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RESEARCH PROPOSAL DEFENSE PRESENTATION

SYSTEMATIC REVIEW ON INFANT ORAL FORMULATIONS FOR

COMMON MEDICAL ISSUES IN MALAYSIA
STUDENT NAME: MR.NARESH A/L JAYABALAN
MATRIX NUMBER: QIUP 201710-001528
MAIN SUPERVISOR: ASSOC. PROF.DR.MAHIBUB MAHAMADