE
CIENCIAS ALIMENTARIAS DEL IFAL | INDIVIDUAL PROJECT FOR THE PROFESSIONAL AND
P-149 14:05-14:10
HUMAN IMPROVEMENT OF IFAL FOOD SCIENCE PROFESSORS
DIAGNÓSTICO INICIAL DEL DESEMPEÑO PROFESIONAL DE LOS PROFESORES NOVELES DE
CIENCIAS DE LOS ALIMENTOS DEL IFAL | INITIAL DIAGNOSIS OF THE PROFESSIONAL
P-150 14:10-14:15
PERFORMANCE OF THE NOVICE TEACHERS OF FOOD SCIENCES OF IFAL
CESFARMA, UN EJEMPLO DE COLABORACIÓN UNIVERSIDAD-EMPRESA. RESUMEN DE SUS
PRIMEROS 15 AÑOS | CESFARMA, AN EXAMPLE OF UNIVERSITY-COMPANY COLLABORATION.
P-151 14:15-14:20
SUMMARY OF ITS FIRST 15 YEARS
COMPORTAMIENTO DE LA COVID-19 EN EL ÁREA DE SALUD SEVILLANO PERTENECIENTE AL
POLICLÍNICO “TURCIOS LIMA”, DEL MUNICIPIO DIEZ DE OCTUBRE | BEHAVIOR OF COVID-19 IN
P-152 14:20-14:25 THE SEVILLANO HEALTH AREA BELONGING TO THE “TURCIOS LIMA” POLYCLINIC, IN THE DIEZ
DE OCTUBRE MUNICIPALITY
Grisel del Toro García, PhD, IFAL-UH, La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxxvi

EVALUACIÓN PRELIMINAR DEL IMPACTO DE LA MAESTRÍA EN TOXICOLOGÍA DEL INSTITUTO

DE FARMACIA Y ALIMENTOS DE LA UNIVERSIDAD DE LA HABANA | PRELIMINARY EVALUATION
P-153 14:25-14:30 OF THE IMPACT OF MASTER IN TOXICOLOGY OF THE PHARMACY AND FOOD INSTITUTE FROM
THE UNIVERSITY OF HAVANA
Beatriz Linares Diego, IFAL-UH, La Habana, Cuba
ESTUDIO PRELIMINAR DE COSTO DE PACIENTES OBSTÉTRICAS COMPLICADAS ATENDIDAS
EN LA SALA DE TERAPIA INTENSIVA DEL HOSPITAL FAUSTINO PÉREZ HERNÁNDEZ |
PRELIMINARY STUDY OF THE COST OF COMPLICATED OBSTETRIC PATIENTS TREATED IN THE
P-154 14:30-14:35
INTENSIVE CARE UNIT OF THE FAUSTINO PÉREZ HERNÁNDEZ HOSPITAL
Lourdes González Fernández, Hospital Provincial Clínico Quirúrgico Comandante Faustino Pérez,
Departamento de Farmacia, Matanzas, Cuba
ARTICULACIÓN DE LA DISCIPLINA PREPARACIÓN PARA LA DEFENSA CON LAS DISCIPLINAS DE
LA CARRERA DE CIENCIAS ALIMENTARIAS | ARTICULATION OF THE DISCIPLINE PREPARATION
P-155 14:35-14:40
FOR THE DEFENSE WITH THE DISCIPLINES OF THE FOOD SCIENCES CAREER
Madeline Ochoa Alomá, IFAL-UH, La Habana, Cuba
REVISIÓN DE LA MEDICACIÓN Y COSTOS ASOCIADOS EN FALLECIDOS POR COVID-19, PRIMER
BIMESTRE 2021, CUBA | REVIEW OF MEDICATION AND ASSOCIATED COSTS IN DECEASED BY
P-156 14:40-14:45
COVID-19, FIRST TWO MONTHS 2021, CUBA
Ingrid Elías Díaz, IFAL-UH, La Habana, Cuba
IMPLEMENTACIÓN DE COMPETENCIAS PROFESIONALES EN EL PROCESO DE TIENDAS |
P-157 14:45-14:50 IMPLEMENTATION OF PROFESSIONAL SKILLS IN THE STORES PROCESS
Lilianne Acosta Cardoso, Escuela de Turismo, La Habana, Cuba
PERCEPCIÓN DE LOS ESTUDIANTES SOBRE LA ASIGNATURA ANÁLISIS QUÍMICO
FARMACÉUTICO EN MODALIDAD NO PRESENCIAL | PERCEPTION OF THE STUDENTS ON THE
P-158 14:50-14:55
PHARMACEUTICAL CHEMICAL ANALYSIS SUBJECT IN NON-PRESENTIAL MODALITY
Amelie González Atá, IFAL-UH, La Habana, Cuba
EL VÍNCULO UNIVERSIDAD-EMPRESA Y SU IMPACTO EN LA MOTIVACIÓN PROFESIONAL DE
LOS ESTUDIANTES DE CIENCIAS FARMACÉUTICAS | UNIVERSITY-COMPANY LINK AND ITS
P-159 14:55-15:00
IMPACT ON THE PROFESSIONAL MOTIVATION OF PHARMACEUTICAL SCIENCES STUDENTS
Mara Fernández, IFAL-UH, La Habana, Cuba
UNIDAD DIDÁCTICA ONLINE EN LA ASIGNATURA MICROBIOLOGÍA GENERAL EN CIENCIAS DE
LOS ALIMENTOS | ONLINE DIDACTIC UNIT IN THE SUBJECT GENERAL MICROBIOLOGY IN FOOD
P-160 15:00-15:05
SCIENCES
Silvia Caridad Morales Ramos, IFAL-UH, La Habana, Cuba
FORMACIÓN CIENTÍFICA E INTERNACIONALIZACIÓN: EXPERIENCIA DEL INSTITUTO DE
FARMACIA Y ALIMENTOS DE LA UNIVERSIDAD DE LA HABANA | SCIENTIFIC TRAINING AND
P-161 (Off-
15:05-15:10 INTERNATIONALIZATION: EXPERIENCE OF THE INSTITUTE OF PHARMACY AND FOOD,
line)
UNIVERSITY OF HAVANA
Maelys Hernández-Almaguer, IFAL-UH, La Habana, Cuba
SATISFACCIÓN ESTUDIANTIL COMO INDICADOR DE CALIDAD DE LA ASIGNATURA BIOLOGÍA
CELULAR EN EL PLAN DE ESTUDIOS E DE LA CARRERA CIENCIAS FARMACÉUTICAS
P-162 (Off- MODALIDAD CURSO DIURNO | STUDENT SATISFACTION AS AN INDICATOR OF QUALITY OF THE
15:10-15:15
line) CELLULAR BIOLOGY SUBJECT IN THE STUDY PLAN E OF THE PHARMACEUTICAL SCIENCES
CAREER, DAYTIME COURSE MODE
Alejandro Fabra González, IFAL-UH, La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxxvii

VIERNES 25 DE NOVIEMBRE | FRIDAY, NOVEMBER 25

SALA 1930 | ROOM 1930
S8-CIENCIAS ALIMENTARIAS | FOOD SCIENCES
- TECNOLOGÍA DE LOS ALIMENTOS | FOOD TECHNOLOGY
COORDINADORES | COORDINATORS: Danae Pérez Santana, PhD / Alicia Casariego Año PhD / Dairon I Guevara IFAL-UH, La
Habana, Cuba
MARKETING NUTRICIONAL, SALUD Y BIENESTAR PARA TODOS, LA NUEVA APUESTA DE LA
INDUSTRIA ALIMENTARIA | NUTRITIONAL MARKETING, HEALTH AND WELL-BEING FOR
CO-81 10:30-10:40
EVERYONE, THE NEW COMMITMENT OF THE FOOD INDUSTRY
Ernesto Cabezas García, IFAL-UH, La Habana, Cuba
FORMULACIÓN Y ESTABILIDAD DE ESPUMAS (AIRES) OBTENIDAS CON LECITINA DE SOYA |
CO-82 10:40- 10:50 FORMULATION AND STABILITY OF FOAMS (AIR) OBTAINED WITH SOY LECITHIN
Jesús Escandell Comesaña, IFAL-UH, La Habana, Cuba
USO DEL CARBÓN DE COCO EN LA INDUSTRIA DEL RON CUBANO | USE OF COCONUT
CHARCOAL IN THE CUBAN RUM INDUSTRY
CO-83 10:50-11:00
Diasney Corrales, Empresa de Bebidas y Refrescos de La Habana. UEB Ronera occidental. Arroyo
Naranjo. Havana, Cuba
PERFIL SENSORIAL DE LA CÁSCARA DEL GRANO DE CACAO TOSTADO CUBANO | SENSORY
CO-84 11:00-11:10 PROFILE OF THE SHELL OF THE ROASTED CUBAN COCOA BEAN
Danae Pérez, PhD, IFAL-UH, La Habana, Cuba
IMPLEMENTACIÓN DE UN PANEL SENSORIAL PARA EL ANÁLISIS Y CONTROL DE CALIDAD DE
LA MIEL DE ABEJA | IMPLEMENTATION OF A SENSORY PANEL FOR ANALYSIS AND QUALITY
CO-85 11:10-11:20
CONTROL OF BEE HONEY
Daymi Madernás Sánchez, Centro de Investigaciones Apícolas (CIAPI), La Habana, Cuba
OPTIMIZACIÓN DE LA CALIDAD SENSORIAL DE UN POSTRE LÁCTEO AROMATIZADO CON
PULPA DE MANGO | OPTIMIZING THE SENSORY QUALITY OF A DAIRY DESSERT FLAVORED
CO-86 11:20-11:30
WITH MANGO PULP
Dairon Iglesias Guevara, IFAL-UH, La Habana, Cuba
LA ELABORACIÓN DE UN HELADO DE CREMA CON HARINA DE YUCA | THE ELABORATION OF
CO-87 11:40-11:50 AN ICE CREAM WITH CASSAVA FLOUR
AnielyM´Boumba, CUJAE, La Habana, Cuba
OBTENCIÓN DE LECHE FERMENTADA ENRIQUECIDA CON EXTRACTO EN POLVO DE FLORES
DE MAJAGUA (Talipariti elatum SW) | OBTAINING FERMENTED MILK ENRICHED WITH POWDERED
CO-88 11:50-12:00
EXTRACT OF MAJAGUA FLOWERS (Talipariti elatum SW)
Alicia Casariego Año, PhD, IFAL-UH, La Habana, Cuba
SUSTITUCIÓN PARCIAL DE HARINA DE TRIGO POR HARINA DE YUCA EN GALLETAS DE SAL |
CO-89 12:00-12:10 PARTIAL REPLACEMENT OF WHEAT FLOUR BY CASSAVA FLOUR IN SALT CRACKERS
Iván González-Góngora, IFAL-UH, La Habana, Cuba
ELABORACIÓN DE UN POSTRE LÁCTEO CON HARINA DE YUCA | MAKING A DAIRY DESSERT
CO-90 12:10-12:20 WITH CASSAVA FLOUR
Yisel León Alomá, Instituto de Investigaciones de la Industria Alimentaria (IIIA), La Habana, Cuba
CLASIFICACIÓN DE LAS MIELES CUBANAS SEGÚN SU ORIGEN BOTÁNICO CON ANÁLISIS
MULTIVARIADO DE SU PERFIL POLIFENÓLICO Y DE FLAVONOIDES | CLASSIFICATION OF
P-163 12:20-12:25 CUBAN HONEYS ACCORDING TO BOTANICAL ORIGIN WITH MULTIVARIATE ANALYSIS OF THEIR
POLYPHENOL AND FLAVONOID PROFILE
Linet Díaz Villavicencio, Centro de Investigaciones Apícolas (CIAPI), La Habana, Cuba
CARACTERIZACIÓN DE UNA CREMA DE CHOCOLATE UNTABLE CON PRODUCTOS APÍCOLAS |
P-164 12:25-12:30 CHARACTERIZATION OF A SPREADABLE CHOCOLATE CREAM WITH BEE PRODUCTS
Mariela Vázquez Martínez, Centro de Investigaciones Apícolas (CIAPI), La Habana, Cuba
BEBIDA REFRESCANTE DE SUERO LÁCTEO CON LA ADICIÓN DE HARINA DE ARROZ Y SABOR
NARANJA | REFRESHING WHEY BEVERAGE WITH THE ADDITION OF RICE FLOUR AND ORANGE
P-165 12:30-12:35
FLAVOR
Dainelis Rodríguez, IFAL-UH, La Habana, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxxviii

SECADO POR ASPERSIÓN DE UN EXTRACTO CONCENTRADO DE FLOR DE MAJAGUA (Talipariti

elatum SW) | SPRAY DRYING OF AN EXTRACT MAJAGUA FLOWER CONCENTRATE (Talipariti
P-166 12:35-12:40
elatum SW)
Dianelis A. Leyva, IFAL-UH, La Habana, Cuba
BEBIDA REFRESCANTE DE SUERO DE LECHE CON FRUCTOOLIGOSACÁRIDOS Y PULPA DE
P-167 (Off- Reproducción ACEROLA (Malpighia Emarginata D.C) | REFRESHING WHEY DRINK WITH
Line) continua FRUCTOOLIGOSACCHARIDES AND ACEROLA PULP (Malpighia Emarginata D.C)
Ana M. Colominas, PhD, IFAL-UH, La Habana, Cuba
EVALUACIÓN SOBRE PARÁMETROS REPRODUCTIVOS DE LA INCLUSIÓN DE DIFERENTES
PORCENTAJES DE PROTEÍNA CRUDA DE FORRAJE DE MORINGA (Moringa oleífera) EN
P-168 (Off- Reproducción RACIONES PARA CONEJOS (Oryctolagus Cuniculus) | EVALUATION ON REPRODUCTIVE
Line) continua PARAMETERS OF THE INCLUSION OF DIFFERENT PERCENTAGES OF CRUDE PROTEIN FROM
MORINGA FORAGE (Moringa oleífera) IN RATIONS FOR RABBITS (Oryctolagus Cuniculus)
Guillermo Ajoy, CNEURO, La Habana, Cuba
ESTABILIDAD DE UN COLORANTE EN POLVO OBTENIDO DE LA FLOR DEL ¨MARPACÍFICO¨
(Hibiscus Rosasinensis L.) | STABILITY OF A POWDER DYE OBTAINED FROM THE FLOWER OF
P-169 (Off- Reproducción
THE ¨MARPACÍFICO¨ (Hibiscus Rosasinensis L)
Line) continua
José A. Arencibia, Facultad Tecnológica, Universidad de Santiago de Chile, Estación Central, Región
Metropolitana, Chile
PAUTAS JURÍDICAS PARA LA PREVENCIÓN Y REDUCCIÓN DE LA VULNERABILIDAD DEL
P-170 (Off- Reproducción FRAUDE ALIMENTARIO EN CUBA | LEGAL GUIDELINES FOR THE PREVENTION AND
Line) continua VULNERABILITY REDUCTION OF FOOD FRAUD IN CUBA
Jorge Rondón Valdés, Universidad de Granma, Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxxxix


S10 – 3er TALLER ESTUDIANTIL DE CIENCIAS FARMACÉUTICAS Y ALIMENTARIAS |
3rd STUDENT WORKSHOP OF PHARMACEUTICAL AND FOOD SCIENCES
COORDINADORES | COORDINATORS: Alicia Casariego Año, PhD / Raisa Mangas Marín, PhD / Luis Michel Rodríguez Gómez, BSc,
CARACTERIZACIÓN DE LOS HÁBITOS ALIMENTICIOS EN ADULTOS MAYORES CON
HIPERTENSIÓN ARTERIAL EN LA COMUNIDAD DE CAMAGÜEY | CHARACTERIZATION OF
P-188 10:30-10:35 EATING HABITS IN OLDER ADULTS WITH ARTERIAL HYPERTENSION IN A CAMAGÜEY
COMMUNITY
Armando A. Macias González, Universidad de Camagüey, Camagüey, Cuba
CRECIMIENTO MICROBIANO DE L. ARIZONENSIS Y S. THERMOPHILUS EN DIFERENTES MEDIOS
DE CULTIVO | MICROBIAL GROWTH OF L. ARIZONENSIS AND S. THERMOPHILUS IN DIFFERENT
P-189 10:35-10:40
CULTURE MEDIA
Daniela Hernández Machado, Universidad de Camagüey, Camagüey, Cuba
SEGURIDAD Y SOBERANÍA ALIMENTARIA EN LA EMPRESA EXTRAHOTELERA PALMARES S.A |
P-190 10:40-10:45 FOOD SECURITY AND SOVEREIGNTY IN THE NON-HOTEL COMPANY PALMARES S.A
Ana Rocío Oliva Álvarez, IFAL-UH, La Habana, Cuba
ENCAPSULACIÓN POR ELECTROSPINNING DEL EXTRACTO DE LA FLOR DE MAJAGUA (Talipariti
elatum SW) EN ESTRUCTURAS ZEIN | ELECTROSPINNING ENCAPSULATION OF MAJAGUA
P-191 10:45-10:50
FLOWER EXTRACT (Talipariti elatum SW.) IN ZEIN STRUCTURES
Marcos A. González Correa, IFAL-UH, La Habana, Cuba
OBTENCIÓN DE UN EXTRACTO EN POLVO DE LA FLOR DE MAJAGUA (Talipariti elatum SW) CON
POTENCIAL USO ALIMENTICIO | OBTAINING A POWDER EXTRACT FROM THE MAJAGUA
P-192 10:50-10:55
FLOWER (Talipariti elatum SW) WITH POTENTIAL FOOD USE.
Ángela A. Peralta González, IFAL-UH, La Habana, Cuba
OBTENCIÓN DE UNA BEBIDA LÁCTEA CON SABOR A CAFÉ A PARTIR DE LECHE DE SOYA Y
SUERO DE LECHE | OBTAINING A COFFEE-FLAVORED DAIRY DRINK USING SOY MILK AND
P-193 10:55-11:00
WHEY
Maykel Negrín Hernández, IFAL-UH, La Habana, Cuba
TAREAS DOCENTES INTEGRADORAS EN EL PERFIL CLÍNICO FARMACÉUTICO: PERCEPCIONES
DE ESTUDIANTES EN EL CONTEXTO COVID-19 | INTEGRATIVE TEACHING TASKS IN THE
P-194 11:00-11:05
PHARMACEUTICAL CLINICAL PROFILE: STUDENTS´PERCEPTIONS IN THE CONTEXT COVID-19
Rut Benita Yero Haber, Universidad de Oriente, Santiago de Cuba, Cuba
USO DEL ACEITE DE SEMILLA DE UVA PARA LA FORMULACIÓN DE CREMAS | USE OF GRAPE
P-195 11:05-11:10 SEED OIL FOR THE FORMULATION OF CREAMS
Melissa Carmona Rodríguez, IFAL-UH, La Habana, Cuba
CARACTERIZACIÓN FARMACOBOTANICA Y FISICOQUIMICA DE PLECTRANTHUS NEOCHILUS
SCHLT (PLANTA DE MEPROBAMATO) | PHARMACOBOTANICAL AND PHYSICOCHEMICAL
P-196 11:10-11:15
CHARACTERIZATION OF PLECTRANTHUS NEOCHILUS SCHLT (MEPROBAMATE PLANT)
Roselis Balseiro Gamboa, IFAL-UH, La Habana, Cuba
ESTUDIO DE PREFORMULACIÓN DE UN TÓNICO FACIAL CON PRODUCTOS DE LA COLMENA Y
ALOE VERA | PREFORMULATION STUDY OF A FACIAL TONIC WITH HIVE PRODUCTS AND ALOE
P-197 11:25-11:30
VERA
Dayan Zahony Walwyn Fonseca, IFAL-UH, La Habana, Cuba
HEMODERIVADOS EN CUBA, PERSPECTIVAS DE DESARROLLO | BLOOD PRODUCTS IN CUBA,
P-198 11:30-11:35 PROSPECTS FOR DEVELOPMENT
Daniela García Urquiza, IFAL-UH, La Habana, Cuba
CARACTERIZACIÓN FARMACOGNÓSTICA Y FITOQUÍMICA DE LAS HOJAS DE RAVENIA
SPECTABILIS QUE CRECE EN CUBA | PHARMACOGNOSTIC AND PHYTOCHEMICAL
P-199 11:35-11:40
CHARACTERIZATION OF THE LEAVES OF RAVENIA SPECTABILIS THAT GROWS IN CUBA
Melissa Ll. Gómez, Universidad Central “Martha Abreu” de las Villas (UCLV), Cuba
P-200 11:40-11:45 ESTANDARIZACIÓN DE UN MODELO EXPERIMENTAL DE INFARTO CEREBRAL HEMORRÁGICO
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxl

POR ADMINISTRACIÓN INTRACEREBRAL DE SANGRE AUTÓLOGA: PARÁMETROS DE ESTRÉS

OXIDATIVO | STANDARDIZATION OF THE EXPERIMENTAL MODEL OF HEMORRHAGIC STROKE
BY INTRACEREBRAL ADMINISTRATION OF AUTOLOGOUS BLOOD: OXIDATIVE STRESS
PARAMETERS
Melissa Laurente Flores, IFAL-UH, La Habana, Cuba
ESTANDARIZACIÓN DEL MODELO EXPERIMENTAL DE INFARTO CEREBRAL HEMORRÁGICO
POR ADMINISTRACIÓN INTRACEREBRAL DE SANGRE AUTÓLOGA: VARIABLES COGNOCITIVAS
(MEMORIA) | STANDARDIZATION OF THE EXPERIMENTAL MODEL OF HEMORRHAGIC STROKE
P-201 11:45-11:50
BY INTRACEREBRAL ADMINISTRATION OF AUTOLOGOUS BLOOD: COGNOSCITIVE VARIABLES
(MEMORY)
Yiliana de la Caridad A. Álvarez, IFAL-UH, La Habana, Cuba
USO DE LAS SEMILLAS DE MORINGA OLEIFERA AND PLUKENETIA VOLUBILIS Y SU APLICACIÓN
EN LA INDUSTRIA FARMACÉUTICA | USE OF MORINGA OLEIFERA AND PLUKENETIA VOLUBILIS
P-202 11:50-11:55
SEEDS AND THEIR APPLICATION IN THE PHARMACEUTICAL INDUSTRY
Antonio González Rosales, IFAL-UH, La Habana, Cuba
LAS COMPETENCIAS PROFESIONALES DE LOS FARMACÉUTICOS CUBANOS | PROFESSIONAL
P-203 11:55-12:00 SKILLS OF CUBAN PHARMACISTS
Adriana Padrón González, IFAL-UH, La Habana, Cuba
CARACTERIZACIÓN DE UN MODELO ANIMAL NO INFECCIOSO QUE MIMETIZA LA
SINTOMATOLOGÍA DE LA COVID-19 | CHARACTERIZATION OF A NON-INFECTIOUS ANIMAL
P-204 12:00-12:05
MODEL THAT MIMICS THE SYMPTOMS OF COVID-19
Olivia Medina Vízcaino, IFAL-UH, La Habana, Cuba
TINTURA DE PROPÓLEOS CON CALIDAD FARMACÉUTICA MEDIANTE MODIFICACIONES DE SU
TECNOLOGÍA DE PRODUCCIÓN | PROPOLIS TINCTURE WITH PHARMACEUTICAL QUALITY
P-205 12:05-12:10
THROUGH MODIFICATIONS OF ITS PRODUCTION TECHNOLOGY
Idalmis Ojeda González, Universidad Central “Martha Abreu” de las Villas (UCLV), Cuba
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxli


S9-CARTELES MIXTOS-CIENCIAS FARMACÉUTICAS | POSTER-MIX PHARMACEUTICAL SCIENCES
COORDINADORES | COORDINATORS: Yolexis Tamayo García, MSc. IFAL-UH, La Habana, Cuba
PRODUCCIONES LIMPIAS EN LA GESTION DE RESIDUOS DE EGF Y PEPTIDOS SINTÉTICOS |
P-171 12:30-12:35 CLEANER PRODUCTIONS IN THE MANAGEMENT OF RESIDUAL EGF AND SYNTHETIC PEPTIDES
Patricia Fernández Guerra, CIGB, La Habana, Cuba
ESTUDIO DE ALMACENAMIENTO A TEMPERATURA AMBIENTE DEL MEDIO DE CULTIVO PFHM II
UTILIZADO PARA LA LÍNEA CELULAR T1H/3E9-1 F6 | STUDY OF STORAGE AT ROOM
P-172 12:35-12:40
TEMPERATURE OF THE PFHMII CULTURE MEDIUM USED FOR THE T1H/3E9-1F6 CELL LINE
Elizabeth Reyes Benítez, CIM, La Habana, Cuba
EVALUACIÓN DEL DESEMPEÑO DE UN MÉTODO ANALÍTICO POR CROMATOGRAFÍA LÍQUIDA
PARA EL CONTROL DE CALIDAD Y ESTABILIDAD DEL PRODUCTO INYECTABLE CLORHIDRATO
DE IRINOTECÁN | EVALUATION OF THE PERFORMANCE OF AN ANALYTICAL METHOD BY
P-173 12:40-12:45
LIQUID CHROMATOGRAPHY FOR QUALITY CONTROL AND STABILITY OF THE INJECTABLE
PRODUCT IRINOTACAN HYDROCHLORIDE
Evelyn Guerra Vidal, AICA, La Habana, Cuba
ESTUDIO DE SEGURIDAD DE HEPARINA SÓDICA 5000 UI/mL EN PACIENTES EN EDAD
GERIÁTRICA. NOTIFICACIONES ESPONTANEAS | SAFETY STUDY OF SODIUM HEPARIN 5000
P-174 12:45-12:50
IU/mL IN GERIATRIC PATIENTS. SPONTANEOUS NOTIFICATIONS
Nancy Burguet, AICA, La Habana, Cuba
ESTUDIO DE ESTABILIDAD PRELIMINAR PARA RESPALDAR EL USO DEL CANDIDATO VACUNAL
ORAL LIOFILIZADO VIVA ATENUADA 638 VIBRIO CHOLERAE DESPUÉS DE LA RECONSTITUCIÓN
P-175 12:50-12:55 | PRELIMINARY STABILITY STUDY TO SUPPORT USE OF FREEZE DRIED LIVE-ATTENUATED 638
VIBRIO CHOLERAE ORAL VACCINE CANDIDATE AFTER RECONSTITUTION
Yolexis Tamayo, IFAL-UH, La Habana, Cuba
EVALUACIÓN DEL CUMPLIMIENTO DE LAS BUENAS PRÁCTICAS DE ALMACENAMIENTO Y
DISTRIBUCION EN LA UEB DE SUMINISTROS FARMACÉUTICOS | ASSESSMENT OF
P-176 12:55-13:00 COMPLIANCE WITH GOOD STORAGE AND DISTRIBUTION PRACTICES IN THE UEB OF
PHARMACEUTICAL SUPPLIES
Yaritza Mendoza Sam, EMCOMED, La Habana, Cuba
GESTIÓN DE DESECHOS SOLIDOS RECICLABLES DEL CENTRO DE INGENIERIA GENETICA Y
P-177 (Off- Reproducción BIOTECNOLOGÍA | MANAGEMENT OF RECYCLABLE SOLID WASTE AT THE CENTER FOR
line) continua GENETIC ENGINEERING AND BIOTECHNOLOGY
Wilson Chávez, CIGB, La Habana, Cuba
DISEÑO DE UN MEDIO DE TRANSPORTE DE LEPTOSPIRA LISTO PARA USAR (LEPTOCEN T LPU)
| DESIGN OF A READY-TO-USE TRANSPORT MEDIUM FOR LEPTOSPIRA (LEPTOCEN T LPU)
line) continua
Angélica María Machado, BioCen, Mayabeque, Cuba
OBTENCIÓN DE UN DIAGNOSTICADOR DE MICROORGANISMOS ANAEROBIOS ESTRICTOS Y
P-179 (Off- Reproducción FACULTATIVOS EN MUESTRAS DE SANGRE | OBTAINING A DIAGNOSTICIAN OF STRICT AND
line) continua FACULTATIVE ANAEROBIC MICROORGANISMS IN BLOOD SAMPLES
Ana I. Brito, BioCen, Mayabeque, Cuba
DESARROLLO DE NUEVAS MATERIAS PRIMAS ALERGÉNICAS PARA LA OBTENCIÓN DE
P-180 (Off- Reproducción VACUNAS ANTIALÉRGICAS | DEVELOPMENT OF NEW ALLERGENIC RAW MATERIALS TO
line) continua OBTAIN ANTI-ALLERGY VACCINES
Benito L Espinosa, BioCen, Mayabeque, Cuba
OBTENCIÓN DEL INGREDIENTE FARMACÉUTICO ACTIVO DE LAS NUEVAS VACUNAS PARA
INMUNOTERAPIA SUBLINGUAL DIVALER-SL Y TRIVALER-SL | OBTAINING THE ACTIVE
PHARMACEUTICAL INGREDIENT OF THE NEW VACCINES FOR SUBLINGUAL IMMUNOTHERAPY
line) continua
DIVALER-SL AND TRIVALER-SL
Damaris Torralba, BioCen, Mayabeque, Cuba
ESTUDIO DE CITOTOXICIDAD E INACTIVACIÓN DE MICROORGANISMOS DEL MEDIO DE
TRANSPORTE VIRAL INACTIVADO TAN | STUDY ON THE CYTOTOXICITY AND INACTIVATION OF
line) continua
MICROORGANISMS OF THE INACTIVATED VIRAL TRANSPORT MEDIUM TAN
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxlii

Melanie Canal Viera, Facultad de Biología, Universidad de La Habana, Cuba

MEJORA DEL PROCESO DE FERMENTACIÓN PARA LA OBTENCIÓN DEL FACTOR DE
P-183 (Off- Reproducción CRECIMIENTO EPIDÉRMICO HUMANO | RECOMBINANTEIMPROVEMENT OF THE
line) continua FERMENTATION PROCESS TO OBTAIN RECOMBINANT HUMAN EPIDERMAL GROWTH FACTOR
Chabelly Cabañas, CIGB, La Habana, Cuba
CALIDAD BIOFARMACÉUTICA ENTRE TABLETAS DE HIDROCLOTIAZIDA 25 MG DE LIBERACIÓN
INMEDIATA (MULTIORIGEN) DE PRODUCCIÓN NACIONAL Y BRASILEÑAS |
P-184 (Off- Reproducción BIOPHARMACEUTICAL QUALITY BETWEEN TABLETS (MULTISOURCE) OF NATIONAL
line) continua PRODUCTION AND BRAZILIAN GENERIC OF IMMEDIATE RELEASE OF HYDROCHLOROTHIAZIDE
25 MG
Mirta Cabrera Reyte, SolMed, Empresa Laboratorios MedSol, La Habana, Cuba
INFLUENCIA DEL ESTRÉS OXIDATIVO EN LA FIBROMYALGIA | INFLUENCE OF OXIDATIVE
STRESS IN FIBROMYALGIA
line) continua
Arlety González Langaney, IFAL-UH, La Habana, Cuba
EVALUACIÓN DE DOS POLÍMEROS INERTES COMO AGENTES RETARDANTES DE LA
LIBERACIÓN EN LAS CARACTERÍSTICAS QUÍMICO-FÍSICAS Y LIBERACIÓN IN VITRO DE
P-186 (Off- Reproducción MICROESFERAS CARGADAS CON ZIDOVUDINA | EVALUATION OF TWO INERT POLYMERS AS A
line) continua RELEASE RETARDING AGENT IN THE PHYSICO-CHEMICALS CHARACTERISTICS AND IN VITRO
RELEASE OF ZIDOVUDINE LOADED MICROSPHERES
Nicté González Alfonso, MSc, CIDEM, La Habana, Cuba
EFECTOS TERAPÉUTICOS DE COMBINACIONES DE ANTICUERPOS ANTI GNRH EN RATONES
ATÍMICOS IMPLANTADOS CON LA LÍNEA TUMORAL HUMANA LNCAP DE CÁNCER DE PRÓSTATA
| THERAPEUTICS EFFECTS OF ANTI GNRH ANTIBODIES COMBINATIONS IN NUDE MICE
line) continua
IMPLANTED WITH THE HUMAN CELL LINE LNCAP
Franklin Fuentes Aguilar, CIGB, Camagüey

SALA 1930 | ROOM 1930
CEREMONIA DE CLAUSURA | CLOSING CEREMONY
COORDINADORES | COORDINATORS:
17:00-18:00
Gledys Reynaldo Fernández, PhD / Gilberto L Pardo-Andreu, PhD
18:00-20:00 FIESTA DE DESPEDIDA | FAREWELL PARTY
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxliii

ECFA 2022
6to
ENCUENTRO INTERNACIONAL DE CIENCIAS Hotel Nacional de Cuba
FARMACÉUTICAS Y ALIMENTARIAS La Habana, 23-25 de Noviembre, 2022
6TH INTERNATIONAL MEETING OF Cuban National Hotel

PHARMACEUTICAL Havana, November 23-25, 2022
AND FOOD SCIENCES
SALA | ROOM MIÉRCOLES 23 NOVEMBER | WEDNESDAY, NOVEMBER 23 JUEVES 24 NOVIEMBRE | THURSDAY NOVEMBER, 24 VIERNES 25 NOVEMBER | FRIDAY, NOVEMBER 25
Comité 8:30-9:00: Acreditación de delegados | Registration of 8:30-9:00: Acreditación de delegados | Registration of

8:30-9:00: Acreditación de delegados | Registration of delegates.
Organizador delegates. delegates.
9:00-9:30: Ceremonia inaugural | Opening ceremony 17:00-20:00 Ceremonia de clausura y actividad de
1930
despedida | Closing ceremony and farewell activity
9:30-10:00: CP-01: ATAXIAS ESPINOCEREBELOSAS: 9:00-9:30: CP-03: DISEÑO MOLECULAR Y EVALUACIÓN DE LAS 9:00-9:30: CP-06: VACUNAS INNOVADORAS Y
DESDE SUS ESTADOS PRE-SINTOMÁTICOS A LOS VACUNAS SOBERANA 02 Y SOBERANA PLUS | MOLECULAR PROYECTOS FARMACÉUTICOS COMO CENTRO DE LA
ENSAYOS CLÍNICOS Y BIOMARCADORES TEMPRANOS | DESIGN AND EVALUATION OF SOBERANA 02 AND SOBERANA CARTERA BIOMÉDICA DEL CIGB | INNOVATIVE
SPINOCEREBELLAR ATAXIAS: FROM PREMANIFEST PLUS VACCINES VACCINES AND PHARMACEUTICAL PROJECTS AS A
STAGE TO EARLY CLINICAL TRIALS AND BIOMARKERS Sonsire Fernández Castillo, PhD, Instituto Finlay de Vacunas, La FOCUS OF THE BIOMEDICAL PIPELINE OF CIGB
Luis Velázquez. PhD, Presidente Academia de Ciencias de Habana, Cuba Gerardo Guillén, PhD, CIGB, La Habana, Cuba
Cuba
10:00-10:30: CP-02: LA FERROPTOSIS COMO BLANCO 9:30-10:00: CP-04: SEGURIDAD ALIMENTARIA Y NUTRICIONAL. 9:30-10:00: CP-07: VACUNA ABDALA ANTI-COVID-19:
1930
FARMACOLÓGICO EN LA ENFERMEDAD | FERROPTOSIS MARCO DE REFERENCIA Y APLICACIÓN | FOOD AND EXPERIENCIA CLÍNICA | ABDALA VACCINE ANTI-COVID-
TARGETING IN DISEASE NUTRITIONAL SECURITY. REFERENTIAL FRAMEWORK AND 19: CLINICAL EXPERIENCE
Tom Vanden Berghe, Assistant Professor University of APPLICATION Verena Muzio, PhD, CIGB, La Habana, Cuba
Antwerp, Guest-Professor University of Ghent, Belgium María Isabel Lantero, PhD, IFAL-UH, La Habana, Cuba
10:00-10:30: CP-05: TRANSMISIÓN DE RESISTENCIA A LOS 10:00-10:30: CP-08: EL RON CUBANO, PATRIMONIO
ANTIMICROBIANOS A TRAVÉS DE LOS ALIMENTOS | INMATERIAL DE LA HUMANIDAD | THE CUBAN RUM,
TRANSMISSION OF ANTIMICROBIAL RESISTANCE THROUGH INTANGIBLE HERITAGE OF HUMANKIND
FOOD Salomé Alemán Carriazo, Ing, Maestra del Ron Cubano,
Yamila Puig, PhD, INHEM, La Habana, Cuba Corporación Cuba Ron S.A.
10:30-11:00: RECESO | COFFEE BREAK 10:30-11:00: RECESO | COFFEE BREAK 13:30-14:00: MERIENDA | SNACK
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxliv

SALA | ROOM MIÉRCOLES 23 NOVEMBER | WEDNESDAY, NOVEMBER 23 JUEVES 24 NOVIEMBRE | THURSDAY NOVEMBER, 24 VIERNES 25 NOVEMBER | FRIDAY, NOVEMBER 25
SIMPOSIOS Y TALLERES | SYMPOSIA AND WORKSHOPS

11:00-14:00 | 15:00-17:00: MIÉRCOLES 23 NOVIEMBRE, JUEVES 24 NOVIEMBRE | WENESDAY NOVEMBER 23, THURSDAY NOVEMBER 24
10:30-13:30 | 14:00-17:00: VIERNES 25 NOVIEMBRE | FRIDAY, NOVEMBER 25
14:00-15:00: ALMUERZO | LUNCH 14:00-15:00: ALMUERZO | LUNCH 13:30-14:00: MERIENDA | SNACK
11:00-14:00 | 15:00-17:00: S2 – TECNOLOGÍA 11:00-13:35 | 15:05-17:00: S6-CIENCIAS ALIMENTARIAS | FOOD 10:30-12:50: S8-CIENCIAS ALIMENTARIAS | FOOD
FARMACÉUTICA, COSMÉTICA Y PRODUCTOS DE LA SCIENCES SCIENCES
COLMENA | PHARMACEUTICAL TECHNOLOGY, COSMETIC - TECNOLOGÍA DE LOS ALIMENTOS | FOOD TECHNOLOGY - TECNOLOGÍA DE LOS ALIMENTOS | FOOD
AND BEES PRODUCTS – ALIMENTACIÓN Y SALUD | DIET AND HEALTH TECHNOLOGY
COORDINADORES | COORDINATORS: Antonio Iraizoz – EVALUACIÓN Y CONTROL DE ALIMENTOS | EVALUATION AND COORDINADORES | COORDINATORS:
Colarte, PhD / Irela Pérez Sánchez, PhD / Patricia Pérez CONTROL OF FOOD Danae Pérez Santana, PhD / Alicia Casariego Año PhD /
Ramos, PhD - CIENCIA Y GASTRONOMÍA | SCIENCE AND GASTRONOMY Dairon I Guevara
IFAL-UH, La Habana, Cuba COORDINADORES | COORDINATORS: IFAL-UH, La Habana, Cuba
Danae Pérez Santana, PhD / Alicia Casariego Año PhD / Dairon I 17:00-18:00: CEREMONIA DE CLAUSURA | CLOSING
Guevara CEREMONY
1930 IFAL-UH, La Habana, Cuba COORDINADORES | COORDINATORS:
Gledys Reynaldo Fernández, PhD / Gilberto L Pardo-
Andreu, PhD, IFAL-UH, La Habana, Cuba
18:00-20:00: ACTIVIDAD DE DESPEDIDA | FAREWELL
15:05-17:00: S6-CIENCIAS ALIMENTARIAS | FOOD SCIENCES ACTIVITY
COORDINADORES | COORDINATORS: María Isabel Lantero, PhD /
René Tejedor Arias, PhD
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxlv

SALA | ROOM MIÉRCOLES 23 NOVEMBER | WEDNESDAY, NOVEMBER 23 JUEVES 24 NOVIEMBRE | THURSDAY NOVEMBER 24 VIERNES 25 NOVEMBER | FRIDAY, NOVEMBER 25
11:00-13:35 | 15:00-17:00: S3 - CONTROL Y 11:00-13:30 | 15:05-17:00: S5 –FARMACOLOGÍA, TOXICOLOGÍA Y 10:30-13:30 | 14:00-15:25: S7 - ENSEÑANZA DE LAS
ASEGURAMIENTO DE LA CALIDAD | QUALITY CONTROL BIOTECNOLOGÍA | PHARMACOLOGY, TOXICOLOGY AND CIENCIAS FARMACÉUTICAS Y ALIMENTARIAS-
AND ASSURANCE BIOTECHNOLOGY SERVICIOS FARMACÉUTICOS-FARMACOECONOMÍA |
COORDINADORES | COORDINATORS: COORDINADORES | COORDINATORS: TEACHING OF PHARMACEUTICAL AND FOOD
Yania Suárez Pérez PhD, PhD / Mirna Fernández-Cervera, PhD Olga Sonia León, PhD, IFAL-UH, Cuba / Yoagne Trapero, PhD, IFAL- SCIENCES-PHARMACEUTICAL SERVICES-
PARISIEN
/ Amelié González Atá, MSc / Yolexis Tamayo García, MSc UH, Cuba / Laura Machín, MSc, IFAL-UH, Cuba PHARMACOECONOMY
IFAL-UH, La Habana, Cuba IFAL-UH, La Habana, Cuba COORDINADORES | COORDINATORS:
Olga María Nieto Acosta, PhD / Caridad Sedeño Argilagos,
PhD / Milena Díaz, PhD
11:00-13:00 | 15:05-16:35: S1_2do SIMPOSIO SOBRE 11:00-13:30 | 15:00-17:00: S4 - PLANTAS MEDICINALES - 10:30-12:20: S10 – 3er TALLER ESTUDIANTIL DE
MUERTE CELULAR REGULADA E INFLAMACIÓN | 2nd PRODUCTOS NATURALES-QUÍMICA MEDICINAL | MEDICINAL CIENCIAS FARMACÉUTICAS Y ALIMENTARIAS |
SIMPOSIUM ON REGULATED CELL DEATH AND PLANTS- NATURAL PRODUCTS-MEDICINAL CHEMISTRY 3rd STUDENT WORKSHOP OF PHARMACEUTICAL AND
INFLAMMATION COORDINADORES | COORDINATORS: FOOD SCIENCES
COORDINADORES | COORDINATORS: Yamilet Irene Gutiérrez Gaitén, PhD, IFAL-UH / Raiza Mangas Marín, COORDINADORES | COORDINATORS: Alicia Casariego
Gilberto L Pardo-Andreu, PhD, IFAL-UH, Cuba / Roberto PhD, IFAL-UH / Yoanna M Álvarez-Ginarte, PhD, FQ-UH, La Habana, Año, PhD / Raisa Mangas Marín, PhD / Luis Michel
Fernández-Acosta, MSc, IFAL-UH, Cuba / Tom Vanden Berghe, Cuba Rodríguez Gómez, BSc
PhD, University of Antwerp, Belgium IFAL-UH, La Habana, Cuba
TAGANANA
12:30-13:00: S9-CARTELES MIXTOS-CIENCIAS

FARMACÉUTICAS | POSTER-MIX PHARMACEUTICAL
SCIENCES
COORDINADORES | COORDINATORS:
Yolexis Tamayo García, MSc
http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sxlvi

Index
Index ..........................................................................................................................................................................................................................................................................1
SHORT COMMUNICATIONS .....................................................................................................................................................................................................................................9
Design and optimization of diclofenac gel 1% as an analgesic and anti-inflammatory for topical use .......................................................................................................10
Development of the analytical method for quantification of diclofenac sodium, methyl and propylparaben by high performance liquid chromatography ............15
Determination of the hydrophilic-lipophilic balance of the lipid extract of Cucurbita pepo L. .....................................................................................................................21
ABSTRACTS .............................................................................................................................................................................................................................................................26
Do polypharmacological phytomedicinal compounds have a future in personalized precision oncology: a kino2omic perspective ....................................................27
Molecular mechanisms of nemorosone-induced ferroptosis in cancer cells ..................................................................................................................................................28
The pore-forming protein sticholysin II triggers regulated cell death .............................................................................................................................................................29
JM-20 treatment reduced neuronal death and astrocyte reactivity induced by ischemia/reperfusion: Involvement of the Akt/GSK-3β signaling pathway ..............30
Antitumor effect of the CIGB-552 peptide in colorectal cancer models ..........................................................................................................................................................31
Effect of IL-2 and mutant variant of IL-2 on peripheral blood mononuclear cells: expansion, characterization and functional activity ................................................32
Antiproliferative potentialities of carvacrol-rich essential oils from Cuban plants based on cell membrane fluidity ...............................................................................33
Mitochondrial contribution to ferroptosis ..........................................................................................................................................................................................................34
Inflammation index as prognostic and predictive factors in patients with lung cancer ................................................................................................................................35
Gossypitrin, a naturally occurring flavonoid, attenuates iron-induced neuronal and mitochondrial damage ..........................................................................................36
Novel iron oxide nanoparticles induce ferroptosis in a panel of cancer cell lines ..........................................................................................................................................37
Evaluation of the toxic effects of two formulations of magnetite nanoparticles on the earthworm Eisenia andrei ..................................................................................38
Marine seagrass extract of Thalassia testudinum suppresses tumor growth, motility and angiogenesis by autophagic stress and immunogenic cell death
pathways .................................................................................................................................................................................................................................................................39
A novel selective peptide targeting the JNK cascade inhibits neuronal ferroptosis and protects against cerebral ischemia in rats ......................................................40
Neuroprotective potential of a novel multitarget hybrid molecule, JM-20, in in vivo and in vitro models of Parkinson’s disease...........................................................41
Histochemical evaluation of the anti-inflammatory and neuroprotective effect of phycocyanobilin in C57BL/6 mice with experimental autoimmune
encephalomyelitis ..................................................................................................................................................................................................................................................42
Glutamate excitoxicity is counteracted by PCB modulation of redox pathway genes ..................................................................................................................................43
Methylene blue reduces doxorubicin-induced cardiotoxicity in rats, but increases their clinical deterioration........................................................................................44
Optimization of a non-infectious mouse model that reproduces the symptoms caused by COVID-19 .......................................................................................................45
Experimental model of hemorrhagic stroke by intracerebral administration of autologous blood: preliminary results .........................................................................46
New evidence of the interaction between the COMMD1 protein and the antitumor peptide CIGB-552 ......................................................................................................47
Cytotoxicity study of polymeric nanoparticles loading carprofen in retinoblastoma cell line .....................................................................................................................48
Relationship between oxidative stress and the degree of facial lipoatrophy in Cuban patients with HIV treated with antiretroviral ....................................................49
Development, optimization and evaluation of nanoparticles loading flurbiprofen: Ex vivo skin permeation in three different species ................................................50
Microemulsions loading baricitinib for autoimmune skin diseases .................................................................................................................................................................51
Development, introduction and generalization of a formulation of moxifloxacin 400 mg coated tablets..................................................................................................52
Improvements applied to the control of losses in the packaging material in the Medilip Oral Liquid Pharmaceutical Laboratory ........................................................53
Validation of the compressed air system of the Adalberto Pesant Serum and Blood Products Company of BioCubaFarma ..................................................................54
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Stability study of the recombinant protein of the receptor binding domain of the SARS-COV-2 virus ........................................................................................................55
Cosmetics in Cuba: opportunities and challenges .............................................................................................................................................................................................56
Cosmetic sciences at the Institute of Pharmacy and Food. Development and potentialities .......................................................................................................................57
Natural handmade cosmetics in Cuba.................................................................................................................................................................................................................58
Development of a dermocosmetic soap based on propolis and honey ..........................................................................................................................................................59
Design of a facial serum with bee products and Aloe vera ................................................................................................................................................................................60
Formulation and stability study of four creams made with bee products ......................................................................................................................................................61
Development of salt-free shampoos for treated and damaged hair ................................................................................................................................................................62
New raw material bentonite L-ascorbic acid: characterization and dermocosmetic applications ..............................................................................................................63
Technological development and stability study of Ritonavir 100 mg coated tablet ......................................................................................................................................64
Technological development of Moxifloxacin eye drops at 0.5% ......................................................................................................................................................................65
Development of Biclofen® injection ......................................................................................................................................................................................................................66
Design and optimization of diclofenac gel 1%, as an analgesic and anti-inflammatory for topical use ......................................................................................................67
Stability in use of the multidose presentation of the Abdala vaccine ..............................................................................................................................................................68
Lyophilized injectables omeprazole and vancomycin: evaluation of the homogeneity of drying ...............................................................................................................69
Technological development of cromolyn sodium 4%, nasal drops .................................................................................................................................................................70
Development of irinotecan hydrochloride injection ..........................................................................................................................................................................................71
Pharmaceutical development of the BioCen-128 formulation in multidose nasal drops for Alzheimer's disease treatment ..................................................................72
Stability study of a new cytostatic product of national production, gemcitabine .........................................................................................................................................73
Development of a new cytostatic of national production, gemcitabine .........................................................................................................................................................74
New formulation of 0.5% salbutamol solution for nebulization ......................................................................................................................................................................75
Incorporation of L-ascorbic acid into a natural bentonite: an alternative to preserve its antioxidant effect .............................................................................................76
Development of a hair growth stimulating lotion with residual tissue from the human placenta ...............................................................................................................77
Experiences in the quality control of forming films of polyvinyl chloride packaging material for light protection in blister pack tablets .............................................78
Influence of stress conditions on metformin-500 tablets..................................................................................................................................................................................79
Pharmaceutical development of new divalent and trivalent anti-allergy vaccines for sublingual immunotherapy .................................................................................80
Lamotrigine-100 mg, its introduction on an industrial scale ............................................................................................................................................................................81
Determination of HLBn of the lipid extract of Cucurbita pepo seeds ...............................................................................................................................................................82
PLGA nanoparticles loading derivative flavanone for transdermal human skin permeation study ............................................................................................................83
Baricitinib liposomes as a new approach for the treatment of Sjörgen’s Syndrome .....................................................................................................................................84
Effect of microneedles in the permeation of baricitinib in human skin ...........................................................................................................................................................85
Bacterial inhibitory action of clindamycin and metronidazole cremi-gel for the treatment of rosacea .....................................................................................................86
Development of microemulsions loading an immunomodulator for the treatment of skin inflammatory diseases ................................................................................87
Evaluation of the transdermal absorption of baricitinib solutions enriched with permeation enhancers .................................................................................................88
2-(5H-chromeno[2,3-b]pyridin-7-yl) propanoic acid loaded nanostructured lipid carriers and their ex vivo evaluation in different mucosa .......................................89
Characterization and release of a cross-linked alginate gel with anti-inflammatory properties .................................................................................................................90
Impact of ICH Q14 on analytical method validation ..........................................................................................................................................................................................91
Biopharmaceutical quality of 100 mg atenolol tablets from different sources ..............................................................................................................................................92

Development of a limit test chromatographic method for degradation products in nitrazepam tablets ...................................................................................................93
Development of the analytical methods for the quantification of diclofenac sodium, methyl and propyl-parabens by high performance liquid chromatography .94
Validation of technology transfer processes: Application to the manufacture of Jusvinza ..........................................................................................................................95
Design, development and generalization in Cuba of the first Transport Medium for Viruses (BTV) for the confirmatory diagnosis of COVID-19 ..................................96
Biosafety management in biotechnological projects in the context of COVID-19 ..........................................................................................................................................97
Design of a "customized" management model for EMCOMED's cold chain ....................................................................................................................................................98
Temperature excursions in the importation of thermo-sensible products by air ..........................................................................................................................................99
Stability study of the Coomassie solution based on the application of statistical tools ............................................................................................................................ 100
Evaluation of the active pharmaceutical ingredient of the BioCen-128 formulation stability ................................................................................................................... 101
Quality of clinical trials documentation audited by CENCEC during COVID-19 ........................................................................................................................................... 102
Risk- management related to the introduction of the manufacturing process of the active pharmaceutical ingredient of the RBD protein in the production system
............................................................................................................................................................................................................................................................................... 103
Failure analysis of problems found in bioprocesses ....................................................................................................................................................................................... 104
Gaps and opportunities for improvement in the Product Quality Review at Novatec ................................................................................................................................ 105
Development of analytical methodologies for the quantification of ambroxol-30 tablets ........................................................................................................................ 106
Development of the analytical technique for determination of the sulfate/carboxylate ratio in raw materials of sodium enoxaparin .............................................. 107
Validation of an analytical method to determine the stability in use of the injectable docetaxel-10 mg/mL ......................................................................................... 108
Validation of two analytical methods for the registration of a new cytostatic product of national production, gemcitabine .............................................................. 109
The validation of an analytical method for the quality control of enrofloxacin in injectable solution ..................................................................................................... 110
Establishing and validation of the Microlowry analytical technique for the quantification of total proteins .......................................................................................... 111
Validation of two analytical methods for the determination of purity for heberprot-P ............................................................................................................................. 112
Advantages of establishing and validating an alternative immunomodulatory assay for the determination of the in vitro potency of HeberFERON® ..................... 113
Validation of the polyacrylamide gel electrophoresis technique for the separation and control of the RBD active pharmaceutical ingredient ............................... 114
Total validation of an ELISA for the quantification of the receptor binding domain in batches of active pharmaceutical ingredient and Abdala finished product 115
Establishing and demonstration of the suitability and performance of the Microbiuret analytical technique in 96-well plates for the quantification of total
proteins ................................................................................................................................................................................................................................................................ 116
Validation of the reverse phase chromatography technique for the identification of the GHRP-6 peptide in the formulation of Acuabio V ...................................... 117
Characterization and certification of the reference material for the CIGB 814 peptide used in the release of the jusvinza .................................................................. 118
Determination of the isoelectric point of the RBD reference material for the release of the API samples of the vaccine candidate against COVID-19 ..................... 119
Determination of the free tetanus toxoid protein, in the active pharmaceutical ingredient of the Haemophilus influenzae type B (HiB) vaccine, by SDS-PAGE with
acrylamide gradient ............................................................................................................................................................................................................................................ 120
Physicochemical comparability of P3R99 mAb produced in three different cell lines................................................................................................................................ 121
Physical-chemical evaluation of the shark liver pool oil ................................................................................................................................................................................ 122
Development of a new alternative viral transport medium for the diagnosis of SARS-CoV-2.................................................................................................................... 123
Documentation management for nasal products derived from recombinant proteins ............................................................................................................................. 124
Improvement to the starting material sampling service at the pharmaceutical supply distribution center ........................................................................................... 125
Influence of the phenological stages in the pharmacognostic parameters and diuretic activity of Xiphidium caeruleum .................................................................... 126
Standardization of the hydroalcoholic extract of the leaves of Lippia alba Mill .......................................................................................................................................... 127
In vitro anticandidal activity of Cubans essential oils from Citrus limon and Plectranthus amboinicus .................................................................................................... 128

Dimerization and D-amino acid substitutions, but not acetylation, increase the inhibitory effect and stability of an interleukin-15 antagonist peptide ............... 129
Obtaining a raw material from Hibiscus sabdariffa L. (Jamaican flower) of national production for the elaboration of natural products ......................................... 130
QSAR models for identification of selective BACE 1/BACE 2 inhibitors in Alzheimer’s disease .................................................................................................................. 131
Covalent modifications of Cm-p5, a peptide derived from marine mollusk, a path towards the development of new pharmacologically viable AMPs .................. 132
Regulatory framework of traditional and complementary medicine. Focus on Cuba ................................................................................................................................ 133
Thalassia testudinum, the most abundant angiosperm in the Caribbean Sea, a look at its anticancer properties under sustainable bases ..................................... 134
Effects of suspension-Abexol®, tablet-Abexol and active ingredient-Abexol on ethanol induced-gastric ulcer in rats ........................................................................... 135
Clinical applications of the natural product curmeric during the COVID-19 pandemic in Cuba ................................................................................................................ 136
Development of an analytical method by HPLC to determine the composition of apitoxin and related products ................................................................................ 137
QSAR properties of conventional antiparasite drugs based on Lipinski’s rule of five ................................................................................................................................. 138
Comparison of chemical composition of the extracts of leaves from Clusia minor L. ................................................................................................................................. 139
Alternative synthesis of a 3,4-dibenzoilated fucose donor ............................................................................................................................................................................ 140
Biological evaluation of aqueous propolis extract obtained by different extraction methods ................................................................................................................. 141
Evaluation of the quality of the apitoxin of Apis mellifera in apiaries located in the west, center, and east of Cuba.............................................................................. 142
Pharmacognostic study, antioxidant and wound healing activity of the hydroalcoholic extract of Guarea guidonia ........................................................................... 143
Pharmacognostic study and hemostatic activity of the hydroalcoholic extract of Trasdescantia spathacea ......................................................................................... 144
Phytochemical study and antilithiatic activity of the aqueous extract of the leaves of Urera baccifera .................................................................................................. 145
Elaboration of antipsoriatic ointment at 15% with soft extract of Alternanthera sessilis L. R. Br .............................................................................................................. 146
Prediction of antihistamine activity using Quantitative Structure Activity Relationships methods ......................................................................................................... 147
Multicomponent synthesis of analogues of the inhibitor keto-ACE .............................................................................................................................................................. 148
Lewis Y: Efficiency of glycosylation from 2 fucose donors .............................................................................................................................................................................. 149
New challenges in the evaluation of quality, safety and efficacy of homeopathic drugs ........................................................................................................................... 150
New Morus alba L. raw material for the Cuban biopharmaceutical and food industries............................................................................................................................ 151
Phytochemistry and nephroprotective activity of hydroalcoholic extracts from leaves and rhizomes of Smilax purhampuy Ruiz ...................................................... 152
Phytochemical profile and topical anti-inflammatory activity of the aqueous extract of Malva pseudolavatera Webb & Berthel ....................................................... 153
Phenolic composition and in vitro inhibitory activity of xanthine oxidase from Mimusops coriacea (A.DC) Miq ..................................................................................... 154
Phytochemical characterization and anti-inflammatory potentialities of the leaves of Nephelium lappaceum L. from Ecuador ........................................................ 155
Physicochemical and phytochemical characterization of aqueous extracts of Corynaea crassa Hook. F ............................................................................................... 156
Ethnobotanical inventory of the two subspecies of Piper aduncum L. in Cuba ........................................................................................................................................... 157
Population pharmacokinetic modeling of fibrinogen in patients with congenital or acquired -chronic or acute- hypofibrinogenemia............................................. 158
Leveraging of Physiologically-Based Pharmacokinetic modeling to inform decision-making in different scenarios. Part I: evaluation of CNS drug delivery ......... 159
Medical ozone: pharmacological mechanisms as basis of its effectiveness on the immune response, vascular dysfunctions, surgery, and COVID-19/SARS-CoV-2
............................................................................................................................................................................................................................................................................... 160
Evaluation of the effects of Compvit-B® on behavioral disorders in a rat model of alcohol withdrawal syndrome ................................................................................ 161
Application of the biopharmaceutical classification system to the basic table of medicines of Cuba: bioequivalence in vivo or dissolution in vitro? ...................... 162
Therapeutic repositioning of the humanized monoclonal antibody itolizumab in COVID-19 ................................................................................................................... 163
Leveraging of Physiologically-Based Pharmacokinetic modeling to inform decision-making in different scenarios. Part II: drug-drug interactions in special
populations .......................................................................................................................................................................................................................................................... 164
Different patron of oxidative stress according to diverse clinical conditions of SARS-CoV-2 Cuban hospitalized patients ................................................................... 165

A novel drug candidate targeting host and viral proteins to inhibit viral infections ................................................................................................................................... 166
Safety and health practices in the handling of carcinogenic substances in laboratories of the Materials Science and Technology Institute .................................... 167
Neuroepo in mild-to-moderate Alzheimer’s clinical syndrome. Phase 2-3 controlled clinical trial .......................................................................................................... 168
Antileishmanial properties beyond the endoperoxide entity ........................................................................................................................................................................ 169
Pharmacometric study of NeuroEPO in a non-human primate model Macaca fascicularis....................................................................................................................... 170
Modeling of growth parameters in Sprague-Dawley rats as an alternative in preclinical toxicology ....................................................................................................... 171
Characterization of adverse drug reactions in the treatment of Cuban hospitalized COVID-19 patients: analysis using a survey, Cuba 2021 ................................... 172
Incorporation of added value in preclinical studies and safety tests of biomolecules with neuroprotective function .......................................................................... 173
External model-based evaluation of population pharmacokinetic models for characterizing the genotype effect on warfarin exposure ......................................... 174
Population pharmacokinetic model to guide the dose selection of nimotuzumab in patients with ADPKD autosomal dominant polycystic kidney disease ......... 175
Proposal of antitumor action mechanisms of Cuban propolis ...................................................................................................................................................................... 176
Relationship between oxidative stress and the degree of facial lipoatrophy in Cuban patients with HIV treated with antiretrovirals................................................ 177
Effects of Amylovis-201 on chronic scopolamine induced memory deficit in mice .................................................................................................................................... 178
Preclinical immuno-safety evidence of CIGB-210, a novel anti-HIV drug candidate ................................................................................................................................... 179
Influence of circulating complement immune complexes in predictive models of clinical evolution in rheumatoid arthritis ............................................................. 180
Detection of polymorphism COMMD1 (rs11125908) by allele-specific PCR applied to rheumatoid arthritis ........................................................................................... 181
Healing activity of chitosan ointment 1% on skin burn damage model in rats Cenp: Wistar .................................................................................................................... 182
In vitro antileishmanial activity of anticancer compounds: conventional drugs and quinoxaline derivatives ........................................................................................ 183
Development of recursive random forest algorithms for the prediction of aqueous solubility of new drugs ......................................................................................... 184
Effect of circadian rhythm on the pharmacokinetics of twice-daily tacrolimus in renal transplant recipients ....................................................................................... 185
CYP3A5*3 and CYP3A4*22 Cluster influencing the new Tacrolimus MeltDose ® formulation target concentration: A population approach........................................ 186
Viability of probiotic microorganisms in symbiotic dairy products during storage .................................................................................................................................... 187
Survival of microencapsulated probiotic strains against simulated gastric, intestinal, and prebiotic conditions ................................................................................. 188
Fermentation of cocoa with the addition of yeast (Saccharomyces cerevisiae) and enzyme (PPO's) in the reduction of heavy metals .............................................. 189
Exogenous induction of Rhizobium japonicum in fermentative mass of two varieties of cocoa as a strategy for cadmium reduction ................................................ 190
Quantitative Risk Analysis of Staphylococcus aureus enterotoxins in fresh artisan cheese ....................................................................................................................... 191
Isolation and characterization of microbial strains from human breast milk.............................................................................................................................................. 192
Improvements in the quality control of nutritional supplements produced by BioCen to prevent anemia ............................................................................................ 193
Safety management system (HACCP) with a focus on the circular economy in mini-industries in Cuba ................................................................................................. 194
Good Manufacturing Practices in the “Rancho Vega” mini-industry ............................................................................................................................................................ 195
Design of a HACCP system in fruit and vegetable processing mini-industry ................................................................................................................................................ 196
Diagnosis of the requirements of the NC ISO/IEC 17025: 2017 in the quality control laboratory of the UEB Paraíso Probiotic Yogurt Factory of the LABIOFAM
injectable products Company ........................................................................................................................................................................................................................... 197
Implementation of a HACCP system in a mini-industry that produces pre-prepared tostones ................................................................................................................ 198
Determination of cadmiun and lead in fresh vegetables................................................................................................................................................................................ 199
Evaluation of a new chromogenic and fluorogenic method for the detection of Salmonella in eggs ....................................................................................................... 200
Development and functional evaluation of a chromogenic and fluorogenic method for the detection of Salmonella in food ............................................................ 201
Evaluation of the management of the “El Caribe” restaurant menu at the Royalton Hicacos Resort & Spa hotel.................................................................................. 202

Dietetic-nutritional quality of the food supply for workers of a company in Matanzas .............................................................................................................................. 203
Perception and consumption of fried foods by students of the Institute of Pharmacy and Food of the University of Havana ............................................................. 204
Dietetic-nutritional quality of the food supply for workers of a company in Matanzas .............................................................................................................................. 205
Use of acetic acid in the prevention of Colibacillosis in farming .................................................................................................................................................................... 206
Application of cassava yogurt in the category of pre-fattening and fattening in a farm of the municipality of Cienfuegos .................................................................. 207
Anaerobic induction of Bradyzobium japonicum in the post-harvest of experimental hybrids of cocoa (Theobroma cacao L.) and its improvement in fermentative
(processed) and sensory quality ....................................................................................................................................................................................................................... 208
Results obtained by the introduction and generalization of the products bio-pharmaceutical industry in Cuba .................................................................................. 209
Economic evaluation of childhood immunization by vaccines Cuba 1962-2019 ......................................................................................................................................... 210
A pilot project on physicians’ use of a scientific-based medical cannabis dosing recommendations guide in Puerto Rico .................................................................. 211
Doctoral program in Pharmaceutical Sciences: 30 years of experience in the training of human resources .......................................................................................... 212
New approaches in the Doctoral Program in Pharmaceutical Sciences at University of Havana ............................................................................................................. 213
ISO 29993/29994 approach to evaluate distance learning. Analysis of a case study in the pandemic stage ........................................................................................... 214
The "University didactic" in the degree of food science at the Institute of Pharmacy and Food of the University of Havana ............................................................... 215
Potentially inadequate prescriptions in older adults in San Miguel del Padrón municipality, Havana, Cuba ......................................................................................... 216
Impact of Risk Communication in the Biotechnological and Pharmaceutical Industry in the context of COVID-19 ............................................................................... 217
Environmental education actions to face climate change from professional training in pharmaceutical and food sciences .............................................................. 218
Master's Degree in Medicine Technology and Control. A Program of Excellence for the professional improvement of pharmaceutical personnel .......................... 219
Master's degree in Clinical Pharmacy at IFAL: results and perspectives ...................................................................................................................................................... 220
Initial diagnosis of the professional performance of the novice teachers of Food Sciences of IFAL ......................................................................................................... 221
Experiences of the use of WhatsApp as an educational and technological resource in postgraduate education ................................................................................... 222
Competences of IFAL pharmacists and their work performance in BioCubaFarma ................................................................................................................................... 223
Comprehensive Medication Management service for inpatients with cardiovascular diseases ................................................................................................................ 224
Use of nifedipine in threatened preterm labor ................................................................................................................................................................................................ 225
Drug interactions and anticholinergic risk in older adults in the San Miguel del Padrón municipality, Havana, Cuba .......................................................................... 226
Individual project for professional and human improvement of IFAL Food Sciences ................................................................................................................................ 227
Initial diagnosis of the professional performance of the novice teachers of Food Sciences of IFAL ......................................................................................................... 228
CESFARMA, an example of collaboration University: Company. Summary of its first 15 years ................................................................................................................. 229
Behavior of COVID-19 in the Sevillano health area belonging to the “Turcios Lima” polyclinic, in the Diez de Octubre municipality ................................................. 230
Preliminary evaluation of the impact of Master in Toxicology of the Pharmacy and Food Institute from the University of Havana .................................................... 231
Preliminary study of the cost of complicated obstetric patients attended in the Intensive Care Unit of the Hospital “Faustino Pérez” ............................................. 232
Articulation of the discipline Preparation for Defense with the disciplines of food sciences career......................................................................................................... 233
Online didactic unit in the subject general microbiology in food sciences .................................................................................................................................................. 234
Implementation of professional skills in the Stores process ......................................................................................................................................................................... 235
University-Company link and its impact on the professional motivation of Pharmaceutical Sciences students ................................................................................... 236
Scientific training and internationalization: experience of the Institute of Pharmacy and Food, University of Havana ........................................................................ 237
Student satisfaction as an indicator of quality of the Cellular Biology subject in the Pharmaceutical Sciences career, daytime course mode ................................. 238
Nutritional marketing, health and well-being for everyone, the new commitment of the food industry ................................................................................................ 239

Use of coconut charcoal in the Cuban rum industry ....................................................................................................................................................................................... 240
Sensory profile of the shell of the roasted Cuban cocoa bean....................................................................................................................................................................... 241
Implementation of a sensory panel for analysis and quality control of bee honey .................................................................................................................................... 242
Optimizing the sensory quality of a dairy dessert flavored with mango pulp.............................................................................................................................................. 243
Obtaining fermented milk enriched with powdered extract of majagua flowers (Talipariti elatum Sw) .................................................................................................. 244
Classification of Cuban honeys according to botanical origin with multivariate analysis of their polyphenol and flavonoid profile .................................................. 245
Characterization of a spreadable chocolate cream with bee products ........................................................................................................................................................ 246
Refreshing whey drink with the addition of rice flour and orange flavor ..................................................................................................................................................... 247
Spray drying of an extract majagua flower concentrate (Talipariti elatum Sw) .......................................................................................................................................... 248
Refreshing whey drink with fructooligosaccharides and acerola pulp (Malpighia emarginata D.C.) ........................................................................................................ 249
Evaluation on reproductive parameters of the inclusion of different percentages of crude protein from moringa forage (Moringa oleifera) in rations for rabbits
(Oryctolagus cuniculus) ....................................................................................................................................................................................................................................... 250
Stability of a powder dye obtained from the flower of the “marpacífico” (Hibiscus rosa sinensis L.) ....................................................................................................... 251
Cleaner productions in the management of residual EGF and synthetic peptides ..................................................................................................................................... 252
Study of storage at room temperature of the PFHMII culture medium used for the T1h/3E9-1F6 cell line.............................................................................................. 253
Evaluation of the performance of an analytical method by liquid chromatography for quality control and stability of the injectable product Irinotacan
hydrochloride ...................................................................................................................................................................................................................................................... 254
Safety study of sodium heparin 5000 IU/mL in geriatric patients. Spontaneous notifications.................................................................................................................. 255
Preliminary stability study to support use of freeze dried live-attenuated 638 Vibrio cholerae oral vaccine candidate after reconstitution...................................... 256
Good storage and distribution practices performance at the pharmaceutical supply distribution center ............................................................................................. 257
Management of recyclable solid waste at the Center for Genetic Engineering and Biotechnology .......................................................................................................... 258
Design of a ready-to-use transport medium for Leptospira (LeptoCen T LPU) ............................................................................................................................................ 259
Obtaining a diagnostician of strict and facultative anaerobic microorganisms in blood samples ........................................................................................................... 260
Development of new allergenic raw materials to obtain anti-allergy vaccines ........................................................................................................................................... 261
Obtaining the active pharmaceutical ingredient of the new vaccines for sublingual immunotherapy DiVALER-SL and TriVALER-SL ................................................. 262
Study on the cytotoxicity and inactivation of microorganisms of the Inactivated Viral Transport Medium TAN .................................................................................... 263
Improvement of the fermentation process to obtain recombinant human epidermal growth factor ..................................................................................................... 264
Biopharmaceutical quality between tablets (multisource) of national production and Brazilian generic of immediate release of hydrochlorothiazide 25 mg ..... 265
Influence of oxidative stress in fibromyalgia ................................................................................................................................................................................................... 266
Evaluation of two inert polymers as a release retarding agent in the physico-chemicals characteristics and in vitro release of Zidovudine loaded microspheres 267
Characterization of eating habits in older adults with arterial hypertension in a Camagüey community ............................................................................................... 268
Microbial growth of L. arizonensis and S. thermophilus in different culture medium ................................................................................................................................. 269
Food sovereignty in the non-hotel company Palmares S.A in its agricultural development ..................................................................................................................... 270
Electrospinning encapsulation of majagua flower extract (Talipartiti elatum S.W.) in zein structures .................................................................................................... 271
Obtaining a powder extract from the majagua flower (Talipariti elatum Sw) with potential food use..................................................................................................... 272
Obtaining a coffee-flavored dairy drink using soy milk and whey ................................................................................................................................................................ 273
Use of grape seed oil for the formulation of creams ....................................................................................................................................................................................... 274
Pharmacobotanical and physicochemical characterization of Plectranthus neochilus Schltr (meprobamate plant) ............................................................................ 275
Pre-formulation study of a facial tonic with bee products and Aloe vera ..................................................................................................................................................... 276

Blood products in Cuba, prospects for development ..................................................................................................................................................................................... 277
Pharmacognostic and phytochemical characterization of the leaves of Ravenia spectabilis that grows in Cuba .................................................................................. 278
Standardization of the experimental model of hemorrhagic stroke by intracerebral administration of autologous blood: oxidative stress parameters ............... 279
Standardization of the experimental model of hemorrhagic stroke by intracerebral administration of autologous blood: cognoscitive variables (memory) ....... 280
Use of Moringa oleifera and Plukenetia volubilis seeds and their application in the pharmaceutical industry ....................................................................................... 281
The professional skills of Cuban pharmacists ................................................................................................................................................................................................. 282
Characterization of a non-infectious animal model that mimics the symptomatology of COVID-19 ....................................................................................................... 283
Propolis tincture with pharmaceutical quality through modifications of its production technology ...................................................................................................... 284
Author index ........................................................................................................................................................................................................................................................ 285

SHORT COMMUNICATIONS

Design and optimization of diclofenac gel 1% as an analgesic

and anti-inflammatory for topical use
Nilia de la Paz Martín-Viaña*, María L. González-Sanabia, José R. Pérez-Mora, Niurys Mantilla-García, Caridad
M. García Peña
Drug Research and Development Center. BioCubaFarma. Ave. 26 # 1605 e/ Calzada de Puentes Grandes and Boyeros. Plaza de la Revolución, Havana,
Cuba.
*e-mail address: nilia.delapaz@cidem.cu; ORCID: 0000-0001-8067-9516
Context: Diclofenac sodium is a compound that belongs to the NSAIDs, METHODOLOGY

it has pronounced anti-rheumatic, anti-inflammatory, analgesic and
antipyretic properties.
Objective: To carry out the design and optimization of the formulation Chemicals and reagents
of a diclofenac gel 1%.
Methods: An experimental statistical design of D-Optimal mixtures was Sodium diclofenac (Amolic Organics, India),
carried out, adjusted to a linear model, as well as the optimization of propylene glycol (Basf, Germany), methylparaben
the formulation. The concentrations of carbopol 940, triethanolamine (UENO Fine Chemicals, Japan), propylparaben (UENO
and isopropyl alcohol were selected as independent variables, as
Fine Chemicals, Japan), isopropyl alcohol (Merck,
response variables pH and extensibility. They were determined at the
beginning, 30, 60, and 90 days after the technological variants were Germany), carbopol 940 (Fagron Ibérica SAU) were
elaborated. In addition, the viscosity and rheological behavior of the used., Spain), triethanolamine (Merck, Germany),
formulation selected as promising was determined, and the results ethylenediamine tetraacetic acid disodium salt
were compared with those of the commercial product Voltaren® Gel.
dihydrate (Merck, Germany), sodium metabisulfite (DC
Results: The proportions of the pharmaceutical excipients and the
values of the response variables considered in the best-selected Fine Chemicals, Spain).
formulation are very close to variant 2 of the experimental design. The
selected formulation showed physical-chemical and technological Methods
properties in accordance with the requirements established for
pharmaceutical gels and similar to the commercial product (Voltaren®
Gel).
Formulation design and optimization
Conclusions: The new formulation of diclofenac sodium gel 1% is
An experimental statistical design of D-Optimal
similar to its commercial product and complies with the quality
parameters studied for its technological development. mixtures was developed and adjusted to a linear model
Keywords: Diclofenac sodium; anti-inflammatory; topical; formulation; using the Design-Expert program. (DX-12) in its version
design; optimization. 12.0.3.0 (Stat-Ease, Inc., Minneapolis, United States) of
the year 2019. The concentrations of carbopol 940 (0.70-
INTRODUCTION
1.00%), triethanolamine (0.50-1.50%), and isopropyl
Sodium diclofenac is a drug from the family of non- alcohol (9.40-10.00%) for a total mixture to vary in the
steroidal anti-inflammatory drugs derived from formulation of 11.90%. For the elaboration of the
phenylacetic acid. It is a good analgesic, as well as variants of the design, the incorporation method was
antipyretic, and has excellent absorption in the used, as a stirring system an electric stirrer (Heidolh RZ
gastrointestinal tract. It is available in the form of salt in R1, Germany) was used. The order of preparation of the
different forms, such as sodium, potassium, epolamine, variants of the formulation was randomized. Design
or diethylamine (Grenier and Carrara, 2018; USP 44, variants were periodically evaluated according to
2021). organoleptic characteristics, pH and extensibility, for a
period of 90 days.

To carry out the optimization, the criteria used in the Table 1. Technological evaluation of the statistical design formulations.
analysis were the following: the independent variables
pH Extensibility (cm2)
remained within the work interval. Limits were
Exp. 60 90 60
established for the dependent variables: the extensibility 2 days 2 days 90 days
days days days
had to be between 35.00 and 45.00 cm2, while the pH had
to be between 7.00 and 8.00. Regarding the level of 1 7.08 7.06 7.09 30.42 30.00 29.94
importance, a maximum (5) was given to pH and the (0.00) (0.02) (0.01) (0.25) (0.09) (0.08)
remaining variables remained at the average value (3). 2 7.33 7.32 7.33 36.57 35.82 35.10
The variant with the highest desirability index was (0.00) (0.00) (0.01) (1.65) (1.10) (0.94)
selected as the optimal formulation. 3 7.61 7.65 7.62 42.02 41.30 41.02
(0.00) (0.04) (0.02) (0.28) (0.76) (0.55)
Viscosity and rheological behavior 4 6.94 6.92 6.90 25.74 24.96 24.43
(0.00) (0.01) (0.00) (1.25) (1.28) (1.27)
To determine the rheological behavior of the
optimized base and the commercial product (Voltaren® 5 7.30 7.30 7.29 37.37 37.05 36.67
Gel), an MCR 302 model rheometer (Anton Paar, (0.01) (0.00) (0.02) (0.83) (0.82) (1.01)
Germany) was used. The measurement system used was 6 7.36 7.36 7.35 33.68 33.25 33.45
the PP25 sensor, with a speed gradient between 1-100 s-1, (0.00) (0.00) (0.01) (1.19) (1.16) (1.10)
the preset working temperature in the equipment was 20 7 7.28 7.28 7.27 31.16 29.98 29.71
± 0.01°C. The data and the graphs obtained were (0.00) (0.02) (0.00) (1.14) (0.78) (0.82)
processed, mathematically, using the RheoPlus Software
version 3.6x. The yield value (σo), the apparent viscosity The pH determinations are necessary to corroborate
(η) at 20 s-1, the consistency index (K) and the flow that the recorded value is compatible with the
index (n) were determined as rheological parameters, components of the formulation, with the stability of the
using equation [1]. For the last two, the linearized Power drug and with the application site to avoid irritations
Law was used (Ramírez, 2006). (Marquele-Oliveira et al., 2007). The pH obtained in all
the experiments was adequate. Formulation four
Log ( - o) = n log  + log K [1] showed a pH below the limit, because in its composition
Where σ: shear stress; o: yield value; n: flow index; γ: velocity gradient; K: it had the maximum level for carbopol 940 (1.00%) and
consistency index. the minimum for triethanolamine (1.20%), of those
evaluated in the design. In relation to time, a slight
RESULTS AND DISCUSSION variation in the pH of the formulations was observed,
evidencing the stability that this property manifested.
Technological evaluation of design variants
During the 90 days of evaluation, the formulations
The organoleptic characteristics of the formulations showed a slight tendency to decrease extensibility, due
remained unchanged during the analyzed period, no to a contraction of the system caused by the
lumps or grit were observed, nor was the consistency of restructuring suffered by semi-solid preparations in the
the base lost. It was possible to verify a difference in the first days of product preparation (Muñoz et al., 2005;
consistency of the formulations of different Mesa et al., 2007). No appreciable difference was
compositions. Table 1 summarizes the results obtained observed in this property for the different formulations,
during the technological evaluation of the preparations with the exception of the four and seven of the same
obtained, in the 90 days that the test elapsed. composition.

Statistical analysis of the applied design one of the independent variables separately when the
other independent variables are in the central position.
In the case of pH, a good adjustment was achieved
Carbopol 940 has a negative effect on the pH. An
without making mathematical modifications to the
increase in this variable produces a decrease in the pH of
variable. Table 2 shows the results obtained during the
the jelly. While an increase in triethanolamine and
study of the best-fit model.
isopropyl alcohol causes an increase in pH, they
positively affect this response, this effect being less
Table 2. Analysis of mathematical models for pH.
accentuated. Taking into consideration the previous
Model Fit (p) Loss of fit (p) r2 PRESS results, the design equation was arrived at, which is
Linear 0.0001 0.053 0.9584 0.042 shown below: pH = - 0.89747 * Carbopol 940 + 1.3592 *
Triethanolamine + 0.63827 * Isopropyl alcohol
Quadratic 0.0023 0.1158 0.9374 1.14
Cubic special 0.1736 0.7155 0.9158 7.45 According to the equation, the three independent
variables studied influence the pH value. The
According to the results achieved, the linear model coefficients are in correspondence with the behavior
was significant, obtaining a probability of less than 0.05 observed in the trace graph (Fig. 2).
for 95% confidence. In addition, it showed a non-
significant loss of fit, a high value of the coefficient of
determination and the lowest value of PRESS, where
some of the points studied had residuals of 0.0,
A: carbopol 940
demonstrating the good fit of the system. B: Triethanolamine
C: Isopropyl alcohol
Fig. 1 shows how the residuals tend to describe a
straight line close to the theoretical distribution (Fig.
1A). Therefore, it can be stated that they come from a
normal distribution. On the other hand, its randomness
and independence were revealed when performing its
graphic representation against the predicted values (Fig.
Figure 2. Trace graph for the pH variable.
1B).
For the extensibility variable, a good fit to the linear
A B model was also obtained by directly plotting the values
of the variable, fulfilling all the established parameters
for this model, as observed in Table 3.
Table 3. Analysis of mathematical models for extensibility.
Model Fit (p) Loss of fit (p) r2 PRESS
Linear 0.0001 1.46 0.9338 21.72
Quadratic 0.6554 1.57 0.9234 44.27
Cubic special 0.8383 1.72 0.9089 156.23

Figure 1. Diagnostic Graphics for pH.
Fig. 3 illustrates the diagnostic graphs for the
The trace graph corresponding to pH is shown in Fig. residuals in the analysis of the extensibility variable.
2. This graph is to analyze the behavior trend of each Complying, as in the previous variable, with normality

(Fig. 3A) and randomness and independence of the The previously stated with respect to the effect that
residuals (Fig. 3B). the components had on the extensibility, observed in the
trace graph (figure 4), is corroborated.
A B
Formulation optimization
From the previous results, the numerical
optimization of the formulation was developed. Of the
three components that were varied in the design, it was
established that isopropyl alcohol was the maximum, to
guarantee the total dissolution of sodium diclofenac,
which participates in the formulation as an active
principle. The remaining independent variables
remained in the range of values that were studied in the
design, with an importance of 3. It was also proposed
Figure 3. Diagnostic graphics for extensibility. that extensibility and pH be in the range studied, with
an importance in the mean value (3) for extensibility and
In the graph of Fig. 4, it can be seen that both
a maximum of importance (5) for pH. As a result, a
triethanolamine and isopropyl alcohol tend to show a
possible optimal preparation was obtained, with a
positive effect on extensibility, causing an increase in
desirability equal to one (Fig. 5), which indicated that
this response when increasing the levels of these
there was a 100% probability of obtaining a formulation
components, triethanolamine being the most
with positive results. The proportions of the components
representative.
in the optimal formulation (Fig. 5), as well as the values
of the response variables considered, are very close to
formulation two of the experimental design, which
supports the effectiveness of the design developed.
A: carbopol 940
B: Triethanolamine
C: Isopropyl alcohol
Figure 4. Trace graph for the extensibility variable.
The opposite occurs with carbopol 940, where a

negative effect is seen, since the extensibility decreases
when the levels of this component increase in the Figure 5. Ramp graph for formulation optimization.
studied interval. The effect caused by the independent
variables in the extensibility of the formulations is Viscosity and rheological behavior
summarized, according to the design, in the following
The analysis of the rheological behavior (Fig. 6) for
equation: Extensibility= - 33.64892 * Carbopol 940 +
the optimized formulation and the commercial product
20.66778 * Triethanolamine + 3.55571 * Isopropyl alcohol

(Voltaren® Gel) showed the non-Newtonian flow Table 4. Rheological parameters.

characteristics, verifying a typical behavior through the
Rheological parameters Optimized formulation Voltaren ® gel
relationship between the shear stress and the velocity
gradient of a pseudoplastic body (Herschel-Bulkley), σ0 (Pa) 18.5 ± 0.01 11.9 ± 0.03
which requires a minimum initial stress value for the -1
η (20 s ) (Pa.s) 9.69 ± 0.02 9.53 ± 0.00
system to break down, decreasing its viscosity and
K 1.87 1.88
starting to flow.
n 0.22 0.23
A B
ACKNOWLEDGMENT
This work is part of a research-development project entitled "New
semisolid medicine in Cuba with analgesic and anti-inflammatory
effect that contains 1% sodium Diclofenac", financed by the Drug
Research and Development Center (CIDEM), Havana, Cuba.
REFERENCES
United State Pharmacopoeia 44-NF 39 (2021)
https://online.uspnf.com/uspnf/document/1_GUID-BCC3C57C-
Figure 6. Rheograms of the optimized formulation (A) and the 5F80-436F-AD1E-DD312EF8EAA9_4_en-US.
commercial product (Voltaren® Gel, B). Grenier A, Carrara D (2018) Diclofenac Formulations. Patent No.: US
10,117,829 B2.
Table 4 shows the values of the rheological Ramírez Navas JS (2006) Fundamentos de Reología de Alimentos. JSR
e-books Cali, Valle. Colombia, pp. 12-16.
parameters for the optimized formulation and the
Marquele-Oliveira F, Fonseca YM, de Freitas O, Fonseca MJV (2007)
commercial product (Voltaren® gel), proving a similar Development of topical functionalized formulations added with
mechanical-structural behavior. Regarding the flow propolis extract: stability, cutaneous absorption and in vivo studies.
indices (n), obtained from the slope of the straight lines, Int J Pharm 342: 40-48.
https://doi.org/10.1016/j.ijpharm.2007.04.026
after adjusting the experimental values to the linearized
Muñoz A, Fernández O, Nuñez L (2005) Chemical and physical
Power Law equation, confirming the type of fluid in all parameters influence on the formulation design of Budesonida
cases (n < 1 Non-Newtonian Pseudoplastic; n = 1 0.025% creams. Rev Mexicana Cienc Farm 36(1): 25-30.
Newtonian) (Lavaselli and Rasia, 2004). These results Mesa JA, García O, Tacoronte JE, Pérez N (2007) Hydrocortisone
acetate stability in 1% cream formulations. Rev Mexicana Cienc
correspond to those obtained for the yield value (σ0), the
Farm 38(4): 37-41.
apparent viscosity (η) and the consistency index (K) (Fig. Lavaselli SA, Rasia RJ (2004) Rheologic and stability of excipients for
6). dermatological preparation, manufacturing with differents
concentrations of the same emulgen. Acta Farm Bonaerense 23(1):
59-66.
CONCLUSION
The optimized formulation showed physicochemical
and technological properties in accordance with the
requirements established for pharmaceutical jellies and
similar to the commercial product (Voltaren® Gel).

Development of the analytical method for quantification of

diclofenac sodium, methyl and propylparaben by high
performance liquid chromatography
Caridad M. García Peña*, Vivian Martínez-Espinosa, Sheyla Fernández-Puentes, Nilia de la Paz Martín-Viaña,
María L. González-Sanabia, José R. Pérez-Mora
Drug Research and Development Center. BioCubaFarma. Ave. 26 # 1605 e/ Calzada de Puentes Grandes and Boyeros. Plaza de la Revolución, Havana,
Cuba.
*e-mail address: caridad.garcia@cidem.cu; ORCID: 0000-0002-6678-4544
Context: diclofenac sodium is a derivative of phenylacetic acid presence of heteroatoms such as nitrogen, oxygen,
and belongs to the group of NSAIDs with pronounced anti-
chlorine and sodium in its structure cause high
inflammatory, analgesic and antipyretic properties. Until now,
the monograph does not appear in official Pharmacopoeias for polarizability of the molecule (Grenier y Carrara,
the quantification of the active pharmaceutical ingredient (API) 2018; USP 44, 2021).
and the preservatives in diclofenac sodium gel.
Objective: to develop the analytical method for the For the quality control and stability study of
quantification of IFA and preservatives and to apply it in the this product, an analytical method was developed
stability study of topical 1% gel. to determine the content of Sodium Diclofenac at
Methods: the analytical method for quality control and stability
study was validated using the parameters: specificity, accuracy,
1%, methylparaben and propylparaben in the
precision (repeatability, intermediate precision), linearity, Jelly, by High Resolution Liquid Chromatography
detection limit and quantification. Stability studies of the (HPLC), because it does not appear reported. The
finished product were carried out at room temperature, for 24 monograph in no Official Pharmacopoeia up to
months, packaged in: 157 × 30 mm aluminum tube, with
polypropylene lid, with perforator per 80 g; PEAD plastic
now and the method was applied in the stability
bottle, with PBD liner and polypropylene screw cap for 240 g; study of the finished product.
Transparent amber glass bottle with polypropylene cap R-53-
400 for 215 g. METHODOLOGY
Results: the results obtained in the validation of the method
were adequate. The results of the stability study carried out
made it possible to demonstrate the stability of Diclofenac Analytical method
topical gel at 1%, in the three containers studied.
Conclusions: the reliability of the analytical method applicable The test technique was developed as described
to quality control and the stability studies of the finished below:
product were evidenced through documentary evidence. The
stability of the gel was demonstrated for 24 months, stored at Preparation of the mobile phase: methanol:
room temperature. phosphate buffer solution at pH 2.5, in proportion
Keys word: diclofenac sodium; topical gel; high resolution liquid (70: 30)
chromatography; validation; stability study.
Preparation of the diluent: methanol: distilled
INTRODUCTION water, in proportion (70: 30)
Sodium diclofenac is a derivative of Preparation of the reference chemical substance

phenylacetic acid and belongs to the group of solution (Sodium diclofenac, methylparaben and
NSAIDs with pronounced anti-inflammatory, propylparaben): Equivalent amounts were weighed
analgesic and antipyretic properties. It is a sodium and dissolved in diluent, later the taken aliquots
salt, it is practically insoluble in acid medium but were dissolved in mobile phase, at concentrations
it is soluble in intestinal medium and in water. The of 50; 14.4 and 1.6 μg/mL, respectively.

Sample preparation: 2.5 g of sample were three different concentrations representing 80, 100,
weighed, transferred to a 50 mL conical flask, 15 120% of the theoretical concentration in the gel,
mL of diluent were added, placed on a sieve for 30 prepared in triplicate. Acceptance criteria: CV ≤
minutes, transferred to a 25 mL volumetric flask, 2.0%, R = 98.0 – 102.0%, Gcal < G tab, tcal < t tab
three washings from the conical flask, with 2 mL
Linearity: It was carried out in a range of
of diluent, adding the washings to the 25 mL
concentrations between 50 and 150%, taking
volumetric flask, making up the volume with
sodium diclofenac, methylparaben and
diluent. Subsequently, the contents of the flask
propylparaben as the chemical reference
were transferred to a conical centrifuge flask,
substance. Three calibration curves were prepared,
centrifuged at 5000 rpm for 5 minutes. Dilutions
with 5 solutions of the chemical reference solution
were made and volume was completed in mobile
that correspond to 50%, 80%, 100%, 120%, 150%, of
phase at concentrations similar to the chemical
the concentrations described in the diclofenac
reference substances.
sodium, gel analysis technique. Solutions prepared
Operational conditions: Flow: 1.0 mL/min; were evaluated in triplicate minimum. The results
Dispenser: 20 μL; Detector: UV; Wavelength: were statistically processed taking into account the
254nm following criteria: Significance of the regression:
The correlation coefficient must be ≥ 0.990 and the
Analytical method validation determination coefficient greater than 0.980;
Coefficient of variation of the response factors
For the validation of the method, we proceeded
(response/concentration ratio), which will not be
as established in the procedures for Validation of
greater than 5.0%.
analytical techniques where the following
parameters were evaluated taking into account Precision: Repeatability: They were performed on
category I (Class C). the same day, by the same analyst, in the same
equipment, a minimum of six replicates prepared
Specificity: It was carried out by comparing
at the concentration described in the analysis
placebos, chemical reference substances
technique, equivalent to 10 μg/mL of diclofenac
(methylparaben, propylparaben and sodium
sodium, 14.4 μg/mL of methylparaben and 1.6
diclofenac) and the sodium diclofenac 1% gel
μg/mL of propylparaben. The established
sample. In addition, the samples were subjected to
criterion was CV ≤ 2.0 %. Intermediate precision: Six
drastic conditions of acid (5 N HCl), basic (5 N
replicates of a sample were evaluated, at a single
NaOH) hydrolysis, sunlight, and heat (70˚C), for a
concentration level of 10 μg/mL of sodium
period of seven days. As a criterion, it was
diclofenac, 14.4 μg/mL of methylparaben, and 1.6
established that there must be similarity of the
μg/mL of propylparaben; and by two analysts, on
retention times of methylparaben, propylparaben
two different days. In each case, the mean,
and sodium diclofenac in the sample in relation to
standard deviation and coefficient of variation
the chemical reference substances. No signals
(CV) were evaluated. Appropriate significance
should be observed in the placebos that show
tests for means and variances were implemented.
interference in the determination of
The established criterion was CV ≤ 2.0 %;
methylparaben, propylparaben and sodium
calculated student t must be less than tabulated t;
diclofenac, in their respective elution zones, nor of
Calculated analysis of variance F should be less
the degradation products, in the 1%sodium
than tabulated F for a significance level of 95%.
diclofenac, gel sample.
Limit of detection and quantification: A calibration
Accuracy: The recovery method was used
curve was made in a range of concentrations of the
following the procedure of placebos loaded at

reference substance of sodium diclofenac between Table 1. Validation of the analytical method.
5 and 25%, taking as a basis for the calculation the Parameter Diclofenac Methylparaben Propylparaben
concentrations declared as 100% in the analysis
Accuracy Rm = 98.74% Rm = 99.95% Rm = 100.02%
technique. 5 solutions of the chemical reference
CV = 0.075 % CV = 0.40 % CV = 0.25 %
solution representing 5%, 10%, 15%, 20%, 25% will
be prepared. Solutions prepared were evaluated in t exp. = 1.765 t exp. = 1.587 t exp = 1.879
triplicate minimum. The results were statistically t tab. = 2.306 t tab. = 2.306 t tab = 2.306
processed taking into account the following p = 0.1856 p = 0.0873 p = 0.3748
criteria:
G cal = 0.663 G exp. = 0.5788 G exp = 0.5519
• Significance of the regression: The correlation
G tab = 0.797 G tab. = 0.870 G tab = 0.870
coefficient must be ≥ 0.990 and the determination
p = 0.7103 p = 0.5321 p = 0.6021
coefficient must be greater than 99.00%, the
equation of the line y=mx +b. Linearity r = 0.9990 r = 0.9994 r = 0.9995
r2 = 99.90 r2 = 99.89% r2 = 99.90%
• Coefficient of variation of the response CVf = 1.35% CVf = 1.37% CVf = 1.19%
factors (response / concentration ratio), which will
Repeatability Xm = 99.14% Xm = 99.52% Xm = 93.86%
not be greater than 5.0%. CV= 1.85% CV= 0.70 % CV= 0.20 %
A curve was made with the standard Intermediate CV= 1.85% CV = 0.52% CV =0.27%
deviations of each point against concentration, and precision
the intercept and slope values were determined. F = 0.4512 F = 1.2825 F = 0.5406
p = 0.6152 p = 0.7915 p = 0.5159
Stability study (p ≥ 0.05) (p ≥ 0.05) (p ≥ 0.05)
t = 0.4238 t = 1.2701 t = 0.9833
The shelf life stability study was carried out at
p = 0.7536 p = 0.2328 p = 0.3487
room temperature (30±2˚C) and 75 ± 5% relative (p ≥ 0.05) (p ≥ 0.05) (p ≥ 0.05)
humidity packaged in a 157 x 30 mm aluminum
CV: coefficient of variation; Rm: medium recovery; exp: experimental; cal: calculated;
tube, with a polypropylene lid, with a perforator r: correlation coefficient; r2 coefficient of determination
for 80 g; HDPE plastic jar, with PBD liner and
polypropylene screw cap for 240 g; Transparent The values of the coefficients of variation
amber glass bottle, with R-53-400 polypropylene turned out to be less than 2.0 %, complying with
lid for 215 g. Analyzing the samples of the batches the established limit. The influence of the
under study at the beginning, 3, 6, 9, 12, 18 and 24 concentration factor on the variability of the
months. accuracy results was estimated by applying the
Cochran test for homogeneity of variances. As
RESULTS AND DISCUSSION shown, the calculated Gs were less than the
tabulated Gs for 95% confidence, k= 3 and n= 3;
Analytical method validation therefore, the variances of the three concentration
levels used are considered equivalent. This fact
The Table 1 reports the results obtained in the indicates that the concentration factor does not
validation study of the analytical method. significantly influence the variability of the
In the accuracy study, the individual and total response measured by the chromatograph used. In
recovery percentage values were found to be this way, the accuracy is demonstrated, not
within the range established for chromatographic manifesting the influence of systematic errors due
methods (98.0 to 102.0%). to excess or default when using the evaluated
methods.

The test results showed that the data obtained secondary peaks but at a different retention time
for each concentration level complied with a than sodium diclofenac.
normal distribution p greater than α=0.05 in all
cases. In addition, the values of the regression and
determination coefficients obtained turned out to
be very close to unity, and also higher than those
established in Annex I of Good Laboratory
Practices of CECMED, 2013. The values obtained
from the coefficients of variation of the response
factors indicate that there is a favorable variability
in the concentration/response relationship for
each level evaluated.
In addition, the detection and quantification
limits, 0.155 and 0.188 µg/mL, respectively, were
determined and verified.
In the Fig. 1 shows the chromatograms
corresponding to the specificity study. In the
specificity study, the placebo, the chemical
reference substance, samples of finished product
of sodium diclofenac 1% gel and samples
subjected to drastic conditions were analyzed. Figure 1. Specificity study.
There were no signs in the placebo in the zone of
The results obtained in the sample subjected to
elution of sodium diclofenac, nor of
acid hydrolysis correspond to the results
methylparaben, nor of propylparaben. It can be
published by Pérez et al., in 2005, in diclofenac
seen that there are no interferences from
samples that were affected in an acid medium.
methylparaben (tr = 4.11 min), propylparaben (tr =
While for the samples subjected to light, they
5.42 min), or sodium diclofenac IFA (tr = 9.11
correspond to what was reported by Correa et al.,
min), in the finished product, since they elute at
in 2014, which demonstrate the degradation
retention times different, evidencing that there is
mechanisms of sodium diclofenac by photolysis
no interference from the individual preservatives,
reactions.
nor from diclofenac in the determination of the
compounds of interest, as in the degraded placebo The degradation of the preserves is evident
samples. under the conditions applied, with a decrease in
the area under the curve corresponding to the
When analyzing the chemical reference
peaks of interest and the appearance of secondary
substances of and the sample of interest, under the
peaks that do not interfere with the quantification
same chromatographic conditions, the equivalence
of the preserves, since they present different
of the chromatograms in terms of the retention
retention times. The results obtained correspond to
times of the peaks can be observed, which
those reported by Benítez et al., in 2006 and by
coincides in all cases.
Alvarado KE, in 2019, for the quantification of
In the samples subjected to drastic conditions parabens in different medicines and
of acid, basic, light and heat hydrolysis, decreases pharmaceutical forms.
were observed in the areas of the peak
corresponding to diclofenac, appearance of

Assessment 0 97.1 97.9 97.2

Stability study 24 96.2 96.8 96.4
The Table 2 reports the results of the stability Microbial count 0 Respond Respond Respond
study in three different containers, for 24 months 24 Respond Respond Respond
stored at room temperature.
Degradation 24 nd nd nd
product
Table 2. Stability study
TA: 157 × 30 mm aluminum tube, with polypropylene lid, with perforator for 80 g;
Parameter Time Bach/Aluminum tube (TA) FP: HDPE plastic jar, with PBD liner and polypropylene screw cap for 240 g; FV:
(h) transparent amber glass bottle, with R-53-400 polypropylene lid for 215 g; CO:
20001 20002 20003 organoleptic characteristics; ND: Not detectable.
CO 0 Respond Respond Respond
24 Respond Respond Respond The stability study results show that the
Identification 0 Respond Respond Respond product maintains its quality specifications. The
pH showed a tendency to increase very little over
pH 0 7.4 7.3 7.4
time, always remaining within the established
24 7.7 7.6 7.9
limits. The API assessment showed a slight
Assessment 0 97.3 98.1 97.4 decrease that was similar in the 3 types of
24 96.5 97.2 96.1 containers, less than the 5.0% established for this
Microbial count 0 Respond Respond Respond
evaluation. During the study the degradation
products are negligible. The contents of preserves
24 Respond Respond Respond
were found within the established limits (90.0 to
Degradation 24 nd nd nd 110.0%) during the duration of the study, these
product
results together with the microbial count
Parameter Time Plastic bottle (FP)
demonstrated the microbiological stability of the
CO 0 Respond Respond Respond finished form evaluated.
0 Respond Respond Respond CONCLUSIONS

Identification 0 7.5 7.5 7.3 The analytical method developed was safe for
pH 24 7.9 7.9 7.8 its application in the quality control and stability
Assessment 0 97.2 97.8 97.1 study of diclofenac gel at 1%. In addition, the
stability of the product was demonstrated for 24
24 95.9 96.8 96.7
months stored in three different containers at
Microbial count 0 Respond Respond Respond
room temperature in Cuba.
Degradation 24 nd nd nd ACKNOWLEDGMENT
product
This work is part of a research-development project entitled
Parameter Time Glass bottle (FV) "New semisolid medicine in Cuba with analgesic and anti-
(h)
inflammatory effect that contains 1% sodium Diclofenac",
CO 0 Respond Respond Respond financed by the Drug Research and Development Center
(CIDEM), Havana, Cuba.

REFERENCES
Identification 0 7.3 7.4 7.4
Grenier A, Carrara D (2018) Diclofenac Formulations. Patent
pH 24 7.6 7.9 7.9 No.: US 10,117,829 B2.

United State Pharmacopoeia 44-NF 39 (2021) diclofenac: Identification of main intermediates and
https://online.uspnf.com/uspnf/document/1_GUID- degradation pathway. Environ Sci Technol 39: 8300.
BCC3C57C-5F80-436F-AD1E-DD312EF8EAA9_4_en-US. https://doi.org/10.1021/es050794n
Anexo I: Buenas Prácticas de Laboratorio: Validación de Alvarado KE, Chavéz MA (2019) Cuantificación de
Métodos de analíticos. Centro Estatal para el Control de preservantes en dos formas farmacéuticas líquidas
Medicamentos (CECMED). 2013. (soluciones y suspensiones). Tesis para optar al grado de
Correa O, Ruiz A, Restrepo M (2014) Estandarización de un Licenciada en Química y Farmacia. Facultad de Química y
método por HPLC para cuantificar diclofenaco en muestras Farmacia. Universidad del Salvador.
de microdiálisis mediante fotoderivatización precolumna. Benítez E, Labrada C, Martínez E, Tamayo O, Díaz E (2006)
Rev Cubana Farm 48(1) Validación de un método analítico para la determinación
Pérez L, Malato S, Gemjak W, Aguera A, Thurman E, Ferrer I, cuantitativa de parabenos en el gel de hidróxido de
Fernández A (2005) Photo-fenton degradation of aluminio. Rev Cubana Farm 40(2).

Determination of the hydrophilic-lipophilic balance of the lipid

extract of Cucurbita pepo L.
José R. Pérez1*, Nilia de la Paz Martín-Viaña1, Antonio Nogueira1, Caridad M. García Peña1, Sheyla Fernández1
Center for Research and Development of Medicines (CIDEM). Avenue. 26 # 1605 e/ Puentes Grandes y Boyeros. Havana. Cuba.
* Email address: jose.perez@cidem.cu; ORCID: 0000-0002-7029-7706
Context: The hydrophilic-lipophilic balance (HLB) is a emulsion, so it is necessary to know the ideal HLB
parameter of great importance in the development of an
to emulsify the system, called critical HLB
emulsion. The mixture of surfactants with a final HLB value
close to the required HLB improves obtaining a stable (Macedo et al., 2006). This critical HLB, also
emulsion. known as optimal or necessary HLB, refers to the
Objective: To determine the value of the required hydrophilic- lipophilic phase.
lipophilic balance of the lipid extract of pumpkin seeds
Cucurbita pepo L. The critical HLB of an oil phase is the HLB
Methods: To calculate the HLBn of the lipid extract, the Griffin value of the mixture of emulsifying agents. Its
equation was used. In determining the HLBn of the extract, 11
emulsions were prepared with a lipophilic emulsifier (Span
knowledge is of great interest since it allows
85®, HLB = 1.8) and another hydrophilic one (Tween 80®, HLB choosing the optimal proportion of surfactants to
= 15.0). In all cases the emulsifying mixture percentage was 5%. obtain the minimum droplet size and emulsion
As a component of the oily phase, the lipidic extract of stability. Furthermore, the emulsions obtained
pumpkin seeds was used at 10% of the emulsion. Once the
phases were mixed, they were homogenized using the
with this HLB value are less likely to vary with the
homogenizer at a speed of 13500 min-1 for 5 min. manufacturing method (Vila Jato, 1997).
Results: The HLBn value of the pumpkin seed lipid extract was
7.0; and lower than that reported in the literature consulted for Many mineral oils have their required HLB
pumpkin seed oil, since it is extracted with ethanol and due to values stated, but essential oils do not. Required
this technique, there are fractions of fatty acids that are not HLB values for essential oils of eucalyptus,
found in this lipid extract and that contribute to the HLBn peppermint, and lipia or bella carpet were
value.
Conclusions: The value of the required hydrophilic-lipophilic determined using the Griffin method. (Rodríguez-
balance (HLBn) of the lipid extract of pumpkin seeds (Cucurbita Rojo et al., 2012), characterized rosemary oil for
pepo L.) obtained is 7.0 the formulation of biodegradable emulsions,
determining its optimal HLB (Rahate and
INTRODUCTION Nagarkar, 2007), used a combination of non-ionic
emulsifiers to determine the HLB of sunflower
The hydrophilic-lipophilic balance (HLB) is a
oils. and sesame.
parameter of great importance in the development
of an emulsion. This system was developed by The HLB value is very important in obtaining
Griffin in the 1950s and tries to provide a partial an emulsion. The mixture of surfactants with a
answer to the search for a mixture of emulsifiers final HLB value close to the required HLB
that is ideal to guarantee the stability of an improves obtaining a stable emulsion (Martínez,
emulsion in question (Vila Jato, 1997). 2019).
Therefore, the HLB is characteristic of the Nanoemulsion technology has been applied in
surfactant or surfactant mixture. However, the the pharmaceutical and cosmetic industries. The
HLB system does not provide information about advantages of nanoemulsions are that they are
the amount of emulsifying agents needed in an suitable for the efficient delivery of drugs and

other bioactives through the skin, due to their Methods

small droplet size (Monroy and Pereira 2020;
Wiseva, 2021). Preparation of emulsions
From the thermodynamic point of view, The emulsions were prepared with a
emulsions are unstable systems and their percentage of emulsifier mixture of 5%, which are
formation does not occur spontaneously, they within the range of 5 to 10%, the range established
require the external action of mixing energy. The for oil-in-water emulsions (Ferreira et al., 2010;
stabilizing action of the surfactant corresponds to Olivia-James, 2017).
the decrease in interfacial tension. Emulsions, after To determine the HLBn of the extract, 11
being formed, have a certain degree of stability emulsions were prepared with a lipophilic
that is determined by the speed with which the emulsifier (Span 85®, HLB = 1.8) and another
system transforms back into two separate phases. hydrophilic one (Tween 80®, HLB = 15.0), whose
This depends on multiple factors, and its analysis only difference consisted in the percentage of
is complex due to the interrelationships between Tween. 80 and Span 85 used, but in each one the
them. Two cross-variables can be analyzed to amount of emulsifier mixture was kept constant
determine which combination favors stability, but and whose compositions are shown in Table 1.
by increasing the number of variables, the studies
become extremely lengthy. For this reason, it is Table 1. Composition of the formulated emulsions (first series).
necessary to study specific systems as the need
Span 85® Tween 80®
arises (Kings and Di; 2012).
Essay HLBn
Quantity % Quantity %
To form a stable emulsion, the presence of a (g) (g)
third component, the emulsifying agent, is E1 5.0 100 0.0 0 1.80
necessary. Emulsifying agents can act by various
E2 4.5 90 0.5 10 3.12
mechanisms (Solans, 2001).
E3 4.0 80 1.0 20 4.44
METHODOLOGY E4 3.5 70 1.5 30 5.76
E5 3.0 60 2.0 40 7.08

Chemicals and reagents E6 2.5 50 2.5 50 8.40
A lipid extract from pumpkin seeds (Cucurbita E7 2.0 40 3.0 60 9.72
pepo L.) was used, obtained at the Natural and E8 1.5 30 3.5 70 11.04
Synthetic Products Production Plant (PPPNS
E9 1.0 20 4.0 80 12.36
Mario Muñoz) belonging to the Drug Research
E10 0.5 10 4.5 90 13.68
and Development Center (CIDEM). The
surfactants used were: Tween 80® (Fluka, E11 0.0 0 5.0 100 15.00
Switzerland) and Span 85® (BDA, England).

In all cases the emulsifying mixture percentage
was 5%. As a component of the oily phase, the
Equipment used
lipid extract of pumpkin seeds (Cucurbita pepo L.)
SARTORIUS brand analytical balance, model to 10% of the emulsion. Once the phases were
ENTRIS 6202-1S, Germany; Technical Balance, mixed, they were homogenized using the Ultra-
SHIMADZU, model UX 620 H, Japan; High speed Turrax homogenizer (IKA, mod. T-25, Staufen,
stirrer, Ultraturrax, Germany. Germany) at a speed of 13500 min-1 for 5 min
(Ferreira et al., 2010). Once the emulsions were

prepared, they were stored at room temperature Analysis of the cremation rate
for 15 days.
It was determined by measuring the height of
the opaque layer of the emulsion (H2) and total
Hydrophilic-lipophilic balance (HLBn) of the
height of the emulsion (H1). To carry out the test,
lipid extract of pumpkin seeds (Cucurbita pepo
10 g of each emulsion were placed in a plastic tube
L.)
(15 mm internal diameter and 125 mm high) and
To calculate the HLBn of the oil, the Griffin stored at room temperature for 15 days, according
equation was used: (Griffin, 1949; Arteaga, 2006). to Charoen et al., 2011. At the end of the storage
time, the calculation was made with equation [2]
[1] (Saengsorn and Jimtaisong, 2017).
Where: HLBT: HLB of the hydrophilic emulsifier (Tween 80®); HLBs: IC = 100 x (H2/H1) [2]
HLB of the lipophilic emulsifier (Span 85®); %T: percentage of the
hydrophilic emulsifier; %S: percentage of lipophilic emulsifier; Where: CI: cremation rate (%); H1: total height of separated phase
%ME: percentage of the emulsifying mixture (mL); H2: total height of the emulsion (mL).
Evaluation of the emulsions: All the elaborated

emulsions were evaluated periodically during 15 RESULTS AND DISCUSSION
days to detect visible modifications or instabilities The HLB required value scan for pumpkin oil
such as: color, separated oil, creaming, flocculation was tested from value 1.8 (lipophilic
and coalescence. (Álvarez, 2013; Olivia-James, surfactant/Span® 85) to value 15.0 (hydrophilic
2017) surfactant/Tween® 80.
The instability can originate from physical All the emulsions were successfully obtained,
phenomena, or from chemical processes. In the which remained stable without visual changes for
former, alterations occur in the spatial distribution 24 hours. Despite the variation of the HLBn
of the components, such as gravitational between the emulsions, no differences were
separation (cremation/sedimentation), observed at room temperature (Table 2), after 5
flocculation, coalescence, partial coalescence, days, since they all had a uniform milky
Ostwald ripening, and phase inversion. Chemical appearance. However, after 15 days, creaming was
processes, on the other hand, influence the observed in all the emulsions, being greater in
chemical structure of the components, such as trials E1, E2, E3, E9, E10 and E11, so they are not
oxidation or hydrolysis. (Huppertz and Kelly, taken into account for the determination of the
2006; Álvarez, 2013). HLBn of the extract.
The most important mechanisms of physical
instability are creaming, sedimentation, For the rest of the trials E4, E5, E6, E7 and E8
flocculation, coalescence, Ostwald ripening, and the cremation index was lower, which is why they
phase inversion. In practice, all these mechanisms were selected for the calculation of the HLBn value
can act simultaneously and can influence each of the lipid extract.
other. However, usually one of these mechanisms Fig. 1 shows the correlation between the
can be dominant, which facilitates its identification cremation index and the HLBn of the lipid extract,
and allows the development of more effective adjusting to the five-order polynomial model. The
methods to control and improve the stability of an HLBn value was confirmed, calculating for which
emulsion (Aranberri, 2006; Álvarez, 2013). the cremation rate was minimal.

Table 2. Organoleptic aspect of the emulsions. Index (CI). The results obtained showed that the emulsion
Days prepared with HLB 7.0 (E-13) presented the lowest
Essay (IC) percentage of IC. Therefore, it was concluded that
0 1 5 15
the HLBn of the lipid extract of pumpkin seeds
E1 L L L L+C 21.67
(Cucurbita pepo L.) was approximately 7.0.
E2 L L L L+C 20.00
Table 3. Composition of the formulated emulsions (second series).
E3 L L L L+C 15.00
Span 85® Tween 80®
E4 L L L L+C 10.34 Essay HLBn
Quantity (g) % Quantity (g) %
E5 L L L L+C 8.47
E12 1.0 20 4.0 80 6.50
E6 L L L L+C 8.62
E13 0.5 10 4.5 90 7.00
E7 L L L L+C 10.34
E14 0.0 0 5.0 100 7.50
E8 L L L L+C 12.07
E9 L L L L+C 15.79 The HLBn results obtained for the lipid extract
E10 L L L L+C 17.24 of pumpkin seeds were similar to those reported
E11 L L L L+C 13.79
for pumpkin oil, whose value was 8.0, and to those
of oils of vegetable origin, determined by several
Legend: L- Milky C-Creamed
authors, for corn oil (6.5) and olive oil (9.0) (Godoy
et al., 2004; Fragoso, s/f).
In 2017, the authors Saengsorn and Jimtaisong
determined the HLB value experimentally for
Sacha inchi oil, using the Griffin method, whose
value was approximately 8.5; since it was the
emulsion that showed the lowest creaming rate.
(Saengsorn and Jimtaisong, 2017). Similar results
were obtained by Mikulcová et al. (2017) when
determining the HLB of hemp oil, obtained from
the seeds of Cannabis sativa L. whose value was 9.0.
The HLBn value of the lipid extract of pumpkin
Figure 1. Correlation of the cremation index and HLBn of the seeds was lower than that reported in the
pumpkin lipid extract.
literature consulted for pumpkin seed oil, since the
With the results obtained, the HLB value that lipid extract is extracted with ethanol and due to
produced the most stable emulsion was selected this extraction technique, there are fractions of
and three runs close to the selected value were fatty acids that are not are in this lipid extract and
prepared. that contribute to the value of HLBn.
The emulsion that showed the lowest IC CONCLUSION

percentage turned out to be the one with an HLB
value of 7.08 (E5), Table 1, so it was decided to use The value of the required hydrophilic-
it to carry out the second run (Table 3). lipophilic balance (HLBn) of the lipid extract of
pumpkin seeds (Cucurbita pepo L.), obtained in the
The experiments of the second series were
PPPNS Mario Muñoz belonging to CIDEM, is 7.0.
repeated with emulsifiers in different amounts for
three formulas with HLB 6.5, 7.0 and 7.5 (Table 3).

ACKNOWLEDGMENT technique: a valuable tool for determination of critical HLB

value of emulsions. AAPS PharmSciTech 7(1): E146-E152.
This work is part of a research project entitled "Development of https://doi.org/10.1208%2Fpt070121
a new medicine, containing Cucurbita pepo oil, for the Martínez SR (2019) Síntesis, purificación y evaluación de
treatment of Benign Prostatic Hyperplasia", financed by the surfactantes a partir de derivados de biomasa. Applied
Center for Research and Development of Medicines (CIDEM). chemistry specialization thesis. Centro de Investigación en
Química Aplicada. Coahuila, México.
Mikulcová V, Kašpárková V, Humpolíček P, Buňková L (2017)
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ABSTRACTS

ECFA 2022. S1-2nd SIMPOSIUM ON REGULATED CELL DEATH AND INFLAMMATION

Gilberto L. Pardo-Andreu, PhD, IFAL-UH, Cuba / Roberto Fernández-Acosta, PhD, IFAL-UH, Cuba / Tom Vanden Berghe, PhD, University of
Antwerp, Belgium
Do polypharmacological phytomedicinal compounds have a

future in personalized precision oncology: a kino2omic
perspective
Wim Vanden Berghe
PPES-IPPON, Department of Biomedical Sciences, University of Antwerp, 2000 Antwerp, Belgium.
wim.vandenberghe@uantwerpen.be
ABSTRACT
Disease relapse and therapy resistance remain key challenges in cancer treatment. Underlying (epi-)mutational events
typically promote tumorigenesis and contribute to multi-drug therapy resistance. Although innovative biomarker “omic”
strategies are instrumental to optimize personalized precision oncology treatments, dynamic epigenetic plasticity of
(immunogenic) cell death pathways and cellular mosaicism of the tumor-immune ecosystem frequently cause therapy
escape, which prevents complete recovery and ultimately triggers disease relapse. Interestingly, ferroptosis, a novel form of
iron-dependent redox and lipid peroxidation-regulated cell death was recently identified as a novel appealing treatment
strategy to overcome multidrug therapy resistance in different cancer types. New ferroptosis therapeutic strategies will be
presented by redox bioactive phytomedicinal compounds, non-thermal plasma treatment and iron-binding heme proteins to
overcome drug resistance. Finally, integrative systems biology (i.e. epigenome-transcriptome-kinome-proteome based)
“kino2omic” approaches are being developed to predict ferroptosis therapy response, which might advance the therapeutic
applicability of ferroptotic compounds in future clinical cancer treatment.
Keywords: cancer; ferroptosis; kino2omic; phytomedicinal


Antwerp, Belgium
Molecular mechanisms of nemorosone-induced ferroptosis

in cancer cells
Roberto Fernández-Acosta1,2*, Behrouz Hassania2,3, Bartosz Wiernicki2,3, Bruno Verstraeten2, Tom Vanden
Berghe2,3,4,5, Peter Vandenabeele2,3,6, Gilberto L. Pardo-Andreu2,7
1Department of Pharmacy, Institute of Pharmacy and Food, University of Havana, 222 St. # 2317, La Coronela, La Lisa, Havana, Cuba. PC
13600.
2VIB Center for Inflammation Research (IRC), Ghent, Belgium. PC 9052.
3Department of Biomedical Molecular Biology (DBMB), Ghent University, Ghent, Belgium. PC 9052.
4Laboratory of Pathophysiology, Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium. PC 2000.
Ferroptosis and Inflammation Research (FAIR), VIB-Ghent University and University of Antwerp, Belgium.
6Methusalem Program, Ghent University, Ghent, Belgium.
7Center for Research and Biological Evaluations, Institute of Pharmacy and Food, University of Havana, 222 St. # 2317, La Coronela, La Lisa,
Havana, Cuba. PC 13600.

*roberto.fernandezac91@gmail.com; 0000-0002-1588-9231
ABSTRACT
Context: The induction of ferroptosis, the biological rust of lipid membranes, is cutting edge in cancer treatment research
nowadays. Recently the crucial role that mitochondria play in cysteine-deprivation-induced ferroptosis has been elucidated,
which allows to expand the searching for new ferroptosis-inducing compounds. The anticancer effect of nemorosone has
been studied extensively; however, the capacity of this natural mitochondrial uncoupler to induce non-apoptotic cell death is
unknown.
Objectives: To characterize the molecular mechanisms of nemorosone-induced ferroptosis in cancer cells.
Methods: Cell death, lipid peroxidation, mitoROS, mitochondrial membrane potential, and Fe2+ levels were measured by
using the following specific fluorescent dyes: SYTOX Green, C11-Bodipy, MitoSOX, TMRE and FeRhoNox-1 respectively.
GSH, ATP and intracellular glutamate levels were determined spectrophotometrically. Oxygen consumption rate was
measured by high resolution respirometry. Activation of the KEAP1-NRF2-HMOX1 axis was identified through RNA
sequencing and validated by RT-qPCR and western blot. HMOX1 knockout cells were obtained by genome editing through
CRISPR-Cas9 technology.
Results: Here we show for the first time that nemorosone triggered a double-edged mechanism of ferroptosis in fibrosarcoma
HT1080 cells. We found that nemorosone dropped the glutathione levels and induced lethal lipid peroxidation as an early
event, while at later time points it over-activated the KEAP1-NRF2-HMOX1 axis, which led to an increase in intracellular
labile Fe2+, lipid ROS, and sensitization to cell death via hemin (HMOX1 substrate) cotreatment.
Conclusions: Nemorosone induces ferroptosis in fibrosarcoma by double-edged targeting mechanism consisting in the drop
of GSH as an early event and the overexpression of HMOX1 as a later event.
Keywords: Fibrosarcoma; GSH; KEAP1-NRF2-HMOX1 axis
Acknowledgments: This research was funded by VLIR (Belgium, grant number: CU2018TEA457A103) and by Ministerio de
Ciencia Tecnología y Medio Ambiente (Cuba, grant number: PN223LH010-035).


Antwerp, Belgium
The pore-forming protein sticholysin II triggers regulated

cell death
Carmen Soto1, Lena de León1, Flavia Llorente1, Olivia Díaz1,Gretchen Bergado2, Alexis Manso2, Lisset
Chao2, Juan C. Rodríguez3, Ivones Hernández Balmaseda4, Idania Rodeiro Guerra4, Uris Ros5, Ana García5,
Luis E. Hernández2, Belinda Sánchez2, Ana M. Hernández1, Carlos Álvarez1*
1Center for Protein Studies, Faculty of Biology, University of Havana and NaNoCancer-Lab-UH- Center of Molecular Immunology, Havana,
Cuba.
2Center of Molecular Immunology, Havana, Cuba.
3National Institute of Oncology and Radiobiology, Havana, Cuba.
4ICIMAR, Havana, Cuba.
5Institute for Genetics and Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of
Cologne, Cologne, Germany.

*calvarez@fbio.uh.cu
ABSTRACT
Context: Sticholysin II (StII) is a pore-forming protein with high cytolytic activity. StII forms 2 nm pores in membranes
eventually leading to cell death.
Objective: To examine the contribution of some intracellular pathways to StII cytotoxicity.
Methods: To evaluate the cytotoxic effects induced by StII on X63 cells MTT assay and flow cytometry studies were used.
Activation of calcium ion fluxes was analyzed by flow cytometry and confocal microscopy. The involvement of intracellular
pathways in the cell death induced by StII was evaluated by MTT in the presence of specific inhibitors. eIF2a
phosphorylation was estimated by Western blot. The release of HMGB1 protein toward the supernatant was evaluated by
ELISA.
Results: Cytotoxic effect of StII on tumoral cells took place at nanomolar concentration and led to an increase in cell volume
and loss of plasma membrane integrity. The presence of calcium in the extracellular medium increased the cell death rate
induced by StII. Even in the absence of Ca2+ in the extracellular medium, StII induced an increase in cytosolic Ca2+ derived
from the endoplasmic reticulum. This Ca2+ was eventually captured by mitochondria eliciting their fragmentation and other
morphological changes. Studies with specific inhibitors showed that ERK1/2, RIP1, and CaMKII are involved in the cell
death mechanism induced by StII. In addition, the toxin induced eIF2α phosphorylation and the release of HMGB1 protein.
Conclusion: StII induces a regulated necrosis with the activation of intracellular pathways.
Keywords: actinoporins; calcium release; regulated cell death; Sticholysin II


Antwerp, Belgium
JM-20 treatment reduced neuronal death and astrocyte

reactivity induced by ischemia/reperfusion: Involvement of
the Akt/GSK-3β signaling pathway
Jeney Ramírez Sánchez1*, Luis A Fonseca Fonseca1, Elisa Nicoloso Simões Pires2, André Meneghetti2, Estael
Ochoa Rodríguez3, Yamila Verdecia Reyes3, René Delgado-Hernández4, Christianne Salbego2, Diogo O.
Souza2, Gilberto L. Pardo-Andreu4, Yanier Núñez Figueredo1*
1Experimental Neuropharmacology Lab, Centro de Investigación y Desarrollo de Medicamentos, Ave 26, No. 1605 Boyeros y Puentes Grandes,
CP 10600, La Habana, Cuba.
2Programa de Pós-graduação em Bioquímica, Departamento de Bioquímica, ICBS, Universidade Federal do Rio Grande do Sul, Rua Ramiro
Barcelos, 2600-Anexo I, Porto Alegre, Rio Grande do Sul 90035-003, Brazil.

3Laboratorio de Síntesis Orgánica, Facultad de Química de La Universidad de La Habana, Zapata s/n entre G y Carlitos Aguirre, Vedado
Plaza de la Revolución, CP 10400, La Habana, Cuba.

4Centro de Estudio para las Investigaciones y Evaluaciones Biológicas, Instituto de Farmacia y Alimentos, ave. 23 # 21425 e/214 y 222, La
Coronela, La Lisa, CP 13600, La Habana, Cuba.

*jeney.ramirez@cidem.cu, yanier.nunez@cidem.cu
ABSTRACT
Context: Stroke is one of the leading causes of morbidity, mortality, and disability worldwide. More than 80% are ischemic,
caused by the reduction of blood supply to the brain. Several interconnected pathophysiological events, including
excitotoxicity, oxidative stress, inflammation, and apoptosis, have been widely considered major therapeutic targets for
ischemic stroke.
Objectives: To evaluate the effect of a novel hybrid molecule, JM-20, on neuronal survival and astrocytes reactivity after
ischemia/reperfusion in vitro and in vivo.
Methods: Organotypic hippocampal slice cultures were subjected to 60 min oxygen-glucose deprivation (OGD). 90 min
middle cerebral artery occlusion (MCAO) model was performed in male Wistar rats to resemble ischemia/reperfusion in
vivo. The involvement of the Akt/GSK-3β signaling pathway on JM-20 neuroprotective effects was examined by Western
blot and astrocytes hypertrophy and proliferation by immunohistochemistry (glial fibrillary acidic protein).
Results: OGD significantly compromised cell survival (it increased propidium iodide incorporation), decreasing levels of the
phosphorylated pro-survival protein Akt (p-Akt) and its downstream target GSK-3β (phosphorylated). The immunocontent
of p-Akt protein also decreased in the cerebral cortex 24 h after MCAO, accompanied by a decreased number of NeuN +.
Widespread reactive astrogliosis in cortex and hippocampus was also observed post-MCAO. On the contrary, JM-20
treatment prevented the activated Akt reduction, neuronal death, and astrocyte reactivity, shifting the balance between cell
death and survival toward the survival path.
Conclusions: Overall, the results reinforce the pharmacological potential of JM-20 as a neuroprotective agent and provide
important new insights about its molecular and cellular targets in relevant models of cerebral ischemia.
Keywords: Akt/GSK-3β signaling pathway; astrogliosis; ischemic stroke; middle cerebral artery occlusion; neuroprotective
effects; oxygen-glucose deprivation


Antwerp, Belgium
Antitumor effect of the CIGB-552 peptide in colorectal

cancer models
Brizaida Oliva Arguelles1*, Hilda E. Garay3, Jorge Fernandez de Cossio2, Lesley A. Stark4, Maribel G.
Vallespi1
1Cancer Biology Group, Pharmaceutical Department, Center for Genetic Engineering and Biotechnology, Ave 31, e/ 158 y 190, Cubanacan,
Playa, Havana, Cuba.
2Department of Bioinformatics, Center for Genetic Engineering and Biotechnology, Ave 31, e/ 158 y 190, Cubanacan, Playa, Havana, Cuba.
3Synthetic Peptides Group, Chemistry-Physics Department, Center for Genetic Engineering and Biotechnology, Ave 31, e/ 158 y 190,
Cubanacan, Playa, Havana, Cuba.

4Edinburgh Cancer Research Centre, IGMM, University of Edinburgh, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, UK.
*brizaida.oliva@cigb.edu.cu
ABSTRACT
Context: The treatment of colorectal cancer through Anticancer Target Therapy constitutes a new paradigm in cancer
treatment. The peptide CIGB-552 is a cell penetrating peptide whose molecular mechanism is related to the modulation of
the COMMD1 protein and the inhibitor of the NF-κB factor.
Objectives: To evaluate the effect of CIGB-552 in several colorectal cancer cell lines and the combination with 5-fluorouracil
(5-FU) and cisplatin (CDDP). Furthermore, we aim to study the effect of CIGB-552 on organoids and cancer stem cells.
Methods: The antiproliferative activity of CIGB-552 alone and in combination with the mentioned chemotherapeutic agents
was analyzed using the software. Calcusyn. Analysis of cell cycle progression was carried out by flow cytometry
(FACSCalibur cytometer) by staining withAnnexin V/propidium iodide.
Results: A synergistic effect was observed regarding CIGB-552-mediated cytotoxicity in combination with 5-FU and CDDP.
Specifically, the combination of CIGB-552 with CDDP in HT-29 cells led to S phase arrest and increased late
apoptotic/necrotic cell populations. Moreover, the CIGB-552 peptide exhibited a significant effect on cancer stem cells and
organoids.
Conclusions: Co-administration of CIGB-552 and CDDP was able to synergistically enhance cytotoxicity in vitro through
premature apoptosis and cell cycle arrest induction. The CIGB-552 peptide also inhibited the proliferation of stem cells and
organoids models. These results provide evidence to support clinical trials using these agents.
Keywords: apoptosis; CIGB-552; colon; synergism


Antwerp, Belgium
Effect of IL-2 and mutant variant of IL-2 on peripheral blood

mononuclear cells: expansion, characterization and
functional activity
Anabel Lavastida-Linares1*, Jenysbel de la C. Hernández-Reyes1*, Raíza Ruiz Llorente2, Tania Carmenate1,
Kalet León1, Nuris Ledón1, Mayrel Labrada-Mon1
1 Center of Molecular Immunology, Havana, Cuba.
2González Coro Hospital, Havana, Cuba.
*alavastida@cim.sld.cu; jenysbelh@cim.sld.cu
ABSTRACT
Context: The adoptive transfer of T cells (ACT) is currently an attractive approach for cancer treatment. One of the modalities
of the ACT protocols includes isolating and in vitro expanding of peripheral mononuclear cells (PBMCs) with IL-2. The severe
toxicity of IL-2 following binding to its high affinity IL-2 receptor alpha (IL-2Rα) has restricted its application in cancer
patients. To overcome this problem, The Center of Molecular Immunology (CIM) designed a variant of IL-2, in which binding
to IL2-Rα was reduced without affecting the affinity for the β or γ subunits of the receptor compared to native IL-2.
Objectives: To evaluate the effect of mutant IL-2 in PBMC proliferation, exhaustion, differentiation and IFN-γ secretion
compared to the wild-type human IL-2 (wtIL-2).
Methods: PBMCs of healthy donors were isolated and expanded in human serum-free RPMI 1640 with 50 UI/mL of wtIL-2 or
mutant IL-2, and CD3/CD28 beads for 14 days. Cells were counted at five-time points (i.e., days 0, 5, 7, 9, 11, and 14), and cell
number was determined by trypan blue exclusion dye. The supernatants were harvested, and IFN-γ secretion levels were
measured using a human IFN-γ ELISA kit. Immunophenotyping of PBMCs was performed before expansion and on day 14 by
flow cytometry.
Results: Cell proliferation assay indicated that the mutant IL-2 induced a higher cell expansion than wtIL-2. Additionally, less
exhaustion and greater expansion of CD8+ T cells was obtained with mutant IL-2 compared to native IL-2. IFN-γ secretion
was significantly increased in response to both IL-2 proteins compared to the untreated control cells.
Conclusions: Our results suggest that mutant IL-2 can be an alternative option in IL-2-associated immunotherapy for cancer
patients.
Keywords: adoptive transfer of T cells; IL-2; immunotherapy; peripheral mononuclear cells


Antwerp, Belgium
Antiproliferative potentialities of carvacrol-rich essential

oils from Cuban plants based on cell membrane fluidity
Lianet Monzote1*, Ramón Scull2, Yamilet Gutiérrez2, Paul Cos3, William Setzer4, Lars Gille5
1Parasitology Department, Institute of Tropical Medicine “Pedro Kouri”, Havana, Cuba.
2Department of Pharmacy, Institute of Pharmacy and Food, Havana University, Cuba.
3Laboratory for Microbiology, Parasitology and Hygiene, University of Antwerp, Belgium.
4Department of Chemistry, University of Alabama in Huntsville, USA.
5Institute of Pharmacology and Toxicology, University of Veterinary Medicine, Vienna, Austria.
*monzote@ipk.sld.cu
ABSTRACT
Context: Plant-derived products are employed in various public health practices as a source of medicines. In particular,
essential oils have been widely used due to their nutritional and therapeutic properties.
Objectives: To determine the chemical composition, antimicrobial, antiparasitic, and cytotoxic properties of essential oil from
Cuban plants.
Methods: The chemical composition of essential oils was determined by gas chromatography coupled with a mass
spectrometric detector. Biological activities were assayed in vitro on bacteria, fungi, protozoa, malignant and non-malignant
cell lines. The membrane fluidity was assessed as a possible mechanism of action of carvacrol on parasite and macrophages
using the electron paramagnetic resonance method.
Results: Essential oils demonstrated a carvacrol-rich essential oils chemotype, which was also tested in the biological
systems. The relevant effects were observed against the parasitic protozoans (Plasmodium falciparum, Trypanosoma spp. and
Leishmania spp.) and malignant cell lines (MCF-7, MCF-7/HT, 22Rv1, and A431 cells), which showed IC50 values < 50
µg/mL. However, no activity was observed on bacteria (Staphylococcus aureus and Escherichia coli) and fungi (Candida
albicans) at this concentration. The antiproliferative activity of the oil could be attributed to carvacrol, which showed same
activity against parasite and malignant cells based on increase of membrane fluidity without causing its rupture.
Conclusions: This study provides evidence about antiparasite and anticancer potential of the essential oil from Cuban plants
based on carvacrol as the main active component. In particular, both antiproliferative and cytotoxic spectrum of carvacrol
were demonstrated and a correlation with the characteristics or composition of membranes in microorganism and
mammalian cells was suggested.
Keywords: anticancer; antiparasite; carvacrol; essential oil; membrane fluidity


Antwerp, Belgium
Mitochondrial contribution to ferroptosis

Gilberto L. Pardo-Andreu1*, Roberto Fernández-Acosta2, Daniel Álvarez-Almiñaque1, Behrouz Hassania3,
Peter Vandenabeele3, Tom Vanden Berghe3,4
1Center for Research and Biological Evaluations, Institute of Pharmaceutical Sciences and Foods, University of Havana, 222 St. # 2317, La
Coronela, La Lisa, Havana, Cuba. PC 13600.
2Department of Pharmacy, Institute of Pharmaceutical Sciences and Foods, University of Havana, 222 St. # 2317, La Coronela, La Lisa, Havana,
Cuba. PC 13600.
3Molecular Signaling and Cell Death Unit, VIB-Ugent Center for Inflammation Research, Department of Biomedical Molecular Biology, Ghent
University (Ghent, Belgium).

4Laboratory of Pathophysiology, Department of Biomedical Sciences, University of Antwerp, 2000 Antwerp, Belgium.
*gpardo@ifal.uh.cu
ABSTRACT
Context: Research on oxidative cell death is producing new mechanisms, such as ferroptosis, in several pathologies,
including cerebral ischemia and hemorrhagic brain insults. Ferroptosis is an oxidative form of regulated necrotic cell death
presenting glutathione (GSH) depletion, disrupted glutathione peroxidase-4 (GPX4) redox defense and detrimental lipid
reactive oxygen species formation. Despite the knowledge of mechanisms of ferroptosis is increasing, the particular role of
mitochondria requires further investigation. Recently, Gao et al. showed that mitochondria play a crucial role in cysteine
deprivation-induced ferroptosis but not in GPX4 inhibition-induced ferroptosis. Mechanistically, cysteine deprivation leads
to mitochondrial membrane potential (MMP) hyperpolarization and lipid peroxide accumulation. However, the mechanisms
by which cysteine deprivation triggers MMP hyperpolarization are not clear.
Objective: To propose a hypothesis to explain the mitochondrial contribution to ferroptosis based on the hydrolytic activity of
the F1FO ATPase.
Results: Our working hypothesis was that the increased hydrolytic activity of the F1FO ATPase (acting in reverse due to
erastine-mediated non-vesiculated cytosolic glutamate accumulation) could drive such hyperpolarization. We have
observed for the first time that oligomycin (1 µg/mL) and JM-20 (10 µM), both inhibitors of F1FO ATPase, protected HT22
and HT1080 cells from erastine (1 µM) and glutamate (10 mM)-induced ferroptosis. Both erastine and glutamate increased
the basal respiration, probably associated with higher availability of intracellular glutamate. Interestingly, cyclosporine A
(CsA), the classical mitochondrial permeability transition inhibitor, did not protect the cells against xCT inhibition. When
ferroptosis was induced by GPX4 inhibition (ML-162), both oligomycin and CsA potentiated cell death.
Conclusions: Mitochondria have indeed a role in ferroptotic cell death in this particular context. JM-20 (10 uM), a specific
inhibitor of the hydrolytic activity of F1FO ATPase, keeps its strong protective effects pointing this electron transport chain
component as a key actor in ferroptosis.
Acknowledgment: This research was funded by VLIR (Belgium, grant number: CU2018TEA457A103) and by Ministerio de
Keywords: ferroptosis; F1FO ATPase; mitochondria


Antwerp, Belgium
Inflammation index as prognostic and predictive factors in

patients with lung cancer
Carmen Viada*, Lisania Reyes, Joel Torres, Nuris Ledón, Agustín Lage
Center of Molecular Immunology, Havana city, Cuba.
*carmen@cim.sld.cu; ORCID: 0000-0002-1604-3545
ABSTRACT
Context: Neutrophil-Lymphocyte Ratio (NLR) and Platelet-Lymphocyte Ratio (PLR) are two indices of inflammation based
on reported neutrophil (N), lymphocyte (L), and platelet (P) counts as prognostic and predictive factors in several solid
tumors.
Objectives: To evaluate the association of inflammation indices with overall survival (OS) in patients with lung cancer.
Methods: A total of 1168 patients with lung cancer, undergoing different treatments (683 with CIMAvax-EGF, 93 with
nimotuzumab, 180 with racotumomab, 52 with Docetaxel and 186 controls), were analyzed. The cut-off value was
determined using X-tile 3.6.1 software. The Kaplan-Meier method was used to analyze the association of three indices with
OS. All statistical analyzes were performed with SPSS version 25 software. Differences were considered statistically
significant when p<0.05.
Results: Kaplan-Meier analyzes revealed that higher NLR and PLR were significantly correlated with poorer OS (p = 0.000
for patients treated with CIMAvaxEGF, p = 0.001 for patients treated with nimotuzumab, p = 0.008 for patients treated with
racotumomab) in patients with lung cancer. Patients with a low index treated with CIMAvaxEGF or nimotuzumab had
longer survival than the control group. Low NLR was found to be a good prognostic factor for lung cancer patients treated
with CIMAvax-EGF. Elevated PLR turned out to be a good prognostic factor for patients treated with nimotuzumab.
Patients with lung cancer and low NLR treated with CIMAvaxEGF survive longer than the control group. Therefore, both
indices have predictive value in patients with lung cancer.
Conclusions: Low NLR has predictive value in lung cancer patients and it is also a good prognostic factor for this pathology.
On the other hands, low PLR had predictive value in lung cancer.
Keywords: neutrophil to lymphocyte ratio; nimotuzumab; non-small cell lung cancer; overall survival; platelet lymphocyte
ratio; systemic immune inflammation index


Antwerp, Belgium
Gossypitrin, a naturally occurring flavonoid, attenuates

iron-induced neuronal and mitochondrial damage
María A. Bécquer-Viart1, Adonis Armentero López1, Daniel Álvarez-Almiñaque1, Roberto Fernández-
Acosta2,Yasser Matos-Peralta3, Richard F. D’Vries4, Javier Marín-Prida1, Gilberto L. Pardo-Andreu1*
1Center for Research and Biological Evaluations, Institute of Pharmaceutical and Food Sciences, University of Havana, 222 St. #2317 b/ 23 and
31, La Coronela, La Lisa, La Habana CP 13600, Cuba;
2Pharmacy Department, Institute of Pharmaceutical and Food Sciences, University of Havana,
222 St. #2317 b/23 and 31, La Coronela, La Lisa, La Habana CP 13600, Cuba;
3Bioinorganic Laboratory, Faculty of Chemistry, University of Havana, Zapata and G, Vedado,
La Habana CP 10400, Cuba

4Facultad de Ciencias Básicas, Universidad Santiago de Cali, Calle 5 # 62-00, Cali CP 76001, Colombia;
*gpardo@ifal.uh.cu
ABSTRACT
Context: The disruption of iron homeostasis is an important factor in the loss of mitochondrial function in neural cells,
leading to neurodegeneration. Pharmacological agents targeting brain iron regulation and iron-mediated mitochondrial
impairment may therefore be therapeutically useful against neurodegeneration. Several iron-chelating agents have been
found to exhibit neuroprotective actions in different experimental models. Our group has observed that catechol-containing
polyphenols interact with iron, thus annulling its catalytic role in promoting ROS. We also recently reported the potent
antioxidant effects of gossypitrin (Gos), a naturally occurring flavonoid, indicating its potential use as a neuroprotective
agent.
Objectives: To assess the protective action of Gos on iron-induced neuronal cell damage.
Methods: The neuroprotective action of Gos (0.001–100 µM) was tested on mouse hippocampal HT-22 cells by means of co-
incubation for 24 h with Gos or Trolox (500 µM), FeCl2 (100 µM), and citrate (1 mM). After 24 h, the cell viability was
measured by the MTT colorimetric assay. Mitochondrial membrane potential and ATP levels were measured in both, cells
and isolated mitochondria. Lipid peroxidation and the formation of hydroxyl (•OH) radicals were estimated by following
malondialdehyde (MDA) generation from isolated mitochondria and the 2-deoxyribose, respectively. The concentration of
Fe(II) was determined by the formation of a red complex with 1,10-phenanthroline, and the consumption of O2 related to
Fe(II) oxidation was measured with a Clark-type electrode. Gos-iron complex formation was estimated by means of UV-Vis
and IR spectra analysis.
Results: Gos was able to rescue HT-22 cells from the damage induced by 100 µM Fe(II)-citrate (EC50 = 8.6 µM). This protection
was linked to the prevention of both iron-induced mitochondrial membrane potential dissipation and ATP depletion. In
isolated mitochondria, Gos (50 µM) elicited an almost complete protection against iron-induced mitochondrial swelling, the
loss of mitochondrial transmembrane potential, and ATP depletion. Gos also prevented Fe(II)-citrate-induced mitochondrial
lipid peroxidation with an IC50 value (12.45 µM). Furthermore, the flavonoid was effective in inhibiting the degradation of
both 15 and 1.5 mM 2-deoxyribose. It also decreased Fe(II) concentration, while increasing O 2 consumption rate, and
impairing the reduction of Fe(III) by ascorbate. Gos–Fe(II) complexes were detected by UV-Vis and IR spectroscopy, with an
apparent Gos-iron stoichiometry of 2:1.
Conclusions: Results suggest that Gos does not generally act as a classical antioxidant, but rather directly affects iron by
maintaining it in its ferric form after stimulating Fe(II) oxidation. Metal ions would therefore be unable to participate in a
Fenton-type reaction and the lipid peroxidation propagation phase. Hence, Gos could be used to treat neuronal diseases
associated with iron-induced oxidative stress and mitochondrial damage.
Keywords: gossypitrin; HT-22; iron; mitochondria; neurodegeneration; neuroprotection


Antwerp, Belgium
Novel iron oxide nanoparticles induce ferroptosis in a panel

of cancer cell lines
Roberto Fernández-Acosta1 , Claudia Iriarte-Mesa2,3 , Daniel Álvarez-Alminaque4, Behrouz Hassannia5,6,
Bartosz Wiernicki5,6, Alicia M. Díaz-García2, Peter Vandenabeele5,6,7, Tom Vanden Berghe5,6,8,9,10, Gilberto L.
Pardo-Andreu4*
1Department of Pharmacy, Institute of Pharmaceutical and Food Sciences, University of Havana, 222 Street # 2317, La Coronela, La Lisa,
Havana 13600, Cuba.
2Laboratory of Bioinorganic (LBI), Department of Inorganic and General Chemistry, Faculty of Chemistry, University of Havana, Zapata y G,
Vedado, Plaza de la Revolución, Havana 10400, Cuba

3Institute of Inorganic Chemistry—Functional Materials, University of Vienna, Währinger Straße 42, 1090 Vienna, Austria.
4Center for Research and Biological Evaluations, Institute of Pharmaceutical and Food Sciences, University of Havana, 222 Street # 2317, La
Coronela, La Lisa, Havana 13600, Cuba.

5VIB Center for Inflammation Research (IRC), 9052 Ghent, Belgium.
6Department of Biomedical Molecular Biology (DBMB), Ghent University, 9052 Ghent, Belgium.
7Methusalem Program, Ghent University, 9052 Ghent, Belgium.
8Laboratory of Pathophysiology, Department of Biomedical Sciences, University of Antwerp, 2000 Antwerp, Belgium.
9Ferroptosis and Inflammation Research (FAIR), VIB Research Center, Ghent University, 9052 Ghent, Belgium.
10Ferroptosis and Inflammation Research (FAIR), University of Antwerp, 2000 Antwerp, Belgium.
*gpardo@ifal.uh.cu
ABSTRACT
Context: The use of nanomaterials rationally engineered to treat cancer is a burgeoning field that has reported great medical
achievements. Iron-based polymeric nano-formulations with precisely tuned physicochemical properties are an expanding
and versatile therapeutic strategy for tumor treatment. Recently, a peculiar type of regulated necrosis named ferroptosis has
gained increased attention as a target for cancer therapy.
Objective: To evaluate the anticancer activity of novel magnetic iron oxide nanoparticles (IONP) functionalized with gallic
acid (GA) and polyacrylic acid (PAA).
Results: Here, we showed for the first time that novel iron oxide nanoparticles coated with gallic acid and polyacrylic acid
(IONP–GA/PAA) possess intrinsic cytotoxic activity on various cancer cell lines. Indeed, IONP–GA/PAA treatment
efficiently induced ferroptosis in glioblastoma, neuroblastoma, and fibrosarcoma cells. IONP–GA/PAA-induced ferroptosis
was blocked by the canonical ferroptosis inhibitors, including deferoxamine and ciclopirox olamine (iron chelators), and
ferrostatin-1, the lipophilic radical trap. These ferroptosis inhibitors also prevented the lipid hydroperoxide generation
promoted by the nanoparticles.
Conclusions: Altogether, we report on novel ferroptosis-inducing iron encapsulated nanoparticles with potent anti-cancer
properties, which have promising potential for further in vivo validation.
Keywords: cancer cells; ferroptosis; IONP–GA/PAA


Antwerp, Belgium
Evaluation of the toxic effects of two formulations of

magnetite nanoparticles on the earthworm Eisenia andrei
Yordanka Domínguez Linares1*, Dayvis Díaz Salazar1, Odette Beiro Castro1, Ahmed Valdés Martínez2,
Yilian Fernández Afonso2, Osmany García Zaldívar3, Yorexis González Alfaro2
1Department of Toxicological Evaluations and Environment, National Center of Toxicology, Havana, Cuba.
2Center for Advanced Studies of Cuba, Havana, Cuba.
3Institute of Materials Sciences and Technologies, University of Havana, Havana, Cuba.
*ecotox@infomed.sld.cu; ORCID: 0000-0001-6199-8757
ABSTRACT
Context: Magnetite nanoparticles (MNPs) with superparamagnetic behavior have unique biocompatibility properties that
allow their application in the field of biomedicine, highlighting their use as carriers of various drugs, including those of
natural origin. Therefore, the use of MNPs is increasing, and consequently, its presence in different environmental
compartments is also on the rise. However, the ecotoxicity of these MNPs in the terrestrial ecosystem has been little
explored.
Objectives: To evaluate the toxic effects caused by two formulations of MNPs on the earthworm Eisenia andrei.
Methods: Different concentrations of the synthesized MNPs were used and were characterized by X-ray diffraction (XRD),
transmission electron microscopy (TEM), and Vibrant Sample Magnetometry (VSM). To determine the toxicity, two tests
were carried out: contact and artificial substrate, where survival, biomass changes, physiological and behavioral alterations,
and reproductive behavior were evaluated.
Results: The characterization of the MNPs showed that they had a mean size of 9 nm. In both toxicity tests, mortality,
changes in weight, physiological and behavioral alterations were observed in the highest concentrations, which
demonstrates the need to analyze the toxicity of MNPs using test batteries that cover different routes and exposure times.
Conclusions: The MNPs showed a toxic effect in the highest concentrations evaluated.
Keywords: Eisenia Andrei; earthworm; magnetite nanoparticles; toxicity


Antwerp, Belgium
Marine seagrass extract of Thalassia testudinum suppresses

tumor growth, motility and angiogenesis by autophagic
stress and immunogenic cell death pathways
Ivones Hernández Balmaseda1*, Idania Rodeiro Guerra1, Ken Declerck2, José A. Herrera Isidrón3, Claudina
Pérez-Novo2, Guy Van Camp4, Olivier De Wever5, Kethia González1, Mayrel Labrada6, Adriana Carr6,
Geovanni Dantas-Cassali7, Diego C. dos Reis7, Livan Delgado-Roche1, Roberto R. Nuñez1, René Delgado-
Hernández8, Miguel D. Fernández1, Miriam T. Paz-Lopes7, Wim Vanden Berghe2
1Departamento de Farmacología, Instituto de Ciencias del Mar (ICIMAR), Plaza de la Revolución, La Habana, Cuba.
2Laboratory of Protein Science, Proteomics and Epigenetic Signaling (PPES) and Integrated Personalized and Precision Oncology Network
(IPPON), Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium.
3Instituto de Ciencia y Tecnología de Materiales (IMRE), Universidad de la Habana, Plaza de la Revolución, La Habana, Cuba.
4Center of Medical Genetics, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.
5Laboratory of Experimental Cancer Research, Department of Radiation Oncology and Experimental Cancer Research, Cancer Research
Institute Ghent (CRIG), Gent, Belgium.

6Center of Molecular Immunology, Havana, Cuba.
7Institute of Biological Sciences (ICB), Federal University of Minas Gerais (UFMG), Belo Horizonte, Brazil.
8Instituto de Farmacia y Alimentos (IFAL), Universidad de La Habana, La Lisa, La Habana, Cuba.
*ivones@icimar.cu; ORCID: 0000-0001-5276-0851
ABSTRACT
Context: Marine plants have become an inexhaustible reservoir of new phytopharmaceuticals for cancer treatment.
Objectives: To evaluate the antitumor efficacy of a standardized polyphenol extract from the marine angiosperm of Thalassia
testudinum (TTE).
Methods: Cell viability was determined by MTT assay in human RKO, SW480, and mouse CT26 colon cancer cells.
Chorioallantoic Membrane (CAM) angiogenesis assay was performed to calculate the angiogenic index. A wound healing
assay was carried out to determine the migration ability of human EA.hy926 endothelial cells. The antitumor effects in vivo
were examined in a syngeneic allograft murine CT26 colorectal cancer model. Transcriptome profiling and systems biology
approaches were applied to further characterize in vitro/in vivo antitumor activities.
Results: MTT assays revealed a dose-dependent decrease of cell viability of RKO, CT26, and SW480 cells upon TTE treatment
with IC50 values of, respectively, 175, 115, and 60 mg/mL. Furthermore, TTE significantly prevented basal and bFGF-
induced angiogenesis in the chicken chorioallantoic membrane angiogenesis assay. In addition, TTE suppressed bFGF-
induced migration of endothelial cells in a wound closure assay. Finally, TTE treatment abrogated CT26 colorectal cancer
growth and increased overall organism survival in a syngeneic murine allograft model. Corresponding transcriptome
profiling and pathway analysis allowed for the identification of the mechanism of action for the antitumor effects of TTE. In
line with our in vitro/in vivo results, TTE treatment triggered ATF4-P53-NFκβ specific gene expression and autophagy stress
pathways.
Conclusions: T. testudinum shows activity in suppression of colon cancer cell growth, cell motility, and angiogenesis pathways
in vitro and promotes antitumor immunogenic cell death in vivo.
Keywords: anti-angiogenic; antitumor; cytotoxicity; gene expression, Thalassia testudinum


Antwerp, Belgium
A novel selective peptide targeting the JNK cascade inhibits

neuronal ferroptosis and protects against cerebral ischemia
in rats
Javier Marín-Prida1*, Daniel Álvarez-Almiñaque1, Yu Tian Wang2, Gilberto L. Pardo-Andreu1
1Center for Research and Biological Evaluations (CEIEB), Institute of Pharmacy and Food, University of Havana, Havana, Cuba.
2Djavad Mowafaghian Centre for Brain Health, University of British Columbia, Vancouver, Canada.
*aleph.neuro@gmail.com
ABSTRACT
Context: Emerging evidence supports the pathophysiological role of ferroptosis in ischemic stroke. The JNK cascade is
implicated in neuronal injury after the iron overload and oxidative stress, both events also involved in the ferroptotic
program. Here we hypothesized that by inhibiting this signaling pathway the neuronal cells may be protected from death
promoted by ferroptosis inducers.
Objectives: To assess the protective effect of a novel JNK-selective inhibitor peptide against ferroptosis in neuronal cells, and
against the brain ischemic damage in rats.
Methods: The mouse hippocampal HT-22 neuronal cell line was incubated (8 x 103/well in a 96-well plate) for 1 h with the
candidate peptide, whose original design followed a previous method, and then co-incubated with different ferroptosis
inducers (erastin, ML-162 or glutamate) and the fluorescence probe SYTOX Green for another 24 h. The fluorescence
intensity was then detected by using a plate reader at 520/485 nm (Em/Ex). The percentage of cell death was determined in
relation to the complete death as induced by Triton X-100 (0.1%) and complete viability (medium without these additives).
The in vivo neuroprotection experiment was carried out in an endothelin-1 (ET-1) rat model of focal cerebral ischemia, in
which the peptide was intraperitoneally administered, and the infarct volume was assessed at 24 h post-stroke by the TTC
assay.
Results: The peptide significantly decreased the ferroptosis death in HT-22 neurons as induced by erastine, glutamate, or
ML-162, in a dose-dependent manner. Similarly, it exerted a potent neuroprotective action against the ET-1-promoted rat
brain ischemia by dramatically limiting the infarct volume to around 7% in relation to the vehicle-treated ischemic animals.
Conclusion: A novel and original peptide that selectively inhibits the JNK cascade protects the neurons from ferroptosis
death, and strongly limits brain infarction in ischemic rats, thus offering a new promising therapy for ischemic stroke.
Keywords: cerebral ischemia; ferroptosis; JNK; neuroprotection


Antwerp, Belgium
Neuroprotective potential of a novel multitarget hybrid

molecule, JM-20, in in vivo and in vitro models of
Parkinson’s disease
Luis A. Fonseca Fonseca1, Laura R. Taño Portuondo1, Jeney Ramírez Sánchez1, Maylín Wong Guerra1,
Yanay Montano Peguero1, Estael Ochoa Rodríguez2, Yamila Verdecia Reyes2, Victor D. Amaral-Silva3,
Silvia Lima Costa3, Gilberto L. Pardo-Andreu4, Yanier Núñez Figueredo1*
1Centro de Investigación y Desarrollo de Medicamentos, Ave 26, No. 1605 Boyeros y Puentes Grandes, CP 10600, La Habana, Cuba.
2Laboratorio de Síntesis Orgánica de La Facultad de Química de La Universidad de La Habana (Zapata s/n entre G y Carlitos Aguirre,
Vedado Plaza de la Revolución, CP 10400, La Habana, Cuba.
3Laboratório de Neuroquímica e Biologia Celular, Instituto de Ciências da Saúde, Universidade Federal da Bahia - UFBA, Av. Reitor Miguel
Calmon s/n, Vale do Canela, CEP 41100-100, Salvador, Bahia, Brazil.

4Centro de Estudio para las Investigaciones y Evaluaciones Biológicas, Instituto de Farmacia y Alimentos, ave. 23 # 21425 e/214 y 222, La
Coronela, La Lisa, CP 13600, Universidad de La Habana, La Habana, Cuba.

*yanier.nunez@cidem.cu
ABSTRACT
Context: The etiology of Parkinson's disease (PD) is not completely understood and is believed to be multifactorial. Neuronal
disorders associated with oxidative stress and mitochondrial dysfunction are widely considered major consequences.
Objectives: To investigate the effect of a novel hybrid molecule, JM-20, in different in vitro and in vivo models induced by 6-
hydroxydopamine (6-OHDA) and rotenone.
Methods: As in vitro models of PD, different cells line were exposed to 6-OHDA or rotenone neurotoxin and treated with JM-
20. Protection against mitochondrial damage was also investigated using isolated rat brain mitochondria. For in vivo
experiments, adult male Wistar rats were lesioned by 6-OHDA infusion in the SNpc or rotenone intraperitoneal injection.
JM-20 was administrated orally, at different doses, through an intragastric gavage. During the evaluations, different
behavioral tests were performed.
Results: Treatment with JM-20 significantly reduced the percentage of motor asymmetry and increased exploration. It
improved the redox state of the SNpc and the striatal tissue of these animals. Also, JM-20 reduced glial fibrillary acidic
protein overexpression and increased tyrosine hydroxylase-positive cell number, both in SNpc. Altogether, these results
demonstrated that JM-20 is a potential neuroprotective agent against 6-OHDA and rotenone-induced damage both in in vitro
and in vivo models. The mechanism underlying JM-20 neuroprotection appears to be associated with the control of oxidative
injury and mitochondrial impairment.
Conclusions: These results indicate a possible neuroprotective effect of JM-20 for the treatment of PD. We are very close to
completing all regulatory clinical studies to initiate the first clinical trial to evaluate the safety and efficacy of this molecule.
Keywords: JM-20; mitochondrial dysfunction; neuroprotection; Parkinson’s disease; oxidative stress


Antwerp, Belgium
Histochemical evaluation of the anti-inflammatory and

neuroprotective effect of phycocyanobilin in C57BL/6 mice
with experimental autoimmune encephalomyelitis
Rocío de la C. Sarduy-Chávez1*, Javier Marín-Prida1, Giselle Pentón-Rol2,3
1Centerfor Research and Biological Evaluations, Institute of Pharmacy and Food, University of Havana, Ave. 23 e/ 214 y 222, La Lisa. PO Box:
430, Havana, Cuba.
2Center for Genetic Engineering and Biotechnology (CIGB), Ave. 31 e/ 158 y 190, Cubanacán, Playa, Havana, Cuba. PO Box 6162.
4Latin American School of Medicine, Calle Panamericana Km 3 1/2, Playa, Havana, 11600, Cuba.
*rociosarduy@gmail.com
ABSTRACT
Context: Multiple Sclerosis (MS) is an autoimmune, inflammatory, and neurodegenerative disease, in which there is a
progressive loss of myelin. It is the most common cause of physical-motor disability in young adults worldwide, and there is
currently no cure available. Given the diverse antioxidant and cytoprotective properties reported for Phycocyanobilin (PCB),
the tetrapyrrolic compound present in the cyanobacteria Spirulina platensis, here we hypothesized its potential use as a
pharmacological disease-modifying treatment for MS.
Objective: To assess the effects of PCB on molecular markers of central nervous system injury and inflammation by using
histochemical techniques in a widely accepted animal model of MS.
Methods: Experimental Autoimmune Encephalomyelitis (EAE) was induced in C57BL/6 mice (n=7-10 per group), randomly
divided into naïve, vehicle (phosphate buffer saline), or PCB-treated groups at 0.1, 0.5, and 1 mg/kg. PCB or vehicle was
given intraperitoneally as a single daily dose for 26 days, starting the day of the immunization. At the end of the treatment
period, animals were humanely euthanized, and their spinal cords were used for immunohistochemical analysis with
primary antibodies targeting Mac-3, CD3, APP, and TPPP/p25. Morphometry was done with the Image J software.
Results: PCB showed a positive effect, in a dose-dependent manner, on these markers in the white matter of EAE-mice spinal
cords. PCB was able to inhibit the overexpression of Mac-3 and CD3 (neuroinflammation), the APP accumulation (axonal
damage) and induced the expression of Olig2 and TPPP/p25 (viable oligodendrocytes).
Conclusions: These results support the potential application of PCB as a novel treatment for MS through ameliorating several
crucial pathophysiological mechanisms of this disease.
Keywords: anti-inflammatory; experimental autoimmune encephalomyelitis; multiple sclerosis; neuroprotection;
phycocyanobilin


Antwerp, Belgium
Glutamate excitoxicity is counteracted by PCB modulation

of redox pathway genes
Majel Cervantes-Llanos*, Daniel Palenzuela Gardon, Beatriz Piniella Matamoros, Hanlet Camacho
Rodríguez, Laura de la C. Bakos Ruiz, Giselle Pentón-Rol
Center for Genetic Engineering and Biotechnology (CIGB), Ave. 31 e/ 158 y 190, Cubanacán, Playa, Havana, PO Box 6162, Cuba.
*majel.cervantes@cigb.edu.cu
ABSTRACT
Context: Modeling neurodegenerative disease processes in vitro is an important step in the verification of the biological
pathways associated with the therapeutic candidates. Excitotoxicity is common in the pathogenesis of neurodegenerative
diseases. The effects of phycocyanobilin (PCB) and the identification of the differentially expressed genes (DEGs) involved in
its pharmacological actions will lead to a better understanding its modes of action and could have an impact on its
therapeutic application.
Objective: To identify DEGs modulated by PCB in neuroblastoma SH-SY5Y cells after the excitotoxic insult with glutamate.
Methods: The effect of PCB on gene modulation was analyzed by qPCR through parametric ANOVA and multivariate
principal component analysis (PCA) in a glutamate-induced excitotoxicity model in the SH-SY5Y cell line.
Results: The results showed that PCA is a robust and powerful method that allows the assessment of gene expression
profiles. We detected the significant down-regulation of the CYBB (NOX2) and HMOX1 by the action of PCB in SH-5YSH
cell line insulted by glutamate.
Conclusion: The mechanisms by which PCB protected cells from excitotoxicity mainly included the reduction of oxidative
stress damage, and could contribute to its clinical efficacy for the treatment of neurodegenerative diseases.
Keywords: differentially expressed genes; neurodegenerative diseases; principal component analysis; qPCR; SH-SY5Y cells


Antwerp, Belgium
Methylene blue reduces doxorubicin-induced cardiotoxicity

in rats, but increases their clinical deterioration
Sofia Diego Díaz*, Daniel Álvarez-Almiñaque, Gilberto L. Pardo-Andreu
Center for Research and Biological Evaluations, Institute of Pharmaceutical Foods Scxiences University of Havana, Havana, Cuba.
*sofi2d96@gmail.com; ORCID: 0000-0002-7250-9733
ABSTRACT
Context: Cardiovascular diseases are the leading cause of death in Cuba, that contrasts with the limited number of preclinical
research in the country prompted by the lack of appropriate experimental models. Doxorubicin is an effective
chemotherapeutic agent frequently used in the clinic, but it has high cardiotoxicity that is exploited for developing
experimental models of heart failure. Methylene blue has antioxidant properties that can be used as a cardioprotective
treatment.
Objective: To evaluate the cardioprotective effects of methylene blue against the heart failure induced by doxorubicin.
Method: Male Wistar rats were used, divided into three groups: control, doxorubicin-exposed (3 mg/kg) and methylene blue-
treated group (2 mg/kg). Mortality, toxic reactions, weight gain, redox status, mitochondrial and heart homogenate
respiration, mitochondrial swelling, histopathology, and iron measurement in isolated mitochondria and heart homogenate
were analyzed.
Results: After the administration of doxorubicin, animals presented adverse reactions. The ratio between the weight of the
heart and the weight of the animal increased, and histopathological damage was observed, suggesting the establishment of
dilated cardiomyopathy. Glutathione and superoxide dismutase activity decreased in cardiac tissue. Mitochondria showed
greater sensitivity to the occurrence of swelling with a diminution in the respiratory capacity. Treatment with methylene
blue did not prevent toxic symptoms, weight loss or oxidative stress, but it rescued mitochondria from swelling, improved
mitochondrial and homogenate respiration, reduced cardiac histopathological damage and prevented dilated
cardiomyopathy.
Conclusions: These contradictory results are possible related with the interaction of doxorubicin and methylene blue with P-
glycoprotein, that it is differentially expressed in the heart (low level of expression) and the others organs like kidneys (high
level of expression) where toxicity seems to be higher.
Keywords: cardiotoxicity; doxorubicin; methylene blue; mitochondria


Antwerp, Belgium
Optimization of a non-infectious mouse model that

reproduces the symptoms caused by COVID-19
Llilian Gómez-Pérez, Javier Marín-Prida, Dayrelis Wilson, Sofia Diego, Daniel Álvarez, Gilberto L. Pardo-
Andreu*
Center for Research and Biological Evaluations, Institute of Pharmaceutical and Foods Sciences, University of Havana, Ave. 23 e/ 214 y 222, La
Lisa. PO Box: 430, Havana, Cuba.
*gpardo@ifal.uh.cu
ABSTRACT
Context: The SARS-CoV-2 virus is the causative agent of the Covid-19 infection that has brought with it millions of infected
and dead around the world since its appearance in China in 2019. Currently, the animal models to study the course of the
disease, as well as clinical and preclinical studies, are infectious, so it is necessary to have the optima biosecurity
infrastructure to be able to use them. Thus, it is important to have a non-infectious animal model that mimics the symptoms
caused by SARS-CoV-2 to safely investigate on the reversal of the disease as well as its deleterious effects on the different
organs of the body and the recovery of its full functionality with the use of drugs that protects the host cells or promote their
recovery after the infection.
Objective: To induce a systemic inflammatory syndrome and hypoxia stage that mimics Covid-19 by intraperitoneal
administration of lipopolysaccharide (LPS) and cyanide salts.
Methods: Systemic inflammatory syndrome and hypoxia stages were induced in Balb/C mice (n = 8-10 per group), randomly
divided into untreated control, vehicle (phosphate buffer saline), lipopolysaccharide (5 mg/kg), sodium cyanide (NaCN, 0.5
mg/kg) and LPS + NaCN-treated groups. All the experimental variants were administered intraperitoneally. The NaCN and
NaCN + LPS groups were injected with NaCN at three doses on alternate days. In the case of the LPS and NaCN + LPS
group, the LPS was administered at a single dose together with the last inoculation of NaCN. Eight days after starting the
experiment, the mitochondrial impairment caused by cyanide was estimated by measuring the oxygen consumption rate
(OCR) in liver homogenate. Animals were bled at 4, 24, 48 and 144 hours after LPS inoculation in order to measure the level
of expression of cytokines in serum. The animals were clinically monitored throughout the experiment.
Results: The OCR was lower in the liver homogenates of the NaCN-treated group with respect to the rest of the groups. In
the case of the LPS + NaCN group, OCR decreased relative to the vehicle and LPS groups. The levels of cytokines IL-2, IL-10,
and IFN-ɣ were higher in the groups administered with LPS than in the rest of the groups. The lethality of the intervention
was below 10%.
Conclusions: The combined administration of NaCN and LPS induced an hypoxic state and an increase in the levels of the
pro-inflammatory cytokines that mimic clinical symptoms of Covid-19, with high survival rates.
Keywords: biomodel; Covid-19, SARS-CoV-2; cytokines; hypoxia; mitochondria; systemic inflammatory syndrome


Antwerp, Belgium
Experimental model of hemorrhagic stroke by intracerebral

administration of autologous blood: preliminary results
Claudia V. Cunill1*, Luis M. Rodríguez2, Viagna V. Cartaya3, María A. Bécquer-Viart4, Adonis Armentero
López4, Gilberto L. Pardo-Andreu4
1Industrial Biotechnology CIGB-Mariel S.A. Mariel, Artemisa, Cuba.
2Pharmacy Department, Institute of Pharmaceutical and Food Sciences, University of Havana, 222 St. # 2317 b/ 23 and 31, La Coronela, La
Lisa, Havana, Cuba. Postal code: 13600.
3Molecular Neurosciences Department, Neuroscience Center of Cuba, 190 St.·# 15202 b/ 25 and 27, Cubanacan, Playa, Havana, Cuba. Postal
code 11600.
4Center for Research and Biological Evaluations, Institute of Pharmaceutical and Food Sciences, University of Havana, 222 St. # 2317 b/ 23 and
31, La Coronela, La Lisa, Havana, Cuba. Postal code: 13600.

*vazquezclaudia1997@gmail.com
ABSTRACT
Context: Currently, strokes in their manifestation of ischemic or hemorrhagic variants constitute one of the health problems
with the highest incidence worldwide. They represent the third cause of death in Cuba. Based on its high incidence and
prevalence, several bio-models have been developed for the study and search for neuroprotective interventions.
Nevertheless, as far as we know, none model has been described in Cuba.
Objective: To characterize an experimental model of hemorrhagic stroke in our experimental conditions.
Methods: Male Sprague-Dawley rats weighing 250-300 g were used, distributed into three groups: Hemorrhagic (H) / 100 µL
of autologous blood, intracerebral route; Sham / Surgery (SS) / 100 µL of 0.9 % saline, intracerebral route; Control (C) /
untreated animals. Some variables indicative of brain damage were evaluated such as the disruption of the blood-brain
barrier and cerebral edema, as well as behavioral variables that reflect neurological hemorrhagic involvement at the clinical
level.
Results: Neurological score showed a significant increase (p < 0.05) in neurological deficits of group H compared to group SS
and C, as well as of group SS relative to group C. Forced locomotion showed a significant increase (p < 0.05) in locomotor
deficits in the group H compared to groups C and SS, replicating the results for the disruption of the BBB and the
quantification of cerebral edema.
Conclusions: An experimental model that integrated clinical and anatomic variables sensitive to hemorrhagic brain damage
was proposed/characterized representing the first available in vivo model of this devastating disease in Cuba that will allow
the evaluation of possible neuroprotective interventions.
Keywords: brain damage; experimental models; hemorrhagic stroke


Antwerp, Belgium
New evidence of the interaction between the COMMD1

protein and the antitumor peptide CIGB-552
Nivaldo G. Hernández*, Julio R. Fernández, Luis Javier González
Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.
*nivaldo.gomez98@gmail.com
ABSTRACT
Context: CIGB552 is a second-generation synthetic antitumor peptide consisting of 20 amino acids. Its biological target is the
pleitropic protein COMMD1, which reaches greater expression in cancer cells. The positive regulation of COMMD1 inhibits
the activity of the nuclear transcription factor kappa B facilitating its ubiquitination and subsequent degradation by the
cellular proteasome.
Objectives: To define the key regions and amino acids involved in the interaction of the protein and the peptide.
Methods: The recombinant protein COMMD1 was expressed in E. coli BL21 from a clone obtained from a previous cloning.
Purification was done by affinity chromatography. A crosslinking was performed between CIGB552 and COMMD1 using
dimethyl suberimidate as a crosslinker reagent. Trypsin was used for digestion, and once the peptide fragments were
obtained they were analyzed by LC-MS / MS.
Results: 1.5 mL of purified recombinant COMMD1 protein with a purity greater than 95% was obtained at a concentration of
4 mg/mL . Crosslinking was effective for the reaction at room temperature for 1 hour with molar ratio 1:2 between protein
and peptide respectively, with a molar excess of 30 times of dimethyl suberimidate. The reaction was confirmed by SDS-
PAGE and Western blot against CIGB552. The chromatograms obtained from LC-MS/MS revealed that the interaction is
given between the residues Lys 1, Lys 5, Lys 12, Lys 14, and Lys 18 of CIGB552 and the residues Lys 28, Lys 78, Lys 100 of
COMMD1.
Conclusions: The results show that CIGB552 interacts with COMMD1 in its N-terminal region. This conclusion differs from
previous results of in vitro interaction through detection experiments of two yeast hybrids, which proposed interaction by
the C-terminal region. Knowledge of the interaction sites will allow the design of a new peptide with greater antitumor
activity.
Keywords: CIGB-552; COMMD1; crosslinking, LC-MS/MS; NF-κB


Antwerp, Belgium
Cytotoxicity study of polymeric nanoparticles loading

carprofen in retinoblastoma cell line
Alexander Parra-Coca1,2, Mireia Mallandrich3,4, Núria Garrós3*, Lídia Gómez-Segura3, Ana C. Calpena
Campmany3,4, Amélia M. Silva2
1Department of Veterinary Medicine and Zootechnic, Faculty of Agriculture Sciences, University of Applied and Environmental Sciences,
Bogota 111166, Colombia.
2Department of Biology and Environment, University of Trás-os-Montes e Alto Douro, Vila Real, Portugal.
3Department of Pharmacy, Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of
Barcelona, 08028 Barcelona, Spain.

4Institute of Nanoscience and Nanotechnology, University of Barcelona. 645 Diagonal Avenue, 08028 Barcelona, Spain.
*ngarroar50@alumnes.ub.edu
ABSTRACT
Context: Carprofen is a non-steroidal anti-inflammatory drug commonly used to treat respiratory and articular diseases in
the veterinary field. Alamar Blue measures quantitatively the metabolic activity and proliferation of cells establishing
cytotoxicity/safety of the tested drugs and products. This assay is important to quantify the drug in the formulation that
could be administered for ocular delivery, avoiding cell damage.
Objectives: To evaluate the cytotoxicity of both blank nanoparticles and nanoparticles loading carprofen in retinoblastoma
cells.
Methods: 0.075% carprofen nanoparticles were prepared with poly lactic-co-glycolic acid as polymer and acetone as organic
solvent using the solvent displacement technique. The cytotoxicity was assessed on Y-79 human retinoblastoma cell line.
Blank nanoparticles and nanoparticles containing carprofen were tested at different concentrations (1.5; 7.5; 15, 37.5, and 75
µg/mL). Cell viability was assayed with alamar blue and determined by absorbance (570 and 620 nm) after 48 hours of
exposure. Data were analyzed by calculating the percentage of alamar blue reduction and is expressed as % of control
(untreated cells).
Results: Concentrations from 1.5 to 15 µg/mL showed cell viability above 80% in 48 hours compared to the control.
Concentrations of 37.5 and 75 µg/mL significantly reduced Y-79 cell viability. Blank nanoparticles did not cause any
cytotoxicity at none of the tested concentrations. Hence, the 0.075% carprofen nanoparticles are a safe and biocompatible
nanostructured system for ophthalmic delivery.
Conclusions: Concentrations below 37.5 µg/mL carprofen in polymeric nanoparticles were safe for ocular administration.
Keywords: Alamar blue; carprofen; cytotoxicity; non-steroidal anti-inflammatory drug; retinoblastoma cells


Antwerp, Belgium
Relationship between oxidative stress and the degree of

facial lipoatrophy in Cuban patients with HIV treated with
antiretroviral
Lillyam Betancourt Peraza*, Carlos Rabeiro, Rosario Gravier Hernández, Lizette Gil del Valle
Pharmacological Research Department, Institute “Pedro Kourí” (IPK), Havana, Cuba.
*lillyam.betancourt@ipk.sld.cu
ABSTRACT
Context: Facial lipoatrophy constitutes one of the possible comorbidities inherent to HIV infection and one of the most
stigmatized adverse effects of antiretroviral therapy in HIV patients. It has been pointed out that there is a relationship
between antiretrovirals and the appearance of alterations in redox metabolism balance. The local and systemic impact of
pro-oxidant events has been recognized as an influential factor in adipose tissue changes.
Objectives: To describe the relationship between oxidative stress and the degree of facial lipoatrophy in HIV/AIDS patients.
Methods: A case-control study was carried out. Blood samples were taken from 90 people fasting for 12 hours. The
individuals were distributed into three groups: HIV/AIDS patients with grades 1 to 3 of facial lipoatrophy, HIV/ AIDS
patients without lipoatrophy (positive control), and supposedly healthy patients (negative control). Hematological,
hemochemical, progression and oxidative stress biomarkers were evaluated. Statistical analysis was performed in
correspondence with the analyzed variables, comparing between the groups of interest.
Results: The groups of patients with HIV/ AIDS showed significant differences in the levels of damage and antioxidant
status with respect to the supposedly healthy subjects. The HIV/ AIDS -lipoatrophy group had significantly higher damage
and lower antioxidant status than the positive and negative control groups.
Conclusions: The present work provides evidence of alterations in the redox metabolism of patients with HIV/ AIDS.
Keywords: AIDS; antiretroviral; HIV; lipodystrophy; redox metabolism

ECFA 2022. S2-PHARMACEUTICAL TECHNOLOGY, COSMETIC AND BEES PRODUCTS

Antonio Iraizoz Colarte, PhD / Irela Pérez Sánchez, PhD / Patricia Pérez Ramos, PhD, IFAL-UH, La Habana, Cuba
Development, optimization and evaluation of nanoparticles

loading flurbiprofen: Ex vivo skin permeation in three
different species
Ana C. Calpena Campmany1,2*
*anacalpena@ub.edu
ABSTRACT
Context: Flurbiprofen is a non-steroidal anti-inflammatory drug used to treat gout, relieve sore throat pain in the short term,
suppress the onset of oedema, and decrease ocular postoperative intense inflammation in both animals and humans. Dermal
and transdermal routes are alternatives to oral administration. However, the poor permeability of flurbiprofen across the
skin is due to its low dissolution, which restricts its absorption. Flurbiprofen loaded in polymeric nanoparticles can
overcome the skin barrier. Nanoparticles offer several advantages like improvement of water-insoluble drug transport
through the skin by ensuring direct contact with the stratum corneum and skin appendages, long-term percutaneous
absorption to cellular uptake, controlling drug release and protecting drugs from physical and chemical instabilities.
Objectives: To investigate the feasibility of the dermal application of freeze-dried and sterilized nanoparticles loading
flurbiprofen. and to evaluate its anti-inflammatory activity and cytotoxic effects.
Methods: Formulations were prepared by the solvent displacement method and physicochemically characterized. Ex vivo
permeation studies were performed in Franz diffusion cells using human and porcine skin. In vivo anti-inflammatory
efficacy was assayed in mice, while cell viability was tested in vitro on human keratinocytes.
Results: Nanoparticles loading flurbiprofen showed a high permeation profile on human and porcine skin. They
demonstrated a reduced anti-inflammatory activity after γ-irradiation without evidence of cytotoxicity.
Conclusions: Nanoparticles loading flurbiprofen are feasible and promising strategies for human and veterinary use in
treatments of skin inflammatory diseases.
Keywords: anti-inflammatory; cytotoxicity; ex vivo skin models; flurbiprofen; polymeric nanoparticles; transdermal delivery


Microemulsions loading baricitinib for autoimmune skin

diseases
Mireia Mallandrich1,2*
*mireia.mallandrich@ub.edu
ABSTRACT
Context: An autoimmune skin disease is a disorder in which the body is attacking its own skin. Symptoms can include
rashes, lesions, scaly patches, blisters and fatigue. Baricitinib is a Janus kinase inhibitor used for the treatment of rheumatoid
arthritis, moderate-to-severe atopic dermatitis, and systemic lupus erythematosus among others. Microemulsions are
suitable systems to enhance the transdermal penetration of drugs.
Objectives: To develop and optimize microemulsions loading baricitinib for topical delivery to enhance the permeability of
baricitinib for local therapy.
Methods: The microemulsions were prepared by weighing baricitinib and adding to it the hydrophilic and oily phases, as
well as the surfactants, followed by sonicationof the mixture for 30 minutes. The optimization of the microemulsions was
conducted by a pseudo-ternary phase diagram considering different proportions of the compounds. The microemulsions
were physicochemically characterized, and the selected formulations were further evaluated in terms of their
biopharmaceutical profiles.
Results: The microemulsions resulted in a small droplet size (below 130 nm) and a narrow polydispersity index. The pH was
close to skin pH. Formulation M7 exhibited the higher drug release.Baricitinib diffused following sigmoidal release kinetics,
whereas it was the one that showed lower permeation through human skin, but it presented the highest amount retained in
the skin.
Conclusions: Based on the solubility of baricitinib, anhydrous microemulsions were developed, which showed suitable
properties for dermal drug delivery.
Keywords: anhydrous microemulsions; autoimmune disease; baricitinib; dermal drug delivery; ex vivo skin models;
immunomodulator


Development, introduction and generalization of a

formulation of moxifloxacin 400 mg coated tablets
Adalberto Izquierdo Castro*, Hector Colomé
Research and Development Group, UEB NOVATEC, MEDSOL Company, Cuba.
*dtecnica.adalberto@ln.medsol.cu
ABSTRACT
Context: This work consisted in designing a formulation of moxifloxacin coated tablets containing 400 mg of the active
ingredient per tablet, which complies with the quality indexes for this pharmaceutical form and provides the desired
therapeutic effect.
Methods: The corresponding formulation studies were carried out. Three technological variants were tested, in which
combinations of various excipients were made in different percentages within the formulation to optimize the
manufacturing process of this product. An analytical technique by High Resolution Liquid Chromatography was
standardized to study the stability of the proposed formulation and determine its expiration date, as well as to control the
tablets.
Results: The technological development of the formulation was satisfactory, obtaining in one of the variants tested a product
that meets all the specifications described in the monograph for its quality control. It was found that the chosen preparation
maintains its physical, chemical and microbiological properties unchanged for a period of 36 months, stored at a
temperature below 30ºC.
Conclusions: The medicine was introduced at an industrial level, without any technological problems.
Keywords: formulation; moxifloxacin; tablets


Improvements applied to the control of losses in the

packaging material in the Medilip Oral Liquid
Pharmaceutical Laboratory
Madelaine Bernard Mendoza1, Antonio Iraizoz Colarte2*
1Medilip Oral Liquid Pharmaceutical Laboratory, Havana, Cuba.
2Department of Pharmacy. Institute of Pharmacy and Food. University of Havana. Cuba.
*airaizoz@ifal.uh.cu; ORCID: 0000-0001-7243-9176
ABSTRACT
Context: Within the pharmaceutical industry, there are factors that impact production performance, which incurs economic
losses. Hence the importance of loss control throughout the value chain.
Objectives: To evaluate and improve the losses of the primary and secondary packaging material in the production process of
the Medilip Oral Liquid Pharmaceutical Laboratory and establish a standardized methodology for its control.
Methods: A diagnosis of the materials in line 1 of the UEB Production packaging was carried out and the causes that
generated the highest percentage of waste were determined by means of the Ishikawa diagram and the Pareto diagram. A
database was designed for the control and quantification of the primary and secondary packaging material of each product
and batch used.
Results: The results showed that there was an overconsumption of material in terms of polypropylene caps with 28 mm
bilabial liner for plastic bottles, labels for bottles and cases, whose main causes were the obsolescence of the equipment,
breakages and the lack of replacement parts.
Conclusions: A methodology for the control and quantification of the losses was established, this allowed to demonstrate that
the main cause of the losses produced was due to the poor condition of the equipment, justifying the request for financing to
be able to incorporate new equipment that allows industrial automation of this process.
Keywords: database; primary packaging material; secondary packaging material; waste


Validation of the compressed air system of the Adalberto

Pesant Serum and Blood Products Company of
BioCubaFarma
Nelliet Vega Rodríguez1, María A. Barrios Álvarez2*
1Serum and Blood Products Company. Adalberto Pesant, BioCubaFarma, Havana, Cuba.
2Institute of Pharmacy and Food of the University of Havana. Cuba.
*mbarrios@ifal.uh.cu; ORCID: 0000-0003-3429-8573
ABSTRACT
Context: The validation studies carried out on the compressed air system of the Adalberto Pesant Serum and Blood Products
Company, belonging to BioCubaFarma, are presented. Compressed air is highly used for various processes in the Serum
Western production plant, so its validation is essential to meet the high-quality standards required in the production of
large-volume parenteral solutions and to have documented evidence of the generation and distribution process, which
delivers air that should meet the specifications and attributes of those standards.
Objective: To validate the process of obtaining and distributing the compressed air system of the Serum Western Plant, up to
phase 2 of the Performance Qualification.
Methods: Determinations of dew point, hydrocarbon content, oil content, microbiological count and detection of pathogenic
microorganisms were made. The physical-chemical and microbiological quality of the air was demonstrated in Phases 1 and
2, complying with the requirements established for each of the evaluations carried out.
Results: The behavior of the evaluated parameters showed that the compressed air system is capable of consistently
generating and distributing air with the required quality and is suitable for the proposed use.
Conclusions: The compressed air system of the Western Serum Plant is in a state of validation.
Keywords: compress air; serum and blood products; validation


Stability study of the recombinant protein of the receptor

binding domain of the SARS-COV-2 virus
Ángela Fidalgo Maceo1*, Gerardo García Illera1, Lourdes Costa Anguiano1, Dareyne Lara Fuentes1, Mayvi
Almora Lara1, Miguel Castillo Ferrer2, Jesús Zamora Sánchez2, Cristina Rodríguez Rodríguez1, Jennifer
Rojas Pérez1, Osniel Cabrera Díaz1, Makis Torres Toledo1, Yanet Alderete Ávila1, Gabriela Enamorado
Cantero1, Yordanka Quiñones Hernández1, Rubén López Edghill1, Verónika Fraud Smikodub3
1Quality Control Direction, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
2ProductionDirection, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
3Technological Development Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
*angela.fidalgo@cigb.edu.cu
ABSTRACT
Context: Stability studies are a fundamental requirement to obtain the sanitary registration of a new medicine. A shelf life
stability study, under stress conditions, was carried out on the formulation of the recombinant protein of the receptor
binding domain of the SARS-COV-2 virus, which is the active pharmaceutical ingredient of the protein subunit of anti-Covid
19 vaccines (Abdala and Mambisa).
Objectives: To determine the storage conditions that will guarantee its quality over time.
Methods: A shelf life stability study was carried out and the fundamental physicochemical and biological properties of the
product were measured (organoleptic characteristics, pH, immunoidentification, protein concentration, purity by SDS-
PAGE, purity by RP-HPLC, carbohydrate quantification, and microbial load). The samples were stored at a temperature of -
20 ± 5ºC for 12 months and at a temperature of 5 ± 3°C for 6 months. In addition, a photostability study was carried out in
order to determine if the product is affected by light.
Results: The results obtained in each storage condition were satisfactory. The formulation properties were kept at a
temperature of 5 ± 3°C for up to 6 months and at temperature of -20 ± 5°C for 12 months.In addition, the formulation was
photostable.
Conclusions: The formulation of the recombinant protein of the receptor binding domain of the SARS-COV-2 virus can be
considered a stable product for the parameters evaluated in the study.
Keywords: active pharmaceutical ingredient; photostability; stability study


Cosmetics in Cuba: opportunities and challenges

Patricia Pérez Ramos*, Irela Pérez Sánchez, Olga M. Nieto Acosta, Milena Díaz Molina
Pharmacy Department. Institute of Pharmacy and Food. University of Havana, Havana, Cuba.
*patry@ifal.uh.cu
ABSTRACT
Context: Globally, the trend in cosmetic science is towards an intelligent, personalized, inclusive, and sustainable cosmetics.
In Cuba, from 2021, new economic actors related to the elaboration of natural handmade cosmetics appear, which have the
opportunity to customize these products and have several sources of natural active ingredients, as well as the responsibility
to ensure the quality and safety of these for human use. But an orderly control of the activity is lacking.
Objective: To analyze the role that scientific and educational organizations should play in the accompaniment, orientation
and training of personnel involved in the production and commercialization of cosmetics.
Methods: A descriptive and analytical study was designed, based on the review of the literature in the period between 2018
and the first quarter of 2022, with the identification of articles related to new trends in cosmetics, worldwide and in Cuba, in
the following databases: Google Scholar, and Medline. In addition, criteria obtained in interviews and workshops with
Cuban entrepreneurs were also considered.
Results: The health scientific societies, through the Cosmetology and Toxicology Groups, together with the Institute of
Pharmacy and Food, motivated by the need for training of the producers, propitiated meetings where conferences, summer
courses, and postgraduate courses were given, so that they received some basic knowledge about the activity they perform.
Conclusions: The training and orientation of the new economic actors is fundamental to guarantee stable and safe products to
the health and welfare of the people.
Keywords: cosmetics; economic actors; natural products; scientific society


Cosmetic sciences at the Institute of Pharmacy and Food.

Development and potentialities
Irela Pérez Sánchez*, Patricia Pérez Ramos, Olga M. Nieto Acosta, Milena Díaz Molina
Pharmacy Department. Institute of Pharmacy and Food. University of Havana, Havana, Cuba.
*irelaps@ifal.uh.cu
ABSTRACT
Context: In the last years, cosmetic sciences have experienced an increase in the use of natural products and the application of
advanced technologies to solve cosmetic problems and assist in certain therapies.
Objective: To analyze the development experienced by cosmetic sciences at the Institute of Pharmacy and Food and its
potential to contribute to the development of the specialty in Cuba.
Methods: The presence of cosmetic sciences in the undergraduate and graduate programs of the Institute of Pharmacy and
Food of the University of Havana was analyzed, as well as its contribution to the education of specialists and the training of
new economic actors linked to this area of knowledge. The contribution of research projects to the specialty in terms of new
knowledge and cosmetic products was also examined.
Results: The Institute of Pharmacy and Food developed several well-articulated programs aimed at teaching cosmetic
sciences from undergraduate to postgraduate at its highest level and training professionals who work in various forms of
economic management with positive results. The investigations carried out in this institution contributed new cosmetics
from Cuban natural sources that favored the well-being of the population. They also supported the advances in new
products and treatments that were made by other institutions.
Conclusions: The Institute of Pharmacy and Food contributed to the formation of new professionals and products related to
cosmetic sciences, demonstrating the potential of its professionals to support the development of this specialty in Cuba.
Keywords: cosmetic research; natural cosmetics; teaching cosmetic sciences


Natural handmade cosmetics in Cuba

Milena Díaz*, Patricia Pérez, Irela Pérez
Institute of Pharmacy and Food. University of Havana, Havana, Cuba.
*mdiaz@ifal.uh.cu
ABSTRACT
Context: Natural cosmetics are of great relevance today since it has come to replace the majority of chemical industrial
products. To carry out this activity, basic knowledge is needed to comply with good manufacturing practices for these
products and their marketing. Currently, in Cuba, the production of natural handmade cosmetics has boomed, but there is
no institution that regulates this activity nor guarantees the safety of its use by consumers.
Objective: To characterize the elaboration, commercialization, and consumption of handmade natural cosmetics in a small
sample of Cuban producers and consumers.
Methods: Two questionnaires were designed, one aimed at producers and the other at consumers of natural handmade
cosmetics, to measure the aspects related to the production and consumption of these products.
Results: A predominance of female producers and consumers was found. Most of the producers have a high educational
level, but they are not specialized in cosmetics, so their products are not made with the necessary basic requirements and
under conditions that guarantee compliance with good manufacturing practices in order to ensure quality for the consumer.
In relation to consumers, the use of soaps, creams, oils, and masks(mostly purchased in the country) predominated, and they
were considered safe just because they were natural.
Conclusions: The craft production activity can represent a risk to the health of consumers. The regulation of this activity by
the relevant institutions is essential to guarantee the safety of consumers.
Keywords: cosmetics; handmade cosmetic; natural cosmetic


Development of a dermocosmetic soap based on propolis

and honey
Diego A. Guamán Anilema1*, Patricia Pérez Ramos2, Irela Pérez Sánchez2, Laura Chao Artola2, Oscar Ledea3
1Prophar S.A.
2Department of Pharmacy. Institute of Pharmacy and Food. University of Havana, Havana Cuba.
3National Center for Researches Scientific, Havana, Cuba.
*diego.arguaman@gmail.com
ABSTRACT
Context: Soaps are cosmetic products for daily use. Their function is to sanitize the skin, but depending on their components,
they can care for and improve the appearance of this organ. Honey and propolis are natural substances of beekeeping origin,
with beneficial properties for the skin. The use of cosmetics with natural active ingredients has gained momentum, and
apicosmetics are included in the advanced.
Objective: To develop a dermocosmetic soap formulation using honey and Apis mellifera propolis as biological actives.
Methods: The chemical compatibility of the biological actives with the possible components of the formulation was studied
by evaluating the pH and organoleptic properties of binary mixtures formed by combinations of the biological actives and
each of the substances to be used in the cosmetic for 14 days. Four soap formulations were prepared, in which the
concentrations of citric acid, glycerin and propolis were varied. The technological properties of the soaps obtained
(appearance, pH, softening wear, foaming power, cracking index and residual moisture) were determined. Samples of each
formulation were placed in a rack (25 - 30 ºC), oven (42 ± 2 ºC) and under direct sunlight; then, appearance, pH and moisture
were determined for 14 days.
Results: During the compatibility study, no noticeable modifications were observed in the properties measured for the
mixtures. The low humidity of the chips affected the soap making process. Meanwhile, the concentrations of citric acid and
glycerin studied affected the quality of the cosmetic. The storage conditions tested caused variations in the humidity of the
soaps.
Conclusions: Honey and propolis were found to be compatible with the substances selected for soap formulation. Variant III
(containing honey 3 %; propolis 3.0 %; glycerin 3.0 %, and citric acid 1.5 %) showed the best results.
Keywords: dermocosmetics; honey; propolis; soap


Design of a facial serum with bee products and Aloe vera

Laura de la C. Amado*, Irela Pérez, Patricia Pérez, Anaela Montalvo León
Department of Pharmacy, Institute of Pharmacy and Food, University of Havana, Havana, 17 100, Cuba.
*laura.amado@ifal.uh.cu
ABSTRACT
Context: Skin aging is a natural and inevitable process. However, its effects can be delayed and minimized by avoiding
certain factors that accelerate it, as well as making use of cosmetics and techniques designed for this purpose. Bee products
and Aloe vera have a natural origin and are recognized because of their beneficial contribution to skin care.
Objective: To design a facial serum using bee products (honey, propolis, apitoxin) and an aqueous extract of Aloe vera as
biological assets.
Methods: The influence of the type of colloid and polyalcohol on the characteristics of the preparation was determined. An
experimental statistical design of a quadratic D-optimal mixture was developed, having glycerin, xanthan gum, and sorbitol
(70 %) as independent variables; while pH and density of the formulation were the dependent variables. A numerical
optimization was developed to establish the optimal formulation, which was prepared with and without apitoxin. Both
formulations were characterized by appearance, pH, and density.
Results: The type of colloid and polyalcohol had a significant effect on the characteristics of the formulation. The applied
mixture experimental design showed that the independent variables studied influenced the density and the pH difference (t
= 0 and t = 5 days), adjusting both variables to a quadratic model. The optimal formulations had similar behavior to that
predicted by design and did not show physical modifications due to changes in temperature (38 ± 2 °C and 8 ± 2 °C), the
action of natural light, and on a shelf for seven days.
Conclusions: The experimental design and the optimization allowed to establish the optimal formulation and its evaluation,
with and without apitoxin, provided satisfactory results. The evaluated packaging and storage conditions did not cause
changes in the appearance of the optimal formulations.
Keywords: apitoxin; pre-formulation studies; serum; skin aging; xanthan gum


Formulation and stability study of four creams made with

bee products
Teresa Giral, Dámarys Suárez*, Gisela Valdés, Rosalina García
Beekeeping Research Center, Havana, Cuba
*apiproduc@ciapi.minag.cu
ABSTRACT
Context: The use of cosmetics made from natural products has become a trend for several years. In particular, bee products,
given their nutraceutical properties, are active ingredients of interest for the development of new formulations.
Objectives: To formulate four creams using bee products and carry out the study of their expiration to determine their useful
life.
Methods: Four cosmetic creams were formulated using bee venom, propolis and honey as active ingredients. The
organoleptic, physical-chemical and microbiological characteristics were evaluated. The stability study was carried out for
two years.
Results: The elaborated creams presented a characteristic color and smell, according to the active ingredients that compose
them, homogeneity and good consistency. The results of the centrifugation, oven and cold tests did not show variations in
the organoleptic characteristics of the creams. There were also no creaming, coalescence or phase separation phenomena,
which casts criteria on the physical stability of the formulation. The four creams met the microbiological quality control
parameters required for this type of preparation for two years.
Conclusions: The study demonstrated the stability of these products from a physical-chemical, microbiological and sensory
point of view, where the parameters analyzed remain stable over time. The useful life of each product was established at two
years.
Keywords: bee venom; cosmetic creams; propolis; honey


Development of salt-free shampoos for treated and

damaged hair
Marietta Navarro-Gómez1*, Mirna Fernández-Cervera2
1Empresa Mixta Suchel Camacho SA. Vía Blanca and Vía Monumental. Zona Industrial Berroa. Havana, Cuba.
2Institute of Pharmacy and Food (IFAL), University of Havana, Cuba. Street 222 # 2317 e/ 23 and 31. La Lisa, Havana, Cuba.
*m.navarro@suchelcamacho.cu; mariettamng@gmail.com
ABSTRACT
Introduction: The hair treatments used to restore hair damaged by chemical or environmental effects require the use of
shampoos for subsequent maintenance, and to avoid, or delay, the loss of the incorporated treatment. Salt-free and sulfate-
free shampoos, or with milder sulfates, are the current market trend. However, there is a deficit of these products in the
Cuban national market.
Objective: To develop a shampoo without salt and sulfates, and another without salt and with sulfates, for treated and
damaged hair.
MethodsThe influence of different surfactants and viscosing agents on the physical, chemical and sensory properties of both
shampoos was evaluated. The formulated variants were evaluated for their stability and microbiological quality.
Results: The physical and chemical characteristics of the selected formulations were adequate, under the conditions tested,
and showed excellent results in the use and sensory tests with different types of hair. Variant A (without salt and without
sulfates) and B (without salt and with sulfates) showed adequate stability, without changes in appearance, pH, active
ingredient, density and viscosity, as well as in microbiological control.
Conclusions: : The batches prepared at laboratory scale, of both formulations, showed good reproducibility, being possible to
scale them, according to the proposed technology and in the current conditions of the manufacturing plant of the Company
Suchel Camacho SA.
Keywords: quality control; salt; shampoo; stability; sulphate


New raw material bentonite L-ascorbic acid:

characterization and dermocosmetic applications
Anaela Montalvo León1*, Irela Pérez Sánchez1 , Dayaris Hernández Oliva2 , Aramis Rivera Denis2
1Pharmacy and Food Institute, University of Havana, Havana, Cuba.
2Zeolite Engineering Laboratory, Institute of Materials Science and Technology, University of Havana, Havana, Cuba.
*annaelaleon@gmail.com; ORCID: 0000-0003-2681-6262
ABSTRACT
Context: Skincare has motivated the creation of new systems and products for its protection. Clays are among the major
products used for these purposes due to their various properties.
Objective: To obtain the composite material bentonite-L-ascorbic acid (BNT-LAA) and include it as an active ingredient in
dermocosmetic formulations.
Methods: The product obtained was characterized by various analytical techniques, and the in vitro release kinetic study was
performed. Then, the composite material obtained was incorporated into three different semi-solid bases and the in vitro
release of L-ascorbic acid from these preparations was evaluated. A quadratic D-optimal mixture experimental design was
used. The preparations were characterized from a technological point of view.
Results: The results obtained showed that the parameters evaluated have a marked influence on the amount of L-ascorbic
acid that is incorporated into the bentonite. The applied techniques confirmed the presence of vitamin in the product
obtained and it was characterized the structures of the starting materials and the compound; while the in vitro release study
showed that the clay compound obtained released the L- ascorbic acid to the dissolution medium by a non-Fick diffusional
mechanism. When evaluating the semi-solid bases containing the composite material, it was found that the base components
influence the antioxidant release rate.
Conclusions: The optimal formulation obtained by means of the experimental statistical design of the tested mixture allowed
the elaboration of the cream with the obtained composite material BNT-LAA. The preparations showed adequate
technological properties to be used as dermocosmetic products.
Keywords: ascorbic acid, bentonite, clay, cosmetic


Technological development and stability study of Ritonavir

100 mg coated tablet
Antonio Iraizoz Barrios*, Ania González Cortezón, Caridad M. García Peña, Marilyn López de Armas,
Eliani Uranga
Drug Research and Development Center. BioCubaFarma. Ave 26 #1605 e/ Calzada de Puentes Grandes and Boyeros. Plaza de la Revolución.
Havana, Cuba.
*antonio.iraizoz@cidem.cu
ABSTRACT
Context: The infection by the human immunodeficiency virus and the most advanced stage of the infection, the acquired
immunodeficiency syndrome, have implied a global health and social impact, and it continues to be a challenge for the
health system worldwide. One of the drugs widely used in our country for antiretroviral therapy against this scourge is
Ritonavir, administered alone or in combination with other drugs in the same pharmacological category.However, it is
necessary to develop this product so that imports can be substituted to have a medicine of this type of national production,
for patients suffering from this disease.
Objective: To develop a Ritonavir 100 mg tablet formulation that meets all the quality standards established internationally
for this product.
Methods: The technological development of the product was carried out, a stage that allowed defining the most suitable
qualitative and quantitative composition for the finished product and the most feasible technological process to introduce it
in the national industry of oral solid formulations. The use of different surfactants to favor the dissolution of the active
ingredient once the product was administered was evaluated. An analytical technique was developed by HPLC for quality
control and stability study of the proposed formulation. The stability study was carried out for 12 months.
Results: A product that satisfactorily complies with all the quality specifications established for solid formulations for oral
use was obtained. The analytical technique developed demonstrated its feasibility for its use in quality control and stability
study of the formulation, resulting in a product that maintains its characteristics unchanged during 12 months of study.
Conclusions: A formulation for oral use was developed, containing Ritonavir 100 mg, which satisfactorily meets all the
quality specifications described for the product.
Keywords: ART; Ritonavir; technological development


Technological development of Moxifloxacin eye drops at

0.5%
Ania González Cortezón1*, Caridad M. García Peña1, Addis Bellma Menéndez1, Odalys Achón Tula1, Vivian
Martínez-Espinosa1, Martha Botet García2, Adelaida Benítez Aguilar2
1Drug Research and Development Center. BioCubaFarma. Ave 26 #1605 e/ Calzada de Puentes Grandes and Boyeros. Plaza de la Revolución.
Havana, Cuba.
2Pharmaceutical Laboratory Julio Trigo, Havana, Cuba.
*ania.gonzalez@cidem.cu
ABSTRACT
Context: Quinolones are a group of numerous and chemically very heterogeneous synthetic antimicrobial agents with wide
therapeutic applications since their introduction in the clinic. Moxifloxacin hydrochloride is a fourth-generation
fluoroquinolone indicated for the ophthalmic treatment of purulent bacterial conjunctivitis caused by strains sensitive to
moxifloxacin.
Objective: To develop a formulation of Moxifloxacin, for ophthalmic use, containing 0.5% of the active substance, which
meets all the quality standards established for this pharmaceutical form, being physically, chemically and microbiologically
stable over time.
Methods: An experimental design of D-Optimal mixtures was carried out, which allowed defining the most suitable
qualitative and quantitative composition for the finished product. The influence of sodium chloride on boric acid to achieve
drug isotonicity was studied. An analytical technique was developed by HPLC for quality control and stability study of the
proposed formulation. The stability study was carried out for 24 months, submitting the registration file to CECMED at the
end of the study.
Results: A product that satisfactorily complies with all the quality specifications established for ophthalmic preparations was
obtained. With the good results of the ophthalmic irritability study, it was shown that the product can be used in ocular
structures. The developed analytical technique demonstrated its feasibility for its use in quality control and formulation
stability study, resulting in a product that maintains its characteristics unchanged during 24 months of study. The drug was
introduced in the Julio Trigo Pharmaceutical Laboratories of the AICA Company, demonstrating its feasibility and
consistency at an industrial scale.
Conclusions: A formulation for ophthalmic use was developed containing Moxifloxacin 0.5%, which satisfactorily meets all
the quality specifications described for the product, which is currently manufactured and marketed by the AICA Company.
Keywords: eye drops; Moxifloxacin


Development of Biclofen® injection

Manuel A. Rivas*, Odalys Madrazo, Yonica Prens
Inovation and Development Unit, Empresa Laboratorios AICA, La Habana, Cuba.
*manuelr@aica.cu
ABSTRACT
Context: Biclofen® is a multi-drug with the presence of five active ingredients. Developed for treating ailments and
improving the quality of life of patients with conditions such as low back pain, fibromyalgia, and neuralgia, among others.
According to the requirements foreseen for this injectable, formulation 1 was developed in 1 mL amber ampoules,
containing cyanocobalamin and sodium diclofenac, and formulation 2, in 2 mL amber ampoules, with pyridoxine, thiamine
and lidocaine.
Objectives: To develop the injectable Biclofen®, complying with the quality specifications for this pharmaceutical form and to
perform quality control and stability studies of the pilot lots.
Methods: The pilot batches were evaluated through the established quality controls, while their behavior over time were
assessed through stability studies using previously validated analytical methods.
Results: The parameters analyzed in the pilot batches met the proposed specifications, both in the quality control and during
the study time of the stability of the formulations.
Conclusions: The injectable Biclofen®, packed in 1- and 2-mL amber ampoules for formulation 1 and 2, respectively, exhibits
adequate physical, chemical and microbiological stability for 12 months, stored at a temperature of 30 ºC and a relative
humidity of 70%.
Keywords: Biclofen; development; injectable; multidrug; stability


Design and optimization of diclofenac gel 1%, as an

analgesic and anti-inflammatory for topical use
Nilia de la Paz Martín-Viaña*, María L. González-Sanabia, José R. Pérez-Mora, Niurys Mantilla-García
Drug Research and Development Center. BioCubaFarma. Ave. 26 # 1605 e/ Calzada de Puentes Grandes and Boyeros. Plaza de la Revolución,
Havana, Cuba.
*nilia.delapaz@cidem.cu
ABSTRACT
Context: Diclofenac sodium is a compound that belongs to the NSAIDs, which exhibits pronounced anti-rheumatic, anti-
inflammatory, analgesic, and antipyretic properties.
Objective: To carry out the design and optimization of the formulation of a diclofenac gel 1%.
Methods: An experimental statistical design of D-Optimal mixtures was carried out, adjusted to a linear model, as well as the
optimization of the formulation. The concentrations of carbopol 940, triethanolamine, and isopropyl alcohol were selected as
independent variables; pH and extensibility were considered as response variables. They were determined at the beginning,
30, 60, and 90 days after the technological variants were elaborated. In addition, the viscosity and rheological behavior of the
formulation selected as promising was determined, and the results were compared with those of the commercial product
Voltaren® Gel.
Results: The proportions of the pharmaceutical excipients, as well as the values of the response variables considered, in the
best selected formulation were very close to variant 2 of the experimental design. The selected formulation showed physical-
chemical and technological properties in accordance with the requirements established for pharmaceutical gels and similar
to the commercial product Voltaren® Gel.
Conclusions: The new formulation of diclofenac sodium gel 1% is similar to its commercial product and complied with the
quality parameters studied for its technological development.
Keysword: anti-inflammatory; design; diclofenac sodium; topical; formulation; optimization


Stability in use of the multidose presentation of the Abdala

vaccine
Gerardo García Illera1*, Ángela Fidalgo Maceo1, Lourdes Costa Anguiano2, Dareyne Lara Fuentes1, Cristina
Rodríguez Rodríguez1, Omar Torres Díaz1
1Group for Stability and Reference Materials, Quality Control Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
2 Director of Quality Control, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
*gerardo.garcia@cigb.edu.cu
ABSTRACT
Context: Due to the serious effects caused by COVID-19 throughout the world and in our country in particular, it was
decided to carry out a health intervention with the Abdala vaccine. Previous studies had shown the safety of the monodose
presentation of this vaccine, but to carry out the health intervention on a massive scale it was necessary to resort to a
multidose presentation. The use of a multidose presentation made it necessary to demonstrate that the repeated punctures
that would be made to the vial do not affect the safety of the product.
Objective: To demonstrate that vials of Abdala vaccine can undertake up to 10 punctures in the stopper without affectation to
the safety or efficacy after a working day.
Methods: The vials were punctured 10 times every 50 minutes and stored between 2 and 8 ºC overnight. Then, laboratory
tests were carried out (organoleptic characteristics, identity by western blot, adsorption of the antigen to the adjuvant, pH,
immunogenicity and sterility) to verify that the quality characteristics of the vaccine were maintained.
Results: It was shown that repeated punctures do not affect the safety or immunogenicity of the product.
Conclusions: The multidose presentation of the Abdala vaccine meets all its quality specifications after undertaking several
punctures in the stopper and being stored overnight between 2 and 8 ºC. So, the use of the multidose presentation of Abdala
is safe and efficacious.
Keywords: Abdala; COVID-19; vaccine


Lyophilized injectables omeprazole and vancomycin:

evaluation of the homogeneity of drying
Laura Martínez Torres1*, Germán Aguila Pérez1, Alejandro García Varona1, Suharmy Pérez Martiatus1,
María V. Martínez Betancourt1, Leyani Lores Ventosa2, Mirna Fernández-Cervera3
1Aica+ Pharmaceutical Laboratories Company. Base Business Unit (UEB) AICA. Havana, Cuba.
2Center of Genetic Engineering and Biotechnology, Havana, Cuba.
3Institute of Pharmacy and Food, University of Havana, Havana, Cuba.
*lauram@aica.cu
ABSTRACT
Objective: To evaluate the homogeneity of the drying of the lyophilized injectables omeprazole and vancomycin.
Methods: For the study of drying homogeneity, bulbs of all the plates of a Lyomega 180 ST DH-RC lyophilizer equipment
from Telstar (Spain) were sampled, evaluating the distribution of the data.
Results: The values of the residual moisture content of the industrial batches of both injectables, estimated by Karl Fischer,
complied with the normal distribution and were below the established limit. It was found that there were no significant
differences between the residual moisture values of the bulbs placed on the same plate and between different plates, not
being so between batches, considering the drying process homogeneous for the products of interest. The newly processed
industrial batches satisfactorily met the quality specifications established for both freeze-dried injectables.
Conclusions: The drying process carried out on the lyophilized injectables of omeprazole and vancomycin was homogeneous
in the existing conditions in the AICA Productive Base Business Unit.
Keywords: homogeneity; lyophilization; omeprazole; vancomycin


Technological development of cromolyn sodium 4%, nasal

drops
Gisela Ramírez Torres*, Odalys Madrazo Alonso, Carlos R. Romeu Carballo, Odalys Betancourt Mora,
Martha Botet García
Group of New Technologies and Cytostatics, Development and Innovation Unit, AICA+ Laboratories Company, Havana, 11 300, Cuba.
*giselar@aica.cu
ABSTRACT
Context: Sodium cromoglycate is considered a bronchial anti-inflammatory. Specifically, it is a mast cell inhibitor. It is the
nasal therapy of choice for the treatment of allergic, seasonal and chronic rhinitis.
Objective: To develop the formulation of the nasal product cromoline sodium 4%.
Methods: The performance evaluation of the spectrometric method was carried out, and a chromatographic method was
developed and validated for the determination of the sodium cromoglycate present in the newly introduced product.
Results: The analysis of the active pharmaceutical ingredient (API) certified by its supplier was carried out, which complied
with the established acceptance limits. With the selected formulation, the pilot scaling was carried out in the production
plant of the Julio Trigo Laboratories. Both methods applied to determine the valuation were specific, linear, precise and
accurate according to current regulations. Stability studies showed that the formulation designed in 10 mL bottles behaved
stably over a period of 12 months and stored at 30 ± 2 ºC temperature.
Conclusions: The API of sodium cromoglycate used met the established requirements. The formulation designed and
elaborated at the laboratory scale met the established quality specifications. The spectrophotometric method allowed the
rapid quantification of the API, and with the chromatographic studies, its usefulness was demonstrated in the stability
studies of the finished product with adequate physical, chemical, and microbiological stability.
Keywords: mast cells; sodium cromoglycate


Development of irinotecan hydrochloride injection

Yusimi Izquierdo Roque*, Carlos R. Romeu Carballo, Evelyn Guerra Vidal, Odalys Madrazo Alonso
Group of New Technologies and Cytostatics and Group of Injectables, Development and Innovation Unit, AICA+ Laboratories Company,
Havana, 11 300, Cuba.
*yusimir@aica.cu
ABSTRACT
Context: Irinotecan hydrochloride is used in the treatment of metastatic colon or rectal cancer, in association with 5-
fluorouracil and leucovorin, in the treatment of small cell lung cancer and in the treatment of pancreatic cancer. In children
between 1 and 18 years of age, there are reports of the use of irinotecan in refractory solid tumors and CNS tumors. It is a
derivative of camptothecin, a substance obtained from the Camptotheca acuminata tree, native to China. In Cuba it is one of
the products that is imported for the treatment of different types of cancer. Its development and introduction are a demand
of the Ministry of Public Health.
Objective: To develop an injectable formulation that meets the established physical-chemical parameters.
Method: A preformulation was carried out at laboratory level. The effect of temperature on the dissolution of the active
pharmaceutical ingredient, the order of addition of the excipients, and the time and the speed of agitation were evaluated.
Results: An injectable formulation was developed, which allowed the evaluation of its stability over time.
Conclusions: A formulation that meets all the required quality parameters was developed, keeping the results within the
established limits. The Product Registration was approved by the CECMED for a period of 18 months.
Keywords: Irinotecan, temperature, formulation


Pharmaceutical development of the BioCen-128 formulation

in multidose nasal drops for Alzheimer's disease treatment
Sachy Rodríguez*, Yenela García, Lais Pérez, Dayana Callejo, Anna Tsoroeva, Heidy Pérez, Eilen Macias,
Alejandro Echagarrua, Silvio Viña, Claudio Rodríguez
1Centro Nacional de Biopreparados (BioCen), Havana, Cuba.
*sachy.rdguez@biocen.cu
ABSTRACT
Context: The nasal route is a promising route for the effective administration of peptides and proteins to the central nervous
system due to the permeability of the nasal mucosa. BioCen-128 in multidose nasal drops is a formulation in development
for Alzheimer's disease treatment, which contains a mixture of proteins and peptides.
Objective: To select the best formulation of BioCen-128 in multidose nasal drops for the pilot scale-up.
Methods: For the selection of the best variant, it was taken into account that the formulation should meet all the quality
criteria and that it should have a preservative agent. Three batches were obtained for the selected formulation, complying
with good manufacturing practices for non-sterile products. The formulation was dispensed in 6R glass bubbles with a
chlorobutyl stopper, metal cap, and a volume of 8 mL. Samples were taken from each batch, and the quality criteria were
evaluated.
Results: The three formulations had a similar composition in relation to the mixture of proteins and peptides,
hydroxypropylcellulose and saline solution. The differences were in the preservative agent. The first formulation did not
contain any, the second contained thiomersal, and the third propylparaben and methylparaben. The third formulation was
selected for the pilot scaling. Three batches with a volume of 2 L each were produced. All of them met all quality
requirements evaluated.
Conclusions: The third formulation of BioCen-128 nasal drop formulation was selected for pilot scale-up. The three batches
formulated met all the quality criteria evaluated.
Keywords: batches; pilot scale-up; stability


Stability study of a new cytostatic product of national

production, gemcitabine
Yusimí Tusell*, Leysi Baro
Development and Innovation Unit, AICA Laboratories Company, Havana, Cuba.
*yusimit@aica.cu
ABSTRACT
Context: Gemcitabine has cytotoxic action that kills tumor cells. It is indicated for treatments of breast, lung, pancreatic,
biliary tract, ovarian, and bladder cancer, among others. This drug is imported, which is expensive for the Cuban health
system.
Objectives: To develop a shelf and accelerated life stability study of gemcitabine solution for injection of national production.
Methods: The pilot scale batches were evaluated through a stability protocol. The behavior over time was also analyzed using
previously validated analytical methods. Results: The parameters analyzed in the pilot scale batches met the proposed
specifications during the time of the study of shelf and accelerated life stability.
Conclusions: Through the stability study, it was possible to demonstrate that a new cytostatic product of national production
is stable from 2 to 8 degrees.
Keywords: cancer; gemcitabine; stability


Development of a new cytostatic of national production,

gemcitabine
Yenilen Troche*, Yusimí Tusell, Ada E. Inguanzo
Development and Innovation Unit, AICA Laboratories Company, Havana, Cuba
*yenilent@aica.cu
ABSTRACT
Context: Gemcitabine has cytotoxic action that kills tumor cells. It is indicated for treatments of breast, lung, pancreatic,
system.
Objectives: To develop a new cytostatic of national production: gemcitabine injection And to perform quality control and
stability studies of laboratory batches.
Methods: The laboratory batches were evaluated through the established quality controls. The behavior over time was also
analyzed through stability studies using previously validated analytical methods.
Results: The parameters analyzed in the laboratory batches complied with the proposed specifications, both in quality control
and the stability’s study of the formulations.
Conclusions: Through the laboratory study, it was possible to obtain a formulation of gemcitabine solution with the quality
required to proceed on a pilot scale and to continue the development of a new cytostatic product of national production.
Keywords: cancer; gemcitabine; development; stability


New formulation of 0.5% salbutamol solution for

nebulization
Carlos R. Romeu Carballo*, Lilliam Besada Moreno, Tania González Lemus, Martha Botet García, Gisela
Ramírez Torres
*carlosr@aica.cu
ABSTRACT
Context: Salbutamol is a beta 2 adrenergic stimulant product that has a selective action on these receptors in bronchial
smooth muscle. The AICA Laboratories Company formulates it in its 0.5% nebulization solution pharmaceutical form to be
used together with intermittent positive pressure ventilation for the treatment of asthmatic conditions (mild, moderate or
severe) and other acute forms of bronchial spasms such as, for example, acute exacerbations of chronic bronchitis and
bronchiectasis. The product showed a tendency to increase in pH value and to form degradation products during storage.
This led to the design of a study for its reformulation.
Objective: To improve quality parameters and extend its expiration date by 12 months.
Methods: A study of the components of the formulation and their possible interactions, as well as the physical-chemical
properties of salbutamol, was carried out.
Results: A formulation was proposed whose stability over time was evaluated. The analytical techniques for the evaluation of
the active principle and the determination of the degradation products were validated.
Conclusions: The new formulation met the quality requirements, there was no evidence of variation in the pH values
throughout the study and the formation of degradation products remained within acceptable limits with values much lower
than those observed in the previous formulation. The CECMED approved the registration of the new product with a validity
period of two years.
Keywords: formulation; salbutamol; stability


Incorporation of L-ascorbic acid into a natural bentonite: an

alternative to preserve its antioxidant effect
Dayaris Hernández1, Anaela Montalvo León2, Claudia Gómez2, Clarence Charnay3, Irela Pérez2, Aramis
Rivera1*
1Zeolites
Engineering Laboratory, Institute of Materials Science and Technology (IMRE), University of Havana, Cuba.
2Department of Pharmacy, Institute of Pharmacy and Food (IFAL), University of Havana, Cuba.
3ICGM, CNRS, ENSCM, University of Montpellier, France Institut Charles Gerhardt de Montpellier, CNRS UMR 5253, Université de
Montpellier, France.
*aramis@imre.uh.cu
ABSTRACT
Context: L-ascorbic acid (LAA), commonly known as vitamin C, is a well-recognized antioxidant compound. However, its
stability can be affected in an aqueous medium at high pH values in the presence of oxygen and metal ions. The
incorporation of LAA in natural materials such as clays can be an alternative to preserve its antioxidant effect in
dermatological formulations. Bentonite (Bent) lamellar 2:1 clay shows excellent swelling, cationic exchange, and adsorptive
properties, with a high ability to accommodate organic species.
Objective: To characterize a natural composite bentonite-L-ascorbic acid (Bent-LAA) obtained at acidic pH, room
temperature, and constant magnetic stirring for 24 hours.
Methods: The LAA loading in the clay was quantified by ultraviolet spectroscopy at 243 nm. The chemical-physical analysis
of the resulting composite material was carried out using different analysis techniques such as X-ray diffraction, infrared
spectroscopy in ATR mode, carbon elemental analyses, thermogravimetric analysis and zeta potential measurements.
Photostability tests were performed by exposing of the Bent-LAA composite to UV light for 8 h.
Results: The analysis of the results allowed corroborating the formation of an intercalation compound in the clay and the
LAA thermal stability in the host. XRD patterns of the irradiated composite showed changes in the position of 001 basal
reflections as a result of increased exposure time.
Keywords: antioxidant; ascorbic acid; bentonite; clay


Development of a hair growth stimulating lotion with

residual tissue from the human placenta
Yadira González1*, Efreín Lauzán1, Maydelin Trujillo1, María A. Gómez1, Carlos R. Hernández1, Ernesto M.
Díaz1, Patricia Pérez2
1Histoterapia Placentaria Center “Dr Carlos M. Miyares Cao” (HISPLACEN), Cuba.
2 Institute of Pharmacy and Food. University of Havana, Cuba.
*yadira@miyares-cao.cu; ORCID: 0000-0001-8576-1711
ABSTRACT
Context: Pilotrofina is a hair growth-stimulating lotion obtained from virgin human placentas. Its production is affected by
the low availability of placentas. Optimizing the use of this raw material with a cleaner production approach leads us to the
use of placental waste in the production of new products.
Objectives: To develop a new hair growth stimulating lotion from residual placental tissue.
Methods: Six batches of the product were made using different batches of residual placental tissue and extracted with a 0,043
mol L-1 saline solution with the subsequent addition of ethanol. The product was evaluated under stress conditions. Three
batches were scaled up, a shelf-life stability study was performed and proteins were identified by electrophoresis. Its
pharmacological activity was tested in the hair follicle cycle model induced by hair removal in C57BL/6 mice.
Results: All six batches of the product showed reproducibility in the results. The samples subjected to stress conditions for 14
days did not undergo variations. The product was stable for one year at room temperature. All three scaled batches showed
reproducibility and visualized low molecular weight proteins by electrophoresis. The product stimulated hair growth with
better results than 2 % minoxidil in the depilated skin area of the mice, with a significant increase in hair length.
Conclusions: A hair growth stimulating hair lotion was elaborated from residual placental tissue.
Keywords: hair growth; human placenta


Experiences in the quality control of forming films of

polyvinyl chloride packaging material for light protection in
blister pack tablets
Ofelia Fariñas Suárez1*, Yenisé Elledías García1, Mirta Cabrera Reyte1, Greydis García Leon2
1Department of Research and Development, UEB SolMed, MedSol Laboratories. Cuba.
2Department of Quality Control, UEB SolMed, MedSol Laboratories. Cuba.
*ofe@ms.medsol.cu
ABSTRACT
Context: The quality of packaging materials is important for the pharmaceutical industry. For example, light protection of
photosensitive finished products is one of the aspects to take into account for its design and manufacture.
Objective: To evaluate the essential characteristic of the container that protects from light in colored polyvinyl chloride (PVC)
tablets packed in blisters.
Method: The light transmission official test reported in the Unites States Pharmacopoeia for plastic packs was verified on two
new suppliers of polyvinyl chloride sheets packing material. Also, these suppliers were studied in eight photosensitive
tablets packaged in blister. The evaluation of the light protection of these containers in tablets was carried out according to
official tests of related substances of the finished products under study.
Results: Both suppliers had small deviations in the light transmission of the PVC sheets; however, in the finished products
packaged in blister and subjected to direct light conditions for 72 hours six products were not affected by direct light and
two of them were rejected for non-compliance.
Conclusions: As a result of the accumulated experience, technical information is gathered that is useful when making
decisions about the quality of the package that is received.
Keywords: light transmission; packing material; photosensitive finished product


Influence of stress conditions on metformin-500 tablets

Taymí Díaz Rodríguez*, Yenisé Elledías García, Carmen R. Cruz Valiente
Department of Research and Development, UEB SolMed, MedSol Laboratories. Cuba
*tdiaz@ms.medsol.cu
ABSTRACT
Context: Metformin is produced in our country both at UEB Solmed and at Novatec, being manufactured in 500 mg tablets.
In the development of new formulations, it is necessary to know the influence of stress conditions on the IFA.
Objective: To evaluate the influence of light and humidity on the stability of metformin tablets.
Method: Exposure to humidity and sunlight was studied using a batch of coated tablets and a batch of uncoated tablets. Both
formulations were packaged in bottle and blister presentation forms. These studies were carried out according to the
established international methodology. The tablets were exposed for three months. Different tests were analyzed such as
organoleptic appearance, average weight, loss due to drying, and organic impurities.
Results: Satisfactory results were obtained in both packages and formulations. When statistically comparing, no differences
were found between both.
Conclusions: An influence of light and humidity on the tablets was not observed in the time studied, regardless of the form of
presentation.
Keywords: humidity; photolysis; stability


Pharmaceutical development of new divalent and trivalent

anti-allergy vaccines for sublingual immunotherapy
Wendy Ramírez*, Damaris Torralba, Mayteé Mateo, Sergio Pérez, Yenisleidy Revilla, Benito L. Espinosa,
Anette García, Amanda Rente, Raysa Cruz, Anna Tsoraeva, Humberto Pérez, Lianet Chui, José J.
Rodríguez, Jorge L. Hernández, Leunam Rodríguez, Eneyce González, Silvio Viña, Vicente L. Sánchez,
Mirielis Fonte, Eilen B. Marcías, Yoselin Bacallao, Yarisel Sardy, Alexis Labrada
Centro Nacional de Biopreparados, Bejucal, Mayabeque, Cuba.
*wendy@biocen.cu
ABSTRACT
Context: A large number of Cuban asthmatics present simultaneous sensitization to Blomia tropicalis (BT) and at least one
species of Dermatophagoides mites, pteronyssinus (DP)/siboney (DS). The optimal treatment should contain both allergens.
Aims: To evaluate the vaccine formulation process and aseptic filling on a pilot scale, as well as perform stability studies.
Methods: The scaling was carried out at the Parenterals 3 Plant (BioCen), under Good Manufacturing Practices (GMP)
conditions. To obtain the divalent vaccine (DiValer-SL), IFAs of DP+BT were mixed in a ratio (1:1).For the trivalent vaccine
(TriValer-SL), DP+DS+BT were mixed (1:1:2 ratio). Stability studies were performed according to approved protocols.
Results: Three batches of each variant were released in 6R vial presentation (3 mL/vial). All met the established
requirements: organoleptic properties, protein composition and content, major allergen, potency, allergenic composition,
glycerol concentration, microbial limit, pH, and volume. The consistency of the process was evidenced in terms of protein
concentration, with a CV < 5 between batches. The stability study showed that all quality attributes were maintained for 90
days at 2 - 8 °C. Batch-to-batch regression analysis indicated no significant trend toward degradation (p = 0.05).
Conclusions: Pharmaceutical development of the product progressed at pilot scale meeting national and international
requirements and ensuring quality control. Taken together, these results support the progress toward the clinical evaluation
in humans of these novel formulations for sublingual immunotherapy.
Keywords: allergy; formulation; mite; stability; vaccines


Lamotrigine-100 mg, its introduction on an industrial scale

Jorge L. Castaño, Beatriz Colominas Bécquer*, Rosangela L. Cabrera Garateix, Yenisé Elledías García, Mirta
Cabrera Reyte
Research and Development Department, UEB SolMed, MedSol, Havana, Cuba.
*beatriz971011@gmail.com
ABSTRACT
Context: This paper presents the results of the introduction on an industrial scale of a new product with anticonvulsant
action, Lamotrigine 100 mg, to replace the importation of this medicine in Cuba.
Objective: To introduce batches of lamotrigine 100 mg on an industrial scale.
Methods: The physical-technological properties of the granules were determined, as well as the tablets obtained in the first 5
batches manufactured during the years 2021 - 2022.
Results: The results obtained in the process during the study allowed to demonstrate that they meet the quality specifications
required for this product. The losses obtained in the process behaved in a similar way in the manufactured batches without
exceeding 3% of the batch weight. The results of residual moisture carried out on the granules showed that a moisture
percentage greater than 1.2% does not affect the punching process; being the highest value obtained 1.44%. The technological
parameters of the tablets obtained during both years (mass, height, hardness, disintegration, and friability) remained very
similar, always within the ranges established by the manufacturing method.
Conclusions: The product lamotrigine 100 mg was introduced at an industrial level in Plant 1 at the UEB SolMed, obtaining
satisfactory results in the physical and technological tests of the granules and tablets, as well as the quality controls for each
stage of the process.
Keywords: Compression; disintegration; friability; granules; humidity; tablets


Determination of HLBn of the lipid extract of Cucurbita

pepo seeds
José R. Pérez-Mora*, Antonio Nogueira-Mendoza, Sheyla Fernández-Puentes, Caridad M. García Peña,
Nilia de la Paz Martín-Viaña
Havana, Cuba.
*jose.perez@cidem.cu
ABSTRACT
Context: The hydrophilic-lipophilic balance (HLBn) is a parameter of great importance in the development of an emulsion.
The mixture of surfactants with a final HLBn value close to the required HLBn improves the obtaining of a stable emulsion.
Objective: To determine the value of the hydrophilic-lipophilic balance required by the lipid extract of pumpkin seeds
Cucurbita pepo L.
Methods: To calculate the HLBn of the lipid extract, the Griffin equation was used. In the determination of the HLBn of the
extract, 11 emulsions were prepared with a lipophilic emulsifier (Span 85®, HLB = 1.8) and another hydrophilic (Tween 80®,
HLB = 15.0). In all cases the percentage of emulsifier mixture was 5%. As a component of the oily phase, the lipid extract of
pumpkin seeds was used at 10% of the emulsion. Once the phases were mixed, they were homogenized using the
homogenizer at a speed of 13,500 min-1 for 5 min.
Results: The HLBn value of the pumpkin seed lipid extract was 7.0, lower than that reported in the literature consulted for
pumpkin seed oil since it is extracted with ethanol and because in this technique, there are fractions of fatty acid that are not
in this lipid extract and that contribute to the HLBn value.
Conclusions: The value obtained for the required hydrophilic-lipophilic balance of the pumpkin seeds (Cucurbita pepo L.) lipid
extract is 7.0.
Keysword: Cucurbita pepo L; Griffin equation; hydrophilic–lipophilic balance; lipid extract


PLGA nanoparticles loading derivative flavanone for

transdermal human skin permeation study
Paola Bustos-Salgado1,2*, Berenice Andrade-Carrera2, Valeri Domínguez-Villegas2,3, Mireia Mallandrich2,4,
Ana Calpena-Campmany2,4, Ma. Luisa Garduño-Ramírez2
2Centro de Investigaciones Químicas, IICBA, Universidad Autónoma del Estado de Morelos; 62209, Cuernavaca, Morelos, México.
3Facultad de Ciencias Químicas e Ingeniería, Universidad Autónoma del Estado de Morelos; 62209, Cuernavaca, Morelos, México.
4Institute of Nanoscience and Nanotechnology (IN 2UB), University of Barcelona, 08028 Barcelona, Spain.
*paola_bustos_salgado@ub.edu
ABSTRACT
Context: The species of the Fabaceae family, in particular the Eysenhardtia genus, have provided important active
compounds as anti-inflammatory enties. Furthermore, the pharmacomodulation of natural flavonoids is considered a drug
design strategy to optimize their pharmacological potential and improve their therapeutic activity. The development of
nanostructured systems would allow the improvement of specific treatments for reducing inflammation.
Objective: To investigate a derivative flavanone (8S)-5-hydroxy-2,2-dimethyl-8-phenyl-3,4,7,8-tetrahydro-2H,6H-Benzo1,2-
b:5,4-b’dipyran-6-one (1a) nanoparticle formulation for evaluating its delivery system behavior intended for topical
administration.
Methods: The derivative flavanone 1a was obtained by cyclization reaction from natural flavanone (2S)-5,7-dihydroxy-6-(3-
methyl-2-buten-1-yl)-2-phenyl-2,3-dihydro-4H-1-Benzopyran-4-one (1). Briefly, a formic acid and flavanone 1 solution was
heated under reflux and then extracted with ethyl acetate after the reaction mixture had cooled for 6 h. The nanoparticles
derivative flavanone 1a (NP1a) were prepared with PLGA and P188 as a surfactant by solvent displacement technique. The
particle size was determined and ex vivo permeation studies were performed with vertical Franz diffusion cells with three
donors’ dermatomed human skin. Samples were withdrawn at different time points for 24 h and quantified by a validated
HPLC method. The derivative flavanone skin extraction was conducted with a mixture of ethanol: water (70:30).
Results: NP1a showed 175.2 ± 0.6 nm of Z-average. Permeated and retained amounts of derivative flavanone 1a after 24 h in
the skin were 43.3 µg and 5.4 µg/cm2, respectively. The average flux was 0.5 µg/h cm².
Conclusions: The NP1a formulation might be a suitable candidate for topical application of derivative flavanone in
inflammatory conditions.
Keywords: derivatives flavanones; ex vivo permeation; nanoparticles
Acknowledgments: The authors are grateful for the Margarita Salas grant.


Baricitinib liposomes as a new approach for the treatment of

Sjörgen’s Syndrome
Núria Garrós1*, Mireia Mallandrich1,4, Óscar Domènech1,4, Maria J. Rodríguez-Lagunas2, Beatriz Clares3,4,
Ana C. Calpena Campmany1,4, Helena Colom1
2Department of Physiology, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 08028 Barcelona, Spain.
3Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Granada, 18071 Granada, Spain.
4Institute of Nanoscience and nanotechnology, University of Barcelona. 645 Diagonal Avenue, 08028 Barcelona, Spain.
*ngarroar50@alumnes.ub.edu
ABSTRACT
Context: Sjögren’s Syndrome is a chronic systemic autoimmune disease affecting from 0.2 to 3% of the general population.
The current treatment for Sjögren’s Syndrome is aimed at controlling symptoms such as dry eyes and xerostomia using local
therapy and systemic therapy with glucocorticoids or immuno-suppressants. Baricitinib is an immunosuppressant drug,
specifically a Janus kinases 1 and 2 selective inhibitor.
Objective: To propose an ocular liposomal formulation loaded with baricitinib for the management of Sjögren’s Syndrome.
Methods: The liposomes were prepared with Lα-phosphatidylcholine or 1-palmitoyl-2-oleoyl-phosphatidylethanolamine:1-
palmitoyl-2-oleoyl-sn-glycerol-3-phosphoglycerol as the lipid component and they were physiochemically characterized.
The in vitro drug release and the ex vivo permeation through corneal and scleral tissues were also assessed. Finally, the
tolerance of the formulations on the ocular tissues was evaluated by the HET-CAM technique, as well as through the
histological analysis of the cornea and sclera, and the cornea transparency.
Results: Both liposomes resulted in small and spherical shapes, with suitable physicochemical properties for the ocular
administration. Lα-phosphatidylcholine led to higher flux, permeation, and retention in the sclera, whereas 1-palmitoyl-2-
oleoyl-phosphatidylethanolamine:1-palmitoyl-2-oleoyl-sn-glycerol-3-phosphoglycerol led to higher flux and permeation in
the cornea. The formulations showed no irritant effects on the chorioallantoic membrane. Additionally, the liposomes did
not affect the cornea transparency when applied and the histological analysis did not reveal any structural alteration.
Conclusions: the two liposomes are promising candidates for further studies in the management of dry eyes in Sjögren’s
Syndrome.
Keywords: janus kinase inhibitor; ocular delivery; ocular tolerance; transcorneal permeation; transscleral permeation


Effect of microneedles in the permeation of baricitinib in

human skin
Roya Mohammadi Meyabadi1,2*, Negar Beirampour1, Núria Garrós1, Ana C. Calpena Campmany1,2, Mireia
Mallandrich1,2
*rmohammo31@alumnes.ub.edu
ABSTRACT
Context: Microneedles are a painless and less invasive method that offers an attractive delivery system for transdermal drug
delivery. Baricitinib is a selective Janus kinase 1 and 2 inhibitor currently used for the oral treatment of autoimmune
diseases.
Objectives: To evaluate the enhancement effect of microneedles in the permeation of baricitinib through human skin.
Methods: Dermatomed human skin was used in ex vivo permeation tests by means of Franz diffusion cells. The system was
thermostated at 32 ºC and the receptor fluid was continuously stirred to comply sink conditions throughout the experiment.
0.6 mL of a saturated solution of baricitinib were applied to the donor compartment and samples were collected from the
receptor fluid at pre-defined time points. After the ex vivo permeation tests, the skin was rinsed and the drug retained in the
skin was extracted by incubating the skin in a solvent and sonicated in the ultrasonic water bath for 20 minutes. Samples
from both the permeation and the drug extraction were analyzed by a validated high-pressure liquid chromatographic
method. Permeation parameters were calculated starting from the amount of drug permeated versus time.
Results: The skin treated with microneedles exhibited a 3-fold flux than the non-treated skin. The same pattern was observed
for the permeability coefficient and the predicted plasma concentration at the steady-state. Regarding the drug remaining in
the skin, the skin treated with microneedles showed about 2.5-fold baricitinib than the non-treated skin.
Conclusions: Microneedles are an effective method to enhance the penetration of baricitinib into the skin.
Keywords: Baricitinib; human skin; microneedles


Bacterial inhibitory action of clindamycin and

metronidazole cremi-gel for the treatment of rosacea
Guillermo de Grau1,2*
1DepartmentMicrobiology, Biology, Healthcare and the Environment, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028
Barcelona, Spain.

*gdegrau@ub.edu
ABSTRACT
Context: Rosacea is a chronic inflammatory skin condition mainly affecting the central regions of the face. Rosacea is
characterized by recurrent episodes of fushing or transient erythema, persistent erythema, phymatous changes, papules,
pustules, and telangiectasia. Several microorganisms have been suggested to play roles in its pathogenesis, however, the
pathogenesis is still unclear. Treatment of rosacea is challenging due to varied manifestations and uncertain etiology, but the
treatment of rosacea often relies on topical antibiotics.
Objectives: To investigate the effectiveness of metronidazole and clindamycin cremi-gel against some cutaneous
microorganism and the interaction between both antibiotics.
Methods: The minimum inhibitory concentration (MIC) for clindamycin, metronidazole and the combination were
determined using the microdilution broth test and a serial dilution of the antibiotics. 10 µL of bacterial culture containing 105
CFU/mL was dispensed into a 96-well plate containing 200 µL of antibiotic and culture media. The agar diffusion test was
used to determine the MIC of the cremi-gel with clindamycin, metronidazole and both antibiotics. Commercial topical
products with clindamycin and metronidazole were used to compare the results. Bacterial suspension containing 108
CFU/mL was uniformly spread in the plates and 10 µL of each cremi-gel and commercial products were added, including a
cremi-gel with no antibiotic.
Results: Microdilution broth test results showed no interaction between both antibiotic and a high level of inhibitory action
for clindamycin. Cremi-gel with clindamycin and clindamycin and metronidazole showed a high inhibitory effect compared
to commercial products.
Conclusions: A cremi-gel with clindamycin and metronidazole can be used to inhibit the principal cutaneous microorganism
with no interaction between both antibiotics.
Keywords: antibiotic interaction; clindamycin; cremi-gel; minimum inhibitory concentration; metronidazole; rosacea


Development of microemulsions loading an

immunomodulator for the treatment of skin inflammatory
diseases
Marc Soriano-Ramírez1*, Roya Mohammadi Mey Abadi1,2, Negar Beirampour1, Núria Garrós1, Ana C.
Calpena Campmany1,2, Mireia Mallandrich1,2
*marcsorianoramirez@gmail.com
ABSTRACT
Context: Skin inflammatory diseases, such as atopic dermatitis or psoriasis, normally occurs with pruritus and localized
lesions resulting from activation of the immune system. The treatment of this condition includes topical corticoids and
immunosuppressants, i.e., Janus kinase inhibitors. Microemulsions are dispersions composed of an oily phase and
hydrophilic phase stabilized by surfactant and co-surfactant.
Objectives: To prepare and characterize microemulsions loading a Janus kinase inhibitor.
Methods: The microemulsions were prepared using a pseudo-ternary diagram. Transcutol® was selected as the hydrophilic
phase, labrafac lipophile as the oily phase, and Lauroglycol and surfadone as the surfactants. The microemulsions were
characterized in terms of pH, droplet size, extensibility, and by their effect on the stratum corneum hydration in mice.
Results: Ten microemulsions were prepared, and we observed sedimentation in 3 of 10. From the 7 remainings, 3 were
selected for the subsequent studies based on the low surfactant proportion. These microemulsions showed a neutral pH and
a small droplet size ranging from 64-170 nm. The extensibility of the microemulsions followed a hyperbolic profile with a
maximum extensibility surface of about 20 cm2. Two microemulsions increased the stratum corneum hydration at 15
minutes and tended to the basal values at 2 hours. The third microemulsion tested did not show improvement in hydration
until 2 hours.
Conclusions: The microemulsions developed showed suitable properties for the topical administration. In view of the
promising results obtained, further studies should be performed to evaluate their efficacy and safety.
Keywords: immunomodulator; Janus kinase inhibitor; microemulsions


Evaluation of the transdermal absorption of baricitinib

solutions enriched with permeation enhancers
Negar Beirampour1*, Maria J. Rodríguez-Lagunas2, Núria Garrós1, Roya Mohammadi Mey Abadi1, Ana C.
Calpena Campmany1,3, Mireia Mallandrich1,3
2 Department of Biochemistry and Physiology, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.
*nbeirabe7@alumnes.ub.edu
ABSTRACT
Context: Baricitinib is an immunosuppressant that acts to inhibit the Janus kinase. The activation pathway of Janus kinase
transcription is one of the main factors causing the pathogenesis of many topical autoimmune diseases. The transdermal
route is a non-invasive alternative for drug administration that allows either local or systemic therapy.
Objectives: To investigate the role of 5 different enhancers in Baricitinib’s permeation profile.
Methods: 2 mg/mL of baricitinib solutions were prepared with and without 5% of the enhancer (1-decanol; myristyl alcohol,
oleic acid, menthol, and octanoic acid). The permeation of baricitinib through human skin was evaluated on Franz cells
under sink conditions at 32 ºC using a biocompatible receptor fluid; 0.6 mL of the formulation was applied to the skin and
samples were collected within 30 h.
Results: Menthol was able to increase the permeation across the skin (flux: 7.71 ± 0.82 J (µg /h)). The opposite effect was
observed in octanoic acid and oleic acid, which hinders the permeation of the drug through the skin. Concerning the drug
retained in the skin, none of the enhancer improved the amount of baricitinib in the tissue compared to the solution of
baricitinib without enhancer.
Conclusions: Mentol is an effective strategy to enhance baricitinib permeation and its retention in the skin and should be
further investigated in dermal formulations.
Keywords: baricitinib; ex vivo permeation; immunomodulator; permeation enhancers; transdermal drug delivery


2-(5H-chromeno[2,3-b]pyridin-7-yl) propanoic acid loaded

nanostructured lipid carriers and their ex vivo evaluation in
different mucosa
Negar Ahmadi1, María Rincón2*, Mireia Mallandrich1,3*
2Department of Materials Science and Physical Chemistry, Faculty of Chemistry, University of Barcelona, C. Martí i Franquès 1-11, 08028
Barcelona, Spain.
*m.rincon@ub.edu, mireia.mallandrich@ub.edu
ABSTRACT
Context: Pranoprofen or 2-(5H-chromeno[2,3-b]pyridin-7-yl)propanoic acid is a non-steroidal anti-inflammatory drug, which
can be used as a safe treatment in local inflammation on mucosal diseases. Lipid nanoparticles have been widely studied
with the objective of improving the penetration of the drugs. The topical route offers advantages, e.g., it avoids the first pass
metabolism, averts the risk of gastrointestinal disturbance, targeting the areas of disease.
Objective: To develop, optimize and evaluate a pranoprofen loading nanostructured lipid carriers.
Methods: A high-pressure homogenization technique was used to produce the nanostructured lipid carriers. They were
characterized for particle size, zeta potential and encapsulation efficiency. To evaluate the capacity to penetrate through
the mucous membranes, ex vivo permeation tests were conducted using different porcine mucosal membranes: buccal,
sublingual, nasal, and vaginal.
Results: A high amount of PF deposited in the sublingual mucosa suggested that the formula is a promising vehicle for the
local delivery of PF in the sublingual mucosa. The predicted plasma levels at the steady state was below the therapeutic
concentration in plasma for all the tissues when the formula is applied on 1 cm2 of tissue, meaning that no systemic effect
was observed and hence confirming the safety of the formulation topically applied, while having a local analgesic and anti-
inflammatory effect.
Conclusions: The optimized formulation may offer a safe and attractive nanotechnological tool in topical treatment of local
inflammation on mucosal diseases.
Keywords: ex vivo permeation studies; inflammation; nanostructured lipid carriers; porcine mucous membrane;¸predicted
plasma levels


Characterization and release of a cross-linked alginate gel

with anti-inflammatory properties
Cristina Silva Baladrón1*, Gladys R. Ramos Yacasi1, Francisco Fernández-Campos1, Ana C. Calpena
Campmany1, Mireia Mallandrich Miret1,2
1Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of
2Institute of Nanoscience and Nanotechnology (IN2UB), University of Barcelona, 08028 Barcelona, Spain.
*cristina.silva.baladron@gmail.com
ABSTRACT
Context: Alginate-based gels show interesting mucoadhesive properties, a very good compatibility profile, and have been
widely used in topical drug delivery systems with successful results. Ketorolac is a non-steroidal anti-inflammatory drug
(NSAID) that acts as an inhibitor of cyclooxygenase 1 and 2 enzymes, exerting antipyretic, analgesic, and anti-inflammatory
functions.
Objective: To develop and characterize a cross-linked hydrogel formula with CA2+ with the active ingredient ketorolac to
have anti-inflammatory properties for mucosal application. To evaluate the capacity of the hydrogel in the release of the
drug in mucous membranes.
Methods: After the development of the formulation of the alginate gel with ketorolac, the hydrogel was characterized at an
organoleptic and morphological level through microscopy (SEM). The in vitro release study was carried out using Franz-type
cells with two types of membranes (PES and nylon) and the corresponding adjustment of different kinetic models to find the
most suitable one.
Results: The gel showed a transparent and dense color appearance and a structure with filament conformations. Ketorolac
released from the hydrogel followed first-order kinetics, where it was completely and slowly released from the nylon
membrane.
Conclusions: The gel presented an ideal structure to store the active ingredient within it and an aspect for its adhesive
application at the local level. An optimal drug release capacity was obtained in the gel for its anti-inflammatory action.
Keywords: Anti-inflammatory; gel; ketorolac

ECFA 2022. S3- QUALITY CONTROL AND ASSURANCE

Yania Suárez Pérez, PhD / Mirna Fernández-Cervera, PhD / Amelié González Atá, MSc/ Yolexis Tamayo García, MSc, IFAL-UH, La Habana,
Cuba
Impact of ICH Q14 on analytical method validation

Yania Suárez Pérez*
Department of Pharmacy, Institute of Pharmacy and Food, University of Havana, Cuba.
*yaniasp@ifal.uh.cu
ABSTRACT
Context: The new ICH Q14 represents a true revolution in the design, validation, and continuous verification of analytical
procedures, with a focus on their life cycle. Accordingly, the ICH Q2(R1) Validation of Analytical Methods and the USP
Monograph have been updated since May 2022.
Objective: To describe the impacts of these changes in the validation of analytical methods.
Methods: A documentary analysis was carried out to identify the main novelties, as well as their impacts on the validation of
analytical methods in general, and in the Cuban context.
Results: The main findings revealed the introduction of the quality by design methodology in the development of analytical
procedures, the use of risk management and experimental design to form an analytical control strategy during the process,
changes in the statistical processing of the data and the uncertainty report of the method, among others. All this reduced
post-approval changes and improved communication with regulatory agencies.
Conclusions: Changes must be implemented in Cuba to improve the analytical methods validation. This will impact
positively on the work of analytical laboratories, in the way of developing and validating analytical procedures. Stronger
criteria and more robust methods will be used, efficiently managed from the design stage and monitored throughout their
life cycle.
Keywords: Analytical procedure development; control strategy; life-cycle management; risk management in analytical
procedure; robustness


Cuba
Biopharmaceutical quality of 100 mg atenolol tablets from

different sources
Ariadna Pérez-Naranjo1, Mirna Fernández-Cervera2*, Alix Parte-Gómez1, Dania Pérez-Ricardo2, Miguel A.
Cabrera-Pérez3
1Unidad Empresarial de Base Reinaldo Gutiérrez. BioCubaFarma. Independencia Ave. # 11129 e/ 2 da and 8. Boyeros, Havana, Cuba.
2Institute
of Pharmacy and Food (IFAL), University of Havana, Cuba. Street 222 # 2317 e/ 23 and 31. La Lisa, Havana, Cuba.
3Centre of Chemical Bioactive. Central University of Las Villas. Santa Clara, Villa Clara, Cuba.
*mirnafc@ifal.uh.cu
ABSTRACT
Context: Atenolol is a cardio-selective β-blocker, which is widely used in the management of hypertension, angina pectoris,
cardiac arrhythmias and acute myocardial infarction.
Objective: To determine the biopharmaceutical quality of multisources of oral administration containing 100 mg of atenolol.
Methods: Tablets of two national formulations were analyzed, one by wet way (A-VH) and one by dry way (A-CD), and two
imported (B and C). The tests carried out were: evaluation of labels and prospectuses, description of the tablets, average
weight, hardness, friability, disintegration, identity and content of atenolol, uniformity of dosing units, dilution test, and
dilution profiles. Simultaneously, the performance of the chromatographic method for the quantification of the analyte in the
in vitro dilution test was verified. To evaluate the drug’s kinetics release, different mathematical models were applied,
including the calculation of the efficiency of the dilution and the area under the curve.
Results: According to the technological and chemical evaluation carried out, all the products met the established quality
specifications. It was demonstrated that the chromatographic method met the criteria established for the intended purpose.
The A-VH tablets were classified as fast dilution, while the rest of the formulations as very fast dilution. A-CD and C
imported tablets showed equal dissolution efficiency values and areas under the curves.
Conclusions: The imported formulations of 100 mg atenolol and the new formulation by direct compression present better
biopharmaceutical quality than the wet formulation.
Keyword: atenolol; dilution; multisources; tablets, validation


Cuba
Development of a limit test chromatographic method for

degradation products in nitrazepam tablets
Yenisé Elledías1*, Ana L. González2, Yania Suárez2
2Institute of Pharmacy and Food (IFAL), University of Havana, Cuba.
*yenise@ms.medsol.cu
ABSTRACT
Context: In Cuba, nitrazepam (NTZ) is produced as 5 mg tablets in SolMed Laboratories. Due to safety reasons,
nitromethane, a reagent used in the mobile phase of the official thin layer chromatography (TLC) method to evaluate
degradation products, will no longer be purchased in the country.
Objective: To develop a valid TLC method for the evaluation of NTZ degradation products in tablets as a limit test.
Method: The official method of the British Pharmacopoeia was slightly modified and compliance with all established
chromatographic criteria was verified; so it was used as a reference. Seven mobile phases, two stationary phases, four
chemical and physical developers (UV at 254 nm) were tested.
Results: The combination of benzene: ethyl acetate: acetic acid (60: 36: 4) was selected as the best mobile phase to resolve the
mixtures of NTZ and its organic impurities A and B, in silica gel GF254 plates / physical development and on silica gel/Van
Urk reagent plates, which had the advantage of detecting stains with different coloration and chromatographic parameters
similar to the reference method.
Conclusions: The method developed with chemical developer was specific against possible interferences generated by the
forced degradation of the NTZ and the excipients of the formulation and guaranteed the adequate detection of impurities A
and B up to levels of 0.1%; Therefore, it was considered valid for the proposed objective.
Keywords: impurities; thin layer chromatography; validation


Cuba
Development of the analytical methods for the

quantification of diclofenac sodium, methyl and propyl-
parabens by high performance liquid chromatography
Caridad M. García Peña*, Vivian Martínez-Espinosa, Sheyla Fernández-Puentes, Nilia de la Paz Martín-
Viaña, María L. González-Sanabia
Havana, Cuba.
*caridad.garcia@cidem.cu
ABSTRACT
Context: Diclofenac sodium is a derivative of phenylacetic acid and belongs to the group of NSAIDs with pronounced anti-
inflammatory, analgesic, and antipyretic properties. Until now, the monograph does not appear in official pharmacopoeias
for the quantification of the active pharmaceutical ingredient (API) and the preservatives in diclofenac sodium gel.
Objective: To develop and validate the analytical method for the quantification of API and preservatives to apply it in the
stability study of topical 1% gel.
Methods: The analytical method for quality control and stability study was validated using the following parameters:
specificity, accuracy, precision (repeatability and intermediate precision), linearity, detection limit, and quantification.
Stability studies of the finished product were carried out at room temperature, for 24 months, packaged in aluminum tube,
PEAD plastic bottle with PBD liner and transparent amber glass bottle.
Results: The results obtained in the validation of the method were adequate. The results of the stability study carried out
made it possible to demonstrate the stability of diclofenac topical gel at 1%, in the three containers studied.
Conclusions: The reliability of the analytical method applicable to quality control and the stability studies of the finished
product were evidenced through documentary evidence. The stability of the gel was demonstrated for 24 months, stored at
room temperature.
Keywords: diclofenac sodium; high resolution liquid chromatography; topical gel; stability study; validation


Cuba
Validation of technology transfer processes: Application to

the manufacture of Jusvinza
Alicia M. Terry García1*, Marco Álvarez Soto1, Claudia Talavera Castro2, Ernesto Suárez Romero3,
Humberto Pérez de la Concepción2, C. Matilde López Abad4, Iliana Delgado Martínez I5, Lisset L. Acosta
Arrate1, Orielys Delgado Carballo2, Raisa Ramos González2, Roland Expósito Pérez1, Alexis Labrada
Rosado6, Tamara Lobaina Rodríguez7, Odalis Espinosa López3
1Development Department, Research and Development Division, BioCen. Cuba.
2Parenteral Products Plant, Production Division, BioCen. Cuba.
3Validation Department, Quality Assurance Division, BioCen. Cuba.
4Formulations Laboratory, Development Division, CIGB. Cuba.
5Production Plant, Production Division, CIGB. Cuba.
6Director of Research and Development, BioCen. Cuba.
7Managing Director, BioCen. Cuba.
*aliciam.terry@biocen.cu
ABSTRACT
Context: Transferring a new drug to production requires meeting quality standards and demonstrating a process capable of
achieving output requirements. Jusvinza, a product developed by CIGB, has demonstrated effective immunoregulatory
action in the treatment of the acute phase of COVID-19.
Objective: To evaluate the validation of the technological transfer of Jusvinza to the production during formulation, filling,
and visual inspection stages.
Methods: The process was carried out following approved procedures and the validation protocol PRO12.11.021, data
collection, Minitab, and group discussions.
Results: Initial batches were manufactured according to the designed procedure, observing delays in final filtration. The
investigation showed a tendency for the product aggregation, affecting filtration. A change in formulation was managed by
establishing two independent sterilizing filtrations prior to mixing. 13 consecutive batches were made with the change
showing no formation of aggregates during dissolution, filtration, and mixing. The validation/qualification status of
equipment, areas, associated processes, and critical support systems was considered. Quality risks, deviations, and changes
were managed. The formulation, filling, and visual inspection stages showed yields greater than 91% and the batches were
conforming to the specifications. Capability analysis showed stable mean and process variation, standard deviation less than
one and no out-of-control points.
Conclusions: The production of consecutive batches in accordance with the specified requirements, and compliance with the
acceptance criteria of the validation protocol, demonstrated that the technology transfer of Jusvinza to production scale is a
consistent process and has been validated satisfactorily.
Keywords: filling process; process consistency; product aggregation; product formulation; sterilizing filtration; validation


Cuba
Design, development and generalization in Cuba of the first

Transport Medium for Viruses (BTV) for the confirmatory
diagnosis of COVID-19
Marilyn Díaz Pérez1*, Alexis Labrada Rosado1, Diana Rosa Viera Oramas1, Tamara Lobaina Rodríguez1,
Manuel Romero Pláceres2, Sonia Resik Aguirre2, Nilda Mieres Díaz1, Raisa Martínez Casanueva3, Gerardo
Guillén Nieto4, José Benito de Armas1, Isabel Rojas Gatorno1, Michel Reyes Morgado1, Yordania Zayas
Ruiz1, Lellany Echazábal Hernández1, Luis C. Hidalgo Guerrero1, Mabel Alfonso Ruiz1, Yanelis Montes
González1, Elsa González Rodríguez1, Anna Tsoraeva1
1National Center of Bioproducts (BioCen), Cuba.
2Pedro Kourí Institute of Tropical Medicine (IPK), Cuba.
3Salvador Allende Clinical-Surgical Hospital, Cuba.
4Center of Genetic Engineering and Biotechnology (CIGB), Cuba.
*marilyn.diaz@biocen.cu
ABSTRACT
Context: Viral transport media are required for the collection, transport, and preservation of SARS-CoV-2 virus clinical
samples until they are analyzed by RT-PCR or antigen testing. In 2020, BioCen developed a generic viral transport medium
(called BTV), according to WHO specifications, for the confirmatory diagnosis of the SARS-CoV-2 virus, the agent of
COVID-19.
Objective: To design, develop, and evaluate from the analytical and clinical point of view, as well as register in the CECMED,
the Medium BTV.
Methods: Experimental designs were carried out until an optimal formulation was obtained, which was scaled to an
industrial level. Its analytical and clinical performance, compatibility with the CNEURO sample collection swab and with
different RT-PCR platforms were evaluated. The kit imported for this purpose (UTM, COPAN or other) was used as a
comparator product.
Results: A chemically defined formulation for the confirmatory diagnosis of the SARS-CoV-2 virus was obtained for the first
time in Cuba, meeting the requirements of the ISO 9001:2015 standard. The new virus transport medium preserved the viral
load of oropharyngeal and nasopharyngeal samples for up to 72h at 4 °C and showed satisfactory agreement with respect to
imported products (Kappa = 0.67, CI: 0.53-0.81). The Sanitary Registry of the product was granted by the CECMED, as risk
class D.
Conclusions: The new BTV Medium was equivalent in its clinical performance to imported products for the same purpose. It
has enabled the epidemiological surveillance of COVID-19 in Cuba, while it provides technological sovereignty and replaces
imports to the country.
Keywords: SARS-CoV-2 virus; viral transporte media


Cuba
Biosafety management in biotechnological projects in the

context of COVID-19
Maria del R. Alemán1*, Ángela Sosa1, Leyenis García2, Abel Hernández2
1Department of Safety and Environmental Control, Direction of Quality Management and Regulatory Affairs, Havana, Cuba.
2Direction of Agriculture and Livestock Research, Havana, Cuba.
*maria.rosario@cigb.edu.cu
ABSTRACT
Context: The COVID-19 pandemic paralyzed the activities of the business sector in all countries of the world. A critical aspect
for the Biotechnological Company Center for Genetic Engineering and Biotechnology with business units in Havana,
Camagüey, and Sancti Spíritus was the decrease in interactions with regulatory authorities such as the Office of
Environmental Regulation and Safety. This increased the risk of affecting a large number of biotechnological projects with
obligations to comply with regulatory requirements approved by environmental licenses on issues as sensitive as human
health, animal health, and the national food plan.
Objectives: To establish a biosecurity management in a variable scenario to guarantee the success of projects in the three
business units.
Methods: Diagnosis of business management through expert analysis, root cause analysis, identification of Weaknesses,
Strengths, Threats and Opportunities (SWOT), design of coordination alternatives, and analysis of design spaces was carried
out.
Results: The design of the space made it possible to identify the internal and external aspects that generated deviations and
low levels of response. The incorporation of new fields in the Authorization Database taking into account the risk scenarios
allowed a better control. Social networks and information technologies were used as tools for communication and transfer of
documents between specialists and the Office of Safety and Environment Regulation.
Conclusions: The robustness of the management system allowed an effective management of 75 licenses during the 2020-2021
periods and the monitoring of the validity conditions imposed by the regulatory authority.
Keywords: Authorization database; quality tools; root-cause analysis; SWOT


Cuba
Design of a "customized" management model for

EMCOMED's cold chain
Diana G. García*
Quality Management, EMCOMED, Havana, Cuba.
*diana.garcia@oc.emcomed.cu
ABSTRACT
Context: A quality cold chain is one in which all the elements necessary for its performance are comprehensively managed.
Objective: To design a "tailor-made" management model for EMCOMED's cold chain, harmonizing "key" elements of quality
assurance for temperature-sensitive products and the regulatory requirements of Good Distribution Practices.
Methods: A search was carried out to select updated and scientifically rigorous bibliography applicable to quality
management of the cold chain. The cause-effect diagram technique was applied to establish the fundamental elements of
integrated cold chain management. A standard operating procedure (SOP) was developed to document its application in the
organization.
Results: The "Integrated Cold Chain Management" model was designed considering four fundamental elements necessary to
guarantee quality. The SOP "Guidelines for the Integrated Management of the Cold Chain" was prepared as the regulatory
basis for its operation at EMCOMED.
Conclusions: The management model designed for EMCOMED's cold chain took into account four fundamental elements.
The guidelines for ensuring the quality of cold chain operations and the preservation of products during handling were
documented in a SOP. The benefits derived from the application of this management model have a positive impact on the
company's economic and social performance and allow it to be used as a reference by similar organizations.
Keywords: Cold chain; quality; management system; standard operating procedure; temperature-sensitive products


Cuba
Temperature excursions in the importation of thermo-

sensible products by air
Tania Calderón Villacampa*
Department of Quality Management, UEB Pharmaceutical Supplies, Drug Marketing and Distribution Company (EMCOMED), Havana,
Cuba.
*tania.calderon@sf.emcomed.cu
ABSTRACT
Context: Thermosensitive pharmaceutical products must be handled and stored at controlled temperatures, thus minimizing
the risk of temperature excursions. More than 50% of these occur while products are in the hands of airlines and airports.
Every year there are large losses for this concept, which implies strict surveillance by the entities in charge of its distribution,
an activity that in Cuba is carried out by EMCOMED.
Objective: To identify the causes of cold chain breaks in the international air transport of heat-sensitive products received at
the EMCOMED Old Havana Distribution Center and to propose corrective measures.
Methods: Descriptive, longitudinal, and retrospective investigation of the temperature excursions in the air transportation of
imported thermosensitive pharmaceutical products during the years 2018 to 2020 was carried out. The sample consisted of
the Commercial Claims to MEDICUBA S.A due to the breaking of the cold chain, identifying the causes and proposing
corrective actions.
Results: Economic losses and expenses for Claims were reduced through conciliation between suppliers and customers. The
stay of thermosensitive products at the airport and in warehouses was minimized. The risks were identified and measures
were adopted to control them, aimed at reinforcing logistics in the transportation of frozen products. The use of passive
means (isothermal packaging with frozen tablets) was expanded for their expedited transportation and monitoring for
defined times.
Conclusions: It is important to improve the logistics in the storage and transportation of these products, while improving the
knowledge and performance of human resources.
Keywords: cold chain; import of pharmaceutical products; thermosensitive


Cuba
Stability study of the Coomassie solution based on the

application of statistical tools
Inalvis Herrera*, Sheila Padrón, Aydi Columbié
Technology Development Direction, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
*inalvis.herrera@cigb.edu.cu
ABSTRACT
Context: The quantification of total proteins is essential for the research experiments carried out in the Department of
Technological Development, and the microcoomassie technique is one of the most used methods due to its simplicity and
speed. In the laboratory, there have been problems with the availability of chemical reagents such as orthophosphoric acid
and absolute ethanol necessary to prepare the coomassie solution (NP12606) used in the technique.
Objectives: To evaluate the stability study of the coomassie solution based on the application of statistical tools.
Methods: The behavior of the BSA curves over time was studied by performing an analysis on different days, with two
different batches of coomassie solution. A comparison of the curves over time to determine significant differences between
them using the Real Stability program was performed.
Results: With the application of the Real stability statistical tool, there were no significant differences between the different
times studied up to 60 days. Similarly, the concentration of the positive control was analyzed over time. Second, the protein
concentration of different types of molecules tested at time zero and 60 days for two different reagent lots was compared. It
was shown that the reagent maintains the property of reacting with the proteins in the samples, allowing an exact and
precise quantification of the analytical method.
Conclusions: It is possible to extend the use of the coomassie solution for up to 60 days, which presupposes a saving in
missing chemical reagents such as orthophosphoric and absolute ethanol.
Keywords: microcoomassie; solution stability


Cuba
Evaluation of the active pharmaceutical ingredient of the

BioCen-128 formulation stability
Nashelly Esquivel Crespo*, Yenela García, Yoel Perea, Mayelín Odelín, Claudia Talavera, Silvio Viña,
Lázaro Sánchez, Gabriel González, Anna Tsoraeva, Ramcy Regalado, Claudio Rodríguez
Centro Nacional de Biopreparados, Mayabeque, Carretera Beltrán km 1 1/2, Cuba.
*nashelly.esquivel@biocen.cu
ABSTRACT
Context: The active pharmaceutical ingredient (API) of BioCen-128 will be used in the development of nasal formulations for
the treatment of Alzheimer's disease with special emphasis on age-related cognitive decline. It is composed of a mixture of
proteins and peptides at a concentration of 1.7 mg/mL, which are obtained from specific fractions of bovine thymus
dissolved in 0.9% sodium chloride solution.
Objective: To evaluate the stability of the quality requirements of the API of BioCen-128 produced under aseptic conditions.
Methods: Three experimental batches of sterile BioCen-128 API were obtained. The process included adjustment to the
protein concentration of 1.7 mg/mL. In addition, sterilizing filtration was carried out into sterile and apyrogenic ethylene
vinyl acetate bags that were kept inside a double sealed polyethylene bag. The batches were used to study their stability for
3 months stored at 2-8°C.
Results: In the case of the sterility and LAL analysis for the three batches of the API of BioCen-128 analyzed, an absence of
microbial growth was observed. With the HPLC chromatographic analysis, a profile with characteristic major peaks in the
range of 14 to 28 min was obtained. In addition, the evaluated batches met the acceptance criteria for the organoleptic
characteristics, pH, concentration of total proteins and of the thymosin alpha 1 protein.
Conclusions: The work demonstrated that the API of BioCen -128 obtained and preserved under the conditions described in
this work is stable for 3 months at 2 - 8°C.
Keywords: BioCen-128 API; nasal formulation; sterile and apyrogenic bags; stability


Cuba
Quality of clinical trials documentation audited by

CENCEC during COVID-19
Rosabel Mollineda Alvaré1*, Sandra Álvarez Guerra2, Amelié González Atá3
1Departamento de Ensayos Clínicos, Centro Nacional Coordinador de Ensayos Clínicos, La Habana, Cuba.
2Departamento de Gestión de la Calidad, Centro Nacional Coordinador de Ensayos Clínicos, La Habana, Cuba.
3Instituto de Farmacia y Alimentos, Universidad de La Habana, La Habana, Cuba.
*rosabel@cencec.sld.cu
ABSTRACT
Context: The National Coordinating Center for Clinical Trials is the leading institution for clinical research in Cuba. To
ensure the quality of the documentation of the trials, it performs audits using Good Clinical Practices (GCP) as a standard.
At the beginning of 2020, the pandemic caused by the SARS-CoV-2 virus determined a new context, focused on mobility
limitations and access to institutions. However, maintaining the quality of the documentation in the trials was always
present.
Objective: To evaluate the quality of the documentation of the clinical trials audited by CENCEC during the COVID-19
pandemic.
Methods: The audit reports, carried out on the documentation of the trials, in the years 2019 and 2020, were used. The
problems detected were identified and compared and the documentation was evaluated in terms of its quality. It was
analyzed whether the results shown in 2020 were determined by the pandemic.
Results: In the two years, problems were detected. The "Absence of essential documents" prevailed as non-compliance in the
Main Folder of the trial, which in 2020 showed an increase, but did not lead to a result of "Non-compliance with GCP". It
was evaluated as "Good Quality" the documentation of the tests audited in both years.
Conclusions: The pandemic did not influence the quality of the documentation, but it did extend the terms of time to resolve
the breaches detected.
Keywords: audit; clinical trial; documentation; pandemic


Cuba
Risk- management related to the introduction of the

manufacturing process of the active pharmaceutical
ingredient of the RBD protein in the production system
Isabel Apezteguía*, Nubia González, Tania González, Joana González, Nestor Expósito, Margarita E. Coba,
Miladys Limonta, Odalys Ruiz
Center for Genetic Engineering and Biotechnology, Havana, Cuba.
*isabel.apezteguia@cigb.edu.cu; ORCID: 0000-0001-9939-6911
ABSTRACT
Context: The use of quality management techniques is necessary for compliance with Good Manufacturing Practices in the
biotechnological sector. The study exposes risk reduction in the manufacturing of the active pharmaceutical ingredient of the
recombinant protein of the receptor binding domain of the SARS-CoV-2 virus (RBD) during the introduction in the
production system.
Objective: To apply the quality risk management to identify and assess the impact of hepatitis B virus surface antigen for the
manufacture of the active pharmaceutical ingredient of the recombinant protein of the receptor-binding domain of the
SARS-CoV-2 virus in the product facility.
Methods: It was applied the failure mode and effects analysis (FMEA).
Results: The potential causes of the failures were the training for the development personnel in the standard operating
procedures of the facility, the mixture between the components and non-dedicated materials used in both production
process, the non-approval of the standard operating procedure of campaign change regarding sanitation and monitoring of
the areas of production, the environmental monitoring program for the new production in the productive area in the
preparation or approval, and the absence of direct quantitative or semi-quantitative method (ELISA) to determine the
concentration of the protein of interest in the different streams of the process.
Conclusions: The actions are proposed to minimize risks and carry out an adequate and feasible introduction of the
manufacture of RBD recombinant protein in the production facility.
Keywords: active pharmaceutical ingredient; risk management


Cuba
Failure analysis of problems found in bioprocesses

Lázaro Cervetto de Armas1, Ángela Sosa Espinosa2*
1Biological Group I, Production Department, CIGB, Havana, Cuba.
2Department of Safety and Environmental Control, Department of GCAR, CIGB, Havana, Cuba.
*angela.sosa@cigb.edu.cu
ABSTRACT
Context: Bioprocesses for obtaining recombinant proteins expressed in Escherichia coli are a widely known strategy. Every
biotechnological process contains independent variables for the researcher in its initial phase, which generates intrinsic
variability in the process. When deviations are obtained in the expected results according to the quality specifications, the
analysis of the factors that influence the process, such as the evaluation of the homogeneity of the cell banks, are
fundamental.
Objective: To generate a failure investigation strategy capable of solving the problems that occur in the different departments
of the company and to determine the main cause of the process consistency failure with the use of tools of quality risk
management. Also, to evaluate the homogeneity of the cell banks involved in the detected failures.
Methods: For the determination of homogeneity, the criteria viability (i) and microbial purity (ii) of the bank was taken into
account. To carry out the assays, the dilution trace seeding methodology described by Pérez-Reytor et al. in 2002 was used,
and selective and differential culture media were used as described by the same authors in 2003.
Results: The evaluated cell bank was not homogeneous, it contained the presence of contaminating coliform, citrate negative
and lactose positive microorganisms in a variable proportion of up to 1x103 process microorganisms, and did not present
lytic phages.
Conclusions: The critical factor of each failures was found and a possibility of improvement for the company was offered.
Keywords: bioprocesses; failure; strategy


Cuba
Gaps and opportunities for improvement in the Product

Quality Review at Novatec
Helen González Abreu1*, Yania Suárez Pérez2, Isabel Jiménez Gómez1
1Quality Management Department. Novatec Laboratory. Medsol Company, Biocubafarma, Havana, Cuba.
2Pharmacy Department, Institute of Pharmacy and Food, University of Havana, Cuba.
*calidad.helen@ln.medsol.cu
ABSTRACT
Context: The Product Quality Review (PQR) is a useful tool to generate more efficient, consistent, and controlled processes.
In the company MedSol, there is a general methodology established for PQR; however, it is not applied to all the products
manufactured by NOVATEC, nor are all the regulatory parameters reviewed, so the incidence of complaints, claims, and
reprocesses continues.
Objective: To identify gaps and opportunities in the methodology established in the NOVATEC Laboratory for PQR.
Methods: A Gap Analysis was applied for the detailed analysis of compliance with regulatory criteria and the results
reflected in two PQR reports were analyzed for the study cases: sertraline 50 mg and loratadine 10 mg tablets produced in
2020.
Results: Significant gaps were identified from the regulatory point of view for 72.2% compliance. In addition, 14 strengths
and 26 weaknesses were detected in the implementation and reporting. Among the gaps, the incorrect use of some quality
tools was highlighted, an approach to prevention was not evidenced, and some regulated aspects or suggested analyzes
were omitted or they were presented in a limited way. The human factor was key for the correct execution of the
methodology, interpretation, and analysis of the data.
Conclusions: The six prioritized short-term improvement options were aimed at correcting the gaps related to data analysis
and modifying the RCP planning due to its direct impact on the quality of products and processes, without the need for
material resources.
Keywords: Continuous improvement; Gap analysis; quality assurance; regulatory aspects


Cuba
Development of analytical methodologies for the

quantification of ambroxol-30 tablets
Renny Small Laza*, Yenisé Elledías García, Dailyn Paz Melgarejo
Department of Research and Development, UEB SolMed, MedSol Laboratories. Cuba.
ABSTRACT
Context: Ambroxol hydrochloride (AMB) is a widely marketed mucolytic agent worldwide. The MEDILIP laboratory is
currently the only national producer in syrup form.
Objective: Due to the inconveniences of this pharmaceutical form and with the purpose of diversifying the production of
AMB in Cuba, a new formulation of 30 mg tablets was recently developed in the Medsol laboratory.
Method: Since it is not described in the pharmacopeias as a finished form, it was necessary to develop the analytical
methodology for the quantification of AMB.
Results: For routine studies, a spectrophotometric method was developed using purified water as solvent measuring at 308
nm. For the method indicating stability, a 5 µm LiChrospher RP-18 column and a mobile phase composed of dibasic
ammonium phosphate buffer at pH 7.0 and acetonitrile in a 50:50 v/v ratio were used. Both methods were validated
according to regulations being linear, exact, precise, and specific compared to placebo.
Conclusions: The method indicating stability was specific against the degradation products and both methods were linear,
precise, and exact in the range studied.
Keywords: high resolution liquid chromatography; UV spectrophotometry; validation


Cuba
Development of the analytical technique for determination

of the sulfate/carboxylate ratio in raw materials of sodium
enoxaparin
Jorge L. Santana Tolosa1*, Vivian M. Tolosa Cubela1, Yania Suárez Pérez2, Yusimí Tussell Martínez1, Yadira
Hernández Rodríguez3
1Unidadde Desarrollo e Innovación (UDI). Empresa Laboratorios AICA, La Habana, Cuba.
2Instituto
de Farmacia y Alimentos (IFAL). Universidad de La Habana, La Habana, Cuba.
3Unidad Empresarial de Base Laboratorios AICA. Empresa Laboratorios AICA, La Habana, Cuba.
*jorges@aica.cu
ABSTRACT
Context: Sodium enoxaparin is a low-molecular-weight heparin, a heparin derived drug with broad international use in
anticoagulant therapies. As part of the development of the manufacturing process of the injectable form of this drug by
Empresa Laboratorios AICA it is required the development of the analytical techniques for control of the quality parameters
of the raw materials of this active pharmaceutical ingredient, as the sulfate/carboxylate ratio.
Objectives: To develop the analytical technique for determination of the sulfate/carboxylate ratio in raw materials of sodium
enoxaparin.
Methods: It was studied the influence of different factors (temperature and geometry of the exchanger bed, sample
concentration, and particle size of the exchanger) in the process of cationic exchange used in the preparation of the samples
for the analysis.
Results: The best results were obtained with the application of one sample over the resin bed per day of work, with the resin
of higher particle size, at higher size of the exchanger bed and with the lowest of the sample concentrations used. In these
conditions, the quality of the results was independent of the tested temperatures.
Conclusions: The developed technique can be used for the quality control of the raw materials of sodium enoxaparin.
Keywords: anticoagulants; enoxaparin; low-molecular-weight heparins


Cuba
Validation of an analytical method to determine the

stability in use of the injectable docetaxel-10 mg/mL
Thais Valdés Parra*, Carlos R. Romeu Carballo
*tvaldesp91@gmail.com
ABSTRACT
Context: Docetaxel is a semi-synthetic drug with proven antitumor activity approved for the treatment of patients with
locally advanced or metastatic breast, hormone-refractory prostate and gastric cancer. In order to improve the stability of the
product currently produced and marketed in our country by the AICA+ Laboratories and to optimize its presentation, it was
reformulated. Docetaxel is administered by slow intravenous infusion in 0.9% sodium chloride or 5% dextrose serum for a
period of no less than 1 hour, so it was necessary to carry out an in-use stability study to guarantee that the new product is
stable under those conditions.
Objective: To develop and validate an analytical method by high-performance liquid chromatography to determine the in-use
stability of the injectable docetaxel-10 mg/mL.
Methods: The validated analytical method was based on the separation of the active ingredient through a chromatographic
column RP 18 (5 µm) (250 × 4.6 mm), with ultraviolet detection at 232 nm. A mobile phase composed of a mixture of
methanol:acetonitrile:wWater (44:26:30) was used, with a flow rate of 1.5 mL/min.
Results: The calibration curve was made in the range of 0.125 mg/mL to 0.375 mg/mL (50 to 150%), with a correlation
coefficient equal to 0.999779. the statistical test for the intercept and slope was considered non-significant. A recovery of
100.48% was obtained in the range of concentrations studied and the Coch’an's (G) and Stud’nt's (t) tests were not
significant. The specificity test showed that the excipients do not interfere with the analyte signal.
Conclusions: The analytical method was linear, exact, and specific in the range of concentrations studied.
Keywords: docetaxel; stability in use; validation


Cuba
Validation of two analytical methods for the registration of

a new cytostatic product of national production,
gemcitabine
Ada E. Inguanzo*, Susset Evans
Development and Innovation Unit, AICA Laboratories Company, Havana, Cuba.
*ainguanzo@aica.cu
ABSTRACT
Context: Gemcitabine exhibits cytotoxic action that kills tumor cells. It is indicated for treatments of breast, lung, pancreatic,
system.
Objective: To evaluate the performance and validation of two analytical techniques for the quality control of a new cytostatic
of national production: gemcitabine solution for injection.
Methods: To validate using validation performance evaluation protocols for the active pharmaceutical ingredient and for the
finished pharmaceutical product.
Results: The evaluated methods complied with the parameters foreseen in their validations, so they are considered validated.
Conclusions: The analytical techniques used for the quantification of gemcitabine were suitable both for the quality control of
the active ingredient or the finished product and for the injectable stability studies.
Keywords: cancer; gemcitabine; validation


Cuba
The validation of an analytical method for the quality

control of enrofloxacin in injectable solution
Maybel González Mirabal1*, L. Sulin González Ferrer2, Yolexis Tamayo García1
1Instituto de Farmacia y Alimentos, Universidad de La Habana, La Habana, Cuba.
2Empresa de Productos Inyectables (LABIOFAM), La Habana, Cuba.
*maybelgm1@gmail.com
ABSTRACT
Context: Enrofloxacin, a third-generation fluoroquinolone, is a broad-spectrum antimicrobial drug against a lot of veterinary
bacterial diseases. LABIOFAM, an injectable company, developed an injectable solution of Enrofloxacin 10% to substitute the
imports of this drug in Cuba. Both the implementation and validation of an analytical method for the quantification of any
drug is an important aspect in the development of any product.
Objectives: To design and validate a spectrophotometric method to quantify enrofloxacin injection.
Methods: The experimental conditions were evaluated. The analytical method was validated taking into account the
contemplated parameters in the validation protocol.
Results: The experimental conditions were defined and the assay was designed as well. The evaluated parameters in the
validation met the proposed criteria. An appropriate specificity was demonstrated against the components of the matrix, as
well as its linearity, accuracy, and precision.
Conclusions: The implemented method was valid for the proposed objective.
Keywords: enrofloxacin; quality control; validation


Cuba
Establishing and validation of the Microlowry analytical

technique for the quantification of total proteins
Sheila Padrón Morales*, Danaydis Fonseca, Aydi Columbié, Daniela Rivero
Analytical Development Group. Department of Technological Development. Center for Genetic Engineering and Biotechnology (CIGB),
Havana, Cuba.
*sheila.padron@cigb.edu.cu
ABSTRACT
Context: In the Laboratory of Analytics Development of the CIGB, a Lowry method is used to quantify total proteins in
different projects. This method has the disadvantage of using reaction volumes of 0.6 mL, making it necessary to use vials to
test the samples and to use plastic or glass cuvettes for the reading of the test in a spectrophotometer. Therefore, the method
takes a long time to give the results when several samples are tested. For this reason, it was decided to establish the
MicroLowry method in 96-well plates, where a smaller volume of reactants is used and the absorbance is read quickly in a
plate reader.
Objective: To validate and demonstrate the performance of the MicroLowry analytical technique in 96-well plates for the
quantification of total proteins.
Methods: Certain parameters were evaluated, such as linearity, system range, accuracy, precision and robustness.
Results: Microlowry method complied with the linearity requirements of the calibration curve in the working range of 100,
80, 60, 40, 20, 10 µg/mL, and was precise and accurate. The system had adequate accuracy. First, the curve standard and the
samples had similar behavior, with an accepted concentration variability between ranges (C.V. between ranges ≤ 10%).
Second, the method is capable of accurately quantifying the concentration of the analyte. The Lowry and Microlowry
methods were to be equivalent. The CVs met the acceptance criteria for CV Repeatability ≤ 10%, CV Intermediate Precision ≤
15%.
Conclusions: It was concluded that the MicroLowry technique is suitable for use in the laboratory.
Keywords: microlowry; validation parameters


Cuba
Validation of two analytical methods for the determination

of purity for heberprot-P
Maylin La O1*, Jennifer Rojas1, Osniel Cabrera1, Mareysis Ruiz1, Galina Moya1, Luis A. Espinosa2, Vladimir
Besada2, Lourdes Costa1
1Quality Control Department. Center for Genetic Engineering and Biotechnology, Biocubafarma, Playa Municipality, Havana, Cuba.
2Directorate of Biomedical Research. Center for Genetic Engineering and Biotechnology, Biocubafarma, Playa Municipality, Havana, Cuba.
*maylin.lao@cigb.edu.cu
ABSTRACT
Context: Heberprot-P is used in the treatment of diabetic foot ulcers.
Objective: To validate the purity assays by RP-HPLC and SDS-PAGE for the analysis of heberprot-P, for the determination of
purityh and drug modifications during stability and storage studies.
Methods: For RP-HPLC, a system (SHIMADZU, Japan) was used: C8 Vydac column from 20 to 80% (0.05% TFA/ACN,
solution B) at 1 mL/min, 226 nm. The API was subjected to pH 2.94 and pH 9.55 at 37 ºC and monitored at 24 h, 48 h, and 72
h. Linearity and LDD/LOQ were evaluated from 0.002, at 30 µg. SDS-PAGE was used a 16.5% acrylamide gel, applying 20
µg of the sample, treated with DTT and -mercaptoethanol, 5 minutes at 95°C. The sample was subjected to three cycles of
freezing, thawing at –20 °C, 20 °C, and 95 °C. For linearity and LDD, it was evaluated from 0.1 to 50 µg.
Results: By RP-HPLC the modifications were the degradation of the ends of the protein, cyclization, and oxidation. The linear
range was between 20 and 60 µg. The LOD and LOQ were established for 5 and 15 µg. By SDS-PAGE, stress generated
aggregates and degradations, with a linear response from 5 to 40 µg of EGF, detecting up to 0.1 µg of protein.
Conclusions: Analytical methods were satisfactorily validated. Both were able to detect degradation products in stress
studies, an international regulatory requirement for the registration of this type of product.
Keywords: Heberprot-P; RP-HPLC; SDS-PAGE; validation


Cuba
Advantages of establishing and validating an alternative

immunomodulatory assay for the determination of the in
vitro potency of HeberFERON®
Luisa G. Silega-Coma1*, H. Gerónimo1, Dayana C. Brito1, Yusnielis Bustamante1, Iliana Delgado2, Iraldo
Bello3, Gustavo Furrazola2, Oscar Cruz2, Gerardo García1, Mabel Izquierdo1, Lourdes B. Costa1
1Biological Department, Quality Control, Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.
2Biomanufacturing Department, Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.
3Clinical Research Department, Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.
*luisa.glenda@cigb.edu.cu
ABSTRACT
Context: The HeberFERON® is the combination of recombinant human interferon alpha-2b and interferon-gamma. The
biological potency is determined by using an antiviral bioassay. Recent editions of the European Pharmacopoeia recommend
a new immunomodulatory in vitro bioassay to evaluate the biological potency, bioassay capable of detecting the expression
of the DR subregion of MHC class II (HLA-DR), in COLO-205 cells, upon contact with IFN-γ.
Objective: To demonstrate the advantages of the establishment and validation of a new alternative immunomodulatory
method to the current antiviral method for the determination of the biological potency of IFN-γ in the HeberFERON®.
Results: The average GVC of the two batches evaluated (6 determinations) was 15.24 and 9.40, lower than the limit
established for the precision of the method (≤ 20%). In all cases, the theoretical (expected) value should be within the
confidence interval of the experimental value (found value) for the assay accuracy. The function of experimental value
against theoretical value described a straight line, where the slope was very close to 1. The results showed a direct
relationship of the expression of rhIFNγ, with increasing dosages of rhIFNγ. rhIFNα2b did not induce any antigenic
expression of the HLA-DR in COLO-205 cells.
Conclusions: The alternative method was less variable, more precise, and specific for IFN-γ.It requires a smaller number of
biological agents, eliminating the work with viral agents anda neutralizing polyclonal antibody. The technique was
validated proving to be precise, exact, linear, and specific, which guarantees reproducible and reliable results according to
the intended purpose.
Keywords: antiviral assay; HeberFERON®; immunomodulatory assay; recombinant human interferon gamma


Cuba
Validation of the polyacrylamide gel electrophoresis

technique for the separation and control of the RBD active
pharmaceutical ingredient
Osniel Cabrera Díaz*, Mareysis Ruiz Pérez, Maylin La O González, Galina Moya Fajardo, Lourdes Costa
Anguiano
Physical-Chemical Department, Quality Control, Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.
*osniel.cabrera@cigb.edu.cu
ABSTRACT
Context: The Abdala vaccine was obtained at the Center for Genetic Engineering and Biotechnology (CIGB) in response to
the COVID-19 disease caused by the SARS-CoV-2 virus.
Objective: To validate the polyacrylamide gel electrophoresis technique for the separation and control of the RBD active
pharmaceutical ingredient (API).
Methods: 10 µg of RBD active pharmaceutical ingredient samples were heated at 95 °C for 10 minutes with reducing buffer.
(Running condition of 30 mA and 250 V.) The parameters of specificity, linearity, detection limit, repeatability, intermediate
precision, and robustness were evaluated.
Results: Degradation and/or aggregation bands were detected in the treated samples (25, 45, and 60 °C) for 120 hours. There
was a loss of purity of 5% at 25 °C, 12% at 45 °C, and 19% at 60 °C. The method was linear between 20-180% of the nominal
amount applied with R2 of 0.96. The method detected up to 0.3 µg of protein. The repeatability CV (%) for purity was ≤ 1 and
for intermediate precision it was ≤ 3. The slightly altered parameters (fixation time, run voltage, and separating gel buffer
pH) with respect to the determination of the RBD API purity did not show purity changes for a significance level of Ha ≥
0.05.
Conclusions: The method was able to detect high and low molecular weight degradations. The method was linear between 2
and 18 µg. Up to 0.3 µg of protein was detected. The method was accurate and repeatable. The method was robust for the
parameters evaluated in relation to purity.
Keywords: degradations; RBD; polyacrylamide gel; purity


Cuba
Total validation of an ELISA for the quantification of the

receptor binding domain in batches of active
pharmaceutical ingredient and Abdala finished product
Yurisleydis Aldama Casas*, Mabel Izquierdo López
Quality Control Department. Center for Genetic Engineering and Biotechnology, Biocubafarma, Av 31 between 158 and 190, zip code: 10600,
Havana, Cuba.
*yurisleydis.aldama@cigb.edu.cu
ABSTRACT
Context: As part of the strategy to raise the analytical standard of the Abdala vaccine, for the identification and/or
quantification of the antigen receptor binding domain (RBD), a sandwich-type enzyme-linked immunosorbent assay (ELISA)
was developed and established, on the base of monoclonal antibodies specific for the binding sites to the RBD antigen, using
orthophenylenediamine as chromogen of the reaction.
Objectives: To perform total validation of the method to evaluate compliance with the parameters to be validated according
to the current Regulation of the CECMED.
Methods: The materials used were properly stored and titled and the equipment was qualified and calibrated. Statistical
analysis were performed using Excel, Statistica and MiniTab 17 programs.
Results: The RBD concentrations obtained for the batches of active pharmaceutical ingredient (API) had a high
correspondence with those obtained by the optical density technique, with a coefficient of variation (CV) between both
methods of less than 20%. For the batches of Finished Product (TP) the concentrations obtained were close to the formulation
values. The validation parameters evaluated all met the established validity criteria. As for specificity it was shown that
there was no interference. The accuracy of the recovered data was between 80 - 120%, and the precision of the CV was less
than 10% and 20%.
Conclusions: According to the results obtained, the established ELISA can be used for the identification and/or quantification
of the RBD antigen in the API of RBD and PT of Abdala.
Keywords: ELISA; API; PT; RBD; validation


Cuba
Establishing and demonstration of the suitability and

performance of the Microbiuret analytical technique in 96-
well plates for the quantification of total proteins
Danaydis Fonseca*, Aydi Columbié, Daniela Rivero, Jessica Brosmenier, Sheila Padrón, Inalvis Herrera,
Yailin Barbon, Makis Torres
Analytical Development Group. Department of Technological Development. Center for Genetic Engineering and Biotechnology, Havana,
Cuba.
*danaydis.fonseca@cigb.edu.cu
ABSTRACT
Context: The Biuret colorimetric method is used in the quantification of peptides and proteins. This assay has been shown to
be accurate, precise, and fast for evaluating protein samples. The antimicrobial peptide Oreochromicin-2 constitutes the
active principle of a formulation injectable that is being developed at the Center for Genetic Engineering and Biotechnology
for veterinary use in pigs.
Objective: To establish a Microbiuret method in 96-well plates and to evaluate its performance and capacity to quantify
Oreochromycin-2 and total proteins.
Methods: From the Biuret method established in Quality Control, modifications were made in the Biuret reagent, procedures,
and reaction volumes to establish and optimize a new Microbiuret method. Linearity and working range, accuracy and
precision of the samples, and robustness of the system were evaluated on different days and by different analysts.
Results: For Microbiuret, it was possible to reduce the final reaction volume from 1200 µL to 300 µL, the composition of the
Biuret reagent was modified, the analytical sensitivity of the method was increased to 0.125 mg/mL and greater speed and
greater analytical capacity were achieved. This new method proved to be linear in the range of 2.0 to 0.125 mg/mL, capable
of accurately and precisely quantifying the analyzed protein samples. It proved to be robust after 15 min of reaction with
Microbiuret solution and its performance was not affected by using different types of water: reagent water, non-pyrogenic
water and MilliQ water.
Conclusions: The new established Microbiuret method proved to be suitable for quantifying total protein.
Keywords: Content or power method; oreochromycin-2; validation parameters


Cuba
Validation of the reverse phase chromatography technique

for the identification of the GHRP-6 peptide in the
formulation of Acuabio V
Maelys Miyares1*, Thais Fernández1, Janett Terrero1, Luis A. Espinosa2
1Technology Development Direction, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
2Biomedical Research Direction, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
*maelys.miyares@cigb.edu.cu
ABSTRACT
Context: The GHRP-6 peptide is the growth hormone-releasing peptide, which improves the quality of fish larvae and
increases defenses against pathogens. The peptide formulation consists of a finished product in powder form, intended for
veterinary application by oral route included in the diet and by immersion route. The reverse phase chromatography is the
established method for the identification of the GHRP-6 peptide in the formulation of Acuabio V.
Objectives: To validate the parameters for the identification method.
Methods: The validated parameters were system suitability, specificity, linearity, identification limit, precision, and
robustness.
Results: In the system suitability test, it was obtained the following parameters: Resolution R 2.3 > 2, Asymmetry Factor T
1.490 < 2, and Theoretical plates N 34 381 > 2000. The method turned out to be selective for the peptide (TR ≈ 20.6 min) and
the placebo (TR ≥ 23.7 min).It was confirmed by ESI-MS mass spectrometry that the main signal 872.44 Da corresponded
with the expected molecular mass of 872.42 ± 0.02 Da. The acid hydrolysis study originated new fractions associated with
degradations of the peptide. The system complied with the requirements of linearity of the calibration curve in the working
range (40-2.5 µg R2 0.98) and the identification limit of 0.04 µg. The method turned out to be precise (repeatability: CV ≤ 1%;
intermediate precision: CV ≤ 2%). The technique showed to be robust against all variations studied in the trial (P values 0.73
> 0.05).
Conclusions: Validation was satisfactory and the method was adequate for the control and release of the product
Keywords: chromatography; finished product; peptide


Cuba
Characterization and certification of the reference material

for the CIGB 814 peptide used in the release of the jusvinza
Cristina Rodríguez Rodríguez1*, Gerardo García Illera1, Omar Torres Díaz1, Adisley Dorta Martínez1,
Ángela Fidalgo Maceo1, Lourdes Costa Anguiano1, Maylin La O González1, Jennifer Rojas Pérez1, Matilde
López Abad2, Dareyne Lara Fuentes1, Vladimir Besada Pérez3
1Quality Control Direction, Center for Genetic Engineering and Biotechnology, Addresses: Avenida 31 entre 158 y 190, Playa, La Habana
11600, Cuba.
2Technological Development Direction, Center for Genetic Engineering and Biotechnology, Addresses: Avenida 31 entre 158 y 190, Playa, La
Habana 11600, Cuba.

3Biomedical Research Direction, Center for Genetic Engineering and Biotechnology, Addresses: Avenida 31 entre 158 y 190, Playa, La Habana
11600, Cuba.
*cristina.rodriguez@cigb.edu.cu
ABSTRACT
Context: Jusvinza is Cuba's first innovative drug based on peptide synthesis, and the global recovery rate after its use in
severe and critical COVID-19 patients exceeds 85 percent, a figure higher than that reported internationally. As part of the
strategy to raise the analytical standard of the reference material used in the release of jusvinza, the certification by the
CECMED of the Reference Material was necessary.
Objectives: To characterize and certify by CECMED the CIGB-814 peptide Reference Material used in the release of jusvinza.
Methods: Regulation No. 22-2012, RP-HPLC method, ESI-MS method, CIGB 814 peptide finished product.
Results: The Reference Material was homogeneous, with a probability value of 0.48. The characterization study by RP-HPLC
method allowed obtaining an intra-assay coefficient of variation in all cases below 1% and between assays below 2%, which
indicated an adequate repeatability and intermediate precision of the results. The uncertainty of the purity was determined
with a confidence level of 95%. The characterization by mass spectrometry allowed obtaining the characteristic spectrum of
the CIGB-814 peptide with a molecular mass of the molecular ion peak of 2986.61 Da, which differs from that expected by
0.03 Da. The accelerate stability study allowed predicting a loss of 1.2 % of purity per year when stored at the recommended
temperature 5 ± 3ºC.
Conclusions: The homogeneity and characterization studies carried out, as well as the documentation presented to the
CECMED, complied with the regulation No. 22-2012, which allowed the certification of the Reference Material by CECMED.
Keywords: CIGB 814 peptide; reference material


Cuba
Determination of the isoelectric point of the RBD reference

material for the release of the API samples of the vaccine
candidate against COVID-19
Raydan Galvez Lemus*, Maylin La O González, Galina Moya Fajardo, Lourdes Anguiano Costa
*raydan.lemus@cigb.edu.cu
ABSTRACT
Context: RBD is a protein developed at the Center for Genetic Engineering and Biotechnology as an active principle for new
vaccine candidate against the COVID-19.
Objective: To characterize the RBD reference material by the isoelectric focusing technique based on the study of the isoforms
profile, as well as the determination of the isoelectric point of the protein.
Methods: A PhastSystem equipment (PHARMACIA, Switzerland) was used, with precast polyacrylamide gels (5% T, 3% C)
range from 3 to 9 pH units, voltage of 2000 V, at a controlled temperature of 15 °C. The SERVA Mix isoelectric point
standard (PPI) was used with a pH range of 3 to 10 (Heidelberg, Germany). One µg of protein was loaded in Phast Gel 8/1
µL sample applicators, with the position of the applicator comb at the anode electrode.
Results: In the tests carried out, the distribution of PPI 3-10 throughout the gel was achieved, as well as the separation and
visualization of the 10 isoforms that characterize it. The isoelectric point was determined by interpolation of the PPI of 3-10
as a function of the migration by each isoform. The separation of the material samples was achieved in the RBD study,
visualizing the presence of 8 major isoforms between the regions 3.5 and 10.25 pH units.
Conclusions: The distribution of PPI 3-10 throughout the gel and the separation and visualization of the 10 isoforms that
characterize it was achieved. Separation of the isoforms from the RBD material samples was also achieved. The characteristic
profile of the samples corroborated the presence of 8 main isoforms found between the regions of 3.5 and 10.25 pH units.
Keywords: Isoeletric focusing , isoforms; protein; RBD; separation


Cuba
Determination of the free tetanus toxoid protein, in the

active pharmaceutical ingredient of the Haemophilus
influenzae type B (HiB) vaccine, by SDS-PAGE with
acrylamide gradient
Mareysis Ruiz Pérez*, Maylin La O González, Galina Moya Fajardo, José L. Marcelo Sains
*mareysis.ruiz@cigb.edu.cu
ABSTRACT
Context: The Cuban vaccine against Haemophilus influenzae type b (Hib) is obtained by chemical synthesis. The production
process of the active pharmaceutical ingredient (API) of this vaccine consists of a poly-condensation reaction between the
polysaccharide (also called PRP) and one of the disaccharide units previously obtained by chemical synthesis, followed by a
conjugation with the tetanus toxoid (TT) to obtain the polysaccharide-protein conjugate (PRP-TT).
Objective: To determine the amount of free protein in the API of the Haemophilus influenzae type b vaccine by electrophoresis
design using an acrylamide gradient of 4-17% in the presence of SDS.
Methods: A gradient of 4 to 17% acrylamide and staining with coomassie blue (R-250) was used. The samples were treated
with reducing buffer (β-mercaptoethanol 10%, bromophenol blue 0.01%, sodium dodecylsulfate 4%, glycerol 20%, and tris-
(hydroxymethyl) aminomethane 0.125 M) and heated 5 min at 95°C. Six mixtures of PRP-TT conjugate and TT were made
adding decreasing amounts of TT (10%, 5%, 2%, 1%, 0.5%, and 0.1%). The gels were analyzed using a densitometer (G-800
BIO-RAD) and the program Quantity One.
Results: The method was able to separate the TT present in the mixtures of API and PRP-TT. The detection limit of the
technique was established between 5% and 10% of TT in the API mixture of PRP-TT conjugate.
Conclusions: The method was able to separate and confirm in PRI-TT conjugates API up to 2 years of manufacture that there
is free TT in a proportion less than 5%. With the results and scientific knowledge of the production process, it was concluded
that the process of conjugating the PRP with the TT does not provide free TT to the API.
Keywords: gradient; polyacrylamide gel; purity


Cuba
Physicochemical comparability of P3R99 mAb produced in

three different cell lines
Yoandra M. Montano1*, José A.G. Pérez1, Tania G. Peña1, Ingrid R. Ramirez1, Yosdel S. López2, Leydi M.V.
García2, Roberto M. Santiesteban3, Julio F.S.T. Pompa3, Victor B. Navarro2, Ayme F. Valdes4
1QC Departament for Products in Development. Center of Molecular Immunology, Havana, Cuba.
2Departament of Immunobiology. Center of Molecular Immunology, Havana, Cuba.
3Analytical and Formulation Departament. Center of Molecular Immunology, Havana, Cuba.
4Process Management Direction. Center of Molecular Immunology, Havana, Cuba.
*yoandra@cim.sld.cu
ABSTRACT
Context: A feature of atherosclerosis progression is the accumulation of sulfated proteoglycans and hyperelongation of
glycosaminoglycan (GAGs) side chains. The monoclonal antibody (mAb) P3R99 is a mouse/human chimeric IgG that
recognizes N-glycolylated gangliosides and sulfated GAGs.
Objective: To perform a physicochemical comparability study of the P3R99 mAb produced in three different cell lines.
Methods: Five batches of P3R99 obtained from HEK-293, CHO-K1, and NS0 cell lines were analyzed.
Results: All variants of P3R99 showed a similar recognition pattern to GAGs and its anti-idiotypic antibody 1E10 by ELISA.
The molecular size of all the batches was around 150 kDa by HPLC and SDS-PAGE and presented a high percentage of
purity, low degradation, and aggregation. The mean particle size determined by DLS was similar among all variants (12.5-
14.4 nm) after filtration and slightly higher than expected for an antibody (10-12 nm). Circular dichroism exhibited a
structure rich in β-sheets (> 40%), whereas cation exchange chromatography confirmed a high content of basic aminoacids
on the surface of P3R99 (theoretical IP: 8.5-9.5), which is critical for its biological function. The glycosylation profiles
produced by CHO and HEK are similar to each other, enriched in the G0F variant (60-70%), while the NS0 profile exposed a
higher content of G1F and G2F variants with terminal lactose and a high percentage of sialylation (15-23%).
Conclusion: The expression of P3R99 in different cell lines mainly affected the glycosylation patterns without affecting its
recognition properties. The most novel result is that could be demonstrated that this antibody has a high content of basic
aminoacids on the surface.
Keywords: CHO-K1; glycosylation; HEK-293; NS0; P3R99


Cuba
Physical-chemical evaluation of the shark liver pool oil

Juan A. Pérez-Carrasco1, Caridad M. García Peña2, Mirna Fernández-Cervera3, Mirta Castiñeira-Díaz3,
Rodny Montes de Oca-Porto4, Daniela de la C. Ferral-García5*
1Inmunoensayo Center, Havana, Cuba.
2Drug Research and Development Center. BioCubaFarma. Ave. 26 # 1605 e/ Calzada de Puentes Grandes and Boyeros. Plaza de la
Revolución, Havana, Cuba.
3Institute of Pharmacy and Food (IFAL), University of Havana, Cuba. Street 222 # 2317 e/ 23 and 31. La Lisa, Havana, Cuba.
4Instituto de Medicina Deportiva, Havana, Cuba.
5Facultad de Tecnología de la Salud “Salvador Allende” , Havana, Cuba.
*caridad.garcia@cidem.cu
ABSTRACT
Context: Multiple benefits are attributed to shark liver oil, despite this there is very little evidence at national and
international level of its chemical composition for use for pharmaceutical purposes, nor is its monograph reported in official
pharmacopoeias.
Objective: To carry out the physical-chemical evaluation of the shark liver pool oil, extracted from sharks that inhabit near the
coasts of the northwestern coast of Cuba, for its subsequent use as an active ingredient in the development of
pharmaceutical formulations.
Methods: The physical-chemical parameters determined were specific density, refractive index, acidity, iodine,
saponification, peroxide, anisidine, and percentage of unsaponifiable matter. The content of vitamins A, D, and E in shark
liver pool oil was quantified by High Resolution Liquid Chromatography (HPLC), using a mobile phase composed of
methanol:water (98:2). Simultaneously, the fundamental lipid composition was determined by using chromatographic
techniques, such as gas chromatography, and spectroscopic techniques, such as IR, GC-EM, and NMR, to identify and
quantify the fatty acids present.
Results: With the process used in the obtaining of the pool oil it was possible to achieve a rich raw material in vitamin A and
palmitic acid, and appropriate quality considering the results of the remaining parameters assessed.
Conclusions: The results obtained show that the pool oil can be considered a potential pharmaceutical active ingredient
because it has a high content of vitamin A and palmitic acid, followed by stearic, oleic and linoleic acids.
Keywords: HPLC; shark liver oil; fat acids; vitamins


Cuba
Development of a new alternative viral transport medium

for the diagnosis of SARS-CoV-2
Diana R. Viera Oramas1*, Marilyn Díaz Pérez1, Alexis Labrada Rosado1, Alberto E. Varela Llanes1, Claudia
Talavera Castro1, María C. Montalvo Villalba2, Julio R. Fernández Masso3, Liem Laguna Oliva4, Brian A.
Mondeja Rodríguez5, Otto Cruz Sui6, Enrique Noa Romero6, Juliet M. Enríquez Puertas6, Dennis Someillan
Iglesias1, Tamara Lobaina Rodríguez1, Lellany Echazábal Hernández1, Yordania Zayas Ruiz1
1National Center for Biopreparations (BioCen). Road Beltrán Km 1½, Bejucal, Mayabeque, Cuba.
2Instituteof Tropical Medicine ¨Pedro Kourí¨ (IPK). Noon Bride Avenue, KM 6 1/2, La Lisa, Havana, 11400, Cuba.
3Center for Genetic Engineering and Biotechnology (CIGB). Ave. 31 No. 15802 e/ 158 y 190, Cubanacán, Playa, Havana, 10600, Cuba.
4Military Hospital Luis Díaz Soto, Monumental Ave 2 ½ . CP19130, Havana, Cuba.
5Center for Advanced Studies (CEA), Km 1 1/2 San Antonio road, Valle Grande, La Lisa, Havana, Cuba.
6SIDA Research Laboratories (LISIDA), Tapaste road and National Highway, San José de las Lajas, CP 32700, Mayabeque, Cuba.
*diana@biocen.cu
ABSTRACT
Context: The BTU Universal Transport Medium is a medium intended for the collection of clinical samples for the diagnosis
of SARS-CoV-2. Its elaboration allows maintaining the epidemiological surveillance system in the country and foresees
possible failures of some of the inputs used in the production of the transport medium for BTV Virus.
Objective: To design and develop the BTU medium in the BioCen Production Plants.
Methods: This new diagnostic was developed from the laboratory stage to production. To do this, using BTV as a
comparative mean, compatibility with RNA extraction systems, viability and stability of SARS-CoV-2, evaluation of clinical
performance, as well as the different quality parameters were evaluated.
Results: Satisfactory results were obtained in the evaluation of the organoleptic, physicochemical characteristics, and the
effectiveness of the antimicrobials in the medium. The virus was viable up to 96 h at 4 °C and up to 24 h at 25 °C. The
medium preserved clinical samples for up to 72 h between 2 to 8 °Cand was compatible with all existing RNA extraction
systems in the country. The evaluation of the clinical performance reflected that there were no significant differences
between the result of the diagnosis with BTU in relation to BTV. The pooled value of κ was found to be 0.660 above 0.6,
indicating substantial agreement.
Conclusions: The product adds to the COVID-19 diagnostic system and reinforces the country's technological sovereignty.
Keywords: BTU Universal Transport Medium; COVID-19; Cuba


Cuba
Documentation management for nasal products derived

from recombinant proteins
Nubia González*, Isabel Apezteguía, Ana Aguilera, Yilian Bermúdez, Odalys Ruiz
Center for Genetic Engineering and Biotechnology, Havana, Cuba.
*nubia.gonzalez@cigb.edu.cu
ABSTRACT
Context: Innovation in the world´s pharmaceutical and biotechnological industry is subject to high regulatory demands.
Cuba has stood out worldwide for obtaining biotechnological products in the Research-Development phase that meet the
quality required according to established standards by national and international regulatory agencies. Several recombinant
proteins have a wide clinical use with very good results in the prevention and treatment of viral diseases. Work is currently
underway on the formulation of recombinant proteins for nasal administration to patients. The presentation of
biopharmaceutical dossier to the national regulatory authority requires the documentation management with a rigorous and
secure manner for its future approval.
Objective: To stablish the documentation management related to biopharmaceutical dossier for nasal products.
Methods: The principles documents were prepared as a biopharmaceutical dossier in accordance with current Good
Manufacturing Practices.
Results: The stablished documents in the pharmaceutical development stage of nasal products, such as detailed information
about formulation process, flowchart, standard operating procedures, master production record, quality specifications, real
and accelerated stability studies of the formulation, and finished product constituted, were included as part of the dossier.
Conclusions: The documentation management for compliance of nasal products, with current regulatory standards of
national and international authorities, was stablished.
Keywords: pharmaceutical development; recombinant protein


Cuba
Improvement to the starting material sampling service at the

pharmaceutical supply distribution center
Agnieska Almeida Hernández*, Yaritza Mendoza Sam
Quality Management Department, Pharmaceutical Supply Distribution Center, Company for Commercialization and Distribution of
Medicines (EMCOMED), Havana, Cuba.
*agnieska.almeida@sf.emcomed.cu
ABSTRACT
Context: It is necessary to ensure the quality of pharmaceutical products from the starting materials and to adopt procedures
of inspection, testing, and sampling across the supply chain. The sampling is a critical operation that requires regulations
according to the Good Storage and Distribution Practices of pharmaceutical products.
Objective: To implement improvements to the starting material sampling operation at the Pharmaceutical Supply
Distribution Center.
Methods: A review and update of the requirement of sampling activities according to the principles of Good Storage and
Distribution Practices was carried out. Some techniques, such as brainstorm and Ishikawa’s diagram, were applied to
analyze the non-compliances related to the activity. It was suggested the improvement of the documentation according to
the regulatory requirements and the customer’s expectations.
Results: The causes of the non-compliances related to the sampling activity were identified. Some improvements were
applied to ensure the quality during the sampling operations, according to the recommendation of foreign and national
regulatory agencies. The procedure that regulates the activity was modified, and 9 complementary work instructions were
approved.
Conclusions: The improvements applied ensured the sampling with quality and safety. At present, this activity follows the
good practices principle.
Keywords: Good Storage and Distribution Practices; sampling

ECFA 2022. S4- MEDICINAL PLANTS - NATURAL PRODUCTS-MEDICINAL CHEMISTRY

Yamilet Irene Gutiérrez Gaitén, PhD, IFAL-UH / Raiza Mangas Marín, PhD, IFAL-UH / Yoanna M Alvarez-Ginarte, PhD, FQ-UH, La Habana,
Cuba
Influence of the phenological stages in the pharmacognostic

parameters and diuretic activity of Xiphidium caeruleum
Carlos R. Núñez Cairo1*, Greysa L. Alvárez Hernández2, Alejandro F. González3, Yamilet I. Gutiérrez
Gaitén3, Ramón Scull Lizama3, Ana C. Noa Rodríguez4
1Department of Physiology, Institute of Basic and Preclinical Sciences “Victoria de Girón”, Havana, Cuba.
2Pharmaceutical Laboratories NOVATEC, Havana, Cuba.
3Department of Pharmacy, Institute of Pharmaceutical and Food Sciences, University of Havana, Havana, Cuba.
*crn@infomed.sld.cu; ORCID: 0000-0003-4079-4688
ABSTRACT
Context: Xiphidium caeruleum is a herb well distributed in Cuba and in other countries of America. Traditionally there are
uses for stomach aches, dermatitis and for the treatment of kidney conditions. However, there is not pharmacological studies
that support its traditional use.
Objective: To evaluate the influence of phenological stage in the pharmacognostic parameters and diuretic activity of
Xiphidium caeruleum.
Methods: The pharmacognostic, phytochemical and diuretic characterization of the plant was carried out according to two
phenological stages (vegetative and flowering) of the plant. The physico-chemical parameters of the quality of the drugs and
their aqueous extracts were analyzed. The chemical composition of the extracts was estimated by thin layer
chromatography, UV and IR spectroscopy, quantification of phenols by Follin-Ciocalteu and flavonoids by the colorimetric
method of aluminum trichloride. The diuretic effect of the extracts was tested in Wistar rats and the results were compared
with furosemide, hydrochlorothiazide, and spironolactone: well stablished diuretic drugs.
Results: Extractable substances indicated the high quantity of metabolites in the aqueous extract, matching with the
traditional applications. All pharmacognostic parameters were higher in the aqueous extract of the leaves collected in a
vegetative stage, including the content of phenols and flavonoids. The diuretic activity of the leaves collected in vegetative
stage was similar to furosemide, while the leaves collected in flowering stage showed an activitysimilar tospironolactone.
This is the first report of results associated with this plant species.
Conclusions: The phenological stage affected the pharmacognostic parameters and diuretic activity of the aqueous extract of
the leaves of Xiphidium caeruleum.
Keywords: flavonoids; natural products; pharmacognosy; phenological stage; phenols; Wistar rats


Cuba
Standardization of the hydroalcoholic extract of the leaves

of Lippia alba Mill
Alejandro F. González1*, Yamilet I. Gutiérrez Gaitén1, Rachel de la C. Hernández Suárez2, Ramón Scull
Lizama1, Ana C. Noa Rodríguez3, Kenn Foubert4, Luc Pieters4
2Pharmaceutical Marketing and Distribution Company, Havana, Cuba.
4Natural Products & Food Research and Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Antwerp,
Belgium.
*afelipe860126@gmail.com; ORCID: 0000-0003-2287-254X
ABSTRACT
Context: Lippia alba is traditionally used as an anti-inflammatory, sedative, analgesic, and for gastrointestinal problems;
however, the information on phytochemical analysis and pharmacological evaluations of the extracts is scarce. In Cuba, the
friction of L. alba leaves is reported as a phytomedicine in the National System of Health; but more studies are required to
complete the information on them.
Objective: To standardize the quality parameters of the leaves and hydroalcoholic extract of L. alba.
Methods: Twelve batches of L. alba leaves were collected between September 2020 and February 2022 in Artemisa and
Havana, Cuba. The physico-chemical parameters of the leaves were determined. The extract of the leaves was obtained
using ethanol 70% as solvent. The extracts of the twelve batches were characterized by their physico-chemical parameters,
TLC and HPLC/DAD profile. Total phenols and flavonoids were quantified by the Folin-Ciocalteu and aluminum chloride
methods, respectively.
Results: The physico-chemical quality parameters of the leaves and hydroalcoholic extract of L. alba were established. The
results of the chemical profile allowed to propose phenols and flavonoids as the main metabolites in the extract, which were
quantified and the quality limits were established. However, batches one and two showed qualitative and quantitative
phytochemical differences associated with a drug degradation process. In addition, the stability of the leaves stored at room
temperature for 18 months was determined.
Conclusions: The quality specifications of the drug and hydroalcoholic extract of L. alba were established. Phenols and
flavonoids were proposed as general chemical markers.
Keywords: chromatography; flavonoids; natural products; pharmacognosy; phenols; quality control


Cuba
In vitro anticandidal activity of Cubans essential oils from

Citrus limon and Plectranthus amboinicus
Rosario E. Velar Martínez1*, Lianet Monzote Fidalgo2, María T. Illnait Zaragozí1, Stephanie Sosa Capetillo3,
Mayda R. Perurena Lancha1, Carlos M. Fernández1, Gerardo F. Martínez Machín1, Jean Vicente Iznaga1
1Laboratorio de Micología, Instituto de Medicina Tropical “Pedro Kourí”, Cuba.
2Laboratorio de Leishmania, Instituto de Medicina Tropical “Pedro Kourí”, Cuba.
3Centro Nacional de Investigaciones Científicas, Cuba.
*velar@ipk.sld.cu
ABSTRACT
Context: Vulvovaginal candidiasis is one of the most frequent infections in the female population; Candida albicans is the main
etiologic agent. Antifungal resistance, as well as their toxicity and limited variety, encourages the search for alternative
phytopharmaceuticals. Essential oils are targets for the exploration of new biomolecules with antifungal effect.
Objectives: To evaluate the in vitro antifungal activity of 15 Cuban essential oils against C. albicans.
Methods: A screening of 15 Cuban essential oils was carried out against C. albicans ATCC 90028 by disk diffusion. The
minimum inhibitory concentration (MIC) and minimum fungicidal concentration of the oils with the highest activity and
their main active compounds were determined by a colorimetric method of broth microdilution using resazurin (3 mM) as a
redox indicator. Fluconazole was the reference drug in the applied techniques.
Results: Eleven essential oils showed activity. Plectranthus amboinicus (56.5 mm) and Citrus lemon (46mm) were stressed for
their inhibition halos. There were no significant differences between these and their respective main compounds, carvacrol
(p = 0.29) and limonene (p = 0.20). These products exhibited fungicidal action in the microdilution test. Limonene was the
phytochemical with the highest potential (MIC = 62.5 μg/mL).
Conclusions: The main active compounds in the essential oils of P. amboinicus and C. lemon are responsible for the activity
against C. albicans. Limonene could be the precursor of a new phytopharmaceutical to be incorporated in the phytotherapy
of vulvovaginal candidiasis in Cuba.
Keywords: antifungal activity; Candida albicans; Citrus lemon; essential oils; limonene; Plectranthus amboinicus; vulvovaginal
candidiasis


Cuba
Dimerization and D-amino acid substitutions, but not

acetylation, increase the inhibitory effect and stability of an
interleukin-15 antagonist peptide
Yunier R. Álvarez1*, Ania C. Rico2, David D. Abreu2, Elianys C. Arguelles1, Osvaldo R. Acosta2, Pedro P.
Pérez3, Dagmara P. Díaz3, Dioslaida U. Noa3, Amalia Hernández Santana3, Hilda G. Pérez2
1Department of Pharmaceuticals, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
2Department of Chemistry and Physics, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
3Animal Facility Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
*yunier.rodriguez@cigb.edu.cu; ORCID: 0000-0001-9428-5606
ABSTRACT
Context: Interleukin (IL)-15 plays an important role in several inflammatory diseases. Previously, our group identified a
sequence 36KVTAMKCFLL45 on human IL-15 that is recognized by IL-15 receptor alpha, named P8 peptide. This peptide
inhibited the IL-15-induced proliferation in CTLL-2 cells with an IC50 of 130 µM. However, the P8 peptide is rapidly
degraded by proteases, limiting its therapeutic application.
Objective: To evaluate the effect of dimerization, D-amino acid substitutions and acetylation on the biological activity and
stability of the P8 peptide.
Methods: The biological activity of the resulting peptides was determined by a proliferation assay using CTLL-2 cells, while
their stability was studied by a degradation assay with proteolytic enzymes.
Results: The substitution of L-Ala by D-Ala ([A4a]P8 peptide) increased the inhibitory effect of P8 peptide five times.
Additionally, the [A4a]P8 peptide dimer showed the most inhibitory effect. At least a three-fold reduction in antagonist
activity of acetylated peptides was exhibited. However, the substitution of the N-terminal L-Lys residue of [A4a]P8 peptide
and its dimer by D-Lys ([K1k;A4a]P8 peptide) did not affect the antagonist effect of the aforementioned peptides. The
[K1k;A4a]P8 peptide dimer was stable to the degradation of trypsin, chymotrypsin, and pepsin up to 48 min. Also, the safety
and immunogenicity studies in BALB/c mice demonstrated that this peptide did not affect the clinical parameters of the
animals, nor generated anti-peptide antibodies.
Conclusions: Our findings reveal that two distinct D-amino acid substitutions and dimerization, but not acetylation, increase
the inhibitory effect and stability of P8 peptide.
Keywords: biological activity; CTLL-2 cells; dimer


Cuba
Obtaining a raw material from Hibiscus sabdariffa L.

(Jamaican flower) of national production for the elaboration
of natural products
Sirley González Laime1*, Claudia Chávez Hernández1, Ana M. Rodríguez Bouzas1, Juan Abreu Payrol1,
Eleanis Cabrera Torrado1, Olga A. Echemendia Arana1, Zamir Cobas Sanchéz1, Caridad M. García Peña2,
Sheyla Fernández-Puentes2, Addis Bellma Menéndez2, Marilyn López de Armas2, Consuelo González
Triana3
1Centrode Investigaciones en Plantas Proteicas y Productos Bionaturales (CIPB), Ave 5ta y 246, Complejo Barlovento, Playa, La Habana, Cuba.
2Centro de Investigación y Desarrollo de Medicamentos (CIDEM), BioCubaFarma. Ave. 26 # 1605 e/ Calzada de Puentes Grandes and
Boyeros. Plaza de la Revolución, La Habana, Cuba.
3Centro Nacional para la Producción de Animales de Laboratorio (CENPALAB). Carretera de Managua, Boyeros, La Habana, Cuba.
*sirley@bionaturasm.cu
ABSTRACT
Context: Jamaica flower (Hibiscus sabdariffa L.) is a plant native to Tropical Africa, widespread throughout the world and
introduced in Cuba. Its calyxes contain polyphenols, anthocyanins, vitamins A and C, therefore, they are of interest to the
food, pharmaceutical and cosmetic industries.
Objective: To obtain a raw material from the flower calyxes of H. sabdariffa for the elaboration of natural products of national
production.
Methods: For the study of crop management, the Guide to Good Agricultural and Collection Practices for Medicinal Plants
was used, and in the manufacturing process of the raw material, the research methodology for the development of a
phytomedicine was applied. Analytical methods for the identification and quantification of compounds were developed and
validated to determine quality specifications. Acute toxicity, microbial load, and storage stability were also evaluated.
Results: The technical guide for its cultivation as a medicinal plant was prepared. The phases of the process to obtain the new
raw material were identified, and its quality specifications were established. The dried calyxes of Hibiscus sabdariffa L.
showed low toxicity at the dose studied. They were free of microbiological contaminants and remained stable under the test
conditions.
Conclusions: The dried calyxes of Hibiscus sabdariffa L. obtained have the quality, safety, and security required to be
considered a raw material in the development of natural products.
Keywords: Hibiscus sabdariffa L.; natural product; raw material


Cuba
QSAR models for identification of selective BACE 1/BACE 2

inhibitors in Alzheimer’s disease
Yoanna M. Álvarez-Ginarte1*, Fabrice Lecrerc2, Luis A. Montero-Cabrera1
1Laboratory of Theoretical and Computational Chemistry, Faculty of Chemistry, University of Havana, 10400, La Habana, Cuba.
2Institute for Integrative Biology of the Cell (I2BC), I2BC CNRS – Univ. Paris Sud. 15 rue Gregor Mandel 91405 Orsay, France.
*yoanna@fq.uh.cu
ABSTRACT
Context: BACE-1 is an aspartate protease that is responsible for the proteolysis of amyloid precursor proteins into beta-
amyloid (Aβ), a neurotoxic peptide in patients with Alzheimer’s disease (AD). As such, BACE-1 is a prime pharmacological
target in the control of Aβ in the brain and its inhibition will be a sound approach in AD therapy.
Objective: To develop quantitative structure activity relationship (QSAR) models for identification of selective inhibitors of
BACE 1/BACE 2 proteins.
Methods: 69 molecules collected from different sources has been assembled. This dataset contains diverse compounds with
different physical-chemical properties. The alvaDesc 2.0.6 software was used for estimating the molecular descriptors.
Results: QSAR model for BACE 1 estimated that molecules with low value of frequency C-C at topological distance 3 and
high values of molar refractivity, topological polar surface area, octanol-water partition coefficient, and a lead-like score
drug-like indices showed a positive contribution in the inhibitors activity. However, the QSAR model for the BACE 2
estimated that molecules with low value of sum of conventional bond orders and Quantitative Estimation of Drug-likeness
and high values of distance/detour ring index, DRAGON consensus drug-like score, and modified lead-like score also
increased the BACE 2 potency.
Conclusions: Selective BACE 1 and BACE 2 inhibitors potency for a list of modified nucleotides implemented in the
CHARMM36 force field was estimated by the QSAR models and three modified nucleotides were identified as lead. This
work will provide a theoretical basis for the molecular design of anti-Alzheimer drugs.
Keywords: Alzheimer; BACE 1; BACE 2; genetic algorithm; QSAR; molecular descriptors


Cuba
Covalent modifications of Cm-p5, a peptide derived from

marine mollusk, a path towards the development of new
pharmacologically viable AMPs
Fidel E. Morales Vicente1*, Melaine González García2, Frank Rosenau3, Hilda Garay1, Ludger Ständker4,
Anselmo J. Otero-González2
1Synthetic Peptides Group, Center for Genetic Engineering and Biotechnology, La Havana 10600, Cuba, P.O. Box 6162, La Habana 10600,
Cuba.
2Center for Protein Studies, Faculty of Biology, University of Havana, 25 and I, 10400 La Habana, Cuba.
3Institute of Pharmaceutical Biotechnology, Ulm University, James-Frank-Ring N27, 89081 Ulm, Germany.
4Core Facility for Functional Peptidomics, Ulm Peptide Pharmaceuticals (U-PEP), University Ulm, Faculty of Medicine, Ulm University, 89081
Ulm, Germany.
*fmorales@cigb.edu.cu; femvicente@gmail.com
ABSTRACT
Context: Sea and freshwater mollusks are promising organisms for the identification of AMPs given that their immune
system mainly relies on the innate response. However, classical AMPs have rapid proteolytic degradation, low activity
compared to traditional antibiotics, high sensitivity to ionic environment, and significant toxicity (especially hemolytic
effect). Cm-p5, a peptide derived from the marine mollusk Cenchritis muricatus, has a significant fungistatic activity against
pathogenic Candida albicans, while exhibiting low toxic effects against cultured mammalian cell lines. However, in a systemic
candidiasis model in mice, intraperitoneal administration of Cm-p5 was unable to control the fungal kidney burden,
probably due to its low metabolic stability.
Objectives: To design a disulfide bridged cyclic analogue of Cm-p5 with improved pharmacological properties.
Methods: Solid phase peptide synthesis, cyclization, and covalent modifications were applied.
Results: Cyclic analogue of Cm-p5showed twice the anti-candida activity. Also, parallel and antiparallel dimers of Cm-p5
showed a moderate activity against Pseudomonas aeruginosa PA14. The three Cm-p5 derivatives inhibited a virulent
extracellular strain of Mycobacterium tuberculosis, in a dose-dependent manner. Moreover, they inhibited HSV-2 infection in a
concentration-dependent manner, but had no effect on infection by the ZIKV or pseudo-particles SARS-CoV-2. Only at
concentrations far superior to the therapeutic windows, the three new Cm-p5 derivatives showed toxicity on some
eukaryotic cells tested. Remarkably, these novel analogues are potent biofilm inhibitors of the super bug C. auris.
Conclusions: The covalent modification by disulfide bridge cyclization/dimerization increases antifungal, antibacterial,
antiviral, and anti-biofilm activities of Cm-p5, together with an increase in metabolic stability.
Keywords: Candida auris; cyclization; dimerization; disulfide bridge; peptide


Cuba
Regulatory framework of traditional and complementary

medicine. Focus on Cuba
Diadelis Remírez
National Centre of the State Quality Control of Drugs, Equipment and Medical Devices. (CECMED), Havana, Cuba.
diadelis@cecmed.cu
ABSTRACT
Context: In the last decade, there has been a global upsurge in the use of traditional medicine and complementary and
alternative medicine in both developed and developing countries. This is one of the main reasons for reinforcing the
surveillance of the safety, efficacy and quality control of traditional medicine and complementary and alternative medicine.
Objective: To describe the WHO strategy for the development of herbal medicinal products, as well as the global status of the
regulations, use of pharmacopeias, categories given to herbal medicines from WHO members, and other important aspects
related to the rational use of complementary medicine.
Methods: To explain the Cuban Regulatory Framework on the above-mentioned topic and to discuss about some important
considerations for investigation focused on marketing authorization of natural products.
Results: Herbal medicines take special consideration at this moment due to their properties.
Conclusion: Drug regulatory authorities should ensure the quality, safety, and efficacy of traditional medicines.
Keywords: Cuba; herbal medicines; regulations


Cuba
Thalassia testudinum, the most abundant angiosperm in the

Caribbean Sea, a look at its anticancer properties under
sustainable bases
Idania Rodeiro Guerra1*, Ivones Hernández Balmaseda1, José A. Herrera Isidrón2, Ilianet Céspedes1, Kethia
González1, Miguel D. Fernández Pérez1, Wim Vanden Berghe3
1Departamento de Farmacología, Instituto de Ciencias del Mar, Plaza de la Revolución, La Habana, Cuba.
2Laboratory of Protein Science, Proteomics and Epigenetic Signaling (PPES), Department of Biomedical Sciences, University of Antwerp,
Antwerp, Belgium.
3Instituto de Ciencia y Tecnología de Materiales, Universidad de la Habana, Plaza de la Revolución, La Habana, Cuba.
*idania.rodeiro@infomed.sld.cu; ORCID: 0000-0002-2692-6050
ABSTRACT
Context: Sea represents a promising source of bioactive compounds. To date, the ability of marine organisms to synthesize
molecules with sui generis pharmacological effects is well recognized.
Objective: To evaluate the anticancer activity of an extract obtained from the angiosperm T. testudinum.
Methods: An evaluation of the effects of the extract and its derivative on non-tumor and cancer cell lines was carried out
using MTT, multi-parametric, crystal violet and comet assays. Cell apoptosis induction was detected by flow cytometry in
HCT15 cells at 48 h using Annexin V-FITC/propidium iodide. Intracellular reactive oxygen species (ROS) generation and
cleaved caspase-3 were measured. The antitumor activity of the T. testudinum extract-polyphenolic fraction (PF) (25 mg/kg)
was also evaluated in a xenograft model in nu/nu mice.
Results: T. testudinum extract exhibited selective cytotoxicity against cancer cells compared to normal cells. High content
screening multi-parametric assay indicated that the extract (up to 100 μg/mL) is able to induce cell death through a
mechanism associated with oxidative stress, DNA damage and hypercalcaemia after 24 h of exposure of HepG2 cells. Comet
assay permitted corroborate that T. testudinum extract induces DNA primary damage in this cell line. On the other hand, PF
or thalassiolin B, the main components, exerted cytotoxicity in colorectal cancer cell and induced apoptosis in HCT15 cells.
The products induced a significant increase of ROS generation, a depletion of sulfhydryl concentration, and an increase in
caspase-3 expression in these cells. PF arrested tumor growth and induced apoptosis in the xenograft mice model.
Conclusions: The results showed the cytotoxic activity of the T. testudinum extract and its derivative associated with the
generation of ROS and pro-apoptotic effects. Altogether, the toxicological studies conducted support an adequate safety
margin. The data is evidence of the beneficial uses of a marine organism and support the bases to develop, under scientific
criteria, a new candidate with therapeutic application.
Keywords: antitumor effects; marine biodiversity; Thalassia testudinum


Cuba
Effects of suspension-Abexol®, tablet-Abexol and active

ingredient-Abexol on ethanol induced-gastric ulcer in rats
Giselle Breña*, Zullyt Zamora-Rodríguez, Ambar Oyarzábal, María F. Pérez, Roxana Vicente, Victor
González, Vivian Molina
Centre of Natural Products, National Centre for Scientific Research, Havana, Cuba.
*giselle.brena@cnic.cu; ORCID: 0000-0002-2751-1420
ABSTRACT
Context: Abexol® is the trade name for the mixture of six high molecular weight primary aliphatic alcohols, isolated and
purified from beeswax. Abexol® is registered in Cuba in tablet form (50 mg) as an antioxidant nutritional supplement. It
exerts gastroprotective effects demonstrated in preclinical and clinical studies.
Objective: To evaluate the effects of a new pharmaceutical formulation, suspension-Abexol, compared to tablet-Abexol and
active ingredient-Abexol on ethanol-induced gastric ulcer in rats.
Methods: The animals were distributed in nine groups: a control without damage and eight groups in which the ulcer was
induced by ethanol: a positive control (with damage), six treated with active ingredient-Abexol, tablet-Abexol and
suspension-Abexol, respectively, at doses of 25 and 200 mg/kg, and one treated with omeprazole (20 mg/kg: reference
substance).
Results: All treatments significantly reduced the ulcer index with respect to the positive control, although suspension-Abexol
produced the greatest reduction. No differences were observed between them in the content of mucus, malondialdehyde
and total proteins in the gastric mucosa.
Conclusions: Suspension-Abexol exerts an effect superior to that of tablets-Abexol and active ingredient-Abexol, at the same
doses, on gastric ulcer induced by ethanol in rats.
Keywords: Abexol®; ethanol-induced ulcer; gastroprotective effects


Cuba
Clinical applications of the natural product curmeric during

the COVID-19 pandemic in Cuba
Tania Valdés-González1,2*
1Center for Technological Applications and Nuclear Development (CEADEN), 5th Ave and 30 street. Miramar. Playa. La Habana Cuba.
2Theragnostic Laboratory, University Hospital General Calixto García. University Ave. And G Street. Vedado. La Habana Cuba.
*taniavaldes@infomed.sld.cu; ORCID: 0000-0001-8526-1266
ABSTRACT
Context: Curmeric is a natural product that contains Curcuma longa extracts. It was used during COVID-19 epidemic in Cuba.
Objective: To investigate the anti-coronavirus and antibacterial effect of curmeric in preclinical studies.
Methods: Curmeric was evaluated in clinical studies for COVID-19 transmission prevention in healthcare workers and in
Primary Healthcare (APS) in lockdown areas with high COVID-19 transmission in Havana. The effect of curmeric on
relieving the symptoms in COVID-19 patients was evaluated at the Hospital Dr. Luis Diaz Soto. Curmeric was also used for
health interventions during the epidemic in Ciego de Avila and Granma provinces.
Results: COVID-19 transmission prevention studies with curmeric in healthcare workers (n = 400) showed significant
differences in COVID-19 positive cases between the study group and the control group. Also, the clinical studies on APS (n =
615) and health interventions (n = 40 000) indicated that curmeric is safe and capable of preventing the disease transmission.
COVID-19 positive patients who used curmeric had an in-hospital stay approximately 4 days shorter than the ones who did
not use it. Moreover, curmeric contributed to improve immunological parameters, including SARS-CoV-2 inhibition percent.
In addition, these patients showed a significative lower symptomatology at the end of the study.
Conclusions: Curmeric showed COVID-19 preventive effects and therapeutic properties as a complement for the COVID-19
treatment therapies. Curmeric has been included in the post-COVID-19 patient rehabilitation protocol of Havana and in the
Basic List of Natural Products in Cuba. Currently, curmeric is produced by Medilip, Biocubafarma, in collaboration with
FARMAHABANA and CEADEN.
Keywords: clinical studies; COVID-19; Curcuma longa; curmeric; natural products


Cuba
Development of an analytical method by HPLC to

determine the composition of apitoxin and related products
Catherine Fagúndez*, Valentina Rodríguez
Pharmacy of Veterinary Hospital Center, Department of Clinic and Veterinary Hospital, Faculty of Veterinary Medicine, UdelaR, Montevideo,
Uruguay.
*cfagundez19@gmail.com; 0000-0002-7315-1438
ABSTRACT
Context: The therapeutic and cosmetic benefits of apitoxin are widely known. On the market, a wide variety of products with
this mixture as an active ingredient can be found in a homeopathic form. This is a planting product for worker and queen
bees, widely in demand and well valued. As it is a mixture of biosynthetic compounds, its composition will depend on the
metabolism of the beetherefore, and the different biological and ecosystem in which the bee live. This work approaches the
regularization of this product in Uruguay, where it does not exist to date, in order to obtain products with the necessary
quality for export, considering the import requirements of the purchasing countries.
Objective: To develop and validate an analytical method to quali-quantify apitoxin and formulations based on this active
principle, preserving good resolution between the peaks referred to the main components of apitoxin, such as melittin,
phospholipase A2 and apamin.
Methods: High Resolution Liquid Chromatography (HPLC) was used.
Results: A method with a final time of 24 minutes was successfully developed and validated, with good resolution between
the main components of the mixture.
Conclusions: An analytical method was developed and validated by HPLC for the determination of the qualitative and
quantitative composition of apitoxin and products derived from it.
Keywords: analytical method; bee venom; composition; validation


Cuba
QSAR properties of conventional antiparasite drugs based

on Lipinski’s rule of five
Adiel González1*, Lars Gille2, Lianet Monzote1
1Parasitology Department, Institute of Tropical Medicine “Pedro Kouri”, Havana City, Cuba.
2Institute of Pharmacology and Toxicology, Department of Biomedical Sciences, University of Veterinary Medicine, Vienna, Austria.
*adiel@ipk.sld.cu
ABSTRACT
Context: Infections caused by protozoan and helminthic parasites are responsible for significant morbidity and mortality in
both tropical and subtropical regions. In the drug discovery process of antiparasitic drugs, a number of generic criteria have
been identified, which include the quantitative structure activity relationship (QSAR) properties that could predict an oral
therapy. According to them, an ideal molecule would comply with Lipinski’s rule of five (RO5).
Objective: To develop a QSAR model based on the physicochemical properties of antiparasitic drugs for clinical use against
the main parasitic protozoa and helminthic.
Methods: A total of 57 compounds were included: 44 for protozoan parasites, 12 for helminthic parasites and 1 indicated in
the treatment of both types of parasitesResults: The first analysis showed that from 57 antiparasitics 80.7% (n = 46) comply
with Lipinski’s rule, while amphotericin B and suramin fail in 3 rules. The second analysis displayed that among diseases,
the most critical compounds that did not meet RO5 are being used against leishmaniasis. Finally, although most of
antiparasitic drugs are administered by oral route, some of these compounds fail in one or two QSAR parameters; while
compounds that are administered by parenteral route fail up to 3 rules.
Conclusion: We suggest that the development of antiparasitic drugs that showed pharmacological potential should not be
deprioritized if QSAR parameters are outside from desirable range, in particular against leishmaniasis.
Keywords: antiparasite; leishmaniasis; QSAR properties; rule of five


Cuba
Comparison of chemical composition of the extracts of

leaves from Clusia minor L.
Raisa Mangas Marín1*, Rodny Montes de Oca2, Lorena Moreno1, José C. Leyva1
1Department of Pharmacy, Institute of Pharmacy and Food (IFAL), University of Havana, La Coronela, La Lisa, Havana, Cuba.
2Antidoping Laboratory, Boyeros, Havana, Cuba.
*raisam@ifal.uh.cu; ORCID: 0000-0003-0883-8257
ABSTRACT
Context: Clusia minor L., a wild bush that is usually found in the forests of western Cuba, is used in traditional medicine to
treat warts and sores. However, there are relatively few reports about the phytochemical and pharmacological
characterizations of C. minor.
Objective: To compare the chemical composition of different extracts of the leaves from Clusia minor L.
Methods: Four extracts (A, B, C, E) were obtained from the dried and ground leaves of the species by maceration using
solvents in increasing order of polarity (hexane, ethyl acetate and methanol) and by direct extraction with ethanol,
respectively. The content of phenols and total flavonoids was determined using the Folin-Ciocalteu and spectrophotometric
methods with aluminum chloride, respectively. Phytochemical characterization was performed by Gas
Chromatography/Mass Spectrometry.
Results: The quantification of total phenols and flavonoids in the leaves of this species allowed to identify their presence in
extracts B, C and E. Extract E and B showed the major content of phenols and flavonoids, respectively. Mass spectrometry
analysis allowed the identification of 57 new compounds for the species and 33 of them for the genus. In extract A,
sesquiterpenes predominated; in extracts B and E, carboxilic acids and derivates; and in extract C, long-chain alkanes.
Vitamin E, β-sitosterol and friedelin were present in all extracts.
Conclusions: The analysis evidenced a great qualitative and quantitative diversity, prevailing hydrocarbons and terpenes.
The increase in polarity favored the extraction of hydrocarbons and aromatic compounds and the decrease in
sesquiterpenes, suggesting a satisfactory extraction process.
Keywords: Clusia minor L.; flavonoids; GC/MS analysis; hydrocarbons; phenols; terpenes


Cuba
Alternative synthesis of a 3,4-dibenzoilated fucose donor

Hilda M. Alarcón Ríos*, Blanca I. Tolón Murguía, Miguel A. López López, Yaneisy Yú Pérez, Dianeisy
Cabrera Cuello, Yanet González Díaz
Finlay Institute of Vaccines, Havana, Cuba.
*hmaria9712@gmail.com
ABSTRACT
Context: Cancer is one of the main causes of death worldwide today due to the rapid adaptation and spread of tumor cells, so
it is imperative to have new drugs for the effective treatment of this pathology, among which are therapeutic vaccines. In
this sense, the Lewis y (Ley) antigen has been shown to be a potential candidate, since it has the special characteristic of being
overexpressed on the surface of tumor cells. The key synthetic challenge in the Ley synthesis is thedifucosylation of N-acetyl
lactosamine derivatives. Although different L-fucose donors have been previously used, the phenyl 3,4-di-O-benzoyl-2-O-
benzyl-1-thio-β-L-fucopyranoside has not been used before with this purpose.
Objectives: To obtain the necessary amounts of phenyl 3,4-di-O-benzoyl-2-O-benzyl-1-thio-β-L-fucopyranoside from L-fucose
trhough an efficient procedure to evaluate the stereoselectivity and yields during the difucosylation of N-acetyl lactosamine
derivatives.
Methods: The synthetic sequence used was as follows: L-fucose per-O-acetylation and glycosylation with thiophenol
following a one-pot method, deacetylation of the per-O-acetylated thioglycoside obtained, 3 and 4 hydroxyl protection with
the benzylidene acetal group, 2-hydroxyl benzylation, benzylidene protective group cleavage and free hydroxyls
benzoylation.
Results: The steps of the synthesis sequence led to a global yield of 64% of the phenyl 3,4-di-O-benzoyl-2-O-benzyl-1-thio-β-
L-fucopyranoside, almost two times higher than that obtained with the method described in the literature.
Conclusions: Through this procedure was possible to obtain phenyl 3,4-di-O-benzoyl-2-O-benzyl-1-thio-β-L-fucopyranoside
efficiently.
Keywords: L-fucose; Lewis Y; synthesis; therapeutic vaccines; tiophenyl glycoside


Cuba
Biological evaluation of aqueous propolis extract obtained

by different extraction methods
Dailen Guanche Gallardos*
Department of Science and Technological Innovation, Beekeeping Research Center. Road from El Cano to Chico, Arroyo Arenas, La Lisa,
Postal Code 19190, Havana City, Cuba.
*investigadora@ciapi.minag.cu, dggallardo@nauta.cu; ORCID: 0000-0002-7178-1807
ABSTRACT
Context: Propolis has antioxidant and antibacterial properties. The hydroalcoholic extract has usually been used because the
biological active substances of propolis are easily soluble in ethanol; however, it has disadvantages as the intolerance of
some people to alcohol and its strong taste that make it difficult to be used. Nevertheless, the aqueous propolis extract could
overcome these difficulties since it has shown antioxidant and antibacterial activities.
Objectives: To compare the aqueous propolis extracts obtained by different extraction procedure through the phenol and
flavonoid content and the biological activities.
Methods: Five methods of extraction were used: maceration with water, with water:ethanol (70:30), with water:ethanol (30:
70) but evaporation of ethanol and redissolved in water, ultrasonic and soxhlet distillation. The content of dry matter, total
phenol and flavonoid, antioxidant and antibacterial activity, and a thin layer chromatography analysis were also conducted.
Results: The extracts obtained by maceration with water:ethanol (70:30) presented the highest values of dry matter, total
flavonoids and phenols and antibacterial activity. The antioxidant activities did not show differences. The antioxidant
properties were not related to the phenolic or flavonoid content. The antibacterial property did show a relationship with the
phenol content. The thin layer chromatography did not show any bands in hydroalcoholic extract at 366 nm, but they were
visible in the different aqueous extracts.
Conclusions: The different aqueous propolis extract presented differences in their composition. The antioxidant activity of the
extracts depends, to a large extent, on the presence of oxidizable groups and not on the content of phenols and flavonoid.
Keywords: antibacterial; antioxidant; phenols propolis


Cuba
Evaluation of the quality of the apitoxin of Apis mellifera in

apiaries located in the west, center, and east of Cuba
Zonia Martínez Benitez1*, Catherine Fagundez Olivencia2, Edison E. Nogueira Roballo3, Nelson León
Concepción4
1Institute of Pharmacy and Food. University of Havana, Havana, Cuba.
2VeterinaryHospital Center, Department of Clinic and Veterinary Hospital, Faculty of Veterinary Medicine, University of the Republic,
Montevideo, Oriental Republic of Uruguay.
3Department of Animal Production, Faculty of Veterinary Medicine. University of the Republic, Montevideo, Oriental Republic of Uruguay.
4UEB Beekeeping Company Villa Clara, Cuba.
*zoniamb@ifal.uh.cu; ORCID: 0000-0002-5810-9549
ABSTRACT
Context: The use of apitoxin or bee venom has been promoted as a therapeutic alternative and in the development of drugs
given its properties for the treatment of various diseases such as traumatic inflammation, rheumatism, osteoarthritis,
rheumatoid arthritis, lumbar and trigeminal neuralgia, sclerosis multiple, radiculitis, as well as its antiviral and anticancer
properties. The quantity and quality of the apitoxin obtained varies significantly according to the climate, the state of health
of the hive, the collecting apparatus, and the extraction technique. Apitoxin is composed of at least 18 compounds with
pharmacological activity, including enzymes, peptides and biogenic amines. Melittin, phospholipase A2 and apamin are the
three main and most studied components of bee venom, responsible for most of the pharmacological effects.
Objectives: To evaluate the quality of apitoxin in five samples from the regions of Artemisa, Villa Clara, Cienfuegos, Sancti
Spiritus, and Camagüey.
Methods: The samples were obtained in a solid state and extracted by electrostimulation. The quantification of the main
components of the apitoxin was performed by HPLC. The determination of total proteins was carried out by the coomassie
method, a result used for the determination of phospholipase A2 activity by spontaneous hydrolysis.
Results: Apamin (1-2%) and melittin (> 50%) values were obtained. The total protein concentration resulted in values above
20 mg/mL for the five samples analyzed. Values greater than 130 IU/mg of phospholipase A2 were found.
Conclusions: It was concluded that the analyzed samples are within the internationally accepted standards, so they comply in
principle with the conditions of use within the pharmaceutical industry. On the other hand, a similarity was corroborated in
terms of the quality of the apitoxin in the five samples analyzed independently where the apiary is located.
Keywords: apamin; apitoxin; bee venom; melittin; phospholipase A2


Cuba
Pharmacognostic study, antioxidant and wound healing

activity of the hydroalcoholic extract of Guarea guidonia
Ramón Scull Lizama1*, Ezequiel Jiménez Laborí1, Yamilet I. Gutiérrez Gaitén1, Alejandro Felipe González1,
Regla M. Casanova Orta2
2Center for Research and Biological Evaluations, Institute of Pharmaceutical and Food Sciences, University of Havana, Havana, Cuba.
*rscull@ifal.uh.cu; ORCID: 0000-0001-6401-221X
ABSTRACT
Context: Guarea guidonia L. Sleumer (Meliaceae) is commonly known as yamagua in Cuba. Traditionally, it is used as an
expectorant, in wound healing, in hematuria and hemorrhage. However, scientific studies related to the plant are limited.
Objective: To determine the pharmacognostic parameters, antioxidant and wound healing activity of the hydroalcoholic
extract of the stems of G. guidonia.
Methods: The quality parameters of the crude drug were determined according to the WHO guidelines for vegetal drugs. An
extract was made by maceration using a 50% hydroalcoholic mixture as solvent. Its quality parameters were measured and
the phytochemical profile was estimated by ultraviolet spectroscopy, thin layer chromatography and spectrophotometric
methods. Finally, antioxidant tests were carried out using the FRAP and DPPH techniques, while the healing activity of the
extract was evaluated at a dose of 200 mg/kg using the excision wound model on the back of the rat.
Results: The pharmacognostic study allowed establishing the main physicochemical quality parameters of the crude drug
and its hydroalcoholic extract. The presence of several phytochemicals was suggested, including phenolic compounds and
the flavonoid quercetin. The extract showed antioxidant activity by the two methods assessed in vitro and it was able to
reduce the size of the wounds on the back of the rats during seven days, with a healing effect comparable to the silver
sulfadiazine, used as a reference drug.
Conclusions: The results obtained provide the first findings on the demonstration of the antioxidant and healing effect of G.
guidonia, which contributes to justify its traditional use.
Keywords: chromatography; DPPH; FRAPP; phenols; spectroscopy; wound healing


Cuba
Pharmacognostic study and hemostatic activity of the

hydroalcoholic extract of Trasdescantia spathacea
Yamilet I. Gutiérrez Gaitén1*, Dayana Bocourt Apan2, Ramón Scull Lizama1, Alejandro Felipe González1,
Regla M. Casanova Orta3, Kenn Foubert4, Luc Pieters4
2Center for Research and Biological Evaluations, Institute of Pharmaceutical and Food Sciences, University of Havana, Havana, Cuba.
3Pharmaceutical Marketing and Distribution Company, Havana, Cuba.
4Natural Products & Food Research and Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Antwerp,
Belgium.
*yamiletgg@ifal.uh.cu; ORCID: 0000-0002-8885-4849
ABSTRACT
Context: Trasdescantia spathacea is traditionally used to treat coughs, vomiting of blood, burns, dysentery, fever, bronchitis,
and psoriasis. The specie is characterized by the presence of phenolic acids, flavonoids and tannins. So far, the antioxidant,
anticancer, antimicrobial, and immunomodulator activities have been reported; however, the hemostatic activity is not
explored yet.
Objectives: To determine the pharmacognostic parameters and the hemostatic activity of the hydroalcoholic extract of the
leaves of T. spathacea.
Methods: Macroscopic and microscopic characteristics, ashes, moisture content, and extractable substances were determined
for quality control of the drug. The hydroalcoholic extract was obtained by maceration with ethanol 30% and it was
characterized by its physico-chemical parameters, phytochemical screening and HPLC/DAD profile. Total phenols and
flavonoids were quantified by the Folin-Ciocalteu and aluminum chloride methods, respectively. Hemostatic activity was
evaluated through the bleeding model in the rat’s leg.
Results: The morphological characteristics of the drugs were described and the physico-chemical parameters were into the
limits established by the Chinese Pharmacopeia. The highest values of extractable substances were obtained with ethanol
30%. Phenolic acids and flavonoids were the majoritarian compounds according to the phytochemical screening and
HPLC/DAD profile. Catechin and epigallocatechin gallate were identified in the extract. The hydroalcoholic extract showed
hemostatic activity with a decrease in bleeding time and the amount of blood expelled was similar to that caused by
phytomenadione.
Conclusions: The results provide the first findings on the hemostatic effects of T. spathacea. In the pharmacognostic study,
phenolic compounds were the main metabolites found in the extract.
Keywords: Catechin; chromatography; epigallocatechin gallate; phenolic compounds; morphology


Cuba
Phytochemical study and antilithiatic activity of the

aqueous extract of the leaves of Urera baccifera
Ana C. Noa Rodríguez1*, Alejandro Felipe González2, Yamilet I. Gutiérrez Gaitén2, Ramón Scull Lizama2,
Carlos R. Núñez Cairo3
2Departmentof Pharmacy, Institute of Pharmaceutical and Food Sciences, University of Havana, Havana, Cuba.
3Department of Physiology, Institute of Basic and Preclinical Sciences “Victoria de Girón”, Havana, Cuba.
*anac941209@gmail.com; ORCID: 0000-0003-2857-1385
ABSTRACT
Context: Urera baccifera, also known as chichicate, is a wild shrub native of America that is present in all the provinces of
Cuba. The aqueous extract of its roots is used in traditional medicine for the treatment of renal lithiasis. In contrast with
traditional medicine, previous studies suggest that the leaves offer better results in pharmacognostic and pharmacological
analysis. Therefore, in the present work, the leaves were analyzed.
Objective: To determine the chemical composition and antilithiatic activity of the aqueous extract of the leaves of U. baccifera.
Methods: Phytochemical composition of the extract was determined by phytochemical screening, TLC, HPLC/UV profile,
and GC/MS. Phenols and flavonoids were quantified according to Folin-Ciocalteu and aluminum chloride methods,
respectively. The antilithiatic activity was determined by the ethylene glycol induced-lithiasis method.
Results: The phytochemical screening, TLC and HPLC/UV profiles showed a predominant content of flavonoids and
phenols in the aqueous extract. Four compounds were identified by GC-MS: 2,2,5-trimethylhexane-3,4-dione, 8-
methyldecanoic acid (methyl ester), oxalic acid, and 1-undecyne. Among them, only oxalic acid had been previously
reported in this specie. The absence of crystal oxalate in the renal tissue after the administration of the extract and the
reduction of calcium in the urine demonstrated the antilithiatic activity of the extract, which can be associated with its
diuretic and antilithiatic activity.
Conclusions: The results of this research demonstrated for the first time the traditional usage of the aqueous extract of U.
baccifera as an antilithiatic drug.
Keywords: antioxidant; chromatography; diuretic; flavonoids; mass spectrometry; phenols


Cuba
Elaboration of antipsoriatic ointment at 15% with soft

extract of Alternanthera sessilis L. R. Br
Eva Salas Olivet1*, Armando Cuéllar Cuéllar1, Wilma García Garay2, Roxana García Cortes3
1Pharmacy Department, Institute of Food and Pharmacy, University of Havana., Cuba.
2Placental Histotherapy Center, Havana, Cuba.
3.ECTI ¨Sierra Maestra¨.
*evaso@ifal.uh.cu; ORCID: 0000-0002-5651-193X
ABSTRACT
Context: Alternanthera sessilis L. R. Br is a creeping plant of the Amarantaceae family, known as bella Maria, abrojo, yerba de
pollo, among others. It is traditionally used for gastrointestinal conditions, as an astringent, diuretic, in urticaria and is
abortifacient; however, scientific information about the plant is scarce.
Objective: To evaluate hydroalcoholic extracts of the species from a pharmacognostic and chemical-pharmaceutical point of
view.
Methods: Hydroalcoholic extracts at 30%, 60% and 85% were prepared by maceration and percolation. The physical-chemical
quality parameters were determined and the composition was analyzed by phytochemical screening and UV and IR
spectroscopy. An ointment was designed using the 30% hydroalcoholic extract as the active ingredient and the antipsoriatic
property was determined in an experimental murine model using Coriodermina as the reference drug.
Results: The pharmacognostic study allowed to establish some quality parameters of the extracts. The phytochemical study
suggested the presence of phenolic compounds, flavonoids, saponins, carotenoids, anthocyanidins, amino acids, alkaloids,
among others. The designed ointment showed evidence of quality and was accepted for the attributes of smell, color,
appearance and homogeneity; it was also able to reduce the psoriatic lesion during the 15 days of the test, with a
regenerative effect of the epidermis comparable to that exerted by Coriodermina.
Conclusions: The research achieved an important contribution to the elucidation of the chemical composition of the plant and
provided the first findings on its efficacy as a topical antipsoriatic treatment, which allows to justify the use of A. sessilis as a
traditional Cuban medicine.
Keywords: Alternanthera sessilis; antipsoriatic effect; ointment; pharmacognosy; phytochemistry


Cuba
Prediction of antihistamine activity using Quantitative

Structure Activity Relationships methods
Melissa Gil Delgado*, Luis A. Torres Gómez, Ivón González Blanco
Institute of Pharmacy and Foods. University of Havana, Havana, Cuba.
*mgildelgado17@gmail.com
ABSTRACT
Context: Antihistamines are responsible for blocking histamine receptors, thus reducing the effects of this amine on the body.
However, the experimental classification of these compounds is accompanied by several limitations such as the high time
invested and the consumption of large amounts of resources. Quantitative Structure Activity Relationships methods reduce
the cost and time spent discovering new drugs.
Objective: To analyze by a topological substructural molecular design (TOPS-MODE) approach the antihistamine activity of a
number of compounds reported in the literature for the identification of new therapeutic candidates.
Methods: The calculation of the spectral moments of the adjacency matrix between edges of the molecular graph with
different parameters that characterize the molecular structures of ninety active and two hundred and fifty inactive
compounds was carried out using MODESLAB software. Ninety-one molecular descriptors related to the activity of these
drugs were calculated.
Results: The functions obtained exhibited a Wilks’ lambda value of 0.421 and a high canonical correlation of 0.835, which
showed its discriminating power.
Conclusions: The model obtained is effective in the prediction of antihistamine activity.
Keywords: Antihistamines; biological activity; molecular descriptors; TOPS-MODE; MODESLAB


Cuba
Multicomponent synthesis of analogues of the inhibitor

keto-ACE
Gerardo M. Ojeda-Carralero1,2*, Javier E. Alfonso-Ramos3, Julio Caballero4, Erik Van der Eycken2,5
1Department of General and Inorganic Chemistry, Faculty of Chemistry, University of Havana, Zapata y G, 10400 Havana, Cuba.
2Laboratory for Organic & Microwave-Assisted Chemistry (LOMAC), Department of Chemistry, KU Leuven, Celestijnenlaan 200F Leuven
Chem&Tech, box 2404, 3001 Leuven, Belgium.
3Laboratory of Computational and Theoretical Chemistry (LQCT), Faculty of Chemistry, University of Havana, Zapata y G, 10400 Havana,
Cuba.
4Centro de Bioinformática y Simulación Molecular (CBSM), Universidad de Talca, 1 Poniente No. 1141, Casilla 721, Talca 3460000, Chile.
5Peoples’ Friendship University of Russia (RUDN University), Miklukho-Maklaya Street 6, 117198 Moscow, Russia.
*gmanuel@fq.uh.cu, gmojedac@gmail.com
ABSTRACT
Context: Angiotensin I Converting Enzyme (ACE-I) plays a central role in the renin-angiotensin system for the control of
blood pressure in the human being. ACE-I degrades the vasodilator bradykinin and converts angiotensin I peptide in
angiotensin II, a potent vasoconstrictor. Therefore, ACE inhibitors such as captopril and lisinopril have been used for the
treatment of high blood pressure (hypertension), unfortunately, with several side effects. Nowadays, researchers focus in the
quest for safer inhibitors with enhanced selectivity towards a specific catalytic domain.
Objective: To synthesizes novel analogues of the C-domain selective inhibitor keto-ACE.
Methods: The Ugi four component reaction was used.
Results: The new synthetic methodology was simple, scalable and allowed to generate structural diversity fast and in high
yields. By changing the isonitrile, carboxylic acid and amine components of the reaction in a combinatorial fashion, a small
library of compounds was prepared. A preliminary molecular docking study of the product structures suggested that they
conserve the ligand-protein interactions usually encountered in complexes of the current marketed inhibitors.
Conclusion: 1H Nuclear Magnetic Resonance experiments and conformational search demonstrated the high flexibility of the
ligand backbone, which strongly influences the binding capability. Further biological experiments will be conducted to
assess the inhibitory activity of the obtained compounds.
Keywords: Angiotensin Converting Enzyme I; C-domain selectivity; conformational search; docking; enzyme inhibitors;
multicomponent reaction; peptoids; Ugi reaction


Cuba
Lewis Y: Efficiency of glycosylation from 2 fucose donors

Yaneisy Yú Pérez*, Blanca I. Tolón Murguía, Miguel A. López López, Hilda M. Alarcón Ríos, Dianeisy
Cabrera Cuello, Yanet González Díaz
Finlay Vaccine Institute, Havana, Cuba.
*yaneyu@finlay.edu.cu
ABSTRACT
Context: Nowadays, the search for efficient synthetic strategies for obtaining tumor-associated carbohydrate antigens is of
great importance in the success of the design and composition of cancer vaccines.
Objective: To obtain the antigenic determinant Lewis Y (Ley) through the difucosylation of the lactosamine acceptor using
two fucose donors.
Methods: The synthesis of this compound was carried out using two fundamental steps. The first step consisted in obtaining
the lactosamine acceptor from the glucosamine acceptor and the galactose donor. For the second stage, two Le y
tetrasaccharides were obtained by difucosylation of the lactosamine acceptor with two L-fucose donors of the thioglycoside
type.
Results: The stages of the synthesis sequence led to a global yield of 72% considering the number of stages involved, as well
as its high complexity.
Conclusions: The synthetic strategy based on difucosylation turned out to be an efficient procedure, which was verified by
obtaining two new protected Ley tetrasaccharides. The best result was obtained from the perbenzylated thioglycoside donor.
Keywords: antigenic determinant; difucosylation; donors of the thioglycoside type L-fucose; galactose donor; glucosamine
acceptor; glycosylation reactions; lactosamine acceptor; Lewis Y


Cuba
New challenges in the evaluation of quality, safety and

efficacy of homeopathic drugs
Fabien Pelaez Cuesta*, Yamira Suárez Pérez, Diadelis Remírez, Niovis Ceballos
National Centre for State Quality Control of Drugs and Medical Devices. (CECMED), Havana, Cuba.
*fabiennecuesta09@gmail.com
ABSTRACT
Context: Nowadays, homeopathy has evolved, becoming a millionaire industry. It was officially recognized in Cuba in 1992
and in 2011 Regulation No. 53 on the requirements for the sanitary registration of homeopathic medicines for human use
was approved.
Objective: To evaluate the current regulatory framework for the registration of homeopathic medicines in Cuba and to
compare the requirements for the health registration of homeopathic medicines in Cuba with other recognized regulatory
agencies.
Methods: The regulatory framework for the Sanitary Registry of Homeopathic Medicines in Cuba, recognized national
regulatory authorities, and WHO recommendations were analyzed. Medicines registered from 2011 to 2022 were
characterized using relevant indicators. The information was summarized in a database created in Excel, a program used for
the interpretation and analysis of the data.
Results: 44 homeopathic medicines were registered in Cuba. 100% of the summary of product characteristics (SMP) were
issued and a recommended use was established instead of indications in correspondence with the requirements for the
registration of recognized National Regulatory Agencies. Once the registered homeopathic medicines were characterized, it
was found that the current regulation should incorporate aspects related to the risk categories.
Conclusions: The current regulation constitutes an effective tool for the control of all homeopathic medicines registered from
2011 to 2022. The need to incorporate aspects related to the risk categories to protect the population is evident.
Keywords: homeopathy, register


Cuba
New Morus alba L. raw material for the Cuban

biopharmaceutical and food industries
Sirley González Laime1*, Claudia Chávez1, Ana M. Rodríguez1, Juan Abreu, Eleanis Cabrera1, Olga A.
Echemendia1, Zamir Cobas1, Caridad M. García Peña2, Sheyla Fernández2, Marlene Prieto3, Dayron Martín3
1Centro de Investigaciones en Plantas Proteicas y Productos Bionaturales (CIPB), Ave 5ta y 246, Complejo Barlovento, Playa, La Habana, Cuba.
2Centro de Investigación y Desarrollo de Medicamentos (CIDEM), BioCubaFarma. Ave. 26 # 1605 e/ Calzada de Puentes Grandes and
Boyeros. Plaza de la Revolución, La Habana, Cuba.
3Estación Experimental de Pastos y Forrajes Indio Hatuey (EEPFIH). Central España Republicana, Perico, Matanzas, Cuba.
*sirley@bionaturasm.cu; ORCID: 0000-0002-1697-8295
ABSTRACT
Context: Morus alba L. is a plant native to the Asian region. It is used in Cuba as food for the silkworm and as fodder for
animal feed. The bioactive compounds in its leaves are of interest to the human health.
Objective: To obtain a national raw material for human consumption from mulberry leaves.
Methods: The study of crop management and its standardization was based in Good Agricultural and Collection Practices for
Medicinal Plants. The process for the manufacture of the raw material and the Research Methodology for the Development
of a Phytomedicine were applied. To determine the quality specifications, analytical methods for the identification and
quantification of compounds were developed and validated. The acute toxicity and the microbial load were also evaluated,
as well as their stability under conservation conditions.
Results: The process map was prepared with a value chain approach to obtain the raw material and the technical guide for
the cultivation of mulberry, as a medicinal plant, was also prepared. The phases that make up the process of obtaining the
raw material were identified and their quality specifications were established. It exhibited low toxicity at the studied dose, it
was free of microbiological contaminants and stable under the test conditions. The tea of mulberry obtained the sanitary
registration.
Conclusions: The new raw material have the quality, safety and security required for the development of natural products.
Keywords: dried mulberry leaves; human uses; Morus alba L.; raw material


Cuba
Phytochemistry and nephroprotective activity of

hydroalcoholic extracts from leaves and rhizomes of Smilax
purhampuy Ruiz
Pilar A. Soledispa Cañarte1*, Raisa Mangas Marín2, Patricia Manzano Santana3, Iván A. Choez Guaranda3
1Facultyof Chemical Sciences “Salvador Allende”. University of Guayaquil. Guayaquil, Ecuador.
2Department of Pharmacy. Institute of Pharmacy and Food. University of Havana. Havana, Cuba.
3Biotechnological Research Center of Ecuador, ESPOL Polytechnic University, Guayaquil, Ecuador.
*pilar.soledispac@ug.edu.ec; 0000-0002-5872-7830
ABSTRACT
Context: The species of the genus Smilax are a vital source of potentially useful compounds that may be effective as
nephroprotective agents, but there is little scientific evidence to support such claims.
Objective: To analyze the chemical composition and nephroprotective activity of hydroalcoholic extracts from leaves and
rhizomes of Smilax purhampuy.
Methods: Hydroalcoholic extracts were prepared by maceration and analyzed by gas chromatography-mass spectrometry
(GC-MS). The gentamicin-induced nephrotoxicity model was tested in Wistar rats at a dose of 80 mg/kg i.p. and the extracts
were administered orally at doses of 100, 200, and 400 mg/kg. Serum creatinine and serum urea were quantified and
histopathological observations of the kidneys were made.
Results: In the leaf extract, 33 compounds were identified. The main ones were palmitic, linoleic and linolenic acid. In the
rhizome extract, 23 phytoconstituents were recognized, predominantly stearic acid, dihydrocorinanteine and palmitic acid.
A significant decrease in the creatinine and urea levels was evidenced in the groups protected with the extracts of leaves and
rhizomes with respect to the gentamicin group in a direct relationship to the dose of the extracts. Renal histopathological
changes were observed in the gentamicin group, while the groups that received the extracts decreased the severity of the
damage.
Conclusions: The results indicate that S. purhampuy has a potential role in ameliorating gentamicin-induced kidney damage,
providing the first findings on its nephroprotective activity.
Keywords: GC-MS; gentamicin; nephroprotection; phytoconstituents; S. purhampuy


Cuba
Phytochemical profile and topical anti-inflammatory

activity of the aqueous extract of Malva pseudolavatera
Webb & Berthel
Glenda M. Sarmiento Tomalá1*, Yamilet I. Gutiérrez Gaitén2, René Delgado-Hernández3, Zoraida C.
Burbano1, Pilar A. Soledispa1, Nicole D. Jaramillo4, Leonardo A. Vargas5, Byron E. Zavala6
1Faculty of Chemical Sciences “Salvador Allende”. University of Guayaquil. Guayaquil, Ecuador.
3Center for Research and Biological Evaluations. Institute of Pharmacy and Food. University of Havana. Havana, Cuba.
4Ecuadorian Consortium of Telecommunications S.A (CONECEL). Ecuador.
5National Telecommunications Corporation, Public Company. Ecuador.
6Information and communications Technologies Unit Ministry of Educations Ecuador.
*glenda.sarmientot@ug.edu.ec; audiniky@hotmail.es; ORCID: 0000-0002-6126-2579
ABSTRACT
Context: Malva pseudolavatera is a very widespread species in Ecuador. It has traditional uses similar to those reported for
Malva sylvestris such as healing, analgesic and antidiarrheal properties, and also to treat urological and respiratory problems,
among other pathologies. However, there is a lack of scientific information to support its consumption.
Objective: To determine the chemical composition and topical anti-inflammatory activity of the aqueous extract of M.
pseudolavatera.
Methods: An aqueous extract was prepared by decoction from the leaves. A liquid-liquid fractionation was carried out with
n-butanol and the butanolic fraction obtained was analyzed by high resolution liquid chromatography-mass spectrometry
(HPLC-MS). The auricular model of acute inflammation and repeated application induced by croton oil in mice was tested.
The extracts were evaluated at concentrations of 5, 10 and 20% and betamethasone dipropionate cream at 0.05% was used as
reference drug.
Results: Several flavonoid glycosides were identified. The presence of gossypetin-3-O-β-D-glucopyranosyl-8-O-β-D-
glucuronopyranoside was notable. The most common aglycones were gossypetin, rutin, kaempferol, and luteolin. An
inhibition of edema was obtained with the aqueous extract at 20% in the two models tested, with percentages of 69.93% and
73.36%, respectively, reaching the therapeutic activity of the positive control group with relevant inhibition of edema.
Conclusions: The first findings on the anti-inflammatory effect of the M. pseudolavatera species are provided, as well as the
detection of several compounds that constitute new reports for the Ecuadorian species, all of which contribute to justify its
traditional use.
Keywords: anti-inflammatory, aqueous extract; croton oil; flavonoids; HPLC-MS; Malva pseudolavatera


Cuba
Phenolic composition and in vitro inhibitory activity of

xanthine oxidase from Mimusops coriacea (A.DC) Miq
Katherine E. Bustamante Pesantes1*, Yamilet I. Gutiérrez Gaitén2, Mercedes Campo Fernández3, Oswaldo
G. Pesantes Domínguez1
3Technical University of Machala. Ecuador.
*katherine.bustamantep@ug.edu.ec, katybupe84@hotmail.com, 0000-0002-3108-9736
ABSTRACT
Context: Xanthine oxidase (XO) is an important target for the treatment of hyperuricemia. As a result, medicinal plants have
been investigated to combat gout by inhibiting the activity of the said enzyme. Mimusops coriacea is used in the treatment of
osteoarticular disorders but has not been explored for such activity and phytochemical studies are limited.
Objective: To determine the phenolic composition and the in vitro XO inhibitory activity of hydroalcoholic extracts from
leaves, bark, and fruits (green and ripe) of the species.
Methods: The crude drug from each plant organ was macerated with an hydroalcoholic mixture at 80%. Phenols were
quantified in the extracts by the Folin-Ciocalteu technique and flavonoids by the aluminum chloride colorimetric method.
The extracts of leaves, bark, and fruits (10, 30, 40, 50 and 60 µg/mL) and allopurinol (reference drug) were tested to measure
the degree of in vitro inhibition of XO, by means of spectrophotometric determination.
Results: The content of phenols and flavonoids was higher for the leaf extract. All extracts showed significant inhibitory
activity on XO in a concentration-dependent manner, being higher for the extract of leaves with percentages of inhibition of
the enzyme comparable to allopurinol. The lowest values of mean inhibitory concentration and therefore higher activity
were recorded for allopurinol (IC50 = 12.42 µg/mL) and the leaf extract (IC50 = 13.23 µg/mL).
Conclusions: The results contribute to the phytochemical study of the species and provide the first findings on the possible
potential of M. coriacea in the treatment of hyperuricemia.
Keywords: allopurinol; bark; extracts; fruits; hydroalcoholic, leaves; xanthine oxidase


Cuba
Phytochemical characterization and anti-inflammatory

potentialities of the leaves of Nephelium lappaceum L. from
Ecuador
Laura L. Valdez López 1*, Yamilet I. Gutiérrez Gaitén2, Juan Abreu Payrol3, Olga M. Nieto Acosta2
1Faculty of Chemical Sciences “Salvador Allende”. University of Guayaquil. Guayaquil, Ecuador.
3Latin American School of Medicine. Havana. Cuba.
*laura.valdezl@ug.edu.ec, ll_valdez@hotmail.com; 0000-0001-5883-0777
ABSTRACT
Context: Nephelium lappaceum (Sapindaceae) is a fruit tree of economic importance in various regions of the world due to its
bioactive potential, of great nutritional and medicinal use. However, there are no antecedents of chemical and biological
studies on the leaves of the species of the sweet and bitter variety that grow in Ecuador.
Objective: To examine the chemical composition and anti-inflammatory activity of hydroalcoholic extracts from the leaves of
the sweet and bitter variety of the species.
Methods: From the dry drug, hydroalcoholic extracts were obtained by maceration with a hydroalcoholic mixture at 80% and
analyzed by liquid chromatography-mass spectrometry. The anti-inflammatory activity was evaluated by means of the
model of plantar edema induced by carrageenan in rats at a dose of 400 mg/kg, using Indomethacin as the reference drug.
Results: The phytochemical study allowed the characterization of eight compounds, between phenolic acids and
ellagitannins, highlighting the corilagin compound with the most intense signal. All the identified compounds constitute
new reports for the two varieties from Ecuador, the presence of tellimagrandin is transcendental, reported for the first time
for the genus Nephelium. The two extracts were able to reduce the inflammation produced by carrageenan with inhibition
percentages comparable to those of Indomethacin, registering values higher than 50% at the fifth hour of the test.
Conclusions: The results provide the first evidence of the chemical composition and anti-inflammatory efficacy of Ecuadorian
varieties, aspects that help justify their traditional use.
Keywords: anti-inflammatory activity; bitter;liquid chromatography-mass spectrometry; sweet


Cuba
Physicochemical and phytochemical characterization of

aqueous extracts of Corynaea crassa Hook. F
Alexandra J. López Barrera1*, Yamilet I. Gutiérrez Gaitén2, Ramón Scull Lizama2, Segundo G. Ruíz Reyes3
3Department of Pharmacy, Faculty of Pharmacy and Biochemistry, National Trujillo University, Trujillo, Peru.
*alexandra.lopezb@ug.edu.ec, tifanyleo@hotmail.com; 0000-0002-7269-6305
ABSTRACT
Context: Corynaea crassa Hook. F. (Balanophoraceae), is a hemiparasitic plant distributed in many regions of America. It has a
referred aphrodisiac effect and its ethanolic extracts have antimicrobial activity. The foregoing has motivated the study of
the plant, mainly of aqueous extracts of which there are no pharmacognostic and phytochemical antecedents.
Objective: To analyze the physicochemical quality parameters and the chemical composition of aqueous extracts of the
species from Ecuador and Peru.
Methods: Aqueous extracts were prepared by decoction, their quality phytochemical parameters were determined, phenols
were quantified by Folin-Ciocalteu and flavonoids by the aluminum chloride colorimetric method. The extracts underwent
liquid-liquid fractionation with dichloromethane, ethyl acetate, and n-butanol. The fractions obtained were analyzed by gas
chromatography-mass spectrometry (GC-MS) with prior derivatization.
Results: Differences were perceived in the physicochemical parameters (pH, relative density, refractive index, total solids,
and capillary height). The content of phenols and flavonoids was higher for the sample from Ecuador. Pinoresinol and
hexadecanoic acid predominated in the dichloromethane fractions. The ethyl acetate fractions had a predominance of p-
hydroxybenzoic acid and catechin, while in the butanolic fractions the main compounds were catechin and rubrolide C, for
the extracts from Ecuador and Peru, respectively.
Conclusions: The work provides novel results on the chemical composition and quality parameters of the aqueous extracts of
the species, essential aspects for the development of future monographs.
Keywords: aqueous extracts; GC-MS; physicochemical parameters; phytochemicals


Cuba
Ethnobotanical inventory of the two subspecies of Piper

aduncum L. in Cuba
Orlando A. Abreu-Guirado1*, Isidro E. Méndez-Santos1, Anabel Domínguez-Mainer1, Roidel Ferrer-
Bandera1, Aines Muños Pérez1, Yariulis Rodríguez-Juquejo1, Luc Pieters2, Paul Cos2, Julio C. Escalona-
Arranz3, Ania Ochoa-Pacheco3
1Facultyof Applied Sciences, University of Camagüey “Ignacio Agramonte Loynaz”, Cuba.
2Facultyof Pharmaceutical, Biomedical and Veterinary Sciences, University of Antwerp, Belgium.
3Faculty of Natural and Exact Sciences, University of Oriente, Santiago de Cuba, Cuba.
*orlando.abreu@reduc.edu.cu; ORCID: 0000-0001-6909-025X
ABSTRACT
Context: Piper aduncum L. is a recognize medicinal plant in Cuba and other countries. Two infraspecific taxa with a particular
geographical distribution occurs in Cuba, P. aduncum subsp. aduncum and P. aduncum subsp. ossanum (endemic). Practically
all ethnobotanic references have been circumscribed to the Western and Central part of the country and Camagüey, were P.
aduncum subsp. ossanum is grown.
Objectives: to document the traditional use of Piper aduncum subsp. aduncum from localities of the Eastern region of Cuba.
Methods: A thorough search was done in relation to the ethnobotany of P. aduncum in available national literature and in
academic databases. An ethnobotanical investigation was carried out interviewing about the use of P. aduncum as a
medicinal plant or any other purpose in localities of the provinces of Guantánamo, Santiago de Cuba, Granma, and
Camagüey. Also, plant sellers in the medicinal plant markets of Santiago de Cuba City and Camagüey City were
interviewed.
Results: In total 48 different uses were recorded, 32 for medicinal use, eight uses as a magic-religious plant, two in veterinary
and as food, and one use as a fuel source and as a building material. The main categories of diseases are associated with skin
disorders, musculoskeletal, and urology. New P. aduncum ethnobotanical records for Cuba or worldwide were found in both
subspecies. Besides, new P. aduncum vernacular names were also provided.
Conclusions: New ethnobotanical records of both Cuban P. aduncum subspecies were documented. Similarities in medicinal
uses are of ethnopharmacological and chemophenetic interest. It is necessary to continue the ethnobotanical research of
Cuban Piper sps.
Keywords: Ethnobotany; Piperaceae; plant traditional use

ECFA 2022. S5- PHARMACOLOGY, TOXICOLOGY AND BIOTECHNOLOGY

Olga Sonia León, PhD, IFAL-UH, Cuba / Yoagne Trapero, PhD, IFAL-UH, Cuba / Laura Machín, MSc, IFAL-UH, Cuba
Population pharmacokinetic modeling of fibrinogen in

patients with congenital or acquired -chronic or acute-
hypofibrinogenemia
Helena Colom1*, Annabel Blasi2,3, Bruno Montoro1,4, Beatriz Fernández-Alarcón1, Antoni Sabaté5,6
2Servei Anestesiologia. Hospital Clinic. Barcelona,, Spain.
3IDIBAPS: Institut Investigació biomédica August Pi i Sunyer. Barcelona, Spain.
4Servei de Farmàcia. Hospital de la Vall d’Hebron. Barcelona, Spain.
5Servei Anestesiologia. Hospital de Bellvitge. Barcelona, Spain.
6IDIBELL: Institut DE Recerca Biomèdica de Bellvitge. Barcelona, Spain.
*helena.colom@ub.edu
ABSTRACT
Context: Fibrinogen a plasma-soluble protein synthesized by the liver is the key substrate for plasmatic blood coagulation
reaching a critically low plasma concentration earlier than other coagulation factors in case of bleeding.
Objectives: The aims of this study are to characterize the fibrinogen pharmacokinetics in patients with acquired -chronic
(cirrhotics) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), where endogenous production takes
place as in afibrinogenemic patients.
Methods: A total of 428 concentration values from 132 patients were analysed. 82 out of 428 were from 41 cirrhotic patients
administered with placebo and 90 out of 428 were from 45 cirrhotic patients that received FC, 161 out of 428 were from 14
afibrinogenemic patients and 95 out of 428 were from 32 severe acute trauma haemorragic patients.
A turnover model that accounted for endogenous production and exogenous dose was fitted using NONMEM74. The
production rate (Ksyn), distribution volume (V), plasma clearance (CL) and concentration yielding to 50% of maximal
fibrinogen production (EC50) were estimated.
Results: Fibrinogen disposition was described by a one-compartmental model with CL and V values of 0.0451 L/h and 4.26
L/70 kg, respectively. Body weight was statistically significant in V. Ksyn values were: 0.00392 g/h (afibrinogenemia),
0.0759 g/h (cirrhotics) and 0.1160 g/h (acute severe trauma). EC50 was 0.973 g/L.
Conclusions: A FC PK turnover model, considering endogenous Fibrinogen generation, for hypo- and afibrinogenemic
patients has been developed; after external evaluation can be used for dose calculation to achieve specified target fibrinogen
concentrations, in each subpopulation.
Keywords: afibrinogenemic and acute severe trauma; cirrhotic; fibrinogen; patients; population pharmacokinetics; turnover
model


Leveraging of Physiologically-Based Pharmacokinetic

modeling to inform decision-making in different scenarios.
Part I: evaluation of CNS drug delivery
Valvanera Vozmediano*, Leyanis Rodríguez-Vera
Center for Pharmacometrics and System Pharmacology (CPSP), Department of Pharmaceutics. College of Pharmacy. University of Florida, FL,
USA.
*valva@cop.ufl.edu; ORCID: 0000-0002-2636-1889
ABSTRACT
Context: Physiologically-based pharmacokinetic (PBPK) modeling and simulation provide a very relevant and useful tool to
properly understand the drug exposure in different organs and tissues. An outstanding aspect of PBPK models is the
integration and interaction of previously existing knowledge on drug-related properties and system-specific (human’s and
animal’s physiology) characteristics, allowing the identification of the most relevant factors involved in drug distribution to
the target site. The validity of the application of PBPK modeling to evaluate differences in drug exposure at the target site
has also been demonstrated by different authorities, e.g., in the field of bioequivalence of topical drug products with the
recent approval of diclofenac sodium topical gel, 1% by the FDA.
Objectives: To characterize the permeability of drugs undergoing passive transport across the blood-brain barrier (BBB) using
PBPK modeling in rats and to evaluate drug disposition at the target site. Methods: Interspecies scaling of the obtained BBB
permeability was applied for predicting the concentrations at the site of action in humans. A central nervous system (CNS)
four-compartment model in R®, which included the intracellular fluid (ICF), extracellular fluid (ECF), cranial cerebro-spinal
fluid (CSF), and spinal CSF was applied and validated for different drugs in rats, and the optimized value of the
permeability in this species used to predict BBB access in humans.
Conclusions: Using this innovative PBPK model, we were able to predict BBB permeability in humans from rat experiments
allowing the prediction of CNS site exposure in humans.
Keywords: Blood-brain barrier permeability; brain delivery; mechanistic modeling; pharmacometrics


Medical ozone: pharmacological mechanisms as basis of its

effectiveness on the immune response, vascular
dysfunctions, surgery, and COVID-19/SARS-CoV-2
Olga S. León Fernández
Institute of Pharmaceutical and Foods Sciences. University of Havana, Cuba.
olga@infomed.sld.cu
ABSTRACT
Context: Medical ozone is a therapeutic concept of proven pleiotropy. This means it will have different effects on multiple
pharmacological targets which have been identified in hundreds of studies (experimental and clinical) on disease models
and patients.
Objective: To highlight the therapeutic targets of medical ozone in different diseases, their relationship, and ozone
application in pathological processes with an oxidative etiology. Injury and antioxidant defenses were determined in disease
models and patients as well as clinical parameters
Methods: Injury and antioxidant defenses were determined in preclinical and clinical studies. mRNA in a chronic arthritis
model was evaluated.
Results: In animal models and patients with rheumatoid arthritis, medical ozone reduced proinflammatory cytokines (TNF-α
and IL-1β) that contribute to “cytokine storm”, synovitis, cartilage and bone-damaging autoantibodies, and oxidative stress.
Vascular complications in patients with diabetes foot were reduced when superoxide radicals scavengers increased
mediated by medical ozone, restoring normal metabolic pathway functions and pancreatic integrity. Ozone prevented
ischemic reperfusion injury and improved the systemic conditions and quality of life of patients with knee osteoarthritis
before and after arthroscopy.
Conclusions: Ozone was effective in oxidative etiology diseases. The integration of the above and other results was the basis
for the introduction of medical ozone as a successful treatment for a new disease: COVID-19 disease.
Keywords: Covid-19; oxidative stress; ozone; SARS-CoV-2


Evaluation of the effects of Compvit-B® on behavioral

disorders in a rat model of alcohol withdrawal syndrome
Viagna Valiña1*, Luis M. Rodríguez2, Claudia M. Vazquez3, María T. Díaz2, Olivia T. González1, Adonis
Armentero López4, Teresa Diez1, Guillermo Ajoy1
1Department of Molecular Neuroscience, Cuban Center for Neurosciences, Havana, Cuba.
2Departament of Pharmacy, Institute of Pharmacy and Food of the “La Habana” University, Havana, Cuba.
3CIGB-Mariel Biotechnological Industrial Complex, Artemisa, Cuba.
4Study Center for Biological Research and Evaluations, Institute for Food and Pharmacy of the “La Habana” University. Havana, Cuba.
*viagna.valina@cneuro.edu.cu
ABSTRACT
Context: Estimates report that approximately 10% of the world's population has alcohol dependence problems. It constitutes
a health problem with great social impact, worsened by the inefficacy of drugs to treat this disorder. Compvit-B® is a Cuban
pharmaceutical product composed of vitamins B1, B6, and B12, whose therapeutic application has shown satisfactory results
in restorative processes of lesions from the Nervous System in experimental animal models and patients.
Objectives: The present work proposes a model of Alcohol Abstinence with the aim of evaluating the effects of drug
treatment with Compvit-B® on behavioral disorders of the animal subjects during abstinence.
Methods: The study was carried out with young Lewis rats. The subjects were randomly selected to form 2 experimental
groups for the abstinence stage (AA) and one control group with no treatment or alcoholic consumption (C). Compvit-B®
was administered at a dose of 1 mL/kg body weight every other day in one of the abstinence groups (AA). The behavioral
evaluation was performed using the Irwin Test, the Forced Locomotion Test, and the Elevated Cross Maze Test.
Results: The results of the behavioral tests show that there was a reduction in anxiety and improvement in motor function in
the animals of the Alcohol Abstinence group treated with Compvit-B® compared to the untreated abstinent animals.
Conclusions: The results suggest that Compvit-B® may improve the behavioral disorders evaluated in this model of Alcohol
Abstinence.
Keywords: alcohol withdrawal; behavioral disorders; experimental model; vitamins


Application of the biopharmaceutical classification system

to the basic table of medicines of Cuba: bioequivalence in
vivo or dissolution in vitro?
Claudia Miranda1*, Miguel A. Cabrera-Pérez1, Mirna Fernández-Cervera2, María I. Reyes Naranjo3
1Centro de Bioactivos Químicos. Universidad Central “Marta Abreu” de Las Villas, Villa Clara, Cuba.
2Departamento de Farmacia. Instituto de Farmacia y Alimentos (IFAL). Universidad de La Habana, La Habana, Cuba.
3Laboratorios SOLMED. MEDSOL, BIOCUBAFARMA, La Habana, Cuba.
*cmiranda@uclv.cu; cbmiranda93@gmail.com; ORCID: 0000-0002-0500-5017
ABSTRACT
Context: The Biopharmaceutical Classification System (BCS) is a valuable tool that allows demonstrating the therapeutic
interchangeability of generic drugs through in vitro assays at a lower cost and time, and with fewer ethical problems than
clinical trials in humans.
Objectives: To classify the Active Pharmaceutical Ingredients (APIs) of the immediate-release oral solids of the Basic Table of
Medicines of Cuba (CBM) that are produced nationally, according to the BCS, and to propose those that could demonstrate
their therapeutic interchangeability through in vitro dissolution assays.
Methods: The list of drugs of the Cuban of 2019 was used and a provisional consensus biopharmaceutical classification is
made, based on different published biopharmaceutical classifications and an extensive review of the literature.
Results: It was identified that approximately 48% of the CBM IFAs present polymorphism and that 12.3% of the oral solid
forms of the Cuban MBC have a narrow therapeutic margin, so they cannot be biowaived. The joint application of various
biopharmaceutical classification methodologies allowed tentatively classifying all the IFAs of the oral solid forms of the
CBM, showing that 66.1% belong to classes 1, 3 and 1/3.
Conclusions: Cuban CBM was provisionally classified, and it was found that more than 66% can be candidates for biowaiver
studies and demonstrate their bioequivalence by comparison of in vitro dissolution profiles, which can be an important tool
for the Cuban regulatory agency and national manufacturing companies.
Keywords: bioequivalence; dissolution; generic products; permeability; solubility; therapeutic equivalence


Therapeutic repositioning of the humanized monoclonal

antibody itolizumab in COVID-19
Mayra Ramos Suzarte
Head of Clinical Trial Department, Clinical Research Direction. Center of Molecular Immunology. 216 and 15. Atabey. Playa. La Habana.
Cuba.
mayra@cim.sld.cu; ORCID: 0000-0002-9058-3224
ABSTRACT
Context: Since the first case of COVID-19 was reported in China in 2019, the world has turned to seeking therapeutic
alternatives for the treatment of this disease. More than 300 million people in the world have been affected by the pandemic.
age and the presence of comorbidities such as high blood pressure, diabetes mellitus, kidney failure, among others, were
aggravating predictors of mortality.
Objectives: To provide a therapeutic alternative against COVID-19 for Cuban patients.
Methods In Cuba, the use of the Cuban humanized monoclonal antibody itolizumab, an anti-lymphocyte CD6 receptor, was
repositioned in the treatment of moderate and severe patients given the possibility of blocking this receptor and inhibiting
the release syndrome of proinflammatory cytokines
Results: After concluding the phase I/II clinical trial, a recovery of more than 80% for severe patients and 90% for moderate
patients was demonstrated, avoiding the critical stage of the disease. It was determined that the Neutrophil/lymphocyte
ratio (NLR) is a predictor of the severity of the disease and that these are restored to normal with the treatments. The
increase in IL6 levels was reduced. Patients who received MAbs had at least two times a lower risk of dying than those who
did not. After receiving the Authorization for Emergency Use from the CECMED, an observational study was carried out in
more than 500 patients where the safety profile in this indication was ratified.
Conclusions: Itolizumab is a promissory and effective therapeutic alternative in COVID-19 treatment.
Keywords: anti-inflammatory; COVID-19; humanized monoclonal antibody; itolizumab repositioning


Leveraging of Physiologically-Based Pharmacokinetic

modeling to inform decision-making in different scenarios.
Part II: drug-drug interactions in special populations
Leyanis Rodríguez-Vera*, Valvanera Vozmediano
Center for Pharmacometrics and System Pharmacology (CPSP), Department of Pharmaceutics. College of Pharmacy. University of Florida, FL,
USA.
*leyanisrodriguez@ufl.edu; ORCID: 0000-0003-1688-7008
ABSTRACT
Context: The use of Physiologically-based pharmacokinetic (PBPK) modeling in support of drug development has been
demonstrated for several routes of administration and it is recommended by the US FDA. Over the past decade, the number
of scientists working in the field of physiological modeling has increased considerably, as it is demonstrated by the recently
growing number of publications in the area as well as the number of regulatory submissions including PBPK modeling. The
main applications have been in the field of drug-drug interactions (DDIs). For example, a clinical pharmacologist from the
Center for Drug Evaluation and Research from the FDA applied PBPK modeling with the ability to predict cytochrome
(CYP) enzyme-mediated DDIs to evaluate the effect of CYP enzyme inhibitors with enough confidence to derive dosing
recommendations and inform the labeling of some drugs in the absence of clinical trials (e.g., including dose adjustments for
patients taking other medications in the Dosing and Administration section of the label). However, the application to predict
DDIs in special populations is still very limited.
Objectives: To demonstrate the application of PBPK to evaluate DDIs in different clinical scenarios in special populations
using omeprazole and phenytoin as model drugs.
Methods: Models were developed and qualified using data from literature including data from DDIs studies in healthy
subjects. Models were then used to evaluate the clinical impact of DDIs in adults and pediatric patients.
Conclusion: The ultimate goal of these efforts was to ensure that all patients who can benefit from both drug therapies are
dosed adequately.
Keywords: drug-drug interaction; mechanistic modeling; pharmacometrics


Different patron of oxidative stress according to diverse

clinical conditions of SARS-CoV-2 Cuban hospitalized
patients
Lizette Gil del Valle1*, Rosario Gravier Hernández1, Mario M. Delgado-Guerra2, Joniel A. Sánchez-
Márquez2, Olga E. López-Fernández2, Miguel A. Acosta1, Teresa Rosell Guerra1, Rodolfo Suárez-Iznaga3,
Raiza Martínez Casanueva3, Zullyt Zamora-Rodríguez4, Lidia A. Fernández-García4, Yusimit Bermudez-
Alfonso1, María C. Hernández González-Abreu1
1Institute “Pedro Kourí” (IPK), Havana, Cuba.
2HospitalErnesto Guevara, University of Informatics’ Science, Havana, Cuba.
3Hospital Salvador Allende, Havana, Cuba
4National Center of Scientific Research, BioCubaFarma, Havana, Cuba.
*lgil@ipk.sld.cu
ABSTRACT
Context: COVID-19 related to SARS-CoV-2 infection generates inflammation with increased reactive oxygen species
production. Drug treatment also influences systemic oxidative stress during pathogenic insult.
Objectives: To determine the redox status in COVID 19 patients of different clinical conditions and to explore the relation
between redox and hematological hemochemical variables through a case-control study.
Methods: Blood samples were drawn from 160 individuals divided into four groups: COVID-19 asymptomatic, COVID-19
symptomatic (low and moderate symptoms), COVID-19 convalescent and presumable healthy subjects (control).
Demographic, redox, hematological, and hemochemical indexes were assessed. Statistical analyses compared the median
values of each variable, explore individual, simultaneous indexes and multivariate alteration.
Results: Relative to the control group, acute COVID-19 and convalescent groups had significant differences in global indexes
of damage and antioxidant status (p < 0,05). The convalescent group showed significantly higher damage (malondialdehyde,
advanced oxidation protein products, nitric oxide) and lower antioxidant enzymatic activities and gluthatione concentration
compared to other groups (p<0.05). Global modification of redox indexes showed more than 80% of individuals with
simultaneous detrimental differences related to a healthy status. Discriminant analysis permit to obtain 2 canonical functions
(p < 0.05) that reflect 98% of redox variables variances with 95% of successful case classifications.
Conclusions: These results corroborate that oxidative stress occurs in different COVID-19 and post-acute conditions with
different molecular alteration of redox indexes. Redox diagnosis should be considering in early diagnosis and treatment of
infection, which would be worthwhile to conduct a more comprehensive study and manage of diseases evolution.
Keywords: antioxidant status; COVID-19; oxidative damage; oxidative stress; SARS-CoV-2


A novel drug candidate targeting host and viral proteins to

inhibit viral infections
Celia Fernández-Ortega1*, Anna Ramírez-Suárez1, Dionne Casillas-Casanova1, Carlos A. Duarte1, Raimundo
Ubieta-Gómez1, Gerardo Guillén1, Ania Cabrales1, Karen Álvarez1, Carmen L. Pérez2, Viviana Falcón1,
Silvio Perea1, Pilar Rodríguez1, Hilda Garay1, Enrique Noa2, Dayami Martín2, Yuliet Enríquez2, Yeniset
Infantes2
1Center for Genetic Engineering and Biotechnology, Ave. 31 e/158 y 190, Cubanacán, Playa, P.O. Box 6162, Havana 10600, Cuba.
2Laboratory for AIDS Research, Carretera de Tapaste y Autopista Nacional, San José de las Lajas, Mayabeque 32700, Cuba.
*celia.fernandez@cigb.edu.cu
ABSTRACT
Context: CIGB-210 is a peptide that inhibits the human immunodeficiency virus (HIV) and acts on the vimentin protein. This
protein forms intermediate filaments in the cytoskeleton, and it is known that the rearrangement of these filaments is related
to viral inhibition in HIV. Vimentin has been related to different stages of the replicative cycle of dissimilar viruses such as
HIV, avian influenza virus, Dengue virus, porcine coronavirus TGEV, SARS-CoV and more recently SARS-CoV-2.
Objective: To evaluate the ability of CIGB-210 to inhibit or interact with different types of viruses.
Methods: The infection assay with native viruses on cell lines; MTT assay; colorimetric assay; the viral titering-TCID50 assay;
surface plasmon resonance.
Results: The peptide was capable of inhibiting the replication of bovine coronavirus. The infection assay with native SARS-
CoV-2 on VeroE6 cells revealed that the peptide also inhibits the replication of the virus. We have detected a high-affinity
interaction between the peptide and the SARS-CoV-2 N protein. We have also detected a direct interaction of the peptide
with proteins from other viruses.
Conclusions: The anti-HIV peptide targeting vimentin is able to inhibit the Mebus bovine coronavirus and SARS-CoV-2. We
describe for the first time an interaction of the peptide with a viral protein. Taken together these results expand the potential
for the use of this anti-HIV peptide in infections caused by coronavirus and other relevant viruses like Dengue and Zika.
Keywords: cytoskeleton; HIV; peptide; SARS-CoV-2; vimentin


Safety and health practices in the handling of carcinogenic

substances in laboratories of the Materials Science and
Technology Institute
Yoagne Trapero1*, Nancy Martínez2, Mayte Alfaro3
1Department of Pharmacy, Institute of Pharmacy and Food, University of Havana, Cuba.
2Institute Materials Science and Technology IMRE, University of Havana, Cuba.
3Faculty of Medical Sciences of Artemisa, Cuba.
*yoagnetq@ifal.uh.cu
ABSTRACT
Context: This article reports the results obtained in the evaluation and Classification of substances and chemical products
classified as carcinogenic according to the International Agency for Research on Cancer (IARC) in the laboratories of the
Institute of Materials Science and Technology (IMRE). The incidence of cancer among the employees motivated this
investigation.
Objective: To analyze the safety and health practices at work in the handling of substances and chemical products classified
as carcinogenic in the IMRE laboratories.
Methods: The inventory of reagents in the IMRE institute laboratories was reviewed. IARC monographs were used for the
classification of carcinogenic substances and chemical products. To determine the type of cancer that each substance
produces, the Guide for the identification, management, and control of carcinogenic agents of a chemical nature was used.
Results: More than 20 chemical substances classified as carcinogenic were found throughout several IMRE locations. The
cancer types that these substances could develop were also identified.
Conclusions: The reported cases of cancer among the institute employees is likely related to exposure to these substances.
Keywords: carcinogenic; chemistry; products; risk; safety and occupational health; substances


Neuroepo in mild-to-moderate Alzheimer’s clinical

syndrome. Phase 2-3 controlled clinical trial
Leslie Pérez Ruiz1*, Saily Pérez Sosa2, Giosmany Bringas Sánchez3, Nelky Urrutia Amable2, Danay López
Brito2, Ana I. Peñalver3, Evelio González Dalmau4, Ana Fernández Nin4, Ariel Viña González4, Zenaida M.
Hernández Fernández5, Yamile Peña Quián6, Juan Batista Cuéllar6, Anay Cordero Eirez3, Carmen
Valenzuela Silva1, Teresita Rodríguez Obaya1
1Departmentof Clinical Trial, Center of Molecular Immunology (CIM), Calle 216 esquina 15, Atabey, Playa, Havana, Cuba. CP 11 600.
2Hospital Iván Portuondo, Calle 78 e/ Ave. 33 y 37, San Antonio de los Baños, Artemisa, Cuba, CP 32 500.
3National Institute of Neurology (INN), Calle 29 esquina D, Vedado, Havana, Cuba, CP 10 400.
4Department of MRI, Cuban Neurosciences Center (CNEURO), Avenida 25, No. 15 007, Cubanacán, Havana, Cuba, CP 11 600.
5Department of MRI, Center of Neurological Restoration (CIREN), Calle 216 esquina 13, Siboney, Playa, Havana, Cuba, CP 11 600.
6Center for Clinical Investigation, CENTIS, Calle 45 No. 4501, esquina a 34, Reparto Kholy, CP 11 300, Havana, Cuba.
*leslie@cim.sld.cu; ORCID: 0000-0001-8492-3774
ABSTRACT
Objective: To evaluate the safety and efficacy of NeuroEPO in the treatment of patients with mild-to-moderate Alzheimer’s
clinical syndrome.
Methods: A double-blind, randomized, placebo-controlled trial enrolled 174 subjects with mild-to-moderate Alzheimer’s
clinical syndrome, was conducted. Patients were randomized to NeuroEPO 0.5 mg or 1.0 mg or placebo, and treated 3
times/week for 48 weeks. The primary endpoint was the change from baseline in the 11-item AD Assessment Scale-
Cognitive subscale (ADAS-Cog11). Secondary endpoints included CIBIC+, GDS, MoCA, NPI, neuropsychological battery,
EGG and cerebral perfusion measured by SPECT.
Results: Surprisingly NeuroEPO treatment reduced ADAS-Cog11 after 48 weeks in -4.0 ± 4.0 and -5.0 ± 5.0 units respectively
for the groups of 0.5 and 1.0 mg dose, while the placebo group increased ADAS-Cog11, as expected, in 4.0 ± 6.0. NeuroEPO
treatment also induced a statistically significant improvement in GDS, MoCA, NPI and neuropsychological battery as
compared to placebo. Regarding the electroencephalography, 72% of the NeuroEPO-treated patients stabilized or decreased the
values of EEG (p=0.003) vs. the placebo group. In reference to cerebral perfusion, 56% of the NeuroEPO-treated patients
improved their parieto-temporal perfusion, whereas none of the placebo group improved. No serious adverse events related
to neuroEPO were reported.
Conclusions: Overall, NeuroEPO significantly improved clinical outcomes with a good safety profile in patients with mild-to-
moderate Alzheimer’s clinical syndrome.
Keywords: Alzheimer´s disease; clinical trials; neuroEPO; neuroprotection


Antileishmanial properties beyond the endoperoxide entity

Laura Machín1*, Lars Gille2, Lianet Monzote3
1Instituto de Farmacia y Alimentos-UH, La Habana, Cuba.
2Universidad de Medicina Veterinaria de Viena, Viena, Austria.
3Instituto de Medicina Tropical Pedro Kourí, La Habana, Cuba.
*laura@ifal.uh.cu
ABSTRACT
Context: Compounds with the endoperoxide function have proven in vitro antileishmanial activity against extracellular
parasites from old-world species.
Objectives: To evaluate the influence of the residual structure on the activity of endoperoxides ascaridole, artemisinin, and
AcEP1118 against Leishmania amazonensis.
Methods: Endoperoxide activation was assessed by electron paramagnetic resonance spectroscopy. The mean inhibitory
concentration on amastigotes (IC50) and peritoneal macrophages determined the selectivity. The GSH precursor N-
acethylcisteine (NAC), was used to detect variations in activities. The effect of treatment (30 mg/kg, 2-4 administrations,
every 4 days) was compared on cutaneous leishmaniasis in BALB/c mice.
Results: After reacting with FeSO4, the most abundant species were DMPO/carbon-centered radicals (•C, •CO). Reactivity
varied (from most to least reactive): AcEP1118 > ascaridole > artemisinin. The compounds were active (IC50 = 8-15 μM), but
cytotoxicity was markedly different. Only ascaridole and artemisinin were selective. The inhibitory activity decreased in the
presence of NAC. Intralesional treatment decreased (p < 0.05) the size of the lesions and the parasite load without differences
(p > 0.05) with Glucantime® (reference drug). No differences were observed among animals treated with endoperoxides.
Conclusions: The antileishmanial activity of these compounds depends on radicals formed after the endoperoxide group
degradation. The reaction rate, activation energy, and radical stability rely on residual structure. This factor influences
cytotoxicity, determining selectivity against Leishmania parasites. The potent in vitro inhibition observed was complemented
with efficacy in the control of experimental cutaneous leishmaniasis. We recommended continuing to study the potential of
these compounds against leishmaniasis.
Keywords: amastigotes; anthracene; artemisinin; ascaridole; BALB/c; Leishmania


Pharmacometric study of NeuroEPO in a non-human

primate model Macaca fascicularis
Adriel Brito Llera1, Helena Colom Codina2, Iliana M. Sosa Testé3, Daniel Jay Pérez3, Parsshava Mehta4,
Leyanis Rodríguez-Vera4, Valvanera Vozmediano4, Teresita de J. Rodríguez Obaya5*
1Department of Science, Technology and Innovation, University of Havana, Cuba.
2Department of Pharmacy and Pharmaceutical and Physicochemical Technology, Faculty of Pharmacy and Food Sciences, University of
Barcelona, Spain.
3CETEX, National Center for the Production of Laboratory Animals, Havana, Cuba.
4Department of Pharmaceutics, Centre for Pharmacometrics and Systems Pharmacology, University of Florida, Gainesville, Florida, USA.
5Molecular Immunology Center, Havana, Cuba.
*teresita@cim.sld.cu
ABSTRACT
Context: Erythropoietin (EPO) is a glycosylated hormone considered the main growth and differentiation factor in erythroid
cells with cytoprotective action on non-hematopoietic tissues like the central nervous system. NeuroEPO, is a nasal
pharmaceutical solution of recombinant human erythropoietin with low sialic acid with proven neuroprotective effects at
the preclinical and clinical levels.
Objectives: To characterize the endogenous production of erythropoietin in the central nervous system and its variations.
Methods: A single dose of intranasal NeuroEPO (5750 IU/kg) was administered to a sparse population of non-human
primates M. fascicularis. The concentration profiles of EPO in plasma of peripheral venous blood and lumbar cerebrospinal
fluid were obtained. A non-compartmental analysis was performed with Phoenix Winnonlin, 8.3.4.295, Certara.
Results: A drug targeting efficiency (> 100%) and a direct transport percentage (90.47%) that support the high biodistribution
of NeuroEPO in the central nervous system administered through mechanisms that directly involve the nerve pathways that
connect the olfactory epithelium with the brain. Additionally, the turnover of basal EPO levels in cerebrospinal fluid and
plasma was modeled by population compartmental modeling in NONMEM 7.4. Four fixed effects were estimated with
FOCEI algorithm (V= 3760 ± 481 mL, Ksyn = 53.4 ± 4.50 IU/h , Kout = 3.60 ± 0.25 IU/h and IC50 = 0.0024 ± 0.00048 IU/mL).
Conclusions: Inhibitory feedback on EPO Synthesis significantly improved the model It is planned to develop a minimally
physiological-based pharmacokinetic model in RStudio and Pumas to characterize the pharmacokinetic parameters of
NeuroEPO in cerebrospinal fluid and plasma in the biomodel used. The study was designed and conducted in accordance
with the international ethical criteria related to non-clinical research in non-human primates and was approved by the
corresponding Ethics Committee.
Keywords: monkey; neuroprotection; NeuroEPO; non-clinical; ´´nose-to-brain´´; pharmacometrics modelling


Modeling of growth parameters in Sprague-Dawley rats as

an alternative in preclinical toxicology
Juan C. Polo Vega, Lizet Aldana Velazco, Jorge Castro Velazco, Yadira Rodríguez Domínguez, Rubén
Amaya Izquierdo, Amalia Hernández Santana, Laura Martínez Pérez
Center for Genetic Engineering and Biotechnology (CIGB), Cuba.
ABSTRACT
Context: Animal models are one of the main tools for preclinical toxicological studies. Although they provide essential
components for research, with multiple benefits for both humans and other species, the costs in terms of animal lives,
potential suffering, and discomfort, are an essential part of considering their use, which is why insists on the search for
alternative replacement methods, among which are computational or “in silico” methods based on mathematical prediction
or simulation models.
Objective: To develop linear regression models to estimate body growth parameters of Sprague-Dawley rats under the
specific conditions of vivarium of the Center for Genetic Engineering and Biotechnology (CIGB).
Methods: A retrospective, longitudinal study was carried out using a sample of untreated rats.
Results: Preliminary mathematical models of excellent statistical quality (R2PROM = 95.9 %) were obtained for the prognosis of
the main body growth parameters of Sprague-Dawley rats according to sex and chronological age.
Conclusions: Once the proposed models have been validated, they would allow the generation of reference patterns to assess
the development of Sprague-Dawley rats, one of the most used species in preclinical toxicology, under the specific
conditions of the CIGB's closed facilities for housing experimental animals, or other similar ones at the national level,
avoiding the use of untreated control animals for the endpoints related to growth measurements.
Keywords: growth; simulation model; Sprague-Dawley rats; toxicology


Characterization of adverse drug reactions in the treatment

of Cuban hospitalized COVID-19 patients: analysis using a
survey, Cuba 2021
Lizette Gil del Valle1*, Pablo Sariol-Resik1, Tatiana Prieto-Dominguez1, Waldemar Baldoquin-Rodríguez1,
Beatriz Sierra-Vázquez1, Ana B. Pérez-Díaz1, Rosario Gravier Hernández1, Mario M. Delgado-Guerra2,
Joniel A. Sánchez-Márquez2, Olga E. López-Fernández2, Faustina Fonseca-Betancourt2, Liana Valdés-Lanza3,
Odalys Orraca-Castillo3, Xaveer Van Ostade4, Wim Vanden Berghe4, Veerle Vanlerberghe5, M. Guadalupe
Guzmán-Tirado1
1Institute “Pedro Kourí” (IPK), Havana, Cuba.
2HospitalErnesto Guevara, University of Informatics’ Science, Havana, Cuba.
3Universidad de Ciencias Médicas de Pinar del Río, Cuba.
4University of Antwerp, Department of Biomedical Sciences (BMW), Faculty of Pharmaceutical, Biomedical and Veterinary Sciences (FBD),
Belgium.
5Institute of Tropical Medicine, Antwerp, Belgium.
*lgil@ipk.sld.cu; ORCID: 0000-0002-8455-5518
ABSTRACT
Context: Compassionate use of potential drugs against SARS-COV2 acute infection could modify its safety profile.
Objectives: To characterize the adverse drug reactions (ADR), together with associated risk factors, among Cuban COVID-19
patients treated with chloroquine (CQ), lopinavir/ritonavir (LPV/r) and interferon α2b (IFN α2b) following Cuban protocol.
Methods: A prospective descriptive analysis of ADR was performed on 200 COVID-19 patients admitted consecutively in
three hospitals in Havana and Pinar del Río from April to July, 2020. Information on demographics, ADRs, outcomes,
behavioral and health-related factors was collected, based on a validated questionnaire and clinical records. Each potential
ADR case was assessed for causality based on WHO-UMC algorithm, concomitant drug influence, and the presence of drug–
drug interaction (DDI).
Results: The total frequency of ADR was 68.5% with predominantly disorders of the general system and gastrointestinal
disorders (45.3% vs 39.7%), 95.1% of ADRs occurred within 10 days after treatment and 42 potential DDI in 55.5% of patients
(61/110) were observed. The prevalence of ADR was: 50.9%, 31.9% and 17.6% for IFN-α2b, LPV/r and CQ, respectively. Sex
(odds ratio (OR): 0.40 [95% confidence interval (CI): 0.211-0.742), age (OR: 2.36 [95% CI: 1.02-5.44]) and the underlying
diseases (OR: 0.12 [95% CI: 0.06-0.23]) were independently associated factors for ADRs (p˂0.05).
Conclusions: The frequency of ADR and potential DDI were high respect it uses in non-pandemic times (malaria, HIV or
inflammatory diseases). The safety profile of drugs, when applied for treatment of COVID-19, showed similar
characteristics. Comorbidities, age group > 37 years old and female sex were associated with ADR.
Keywords: adverse drug reaction; chloroquine; compassionate use; interferon alpha 2 b; lopinavir-ritonavir; SARS CoV2


Incorporation of added value in preclinical studies and

safety tests of biomolecules with neuroprotective function
Teresa Diez*, Olivia T. González, Ernesto Rodríguez, Viagna Valiña, Guillermo Ajoy
Department of Molecular Neuroscience, Cuban Center for Neurosciences, Havana, Cuba.
*teresa.diez@cneuro.edu.cu
ABSTRACT
Context: The use of animal models is currently a determining factor in scientific research development. The Cuban Center for
Neurosciences has a colony of non-human primates of Macaca arctoides specie, mostly naturally aged. These primates have
been living in captivity for several decades, in conditions that differ from their natural environment in terms of habitat,
demography, structure, and social dynamics.
Objectives: The goal is to evaluate, in a blank trial, the mechanisms used to incorporate added value in preclinical studies and
safety tests in the Macaca arctoides colony from Cuban Center for Neurosciences
Methods: Seventeen animals of different age groups and sex were selected, and grouped in 11 cages composed of one animal,
pairs of females and males, or three animals. A tactile device plus positive reinforcement was used as the only means of
socialization. Through the continuous observation method, a count (from 0 to 4) was made to measure parameters such as
feeding, socialization, and learning. The animals were evaluated physiologically, cognitively, and behaviorally before being
declared suitable candidates for the development of studies to estimate the efficacy and safety of substances of interest for
their neuroprotective function.
Results: The animals learned to cooperate voluntarily in the procedures used, offering an improvement in their interactions,
increasing their sensory stimulation, and decreasing stress, which can be translated into more reliable research results.
Conclusions: The use of tactile devices together with positive reinforcement training allows the behavioral characterization
and selection of non-human primates for use as biomodels in preclinical studies and safety tests in the study of active
ingredients of interest. In addition, these means influence the animals by increasing their sensory stimulation and decreasing
their stress.
Keywords: evaluation; Macaca; positive reinforcement; training


External model-based evaluation of population

pharmacokinetic models for characterizing the genotype
effect on warfarin exposure
Gledys Reynaldo Fernández1, Victor Mangas2,3*, Karine Rodríguez2, Stephanie Reyes4, Cornelis Vlaar4,
Vilmali López5,6, Jean-Christophe M. Monbaliu7, Torsten Stelzer4, Leyanis Rodríguez8, Camila de las M. de
las Barreras1, Jorge Duconge4
1Institute of Pharmacy and Foods, University of Havana, Havana, Cuba.
2Department of Pharmacy and Pharmaceutical Technology and Parasitology, University of Valencia, Valencia, Spain.
3Interuniversity Research Institute for Molecular Recognition and Technological Development, Polytechnic University of Valencia, Valencia,
Spain.
4Department of Pharmaceutical Sciences, School of Pharmacy, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico
00936, USA.
5Department of Chemistry, University of Puerto Rico Río Piedras Campus, San Juan, USA.
6Crystallization Design Institute, Molecular Sciences Research Center, University of Puerto Rico, San Juan, USA.
7Center for Integrated Technology and Organic Synthesis, MolSys Research Unit, University of Liège, Liège (Sart Tilman), Liège, Belgium.
8Center for Pharmacometrics & System Pharmacology. College of Pharmacy. University of Florida.
*victor.mangas@uv.es
ABSTRACT
Context: The role of genetic polymorphisms to partially characterize the inter-individual variability (IIV) on warfarin
exposure has been established. In addition, several population pharmacokinetic models accounting for the interplay
between genetic polymorphisms on pharmacokinetic parameters have been published [Hamberg AK, et al., 2007; Reyes-
González et al., 2020]. However, their predictive performance and their comparability remain unknown.
Objectives: To evaluate the prediction capacity of two population pharmacokinetic models of warfarin for characterizing the
CYP2C9 genotype effect on warfarin exposure.
Methods: The study design included 9 typical subjects, each corresponding to genetic polymorphisms. A simulation-based
analysis was conducted using the published models to obtain the steady-state levels of warfarin in a typical subject (70 kg of
body weight, 71 years old) who received a dose of 5 mg/day. The pharmacokinetic models had one and two -compartments
with a first-order absorption rate constant. The elimination rate constant (Ke) of warfarin in the published models ranges
from 0.0106 to 0.005 h-1. IIV was modeled exponentially and kept fixed to the original value from the reference models.
Residual unexplained variability (RUV) was described with an additive model. All data analyses were performed based on
the population approach with the software NONMEM v7.4. Once the predictions were obtained, the 90% prediction
intervals of the 5th and 95th percentile were calculated and compared via graphical analysis (R v4.2.0).
Results: The obtained simulations show a clear graphical correspondence between the two models since the 90 % prediction
intervals from both models overlap in most of the time intervals and in all the genotypes, except for the *2/*2 genotype.
Conclusions: The predictive capacity of two pharmacokinetic models has been successfully evaluated by graphical analysis.
Both models can be applied to simulate favorable warfarin concentration-time profiles in subjects with CYP2C9 genetic
polymorphisms, thus constituting a valuable tool to facilitate the optimization of current dosing regimens.
Keywords: external evaluation; population pharmacokinetics models; warfarin


Population pharmacokinetic model to guide the dose

selection of nimotuzumab in patients with ADPKD
autosomal dominant polycystic kidney disease
Niurys de Castro Suárez1*, Mirjam N. Trame2, Víctor Mangas Sanjuán3,4, Mayra Ramos Suzarte5, Gledys
Reynaldo Fernández1, Anaelys R. Maceo Sinabele6, Liris Pacheco Amoros7, Leyanis Rodríguez-Vera8
1Pharmacy Department, Institute of Food and Pharmacy, University of Havana, Havana, Cuba.
2Certara Strategic Consulting, Boston, USA.
3Department of Pharmacy and Pharmaceutical Technology and Parasitology, University of Valencia, Valencia, Spain.
4Interuniversity Research Institute for Molecular Recognition and Technological Development, Polytechnic University of Valencia, Valencia,
Spain.
5Center of Molecular Immunology (CIM), Havana, Cuba.
6National Center Coordinating of Clinical Trials (CENCEC), Havana, Cuba.
7State’s Center for Drug Quality Control (CECMED) Havana, Cuba.
8Center for Pharmacometrics and System Pharmacology, Department of Pharmaceutics. College of Pharmacy, University of Florida, USA.
*amaranthfan@gmail.com
ABSTRACT
Context: Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disease characterized by an overexpression of
the epidermal growth factor receptor (EGFR). Nimotuzumab is a recombinant humanized monoclonal antibody against
human EGFR.
Objectives: The aims of this study are to develop a population pharmacokinetic (PopPK) model for nimotuzumab as well as
to identify demographic and clinical predictive factors of the pharmacokinetic (PK) variability.
Methods: The PopPK of nimotuzumab was characterized using a nonlinear mixed-effect modeling approach with
NONMEM®. A total of 422 log-transformed concentration-versus-time datapoints from 20 patients with ADPKD enrolled in
a single-center phase I clinical trial were used. This clinical trial was authorized in 2009 (number 442/05.014.08-B, volume 06,
folio 000402).
Results: Quasi-steady state approximation of the full target-mediated drug disposition model with constant target
concentration best described the concentration-time profiles. A turnover mediator was included which stimulates the non-
specific clearance of mAb in the central compartment to explain the reduced levels at higher doses. Covariates had no
influence on the PK parameters. The model was able to detect that the maximum effective dose in ADPKD subjects is 100
mg.
Conclusions: This is the first PopPK study of nimotuzumab in non-oncological diseases. The developed PopPK model may be
used to guide the dose selection for nimotuzumab during routine clinical practice in patients with ADPKD. The model will
further support the ongoing investigations of the PK/PD relationships of nimotuzumab to improve its therapeutic use in
other disease areas.
Keywords: autosomal dominant polycystic kidney disease; nimotuzumab; pharmacokinetic; population pharmacokinetic


Proposal of antitumor action mechanisms of Cuban propolis

Amanda Troya Pérez1*, Evelyn Victorero Alonso2
1Pharmacy Department. Institute of Pharmacy and Food. University of Havana, Cuba.
2ECTI Sierra Maestra.
*amanda.troya@ifal.uh.cu
ABSTRACT
Context: Worldwide, cancer is the second leading cause of death after cardiovascular diseases. Malignant cells are
characterized by eight hallmarks, which are targets for therapies that eradicate them. In the search for these therapies, there
has been extensive research on the application of natural products, including Cuban propolis. Research on the antitumor
action of this product has increased in recent decades. Despite this, the information is still not sufficient.
Objective: To propose possible mechanisms of action of Cuban propolis on several tumor sites based on the effects
demonstrated by its components individually.
Method: A descriptive and analytical study, based on the review of the literature in the period between the years 1990 and
the second quarter of 2021, was convinced with the identification of articles related to the antitumor activity of Cuban
propolis and its isolated components in the Databases: Google Scholar, Medline, and PubMed.
Results: Has been confirmed that Brown propolis is rich in polyisoprenylated benzophenones, while red and yellow propolis
are enriched with flavonoids and triterpenoids, respectively; and its antitumor activity has been proved on colorectal,
hepatocellular, breast and larynx cancer.
Conclusion: Finally, it is proposed that they could exert their antitumor activity through inhibition of invasion and metastasis,
activation of tumor suppression, immunomodulation and elimination of cell death resistance, replicative immortality, and
proliferative signaling of cancer cells in other locations.
Keywords: action mechanisms; cancer; natural products; propolis


Relationship between oxidative stress and the degree of

facial lipoatrophy in Cuban patients with HIV treated with
antiretrovirals
Lillyam Betancourt Peraza*, Carlos Rabeiro Martínez, Rosario Gravier Hernández, Lizette Gil del Valle
Pharmacological Research Department, Institute “Pedro Kourí” (IPK), Havana, Cuba.
*lillyam.betancourt@ipk.sld.cu
ABSTRACT
Context: Facial lipoatrophy constitutes one of the possible comorbidities inherent to HIV infection and one of the most
stigmatized adverse effects of antiretroviral therapy in these patients. It has been pointed out that there is a relationship
between antiretrovirals and the appearance of alterations in redox metabolism balance. The local and systemic impact of
pro-oxidant events has been recognized as an influential factor in adipose tissue changes.
Objectives: To describe the relationship between oxidative stress and the degree of facial lipoatrophy in patients with
HIV/aids.
Methods: A case-control study was carried out. Blood samples were taken from 90 people fasting for 12 hours. The
individuals were distributed into three groups: HIV/aids patients with grades 1 to 3 of facial lipoatrophy, HIV/aids patients
without lipoatrophy (positive control), and supposedly healthy patients (negative control). Hematological, hemochemical,
progression and oxidative stress biomarkers were evaluated either. Statistical analysis was performed in correspondence
with the analyzed variables, comparing the groups of interest.
Results: The groups of patients with HIV/aids showed significant differences in the levels of damage and antioxidant status
with respect to the supposedly healthy subjects. The HIV/aids-Lipoatrophy group had significantly higher damage and
lower antioxidant status than the positive and negative control groups.
Conclusions: The present work provides evidence of the presence of alterations in the redox metabolism of patients with
HIV/aids.
Keywords: aids; antiretroviral; HIV; lipodystrophy; redox metabolism


Effects of Amylovis-201 on chronic scopolamine induced

memory deficit in mice
Karla M. Freyre, Teidy G. Jiménez, Laura O. Tamayo, Roberto Menéndez-Soto*
Department of Neuropharmacology, Cuban Neuroscience Center, Havana, 11300, Cuba.
*roberto.menendez@cneuro.edu.cu; rmenendezsoto@gmail.com; ORCID: 0000-0003-2961-9651
ABSTRACT
Context: CNEURO 201 is a new compound candidate for the treatment of Alzheimer's disease (AD).
Objectives: To evaluate the efficacy of CNEURO-201(1 mg/kg, once-a-day, 10 days, op) on learning and memory in an animal
model of cognitive deficit induced by Scopolamine (1 mg/kg, once-a-day, 10-day ip).
Methods: Morris Water Maze (MWM) was used as a standard behavioral test.
Results: During the spatial training acquisition, escape latency revealed learning deficits in Scopolamine-treated mice when
compared to controls, whereas mice treated with Scopolamine and CNEURO 201 improved acquisition spatial memory on
the third and fourth day of training when compared to scopolamine group (p< 0.05 and 0< 0.01, two factorial ANOVA
followed by Bonferroni). The probe trail demonstrated that Scopolamine group shows marked disturbances in spatial
strategy in comparison with the control group. However, CNEURO 201 treated mice show a better long-term spatial strategy
when compared with scopolamine group as judged by the shorter latency in finding the target quadrant (p < 0.0), higher
number of crossings (p<0.01) and longer distance traveled in the target quadrant p < 0.05 (One-way ANOVA followed by
Turkey test).
Conclusions: The present results demonstrated that CNEURO 201 (1 mg/kg, op) prevents the cognitive deficit induced by
chronic scopolamine. These results could be associated with AchE inhibition previously observed by CNEURO 201 in vitro.
However, this should be confirmed in vivo. Our study showed that CNEURO- 201 can improve cognitive and memory
functions even at the dysfunction of cholinergic. Hence, CNEURO 201 could be a promising compound to treat AD.
Keywords: Alzheimer’s disease; cognitive deficit; CNEURO 201; scopolamine-induced amnesia


Preclinical immuno-safety evidence of CIGB-210, a novel

anti-HIV drug candidate
Anna C. Ramírez-Suárez1, Taimi Paneque-Guerrero1, Dionne Casillas-Casanova1*, Karelia Cosme2, Dania
Bacardí2, Carlos A. Duarte1, Julio Ancízar2, Emma Brown2, Jorge Castro2, José Suárez-Alba2, Hilda Garay3,
Karla Pereira1, Celia Fernández-Ortega1
1Pharmaceutical Department, Center for Genetic Engineering and Biotechnology, Ave. 31 e/158 y 190, Cubanacán, Playa, P.O. Box 6162,
Havana 10600, Cuba.
2Preclinical Research Department, Center for Genetic Engineering and Biotechnology, Ave. 31 e/158 y 190, Cubanacán, Playa, P.O. Box 6162,
Havana 10600, Cuba.

3Chemical and Physical Department, Center for Genetic Engineering and Biotechnology, Ave. 31 e/158 y 190, Cubanacán, Playa, P.O. Box
6162, Havana 10600, Cuba.

*dionne.casillas@cigb.edu.cu
ABSTRACT
Context: The need to improve HIV current therapy efficacy has led to novel biological approaches in the search for new
drugs with antiviral activity. CIGB-210 is a peptide drug candidate which inhibits HIV replication. This candidate targeted
the cytoskeleton protein vimentin conferring novelty to this approach. Efficacy and safety are the most important issues in
the development of drugs. Current HIV treatments are administered for a lifelong; consequently, continuous administration
regimens must be assayed in animal models during the pre-clinical stage.
Objective: To investigate the effect of repeated doses of CIGB-210 in C57BL6 mice.
Methods: MTS assay; CFSE assay; ELISPOT assay; Macro and microscopic evaluation of organs.
Results: CIGB-210 treated animals showed no symptoms, abnormal behavior or macroscopic alterations in the organs studied
as compared with placebo. All the animals gained weight during the study. Microscopic analysis of tissues evidenced the
absence of morphological changes in the thymus, small and large intestines, stomach, kidney, brain, or cerebellum. The
proliferative response of splenocytes and their capacity to secrete gamma interferon was not compromised by the repeated
administration of CIGB-210. Not statistically significant differences were detected for any of the parameters evaluated.
Conclusions: CIGB-210 was well tolerated in C57BL6 mice. The absence of damages attributed to the CIGB-210
administration, particularly in organs involved in immune responses and the preservation of the functionalities of the
immune system is especially relevant for the safety of this potential drug because it is intended to treat patients where
immunosuppression is one of the hallmarks of the disease.
Keywords: C57BL6; cytoskeleton; HIV; peptide; vimentin


Influence of circulating complement immune complexes in

predictive models of clinical evolution in rheumatoid
arthritis
Maité Martiatu Hendrich*, Goitybell Martínez Téllez, Vicky Sánchez Rodríguez
Centro Nacional de Genética Médica. La Habana, Cuba.
*maite@cngen.sld.cu; ORCID: 0000-0002-0117-4665
ABSTRACT
Context: The complement system is a main component of the immune system and plays a central role in many protective
immune processes. However, inappropriate complement activation underlies the pathogenesis of autoimmune diseases,
such as rheumatoid arthritis.
Objective: To identify the influence of circulating complement immune complexes, linked to C1q and C3d, in predictive
models of clinical evolution, associated with autoantibodies, sex and smoking in rheumatoid arthritis.
Methods: A 6-month prospective longitudinal study was conducted with 60 Cuban patients with rheumatoid arthritis first
treated with methotrexate. The erythrocyte sedimentation rate and the indicator of clinical disease activity were determined.
Circulating immune complexes with complement proteins C1q and C3d, anti-citrullinated protein antibodies and
rheumatoid factor were determined by enzyme-linked immunosorbent assays.
Results: The decrease in clinical activity observed during treatment corresponds to the decrease in concentrations of
circulating immune complex with C1q and C3d proteins (p <0.0001). The multivariate analisys demonstrated the influence
of circulating immune complexes formed by C1q and C3d proteins determined at the start of treatment on the clinical
activity of patients at 6 months of treatment in various prediction models (p <0.0001).
Conclusion: Circulating immune complexes formed by proteins C1q and C3d predict the clinical course of patients with
rheumatoid arthritis, associated with autoantibodies, sex and smoking.
Keywords: circulating immune complexes; complement proteins; clinical activity; rheumatoid arthritis; sex; smoking


Detection of polymorphism COMMD1 (rs11125908) by

allele-specific PCR applied to rheumatoid arthritis
Maidel C. Álvarez1*, Julio R.F. Massó1, María del Carmen Domínguez Horta1, Alberto C. Benítez2, Tamara
Díaz Argudin2, Laura de la C. Bakos Ruiz2, Hugo Nodarse Cuni2, Dinorah Prada Hernández3, Jorge A.
Gómez Morejón3, Araceli Chico Capote4
1Pharmaceutical
Department, Center for Genetic Engineering and Biotechnology, Cubanacan, P.O. Box 6162, Havana, Cuba.
2PharmacogenomicsDepartment, Center for Genetic Engineering and Biotechnology, Cubanacan, P.O. Box 6162, Havana, Cuba.
3Cuban Rheumatology Institute, Clinics and Surgery "10 de Octubre" Hospital, 10 de Octubre, CP10300, Havana, Cuba.
4Hermanos Ameijeiras Surgical Clinical Hospital, Havana Center, CP. 10400, Havana, Cuba.
*maidel.carpio@cigb.edu.cu
ABSTRACT
Context: SNPs are primarily responsible for genetic variations. SNP identification is of great importance for personalized
medicine. Rheumatoid arthritis (RA) is characterized by inflammation of the synovial membrane, cartilage destruction, bone
erosion, joint deformity, and functional disability. COMMD1 is a pleiotropic protein involved in the regulation of NF-kB
important in the evolution of RA. The presence of the minority allele G of the polymorphism rs11125908 in Commd1 gene
has been associated with a higher expression of COMMD1 and a decrease in bone erosions in patients. The frequency of the
rs11125908 polymorphism for the Cuban population and its association with RA has not been described.
Objectives: To analyze the association of the polymorphism rs11125908 with RA disease through a case-control study.
Methods: AS-PCR technique was used for genotyping of 150 controls and 161 cases. Association statistical analysis was
conducted using EPIDAT-3.1.
Results: The association of the polymorphism with the disease was analyzed according to the model of inheritance. Carriers
of the AG-GG genotypes showed a significantly increased risk of RA in the dominant model (OR=1.68; [1.07-2,64 at 95%CI];
P = 0.02). In the codominant, recessive, and additive models, the risk of RA is not estimated.
Conclusions: The allelic frequency of the polymorphism rs11125908 in the control samples of the Cuban population was
0.7033 for the allele A and 0.2967 for the allele G. Studies concluded that the rs11125908 polymorphism of the Commd1 gene
could be related to RA.
Keywords: COMMD1; SNP


Healing activity of chitosan ointment 1% on skin burn

damage model in rats Cenp: Wistar
Addis Bellma Menéndez*, Yanet Mora Hernández, Guillermo Aparicio López, Odalys Valdés Martínez,
Evelyn Spencer Hernández, Jesús Domínguez Peña, Enrique Villavicencio Menéndez, Nilia de la Paz
Martín-Viaña
Havana, Cuba.
*addis.bellma@cidem.cu
ABSTRACT
Context: Chitosan is a natural, biodegradable, and biocompatible polymer, a substance that is very abundant in nature. One
of the most studied pharmacological effects is its dermoregenerating actions that confer useful properties for the treatment
of burns and wounds and even in the cosmetics industry.
Objectives: To determine the healing effect of chitosan ointment 1% in a rat skin burn injury model.
Methods: The non-clinical model was based on inducing burns in male rats Cenp: Wistar skin male, with a metallic device of
1 cm in diameter, previously immersed in boiling water (100 °C), it was placed without pressure on the skin of the animal in
the dorsal area for 20 seconds, with the aim of achieving a second-degree burn. Four treatment groups were considered:
control, placebo, chitosan ointment 1% and silver sulfadiazine cream. For each of the treatments, 0.030 g of each formulation
was administered for 14 days daily.
Results: The group administered with chitosan ointment 1% showed an increase in the speed of healing, which is evident
from the seventh day, at which time these differences reach levels of statistical significance compared to the groups
administered with the control group, placebo ointment and silver sulfadiazine. This fact becomes more evident after the
ninth day of administration since in all experimental groups significant differences are reached compared to the control.
Conclusions: The results of the present study suggest that chitosan ointment 1% promoted healing in the rat second-degree
burn damage model, applied for 14 days at the rate of one daily administration.
Keywords: polymer; rats; scorch; wound healing


In vitro antileishmanial activity of anticancer compounds:

conventional drugs and quinoxaline derivatives
Yesli García1*, Lianet Monzote1, Adiel González1, Laura Machín2, Andrey E. Shchekotikhin3, Alexander M.
Scherbakov4
1Departamento de Parasitología, Instituto de Medicina Tropical Pedro Kourí, La Habana, Cuba.
2Instituto
de Farmacia y Alimentos, Universidad de la Habana, Cuba.
3Laboratory of Chemical Transformations of Antibiotics, Gause Institute of New Antibiotics, 11 B. Pirogovskaya St., Moscow 119021, Russia.
4Department of Experimental Tumor Biology, Blokhin N.N. National Medical Research Center of Oncology, 24 Kashirskoye sh., Moscow
115522, Russia.
*yesli981117@gmail.com
ABSTRACT
Context: Leishmaniasis is a neglected tropical disease caused by protozoan parasites of the genus Leishmania. The main
control measure to treat this disease is chemotherapy. At present, there are no vaccines available to treat leishmaniasis.
Existing drugs for its treatment are expensive, toxic, and relapses have increased. Therefore, it is necessary to broaden the
search for new therapeutic alternatives.
Objectives: The aim of this work is to evaluate the antileishmanial activity of compounds with anticancer activity, including
conventional drugs and quinoxaline derivatives under development.
Methods: For this purpose, the in vitro activity and cytotoxicity of the studied compounds on Leishmania amazonensis
promastigotes and BALB/c mouse peritoneal macrophages, respectively, were determined. Using computational models,
the physicochemical properties of each product were obtained to analyze whether they complied with Lipinski's rule.
Results: The compounds evaluated in the in vitro studies were able to inhibit parasite growth with CI50 values < 100 µM.
Related to cytotoxicity, only 3 compounds showed a selectivity index > 5, including miltefosine and two quinoxaline
derivatives. All compounds complied with Lipinski's rule, since there were no violations in any of the calculated parameters.
These results may promote future research related to pharmacological repositioning for the treatment of leishmaniasis based
on the observed potential of anticancer drugs. On the other hand, derivative No. 9 (3-amino-2-cyano-7-
methoxyquininoxaline 1,4-dioxide) showed good activity, selectivity and physicochemical profile.
Conclusions: This study demonstrated the antileishmanial potentialities of anticancer compounds against L. amazonensis,
including conventional drugs and quinoxaline derivatives.
Keywords: Leishmania amazonensis; Lipinski's rule; macrophages; promastigotes quinoxaline derivatives


Development of recursive random forest algorithms for the

prediction of aqueous solubility of new drugs
Gabriela Falcón-Cano1*, Christophe Molina2, Miguel A. Cabrera-Pérez1,3
1Unidadde Modelación y Experimentación Biofarmacéutica. Centro de Bioactivos Químicos. Universidad Central “Marta Abreu” de las Villas.
Santa Clara, Villa Clara, Cuba.
2PIKAÏROS, S.A. Saint Orens de Gameville, France.
3Departamento de Ciencias Farmacéuticas, Facultad de Ciencias, Universidad Católica del Norte, Angamos 0610, Antofagasta, Chile.
*gfalcon@uclv.cu
ABSTRACT
Context: Computational prediction of aqueous solubility plays a critical role during the drug design and development stages.
Traditionally, the limited performance of in-silico solubility models has been attributed to the lack of high-quality solubility
data for drugs and drug-like molecules. However, recent studies suggest that the poor reliability of solubility models is not
related to the quality of experimental data and that more accurate methodologies are needed to predict the aqueous
solubility of new molecules.
Objective: To develop a computational model based on novel modeling techniques to predict the aqueous solubility of new
molecules.
Methods: All steps of the modeling methodology were automated in the KNIME analytical platform. Recommended good
practices for chemical and experimental data curation were followed to obtain a structurally diverse aqueous solubility
database. Two new recursive random forest approaches were developed for data cleaning and variable selection. A
consensus model based on regression and classification tree algorithms was implemented to correlate the molecular
descriptors with solubility data.
Results: The model was successfully validated by cross-validation and using an external validation set, achieving statistics
comparable to, or even surpassing previously published models. In addition, the model was validated with two external sets
from the second “Solubility Challenge”, achieving comparable results to the top-ranked models from the challenge.
Conclusions: The KNIME workflow is freely available online to ensure the reproducibility of the model and its application as
a tool for preliminary assessment of the aqueous solubility of new molecules.
Keywords: aqueous solubility; ADME; KNIME; machine learning; Quantitative Structure-Property Relationship (QSPR);
random forest; supervised recursive selection


Effect of circadian rhythm on the pharmacokinetics of twice-

daily tacrolimus in renal transplant recipients
Beatriz Fernández1*, Zeyar Mohammed Ali1, Pere Fontova2, Anna Vidal-Alabró2, Marinda Meertens1, Josep
M. Grinyó2, Nuria Lloberas2, Helena Colom1
2Nephrology Department, IDIBELL, Hospital Universitari de Bellvitge. Department of Clinical Sciences, Campus Bellvitge, University of
Barcelona, Spain.
*bea.fernandez.a@gmail.com
ABSTRACT
Context: Tacrolimus is an immunosuppressant drug used to prevent graft rejection after solid-organ transplantation.
Tacrolimus pharmacokinetics profile shows a large inter- and intraindividual variability. Circadian rhythm and genetic
polymorphisms on cytochrome P450 enzymes are some of the factors that can explain part of this variability.
Objectives: Develop a population pharmacokinetic model to describe the influence of the circadian rhythm and metabolic
polymorphisms on tacrolimus pharmacokinetics in renal transplant patients after an immediate-release oral formulation.
Methods: Tacrolimus exposure data from 36 patients treated with tacrolimus twice daily were simultaneously analyzed. Day
(0-12 h) and night (12-24 h) areas under the curve were described by intensive sampling. A population pharmacokinetic
analysis was performed using nonlinear mixed-effects modeling with NONMEM.
Results: A two-compartment model with first-order absorption, lag time and linear elimination best described the
experimental data obtained. Interindividual variability was associated with clearance, central compartment distribution
volume and intercompartmental clearance, assuming a log-normal distribution. The effect of the circadian rhythm on
clearance and absorption rate constant was modeled with a cosine function, accordingly, Akaike information criterion
decreased. The introduction of CYP3A5 polymorphisms as a covariate on clearance decreased the objective function value
significantly (p < 0.001). The prediction-corrected visual predictive check proved the descriptive and predictive capacity of
the developed model.
Conclusions: The generated model was able to describe the variation on tacrolimus pharmacokinetics because of the circadian
rhythm and the influence of genetic polymorphisms of CYP3A5 on clearance which can be an important factor to optimize
tacrolimus dosage.
Keywords: circadian rhythm; cytochrome P450 CYP3A; genetic polymorphisms; kidney transplantation; metabolism;
population pharmacokinetics


CYP3A5*3 and CYP3A4*22 Cluster influencing the new

Tacrolimus MeltDose® formulation target concentration: A
population approach
Zeyar Mohammed Ali1,2, Marinda Meertens1,2, Beatriz Fernández1,2, Pere Fontova1, Anna Vidal-Alabró1,
Helena Colom2*, Nuria Lloberas1
1Laboratory4122, Nephrology Service and Laboratory of Experimental Nephrology, University of Barcelona, Campus Bellvitge, Pavelló de
Govern, Feixa Llarga, s/n, L’Hospitalet de Llobregat, 08907 Barcelona, Spain.
2Biopharmaceutics and Pharmacokinetics Unit, Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry
Department, School of Pharmacy, University of Barcelona, Barcelona, Spain.

*helena.colom@ub.edu
ABSTRACT
Context: The high inter-patient and intra-patient variability of tacrolimus in addition to the narrow therapeutic index makes
it challenging to establish an optimal dose for the drug. A new tacrolimus MeltDose® formulation has been developed,
which increases bioavailability and reduces fluctuation between maximum and pre-dose concentrations compared with the
immediate-release formulation. However, there have been only a few studies to investigate the effect of genetic
polymorphism on the formulation.
Objectives: Develop a population pharmacokinetics model for Tacrolimus MeltDose ® formulation to establish optimal dose
and evaluate the influence of CYP3A5 (*1/*3, *3/*3) and CYP3A4 (*1/*1, *1/*22) polymorphism on the clearance of the
formulation.
Methods: 655 samples were obtained from 98 stable renal transplant patients using a once-daily TAC MeltDose® formulation.
Thirty were from a prospective, non-randomized single-center trial with a full AUC profile, the rest from the clinical routine
check-ups with pre-dose sampling. Patients were categorized as Rapid, Intermediate, and Low metabolizers according to the
CYP3A4 and CYP3A5 cluster polymorphism.
Results: The PK profile is well described by a two-compartment model with time-lagged first-order absorption modeled with
transit compartment models. The CYP3A5*3 G>A(rs776746) and CYP3A4*22 C>T (rs35599367) single nucleotide
polymorphisms cluster were identified as significant covariates reducing 12.5% the inter-patient variability in CL and each
cluster population had a different clearance value.
Conclusions: A PopPK model was successfully developed for TAC MeltDose® in stable kidney recipients. A personalized
dosing strategy for the formulation in renal transplant patients could be achieved by consideration of different genetic
cluster polymorphisms.
Keywords: MeltDose®; population pharmacokinetics; renal transplant; tacrolimus; transit model

ECFA 2022. S6- FOOD SCIENCES AND TECHNOLOGY-DIET AND HEALTH-EVALUATION AND CONTROL OF FOOD-SCIENCE AND
GASTRONOMY
René Tejedor Arias, PhD / María Isabel Lantero, PhD
Viability of probiotic microorganisms in symbiotic dairy

products during storage
René Tejedor Arias1*, Aldo Hernández Monzón1, Clara Águila Thalenko1,2, Ramón De Cangas Morán1,3, Luz
A. Caballero Pérez1,4
1Instituteof Pharmacy and Foods (IFAL). University of Havana (UH). Cuba.
2Labiofam. Havana, Cuba.
3Feed Your Health Foundation, Asturias, Spain. IFAL-UH doctoral student.
4University of Pamplona, North Santander, Colombia. IFAL-UH doctoral student.
*renetejedor09@yahoo.es
ABSTRACT
Context: Symbiotic functional foods combine probiotic microorganisms and prebiotic substances, which, when consumed in
adequate amounts, produce beneficial effects on health. The viability of probiotics under food processing and storage
conditions will be relevant for their subsequent transit through the digestive system and integration into the microbiome.
Objective: To determine, during storage under controlled conditions, the viability of the probiotics used as co-cultures in the
design of three symbiotic dairy products.
Methods: In the foods developed, co-cultures of recognized probiotic strains were used: a) fermented milk with
fructooligosaccharides: Bifidobacterium bifidum and yogurt culture (1:1); b) fresh cheese with vegetable ingredients:
Lactobacillus acidophilus and Lactobacillus casei (1:1) and c) milk ice cream: Lactobacillus rhamnosus, Lactobacillus plantarum and
Saccharomyces boulardii (1:1:1). Viability was determined with MRS Agar with or without antibiotics for bacteria and
Saboreaud Dextrose Agar for yeasts at different storage periods.
Results: The probiotic counts during storage were above the recommended therapeutic values by FAO (6 - 7 log UFC/g). For
milk fermented for 30 days at 4-6 °C and in fresh cheese for 14 days at 6-8 °C, with good sensory quality and safety in both.
In ice cream, microencapsulated probiotics, spray-dried in a prebiotic matrix, met these criteria for five months at -18 ± 1 °C.
Conclusions: The designed symbiotic dairy products maintained the probiotic therapeutic values recommended during their
shelf life, for this reason, they could be used as functional probiotic products in human feeding.
Keywords: dairy products; functional foods; prebiotics; probiotics; viability

GASTRONOMY
Survival of microencapsulated probiotic strains against

simulated gastric, intestinal, and prebiotic conditions
Luz A. Caballero Pérez1,2*, René Tejedor Arias2, Elaysa J. Salas Osorio3
1Universityof Pamplona. GIBA Research Group. Pamplona, Norte de Santander, Colombia - UH - IFAL, PhD student in Food Science.
2University of Havana, Institute of Pharmacy and Food, IFAL, Doctorate in Food Sciences. Havana Cuba.
3University of the Andes, Faculty of Dentistry, Department of Biopathology. Biopathology Research Group. Mérida, Venezuela.
*luzcaballero@unipamplona.edu.co
ABSTRACT
Introduction: In previous works was achieved the microencapsulation of a mixed culture of three probiotic strains in a
prebiotic matrix constituted by native cassava starch, sodium alginate and oat flour by spray drying.
Objective: To evaluate the survival of the microencapsulated probiotic mixed culture to gastric, intestinal, and prebiotic
conditions in vitro.
Methods: Gastric simulation was evaluated at three pH levels (1.0, 2.0 and 3.0), intestinal with bile salts at 0.1, 0.2 and 0.3%
(v/v), pH 7.5 (30 min and agitation for 4 h) and prebiotic test using MRS culture liquid with and without sugar source,
inoculating the microencapsulated and free probiotic strains at 36 ± 1 °C, with microbial counts for 24 hours.
Results: The viability of the mixed culture of probiotic strains microencapsulated in a prebiotic matrix was maintained at
79.35-82.85% for lactobacilli and 78.06-78.63% for S. boulardii yeast, at pH 1.0 and bile concentration (0.3%) after four hours of
exposure, while the mixed culture in the free state reduced its viability, 47% at pH 1.0 and 68% at 0.3% bile. The
microcapsules were shown to serve as a prebiotic wall system with S. boulardii counts of 9.34 log-ufc/g and 10.02 log-ufc/g
for lactobacilli at 20 hours.
Conclusion: The results demonstrated the protection exerted by the prebiotic microspheres obtained by spray drying against
the stressful conditions of the simulated gastrointestinal and prebiotic system, maintaining the therapeutic levels of the
probiotic strains.
Keywords: gastrointestinal barrier; Lactobacillus; prebiotics; S. boulardii; survival

GASTRONOMY
Fermentation of cocoa with the addition of yeast

(Saccharomyces cerevisiae) and enzyme (PPO's) in the
reduction of heavy metals
Luis H. Vásquez1,3*, Jaime F. Vera1, Kerly E. Alvarado1,3, Frank G. Intriago2
1Faculty of Industrial Sciences and Production "La Represa" km 7.5 via Quevedo San Carlos, Province of Los Ríos. Ecuador.
2Faculty of Zootechnical Sciences, Sitio Ánima, Km 2.5 via Chone-Boyacá. Chone-Manabi. Ecuador.
3Graduate Institute, Master in Agroindustry, Technical University of Manabí. Ecuador.
*luis.vasquez2015@uteq.edu.ec; ORCID: 0000-0003-1850-0217
ABSTRACT
Context: Cocoa has economic and productive significance within Ecuadorian territory and countries where this type of crop
is developed.
Objectives: To assess the effect of the addition of Saccharomyces cerevisiae yeast and polyphenoloxidase enzymes during
fermentation.
Methods: A (DCA) was used with bifactorial arrangement. Three percentages of yeast (0, 0.5 and 1%) and three percentages
of enzymes (0, 2.0 and 2.5%) were evaluated. The micro-fermenting boxes with a capacity of 2 kg were adapted. During the
fermentation, the temperature, pH, °Brix were measured; drying was carried out with humidity of 7% and the Seed Index,
Percentage of test and cotyledon, cutting test, pH, °Brix, sensory analysis and cadmium were assessed.
Results: The results show an increase in temperature (43.03 °C) and pH (5.44) in treatment 7 corresponds to Yeast at 1 % w /
w without enzyme (0.0%) (control) and a decrease in °Brix (6.04). Cutting tests showed significant effects on fermented
grains by including yeast and enzyme. The sensory evaluation resulted in statistical differences in the taste parameter
(spices) best treatment T6 consists of Yeast 0.5% w/w with enzyme induction (PPO s) (2.5%) And T9 Yeast at 1 % w/w with
enzyme induction (PPO s) (2.5%) unlike the control.
Conclusions: The presence of cadmium complied with the requirements established in regulation 488/2014 of the European
Union (< 0.80 mg / kg) there was a decrease in cadmium from 0.32 (control) to 0.20 mg/kg.
Keywords: cacao; cadmium; physicochemical; polyphenoloxidases; Saccharomyces cerevisiae

GASTRONOMY
Exogenous induction of Rhizobium japonicum in

fermentative mass of two varieties of cocoa as a strategy for
cadmium reduction
Kerly E. Alvarado1,3*, Jaime F. Vera1, Luis H. Vásquez1,3, Frank G. Intriago2
1 Faculty of Industrial Sciences and Production "La Represa" km 7.5 via Quevedo San Carlos, Province of Los Ríos. Ecuador.
2Faculty of Zootechnical Sciences, Sitio Ánima, Km 2.5 via Chone-Boyacá. Chone-Manabi. Ecuador.
3Graduate Institute, Master in Agroindustry, Technical University of Manabí. Ecuador.
*kerly.alvarado2015@uteq.edu.ec; ORCID: 0000-0003-0494-7085
ABSTRACT
Context: The Ecuadorian cocoa paste used to produce chocolate must comply with Regulation 488/2014 regarding
permissible levels of cadmium, for marketing in the European Union.
Objectives: To evaluate the effect of the application of Rhizobium japonicum in fermentation on the reduction of cadmium
content in cocoa almonds. In the same way, the ability to improve sensory aspects was determined, with the induction of the
microorganism.
Methods: Once harvested, different concentrations of 3% and 5% were inoculated. During the fermentation time,
physicochemical analyses (pH, °Brix and temperature) were carried out. At the end of the fermentation process, the almonds
were dried in the sun for 6 days. In the dried almonds, the cutting test was carried out to know the fermentative state
according to the INEN 176/2018 standard. In cocoa paste, a sensory analysis was applied where aroma, taste, bitterness was
evaluated, with the help of a panel of experts.
Results: The application of the microorganism allowed to reduce the cadmium content from 0.36 to 0.29 mg/kg (ppm) that
are within the admitted parameters of the European Union. From a cost analysis, the profitability of this type of treatment
was determined, resulting in a cost of 52.02 USD in the control samples, T1 and T4 and 53.94 USD for inductions T2, T3, T5,
T6.
Conclusions: The induction of microorganisms contributed to the decrease in cadmium content in cocoa samples.
Keywords: analysis; cadmium; cocoa; sensory; treatment

GASTRONOMY
Quantitative Risk Analysis of Staphylococcus aureus

enterotoxins in fresh artisan cheese
Ailin Martínez 1*, Nivian Montes de Oca1, Dianys Remón1, René Tejedor Arias2, Maivis Hernández2
1Trial Center for Quality Control of Foods (CENLAC), National Center for Animal and Plant Health/Animal Health Department, Jamaica
Road and National Highway Km 23 1/2, PO Box 10, PC 32700, San José de las Lajas, Mayabeque, Cuba.
2Institute of Pharmacy and Foods, University of Havana. 23 Avenue 21425, La Coronela, la Lisa, Havana City, Cuba.
*ailin@censa.edu.cu; ORCID: 000-0003-0716-9290
ABSTRACT
Context: Chesees made from unpasteurized milk are a potential source of transmission of pathogenic microorganisms. In
Cuba, an important proportion of fresh cheese is made in artisan cheesemaking. Microbial hazards have been identified in
artisan cheese made from raw milk. Different studies report contamination with S. aureus in artisan fresh cheeses.
Objectives: To estimate the risk of intoxication due to the consumption of artisan fresh cheeses contaminated with
Staphylococcus aureus enterotoxins.
Methods: The model was constructed as a series of unit operations according to Quantitative Risk Assessment Model,
including the evaluation of the initial contamination during the cheese manufacturing process, the growth during storage
and dose-response after consumption. 95 cheese samples were used to determine the uncertainty of the prevalence of
enterotoxigenic S. aureus. The @Risk program version 7.5 (Palisade, USA) was used to run the Monte Carlo simulations, 1000
iterations.
Results: The model predicted that in 51.7% of cases, consumers are exposed to a minimal dose of S. aureus enterotoxins, while
46.9% of people will be at risk of getting ill for enterotoxins of S. aureus by artisan fresh cheese consumption.
Conclusions: Good manufacturing practices, adequate storage conditions and inspections at cheese production farms and
points of sale by health authorities are essential to ensure that products are available to consumers in good sanitary
conditions.
Keywords: cheese; Risk Assessment; safety; Staphylococcal Enterotoxins

GASTRONOMY
Isolation and characterization of microbial strains from

human breast milk
Taimy Hernández1, Ileana Sánchez2, Naldis López1, Leyanis Prieto1, Amilcar Arenal3*
1Department of Food Science and Technology. Faculty of Applied Sciences. University of Camagüey, Circunvalación Norte, entre Ave. Ignacio
Agramonte y Camino Viejo Nuevitas, Camagüey, Cuba. CP: 74650.
2Microbiology Laboratory. Centre for Genetic Engineering and Biotechnology of Camagüey, Circunvalación Norte P.O. Box. 387, Camagüey,
Cuba. CP: 70100.

3Faculty of Agriculture Sciences. University of Camagüey, Circunvalación Norte, entre Ave. Ignacio Agramonte y Camino Viejo Nuevitas,
Camagüey, CP: 74650, Cuba.

*taimy.hernandez@reduc.edu.cu
ABSTRACT
Context: The evidence about the probiotic´s benefits on health is increasing. Most probiotics comes from fermented foods and
human guts. However, an interest in human milk as an isolation source has recently emerged.
Objectives: The present study aimed to characterize microbial isolates from human breast milk.
Methods: The isolates were identified using its 16S rDNA sequences and biochemical characteristics. The characterization of
the isolates was carried out by determining their resistance to gastrointestinal conditions (pH, bile salts and lysozyme,
antibiotic resistance), antimicrobial activity, biofilm formation, exopolysaccharide production and carbohydrate
fermentation profile.
Results: Five isolates were obtained belonging to the species of Lactobacillus fermentum and Lactobacillus arizonensis, with
probiotic properties. The isolates LT1512 and LM1563C presented the best probiotic properties due to high percentages of
survival under gastrointestinal conditions, antimicrobial properties against Escherichia coli, antibiotic resistance, biofilm
formation and a wide fermentative characteristic related to carbohydrates contained in food.
Conclusions: This study confirmed that the breast milk of women with a healthy food pattern is a good source of isolation
from lactic acid bacteria. Five isolates were obtained with good probiotic potential.
Keywords: dairy; lactic acid bacteria; Lactobacillus; probiotic

GASTRONOMY
Improvements in the quality control of nutritional

supplements produced by BioCen to prevent anemia
Yenela García1*, Nashelly Esquivel1, Lais Pérez 2, Eduardo Besada 2, Rosa M. Simpson2, Mitchel Reyes1,
Merlin Falcón1, Digna Álvarez1, Felicia Poey1, Sara Hernández1
1Laboratorio de Antianémicos y Nutracéuticos. Centro Nacional de Biopreparados (Biocen). Carretera Beltrán km 1 1/2, Bejucal. Mayabeque.
Cuba.
2Empresa Laboratorio Farmacéutico Roberto Escudero. Avenida 20 de Mayo No. 540. Cerro, La Habana. Cuba.
*yenela@biocen.cu
ABSTRACT
Context: The nutritional supplements in tablets as NEOTROFIN®, NEOTROFIN CF® and COMBIFER® and the liquid form
called TROFINVITAL®, are used to prevent anemia in pregnant women, women of childbearing age, the elderly, and
children. These products contain an enzymatic hydrolyzate of bovine blood as the main bioactive ingredient. All
formulations of these nutritional supplements contain sodium benzoate as a preservative substance.
Objetive: To evaluate new quality requirements in nutritional supplements and to study the stability of these new
requirements in the proposed guarantee period.
Methods: The sodium benzoate content quality requirement was incorporated into the Dehydrated Blood Hydrolyzate (DBH)
used to manufacture the supplements in tablets, as well as into the TROFINVITAL® product, for which a quantification
method was developed by HPLC. In all products, the acceptance limit for iron content was modified by using a new
analytical method for the quantification and the total protein test was added.
Results: The industrial batches of DBH and nutritional supplements met the new quality specification for the new
requirements. TROFINVITAL® was shown to maintain its quality requirements for 24 months, DBH for 9 months and tablets
for up to 12 months.
Conclusions: The improvements in the quality control of all products were incorporated into the health registry at the
regulatory entity in Cuba, INHEM. Finally, these changes in the quality control of all products were approved by the BioCen
Quality Management System.
Keywords: anemia; quality control; nutritional supplements

GASTRONOMY
Safety management system (HACCP) with a focus on the

circular economy in mini-industries in Cuba
Jenny Correa Soto1*, Yanelis Chongo Quiñones2
1Center for Energy and Enviromental Studies, University of Cienfuegos, Cienfuegos, Cuba.
2Leader of the Department of Organization and Improvement, Integral Agricultural Company Cienfuegos, Cienfuegos, Cuba.
*jcorrea@ucf.edu.cu
ABSTRACT
Context: The preparation of safe and quality food from mini-industries; requires that it be carried out in a friendly and
sustainable way, based on the principle of Circular Economy.
Objectives: Demonstrate the need for a food safety management system with a focus on the Circular Economy
Methods: The food industry, especially mini-industries, is one of the productive sectors with the greatest impact on the
environment, due to the levels of raw materials and energy used or waste resulting from the process. These present their
limitations that they have not been able to achieve the required food safety in their products, therefore they demand a
Hazard Analysis and Critical Control Points (HACCP) system.
Results: The UEB Integral Agropecuaria Aguada has a meat and a dairy mini-industry to give continuity to the production
process of the Buffalo Genetic Project, which requires conceiving in its productions a model that guarantees food safety with
a Circular Economy approach, based on a scheme circular extraction – design – production – consumption – recycling,
where the materials are recycled and can be reintegrated into the production process and the same cycle is continued;
emphasizing the reuse and recovery of waste as a fundamental axis, maintaining the value of the products offered and the
materials used in their production for as long as possible, waste is reduced to the maximum and energy efficiency is
increased.
Conclusions: This management model will help mini-industries to generate advantages over their competitors by reflecting
that their productions are safe in a sustainable way.
Keywords: circular economy; Hazard Analysis and Critical Control Points; mini-industries; safe management system

GASTRONOMY
Good Manufacturing Practices in the “Rancho Vega” mini-

industry
Anaiza Pérez*, Aday Oliva
Institute of Pharmacy and Foods, University of Havana. Cuba.
*aperezmartinto@gmail.com
ABSTRACT
Context: Foodborne Diseases are a serious problem for the health of consumers and contribute significantly to increase
diseases and mortality. This is caused by contamination of derived of virus, bacteria, fungus, and parasites in any stage of
food production.
Objective: To evaluate the Good Manufacturing Procedures (GMP) in the “Rancho Vega” mini-industry.
Methods: Sanitary Inspection Guide was applied in coordination with the management's entity and INHEM/MINSAP. The
level of knowledge of the handlers and managers in relation to food hygiene was diagnosed. Sanitation Standard Operating
Procedures were evaluated by the entity, and microbiological determinations were carried out for the syrups and jams.
Results: The application of the Sanitary Inspection Guide showed 87 % and 94 % of qualitative and quantitative positivity
results, respectively. The survey showed poor knowledge of the handlers regarding the factors that contribute to food
contamination and the incorrect use of the cleaning and disinfection program applied to the center.
Conclusions: The application of the Sanitary Inspection Guide demonstrated adequate hygienic conditions. Compliance of the
Going-Forward Principle was evidenced, and the products of mini-industry were within the established microbiological
standards.
Keywords: food hygiene; foodborne diseases; going-forward principle; mini-industry

GASTRONOMY
Design of a HACCP system in fruit and vegetable

processing mini-industry
Rocio Cartaya Quintero1*, Amaya Cabrera Muñoz1, Roxana Hidalgo Fernández2, Lourdes Pérez Méndez3
1Department of Food, Institute of Pharmacy and Food, University of Havana, La Lisa, Havana, Cuba.
2Laboratory S.I.S. Cubacontrol S.A., Caudal Group, La Lisa, Havana, Cuba.
3Center for quality management and development, Havana, Cuba.
*rociocq@yandex.com, ORCID: 0000-0001-7280-9237
ABSTRACT
Context: Safety is an essential requirement for food quality that must be guaranteed throughout the entire agri-food chain.
Objectives: It is necessary in the current context to guarantee food safety and suitability, so it was proposed as a general
objective to design a Hazard Analysis and Critical Control Points (HACCP) system that contributes to the management of
food safety in the mini-industry “Amanecer” fruit and vegetable processor.
Methods: The diagnosis of the prerequisites was based on NC 143: 2010 and used documentary review, on-site observation of
compliance with the requirements established in the applicable Cuban regulations and interviews with workers; while the
design of the HACCP system was based on the methodology of NC 136: 2017. The investigation was carried out in January
2021.
Results: The fulfillment of the prerequisites and the good hygiene preparation of the food handlers and the storekeeper was
evidenced, verifying the compliance and effectiveness of the training program. The absence of records of the microbiological
evaluations of the water was identified as the main deficiency. The HACCP system was designed to identify the heat
treatment and packaging operations as critical control points, defining their critical limits, preventive measures, and
corrective actions for each one. Several records were proposed to complement the documentary information on the mini-
industry.
Conclusions: The mini-industry is able to adequately implement the designed HACCP system and improve the safety of its
food production.
Keywords: fruits and vegetables; food safety; HACCP system; mini-industry

GASTRONOMY
Diagnosis of the requirements of the NC ISO/IEC 17025:

2017 in the quality control laboratory of the UEB Paraíso
Probiotic Yogurt Factory of the LABIOFAM injectable
products Company
Claudia Aguabella*, Ana M. Colominas
Department of Food Sciences, Faculty of Pharmacy and Food, University of Havana, Cuba.
*aguabellaclaudia@gmail.com
ABSTRACT
Context: The NC ISO/IEC 17025: 2017 "General requirements for the competence of testing and calibration laboratories"
guarantees the technical qualifications necessary to generate valid and reliable results. For the Quality Control Laboratory of
the UEB Paraíso Probiotic Yogurt Factory, it is of vital importance to demonstrate its competence in the analysis of the
attributes that it controls, to guarantee the market a yogurt of the highest quality.
Objective: Carry out a diagnosis in the Quality Control Laboratory of the UEB Paraíso Probiotic Yogurt Factory to evaluate
the degree of compliance with the requirements established in the Cuban Standard ISO / IEC 17025: 2017.
Methods: A diagnosis was developed in the Quality Control Laboratory to evaluate the degree of compliance with the
requirements demanded in the Cuban Standard ISO/IEC 17025: 2017 using a checklist as an instrument.
Results: It was found that the laboratory under study partially complies with the provisions of the standard.
Conclusions: Based on the results obtained, a set of suggestions and recommendations are proposed to achieve full
compliance with the requirements of the NC ISO/IEC 17025: 2017 and aspire to the future accreditation of the Quality
Laboratory of the UEB Paraíso Probiotic Yogurt Factory.
Keywords: check list; quality diagnosis; quality standards

GASTRONOMY
Implementation of a HACCP system in a mini-industry that

produces pre-prepared tostones
Yanelis Chongo Quiñones1*, Rocio Cartaya Quintero2, Rosanny La O Castellón3, Jenny Correa Soto4
2Department of Food, Institute of Pharmacy and Food, University of Havana, La Lisa, Havana, Cuba.
3Integral Agricultural Company Cienfuegos, Cienfuegos, Cuba.
4Center for Energy and Enviromental Studies, University of Cienfuegos, Cienfuegos, Cuba.
*yanelischongo@gmail.com
ABSTRACT
Context: Food safety in food processing mini-industries is a topic of great relevance and social impact.
Objectives: Implement a HACCP system to improve food safety management in the “El Tostón” mini-industry.
Methods: The procedure was based on the stages of the Deming cycle and NC 136:2017. To diagnose the HACCP
prerequisites, the checklist of the Hygiene and Quality Management instrument was used. To identify the dangers that
threaten the quality and safety of the pre-processed toston, the following were used: process diagrams, cause-effect matrix,
multiple voting and control charts; to classify the risks: risk matrix and to determine the critical control points: decision tree.
The critical limits were established taking into consideration the current regulations, the available scientific literature, and
the criteria of specialists.
Results: In the evaluation of the prerequisites of the HACCP system, the greatest deficiencies were in the pest control plans,
training and control of handlers, and traceability control. Biological contamination due to insufficient time and temperature
of vaporization and deep freezing, incorrect handling and poor hygienic practices and poor conservation and transportation
were identified as the main root causes that affect the safety of the product. The processes were determined as PCC:
vaporization, deep freezing, and storage; corrective measures were established, and the critical variables involved in them
were monitored.
Conclusions: The implementation of the proposed system contributed to the improvement of the quality and safety of pre-
processed toston.
Keywords: food processing mini-industry; food safety; HACCP system; toston

GASTRONOMY
Determination of cadmiun and lead in fresh vegetables

Lyi Wong Trujillo1*, Ariel González García2, Carlos García Pino1
1Sanitary Chemistry Section, National Institute of Hygiene, Epidemiology and Microbiology, La Habana, Cuba.
2Tauro´s Company, La Habana, Cuba.
*lyi@infomed.sld.cu
ABSTRACT
Context: The demand for fresh vegetables by the population has increased and to the same extent the risk of exposure to
heavy metals resulting from soils exposed to pesticides or inorganic fertilizers, untreated or residual irrigation water,
anthropogenic activities, etc. A long-term intake of high concentrations of them has a negative impact on human health.
Objectives: To determine cadmium (Cd) and lead (Pb) in fresh vegetables by Flame Atomic Absorption Spectrophotometry
and to apply it in sample analysis and verify according to regulations.
Method: The study was carried out in two parts: the validation of the methodology and later the processing, determination
and reading of the results of several samples used of fresh vegetables from various organic farms in Havana City. The
validation process was carried out according to NC-TS 368: 2010. The detection limit, quantification limit, precision,
linearity, and accuracy of the analytical methodology were evaluated. They were processed and mineralized by dry method
and the readings were made in FAAS.
Results: The parameters evaluated for the method were satisfactory, demonstrating that the method meets the established
analytical requirements, offering reliable results for the Cd and Pb analysis, all the parameters were acceptable except for the
detection and quantification limits.
Conclusions: Pb was not detected in the analyzed samples by the quantification method used and the Cd values obtained
were below the maximum permissible limits established by Codex Stand 193: 2015 standards. The concentrations found for
both metals are lower than those reported by NC 493:2015 ¨Metal Contaminants in Food Sanitary Regulations.
Keywords: Flame Atomic Absorption Spectrophotometry; organic farm; validation

GASTRONOMY
Evaluation of a new chromogenic and fluorogenic method

for the detection of Salmonella in eggs
Chavely Galvez Encinosa1*, Ivonne Alfonso Valdez1, Silvia C. Morales Ramos2
1Microbiological Diagnosis Group, Research and Development Directorate, National Center for Biopreparations, Carretera Beltrán, Km 3 ½
Bejucal, Zip Code 32600, Mayabeque, Cuba.
2Institute of Pharmacy and Food (IFAL). University of Havana, Cuba.
*chavely.galvez@biocen.cu
ABSTRACT
Context: Worldwide, the incidence of Salmonella in food is high, affecting a large number of people every year with the
increase of new serotypes and more resistant strains. That is why it is important to carry out quality control, using new
methodologies that reduce detection time and guarantee the safety of the final product. The National Center for
Biopreparations proposes an alternative chromogenic and fluorogenic methodology for the detection of Salmonella using the
CromoCen® SALM medium, in accordance with NC 1270:2018.
Objectives: To evaluate an alternative methodology for the detection of Salmonella in raw eggs in combination with
CromoCen® SALM.
Methods: For the evaluation of the method, the shell, white, mixture of yolk with white and the egg yolk were processed.
Quality parameters were determined according to ISO 16140:2016 and the alternative method with respect to ISO 6579:2017.
Results: The alternative method was more efficient than the reference methodology, with sensitivity values of 100% and
accuracy greater than 95% for raw egg. The alternative methodology can detect Salmonella in a contaminated sample even at
a concentration of 1 cfu/25 g of sample with a sensitivity equal to the reference method to detect the analyte.
Conclusions: The alternative methodology was efficient according to the parameters established in ISO 16140: 2016,
guaranteeing the quality and safety of food to be consumed safely by the population. A faster, more advantageous and
efficient methodology was considered.
Keywords: detection limit; egg; sensitivity; veracity

GASTRONOMY
Development and functional evaluation of a chromogenic

and fluorogenic method for the detection of Salmonella in
food
Ivonne Alfonso*, Claudio Rodríguez, Raisa Zhurbenko, Yordania Zayas, Claudia Filgueira
Department of Microbiological Diagnostics, Centro Nacional de Biopreparados, Bejucal, Mayabeque, Cuba.
*ivonne.alfonso@biocen.cu
ABSTRACT
Context: Technological innovation drives the search for efficient solutions, capable of creating or perfecting techniques and
the application of science to improve results.
Objectives: To develop and evaluate a new chromogenic and fluorogenic method for Salmonella detection with a CromoCen®
SALM culture medium.
Methods: The nutritional, selective and differential capacity of a culture medium for Salmonella diagnosis was evaluated
according to ISO 11133. 64 Salmonella strains and other bacteria and yeast strains were selected. The inclusivity and the
exclusivity were calculated with 60 strains. The sensitivity, relative-trueness, and level of detection of the alternative method
were calculated according to ISO 16140 with 348 samples of poultry meat, its derivatives and chicken eggs.
Results: CromoCen® SALM was able to promote the growth of Salmonella and inhibit other bacteria and yeasts, with
productivity and selectivity values according to ISO 11133. The composition was able to differentiate Salmonella from the rest
of the tested microorganisms. Its ability to detect two groups of serotypes of Salmonella was confirmed. The sensitivity and
relative-trueness values were higher than 92.98% and the level of detection was less than 1cfu/25g of product.
Conclusions: A highly nutritive, selective, and differential chromogenic and fluorogenic composition was obtained, capable of
detecting the growth of Salmonella, and differentiating the Typhi y Paratyphi serotypes from the rest of the microbial
population. An alternative method was designed for the detection of Salmonella, being precise and equivalent to the
reference methodology, which assures the reliability and reproducibility of the results.
Keywords: bacterial diagnosis; chromogenic and fluorogenic medium; Salmonella detection; poultry

GASTRONOMY
Evaluation of the management of the “El Caribe” restaurant

menu at the Royalton Hicacos Resort & Spa hotel
Olga L. Sosa1*, Yudenis Reyes2, Yadrián A. García3
1UEB Catering Trade and Gastronomy Airport Varadero. Regalito Highway Km 5 1/2, Juan Gualberto Gómez Airport C.P. 42200, Matanzas,
Cuba.
2Institute of Pharmacy and Food. University of Havana. Av. 23 No. 21425, C.P. 13600, Havana, Cuba.
3Faculty of Business Sciences of the University of Matanzas. CP 44 740, Matanzas, Cuba.
*olgasosa1998@gmail.com
ABSTRACT
Context: The menu card is a valuable instrument within the gastronomic business and its evaluation constitutes a vital
compliance activity since it has the responsibility of promoting the consumption of the offer and generating profits for the
installation.
Objective: to evaluate the management of the “El Caribe” restaurant menu at the Royalton Hicacos Resort & Spa hotel.
Methods: the analysis of the structure of the menu was carried out, according to the requirements set forth in NC-126:2001
and the Bmuti tool, menu engineering matrix for all-inclusive modality, was applied.
Results: the structure of the menu is simple and fails to comply with some established parameters; the menu engineering
showed that the dishes have medium-high popularity and that they are below the average cost limit so that the acceptance
of the offer by customers is satisfactory and there is adequate cost management. Corrective actions were proposed for the
studied facility.
Conclusions: the menu card has a simple structure, little variety in the offer, and presents non-compliance with the
requirements established by the Cuban standard. There are dishes that vary their position within the menu from one month
to another.
Keywords: evaluation menu card; menu engineering

GASTRONOMY
Dietetic-nutritional quality of the food supply for workers

of a company in Matanzas
Yudenis Reyes*, Danae Pérez, Roberto León
Department of Food, Institute of Pharmacy and Food, University of Havana, La Lisa, Havana, Cuba. Ave. 23 No. 21425, C.P. 13600.
*yudenisr@gmail.com
ABSTRACT
Context: The nutritional quality of foods supply is an important issue in all type of diets that should be carefully consider by
administrations. For this, the dietary-nutritional principles of a healthy menu must be considered.
Objectives: To evaluate the dietary-nutritional quality of the food supply for workers of a company in Matanzas.
Methods: Measurements of anthropometric indicators were used for the initial nutritional evaluation of the study group. The
dietary evaluation of the food supply was carried out by the Ceres+ program.
Results: The sample of workers has a good nutritional status from the anthropometric point of view, most of them are of
normal weight with an average body mass index (BMI) like that established as healthy. The menus offered are not
recommended or correct.
Conclusions: The dietary-nutritional quality of the food supply to workers is low, due to the little variety at breakfast and the
scarce presence of fruits and vegetables. An imbalance was found in the nutritional contribution of macronutrients and the
menus are not sufficient to cover the needs of some vitamins.
Keywords: food for workers; food supply; menu; quality

GASTRONOMY
Perception and consumption of fried foods by students of

the Institute of Pharmacy and Food of the University of
Havana
Rosamelys Ramos1*, Manuel de J. Álvarez2
1Instituto de Farmacia y Alimentos, Universidad de La Habana. Ave. 23 No. 21425, C.P. 13600, La Habana, Cuba.
2Dirección de Ciencia, Tecnología e Innovación, Universidad de La Habana. Calle M e/ 21 y 19, C.P. 10400, La Habana, Cuba.
*rosamelysrs@gmail.com
ABSTRACT
Context: Currently, fried foods enjoy great universal acceptance due to their sensory characteristics and the advantages of the
culinary technique. During the frying process, undesirable and potentially toxic substances are produced, affecting the
nutritional value of the product and the health of the consumer. In Cuba, no previous research has been carried out on the
public perception and consumption of fried foods; constituting an interesting sector to carry out studies on the subject,
university students due to their age and level of education.
Objective: To identify the perception and consumption of fried foods by students at the Institute of Pharmacy and Food of the
University of Havana.
Methods: Taking the total enrollment of the Institute as the population to be evaluated, a self-administered survey was
developed and applied to 32 Cuban students of the Regular Course of all years of the Degrees in Food Sciences and
Pharmaceutical Sciences, selected at random.
Results: 65.6 % of the respondents do not have knowledge about the subject; they all eat fried food, mainly made at home.
The majority consumption frequency was 1 or 2 days a week and only 6.2 % consume them daily. The most consumed fried
foods were fried vegetables, eggs, chicken, and those known as fritters.
Conclusions: The respondents are unaware of the frying process and the effects on health due to the high consumption of
fried products; however, they all consume them regularly, including fried vegetables, eggs, chicken, and those known as
fried foods.
Keywords: consumption; fried foods; fryind process; perception

GASTRONOMY
Dietetic-nutritional quality of the food supply for workers

of a company in Matanzas
Roberto León1*,Yudenis Reyes2, Danae Pérez2, Viviana Camejo3
1Dairy products company, UEB Cárdenas. Varadero Highway, Santa Marta Cárdenas, Matanzas. C.P. 42110.
2Department of Food, Institute of Pharmacy and Food, University of Havana, La Lisa, Havana, Cuba. Ave. 23 No. 21425, C.P. 13600.
3Combined fishing industry of Cárdenas. Cárdenas highway to Recreo, Matanzas. C.P. 42110.
*robertojavierleongarcia@gmail.com
ABSTRACT
Context: The humanistic approach of the socialist society and the attention given to the food service of different population
groups has been a priority of the Cuban Revolution. Hence, each company or institution must guarantee a quality food
supply that meets the nutritional requirements of its workers. For this, the dietary-nutritional principles of a healthy menu
must be considered.
Objectives: to evaluate the dietary-nutritional quality of the food supply for workers of a company in Matanzas.
Methods: Measurements of anthropometric indicators were used for the initial nutritional evaluation of the study group. The
dietary evaluation of the food supply was carried out by the Ceres+ program.
Results: The sample of workers has a good nutritional status from the anthropometric point of view, most of them are of
normal weight with an average body mass index (BMI) like that established as healthy. The menus offered are not
recommended or correct.
Conclusions: the dietary-nutritional quality of the food supply to workers is low, due to the little variety at breakfast and the
scarce presence of fruits and vegetables. An imbalance was found in the nutritional contribution of macronutrients and the
menus are not sufficient to cover the needs of some vitamins.
Keywords: food for workers; food supply; menu; quality

GASTRONOMY
Use of acetic acid in the prevention of Colibacillosis in

farming
Lourdes León Puerto1*, Yanelis Chongo Quiñones2, Yamary García Guerra1
1Specialist for Livestock and Veterinary Activity, Integral Agricultural Company Cienfuegos, Cienfuegos, Cuba.
*epganaderia@integral.cfg.geg.cu
ABSTRACT
Context: Lactating pigs, a few days after birth, tend to be infected by pathogenic strains of E. coli, causing digestive problems
that easily weaken the animal, which does not live for long. Abnormalities of the digestive system often cause financial loss
due to reduced efficiency or death. Other losses originate from treatments and prophylaxis against diseases. The use of
organic acids reduces the load of coliforms and pathogenic bacteria in the gastrointestinal tract, which considerably reduces
the use of antibiotics, thus reducing economic losses and obtaining healthier and safer foods of animal origin.
Objectives: Apply 3% acetic acid in the prevention of colibacillosis in piglets.
Methods: The work was carried out in the Pig Breeding Unit No. 1, located in the municipality of Palmira, Cienfuegos
province, belonging to the Cienfuegos Pork Company. The treatment was applied in the maternity area, ship No. 5 with a
total of 822 hybrid offspring, under the same exploitation and management system. Which are grouped into two groups.
Group A: Treatment with 3% acetic acid was applied via water at a rate of 5 mL/L, from the third day of birth for a period of
fifteen days, consumption at will with permanent medication. This group is made up of 408 heads
Group B: Control group with 414 heads.
The incidence of Colibacillosis, mortality and morbidity due to this entity, and the weight of the animals at birth and
weaning were assessed for the breeding category of both groups. The diagnosis was issued by the provincial laboratory of
INV Cienfuegos. The expenses incurred in applying the treatment and the benefits provided to the unit are considered.
Results: It was possible to appreciate the decrease in the affectation by colibacillosis in each of the groups formed where a
morbidity of 10.78% is observed in the treated group, while in the control it reaches 30.43%, this result is given using acetic
acid since it reduces the load of coliforms and pathogenic bacteria in the gastrointestinal tract. The mortality of group A was
lower with a total of 23 heads which represents 6.41%, while in B the losses are 42 heads for 12%.
When evaluating the weight, we can say that there were no significant differences between the groups, for both at birth the
average weight was 1.5 kg. However, there were differences at weaning where group A reached an average weight of 6.9 kg
with a total weight of 2,656.5 tons, while group B obtained 2,269.2 tons for an average of 6.1 kg, which could be due to the
inhibitory effect of organic acids on the microbial population in the gastrointestinal tract reducing the metabolic needs of the
microflora.
Conclusions: It was possible to reduce the affectation by colibacillosis, in the treated group by 10.7%, while in the control it
was 30.43%, decreasing mortality and the total weight increase of 387.3 kg in pigs.
Keywords: acetic acid; colibacillosis; mortality; pigs

GASTRONOMY
Application of cassava yogurt in the category of pre-

fattening and fattening in a farm of the municipality of
Cienfuegos
Yamary García Guerra1*, Yanelis Chongo Quiñones2, Lourdes León Puerto3
1Specialist for Livestock and Veterinary Activity, Department of Organization and Improvement, Integral Agricultural Company Cienfuegos,
Street 37 # 4807 e/ 48 y 50, Cienfuegos, 55100, Cuba.
3Specialist for Livestock and Veterinary Activity, Integral Agricultural Company Cienfuegos, Cienfuegos, Cuba.
*epganaderia@integral.cfg.geg.cu
ABSTRACT
Context: The use of cassava yogurt in diets for pigs can be a very important alternative in the solution at the present time, to
the substitution of imports, since it is considered a viable protein source, easy to manufacture for producers, and at the same
time it is easy to grow a product that does not require large investments for planting and harvesting.
Objectives: To evaluate the indicators of efficiency, weight and conversion in young pigs fed cassava yogurt diets and pigs in
the fattening category.
Methods: The experiment was carried out on the farm of producer Alfredo Listre in the municipality of Cienfuegos, during
the months of August-December 2021. For this, two groups of 20 animals each were formed, in the category of pre-fattening
and fattening, respectively. At the beginning of the experiment, the pre-baits weighed an average of 18kg and the fattens
35kg.
Cassava yogurt was added to the diet of pre-fattening gradually in the experiment for weeks until adding 1 liter of yogurt
per animal per day with 50% of the diet with feed B mixed and in the case of fattening it begins with the liter per animal and
ends its phase with the inclusion of 5 liters per animal in each ration, administering three rations per day. This yogurt was
prepared on the farm itself with the producer's harvest residues, chopping it and applying the methodology indicated by
GRUPOR, a week after preparation it was added to the diet. Average weight was evaluated at the beginning of the
experiment and at the end of it, as well as its conversion.
Results: During the experiment, it was observed that the animals showed a characteristic pattern for food consumption, with
a very fast intake of cassava yogurt both in pre-fattening and fattening. A clinical observation of the mass was maintained
throughout the period, not confronting any symptoms of reaction to said food, there were no diarrheal disorders or other
dietary causes. The animals showed a characteristic pattern of consumption, with rapid ingestion of the cassava yogurt.
Daily feed intake was lower than expected in group A, due to considerable consumption of cassava yogurt, and average
weight gain in pre-fattening was 2.5% and in fattening 7.5% higher than group B.
Conclusions: The application of cassava yogurt constitutes a great alternative in substitution of imports, being feasible for pig
rearing, achieving weight improvement and conversion without affecting the animal's health.
Keywords: cassava yogurt; farm; pigs

GASTRONOMY
Anaerobic induction of Bradyzobium japonicum in the post-

harvest of experimental hybrids of cocoa (Theobroma cacao
L.) and its improvement in fermentative (processed) and
sensory quality
Jaime F. Vera1*, Diego A. Tuarez2, Cyntia Y. Erazo2, Luis H. Vásquez2,3, Kerly E. Alvarado2,3, Frank G.
Intriago4, Arelis E. Gaibor2, Piedad F. Yepez2, Victor L. Castro5
1Doctoral student at the American University of Europe Mexico- Cancún. Faculty of Industry and Production, Professor - Researcher in cocoa
cultivation. State Technical University of Quevedo, Experimental Campus La María Km, 7 via El Empalme, Los Ríos, Ecuador.
2Faculty of Industry and Production, Professor - Researcher in cocoa cultivation. State Technical University of Quevedo, Experimental Campus
La María Km, 7 via El Empalme, Los Ríos, Ecuador.

3Postgraduate Institute, Master's Degree in Agroindustry, Technical University of Manabí, Ecuador.
4Department of Agroindustrial Processes, Faculty of Zootechnical Sciences, Technical University of Manabí, Ecuador.
5Universidad Agraria de Ecuador, Alicos S.A.
*jverac@uteq.edu.ec; ORCID: 0000-0001-6127-2307
ABSTRACT
Context: The most important raw material at an international level in European countries is cocoa for its great economic
contribution to small and medium farmers and the origin of hybrids and cocoa clones to improve the quality of the bean.
Objectives: to analyze the incidence of Bradyzobium japonicum in the fermentation stage of National He Hybrid cocoa by
applying different concentrations of 0% (control), 3%, and 5% according to the treatment arrangement.
Methods: It was used (DCA), consisting of 6 treatments and 4 repetitions being the control the National, the statistical
analysis was carried out through the analysis of variance ANDEVA.
Results: The results found were the percentage of T3 "Cocoa Hybrid" (R3I0) (15.15%) induction at (3%) and T6 "National
Cocoa" (I3N0) (15.50%) corresponding to (5%); the seed index T3 "Cocoa Hybrid" at 3% (1.40%) and T6 at 5% (I3N0) (1.46%).
Pcutting wheel, for fermented beans T5 (I2N0) with 77.75%, for T6 "National cocoa" at 5% (I3N0) with 68.50% and T3 at 5%
"Hybrid Cocoa" (R3I0) with 66.00%, in violet beans the T5 "National cocoa" at 3% (I2N0) (21.75) "Hybrid cocoa" (R3I0)
(0.50%). In the sensory evaluation T6 "Cacao Nacional" with induction of 3% (I3N0) (27.40%) and T3 "Cocoa hybrid" (R3I0) at
5% (R2I0) (26.03%) the aroma, acidity, an adequate bitterness and highlighting the floral arroma of cocoa were selected.
Conclusions: The higher the percentage of inoculation of microorganisms, the better the fermentation quality.
Keywords: Analysis; cadmium; cocoa; sensory; treatment.

ECFA 2022. S7- TEACHING OF PHARMACEUTICAL AND FOOD SCIENCES-PHARMACEUTICAL SERVICES-PHARMACOECONOMY

Olga María Nieto Acosta, PhD / Caridad Sedeño Argilagos, PhD / Milena Díaz, PhD, IFAL-UH, La Habana, Cuba
Results obtained by the introduction and generalization of

the products bio-pharmaceutical industry in Cuba
Manuel M. Collazo Herrera
National Institute of Hygiene, Epidemiology and Microbiology (INHEM), MINSAP, La Habana, Cuba.
manuel@inhem.sld.cu, manuelcollazoh@infomed.sld.cu; ORCID: 0000-0001-7594-3772
ABSTRACT
Context: The Cuban bio-pharmaceutical industry has had a vertiginous development in recent years, so it is necessary to
evaluate the results obtained in terms of health and economics of the new products developed by this industry in the
country.
Objective: To evaluate of the advances that the Cuban Public Health System has with respect to the field of economic
evaluation of medicines.
Methods: Different analysis techniques were used for the complete economic evaluations, such as cost-effectiveness, cost
minimization, and cost-benefit.
Results: The economic evaluation studies carried out on the products of the Cuban bio-pharmaceutical industry in the stages
of clinical trials are exposed, as well as in the introduction and generalization of their use in the context of the National
Health System, and that contemplates the economic and health effects of antiretroviral drugs for HIV/AIDS, national
vaccines for the prevention of infectious diseases in children, ozonized oil solution (Oleozón®) for the treatment of impetigo,
Heberprot P® for the therapy of diabetic foot ulcer and the use of the monoclonal antibody nimotuzumab for the health care
of patients with head and neck cancer,
Conclusions: By carrying out these studies, it has been possible to determine the economic and health impacts obtained using
these medications in the country's usual clinical practice, with their corresponding results in terms of benefits for the health
of patients, as well as by the savings produced in the substitution of imports for the purposes of the national economy.
Keywords: benefits; impacts; pharmacoeconomic


Economic evaluation of childhood immunization by

vaccines Cuba 1962-2019
Manuel M. Collazo Herrera
National Institute of Hygiene, Epidemiology and Microbiology (INHEM), MINSAP, La Habana, Cuba.
manuel@inhem.sld.cu, manuelcollazoh@infomed.sld.cu; ORCID: 0000-0001-7594-3772
ABSTRACT
Context: The Cuban bio-pharmaceutical industry has had a vertiginous development in vaccines during recent years.
Objective: To determinate the economic and health implications obtained by the implementation of childhood immunization
by vaccines in Cuba (1962-2019).
Methods: A comparison of the incidence rates for infectious diseases was made from the beginning of the program for 57
years. The cost potentially avoided with the different alternatives (Actual Immunization versus Hypothetical Reference
Immunization) was estimated. A cost analysis was carried out to find out the difference in the total amounts per applied
dose of vaccines with the different alternatives, and the economic benefits were estimated in the direct costs avoided for
health care.
Results: With childhood immunization by vaccines, an elimination of eight diseases has been obtained and the incidence
rates of other infections have been reduced. With the Real Immunization scheme, a potentially avoided cost of more than
USD $192 million could be estimated, which represents 31% of this economic amount compared to the supposed option of
having to totally import these products, and could obtain a favorable cost-benefit ratio, since for each dollar invested in
vaccines, a benefit between USD $5-6 of the cost of health care.
Conclusions: Child immunization in Cuba during 57 years of its implementation has produced an impact on the health of the
child population, as well as an economic effect due to the cost avoided in the substitution of imports and the direct cost
avoided of the infectious diseases.
Keywords: cost benefit; impacts; vaccines


A pilot project on physicians’ use of a scientific-based

medical cannabis dosing recommendations guide in Puerto
Rico
Stephanie R. Beltrán Rosario, Gabriel O. Rodríguez Narvaez, Juan A. Bernier Piñeiro*, Joseph Bloom
Oquendo
School of Pharmacy, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.
*bernierjuan@gmail.com
ABSTRACT
Context: Currently it is legal in Puerto Rico for patients with debilitating medical conditions defined in the law num. 42-2017
and regulation num. 9038 to acquire medical cannabis (MC) from designated dispensaries. Recommendations of MC rarely
contain dosing and/or formulation specifications. The research is aimed at analyzing the response of Medical Cannabis
Recommending Physicians (MCRPs) in Puerto Rico to a guide on specific dosing, formulation, and indications of MC.
Objectives: To measure the usefulness of the Medical Cannabis Dosing Guide in MCRPs in the Arecibo, Bayamón and
Metro/Fajardo regions of Puerto Rico.
Methods: The project’s design is divided into five sections: (i) Medical Cannabis Dosing Guide Development, (ii) Guide
Distribution and Use Tutorial, (iii) Questionnaire Development and Distribution, (iv) Data Handling.
Results: A total of 15 MCRPs were included in the study. 67% stated that the guide was quite a lot or a lot useful. A total of
80% responded that they would totally agree on receiving other versions of the Medical Cannabis Dosage Guide and the
same amount described the likeliness of using it in the future as quite a lot or a lot.
Conclusion: The guide created represents an initial step in improving the therapy and management of debilitating conditions
of the individuals that are licensed to use MC in Puerto Rico. Most MCRPs in the northern region of Puerto Rico concluded
that the medical cannabis dosing, formulation, and indication guide were quite a lot or a lot useful.
Keywords: dosing guide; medical cannabis; Puerto Rico


Doctoral program in Pharmaceutical Sciences: 30 years of

experience in the training of human resources
Caridad Sedeño Argilagos*, Olga M. Nieto Acosta, Mirna Fernández-Cervera
Institute of Pharmacy and Food (IFAL), Department of Pharmacy. University of Havana, Cuba. Street 222 # 2317 e/ 23 y 31. La Lisa. Havana,
Cuba.
*cary@ifal.uh.cu
ABSTRACT
Context: Doctoral training programs constitute the highest level for scientific-technical preparation of the human resources
necessary in society, where universities and their professors play a fundamental role in this postgraduate academic training.
Objective: characterize the features of the Doctoral Program in Pharmaceutical Sciences from 1992 to 2021.
Methods: A descriptive investigation was carried out aimed at characterizing a certain phenomenon, specifying properties,
traits, and guidelines, and integrating quantitative and qualitative elements. Literature review techniques were used and the
historical-logical and analytical-synthetic. The totality of Doctorate Theses in Pharmaceutical Sciences presented from the
years 1993 to 2021 was selected as a sample.
Results: The Pharmacy and Food Institute, belonging to Havana University, has 30 years of experience in this doctoral
program, with excellent results, from which 163 doctors have graduated, from organizations in the health sector. In the
quality of de Doctoral Program in Pharmaceutical Sciences, the social impact of its results is combined, with the competence
of the doctor graduate and his contributions to the specialty, as well as excellence in the development and assurance of the
training process of professionals in this variant of postgraduate academic training.
Conclusions: The human capital formed, after 30 years of experience, has been essential for the development of the Cuban
biopharmaceutical industry, the national pharmaceutical industry, and the improvement of the pharmaceutical services
available in society.
Keysword: Cuba; doctorate; pharmaceutical sciences; postgraduate


New approaches in the Doctoral Program in Pharmaceutical

Sciences at University of Havana
Olga M. Nieto Acosta*, Caridad Sedeño Argilagos, Mirna Fernández-Cervera
Institute of Pharmacy and Food (IFAL), Department of Pharmacy. University of Havana, Cuba. Street 222 # 2317 e/ 23 y 31. La Lisa. Havana,
Cuba.
*omn@ifal.uh.cu; ORCID: 0000-0001-7216-7887
ABSTRACT
Context: Since 1992, the Doctoral Program in Pharmaceutical Sciences was approved, going through three stages since its
creation: (1) 1992-2005 the tutelary program was developed; (2) 2005-2018 the tutelary and a collaborative curricular
program were maintained, which provided credits; and (3) like 2018, a new and unique doctoral program with credits.
Objective: To characterize these Doctoral Programs based on their changes in training.
Methods: A descriptive research was carried out aimed at assessing the stages of training in the programs that have worked,
similarities and differences that have characterized them, integrating quantitative-qualitative elements. Bibliographic review
techniques, document signing, and the historical-logical and analytical-synthetic methods were used. Selected sample: the
three Programs developed.
Results: All the Programs have allowed doctoral training, have required contributions from research, publications, language
exams and social problems. The tutelary required theoretical training with a specialty exam. The collaborative curriculum
carried out the theoretical part through courses. The new program is more flexible, and the doctoral student can complete
the theoretical training component by demonstrating the domain of themes related to their line of research, their
investigative progress is monitored collectively, and the writing and pre-defense of the thesis complete the credits.
Conclusions: The current Program corresponds to the most generalized trends at this level of training, focused on scientific
research and innovation, together with a theoretical-methodological base in this area of knowledge and contributions to the
strategic human health sector.
Keywords: academic program; changes; new improvement; postgraduate


ISO 29993/29994 approach to evaluate distance learning.

Analysis of a case study in the pandemic stage
Yania Suárez Pérez*
*yaniasp@ifal.uh.cu
ABSTRACT
Context: The international standards ISO 29993 and 29994 specify the requirements for non-formal learning, including
distance learning, to be considered as a reference framework for self-assessment. In the pandemic stage, the teaching of
Pharmaceutical Sciences transitioned to the distance modality using the EVEA platform designed at the University of
Havana.
Objective: To evaluate the quality of distance learning in the subject “Quality in the pharmaceutical industry (CIF)” during
the pandemic stage through the ISO 29993/29994 approach.
Methods: A comparative analysis was carried out on the results obtained in a survey carried out through the EVEA platform,
to a representative sample of students of the day course, and by meeting those who attended CIF in 2021. ISO 29993/29994
requirements were considered. to assess the quality of distance education.
Results: The main stratified gaps were identified in terms of satisfaction with student expectations, level of learning and
teaching methods, adequacy of educational resources and organizational aspects; that allowed the improvement of the
service. In general, satisfactory results were obtained with no appreciable differences among the criteria of students from
different backgrounds: 57% were “very satisfied” with the development of the subject and the rest, were “satisfied”. No
negative responses were obtained.
Conclusions: The experiences in the implementation of distance learning in the CIF subject denoted a high level of compliance
with the requirements established in the international standards ISO 29993/39994.
Keywords: distance education; evaluation of the learning service; pharmaceutical science


The "University didactic" in the degree of food science at the

Institute of Pharmacy and Food of the University of Havana
Genoveva M. del Valle García1*, Lizette Gil del Valle2, Silvia C. Morales Racer1
1Institute of Pharmacy and Foods Sciences. University of Havana, Cuba.
2Tropical Medicine Institute “Pedro Kouri”, Cuba.
*genoveva.delvalle@ifal.uh.cu
ABSTRACT
Objective: the objective of this work is to reveal the scientific character of Didactics and its importance to guide and develop
students as subjects of their learning at a higher level.
Methods: A bibliographic study of the concepts: Didactics and University Didactics was carried out, according to classical
and contemporary specialists, and the one assumed by the group of authors of the subject at the Institute of Pharmacy and
Food in the University was assumed as the most general expression of university didactics. University of Havana, 2018,
states that it is "a science that allows an objective and critical analysis of the Educational Teaching Process at the higher level
in which they are immersed, the teachers of the different subjects of the curriculum, the conditions in which it is developed
this process and the performance of the students as essential protagonists of it, everything that enables the construction of
their own learning strategies, in a conscious way..., guaranteeing future performance as teachers..."
The main features that characterize such a complex process are also pointed out and experiences and experiences that enrich
it are valued.
Results: The laws and didactic principles that support the educational teaching process and the strategy that was used for its
development are proposed.
Conclusions: The University Didactics subject contributes to the comprehensive training of students and in a particular way
prepares them to assume the role of teacher with motivation, security and scientific foundations.
Keywords: didactics; University didactics


Potentially inadequate prescriptions in older adults in San

Miguel del Padrón municipality, Havana, Cuba
Yoanna Herrera Preval*, Milena Díaz Molina
Department of Pharmacy, Pharmacy and Food Institute, University of Havana, Cuba.
*ypreval@ifal.uh.cu; ORCID: 0000-0002-3937-7257
ABSTRACT
Context: Older adults are vulnerable to the inadequate prescription of medicines due to all factors associated with aging,
comorbidities and the use of various drugs for the treatment of different diseases.
Objectives: To evaluate potentially inadequate prescriptions in elderly patients in San Miguel del Padrón municipality, from
January to December 2019.
Methods: For the determination of potentially inadequate prescriptions, the STOPP/START criteria, and the Cuban Criteria
for potentially inappropriate medication for the elderly were used in a sample of patients from U-648, from the health area
"Hermanos Ruiz Aboy" Teaching Polyclinic in San Miguel del Padrón municipality. Descriptive and inferential statistical
tools were applied for data analysis. To analyze the degree of concordance between the international and Cuban methods,
the contingency tables and the kappa statistical test were used.
Results: 100% of the population had potentially inadequate prescriptions. 757 potentially inadequate prescriptions were
detected and 783 in which prescription omission prevailed; the most common errors were those of prescription. The drug
groups that directly influenced these results were: non-steroidal anti-inflammatory drugs, statins, benzodiazepines,
antiplatelets and hypoglycemic agents. In addition, the antihypertensive–non-steroidal anti-inflammatory combination was
the most common risk interaction in that population.
Conclusions: STOPP/START criteria and Cuban criteria are very useful in assessing potentially inadequate prescriptions in
older adults and from a clinical point of view the results of their application are of great value to achieving more effective
and safer pharmacotherapeutics for this group, confirming the need for pharmacotherapeutic follow-up that ensures the
actions of the pharmaceutical professionals within the health team.
Keywords: inadequate prescriptions; Older adult; STOPP/ START


Impact of Risk Communication in the Biotechnological and

Pharmaceutical Industry in the context of COVID-19
Ángela E. Sosa
Department of Safety and Environmental Control, Direction of Quality Management and Regulatory Affairs, Cuba.
angela.sosa@cigb.edu.cu
ABSTRACT
Context: The Center for Genetic Engineering and Biotechnology maintains a biosafety and environmental protection program
training. This program was extended to other centers of the Pharmaceutical Industry. The COVID-19 pandemic changed the
risk scenario in all the centers due to the behavior of the epidemic and the strategic mission of the BioCubaFarma entities in
its intervention.
Objectives: To carry out an investigation in four stages. 1) training needs analysis, 2) general planning of training by risk
group, 3) training actions execution, 4) evaluation of training impact on staff performance.
Methods: For the design of the didactics of the training action, the “close method” and “problem-based teaching” were used.
The specialized courses for the companies that assumed the diagnosis by polymerase chain reaction also included an
analysis of failure scenarios in the processes.
Results: Specialized courses were given to more than 400 workers and general training by work groups to more than 3,000
workers in the sector in the 2020-2021 period. This made it possible to carry out the biosafety risk assessment of the
diagnostic process and the establishment of biosafety in the diagnostic areas. The risk communication actions included the
personnel of the centers and the foreign personnel of the Center for Genetic Engineering and Biotechnology Mariel.
Conclusions: The training actions based on these methods increased the risk perception of the personnel. These actions were
essential for the implementation of biosafety measures and the establishment of legislation in all Superior Organization of
Business Management BioCubaFarma companies.
Keywords: biosafety; risk communication


Environmental education actions to face climate change

from professional training in pharmaceutical and food
sciences
Damaris García*, Whilmer Armas, Gilberto Suárez , Javier A. Ramy, Alicia Casariego Año
Institute of Pharmacy and Food. University of Havana. Ave. 23 No. 21425, C.P. 13600, Havana, Cuba.
*damarisgl@ifal.uh.cu
ABSTRACT
Context: Currently, accelerated climate change is identified as one of the most important concerns of humanity, taking rise in
recent years its relationship with the intensification of numerous problems at all scales, which affect society, the laws and
concepts on the environment and the life task constitutes an important challenge of the university task. Therefore, it requires
an interdisciplinary approach to environmental training because of the articulation of the different disciplines that allow
responding to the State Plan for Confronting Climate Change of the Republic of Cuba (Life Task) in the IFAL-UH, increasing
the levels of participation and leadership of teachers and students with a responsible attitude.
Objective: To promote knowledge about climate change, its impacts and possible mitigation and adaptation actions from
professional training in Pharmaceutical Sciences and Food Sciences.
Methods: Empirical and theoretical methods were used, which allowed us to study environmental training at IFAL-UH from
an interdisciplinary approach.
Results: It was evidenced in the presentation of works at the Student Scientific Conference with the themes Proposal of
environmental strategy for the IFAL. Diagnosis of the environmental situation of IFAL and Environmental Strategy:
management of chemical reagents and hazardous waste. University outreach activities were developed, such as community
intervention aimed at education in caring for the environment in the Palenque-Victoria community, sanitation and
beautification of the Quintana park in Alturas de La Lisa, discussion on nutrition in the elderly, with members of the
University of the Elderly and Circles of Grandparents, Neighborhood debates on the prevention of toxic addictions, the use
of natural and traditional medicine and Creation of a scientific society on environmental education, "Salvemos el Quibú." In
addition, four articles were published entitled: Student scientific conferences, a path for interdisciplinary integration in
environmental education, Linking institutional actions for disaster reduction from the undergraduate training process,
Environmental Strategy Proposal for IFAL and Environmental management and its contribution to students of
Pharmaceutical Sciences.
Conclusions: an environmental culture should be fostered in students, professors, and workers of the IFAL-UH through
extension activities, stimulating the link to scientific projects on environmental education and including environmental
content in the curricula.
Keywords: extension; integration; management; prevention; sustainable


Master's Degree in Medicine Technology and Control. A

Program of Excellence for the professional improvement of
pharmaceutical personnel
Antonio Iraizoz Colarte*, María A. Barrios Álvarez, Olga M. Nieto Acosta
Departamento de Farmacia. Instituto de Farmacia y Alimentos. Universidad de la Habana, Cuba.
*airaizoz@ifal.uh.cu; ORCID: 0000-0001-7243-9176
ABSTRACT
Context: Researchers, professors, technologists and other workers in science, technology, and innovation are considered the
fundamental resource for the exercise of these activities, so they must possess and analyze information on scientific and
technological knowledge available worldwide to support the creation and management of new knowledge and its transfer,
assimilation, adaptation, application and dissemination, in correspondence with the conditions of the country.
Objectives: Promote the generation, assimilation and application of knowledge and technologies and increase research and
innovation in the field of Pharmaceutical Technology and Medicine Quality Control and strengthen its use in all sectors and
management levels, such as an essential tool to enrich the impact of science, technology, and innovation activity in the
pharmaceutical industry.
Methods: The contents of a Postgraduate Teaching Program are presented to obtain the Academic Title of Master in Science
(MSc), of professionals specialized in the design, preparation and analysis of medicines, updated and in full correspondence
with the quality requirements established by the World Health Organization (WHO) and different regulatory bodies in the
fields of Pharmaceutical Technology and Medicines Quality Control
Results: The results achieved since the creation of the program in 1993 to the present are presented and analyzed,
highlighting the graduation of more than 500 MSc, nationals and foreigners, and the opinions of graduates and employers
about its relevance and contributions, the delivery of the program in foreign universities and in two other Cuban provinces.
Graduates obtain 73 valid credits for the future obtaining of the Scientific Degree of Doctor of Pharmaceutical Sciences
(PhD).
Conclusions: The Master's Program in Drug Technology and Control has notably increased the scientific and practical
knowledge of the more than 500 professionals who have graduated from it and promoted interest in research and innovation
in their fields of knowledge. Due to its efficient performance, it has been accredited by the National Accreditation Board of
the Republic of Cuba with the highest Qualification.
Keywords: innovation; master's degree; graduates; technology


Master's degree in Clinical Pharmacy at IFAL: results and

perspectives
Milena Díaz Molina*
Institute of Pharmacy and Food, University of Havana, La Lisa, Havana, Cuba. Ave. 23 No. 21425, C.P. 13600.
*mdiaz@ifal.uh.cu
ABSTRACT
Context: The master's degree in Clinical Pharmacy is one of the oldest at the University of Havana, with almost 30 years of
execution. It has been aimed at training, upgrading, and updating pharmaceutical professionals in the healthcare, clinical,
and research areas aimed at achieving a rational use of medicines.
Objectives: To show some of the most relevant results of the program, as well as future work projections.
Methods: Different indicators were evaluated according to the methodology designed at IFAL to measure the impact of
postgraduate programs, as well as the indicators established for external evaluations.
Results: The program has a national and international scope. It has graduated 245 students, 69 of them foreigners. More than
90% of the faculty hold a Doctorate in Sciences, with great professional prestige. The origin of the students is from the
Pharmaceutical Services, research centers and drug distribution and marketing company, fundamentally. The worst
indicator detected was the impact of the graduate in the program and the best, the satisfaction of the employers with the
graduates. The results of the application of the said methodology, as well as the results of the external evaluation of 2018,
allowing for establishing modifications aimed at overcoming the deficiencies detected. Of these, the need for a greater
commitment of the institutions of origin to the satisfactory completion of the thesis stands out. One new required course was
included and three were renamed, along with their update. The definition of the thesis topic and the scientific tutor from the
moment of enrollment were included as an entry requirement.
Conclusions: The Master of Clinical Pharmacy maintains a coherent, sustained, and ascending work that has allowed it to
achieve satisfactory results in its performance as part of the continuous improvement of its program and based on the
weaknesses detected in previous external evaluations.
Keywords: academic program; Master in Clinical Pharmacy


Initial diagnosis of the professional performance of the

novice teachers of Food Sciences of IFAL
Whilmer Armas*, Yudenis Reyes, Damaris García, Elizabeth López
Department of general training, Institute of Pharmacy and Food, University of Havana, La Lisa, Havana, Cuba. Ave. 23 No. 21425, C.P. 13600.
*warmas@ifal.uh.cu
ABSTRACT
Context: The IFAL teachers of the specialty of Food Sciences have within their functions the training of professionals with a
high sense of responsibility, and ethics in the profession, by demonstrating creativity, independence, and values that imply
their commitment to society and the environment. However, university graduates (novice teachers) of this career do not
have a pedagogical profile and once in the exercise of teaching they must face dissimilar challenges in the training of other
professionals. The foregoing reveals the importance of knowing the current state of the professional performance of novice
teachers, which allows proposing alternative solutions to the identified problems, to contribute positively to the
improvement of the professional performance of these teachers.
Objectives: identify the main problems and potentialities in the professional performance of the novice teachers of Food
Sciences at IFAL
Methods: Technology was used to determine the problems and potentialities of Advanced Education, proposed by Añorga
(1997).
Results: teachers, although they received some professional improvement activity, say course, was not related to the
identification of their learning needs. The participation of teachers in pedagogical scientific events is scarce, as well as the
publications of articles on pedagogical topics, referring to a higher rate of publication in topics of the specialty. Teachers
access printed and/or digital literature and 68.5% occasionally do so, due to the scarcity of updated literature in the
institution's library and the difficult process of printing new books for the career bibliographic plan. They referred to the
frequent internet connection problems and the dominance of the Moodle platform.
Conclusions: In relation to the indicators evaluated in the diagnosis of the current state of professional performance, novice
Food Science teachers showed a low level of knowledge about their performance.
Keywords: improvement; novice teacher; professional performance


Experiences of the use of WhatsApp as an educational and

technological resource in postgraduate education
Caridad Sedeño Argilagos1*, María J. Carballo Fernández2
1Pharmacy Department, Institute of Pharmaceutical and Foods Sicences. Havana University. Cuba.
2Drugs Department and Medical Technologies. Health Province Direction, Matanzas, Cuba.
*cary@ifal.uh.cu
ABSTRACT
Context: Information and communication technologies emerged as an alternative to continue educational work during the
COVID-19 pandemic. WhatsApp has become one of the most used media, given the possibilities it brings to the construction
of knowledge and the various interaction options under the guidance of a professor.
Objective: To identify the attributes that master students assign to a postgraduate course that was taught through the use of
Whatsapp.
Methods: A cross-sectional descriptive investigation was carried out in the months of June and July 2022 at the end of the
course of the Master's program in Clinical Pharmacy, which lasted 11 weeks, with a frequency of two hours per week. Each
main conference was sent using WhatsApp a week in advance of the scheduled meeting. Once the course was finished, a
questionnaire was applied to a sample of 26 students, who had to classify 17 attributes in the categories of positive, negative,
and interesting, taking into account this technological media.
Results: 58% and 11%, respectively were classified as positive and interesting attributes, all related to the didactic of learning,
such as understanding of educational material, motivation, personalized and group interaction. 32% classified as negative
aspects related to the operation of the virtual media, such as slow connection, information unrelated to the subject and
generation of stress due to the variability of the connection.
Conclusions: The use of Whatsapp was a tool that promoted motivation, participation and interaction in the course and was
useful as a didactic resource for learning.
Keywords: didactic; distance education; internet


Competences of IFAL pharmacists and their work

performance in BioCubaFarma
Yania Suárez Pérez1, Hermes U. Guerra González2*, Olga M. Nieto Acosta1
1Department of Pharmacy, Institute of Pharmacy and Food, University of Havana, Cuba.
2Management, Training and Development Specialist. CESFARMA. BioCubaFarma. Ave 222 # 2317 e/ 31 y 23, La Coronela, La Lisa, CP 13600.
Havana, Cuba.
*hermes@cesfarma.biocubafarma.cu
ABSTRACT
Context: The follow-up of graduates allows us to assess the relationship between the competencies of the professional profile
acquired in the training stage and those demanded by the world of work. Considering the IFAL's responsibility in this task
and the existing link with CESFARMA, as a facilitator of the process, priority was given to this research.
Objective: To evaluate the satisfaction of the graduates located in BioCubaFarma regarding the training received and its
impact on professional performance. Methods:
Methods: The methodology to evaluate the impact of the career was partially applied to a representative sample of graduates.
For processing and analysis, the results were stratified by discharge time and study modality. The indicators related to
general and specific competencies and global satisfaction were compared. In addition, recommendations for improvement
were identified.
Results: The general (4.28) and specific (4.16) competencies were rated as good. 100% expressed interest in postgraduate
improvement with priority towards the courses offered at IFAL. Gaps in the development of practical skills was the main
cause of dissatisfaction, being more important in pharmacists who graduated in the last decade. However, the general index
of satisfaction with the training received was 4.14.
Conclusions: The pharmacist is a professional with excellent training, who adapts to various jobs in the pharmaceutical
industry, due to his broad profile. The close IFAL-CESFARMA-BioCubaFarma relationship favors the continuous
improvement of the graduate and his link with the University, as well as the projection of improvements in the pharmacist's
practical training.
Keywords: follow-up of graduates; general competences; pharmaceutical science; practical skills


Comprehensive Medication Management service for

inpatients with cardiovascular diseases
Maraelys Morales González1*, Evelyn I. Rojas Vázquez1, Lizandra Fuentes de la Torre2, Beltis Villanona
Pons1,2, Niurka M. Dupotey Varela1
1Department of Pharmacy, Universidad de Oriente, Ave. Patricio Lumumba s/n. Altos de Quintero, Santiago de Cuba, CP. 90500, Cuba.
2Department of Pharmacy, “Saturnino Lora” Provincial Hospital in Santiago de Cuba, Ave Los Libertadores, Santiago de Cuba, Cuba.
*maraelys@uo.edu.cu; ORCID: 0000-0003-0350-2797
ABSTRACT
Context: Comprehensive medication management service aims to provide pharmaceutical care with a patient-centered
approach, which ensures the optimization of pharmacotherapy and through rational clinical decision-making, obtaining
defined results that improve the patient’s clinical status.
Objectives: To describe a pilot implementation of the comprehensive medication management service provided to inpatients
with cardiovascular diseases.
Methods: A longitudinal, prospective and intervention study was carried out, with qualitative research elements. The sample
included patients with cardiovascular diseases and more than five days from the Cardiology Service of the “Saturnino Lora”
Provincial Hospital in Santiago de Cuba. The care process was developed according to the OFIL's Guide for the
implementation of Comprehensive Medication Management. The patients’ medication experiences were evaluated
according to Ramalho de Oliveira et al. The evaluation of drug-related problems and the clinical outcomes was carried out
according to the Pharmacotherapy Work-up Method.
Results: 20 patients were included, 65% male. The mean age was 66.2 ± 13.1 years. 80% of the patients had hypertension.
100% received antihypertensive and antithrombotic drugs. Body effects were identified as the patients’ medication
experiences in 30%. 133 drug-related problems were detected and 45.1% corresponded to safety problems. 155
pharmaceutical interventions were performed and 89% were accepted. 90% of the patients achieved positive clinical
outcomes.
Conclusions: The pilot implementation of the comprehensive medication management service contributed to the resolution of
drug-related problems and showed positive clinical outcomes in patients with cardiovascular diseases.
Keywords: clinical pharmacy; comprehensive medication management; drug-related problems; patient-centered care


Use of nifedipine in threatened preterm labor

Olga M. Osa Echenique1*, Lourdes L. González Fernández2
1José Ramón López Tabranes Gynecobstetric Hospital, Department of Pharmacy. Street 53 between 260 and 256. Versalles. Matanzas, Cuba.
2Comandante Faustino Pérez Surgical Clinical Provincial Hospital, Department of Pharmacy. Kilometre 101, Central Highway. Matanzas,
Cuba.
*nayivys.mtz@infomed.sld.cu
ABSTRACT
Context: Spontaneous preterm birth is responsible for more than 50% of preterm births, it is a problem of great magnitude for
public health, which transcends health, with great social and economic impact and influence on the family and society.
Objective: to verify the effectiveness of treatment with nifedipine in pregnant women who presented spontaneous preterm
birth.
Methods: A retrospective descriptive research was carried out in the obstetrics service of the José Ramón López Tabranes
Maternal Hospital in Matanzas, Cuba, during the years 2019-2020, in 41 patients admitted with the threat of spontaneous
preterm birth from the municipalities of Matanzas, Cardenas and Jagüey Grande. On admission, they were administered
nifedipine 30 mg orally and the administration of nifedipine 10-20 mg was continued every 6-8 hours, for a further 72 hours,
according to the Cuban Obstetric Guidelines.
Results: in this sample, 88% were between 20-39 years old, 56% of white skin color. At admission, 90% had 34 or less
gestation and after administering treatment, 64% delivered after 34 weeks, a favorable fetal period for lung maturation. 44%
of the newborns were classified as low birth weight, coinciding with the 18 pregnant women who presented spontaneous
preterm birth at admission, with 34 weeks or less.
Conclusions: the effectiveness of treatment with nifedipine was demonstrated in the sample of pregnant women who
presented spontaneous preterm labor, prolonging the presentation of labor after 34 weeks of gestation.
Keywords: nifedipine as a tocolytic; spontaneous preterm birth; treatment


Drug interactions and anticholinergic risk in older adults in

the San Miguel del Padrón municipality, Havana, Cuba
Yoanna Herrera Preval*, Milena Díaz Molina
*ypreval@ifal.uh.cu; ORCID: 0000-0002-3937-7257
ABSTRACT
Context: Older adults present various comorbidities and consequently are highly prone to polypharmacy. Said
polypharmacy favors the occurrence of pharmacological interactions and the presence of the anticholinergic effect, which
increases the risk of suffering adverse reactions
Objective: To identify drug interactions and anticholinergic risk in a sample of elderly patients from San Miguel del Padrón
municipality, Havana, Cuba.
Methods: For the determination of pharmacological interactions, the list of Clinically Relevant Pharmacological Interactions
was used, which should be avoided or used with caution in the Elderly (IMM-CR). The anticholinergic effect scale was used
to analyze the anticholinergic risk of the drugs. Both lists are part of the Cuban criteria for Potentially Inappropriate
Medication for the elderly. Both methods were applied to a sample of patients from U-648, from the “Hermanos Ruiz Aboy”
Teaching Polyclinic health area of the San Miguel del Padrón municipality. Descriptive and inferential statistical tools were
applied for data analysis.
Results: The female gender predominated in the sample (70.4%) and the general mean age was 75.3 years old. 82.9% of the
sample presented at least one drug interaction. The highest incidence was associated with interactions between
antihypertensive and non-steroidal anti-inflammatory drugs. The anticholinergic risk observed in the sample was 25%. The
anticholinergic burden presented by the patients was slight. Antihistamines were the drugs with the highest incidence in
terms of the prevalence of risk.
Conclusions: Drug interactions and anticholinergic load in older adults lead to the presence of serious adverse reactions.
Pharmacotherapeutic follow-up is necessary for this age group and the incorporation of the pharmacist into the
multidisciplinary teams dedicated to the care of the elderly since it undoubtedly contributes to the improvement of the
quality of life of these patients.
Keywords: adverse reactions; anticholinergic risk; elderly; drug interactions


Individual project for professional and human

improvement of IFAL Food Sciences
Yudenis Reyes1*, Lidisbet Cardoso2, Whilmer Armas1, Elizabeth López1
1Department of Food, Institute of Pharmacy and Food, Ave. 23 No. 5 21425, C.P. 13600. University of Havana, La Lisa, Havana, Cuba.
2Enrique José Varona University of Pedagogical Sciences. 108 street No.29F08, CP 11400, Havana, Cuba.
*yudenisrg@gmail.com
ABSTRACT
Context: The individual project for professional and human improvement of IFAL Food Sciences teachers is a technology of
Advanced Education, which by contemplating professional, family, and social roles aims to contribute to professional and
human improvement and the achievement of positive transformations of teachers. professionally and humanly.
Objectives: propose the individual project of the professional and human improvement of the teachers of Food Sciences of the
IFAL.
Methods: Technology was used to determine the problems and potentialities of Advanced Education, followed by the
application of sequential steps for the elaboration of an individual Project for professional and human improvement
described by Reyes (2021).
Results: The result of the use of this technology is found in teachers, at the time of assuming challenges from the instructive
and educational, as well as, in raising self-esteem, which will favor assuming reality and improving it through the proposal
of solutions to environmental problems.
Conclusions: The elaboration of the individual Project of professional and human improvement offers teachers the
opportunity to appropriate essential knowledge and skills that are reversed in the improvement of their pedagogical
professional performance in educational practice and -consequently- in the institutional development of IFAL.
Keywords: professional performance; teachers


Initial diagnosis of the professional performance of the

novice teachers of Food Sciences of IFAL
Yudenis Reyes1*, Elizabeth López1, Whilmer Armas1, Lidisbet Cardoso2
1Department of Food, Institute of Pharmacy and Food, Ave. 23 No. 5 21425, C.P. 13600. University of Havana, La Lisa, Havana, Cuba.
2Enrique José Varona University of Pedagogical Sciences. 108 street No.29F08, CP 11400, Havana, Cuba.
ABSTRACT
Context: The IFAL teachers of the specialty of Food Sciences have within their functions the training of professionals with a
high sense of responsibility, ethics in the profession, by demonstrating creativity, independence and values that imply their
commitment to society and the environment. However, university graduates (novice teachers) of this career do not have a
pedagogical profile and once in the exercise of teaching they have to face dissimilar challenges in the training of other
professionals. The foregoing reveals the importance of knowing the current state of the professional performance of novice
teachers, which allows proposing alternative solutions to the identified problems, in order to contribute positively to the
improvement of the professional performance of these teachers.
Objectives: identify the main problems and potentialities in the professional performance of the novice teachers of Food
Sciences of IFAL
Methods: Technology was used to determine problems and potentialities of Advanced Education, proposed by Añorga
(1997).
Results: teachers, although they received some professional improvement activity, say course, was not related to the
identification of their learning needs. The participation of teachers in pedagogical scientific events is scarce, as well as the
publications of articles on pedagogical topics, referring to a higher rate of publication in topics of the specialty. Teachers
access printed and/or digital literature and 68.5% occasionally do so, due to the scarcity of updated literature in the
institution's library and the difficult process of printing new books for the career bibliographic plan. They referred to the
frequent internet connection problems and the dominance of the Moodle platform.
Conclusions: In relation to the indicators evaluated in the diagnosis of the current state of professional performance, novice
Food Science teachers showed a low level of knowledge about their performance.
Keywords: improvement; novice teachers; professional performance


CESFARMA, an example of collaboration University:

Company. Summary of its first 15 years
Antonio Iraizoz Colarte1*, Hermes U. Guerra González2
1Department of Pharmacy. Institute of Pharmacy and Food. University of Havana. Cuba.
2BIOCUBAFARMA, Havana, Cuba
*airaizoz@ifal.uh.cu
ABSTRACT
Context: The Center for Higher Pharmaceutical Studies (CESFARMA), was inaugurated on October 8, 2007, as a collaboration
agreement between the Institute of Pharmacy and Food of the University of Havana (IFAL-UH) and the Cuban
Pharmaceutical Industry, first represented by the QUIMEFA Business Group and from 2012 by OSDE BIOCUBAFARMA. In
the present work the main achievements and activities carried out are exposed.
Methods: The main activities carried out are related, expressing their significance and importance for the related institutions
and for society in general.
Results: The benefits achieved by both institutions because of this collaboration are revealed and analyzed, demonstrating
the socio-economic importance of University: Company relations.
Conclusions: Based on the collaboration established by the IFAL-UH, it substantially improved its classroom and computer
laboratory facilities, and the pharmaceutical industry has been able to graduate a large number of its mid-level technicians as
Bachelors of Pharmaceutical Sciences and increase the training of its professionals. through doctorate programs, Master's
degrees, Diplomas and Bachelor's degrees through the modality of Courses by Meetings. Since the creation of CESFARMA,
scientific collaboration has also increased.
Keywords: BIOCUBAFARMA; CESFARMA; Master and PhD programs


Behavior of COVID-19 in the Sevillano health area

belonging to the “Turcios Lima” polyclinic, in the Diez de
Octubre municipality
Laura Polo Portelles1, Grisel Del Toro García2*
18 de Marzo Pharmaceutic, 22 Km Monumental avenue, Cotorro, Havana, Cuba.
2Department of Pharmacy, Pharmacy and Food Institute, The University of Havana, Havana, Cuba.
*g.deltoro@ifal.uh.cu; ORCID: 0000-0003-0762-2825
ABSTRACT
Context: For more than a year, the key element in prevention and control has been primary health care with an active
investigation, case classification, treatment of risk and vulnerable groups, as well as follow-up of contacts and discharge of
the sick.
Objectives: To contribute to this comprehensive approach, a scientific investigation was carried out in order to determine the
behavior of COVID-19 in the Sevillano health area belonging to the “Turcios Lima” polyclinic, in the Diez de Octubre
municipality.
Methods: A descriptive statistical cross-sectional study was carried out on the confirmed cases belonging to the medical office
number 16, from January through June 2021, by reviewing the medical records.
Results: A non-significant predominance of female patients with COVID-19, asymptomatic and moderate status was found;
with an average 42,74 ± 21,89 years. 52,63% of the patients did not report a personal pathological history; 60,5% presented at
least one comorbidity, hypertension, diabetes mellitus and bronchial asthma were the most representative. 63,15 and 56,84%
of patients received treatment with interferon and nasalferon, respectively, in addition to antibiotic therapy, mainly with
azithromycin. A significant statistical correlation was found between the patient's clinical status and personal pathological
history, but not with age and gender.
Keywords: comorbidity; coronavirus; COVID-19 treatment; SARS-CoV


Preliminary evaluation of the impact of Master in

Toxicology of the Pharmacy and Food Institute from the
University of Havana
Beatriz Linares Diego*, Grisel del Toro García, Yoagne M. Trapero Quintana
*blinaresdiego@gmail.com; ORCID: 0000-0002-4385-8125
ABSTRACT
Context: In the context of the development of academic master's programs, the impact evaluation allows knowing the
changes that occur or should occur in the graduates due to the effect or influence of the syllabus, sometime after the training
actions have been applied.
Objectives: To evaluate preliminarily the impact of the master's program in Toxicology of the Pharmacy and Food Institute
from the University of Havana.
Methods: The existing methodology in the institute was applied to evaluate the impact of master's programs, which is based
on the definition of nine quality indicators, aimed at external and internal customers, with measurement criteria associated
with four levels.
Results: 60 and 50% of the graduates and teachers, respectively, who participated in the fifth, sixth, and seventh editions of
the master's degree from 2012 to 2019, were surveyed. Only seven indicators out of nine were evaluated, three of them were
excellent, one good, two fair, and none was rated poor.
Conclusions: The improvement of the program and compliance with the improvement plan established at the close of the 5th
edition was verified.
Keywords: impact of master's programs; Pharmacy and Food Institute; toxicology


Preliminary study of the cost of complicated obstetric

patients attended in the Intensive Care Unit of the Hospital
“Faustino Pérez”
Lourdes González Fernández*
Department of Pharmacy, Commandant Faustino Pérez Surgical Clinical Provincial Hospital,. Kilometer 101, Central Highway. Matanzas,
Cuba.
*lourdesgf.mtz@infomed.sld.cu
ABSTRACT
Context: In Cuba, the constitution declares that the entire population has the right to care for and protect their health, having
as a principle that the medical care is free, regardless of the cost derived from it and in the Maternal and Child Program, the
bases for prioritized care for pregnant women are declared.
Objective: to show the most significant direct cost for admission of complicated obstetric patients who required care in the
intensive care unit of the hospital.
Methods: A descriptive investigation of the direct costs of four obstetric patients who were admitted to intensive care at the
Faustino Pérez Hernández Hospital in Matanzas, Cuba, in November 2019, due to the complications presented, was carried
out. The most significant direct costs were analyzed, such as the costs per day for medications and per day for therapy. The
mean and standard deviation were calculated.
Results: the reasons for admission were diverse, two pregnant women with preeclampsia and eclampsia and two puerperal
women, one with liver disease during pregnancy and the other with major obstetric hemorrhage. They had a mean stay of
18.5 days, a mean drug cost of 699.91/day and a mean cost of ward admission of 758.86/day. The direct costs for
medications were 12,948.33 and for admission to the ward, 14,038.91, with a total cost of 26,987.24.
Conclusions: the results demonstrate the high costs assumed by the State to comply with the principle of guaranteeing free
health care to the population.
Keywords: cost studies; hospitalization direct costs


Articulation of the discipline Preparation for Defense with

the disciplines of food sciences career
Madeline Ochoa Alomá1*, Luisa M. Gómez Arcia2, Gerardo Valdés Tamayo1
1Institute of Pharmacy and Food. University of Havana. Ave. 23 No. 21425, C.P. 13600, Havana, Cuba.
2Department of Military Teaching, University of Havana, Cuba.
*madelineochoa@ifal.uh.cu
ABSTRACT
Context: The Preparation for Defense discipline requires an interdisciplinary approach with the rest of the disciplines of the
Food Sciences degree. In the context of the Covid - 19 pandemic, methodological transformations were carried out to
guarantee learning in the new conditions.
Objective: To determine the results obtained in the articulation of the Preparation for Defense discipline, with the rest of the
disciplines during that stage.
Methods: Observation, interviews, and surveys.
Results: It was found that the students were able to carry out, with the proper orientation and great independence,
investigative work on the production, conservation of food and nutrition during natural and health disasters; nutritional
evaluations of population groups; diagnosis on compliance with the Decree Law on Food Safety; study of the toxic effects of
substances generated during food processing and environmental protection, among others. In the Security and National
Defense subject, its contents were integrated with the problems of the profession. An effective use of the bibliography
consulted, and a wide use of digital platforms were demonstrated. As a result, an active participation in the Telegram
channel and in the Scientific Cycle was obtained; presentation of five papers at the 1st Security and Defense Forum convened
by the FEU, two papers at the International University Congress 2022, and at the First Local Development Fair in Havana, as
well as excellent results in the control of the Ministry of Higher Education.
Keywords: Covid-19 pandemic; Interdisciplinary; National Security and Defense; research results


Online didactic unit in the subject general microbiology in

food sciences
Silvia C. Morales Ramos*, Genoveva M. del Valle García, Anaiza Pérez Martinto
Institute of Pharmacy and Food. University of Havana. Ave. 23 No. 21425, C.P. 13600, Havana, Cuba.
*scmorales@ifal.uh.cu
ABSTRACT
Context: The didactic unit constitutes a tool to impart knowledge y accepts variability of activities and methodologies, in
which all the elements that interfere in the teaching-learning process are interrelated.
Objective: To propose and apply a didactic unit framed in the virtual modality as an integrating axis of the teaching-learning
process, providing consistency and significance.
Methods: A didactic unit was made to the contents of the subject to plan the virtual teaching-learning process and evaluation
criteria, theoretical explanations, learning objectives, exercises and achievement indicators were assumed. Problem-based
learning, scientific research, collaborative work, and case method were used as methods and techniques. Among the didactic
processes, doubts were clarified, concepts were structured, and brief explanations were made through presentations.
Results: Among the most relevant results are the resolution of problems and the integration and application of the contents
of the program to real and simulated events.
Conclusions: The didactic unit contributes to promote the development of interpersonal skills, prepares them in an integral
way in the contents of the program and improves the information processing activity.
Keywords: case method; didactic unit; problem-based learning


Implementation of professional skills in the Stores process

Lilianne Acosta Cardoso1*, Rolsa A. Lilly González1, Juan J. Machín González1, Yudenis Reyes2
1Branch School of Tourism, Prado y Trocadoro , Havana, Cuba.
*lilyacosta9793@gmail.com
ABSTRACT
Context: As an integration of the activities of the main processes of the human capital system, the implementation of
professional skills in the process of Tiendas Caracol SA becomes relevant as part of their validation for the job profiles of the
Sales Clerk and the Sales Clerk Head of Brigade of the Ministry of Tourism during 2021. All of which is aimed at improving
its effectiveness and increasing competitiveness in the markets.
Objective: Propose the implementation of professional skills in the Stores process
Methods: The technology was used to determine the problems and potentialities of Advanced Education, for the initial
characterization of the professionals, followed by the validation of the competencies for the job profiles under study. As
logical procedures of thought, the following were used: analysis, synthesis, and induction-deduction, which allowed
processing, systematizing and interpreting the information related to the improvement of the performance of store
personnel.
Results: The result of the use of this technology allows us to characterize the current state of professional performance.
Transformations are verified at the time of assuming challenges, as well as, in raising competitiveness, which will favor the
improvement of their performance and the response to problems of the individual or collective environment.
Conclusions: The implementation of professional skills in Tiendas Caracol S.A has the impact, scientific-technical and
economic-social benefits in improving the superior professional performance (DPS) of workers, which becomes quality,
productivity, efficiency and efficacy and effectiveness, being comparatively assessed before, during and after its
implementation.
Keywords: Professional skills; Store process


University-Company link and its impact on the professional

motivation of Pharmaceutical Sciences students
Mara Fernández*, Milena Díaz
Institute of Pharmacy and Food (IFAL), University of Havana, Cuba. Street 222 # 2317 e/ 23 and 31. La Lisa, Havana, Cuba.
*mara.fernandez@ifal.uh.cu
ABSTRACT
Context: The Cuban government is immersed in the implementation of transformations to achieve economic development
that meets the needs of society, supported by the management model oriented towards innovation and the application of
science in its design and execution. On the other hand, Cuban Higher Education is called to achieve a University-Company
link that has repercussions on mutual benefits.
Objective: To present the experiences of conducting visits by first-year Pharmaceutical Sciences students to scientific centers
in the sector and its impact on professional motivation.
Methods: Readjustments were made in the program of the subject Introduction to Pharmaceutical Sciences, devoting a greater
number of hours to visits to the centers. The pertinent coordination was carried out and the objectives were defined,
including the selection of the specialists to serve them. A questionnaire was designed to measure student satisfaction with
the activities carried out.
Results: The adjustments made implied the dedication of 50% of the total time of the subject to the designed visits. Five
OSDE BIOCUBAFARMA institutions were visited, with an attendance rate above 92%. A 100% satisfaction was achieved,
declaring that the visits allowed the satisfactory elaboration of the course work of the subject. Of these, nine were presented
in the IFAL scientific cycle.
Conclusions: The University-Company link can be a useful resource in achieving greater professional motivation for the
career from the first years, through the subject Introduction to Pharmaceutical Sciences.
Keywords: introduction to Pharmaceutical Sciences; university-company link; professional motivation


Scientific training and internationalization: experience of

the Institute of Pharmacy and Food, University of Havana
Maelys Hernández-Almaguer*, Mirna Fernández-Cervera, Laura Machín-Galarza, Raisa Mangas Marín,
Marian Hernández-Colina
Institute of Pharmacy and Food (IFAL), University of Havana, Cuba. Street 222 # 2317 e/ 23 and 31. La Lisa, Havana, Cuba.
*maelysha86@gmail.com; ORCID: 0000-0002-2727-2183
ABSTRACT
Context: The university professor, in addition to transmitting knowledge, must participate and promote scientific research,
an indicator widely used for the recognition of universities. Similarly, exogenous links and links with their environment play
an important role in professional and scientific training.
Objectives: To analyze the indicators of scientific training and internationalization at the Institute of Pharmacy and Food
during the period between 2011 - 2021.
Methods: To obtain the data of this research, techniques such as bibliographic review, and document signing were used, and
historical-logical, analytical-synthetic and inductive-deductive methods were used for their evaluation.
Results: It is shown that the predominance of professionals with a PhD title has contributed to the publication of the results.
Between a 30 and 40% of articles are found in groups 1 and 2, respectively. Despite the national and international recognition
received, it is necessary new strategies to improve the scientific production of each researcher/professor, in correspondence
with the requirements demanded by biomedical and food sciences. Regarding international students, training through
undergraduate and master's courses has been greater in Pharmacy, while the graduation of doctors in Food Sciences has
prevailed.
Conclusions: IFAL's investigative work has been recognized through various national and international awards. Academic
mobility, participation in scholarships and courses taught abroad have been influenced by the international situation. The
prepared documentation for the internationalization process is a starting point to normalize the activity and achieve greater
control of the process.
Keywords: Institute of Pharmacy and Food Sciences; internationalization; scientific training, university professor


Student satisfaction as an indicator of quality of the Cellular

Biology subject in the Pharmaceutical Sciences career,
daytime course mode
Alejandro Fabra González*, Beatriz Linares Diego, Yoanna Herrera Preval
*afg121098@gmail.com; ORCID: 0000-0002-43207568
ABSTRACT
Context: With the implementation of the E curriculum, the Cell Biology subject began to be taught in the first year of the
Pharmaceutical Sciences career in the daytime course mode. This change represented a new challenge for the biomedical
sciences group of the pharmacy department in the pharmacy and food institute.
Objectives: to evaluate the level of student satisfaction as a quality indicator of the Cellular Biology subject in the E
curriculum of the Pharmaceutical Sciences career, daytime course mode.
Methods: A non-experimental, descriptive research was carried out where a survey was applied to 162 students belonging to
the first and second year of the Pharmaceutical Sciences career, daytime course.
Results: The results showed a high level of satisfaction associated with the needs of the topics taught, while less favorable
results were evidenced in terms of mastery acquired in the topics that make up the subject.
Conclusions: although the level of satisfaction was high, the qualitative results expressed the need to continue improving the
quality with which the subject is taught.
Keywords: Cell Biology; daytime course mode; E curriculum student satisfaction; Pharmaceutical Sciences

ECFA 2022. S8- FOOD SCIENCE AND TECHNOLOGY

Danae Pérez Santana, PhD / Alicia Casariego Año PhD/ Dairon I Guevara IFAL-UH, La Habana, Cuba
Nutritional marketing, health and well-being for everyone,

the new commitment of the food industry
Ernesto Cabezas García*
Institute of Pharmacy and Food, University of Havana, Cuba.
*ernecabezas@gmail.com
ABSTRACT
Context: Nutritional marketing has become in recent years a benchmark of good work in the food industry; the traditional
promotion of food has migrated its actions towards a healthier approach. Modern food companies have entered
contradiction with their own interests, desires and consumer health, forcing us to rethink food production and its impact on
the economy, society and life in all its forms. Supplying the nutritional deficits that the world population faces is
increasingly complex in the current conditions, however, nutritional marketing offers new paths of preservation, tradition
and healthy consumption based on the Slow Food, Zero Km and Smart Food currents, all a commitment to social
transformation.
Objectives: To analyze the importance of nutritional marketing in the continuous improvement of the Food Industry, as a key
element to increase consumer confidence, loyalty, health, and quality perception; in whose purpose the usual theoretical and
empirical methods are used, such as the analytic-synthetic, the hypothetical-deductive, the documentary review and others.
Results: The fundamental result to which it arrives, resides in obtaining a validated theoretical base that will allow to
prosecute in better conditions, the transformation of the food management of the industry and the commercialization of food
products oriented to the increase of the health and well-being of consumers, based on the management of nutritional
marketing as a driving force behind transformations in the industry towards a more humane and responsible approach to
food, in which the environment and ecological diversity are respected and protected as invaluable heritage wealth.
Keywords: kilometer zero; marketing; nutrition; slow food, smart food


Use of coconut charcoal in the Cuban rum industry

Diasney Corrales1*, Yusmel Cabrera1, Brayan Valdes2, Yudenis Reyes2
1Havana Beverage and Soft Drink Company. UEB Ronera occidental. Ave. Camilo Cienfuegos No. 1501, between Línea del ferrocarril and
Carretera del Lucero. Arroyo Naranjo. Havana, Cuba.
ABSTRACT
Context: From the coconut shell it is possible to obtain different types of activated carbons for different applications varying
the preparation conditions. Activated carbon has a high international cost and in the rum industry this is essential for the
treatments of alcohols and brandy prior to aging. It was found that in the processes of benefit of the raw materials there were
no significant differences from the chemical-physical point between the filtrates obtained with the national coal and those of
the commercial coal RAK 08, which demonstrates the usefulness of the new national coal as a substitute for the product that
is imported.
Objective: to evaluate the use of treated activated coconut charcoal as a filter medium in the products of the UEB Combinado
Ronera Occidental.
Methods: the experimental part of this research was developed in the UEB Ronera Occidental of the Beverage and Soft Drinks
Company of Havana. For the chemical-physical characterization of coconut charcoal and raw materials, determinations were
made of alcoholic strength according to the NC. 290: 2007 of total acidity according to CN 291: 2011 of pH according to NC
83 03–4, of alkalinity. According to IAS-5.073-M.E. and calcium and magnesium by the atomic absorption spectrometry
method described in NC 83-02-8. The sensory evaluation of the solutions before and after filtered by coconut charcoal and
RAK-08 was carried out with tasters and consumers and the determination of the intensity of dyes was carried out as
described in NC 529: 2007.
Results: it was found that in the processes of the benefit of the raw materials there were no significant differences from the
chemical-physical point between the filtrates obtained with the national coal and those of the commercial coal RAK 08,
which demonstrates the usefulness of the new national coal as a substitute for the product that is imported.
Conclusions: the use of national coconut charcoal does not alter compliance with the quality specifications of the product
compared to the traditional one, its use in the rum industry is feasible considering the chemical-physical and sensory aspects
evaluated.
Keywords: activated carbon; coconut; filtration


Sensory profile of the shell of the roasted Cuban cocoa bean

Danae Pérez1*, José L. Rodríguez2, Leyra Herrera2, Rosa K. Renté1
1Department of Food, Institute of Pharmacy and Food, University of Havana, La Lisa, Havana, Cuba. Ave. 23 No. 21425, C.P. 13600, La
Habana, Cuba.
2Research Institute for the Food Industry. Carr. Guatao km 3½, C.P. 19200, La Habana, Cuba.
*danaeps@ifal.uh.cu
ABSTRACT
Context: The cocoa shell is a by-product of cocoa processing, it has a crunchy appearance, a brown color and an aroma very
similar to cocoa and chocolate. It is also a source of fiber compounds and antioxidants, which makes it possible to use it in
food formulation. The main result was that the cocoa, seed, roasted, herbal odor descriptors and cocoa, seed, acid, bitter
flavors, and astringency as bucotactile sensation were perceived by the judges as alterations with intensities between light
and normal.
Objectives: to carry out the partial sensory profile of the roasted cocoa husk of Cuban cocoa mixtures.
Methods: Cocoa powder was used as a reference product for the familiarization and generation of descriptors, as well as
samples of roasted cocoa shell; following the methodology described in NC-ISO 11035:2015
Results: The main result was that the cocoa, seed, roasted, herbal odor descriptors and cocoa, seed, acid, bitter flavors, and
astringency as bucotactile sensation were perceived by the trained judges with intensities between light to normal.
Conclusions: the shell of the roasted Cuban cocoa bean presents sensory descriptors like cocoa powder, so it can be used as a
substitute for this raw material.
Keywords: cocoa powder; cocoa shell; sensory profile.


Implementation of a sensory panel for analysis and quality

control of bee honey
Daymi Mádernas Sánchez*
Quality Direction, Beekeeping Research Center, La Habana, Cuba.
*daymi0924@gmail.com
ABSTRACT
Context: In the Beekeeping Research Center, as part of the quality analysis applied to honey, there is a sensory analysis that
needesf a sensory panel made up of 7 previously trained judges and a president of the the sensory evaluation commission.
Due to the variability of the conditions and the time elapsed, the existing sensory panel underwent changes in its
composition and training, which led to the temporary stoppage of the provision of this service. Therefore, with the objective
of reactivating this activity, 21 possible tasting judges were recruited, to whom the different stages of the process of pre-
selection and selection of tasters were applied to evaluate their capacities, they were subjected to a theoretical and practical
training as part of their training as tasting judges. Through the application of different analytical tests, a process of training
and discarding the possible judges captured in the selection stage was carried out, from which the 7 sensory judges that
made up the sensory evaluation panel and the president of the judges were finally selected for the Commission. Also
obtaining a reserve of 6 sensory judges already trained with whom it will be counted in case the need to supply a judge of
the panel, thus being implemented the sensory panel of the center for the sensory evaluation of the quality of the honey of
bees.
Objective: Implement a sensory panel highly trained in sensory evaluation and quality control of honeybees.
Methods: Pre-selection and selection tests, Flavor profile, Quantitative Descriptive Analysis, Sensory Evaluation Analytical
Procedure.
Results: 7 sensory judges were selected with a high degree of homogeneity in the results obtained in the tests applied. A
reserve of 6 judges with similar results in the tests carried out was also obtained.
Conclusions: The process of theoretical and practical training of the judges was considered effective due to the high
homogeneity obtained in the results of the application of the tests carried out.
Keywords: capabilities; implementation; judges, sensory analysis; sensory panel; training


Optimizing the sensory quality of a dairy dessert flavored

with mango pulp
Dairon Iglesias Guevara1*, Joe Doyharzabal Jiménez1, Cira Duarte2, Alicia Casariego Año1
1Food Department, Pharmacy and Food Institute of the University of Havana, Havana, Cuba.
2Department of Sciences, Research Institute for the Food Industry, Ministries of the Food Industry, Havana, Cuba.
*daironig1993@gmail.com; ORCID: 0000-0002-0044-6083
ABSTRACT
Context: The dairy industry, in the production of derivative products, especially cheese, generates large amounts of whey.
Whey proteins have an adequate balance of amino acids, which gives them a very high biological value and technological
potential as they can form gels. Through acidification and heat treatment of whey, they precipitate the largest amount of
proteins present, obtaining a protein concentrate called cottage cheese.
Objectives: Optimize the sensory quality of the dairy dessert made with whey proteins and flavored with mango pulp.
Methods: The numerical optimization method was obtained through an I-Optimal response surface, generating a mixed
model. The selected factors were mango pulp (13-30%) and water (16-33%); the variations were subject to the maximum
allowable of these components for the mixture. The samples were evaluated using a 10 cm structured linear scale.
Results: The descriptors mango odor, dairy note, milk flavor, sweet flavor, acid flavor and consistency did not vary with the
concentration of pulp in the formulation. Although the flavor and color of the mango were much more pronounced for the
highest concentration of pulp, the behavior was also appreciated by the bitter aftertaste, the creaminess, and the sensory
quality of the product. Sensory quality was more influenced by creaminess.
Conclusions: For the combination of 21.6% mango pulp and 24.4, the values of the sensory reputations issued by the judges
were optimized, obtaining an excellent quality, a creaminess between moderate and marked that evokes mango ice cream.
Keywords: curd; dessert; formulation; sensory evaluation


Obtaining fermented milk enriched with powdered extract

of majagua flowers (Talipariti elatum Sw)
Alicia Casariego Año*, Dairon Iglesias Guevara, Laura D. Alfaro, Joe D. Jiménez
Food Department, Pharmacy and Food Institute of the University of Havana, Havana, Cuba.
*alicas70@gmail.com; ORCID: 0000-0002-7687-5984
ABSTRACT
Context: The search for new products with functional properties that can provide, in addition to the nutritional value, other
biologically active components that exert beneficial effects on one or several functions of the organism, constitutes one of the
most important challenges of the industry.
Objectives: To obtain a fermented milk with the addition of majagua flower extract (Talipariti elatum Sw.) as a source of
polyphenolic compounds.
Methods: Whole milk powder, sugar, powdered majagua flower extract and microorganisms with prebiotic potential were
removed. Fermented milk was made with a culture mixture of Lactobacillus bulgaricus and Bifidobacterium sp (3:1). The
powdered extract was added in increasing concentrations from 0% to 0.5% with respect to the milk to be used in the
formulation.
Results: The addition of the extract to the fermented milk reduced the maximum rate of acidification, which resulted in a
relatively slower acidification, although values of pH 4.6 were obtained in similar times. The addition of the extract did not
modify the acidification curve. From the sensory point of view, the alterations were subject to slight changes in appearance
due to color effects, a fact that conditioned the variations observed in general acceptance.
Conclusions: A fermented milk with an acceptance degree of "I like it slightly" and a total polyphenol content of 6.56 mg
AGE/100g of fermented milk with an addition of 0.32% (w/v) of the powdered extract was obtained, fermentation time of
3.4 h and final pH of 4.55.
Keywords: fermentation kinetics; polyphenols; sensory acceptance; syneresis


Classification of Cuban honeys according to botanical

origin with multivariate analysis of their polyphenol and
flavonoid profile
Linet Díaz Villavicencio1*, William E. Cáceres Hernández1, Alen N. Baeza Fonte2, Dámarys Suárez Gómez1
1Beekeeping Research Center, Havana, Cuba.
2Science and Technology of Materials Institute, University of Havana, Havana, Cuba.
*quimica@ciapi.minag.cu
ABSTRACT
Context: Monofloral honeys have distinctive sensory and nutraceutical characteristics of polyfloral honey. To guarantee their
authenticity and quality, it is essential to have tools to establish its botanical origin. In addition to the classical techniques, it
is possible to determine the botanical origin by chemometrics.
Objective: Classify Cuban monofloral honeys from five different blooms, according to their botanical origin, using principal
components analysis of their polyphenols and flavonoids profile.
Methods: The profiles were obtained by High Performance Liquid Chromatography with a diode array detector. The
samples were introduced by direct injection. In the method performance, different wavelengths and mobile phase were
evaluated. Principal component analysis was performed using The Unscrambler X software.
Results: A reverse phase chromatographic method was developed to obtain the polyphenol and flavonoid profiles of honeys,
at 260 nm and using a gradient of 0.1 % formic acid and methanol as mobile phase. A classification model was built for the
samples according to their botanical origin, applying principal component analysis. The freshness index of honey did not
affect the classification.
Conclusions: The chemometric evaluation of the chromatographic profile of polyphenols and flavonoids allowed the
construction of a model capable of grouping honeys according to their botanical origin. It was possible to efficiently classify
the five groups studied. The developed methodology is an alternative to the traditional technics to identify the botanical
origin.
Keywords: authenticity; chemometrics; chromatography; monofloral honey; principal components analisys


Characterization of a spreadable chocolate cream with bee

products
Mariela Vázquez Martínez*, Mario Fajardo Cárdenas, Rosalina García Neninger
Beekeeping Research Center, Havana, Cuba.
*reserva_m@ciapi.minag.cu
ABSTRACT
Context: Honeybee and propolis are hive products made by bees, to which dissimilar properties that benefit health are
attributed. Chocolate is known worldwide for its use in baking and confectionery, its composition highlights the high
number of polyphenols, mainly flavonoids. Currently, chocolate creams are produced with various ingredients in order to
be used in pastries and confectionery. Studies show that it is possible to use bee products such as honey and propolis to
obtain these creams. Due to the need to diversify the use of hive products, it is necessary to carry out new research aimed at
obtaining new finished forms.
Objective: Characterize a chocolate cream with bee products made at the Center for Beekeeping Research. It started from
obtaining a chocolate cream on a laboratory scale.
Methods: The cream was characterized by physical and chemical methods such as the determination of density, total solids,
water activity, consistency, refractive index and °Brix.
Results: The cream has a humidity of 12.13 %, for an 87.87 % dry matter, density equal to 1.2338 g/mL, water activity of 0.774
and a consistency of 9.5 cm. At 20°C, this cream presents 75.4 °Brix and a refractive index equal to 1.4789 nD.
Conclusions: The cream has the sanitary quality required for this type of product according to the standards. Its quality is
suitable to be consumed as a dessert, accompanied by bread and biscuits or as an ingredient in confectionery.
Keywords: honeybee; physico-chemical parameters; propolis


Refreshing whey drink with the addition of rice flour and

orange flavor
Dainelis Rodríguez*, Ana M. Colominas
Food Department, Pharmacy and Food Institute of the University of Havana, Havana, Cuba.
*dainelis@ifal.uh.cu
ABSTRACT
Context: Whey is the liquid residue obtained from the manufacture of cheeses with usable nutritional value. It contains
practically all the lactose in milk, proteins of high biological value, water-soluble and fat-soluble vitamins, and minerals. In
Cuba, high volumes of cheese whey are produced that have little industrial use, which prevents the use of their nutritional
qualities.
Objectives: The present work pursues the objective of developing a refreshing whey drink with the addition of rice flour and
orange flavor.
Methods: A mixture design was applied using the Design–expert version 8.0 program where the dependent variables were:
whey (79.95 to 84.15%), concentrated orange juice (7 to 11%) and guar gum (0.1 to 0.3%), and the dose of sugar (5.0%) and
gelatinized rice flour (3.75%) was fixed. The response variables defined were acceptability and stability. The best formulation
was sensory characterized.
Results: The best formulation was composed of whey (84.15%), orange concentrate (7%), refined sugar (5%), rice flour (3.75%)
and guar gum (0.1%). The semi-trained tasters gave the drink the comprehensive evaluation of I like it. Orange odour
intensity was rated as light to moderate, orange flavour as moderate, and consistency as light. The drink was stable at 24
hours to elaborate.
Keywords: fruit whey drinks; rice flour; sensory acceptability whey


Spray drying of an extract majagua flower concentrate

(Talipariti elatum Sw)
Dianelis A. Leyva1*, Dairon Iglesias Guevara1, Alicia Casariego Año1, Mario A. G. Pérez2
1Food Department, Pharmacy and Food Institute of the University of Havana, Havana, Cuba.
2Departamento de Ciencias Biológicas, Facultad de Ciencias de la Salud, Universidad Técnica de Manabí. Ave. Urbina, Portoviejo 130105,
Manabí, Ecuador.
*dianelis_al@yahoo.com; ORCID: 0000-0002-0133-0090
ABSTRACT
Context: Plant extracts are a rich and complex source of active ingredients from various chemical and physical properties,
which make it a viable alternative for the food industry. The majagua flower is considered an important source of bioactive
compounds such as phytosterols, phenols, organic acids, some of these with antioxidant properties. In the food industry,
interest in additives in powder form has increased that it is guaranteed to maintain the physical-chemical and
microbiological properties of the product.
Objectives: to obtain an extract in powder form for food use from a concentrated extract of majagua flowers by spray drying.
Methods: The optimization of the spray drying was carried out based on the contents of polyphenols, total anthocyanins,
humidity, hygroscopicity, antioxidant capacity and process performance. The air inlet temperature was varied between 150
and 180 ºC, while the air outlet temperature was kept constant (70-75 ºC); the total solids of the mixture were adjusted from
25 to 33%.
Results: The content of total solids of the concentrated extract influenced (p ≤ 0.05) in the contents of polyphenols and total
anthocyanins, antioxidant activity of the powder extract and performance of the process, while the temperature influenced
(p ≤ 0.05) in the humidity, hygroscopicity and performance of the drying process.
Conclusions: The optimal drying conditions to obtain the powder extract corresponded to 174.6 ºC for the air inlet
temperature and 28.69% of total solids of the mixture. The optimized extract powder reached around 65% drying
performance.
Keywords: majagua flowers; physical-chemical parameters; spray drying


Refreshing whey drink with fructooligosaccharides and

acerola pulp (Malpighia emarginata D.C.)
Ana M. Colominas, Dainelis Rodríguez*
Institute of Pharmaceutical and Foods Sciences, University of Havana, Cuba.
*dainelis@ifal.uh.cu
ABSTRACT
Context: Whey is the liquid resulting from the coagulation of caseins which, due to its high nutritional value and large
production volumes, is considered the most polluting co-product of the dairy industry. It contains practically all the lactose
in milk (4.6 to 5.2%), protein (0.60 to 1.0%), fat (0.3 to 0.5%) and mineral salts (0.3 to 0.8%). In Cuba, high volumes of cheese
whey are produced, mainly destined for animal feed. On the other hand, fructooligosaccharides, due to their prebiotic action
and acerola pulp as a source of vitamin C, have beneficial effects for human health when added to beverages.
Objectives: The general objective of this work is to use whey in the elaboration of a refreshing drink with
fructooligosaccharides and acerola pulp.
Methods: A mixture design was applied using the Design Expert version 8.06 program where the independent variables were
defined: whey (58 to 68%) and acerola pulp (20 to 30%), keeping fixed the dose of fructooligosaccharides (12%). The response
variables were acceptability and stability.
Results: The best formulation is composed of whey (68%), acerola pulp (20%) and syrup of FOS (12%); pH equal to 3.9 and
acidity (0.99%) expressed as % citric acid and acidity 0.45% expressed as lactic acid. The drink was characterized by
homogeneity, colour, odour, and flavour of acerola moderate; viscosity, sour taste and "light" sweet. The overall quality was
very good. The population tasters evaluated the drink between I like it (53%) and I like it a lot (22%)
Keywords: fructooligosaccharides; sensory evaluation; whey


Evaluation on reproductive parameters of the inclusion of

different percentages of crude protein from moringa forage
(Moringa oleifera) in rations for rabbits (Oryctolagus
cuniculus)
Guillermo Ajoy*, Olivia T. González, Teresa Diez, Viagna Valiña
Departament of Molecular Neuroscience, Cuban Center for Neurosciences, 190 y 25, Reparto Cubanacán, Playa, Havana, Cuba.
*guillermo.ajoy@cneuro.edu.cu
ABSTRACT
Objective: To evaluate the inclusion of different percentages of moringa crude protein (Moringa oleifera) in rations of breeding
rabbits (Oryctolagus cuniculus) and its effect on reproductive parameters, as one of the fundamental nutrients that affect
reproduction, along with vitamins, minerals, energy and fat.
Methods: Fifty rabbits of different breeds were used, five experimental diets with different inclusion levels of moringa crude
protein were assigned to evaluate. Crude protein was offered in the animals' diet in the form of fresh moringa leaves at
different inclusion levels. The parameters evaluated were litter size at birth and at weaning, litter weight at weaning,
gestation duration and litter weight gain.
Results: The litter size born decreased in the inclusion values of 25, 50 and 75%, these differences being significant when
compared to the values of 0 and 100%. The size of the litter at weaning presents higher values at the inclusion levels of 0 and
100% and significantly different at 25, 50 and 75%. The weight of the litter at weaning presents significant differences for 50
and 25% with respect to 0, 75 and 100%. Weight gain was significantly different for 25, 50 and 75% compared to 0 and 100%,
being higher in the former. No significant differences were observed in the duration of gestation.
Conclusions: It is concluded that the inclusion levels of 75, 0 and 25% of crude protein in moringa forage allow a greater daily
weight gain. Despite the significant differences of certain values, all parameters remained within the ranges reported for the
species, which allows concluding that the crude protein included in fresh moringa forage can be supplied without affecting
reproductive parameters.
Keywords: crude protein; moringa; reproduction


Stability of a powder dye obtained from the flower of the

“marpacífico” (Hibiscus rosa sinensis L.)
José A. Arencibia1*, Ileana Oceguera2, Alicia Casariego Año2, Yanelis Ruiz Díaz3
1Facultad Tecnológica, Universidad de Santiago de Chile, Estación Central, Región Metropolitana, Chile.
2Departamento de Alimentos, Instituto de Farmacia y Alimentos, Universidad de La Habana, La Habana, Cuba.
3Facultad de Ciencias Químicas y Farmacéuticas. Universidad de Chile, Santiago, Región Metropolitana, Chile.
*jose.arencibia@usach.cl
ABSTRACT
Context: The ¨marpacífico¨ (Hibiscus rosa sinensis L.) is a shrub widely distributed in Cuba. The flowers of this plant contain
many phytochemicals. Among them are anthocyanins, which represent the most important group of water-soluble pigments
due to their potential effects on human health. However, these pigments are sensitive to environmental factors such as
temperature.
Objectives: To evaluate the stability of a dye powder obtained by spray drying from ¨marpacífico¨ flower.
Methods: The analyses of the powdered dye were carried out at the beginning and every four, three and two days depending
on the temperature, until 21 days of storage at 25, 35, 45 and 55 ºC were completed. The order of anthocyanin degradation
kinetics was determined from the variation of the concentration of anthocyanins present in the powders (C) as a function of
heating time (t).
Results:The colorant presented a total polyphenol content of 6726 mg/100 g of powder, of total flavonoids of 400 mg/100 g
of powder and of total anthocyanins of 380,9 mg/100 g of powder. Its antioxidant capacity was 837,5 mM/g with a
hygroscopicity of 22,9 % and a dissolution time of 47,33 s. It was also characterized by a moderate or acceptable flow
capacity and low cohesiveness.
Conclusions: Increasing the storage temperature increased (p ≤ 0.05) the loss of anthocyanins during storage. The degradation
of anthocyanins corresponded with a kinetics of order one; the half-life, the 90 % time, and the Q10 temperature coefficient
decrease as the storage temperature increases.
Keywords: anthocyanins; colorant; stability; temperature.

ECFA 2022. S9- POSTER-MIX PHARMACEUTICAL SCIENCES

Yolexis Tamayo García, MSc. IFAL-UH, La Habana, Cuba
Cleaner productions in the management of residual EGF

and synthetic peptides
Patricia Fernández1*, Ángela E. Sosa1, Pedro L. Sama2, Lamay Dorta3
1Department of Safety and Environmental Control, Direction of Quality Management and Regulatory Affairs, Cuba.
2Direction Protection and Security, Cuba.
3Departament Industrial Safety. Direction of Production, Center of Genetic Engineering and Biotechnology, Havana. Cuba.
*patricia.fernandez@cigb.edu.cu
ABSTRACT
Context: The Biotechnology Industry generates different types of waste, including mixtures of chemicals considered
dangerous. In the country there are few options for the final destination of this waste. Companies must implement a plan for
their environmentally safe management. At the CIGB this plan included storage in confined conditions. The large-scale
production of the peptides makes this alternative unviable.
Objectives: To establish actions that guarantee a safe management for chemical waste derived from the production of
Epidermal Growth Factor (EGF) and synthetic peptides.
Methods: With the application of cleaner production actions, it is possible to give a final destination to both chemical
mixtures and other waste, including glass, plastic and aluminum bottles of reagents that are used and require a final
destination.
Results: Through the study of each type of waste, a reduction in their environmental impact is achieved, preventing
contamination during the life cycle of these productions.
Conclusions: This work is applicable to the entire biotechnological, pharmaceutical, cosmetic industry that they use for the
elaboration of their similar chemical reactive products.
Keywords: chemicals dangerous; cleaner production; waste life cycle


Study of storage at room temperature of the PFHMII culture

medium used for the T1h/3E9-1F6 cell line
Elizabeth Reyes Benítez*, Arianna Padrón, Fernández Aneet, Rudens Velo
Center of Molecular Immunology (CIM), Havana, Cuba.
*elizabeth@cim.sld.cu
ABSTRACT
Context: The storage conditions of the culture medium impact the variables of pH and conductivity and affect the
performance of the culture associated with proliferation and viability.
Objective: To evaluate the storage conditions at room temperature (21 ± 4°C) of three batches of PFHMII culture media
through growth kinetics.
Methods: For this purpose, the cell line T1h/3E9-1F6 that produces the monoclonal antibody Itolizumab was cultivated in
shaken flasks at 37°C every 15 days in duplicate for 30 days. The parameters to evaluate cell growth were cell concentration
and viability, while pH and conductivity were measured as physical-chemical properties.
Results: All the physical-chemical and kinetic growth parameters in the times evaluated were maintained within the control
limits in a consistent and reproducible manner during the 30 days of the storage study. The maximum alive cell
concentration (Xv max) at 30 days was similar to the value obtained for Xv max at time zero, around 0.9 × 106 cells/mL, and
the viability greater than 90%. There were no statistically significant differences in the specific growth rates in the three
batches evaluated.
Conclusions: In general, the PFHMII culture medium stored at room temperature is stable for 30 days, and under the
conditions tested, it can be used in the cell culture stage of the T1h/3E9-1F6 line, without affecting the growth or
morphology of the cells.
Keywords: Cell culture medium; growth kinetic; monoclonal antibody; room temperature; stability


Evaluation of the performance of an analytical method by

liquid chromatography for quality control and stability of
the injectable product Irinotacan hydrochloride
Evelyn Guerra Vidal*, Yusimi Izquierdo Roque, Carlos R. Romeu Carballo
Group of injectables, Development and Innovation Unit, AICA+ Laboratories Company, Havana, 11 300, Cuba.
*evelyng@aica.cu
ABSTRACT
Context: Irinotecan and its metabolite SN-38 act by inhibiting topoisomerase I, a cellular enzyme that maintains the
topographic structure of DNA during translation, transcription, and mitosis. This product is highly consumed in our country
and is currently imported at very high prices. In order to substitute imports, our Company took on the task of developing
this medicine.
Objective: Design and validate a chromatographic method to perform Quality Control and Stability Studies of the Irinotecan
Hydrochloride product.
Method: The parameters precision, accuracy and specificity were evaluated.
Result: The analytical techniques for the evaluation of the active principle in the injectable were validated.
Conclusions: The designed method was linear with correlation coefficients greater than 0.99, exact with recovery percentages
of 100.05%, specific and precise with variation coefficients less than 2% and without significant differences between days or
between analysts obtained by a Fischer F statistician. greater than 0.05, in a concentration range between 90-110%.
Keywords: Irinotecan


Safety study of sodium heparin 5000 IU/mL in geriatric

patients. Spontaneous notifications
Nancy Burguet1*, Allelen Campaña2, Yenilen Troche1
1Development and Innovation Unit, AICA Laboratories Company, Havana, Cuba.
2Department of Biomedical and Biotechnological Sciences, University of La Rioja, Spain.
*nburguet@aica.cu
ABSTRACT
Context: In Cuba, in 2018 the reformulation of sodium heparin 5000 IU/mL was carried out, as a continuous quality
improvement. It is a product with less than five years in the national market, so its safety in usual clinical practice must be
evaluated.
Objectives: To evaluate the safety of this product in geriatric patients through spontaneous notifications, from June 2018 to
December 2021, in Cuba.
Methods: Observational, descriptive, and cross-sectional study of case series. The universe included 17 patients of 70.8 years
old, who were treated with sodium heparin 5000 IU/mL. Type of event, affected organ systems, patient sex was analyzed.
Pathological history, route, dose of administration and reason for medical prescription were also evaluated. They were
classified in severity, causality, and frequency.
Results: 0.03% of adverse events were reported in geriatric patients. Bleeding stands out as the main event. The most affected
organ systems were skin and genitourinary (35.2%). The male sex predominated. The pathological antecedents conditioned
the appearance of these events. The route, dose of administration and reason for prescription complied with that described
in the Summary of Product Characteristics. Adverse events were classified as mild, probable, and frequent. Only a patient
showed a serious adverse effect with a favorable outcome for life.
Conclusions: the use of sodium heparin 5000 IU/mL does not constitute a health problem over time under study for patients
of geriatric age. It can be argued that it is a safe product.
Keywords: adverse events; geriatric age; spontaneous notifications; sodium heparin


Preliminary stability study to support use of freeze dried

live-attenuated 638 Vibrio cholerae oral vaccine candidate
after reconstitution
Yolexis Tamayo1*, Alina Cruz2, Bárbara M. González3, Aleida Mandiarote2, Elizabeth Pérez3, Roselyn
Martínez3
1Institute of Pharmacy and Foods. University of Havana, Havana, Cuba.
2Center of Molecular Immunology, Havana Cuba.
3Finlay Institute of Vaccines, Havana Cuba.
*yolexis.tamayogarcia@ifal.uh.cu
ABSTRACT
Context: Cholera remains a major global public health threat in most impoverished countries where good infrastructure,
clean water, sanitation, and hygiene are poor or unavailable. Only three inactivated vaccines have WHO-prequalification,
and the US FDA has recently approved a live attenuated oral cholera vaccine CVD 103-Hg. Cuban 638 vaccine is a
lyophilized live attenuated oral vaccine, containing the 638 attenuated strain as active pharmaceutical ingredient. Live
attenuated bacterial vaccines are commonly susceptible to instabilities caused by high residual moisture, extreme
temperatures, ultraviolet radiation, and insufficient excipients. It is important to monitor the stability of these vaccines
throughout their formulation and manufacture. In the case of freeze-dried vaccines data to support proposed use of vaccine
after reconstitution, maximum storage period and storage conditions should be generated as part of the stability study
performed on the final lot.
Objectives: To evaluate the stability of the freeze dried live-attenuated 638 Vibrio cholerae oral vaccine candidate after
reconstitution.
Methods: Two different designs for the reconstitution of an oral dose of vaccine were used and potency expressed as
CFU/dose was evaluated using a single plate serial dilution test.
Results: According with vaccine quality specification, both designs of reconstitution showed satisfactory results.
Conclusions: Freeze dried live-attenuated 638 Vibrio cholerae oral vaccine candidate keeps its potency after reconstitution
during the period evaluated.
Keywords: live bacterial vaccines; potency; stability


Good storage and distribution practices performance at the

pharmaceutical supply distribution center
Yaritza Mendoza Sam1*, Gledys Reynaldo Fernández2
1Quality Management Department, Pharmaceutical Supply Distribution Center, Company for Commercialization and Distribution of
Medicines (EMCOMED), Havana, Cuba.
2Pharmacy Department. Institute of Pharmaceutical and Foods Sciences. University of Havana, Cuba.
*yaritza.mendoza@sf.emcomed.cu
ABSTRACT
Context: The Good Storage and Distribution practices ensure the quality of pharmaceutical products, including the starting
materials. The non-compliances of their requirements delay the Pharmaceutical Operations License. This is the challenge of
the Pharmaceutical Supply Distribution Center since its foundation.
Objective: To value the performance of the Good Storage and Distribution Practices requirements at the Pharmaceutical
Supply Distribution Center from January 2020 to January 2022.
Methods: It had carried a descriptive and longitudinal research. The non-compliances managed according to the
methodology of the EMCOMED’s procedure, and their causes identified. It had valued the personnel´s knowledge. It was
suggested the improvement to the training of the personnel and the documentary system. After had valued the impact of the
improvements.
Results: 77, 8% of the non-compliance were from internal sources, mainly self-inspections. The non-compliance were mainly
about the infrastructure (35, 2%), documentation (20, 4%) and storage conditions (13, 0%). The 52, 8% were due to the
personnel. The improvement related to their training increased their knowledge and their performance. The improvement
about documentation allowed to close all the non-compliance related these requirements. The management of the non-
compliance was appropriated, they were closed the 93,6%.
Conclusions: The management of the non-compliance at the UEB has appropriated. This center insures an acceptable
performance of the Good Storage and Distribution Practices´ requirements.
Keywords: Good Storage and Distribution Practices; non-compliances; requirements


Management of recyclable solid waste at the Center for

Genetic Engineering and Biotechnology
Wilson Chávez1*, Jovany Fi2, Oreste Cabañas2, Ángela E. Sosa1
1Department of Safety and Environmental Control, Direction of Quality Management and Regulatory Affairs, Center of Genetic Engineering
and Biotechnology, Havana. Cuba.
2Departament Industrial Safety. Direction of Production, Center of Genetic Engineering and Biotechnology, Havana. Cuba.
*wilson.chavez@cigb.edu.cu
ABSTRACT
Context: The generation of solid waste in the biotechnological and pharmaceutical industry is a growing problem due to the
amount of single-use materials that are incorporated into the processes. The Center for Genetic Engineering and
Biotechnology in 2019 maintained effective management of its waste generation. However, the effect of the COVID-19
pandemic affected the management of recyclable solid waste generated by the company in the 2020-2021 periods and its
final destination to third parties.
Objectives: To reverse this problem, developing a prevention plan that takes risks into account is the objective of this work.
Methods: The methods used were diagnosis by direct observation methods, application of data collection techniques,
interviews and inspection, SWOT analysis (strengths, weaknesses, opportunities, and threats) and root cause.
Results: Based on this analysis, an action plan is carried out to achieve the sustainability of the delivery of raw material, using
the strengths identified to counteract external threats to the CIGB. The risk prevention plan includes actions to integrate
business processes for waste classification, planning the use of motor vehicles, transportation, conciliation, accounting
control and systematic information to the general management of the actions carried out.
Conclusions: The most important result of this management is the awareness of all the actors of the company and the
promotion of a culture of recycling in the workers.
Keywords: recycling; waste solid biotechnological


Design of a ready-to-use transport medium for Leptospira

(LeptoCen T LPU)
Angélica M. Machado*, Dennis Someillan, Marilyn Díaz, Diana R. Viera, Ana L. Cabrera
Microbiological Diagnosis Group, Directorate of the National Center for Biopreparations (BioCen), Bejucal, Mayabeque, Cuba.
*angelica.machado@biocen.cu
ABSTRACT
Context: Leptospirosis is a re-emerging disease caused by bacteria of the genus Leptospira. In our country, its diagnosis in
laboratories is laborious and expensive, so BioCen's Microbiological Diagnosis Group developed a transport medium for
suspected Leptospira samples to respond to the demand for this product.
Objectives: To design a formulation for the transport medium for Leptospira spp., which meets the quality parameters
established for this product.
Methods: Medium Base for Leptospira F and rabbit and sheep serum supplement were used in the formulation of 11 variants.
They were evaluated taking into account: physical-chemical and organoleptic characteristics according to the treatment
carried out on the serum, sterility of the finished medium and viability of the target strains in it.
Results: The two variants with sheep and rabbit serum inactivated at 56 ºC for 2h, centrifuged, decanted, and filtered through
a 0.2 µm pore membrane, showed the best results in terms of physical-chemical and organoleptic characteristics, being
slightly superior for the sheep serum. All variants maintained their sterile condition. Both variants with animal serum
maintained the viability of the strains up to 30 days, with the microbial growth being more stable during that period for the
variant with sheep serum.
Conclusions: A formulation of the Transport Medium for Leptospira ready-to-use was defined, with decanted and filtered
inactivated sheep serum, which meets the quality requirements established for this product, which will guarantee a safe
transfer of the samples and their accurate diagnosis.
Keywords: centrifugation; decantation; filtration; inactivation; leptospirosis; rabbit; serum; sheep; strains; variants


Obtaining a diagnostician of strict and facultative anaerobic

microorganisms in blood samples
Ana I. Brito*, Marilyn Díaz, Dennis Someillan, Claudio Rodríguez, Raisa Zhurbenko
Microbiological Diagnosis Group, Research and Development Department, National Center for Biopreparations, Mayabeque, Cuba.
*anairis.brito@biocen.cu; ORCID: 0000-0001-5698-0085
ABSTRACT
Context: Diagnosis of anaerobic microorganisms in bloodstream in Cuba is depressed. Rescue it, could be an opportunity for
improve the Microbiology Service in the Intensives Care Unit.
Objetives: To obtain a diagnostician for stricts and facultative anaerobic microorganisms in bloodstream.
Methods: To definite a composition of a medium of enrichment to promote growth of stricts and facultative anaerobic
microorganisms. It was evaluated against certified strains and clinical isolates in an anaerobic atmosphere. A methodology
for the formulation, sterilization, and filling with an anaerobic atmosphere in the final primary container was tested. The
response of the new product against microorganisms of the Clostridium genus and the HemoAnaerobic and HemoAnaerobic
Neonatal reference, CPM Commercial Firm, Italy, was evaluated.
Results: The new composition showed satisfactory microbiological results. During the formulation stage, the application of
vacuum, nitrogen injection and sterilizing filtration were determined. The technological process culminated with the aseptic
filling in an anaerobic atmosphere in two presentations. The diagnosis tester met the microbiological quality requirements,
with good microbial recovery of the Clostridium perfringens and Clostridium sporogenes collection strains.
Conclusions: The methodology for obtaining a diagnosis of strict and facultative anaerobic microorganisms in blood samples
was developed. The new composition responded satisfactorily against certified microbial strains and from clinical isolates.
The design of the technological process included the formulation stage, sterilizing filtration, and packaging in an anaerobic
atmosphere of two presentations, 80 and 9 mL. The quality control showed that it responded satisfactorily against the strains
of the Clostridium genus tested.
Keywords: blood culture; methodology; technological process


Development of new allergenic raw materials to obtain anti-

allergy vaccines
Benito L. Espinosa*, Damaris Torralba, Bárbara Luis, Mayteé Mateo, Wendy Ramírez, Yenisleidy Revilla,
Raysa Cruz, Alexis Labrada
Centro Nacional de Biopreparados, Mayabeque, Cuba.
*chino@biocen.cu
ABSTRACT
Context: The Allergenic Raw Material (MPA) of mites is the starting material to produce vaccines used in allergen-specific
immunotherapy.
Objective: Demonstrate that by adding the defatting step in the production of MPA, the parameters established in the quality
specifications are not altered and demonstrate its stability.
Methods: A study was carried out with 3 batches of MPA from each species Blomia tropicalis (BT), Dermatophagoides siboney
(DS) and Dermatophagoides pteronyssinus (DP) which were compared before and after the defatting process. Protein
composition (SDS-PAGE), protein content (Lowry), Group 1 major allergen content (ELISA) for DSB and DPT and Inhibition
Elisa for BLT, as well as microbial limit were determined. A shelf-life stability study was conducted for 36 months at -20 °C.
Results: All the quality indicators were kept within the parameters established in their specifications without significant
differences between defatted and non-defatted MPA. The results of the SDS-PAGE show similar profiles without appreciable
changes in the molecular weights of the bands and without loss of the bands of interest. There was no evidence of microbial
contamination after defatting and there was a tendency towards the reduction of microorganisms. The stability study
showed that no parameter is affected during the 36 months of study.
Conclusions: The defatting process did not affect the quality requirements of the MPA and its stability was demonstrated.
This stage would be essential to obtain batches of vaccines with higher concentrations.
Keywords: allergy; defatting; immunotherapy; mites; stability


Obtaining the active pharmaceutical ingredient of the new

vaccines for sublingual immunotherapy DiVALER-SL and
TriVALER-SL
Damaris Torralba*, Mayteé Mateo, Wendy Ramírez, Yenisleidy Revilla, Raysa Cruz, Benito Luis, Anette
García, Amanda Rente, Yarelis Martínez, Yoel Perea, Mayelín Odelín, Yuliet Pino, Yudelin Rivero, Eilen B.
Marcías, Yoselin Bacallao, Yarisel Sardy, Mirielis Fonte, Alexis Labrada
Centro Nacional de Biopreparados, Mayabeque, Cuba.
*damaris.torralba@biocen.cu
ABSTRACT
Context: DiVALER-SL and TriVALER-SL are the synonyms used for the new divalent and trivalent vaccines for allergen-
specific immunotherapy by the sublingual route. Due to their route of administration, sublingual vaccines must be vaccines
with a higher concentration. These vaccines are produced from allergenic raw material (MPA) of house dust mites.
Objective: Obtain more concentrated Active Pharmaceutical Ingredients (APIs) that allow us to meet the requirements of
sublingual vaccines for allergen-specific immunotherapy.
Methods: The process for obtaining the IFAs was carried out at BioCen's Active Ingredients Plant, under Good Production
Practices conditions. The defatted MPA of the species Dermatophagoides pteronyssinus, Dermatophagoides siboney and Blomia
tropicalis was used. A 1:10 extraction, centrifugation, clarifying filtration, concentration/diafiltration and microfiltration were
performed, and the established quality controls were performed (organoleptic, protein composition, protein content,
allergenic potency and quantification of major allergens Der p1 and Der s1 ). Stability study was carried out at -20⁰C.
Results: 9 batches of concentrated active ingredients were obtained and released, 3 of each species. All batches met the
requirements established to be used in the production of the new vaccines. The stability study is currently in 3 months,
although it is a study planned for 12 months, to date all batches meet the quality requirements.
Conclusions: New, more concentrated IFAs were obtained to guarantee the production of new anti-allergy vaccines for the
sublingual route.
Keywords: allergy; defatting; immunotherapy; mites; stability


Study on the cytotoxicity and inactivation of

microorganisms of the Inactivated Viral Transport Medium
TAN
Melanie Canal Viera1*, Diana R. Viera Oramas2, Enrique Noa Romero3, Juliet M. Enríquez Puertas3, Alexis
Labrada Rosado2, Lellany Echazábal Hernández2, Yordania Zayas Ruiz2
1Facultyof Biology, University of Havana. 25th Street No. 455 Vedado Havana city. Cuba.
2NationalCenter for Biopreparations (BioCen). Road Beltrán Km 1½, Bejucal, Mayabeque, Cuba.
3SIDA Research Laboratories (LISIDA). Tapaste road and National Highway, San José de las Lajas, CP 32700, Mayabeque, Cuba.
*canalvieramelanie@gmail.com
ABSTRACT
Context: The National Center for Biopreparations (BioCen), with its contributions to help respond to the COVID-19
pandemic, developed the Inactivated Viral Transport Medium to substitute imports and ensure the technological
sovereignty of the Cuban diagnostic system.
Objective: To evaluate the cytotoxicity of TAN Medium in Vero E6 cells and its ability to inactivate the growth of different
microorganisms.
Methods: Different microbial suspensions were inoculated in vials of the Medium for 30 min at room temperature and then
subcultured on Tryptone Soy Agar or Sabouraud Dextrose Agar plates. Consecutively, the cytotoxicity was evaluated from
various dilutions (1:20, 1:50, 1:80, 1:100 and 1:200) of the TAN medium on the Vero E6 cell line, determining up to which
dilution they were toxic, in compared to cell controls without medium.
Results: The cytotoxicity of the TAN Medium turned out to be from slight to moderate, due to the fact that changes were
observed in the 1:20 (v/v), 1:50 (v/v) and 1:80 (v/v) dilutions perceptible in the cells in all challenges. On the other hand, the
results of the inactivation showed the total absence of the growth of the different microorganisms used as challenges.
Conclusions: The results shown in this study confirmed the quality of the product and its functionality. This will ensure that
exposure to the virus is reduced at the community level, especially among healthcare workers.
Keywords: chaotropic agent; COVID-19; dilution; Medium TAN; Vero E6 cells


Improvement of the fermentation process to obtain

recombinant human epidermal growth factor
Chabelly Cabañas, Regla M. Bonilla, Analeydis García, Odalys Ruiz, Rosalí Ávila
Department of Fermentation, Center of Genetic Engineering and Biotechnology, Avenue 31 between 158th and 190th street. Cubanacán, Playa,
Havana, Cuba.
*chabelly.cabanas@cigb.edu.cu
ABSTRACT
Context: Recombinant Human Epidermal Growth Factor is a protein capable of increasing the speed of wound and ulcer
healing in different tissues of the human body. Currently at the Center for Genetic Engineering and Biotechnology, there is
an increased fermentation process, using the yeast Saccharomyces cerevisiae, to obtain this recombinant protein at 5 L level.
The culture medium can be questioned by first world regulatory agencies since it contains bacteriological peptone of animal
origin.
Objective: For this reason, experimental studies were developed aimed at substituting the animal peptone for peptone of
plant origin in the culture medium, complying with the established quality and safety requirements.
Methods: Subsequently, experimental designs were carried out at shaker scale, to evaluate the influence of amino acids as a
supplement to complement the vegetable peptone in the initial medium.
Results: In this way, an improved fermentation process was established, on a 5 L scale, using vegetable peptone,
supplemented with the amino acids histidine, leucine, proline, methionine, lysine, glycine and cysteine in the culture
medium, with adjustments in the operating parameters, without affecting the yields of the current process (cell growth
greater than 80 g/L, specific protein concentration greater than 48 µg/mL and total protein greater than 0.45 mg/mL),
allowing in turn to meet , with the quality specifications of the intermediate product.
Keywords: culture medium; recombinant protein; Saccharomyces cerevisiae


Biopharmaceutical quality between tablets (multisource) of

national production and Brazilian generic of immediate
release of hydrochlorothiazide 25 mg
Mirta Cabrera Reyte1*, Yenisé Elledías García1, Mirna Fernández-Cervera2
2Institute of Pharmacy and Food (IFAL), University of Havana, Cuba.
*mirta@ms.medsol.cu
ABSTRACT
Context: Hydrochlorothiazide is a first-choice diuretic belonging to the thiazide group, used mainly in the treatment of
arterial hypertension; belonging to Class III within the Biopharmaceutical Classification System.
Objective: To establish if there is pharmaceutical quality between three multisource batches of Hydrochlorothiazide - 25 mg.
Method: The study requires representing a batch of medication, a dissolution profile in each of the following media:
hydrochloric acid buffer pH 1.2, sodium acetate buffer pH 4.5 and potassium phosphate buffer pH 6.8.
Results: The dissolution profiles in the three dissolution media show that the coefficient of variation was less than 20% at the
times less than 15 minutes and less than 10% in times greater than 15 minutes, which allows using the average dissolution
percentage and developing the corresponding dissolution profile. the percentage of dissolution of the batches of national
production was greater than 85% of its content in less than 15 minutes, while that of the generic reference drug was within
20 minutes.
Conclusions: It was shown when performing the dissolution profiles in the different media (pH 1.2; 4.5; and 6.8) that there is
no dissolution criterion in these media. Since they do not meet any of the values of f1 and f2.
Keywords: Dissolution profile; generic; similarity factor


Influence of oxidative stress in fibromyalgia

Arlety González Langaney*, María T. Díaz Soto
*arletygl99@gmail.com
ABSTRACT
Context: In the last few years with the development of science and technology, the Scientific Community has taken great
interest in the incidence of reactive oxygen species in multiple diseases. The association of Oxidative Stress (OE) with
diseases is controversial because in many cases it is questioned whether the OE involved is a cause or consequence of them,
but its relationship with progression is unquestionable. Fibromyalgia (FM) is a chronic disease that causes pain, stiffness and
tenderness in muscles, tendons, and joints. It is also characterized by sleep disturbances, tiredness, fatigue, anxiety,
depression, and alterations in intestinal functions. The etiology of fibromyalgia remains unknown, but recent advances and
discoveries argue for the implication of oxidative stress in the development and maintenance of the disease. In this work, a
bibliographic review was carried out in the search for updated information on fibromyalgia and oxidative stress. The main
characteristics of the disease were reviewed from the point of view of oxidative stress to find its relationship with the main
symptoms suffered by the patient.
Objectives: To analyze from a molecular perspective the relationship between neuronal imbalance and redox state in
fibromialgia (FM), to deepen the relationship between redox state markers and pain mediators involved in FM and to
analyze the influence of pharmacological and non-pharmacological treatments of FM in the redox balance.
Methods: An exploratory bibliographic review of national and international publications was carried out, using as search
terms: fibromialgia, pain, oxidative stress.
Results: There is a relationship between the main symptoms of FM and oxidative stress, coexisting decreased serotonin,
GABA, dopamine, increased glutamate, substance P and cytokines. Pharmacological treatment used in FM, such as
antidepressants and analgesics, and non- pharmacological treatment, also have antioxidant effects.
Conclusions: Fibromyalgia is a disease in which there is an underlying alteration in the celular oxidation-reduction balance, a
consequence of an increase in free radicals and a deficiency in organic antioxidant capacity.
Keywords: Fibromyalgia; oxidative stress; pain; reactive oxygen species; symptoms; treatments


Evaluation of two inert polymers as a release retarding

agent in the physico-chemicals characteristics and in vitro
release of Zidovudine loaded microspheres
Nicté González Alfonso*, Dianelis Fernández, Martha Gómez, Leopoldo Núñez, Orlando Lafita
Center for Pharmaceuticals Research and Development. Av. 26 # 1605 e/ Ave. Boyeros and Puentes Grandes, Havana, Cuba.
*nicte.gonzalez@cidem.cu
ABSTRACT
Context: Novel controlled-release Zidovudine formulation would contribute to the long-lasting HIV treatment adhesion
Objectives: The purpose of this investigation was to study the influence of the polymer as a release retarding agent in the
physico-chemicals characteristics of Zidovudine (AZT) loaded sustained release microspheres, and in vitro drug release
behavior from an oral pharmaceutical form.
Methods: The AZT microspheres was obtained by the Emulsion/Evaporation of Solvents technique, structuring the
experiment with the objective of evaluating the effect in the formulation of two inert polymers such as ethylcellulose and
Eudragit, the samples were characterized by: particles size distribution, yield, loading efficiency, percentage of loose surface
crystals and residual solvents. The dissolution assays were performed using an amount of microspheres corresponding to
150 mg of AZT filled in hard gelatin capsules, evaluating the kinetics drug release for each experience in comparison with
the conventional product, RETROVIR.
Results: The study revealed the influence of physico-chemicals properties of each polymer on the characteristics of the
microspheres and on the in vitro drug release behavior from them. In both cases the AZT was released by anomalous
diffusion mechanisms.
Conclusions: The best results in loading efficiency, capability to control in vitro drug release, as well as the biggest yields in
the process were exhibited by the formulation containing Eudragit/AZT.
Keywords: drug release; ethylcellulose; eudragit.

S10- 3rd STUDENT WORKSHOP OF PHARMACEUTICAL AND FOOD SCIENCES

Alicia Casariego Año, PhD / Raisa Mangas Marín, PhD / Luis Michel Rodríguez Gómez, BSc, IFAL-UH, La Habana, Cuba
Characterization of eating habits in older adults with arterial

hypertension in a Camagüey community
Armando A. Macias González1*, Mabel de los A. Fuentes Lorente2, Lourdes M. Crespo Zafra2
1Undergraduate Student in Food Sciences. 2Department of Food Science and Technology, University of Camagüey Ignacio Agramonte Loynaz. North
Beltway, between Ave. Ignacio Agramonte and Camino Viejo Nuevitas, Postal code: 74650. Camagüey, Cuba.
*amado.macias@reduc.edu.cu
ABSTRACT
Context: The Cuban population shows a trend towards aging and an increase in life expectancy. However, more than two million
Cubans suffer from hypertension, showing an increase in the number of cases from 30.9% in 2010 to 37.2% in 2019, with a high
incidence of older adults. Nutrition and the formation of correct eating habits play an important role in the prevention and
management of this disease.
Objective: To characterize the eating habits in a group of older adults with hypertension, in a health area of the municipality of
Camaguey.
Methods: An observational cross-sectional study was carried out. The population studied was 168 hypertensive older adults from the
La Mascota neighborhood and the sample was made up of a simple non-probabilistic random sampling. A structured interview was
used to collect the data. The information obtained was processed using the statistical package SPSS-21.0.
Results: 38% of the interviewees are between 60 - 70 years of age. 39% have a primary level. Regarding eating habits, 53% do not
consume vegetables every day, 21% report eating at least one fruit daily, 32% eat high salt, 65% declare an abundant consumption
of sugar and 76% use little fat. 32% say they drink less than six glasses of water daily.
Conclusions: The eating habits in this population are inadequate: excessive consumption of sugar, deficit of white meats, fruits,
vegetables, and excess of salt.
Keywords: eating habits; elderly; hypertension; nutritional condition


Microbial growth of L. arizonensis and S. thermophilus in

different culture medium
Rosalesmi Rodríguez Odel1*, Daniela R. Hernández Machado1, Taimy Hernández Sariego2, Amilcar Arenal3
1Undergraduatestudent in Food Science, 2Departament of Food Science and Technology, 3Faculty of Agricultural Science, University of Camagüey
Ignacio Agramonte Loynaz. North Bypass, between Ave. Ignacio Agramonte y Camino Viejo Nuevitas, Camagüey, Postal code: 74650. Cuba.
*rosalesmi.rodriguez@reduc.edu.cu
ABSTRACT
Context: The production and consumption of fermented milk is increasing due to the benefits they have for human healt. Its
elaboration is characterized by the growth in symbiosis of microorganisms, which must be controlled and quantified selectively.
Objective: To evaluate the microbial growth of L. arizonensis and S. thermophilus in different culture medium, for the selective
quantification of their growth in symbiosis within fermented milk.
Methods: Strains were grown independently in skim milk powder. Samples of the inoculated milk were taken and plated in different
culture medium: MRS, MRS-fructose, MRS-maltose y M17. Growth was evaluated and the ideal culture medium for selective
quantification in symbiosis was identified. Subsequently, the strains were grown in symbiosis, the samples were taken at 0, 4 and 24
hours and they were plated in the culture medium determined as suitable. The plates were incubated at 37°C for 72 hours under
anaerobic conditions. They microbial concentration of both strains was determined.
Results: It was observed that L. arizonensis grows in all culture medium, but its growth is different in M17. The isolated growth of S.
thermophilus can be better appreciated in MRS and M17. The differences between both strains in terms of size, color, shape, borders,
and surfaces of the colonies could be appreciated.
Conclusions: The best culture medium to selectively quantify both microorganisms is MRS. L. arizonensis y S. thermophilus grew up to
8 log units in symbiosis.
Keywords: culture medium; fermented milk; lactic acid bacteria; selective quantification


Food sovereignty in the non-hotel company Palmares S.A in its

agricultural development
Ana R. Oliva Álvarez*, Sabrina Calero de la Nuez, Carmen L. García Guillén
Department of Food Science and Technology, University of Havana, Havana, Cuba.
*sabrinacalero62@gmail.com
ABSTRACT
Context: The increase in agricultural production and the reduction of dependence on imports are problems facing agriculture in
Cuba today. Given this situation, the Cuban State has drawn up measures and policies to guarantee the rights to healthy and
adequate food for the population. The materialization of these policies is the SAN Plan, which defines the importance of achieving
food sovereignty as a sustainable strategy for the production, distribution and consumption of food based on small and medium
production.
Objectives: Determine the influence of the food sovereignty policy in the non-hotel company Palmares S.A in its agricultural
development.
Methods: Documentary analysis, interviews with company managers and direct observation.
Results: The need for agreements and contracts with MINAGRI for training and access to equipment and technology for agricultural
development is identified. At least one input team per Branch is needed for agricultural development on land of more than 1
hectare. There is a lack of stable availability of seedbeds, insecticides, biofertilizers for the management of crops. There are no
agricultural implements for the preparation and maintenance of the land, as well as tools. Need for staff for the permanent care of
young animals and crops of more than 1 hectare.
Conclusions: The Company has an incipient agricultural development that must be polished through agreements and consultancies.
Keywords: agricultural development; food sovereignty; SAN Plan


Electrospinning encapsulation of majagua flower extract

(Talipartiti elatum S.W.) in zein structures
Marcos A. González Correa*, Maikel Negrín Hernández, Dairon Iglesias Guevara
Department of Food Science and Technology, University of Havana, Havana, Cuba.
*marcosglezc2000@gmail.com
ABSTRACT
Context: The majagua flower (Talipariti elatum S.W.) is an important source of active ingredients with high antioxidant,
neuroprotective, antimicrobial, radical scavenger activity, and agents that contribute to anticancer and cardioprotective action; but
these are highly degraded during processing and storage due to their chemical structure.
Objectives: To achieve optimal stabilization of the bioactive compounds of the majagua flower extract through encapsulation by the
electrospinning technique, using zein as a protective matrix.
Methods: Three samples (10%, 20%, and 30% p/p) of the extract were prepared and characterized according to pH, electrical
conductivity, and viscosity. A morphological characterization of the particles obtained corresponding to each sample was carried
out by means of scanning electron microscopy and the study of the release models was carried out, adjusting to the Kopcha, Ritger-
Peppas and Peppas-Sahlin models
Results: The highest encapsulation efficiency was observed for the sample of 10% w/w of the extract (around 71%). The
morphological characterization showed a similarity with respect to the morphologies previously reported under the same method,
produced from different concentrations of the protein. The study of the release models demonstrates a controlled release in the
medium, showing diffusion as the dominant release mechanism.
Conclusions: The stabilization of the bioactive compounds of the majagua flower extract was achieved with the sample of 10% p/p in
zein, with an adequate morphology of the particles and eventual release of the extract by diffusion, making it possible to exert its
biological activities.
Keywords: bioactive compounds; electrospinning; encapsulation; zein


Obtaining a powder extract from the majagua flower (Talipariti

elatum Sw) with potential food use
Ángela A.P. González*, Dairon Iglesias Guevara, Alicia Casariego Año
Food Department, Pharmacy and Food Institute, University of Havana, Havana, Cuba.
*angelaalegna.peralta@gmail.com
ABSTRACT
Context: The phytochemical compounds present in plant extracts are of great variety and concentration. Phytochemical tests suggest
the presence of triterpenes and steroids, phenols and tannins, flavonoids, mucilages, bitter (slightly) and astringent principles in the
majagua flower.
Objectives: Obtain a lyophilized product, with adequate moisture and high polyphenol content from concentrated extract of majagua
flower (Talipariti elatum Sw).
Methods: A hydroalcoholic extract was prepared from the flower petals, which was concentrated until obtaining between 10 and
11% of total solids. The optimization of the lyophilization process was carried out based on the content of total polyphenols and
anthocyanins, antioxidant capacity, and adequate humidity and the final total solids content in the suspension of extract plus
maltodextrin was evaluated. Through the use of optimal I response surface design, a mathematical model was generated that could
describe the behavior of the variables according to the process conditions.
Results: A strong positive correlation of 77 and 87% was found between the content of total polyphenols, total anthocyanins and
antioxidant capacity, respectively. The addition of maltodextrin in the extract had a negative influence on the content of
polyphenolic compounds and total anthocyanins per 100 g of powdered extract obtained. Moisture was always maintained above
8%, having a tendency to decrease as maltodextrin content increased, reaching a minimum of 28% solids in the extract.
Conclusions: An optimum was obtained for 26% of total solids with 15% of maltodextrin and a statistical convenience of 64.1%.
Keywords: concentrated extract; lyophilization; majagua flower; polyphenols


Obtaining a coffee-flavored dairy drink using soy milk and

whey
Y. Castro Velazquez1, Dairon Iglesias Guevara2, Marcos A. González Correa2, Maikel Negrin Hernández2*
1Department of Food Science and Technology, University of Santiago de Chile, Santiago de Chile, Chile.
2Department of Food Sciences, Institute of Pharmacy and Food, University of Havana, Havana, Cuba.
*maikelnegrin97032805@gmail.com
ABSTRACT
Context: The proper use of waste or residues originating from the food industries corresponds to the events that have occurred over
the years in de cheese industries due to their waste.
Objectives: To obtain a dairy drink by conveniently mixing the raw materials whey, cow´s milk and soy milk.
Methods: In the first instance, the products to be used in the formulation of the beverages were physically and chemically
characterized. A factorial design was carried out (32), where the levels of starch and why were established. For this, the sugar
concentration (7%) was fixed in the formulation of each of the experimental runs and the rest was completed with the components
whole cow´s milk and soy milk (7% of total solids) mixed in a ratio 7/3. The best evaluated formulation was developed on a pilot
scale and characterized.
Results: The best evaluated formulation by the tasters was the one containing 1.2% starch and 30% whey. The sensory
characterization of the drink showed excellent quality. The beverage had a total solids content of 17.8% and an acidity of 0.07%,
measured as lactic acid. This complied with the required sanitary specifications.
Conclusions: The evaluated formulation had an excellent acceptance by consumers and a quality according to the established
parameters. The use of whey and soy milk in the formulation constitutes a novel aspect of the investigation.
Keywords: cow´s milk; dairy drink; soy milk; whey


Use of grape seed oil for the formulation of creams

Melissa Carmona Rodríguez*, Iriana Mendez Jorge, Joe Doyharzabal Jiménez
*melissacarmona2911@gmail.com
ABSTRACT
Context: In this work, a bibliographical review was carried out on grape seed oil, of which it is known that many of its components
show remarkable antioxidant and anti-inflammatory activities. The research began to focus on the importance of this oil not only in
the food industry, but also in the pharmaceutical industry, highlighting the cosmetic part and its use for the manufacture of skin
creams, making a reference to creams, their production and the benefits of using Nutraceuticals in skin creams.
Objectives: To study the multiple benefits of grape seed oil belonging to the "Vitis vinifera" spice and to propose formulations with
partial and total replacement of the oil initially used for creams, by grape seed oil.
Methods: Several bases were consulted and from them, numerous articles.
Results: It was found that grape seed oil is of great importance due to the presence of Vitamin E in its composition, is an antioxidant
that protects the other vitamins. After the pertinent analyzes it was shown that the pressing process by which this oil is obtained
offers a higher quality of the material for its use in the cosmetic industry.
Conclusions: The Vitamin E, in addition to its antioxidant activity, shows a great capacity to delay skin aging. As a recommendation,
a more in-depth study is proposed on the ability of this oil to oxidize, a factor that affects its stability over time.
Keywords: extraction; nutraceuticals; skin; stability


Pharmacobotanical and physicochemical characterization of

Plectranthus neochilus Schltr (meprobamate plant)
Roselis B. Gamboa, Adianez E. Rodríguez*, Yamilet Irene G. Gaitén, Alejandro F. González, Silvia B. Malacón,
Ramón S. Lizama
Institute of Pharmaceutical and Food Sciences University of Havana, 222 St. # 2317 b/ 23 and 31, La Coronela, La Lisa, Havana, PC 13600, Cuba.
*adianezestevez26@gmail.com
ABSTRACT
Context: Plectranthus neochilus Schltr, from the Lamiaceae family is a species recently introduced to Cuba and widely used for the
sedative effects attributed to it by the population. It is also used within traditional medicine in the treatment of liver failure and
dyspepsia. The plant lacks pharmacognostic information that allows establishing its quality.
Objective: To characterize from the pharmacobotanical and psysicochemical point of view the leaves and stems of Plectranthus
neochilus Schltr.
Methods: The macro and microscopic evaluation of the species was carried out and some physicochemical parameters were
determined to the raw drug (residual moisture, ashes, and soluble substances) and phytochemical screening. A hydroalcoholic
extract was prepared by maceration and its quality parameters (pH, refractive index, total solids, relative density, and capillary
analysis) were measured.
Results: The pharmacognostic study allowed establishing some quality parameters of the drug and its extract, the
micromorphological characteristics being transcendental. Phytochemical assays suggested the possible presence of lactones,
triterpenoids, and coumarins, reducing substances, saponins, tannins, quinones and flavonoids.
Conclusions: The results of this research provide the first results on the pharmacognostic characterization of the development of the
future monograph of the plant, as well as for the planned pharmacological studies of the properties attributed by the population.
Keywords: pharmacobotany; physicochemical parameters; Plectranthus neochilus


Pre-formulation study of a facial tonic with bee products and Aloe vera
Dayan Zahony, María L. López, Christian Martínez, Laura Amado*, Irela Pérez
*laura.amado@ifal.uh.cu
ABSTRACT
Context: Natural cosmetics have experienced an accelerated development in the last few decades as a highly beneficial alternative to
conventional cosmetics. Several natural products are used in different types of cosmetics. The chemical compositions of honey,
propolis and Aloe vera give them antioxidant, nutritive, antimicrobial, and moisturizing properties, among others, and make them
active ingredients selectable for the formulation of products capable of preventing, controlling and improving the condition of the
skin.
Objective: To evaluate the influence of some components of a facial tonic formulation on the technological properties of the cosmetic.
Methods: Four formulations (A, B, C and D) containing honey, propolis and aqueous extract of Aloe vera as biological assets were
developed. Two variants of each formulation were tested; the only difference between them was the type of honey used (from
Melipona and from Apis mellifera). Physical stability was evaluated considering organoleptic properties, pH and the influence of
extreme temperature conditions (40 °C).
Results: At the beginning of the trials the preparations were homogeneous, bright, and translucent solutions; however, in those
containing propolis (A, B and C) a dark precipitate was observed at the end of the study. The pH values obtained were similar to
the pH of the skin with minimal differences over time.
Conclusions: The presence of propolis affected the physical stability of the preparation. The type of honey used did not influence the
pH of the facial tonics. Temperature accelerated the manifestations of physical instability and influenced the pH fluctuations of
some formulations. Formulation D presented the best results.
Keywords: bee products; cosmetics; facial tonic; physical stability


Blood products in Cuba, prospects for development

Daniela García Urquiza*
*danicu003@gmail.com
ABSTRACT
Context: Blood products are drugs whose active ingredient comes from the blood plasma of healthy human donors and are obtained
through an adequate fractionation and purification process, which requires high technology and rigorous production processes.
With the fractionation of blood plasma can be obtained more than 20 products. The most demanded blood products in the market
are albumin and immunoglobulins. The latter have been used safely for decades to treat autoimmune diseases, immunodeficiencies,
and certain bacterial and viral infections. With the emergence of the new coronavirus, a large number of studies began to be carried
out on the effectiveness of intravenous immunoglobulins in this disease. In our country, a clinical trial was carried out with the anti-
SARS-CoV-2 gamma globulin product, which showed encouraging results in phase I in terms of safety and effectiveness.
Objectives: To expose the characteristics and the importance for human health of blood-derived medicines.
Methods: In order to respond to the proposed objectives, the Blood Products Plant was visited, and participants participated in the
fractionation, formulation and packaging process, as well as in the quality control and assurance processes.
Results: With the completion of this work, it was found that Cuba has an infrastructure created to obtain and produce blood
products, which starts from plasmapheresis centers and blood banks to industry.
Conclusions: For more than three decades, the Cuban biopharmaceutical industry has developed and produced the main lines of
blood-derived medicines, as a result of the priority granted by the State.
Keywords: Aica+; Blood products; immunoglobulin; plasma


Pharmacognostic and phytochemical characterization of the

leaves of Ravenia spectabilis that grows in Cuba
Melissa Ll. Gómez*, María E. Jorge, Yanelis Saucedo
Department of Pharmaceutical Sciences. Central University “Marta Abreu” de las Villas, Santa Clara, Villa Clara, Cuba.
*mgsaucedo@uclv.cu
ABSTRACT
Context: Ravenia spectabilis is a promising plant species in the pharmaceutical field due to its antimicrobial and antioxidant actions.
No studies have been described in Cuba that evaluate the chemical composition of the plant.
Objective: To evaluate from the pharmacognostic and phytochemical point of view the extracts obtained from the leaves of Ravenia
spectabilis with a view to their therapeutic use.
Methods: The standardization of drying in the shade and in an oven at 30ºC was carried out. The phytochemical evaluation includes
a qualitative screening of the possible metabolites in the different plant extracts. The identification of the main metabolites that
contribute to the pharmacological actions of the plant was developed by means of Thin Layer Chromatography under different
chromatographic conditions. The content of phenols and flavonoids was determined using techniques such as Folin-Ciocalteau and
the AlCl3 colorimetric method, respectively.
Results: The oven drying method was the most appropiate according to the parameters evaluated. The total ash values were within
the permissible limits. The presence of flavonoids, tannins, steroids, alkaloids and coumarins was detected by phytochemical
screening. The metanolic extract showed the highest levels of total phenols and flavonoids with values of 303.47 mg EAG/g of
extract and 2201 mg ER/g of extract, respectively, and the best chromatographic profile.
Conclusions: The metanolic extract presented the highest content of fenolic compounds and the best chromatographic fingerprint
indicative of these metabolites. The results obtained lay the foundations for research aimed at the development of new active
ingredients for the pharmaceutical industry.
Keywords: flavonoids; pharmacognostic parameters; Ravenia spectabilis


Standardization of the experimental model of hemorrhagic

stroke by intracerebral administration of autologous blood:
oxidative stress parameters
Melissa L. Flores*, Yiliana de la C.A. Álvarez, María A. Bécquer-Viart, Adonis Armentero López, Gilberto L.
Pardo-Andreu
Center for Research and Biological Evaluations, Institute of Pharmaceutical and Food Sciences, University of Havana, 222 St. # 2317 b/ 23 and 31, La
Coronela, La Lisa, Postal code: 13600. Havana, Cuba.
*melissalaurenteflores@gmail.com
ABSTRACT
Context: Cerebrovascular accidents are the cause of important health limitations, disabilities and are currently one of the leading
causes of death worldwide. In 2019, Cuba disclosed cerebrovascular accidents as the third cause of death with 10008 deaths and a
rate of 89.1 per 100,000 populations. Due to an increasing understanding of the biochemical and genetic processes that take place
during these accidents, the development of new neuroprotective therapies has increased.
Objective: To characterize from the biochemical point of view an experimental model of hemorrhagic stroke by intracerebral
administration of autologous blood in Sprague-Dawley rats.
Methods: Sprague-Dawley rats weighing 250 - 300g were used and distributed in four groups: [Hemorrhagic/ 100 µL of autologous
blood; Sham/ 100 µL NaCl 0.9 %; Control/ untreated animals; Treated/ 0,5 - 1 mg / kg of methylene blue]. Variables indicative of
brain damage, such as oxidative stress markers, were evaluated by measuring total nitrites, reduced and oxidized glutathione, and
Superoxide Dismutase, glutathione peroxidase, and glutathione reductase activities.
Results: The results demonstrated the occurrence of oxidative stress in different brain regions of the ischemic animals.
Conclusions: The experimental model of hemorrhagic stroke induced by intracerebral administration of autologous blood in
Sprague-Dawley rats was characterized by an induction of oxidative stress in brain parenchima.
Keywords: brain; biomodels; hemorrhagic stroke; oxidative stress.


Standardization of the experimental model of hemorrhagic

stroke by intracerebral administration of autologous blood:
cognoscitive variables (memory)
Yiliana de la C.A. Álvarez*, Melissa L. Flores, María A. Bécquer-Viart, Adonis Armentero López, Gilberto L.
Pardo-Andreu
Center for Research and Biological Evaluations, Institute of Pharmaceutical and Food Sciences, University of Havana, 222 St. # 2317 b/ 23 and 31, La
Coronela, La Lisa, Postal code: 13600. Havana, Cuba.
*yilianaalfonso@nauta.cu
ABSTRACT
Context: Currently, cerebrovascular accidents are a serious health problem with a growing trend. Worldwide they represent the
second cause of death and dementia in the elderly. In 2019, Cuba disclosed cerebrovascular accidents as the third cause of death
with 10008 deaths and a rate of 89.1 per 100,000 populations. Due to its high incidence and prevalence, several biomodels have been
developed for its analysis and investigation of neuroprotective interventions.
Objective: To characterize from a non-clinical cognitive point of view an experimental model of hemorrhagic stroke by intracerebral
administration of autologous blood in Sprague-Dawley rats.
Methods: Sprague-Dawley rats weighing 250 – 300 g were used and distributed in four groups: [Hemorrhagic/ 100 µL of autologous
blood; Sham/ 100 µL NaCl 0.9 %; Control/ untreated animals; Treated/ 0.5 - 1 mg / kg of methylene blue]. Short-term memory was
evaluated as a non-clinical cognitive variable through the open field test for spontaneous locomotion and the novel object
recognition test.
Results: The results showed evidence of deficits in short-term memory processes at 72 hours after the injury.
Conclusions: The experimental model of hemorrhagic stroke by intracerebral administration of autologous blood in Sprague-Dawley
rats was characterized by a deterioration at 72 hours of the non-clinical cognitive variable evaluated (short-term memory).
Keywords: brain damage; cognoscitive variables; biomodels, hemorrhagic stroke, memory


Use of Moringa oleifera and Plukenetia volubilis seeds and their

application in the pharmaceutical industry
Antonio J. González*, Dairon Iglesias Guevara, Joe Doyharzabal
*ag7539647@gmail.com
ABSTRACT
Context: For many years, M. oleifera and P. volubilis have provided different nutritional alternatives in different fields of health, since
a large part of their sources such as leaves, stems, seeds, roots, fruit, and flowers are used as a nutritional supplement due to their
high content of vitamins, iron, phosphorus, amino acids, proteins, calories, and carotenoid derivatives. In general, in the seeds of
both plants there is a high protein content, valuable not only from a nutritional point of view. Among its constituents are lectins,
which may have intrinsic antiviral action, but also have the potential to generate bioactive peptides by hydrolysis with proteases,
taking advantage of conserved motifs linked to certain biological activities, thus becoming important supplements with
nutraceutical value, useful for strengthen the human organism, in particular in conditions of threat to health.
Objectives: Investigate the compounds of interest of M. Oleifera and P. Volubilis seeds for their use in the pharmaceutical industry.
Methods: Several bases were consulted and from them, numerous articles.
Results: M. oleifera and P. volubilis seeds have high contents of components such as proteins, vitamins and amino acids that can be
used in the pharmaceutical industry for the production of phytopharmaceuticals.
Conclusions: Due to the high protein content of the seeds of both plants, they can be used both in the preparation of conventional
pharmaceutical forms and cosmetic products.
Keywords: M. oleifera; P. volubilis; seeds; proteins


The professional skills of Cuban pharmacists

Adriana Padrón González*, Regla Y. Rolando Castellanos, Jessica Páez Morales, Liliana Mateu López, Mara
Fernández Valdespino, Luis M. Rodríguez Gómez
*adrianapadron@estudiantes.ifal.uh.cu
ABSTRACT
Context: Professional competencies are defined as the integration of knowledge, skills and attitudes that allow quality professional
performance. It is not only determined by theoretical skills, but also by thinking, character, values and good handling of problem
situations. Pharmacy is one of the branches of health, so the competence of pharmacists, to identify, design, analyze, control, and
produce drugs and medicines, is of vital importance; in addition to preparing, supplying, and dispensing these, providing
therapeutic advice on pharmacotherapy, among others.
Objectives: To determinate the knowledge that Cuban pharmacists have about professional skills.
Methods: An analytical observational research was carried out in pharmacies of different municipalities, a survey was used as a tool
and the statistical program SPSS was used for the processing of the variables. A total of 32 workers from the community pharmacies
visited were surveyed, constituting the study sample.
Results: It was concluded that the school level with the highest percentage was high school, and the staff is not familiar with the
term professional skills, however, once exposed, it was observed that they do comply with them in their performance. The results
show that the highest incidence is found in the lack of knowledge of technical words such as pharmacotherapy, pharmacognosy
and toxicological effect; Many workers in the administrative area do not consider it necessary to know them.
Conclusions: It is recommended to delve into the subject, to broaden the interest due to the benefit in professional performance and
to generalize the result of the investigation in other territories.
Keywords: competition; pharmacy; pharmacognosy; pharmacotherapy; toxicological


Characterization of a non-infectious animal model that mimics

the symptomatology of COVID-19
Olivia N. Medina-Vizcaíno, Llilian Gómez-Pérez, Dayrelis Wilson, Gilberto L. Pardo-Andreu*
Center for Research and Biological Evaluations. Institute of Pharmacy and Food, University of Havana, Ave. 23 %214 and 222, La Lisa. PO Box: 430,
Havana, Cuba.
*gpardo@ifal.uh.cu
ABSTRACT
Context: SARS-CoV-2 is the causal agent of the COVID-19 infection that has caused millions of deaths around the world. The
biomedical research on the new disesase have been limited because there is not a robust animal model that allows the study of the
virus's replicative cycle, the course of the disease, or to test the efficacy of different drugs. Current animal models are highly
infectious and require top Biosafety infrastructure. The development of non-infectious animal models that safely mimic the
symptoms caused by SARS-CoV-2 is required.
Objective: To characterize a non-infectious murine model that exhibits the cytokine storm associated with severe systemic
inflammatory syndrome and hypoxia similar as COVID-19.
Methods: Two of the main pathological components of COVID-19 were mimicked in Balb/C mice; severe hypoxia and cytokine
storm. For the first symptom, different cyanide salts were used, in different doses (0.1, 0.5 and 2.5 mg/kg); then the respiratory
capacities were determined in liver homogenate. To mimic the cytokine storm, a single administration of bacterial
lipopolysaccharide (LPS) was performed at different doses (2.5 and 5 mg/kg) and the levels of cytokines IL-2, IL-4 and IFNγ were
determined by ELISA techniques.
Results: The dose of 0.5 mg/kg of NaCN, administered 3 times on alternate days, was established as the one that causes the greatest
inhibition of mitochondrial respiration and the dose of 5 mg/kg of LPS in a single dose, as thus that maintains highest cytokine
titers over time.
Conclusion: The administration of LPS and NaCN at the established doses replicated the cytokine storm and hypoxia caused by
COVID-19, respectively.
Keywords: biomodels; Covid-19; cytokines; hypoxia; systemic inflammatory syndrome; mitochondrial impairment


Propolis tincture with pharmaceutical quality through

modifications of its production technology
Idalmis K. Ojeda*, Melissa Ll. Gómez, Dina B. Aguado
Department of Pharmaceutical Sciences. Central University “Marta Abreu” de las Villas, Santa Clara, Villa Clara, Cuba.
*mgsaucedo@uclv.cu
ABSTRACT
Context: The propolis tincture made in the Villa Clara Local Production Centers is highly demanded due to its diversity of uses.
Objective: To optimize the technology to produce propolis tincture for pharmaceutical purposes, used in the Local Production
Centers of Villa Clara.
Methods: A 23 factorial design of experiments was carried out. The independent factors and their levels were: type of menses (70%
and 96% etanol), extraction time (7 and 14 days) and variety of propolis (brown and reddish brown). The response variable
(dependent) to consider was the content of total solids. Other quality parameters evaluated at dyeing were relative density,
refractive index and pH.
Results: The highest content of total solids (24%) was obtained for the condition where reddish brown propolis was used, 96% etanol
as menses and extraction time of 7 days. The pH, refractive index and relative density of the dye gave similar results to those of
other dyes of natural origin reported in the literature.
Conclusions: The type of menses and variety of propolis had a significant influence on the content of total solids. Other quality
indexes not included in the control of the quality of the dye were determined, which constitutes a novel aspect of the investigation.
Keywords: quality indices; propolis; processing technology; tincture

Author index
Abel Hernández, 97 Amélia M. Silva, 48 Antonio Iraizoz Colarte, xv, xvi, Caridad Sedeño Argilagos,
Ada E. Inguanzo, 74, 109 Amelié González Atá, xix, xx, xxxv, xxxvi, xlv, 53, 219, xxxiv, xxxvi, xlvi, 212, 213,
Adalberto Izquierdo Castro, xv, xlvi, 102 229 222
52 Amilcar Arenal, 192, 269 Antonio J. González, 281 Carlos A. Duarte, 166, 179
Aday Oliva, 195 Ana Aguilera, 124 Antonio Nogueira, 21, 82 Carlos Álvarez, 29
Addis Bellma Menéndez, xxix, Ana B. Pérez-Díaz, 172 Antonio Nogueira-Mendoza, Carlos García Pino, 199
65, 130, 182 Ana C. Calpena Campmany, 82 Carlos M. Fernández, 128
Adelaida Benítez Aguilar, 65 48, 50, 84, 85, 87, 88, 90 Araceli Chico Capote, 181 Carlos R. Hernández, 77
Adianez E. Rodríguez, 275 Ana C. Noa Rodríguez, 126, Aramis Rivera, 63, 76 Carlos R. Núñez Cairo, 126, 145
Adiel González, xxv, 138, 183 127, 145 Aramis Rivera Denis, 63 Carlos R. Romeu Carballo, 70,
Adisley Dorta Martínez, 118 Ana Fernández Nin, 168 Arelis E. Gaibor, 208 71, 75, 108, 254
Adonis Armentero López, 36, Ana García, 29 Ariadna Pérez-Naranjo, 92 Carlos Rabeiro, 49, 177
46, 161, 279, 280 Ana I. Brito, xlii, 260 Arianna Padrón, 253 Carlos Rabeiro Martínez, 177
Adriana Carr, 39 Ana I. Peñalver, 168 Ariel González García, 199 Carmen L. García Guillén, 270
Adriana Padrón González, xli, Ana L. Cabrera, 259 Ariel Viña González, 168 Carmen L. Pérez, 166
282 Ana L. González, 93 Arlety González Langaney, xliii, Carmen R. Cruz Valiente, 79
Adriel Brito Llera, x, xxviii, 170 Ana M. Colominas, xxxix, 197, 266 Carmen Soto, xi, 29
Agnieska Almeida Hernández, 247, 249 Armando A. Macias González, Carmen Valenzuela Silva, 168
xxii, 125 Ana M. Hernández, 29 xl, 268 Carmen Viada, xiii, 35
Agustín Lage, 35 Ana M. Rodríguez, 130, 151 Armando Cuéllar Cuéllar, 146 Catherine Fagúndez, xxiv, 137
Ahmed Valdés Martínez, 38 Ana M. Rodríguez Bouzas, 130 Aydi Columbié, 100, 111, 116 Catherine Fagundez Olivencia,
Ailin Martínez, xxxi, 191 Ana R. Oliva Álvarez, 270 Ayme F. Valdes, 121 142
Aines Muños Pérez, 157 Anabel Domínguez-Mainer, Bárbara Luis, 261 Celia Fernández-Ortega, xxvii,
Alberto C. Benítez, 181 157 Bárbara M. González, 256 166, 179
Alberto E. Varela Llanes, 123 Anabel Lavastida-Linares, 32 Bartosz Wiernicki, 28, 37 Chabelly Cabañas, xliii, 264
Aldo Hernández Monzón, 187 Anaela Montalvo León, xvi, 60, Beatriz Clares, 84 Chavely Galvez Encinosa, xxxii,
Aleida Mandiarote, 256 63, 76 Beatriz Colominas Bécquer, 81 200
Alejandro Echagarrua, 72 Anaelys R. Maceo Sinabele, Beatriz Fernández, xxx, 158, Christian Martínez, 276
Alejandro F. González, 126, 175 185, 186 Christianne Salbego, 30
127, 275 Anaiza Pérez, xxxi, 195, 234 Beatriz Fernández-Alarcón, Christophe Molina, 184
Alejandro Fabra González, Anaiza Pérez Martinto, 234 158 Cira Duarte, 243
xxxvii, 238 Analeydis García, 264 Beatriz Linares Diego, xxxvii, Clara Águila Thalenko, 187
Alejandro Felipe González, Anay Cordero Eirez, 168 231, 238 Clarence Charnay, 76
xxiii, 143, 144, 145 André Meneghetti, 30 Beatriz Piniella Matamoros, 43 Claudia Aguabella, 197
Alejandro García Varona, 69 Andrey E. Shchekotikhin, 183 Beatriz Sierra-Vázquez, 172 Claudia Chávez, 130, 151
Alen N. Baeza Fonte, 245 Anette García, xxi, 80, 262 Behrouz Hassania, 28, 34 Claudia Chávez Hernández,
Alexander M. Scherbakov, 183 Ángela A.P. González, 272 Behrouz Hassannia, 37 130
Alexander Parra-Coca, xiv, 48 Ángela E. Sosa, xxxv, 217, 252, Belinda Sánchez, 29 Claudia Filgueira, 201
Alexandra J. López Barrera, 258 Beltis Villanona Pons, 224 Claudia Gómez, 76
156 Ángela Fidalgo Maceo, xv, 55, Benito L. Espinosa, 80, 261 Claudia Iriarte-Mesa, 37
Alexis Labrada, 80, 95, 96, 123, 68, 118 Benito Luis, 262 Claudia M. Vazquez, 161
261, 262, 263 Ángela Sosa, 97, 104 Berenice Andrade-Carrera, 83 Claudia Miranda, xxvii, 162
Alexis Labrada Rosado, 95, 96, Ángela Sosa Espinosa, 104 Blanca I. Tolón Murguía, 140, Claudia Talavera, 95, 101, 123
123, 263 Angélica M. Machado, 259 149 Claudia Talavera Castro, 95,
Alexis Manso, 29 Ania C. Rico, 129 Brayan Valdes, 240 123
Alicia Casariego Año, iii, xxx, Ania Cabrales, 166 Brian A. Mondeja Rodríguez, Claudia V. Cunill, 46
xxxviii, xl, xlv, xlvi, 218, Ania González Cortezón, xvi, 123 Claudina Pérez-Novo, 39
243, 244, 248, 251, 272 64, 65 Brizaida Oliva Arguelles, xii, 31 Claudio Rodríguez, 72, 101,
Alicia M. Díaz-García, 37 Ania Ochoa-Pacheco, 157 Bruno Montoro, 158 201, 260
Alicia M. Terry García, xix, 95 Anna C. Ramírez-Suárez, 179 Bruno Verstraeten, 28 Consuelo González Triana, 130
Alina Cruz, 256 Anna Ramírez-Suárez, 166 Byron E. Zavala, 153 Cornelis Vlaar, 174
Alix Parte-Gómez, 92 Anna Tsoraeva, 80, 96, 101 C. Matilde López Abad, 95 Cristina Rodríguez Rodríguez,
Allelen Campaña, 255 Anna Tsoroeva, 72 Camila de las M. de las 55, 68, 118
Amalia Hernández Santana, Anna Vidal-Alabró, 185, 186 Barreras, 174 Cristina Silva Baladrón, xviii,
129, 171 Annabel Blasi, 158 Caridad M. García Peña, 10, 15, 90
Amanda Rente, 80, 262 Anselmo J. Otero-González, 21, 64, 65, 82, 94, 122, 130, Cyntia Y. Erazo, 208
Amanda Troya Pérez, xxix, 176 132 151 Dagmara P. Díaz, 129
Amaya Cabrera Muñoz, 196 Antoni Sabaté, 158 Dailen Guanche Gallardos, 141
Ambar Oyarzábal, 135 Antonio Iraizoz Barrios, 64 Dailyn Paz Melgarejo, 106

Dainelis Rodríguez, xxxix, 247, Diego A. Tuarez, 208 Gabriel González, 101 Helena Colom Codina, 170
249 Diego C. dos Reis, 39 Gabriel O. Rodríguez Narvaez, Hermes U. Guerra González,
Dairon Iglesias Guevara, Digna Álvarez, 193 211 223, 229
xxxviii, 243, 244, 248, 271, Dina B. Aguado, 284 Gabriela Enamorado Cantero, Hilda E. Garay, 31
272, 273, 281 Dinorah Prada Hernández, 181 55 Hilda G. Pérez, 129
Damaris García, xxxv, 218, 221 Diogo O. Souza, 30 Gabriela Falcón-Cano, xxx, 184 Hilda Garay, 132, 166, 179
Damaris Torralba, xlii, 80, 261, Dionne Casillas-Casanova, Galina Moya, 112, 114, 119, Hilda M. Alarcón Ríos, 140, 149
262 166, 179 120 Hugo Nodarse Cuni, 181
Dámarys Suárez, xvi, 61, 245 Dioslaida U. Noa, 129 Galina Moya Fajardo, 114, 119, Humberto Pérez, 80, 95
Dámarys Suárez Gómez, xvi, Edison E. Nogueira Roballo, 120 Humberto Pérez de la
245 142 Genoveva M. del Valle García, Concepción, 95
Danae Pérez, iii, xxxviii, xlv, Eduardo Besada, 193 215, 234 Idalmis K. Ojeda, 284
203, 205, 241 Efreín Lauzán, 77 Geovanni Dantas-Cassali, 39 Idania Rodeiro Guerra, xxiv,
Danay López Brito, 168 Eilen B. Marcías, 80, 262 Gerardo F. Martínez Machín, 29, 39, 134
Danaydis Fonseca, xxi, 111, Eilen Macias, 72 128 Ileana Oceguera, 251
116 Elaysa J. Salas Osorio, 188 Gerardo García, xvi, 55, 68, Ileana Sánchez, 192
Dania Bacardí, 179 Eleanis Cabrera, xxvi, 130, 151 113, 118 Iliana Delgado, 95, 113
Dania Pérez-Ricardo, 92 Eleanis Cabrera Torrado, xxvi, Gerardo García Illera, xvi, 55, Iliana Delgado Martínez I, 95
Daniel Álvarez, xiii, xiv, 34, 36, 130 68, 118 Iliana M. Sosa Testé, 170
37, 40, 44, 45 Eliani Uranga, 64 Gerardo Guillén, xxxiv, xliv, 96, Ilianet Céspedes, 134
Daniel Álvarez-Alminaque, 37 Elianys C. Arguelles, 129 166 Inalvis Herrera, xx, 100, 116
Daniel Álvarez-Almiñaque, 34, Elisa Nicoloso Simões Pires, 30 Gerardo Guillén Nieto, 96 Ingrid R. Ramirez, 121
36, 40, 44 Elizabeth López, 221, 227, 228 Gerardo M. Ojeda-Carralero, Iraldo Bello, 113
Daniel Jay Pérez, 170 Elizabeth Pérez, 256 xxvi, 148 Irela Pérez, iii, xv, xvi, xlv, 56,
Daniel Palenzuela Gardon, 43 Elizabeth Reyes Benítez, xlii, Gerardo Valdés Tamayo, 233 57, 58, 59, 60, 63, 76, 276
Daniela de la C. Ferral-García, 253 Germán Aguila Pérez, 69 Irela Pérez Sánchez, iii, xv, xvi,
122 Elsa González Rodríguez, 96 Gilberto L. Pardo-Andreu, 28, xlv, 56, 57, 59, 63
Daniela García Urquiza, xl, 277 Emma Brown, 179 30, 34, 36, 37, 40, 41, 44, Iriana Mendez Jorge, 274
Daniela R. Hernández Eneyce González, 80 45, 46, 279, 280, 283 Isabel Apezteguía, xx, 103, 124
Machado, 269 Enrique Noa, 123, 166, 263 Gilberto Pardo-Andreu, ii Isabel Jiménez Gómez, 105
Daniela Rivero, 111, 116 Enrique Noa Romero, 123, 263 Gilberto Suárez, iii, 218 Isabel Rojas Gatorno, 96
Dareyne Lara Fuentes, 55, 68, Enrique Villavicencio Giosmany Bringas Sánchez, Isidro E. Méndez-Santos, 157
118 Menéndez, 182 168 Iván A. Choez Guaranda, 152
David D. Abreu, 129 Erik Van der Eycken, 148 Gisela Ramírez Torres, xvi, 70, Ivón González Blanco, 147
Dayami Martín, 166 Ernesto Cabezas García, 75 Ivones Hernández Balmaseda,
Dayan Zahony, xl, 276 xxxviii, 239 Gisela Valdés, 61 29, 39, 134
Dayana Bocourt Apan, 144 Ernesto M. Díaz, 77 Giselle Breña, xxiv, 135 Ivonne Alfonso, xxxii, 200, 201
Dayana C. Brito, 113 Ernesto Rodríguez, 173 Giselle Pentón-Rol, 42, 43 Ivonne Alfonso Valdez, 200
Dayana Callejo, 72 Ernesto Suárez Romero, 95 Gladys R. Ramos Yacasi, 90 Jaime F. Vera, 189, 190, 208
Dayaris Hernández, xvii, 63, 76 Estael Ochoa Rodríguez, 30, 41 Gledys Reynaldo Fernández, Janett Terrero, 117
Dayaris Hernández Oliva, 63 Eva Salas Olivet, xxv, 146 iii, xxix, xliii, xlv, 174, 175, Javier A. Ramy, 218
Daymi Mádernas Sánchez, 242 Evelio González Dalmau, 168 257 Javier E. Alfonso-Ramos, 148
Dayrelis Wilson, 45, 283 Evelyn Guerra Vidal, xlii, 71, Glenda M. Sarmiento Tomalá, Javier Marín Prida, ii
Dayron Martín, 151 254 xxvi, 153 Javier Marín-Prida, 36, 40, 42,
Dayvis Díaz Salazar, 38 Evelyn I. Rojas Vázquez, 224 Goitybell Martínez Téllez, 180 45
Dennis Someillan, 123, 259, Evelyn Spencer Hernández, Gretchen Bergado, 29 Jean Vicente Iznaga, 128
260 182 Greydis García Leon, 78 Jean-Christophe M. Monbaliu,
Dennis Someillan Iglesias, 123 Evelyn Victorero Alonso, 176 Greysa L. Alvárez Hernández, 174
Diadelis Remírez, xxiv, 133, Ezequiel Jiménez Laborí, 143 126 Jeney Ramírez Sánchez, xii,
150 Fabien Pelaez Cuesta, xxvi, 150 Grisel Del Toro García, 230 30, 41
Diana G. García, xix, 98 Fabrice Lecrerc, 131 Guillermo Ajoy, xxxix, 161, 173, Jennifer Rojas, 55, 112, 118
Diana R. Viera, 123, 259, 263 Faustina Fonseca-Betancourt, 250 Jennifer Rojas Pérez, 55, 118
Diana R. Viera Oramas, 123, 172 Guillermo Aparicio López, 182 Jenny Correa Soto, xxxi, 194,
263 Felicia Poey, 193 Guillermo de Grau, xviii, 86 198
Diana Rosa Viera Oramas, xxii, Fernández Aneet, 253 Gustavo Furrazola, 113 Jenysbel de la C. Hernández-
96 Fidel E. Morales Vicente, xxiv, Guy Van Camp, 39 Reyes, 32
Dianeisy Cabrera Cuello, 140, 132 H. Gerónimo, 113 Jessica Brosmenier, 116
149 Flavia Llorente, 29 Hanlet Camacho Rodríguez, 43 Jessica Páez Morales, 282
Dianelis A. Leyva, xxxix, 248 Francisco Fernández-Campos, Hector Colomé, 52 Jesús Domínguez Peña, 182
Dianelis Fernández, 267 90 Heidy Pérez, 72 Jesús Zamora Sánchez, 55
Dianys Remón, 191 Frank G. Intriago, 189, 190, 208 Helen González Abreu, xx, 105 Joana González, 103
Diasney Corrales, xxxviii, 240 Frank Rosenau, 132 Helena Colom, ix, xxvii, 84, Joe D. Jiménez, 244
Diego A. Guamán Anilema, 59 Gabino Garrido, ii 158, 170, 185, 186

Joe Doyharzabal, iii, 243, 274, Lamay Dorta, 252 Lizandra Fuentes de la Torre, Makis Torres, 55, 116
281 Lars Gille, 33, 138, 169 224 Makis Torres Toledo, 55
Joe Doyharzabal Jiménez, iii, Laura Amado, 276 Lizet Aldana Velazco, xxviii, Manuel A. Rivas, 66
243, 274 Laura Chao Artola, 59 171 Manuel de J. Álvarez, 204
Joel Torres, 35 Laura D. Alfaro, 244 Lizette Gil del Valle, xxvii, 49, Manuel M. Collazo Herrera,
Joniel A. Sánchez-Márquez, Laura de la C. Amado, 60 165, 172, 177, 215 209, 210
165, 172 Laura de la C. Bakos Ruiz, 43, Llilian Gómez-Pérez, 45, 283 Manuel Romero Pláceres, 96
Jorge A. Gómez Morejón, 181 181 Lorena Moreno, 139 Mara Fernández, xxxvii, 236,
Jorge Castro, 171, 179 Laura L. Valdez López, 155 Lourdes Anguiano Costa, 119 282
Jorge Castro Velazco, 171 Laura Machín, xxvii, xxviii, xlvi, Lourdes B. Costa, 113 Mara Fernández Valdespino,
Jorge Duconge, 174 169, 183, 237 Lourdes Costa, 55, 68, 112, 282
Jorge Fernandez de Cossio, 31 Laura Machín-Galarza, 237 114, 118 Maraelys Morales González,
Jorge L. Castaño, 81 Laura Martínez Pérez, 171 Lourdes Costa Anguiano, 55, xxxvi, 224
Jorge L. Hernández, 80 Laura Martínez Torres, xvi, 69 68, 114, 118 Marc Soriano-Ramírez, xviii, 87
Jorge L. Santana Tolosa, 107 Laura O. Tamayo, 178 Lourdes González Fernández, Marco Álvarez Soto, 95
José A. Arencibia, xxxix, 251 Laura Polo Portelles, 230 xxxvii, 232 Marcos A. González Correa, xl,
José A. Herrera Isidrón, 39, 134 Laura R. Taño Portuondo, 41 Lourdes L. González 271, 273
José A.G. Pérez, 121 Lázaro Cervetto de Armas, xx, Fernández, 225 Mareysis Ruiz, xxii, 112, 114,
José Benito de Armas, 96 104 Lourdes León Puerto, xxxiii, 120
José C. Leyva, 139 Lázaro Sánchez, 101 206, 207 Mareysis Ruiz Pérez, xxii, 114,
José J. Rodríguez, 80 Lellany Echazábal Hernández, Lourdes M. Crespo Zafra, 268 120
José L. Marcelo Sains, 120 96, 123, 263 Lourdes Pérez Méndez, 196 Margarita E. Coba, 103
José L. Rodríguez, 241 Lena de León, 29 Luc Pieters, 127, 144, 157 María A. Barrios Álvarez, 54,
José R. Pérez, 10, 15, 21, 67, 82 Leonardo A. Vargas, 153 Ludger Ständker, 132 219
José R. Pérez-Mora, 10, 15, 67, Leopoldo Núñez, 267 Luis A Fonseca Fonseca, 30 María A. Bécquer-Viart, xiii, 36,
82 Lesley A. Stark, 31 Luis A. Espinosa, 117 46, 279, 280
José Suárez-Alba, 179 Leslie Pérez Ruiz, xxviii, 168 Luis A. Fonseca Fonseca, 41 María A. Gómez, 77
Josep M. Grinyó, 185 Leunam Rodríguez, 80 Luis A. Montero-Cabrera, 131 María C. Hernández González-
Joseph Bloom Oquendo, 211 Leyani Lores Ventosa, 69 Luis A. Torres Gómez, 147 Abreu, 165
Jovany Fi, 258 Leyanis Prieto, 192 Luis C. Hidalgo Guerrero, 96 María C. Montalvo Villalba, 123
Juan A. Bernier Piñeiro, xxxiv, Leyanis Rodríguez, xxvii, 159, Luis E. Hernández, 29 María del Carmen Domínguez
211 164, 170, 174, 175 Luis H. Vásquez, 189, 190, 208 Horta, 181
Juan A. Pérez-Carrasco, 122 Leyanis Rodríguez-Vera, xxvii, Luis Javier González, 47 Maria del R. Alemán, 97
Juan Abreu, 130, 151, 155 159, 164, 170, 175 Luis M. Rodríguez, 46, 161, 282 María E. Jorge, 278
Juan Abreu Payrol, 130, 155 Leydi M.V. García, 121 Luis M. Rodríguez Gómez, 282 María F. Pérez, 135
Juan Batista Cuéllar, 168 Leyenis García, 97 Luisa G. Silega-Coma, xxi, 113 María I. Reyes Naranjo, 162
Juan C. Polo Vega, 171 Leyra Herrera, 241 Luisa M. Gómez Arcia, 233 María J. Carballo Fernández,
Juan C. Rodríguez, 29 Leysi Baro, 73 Luz A. Caballero Pérez, 187, 222
Juan J. Machín González, 235 Liana Valdés-Lanza, 172 188 Maria J. Rodríguez-Lagunas,
Juliet M. Enríquez Puertas, Lianet Chui, 80 Lyi Wong Trujillo, xxxii, 199 84, 88
123, 263 Lianet Monzote, xii, 33, 128, M. Guadalupe Guzmán-Tirado, María L. González-Sanabia, 10,
Julio Ancízar, 179 138, 169, 183 172 15, 67, 94
Julio C. Escalona-Arranz, 157 Lianet Monzote Fidalgo, xii, Ma. Luisa Garduño-Ramírez, María L. López, 276
Julio Caballero, 148 128 83 María Rincón, 89
Julio F.S.T. Pompa, 121 Lidia A. Fernández-García, 165 Mabel Alfonso Ruiz, 96 María T. Díaz, 161, 266
Julio R. Fernández, 47, 123 Lídia Gómez-Segura, 48 Mabel de los A. Fuentes María T. Díaz Soto, 266
Julio R. Fernández Masso, 123 Lidisbet Cardoso, 227, 228 Lorente, 268 María T. Illnait Zaragozí, 128
Julio R.F. Massó, 181 Liem Laguna Oliva, 123 Mabel Izquierdo, 113, 115 María V. Martínez Betancourt,
Kalet León, 32 Liliana Mateu López, iii, vi, vii, Mabel Izquierdo López, 115 69
Karelia Cosme, 179 282 Madelaine Bernard Mendoza, Marian Hernández-Colina, 237
Karen Álvarez, 166 Lilianne Acosta Cardoso, 53 Maribel G. Vallespi, 31
Karine Rodríguez, 174 xxxvii, 235 Madeline Ochoa Alomá, xxxvii, Mariela Vázquez Martínez,
Karla M. Freyre, xxix, 178 Lilliam Besada Moreno, 75 233 xxxviii, 246
Karla Pereira, 179 Lillyam Betancourt Peraza, xiv, Maelys Hernández-Almaguer, Marietta Navarro-Gómez, 62
Katherine E. Bustamante xxix, 49, 177 xxxvii, 237 Marilyn Díaz, xix, 96, 123, 259,
Pesantes, 154 Linet Díaz Villavicencio, xxxviii, Maelys Miyares, xxii, 117 260
Ken Declerck, 39 245 Maidel C. Álvarez, 181 Marilyn Díaz Pérez, xix, 96, 123
Kenn Foubert, 127, 144 Liris Pacheco Amoros, 175 Maikel Negrin Hernández, 273 Marilyn López de Armas, 64,
Kerly E. Alvarado, 189, 190, Lisania Reyes, 35 Maikel Negrín Hernández, 271 130
208 Lisset Chao, 29 Maité Martiatu Hendrich, xxix, Marinda Meertens, 185, 186
Kethia González, 39, 134 Lisset L. Acosta Arrate, 95 180 Mario A. G. Pérez, 248
L. Sulin González Ferrer, 110 Livan Delgado-Roche, 39 Maivis Hernández, 191 Mario Fajardo Cárdenas, 246
Lais Pérez, 72, 193 Majel Cervantes-Llanos, xiii, 43

Mario M. Delgado-Guerra, 165, Mirta Castiñeira-Díaz, 122 Orlando A. Abreu-Guirado, 157 Richard F. D’Vries, 36
172 Mitchel Reyes, 193 Orlando Lafita, 267 Roberto Fernández-Acosta, ii,
Marisela Valdés, ii Muammar Fawwaz, v Oscar Cruz, 113 xi, xiii, xlvi, 28, 34, 36, 37
Marlene Prieto, 151 Naldis López, 192 Óscar Domènech, 84 Roberto León, xxxiii, 203, 205
Martha Botet García, 65, 70, 75 Nancy Burguet, xlii, 255 Oscar Ledea, 59 Roberto M. Santiesteban, 121
Martha Gómez, 267 Nancy Martínez, 167 Osmany García Zaldívar, 38 Roberto Menéndez-Soto, 178
Matilde López Abad, 118 Nashelly Esquivel, xx, 101, 193 Osniel Cabrera, xxi, 55, 112, Roberto R. Nuñez, 39
Maybel González Mirabal, xxi, Nashelly Esquivel Crespo, xx, 114 Rocio Cartaya Quintero, xxxi,
110 101 Osniel Cabrera Díaz, xxi, 55, xxxiii, 196, 198
Mayda R. Perurena Lancha, Negar Ahmadi, xviii, 89 114 Rocío de la C. Sarduy-Chávez,
128 Negar Beirampour, xviii, 85, Osvaldo R. Acosta, 129 42
Maydelin Trujillo, 77 87, 88 Oswaldo G. Pesantes Rodny Montes de Oca, 122,
Mayelín Odelín, 101, 262 Nelky Urrutia Amable, 168 Domínguez, 154 139
Maylin La O, xxi, 112, 114, 118, Nelliet Vega Rodríguez, 54 Otto Cruz Sui, 123 Rodny Montes de Oca-Porto,
119, 120 Nelson León Concepción, 142 Pablo Sariol-Resik, 172 122
Maylin La O González, 114, Nestor Expósito, 103 Paola Bustos-Salgado, xviii, 83 Rodolfo Suárez-Iznaga, 165
118, 119, 120 Nicole D. Jaramillo, 153 Parsshava Mehta, 170 Roidel Ferrer-Bandera, 157
Maylín Wong Guerra, 41 Nicté González Alfonso, xliii, Patricia Fernández, xlii, 252 Roland Expósito Pérez, 95
Mayra Ramos Suzarte, xxvii, 267 Patricia Manzano Santana, 152 Rolsa A. Lilly González, 235
163, 175 Nilda Mieres Díaz, 96 Patricia Pérez, iii, xv, xvi, xlv, Rosa K. Renté, 241
Mayrel Labrada, 32, 39 Nilia de la Paz Martín-Viaña, 56, 57, 58, 59, 60, 77 Rosa M. Simpson, 193
Mayrel Labrada-Mon, 32 xvi, 10, 15, 21, 67, 82, 94, Patricia Pérez Ramos, iii, xv, Rosabel Mollineda Alvaré, xx,
Mayte Alfaro, 167 182 xvi, xlv, 56, 57, 59 102
Mayteé Mateo, xvii, 80, 261, Niovis Ceballos, 150 Paul Cos, 33, 157 Rosalesmi Rodríguez Odel, 269
262 Niurka M. Dupotey Varela, 224 Pedro L. Sama, 252 Rosalí Ávila, 264
Mayvi Almora Lara, 55 Niurys de Castro Suárez, iii, Pedro P. Pérez, 129 Rosalina García, 61, 246
Melaine González García, 132 xxix, 175 Pere Fontova, 185, 186 Rosalina García Neninger, 246
Melanie Canal Viera, xliii, 263 Niurys Mantilla-García, 10, 67 Peter Vandenabeele, 28, 34, 37 Rosamelys Ramos, xxxii, 204
Melissa Carmona Rodríguez, Nivaldo G. Hernández, xiv, 47 Piedad F. Yepez, 208 Rosangela L. Cabrera Garateix,
xl, 274 Nivian Montes de Oca, 191 Pilar A. Soledispa, xxvi, 152, 81
Melissa Gil Delgado, xxv, 147 Nubia González, xxii, 103, 124 153 Rosanny La O Castellón, 198
Melissa L. Flores, 279, 280 Núria Garrós, xviii, 48, 84, 85, Pilar A. Soledispa Cañarte, Rosario E. Velar Martínez, xxiii,
Melissa Ll. Gómez, xli, 278, 284 87, 88 xxvi, 152 128
Mercedes Campo Fernández, Nuria Lloberas, 185, 186 Pilar Rodríguez, 166 Rosario Gravier Hernández,
154 Nuris Ledón, 32, 35 Rachel de la C. Hernández xxviii, 49, 165, 172, 177
Merlin Falcón, 193 Odalis Espinosa López, 95 Suárez, 127 Roselis B. Gamboa, 275
Michel Reyes Morgado, 96 Odalys Achón Tula, 65 Raimundo Ubieta-Gómez, 166 Roselyn Martínez, 256
Miguel A. Acosta, 165 Odalys Betancourt Mora, 70 Raisa Mangas Marín, iii, xxv, xl, Roxana García Cortes, 146
Miguel A. Cabrera-Pérez, 92, Odalys Madrazo, 66, 70, 71 xlvi, 139, 152, 237 Roxana Hidalgo Fernández,
162, 184 Odalys Madrazo Alonso, 70, 71 Raisa Martínez Casanueva, 96 196
Miguel A. López López, 140, Odalys Orraca-Castillo, 172 Raisa Ramos González, 95 Roxana Vicente, 135
149 Odalys Ruiz, 103, 124, 264 Raisa Zhurbenko, 201, 260 Roya Mohammadi Mey Abadi,
Miguel Castillo Ferrer, 55 Odalys Valdés Martínez, 182 Raiza Martínez Casanueva, 165 87, 88
Miguel D. Fernández, 39, 134 Odette Beiro Castro, 38 Raíza Ruiz Llorente, 32 Roya Mohammadi Meyabadi,
Miguel D. Fernández Pérez, Ofelia Fariñas Suárez, xvii, 78 Ramcy Regalado, 101 xviii, 85
134 Olga A. Echemendia, 130, 151 Ramón De Cangas Morán, 187 Rubén Amaya Izquierdo, 171
Miladys Limonta, 103 Olga A. Echemendia Arana, Ramón S. Lizama, 275 Rubén López Edghill, 55
Milena Díaz, iii, xv, xxxiv, xxxv, 130 Ramón Scull, xxv, 33, 126, 127, Rudens Velo, 253
xxxvi, xlvi, 56, 57, 58, 216, Olga E. López-Fernández, 165, 143, 144, 145, 156 Sabrina Calero de la Nuez, 270
220, 226, 236 172 Ramón Scull Lizama, xxv, 126, Sachy Rodríguez, xvii, 72
Milena Díaz Molina, iii, xxxv, Olga L. Sosa, 202 127, 143, 144, 145, 156 Saily Pérez Sosa, 168
56, 57, 216, 220, 226 Olga M. Nieto Acosta, 56, 57, Raydan Galvez Lemus, 119 Sandra Álvarez Guerra, 102
Mireia Mallandrich, x, xv, 48, 155, 212, 213, 219, 223 Raysa Cruz, 80, 261, 262 Sara Hernández, 193
51, 83, 84, 85, 87, 88, 89, 90 Olga M. Osa Echenique, 225 Regla M. Bonilla, 264 Segundo G. Ruíz Reyes, 156
Mireia Mallandrich Miret, 90 Olga S. León Fernández, 160 Regla M. Casanova Orta, 143, Sergio Pérez, 80
Miriam T. Paz-Lopes, 39 Olivia Díaz, 29 144 Sheila Padrón, xxi, 100, 111,
Mirielis Fonte, 80, 262 Olivia N. Medina-Vizcaíno, 283 Regla Y. Rolando Castellanos, 116
Mirjam N. Trame, 175 Olivia T. González, 161, 173, 282 Sheila Padrón Morales, xxi, 111
Mirna Fernández-Cervera, xix, 250 René Delgado-Hernández, 30, Sheyla Fernández, 15, 21, 82,
xx, xlvi, 62, 69, 92, 122, Olivier De Wever, 39 39, 153 94, 130, 151
162, 212, 213, 237, 265 Omar Torres Díaz, 68, 118 René Tejedor Arias, iii, xxx, Sheyla Fernández-Puentes, 15,
Mirta Cabrera Reyte, xliii, 78, Oreste Cabañas, 258 xxxii, xlv, 187, 188, 191 82, 94, 130
81, 265 Orielys Delgado Carballo, 95 Renny Small Laza, xx, 106 Silvia B. Malacón, 275

Silvia C. Morales Racer, 215 Valvanera Vozmediano, xxvii, Yamile Peña Quián, 168 Yoanna Herrera Preval, xxxv,
Silvia C. Morales Ramos, 200, 159, 164, 170 Yamilet Gutiérrez, xxv, 33 xxxvi, 216, 226, 238
234 Veerle Vanlerberghe, 172 Yamilet I. Gutiérrez Gaitén, Yoanna M. Álvarez-Ginarte,
Silvia Lima Costa, 41 Verónika Fraud Smikodub, 55 126, 127, 143, 144, 145, 131
Silvio Perea, 166 Viagna V. Cartaya, 46 153, 154, 155, 156 Yoel Perea, 101, 262
Silvio Viña, 72, 80, 101 Viagna Valiña, xxvii, 161, 173, Yamilet Irene G. Gaitén, 275 Yolexis Tamayo, xix, xx, xlii,
Sirley González Laime, xxiv, 250 Yamira Suárez Pérez, 150 xlvi, 110, 256
130, 151 Vicente L. Sánchez, 80 Yanay Montano Peguero, 41 Yolexis Tamayo García, xix, xx,
Sofia Diego, 44, 45 Vicky Sánchez Rodríguez, 180 Yaneisy Yú Pérez, xxvi, 140, 149 xlii, xlvi, 110
Sofia Diego Díaz, 44 Victor B. Navarro, 121 Yanelis Chongo Quiñones, Yonica Prens, 66
Sonia Resik Aguirre, 96 Victor D. Amaral-Silva, 41 xxxii, 194, 198, 206, 207 Yordania Zayas, 96, 123, 201,
Stephanie R. Beltrán Rosario, Victor González, 135 Yanelis Montes González, 96 263
211 Victor L. Castro, 208 Yanelis Ruiz Díaz, 251 Yordania Zayas Ruiz, 96, 123,
Stephanie Reyes, 174 Victor Mangas, 174 Yanelis Saucedo, 278 263
Stephanie Sosa Capetillo, 128 Víctor Mangas Sanjuán, 175 Yanet Alderete Ávila, 55 Yordanka Domínguez Linares,
Suharmy Pérez Martiatus, 69 Vilmali López, 174 Yanet González Díaz, 140, 149 xiii, 38
Susset Evans, 109 Vivian M. Tolosa Cubela, 107 Yanet Mora Hernández, 182 Yordanka Quiñones
Taimi Paneque-Guerrero, 179 Vivian Martínez-Espinosa, 15, Yania Suárez, iii, xix, xx, xxxv, Hernández, 55
Taimy Hernández, xxxi, 192, 65, 94 xlvi, 91, 93, 105, 107, 214, Yorexis González Alfaro, 38
269 Vivian Molina, 135 223 Yosdel S. López, 121
Taimy Hernández Sariego, 269 Viviana Camejo, 205 Yania Suárez Pérez, iii, xix, xx, Yoselin Bacallao, 80, 262
Tamara Díaz Argudin, 181 Viviana Falcón, 166 xlvi, 91, 105, 107, 214, 223 Yu Tian Wang, 40
Tamara Lobaina Rodríguez, Vladimir Besada, 112, 118 Yanier Núñez Figueredo, 30, 41 Yudelin Rivero, 262
95, 96, 123 Vladimir Besada Pérez, 118 Yarelis Martínez, xx, 262 Yudenis Reyes, iii, xxxii, xxxvi,
Tania Calderón Villacampa, xx, Waldemar Baldoquin- Yarisel Sardy, 80, 262 202, 203, 205, 221, 227,
99 Rodríguez, 172 Yaritza Mendoza Sam, xlii, 125, 228, 235, 240
Tania Carmenate, 32 Wendy Ramírez, xvii, 80, 261, 257 Yuliet Enríquez, 166
Tania G. Peña, 121 262 Yariulis Rodríguez-Juquejo, Yuliet Pino, 262
Tania González, 75, 103 Whilmer Armas, xxxv, 218, 221, 157 Yunier R. Álvarez, 129
Tania González Lemus, 75 227, 228 Yasser Matos-Peralta, 36 Yurisleydis Aldama Casas, xxi,
Tania Valdés-González, 136 William E. Cáceres Hernández, Yenela García, xxxi, 72, 101, 115
Tatiana Prieto-Dominguez, 245 193 Yusimi Izquierdo Roque, xvii,
172 William Setzer, 33 Yenilen Troche, xvii, 74, 255 71, 254
Taymí Díaz Rodríguez, xvii, 79 Wilma García Garay, 146 Yenisé Elledías, 78, 79, 81, 93, Yusimí Tusell, xvii, 73, 74
Teidy G. Jiménez, 178 Wilson Chávez, xlii, 258 106, 265 Yusimí Tussell Martínez, 107
Teresa Diez, xxviii, 161, 173, Wim Vanden Berghe, xi, 27, 39, Yenisé Elledías García, 78, 79, Yusimit Bermudez-Alfonso,
250 134, 172 81, 106, 265 165
Teresa Giral, 61 Xaveer Van Ostade, 172 Yeniset Infantes, 166 Yusmel Cabrera, 240
Teresa Rosell Guerra, 165 Xavier Garrido, ii Yenisleidy Revilla, 80, 261, 262 Yusnielis Bustamante, xxi, 113
Teresita de J. Rodríguez Y. Castro Velazquez, 273 Yesli García, 183 Zamir Cobas, 130, 151
Obaya, 170 Yadira González, xvii, 77 Yilian Bermúdez, 124 Zamir Cobas Sanchéz, 130
Teresita Rodríguez Obaya, 168 Yadira Hernández Rodríguez, Yilian Fernández Afonso, 38 Zenaida M. Hernández
Thais Fernández, 117 107 Yiliana de la C.A. Álvarez, 279, Fernández, 168
Thais Valdés Parra, xx, 108 Yadira Rodríguez Domínguez, 280 Zeyar Mohammed Ali, xxx, 185,
Tom Vanden Berghe, xi, xliv, 171 Yoagne M. Trapero Quintana, 186
xlvi, 28, 34, 37 Yadrián A. García, 202 231 Zonia Martínez Benitez, xxv,
Torsten Stelzer, 174 Yailin Barbon, 116 Yoagne Trapero, xxvii, xxviii, 142
Uris Ros, 29 Yamary García Guerra, xxxiii, xlvi, 167 Zoraida C. Burbano, 153
Valentina Rodríguez, 137 206, 207 Yoandra M. Montano, xxii, 121 Zullyt Zamora-Rodríguez, 135,
Valeri Domínguez-Villegas, 83 Yamila Verdecia Reyes, 30, 41 165

6TH International Meeting of Pharmaceutical and Food Sciences (Ecfa 2022)

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@2022 Journal of Pharmacy & Pharmacognosy Research, 10(Supplement 1), December, 2022

6to ENCUENTRO INTERNACIONAL DE CIENCIAS FARMACÉUTICAS

6TH INTERNATIONAL MEETING OF PHARMACEUTICAL

COMUNICACIONES CORTAS Y LIBRO DE RESÚMENES

SHORT COMMUNICATION AND ABSTRACT BOOK

Hotel Nacional de Cuba

Cuban National Hotel

Sitio web: http://eventos.uh.cu/eventos/ifal/

Editing, design and realization:

Editorial Scientific Council:

© Instituto de Farmacia y Alimentos, Universidad de La Habana, Cuba.

http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sii

PRESIDENTES DE HONOR | HONORIFIC PRESIDENTS

PRESIDENTE DEL EVENTO | PRESIDENT OF THE MEETING

COMITÉ ORGANIZADOR | ORGANIZING COMITÉ CIENTÍFICO | SCIENTIFIC

COORDINADOR GENERAL | GENERAL PRESIDENTE | PRESIDENT

http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Siii

Organizado por | Organized by

Instituto de Farmacia y Alimentos, Universidad de La Habana, Cuba | Institute of Pharmacy and

Organización Superior de Dirección Empresarial, Grupo de las Industrias Biotecnológica y Farmacéutica

Ministerio de Educación Superior (MES), Cuba | Cuban Ministry of Higher Education

Ministerio de la Industria Alimenticia (MINAL), Cuba | Cuban Ministry of Food Industry

Centro de Inmunología Molecular (CIM), Cuba | Center of Molecular Immunology, Cuba

Instituto “Finlay” de Vacunas, Cuba | “Finlay” Institute for Vaccines, Cuba

Empresa Laboratorios Farmacéuticos “AICA”, Cuba | Pharmaceutical Laboratories “AICA”, Cuba

Empresa Apícola Cubana (APICUBA) | Cuban Apiarian Company

Proyecto “Mecanismos moleculares de la muerte y sobrevivencia celular en la inflamación, degeneración e

Journal of Pharmacy & Pharmacognosy Research

http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Siv

STATEMENT OF PEER REVIEW

6th International Meeting of Pharmaceutical and Food Sciences

November 23-25, 2022.

http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sv

Estimados Delegados e Invitados:

El Instituto de Farmacia y Alimentos de la Universidad de La Habana, Cuba, con el auspicio de

Liliana Mateu López, PhD

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Dear Delegates and Guests:

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Cuotas de inscripción | Registration Fees

PARTICIPANTES CUBANOS | PARTICIPANTS FROM CUBA

PARTICIPANTES EXTRANJEROS | FOREIGN PARTICIPANTS

CURSOS PRE-CONGRESOS | PRE-CONGRESS COURSES: 70.00 / 50.00 USD (Profesionales / Estudiantes

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PROGRAMA CIENTÍFICO | SCIENTIFIC PROGRAM

CURSOS PRECONGRESO | PRECONGRESS COURSES

Lugar | Place: Centro de Convenciones “Enrique José Varona”, Universidad de La Habana

08:30-09:00 Acreditación y bienvenida | Registration and welcome

http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Six

Dr. Mireia Mallandrich

MC. Adriel Brito Llera

08:30-09:00 Acreditación y bienvenida | Registration and welcome

http://jppres.com J Pharm Pharmacogn Res (2022) 10(suppl. 1): Sx

MIÉRCOLES 23 NOVIEMBRE | WEDNESDAY, NOVEMBER 23

9:00-9:30 CEREMONIA INAUGURAL | OPENING CEREMONY

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INVOLVEMENT OF THE Akt/GSK-3β SIGNALING PATHWAY

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MIÉRCOLES 23 NOVIEMBRE | WEDNESDAY, NOVEMBER 23

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THEIR CLINICAL DETERIORATION

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MIÉRCOLES 23 NOVIEMBRE | WEDNESDAY, NOVEMBER 23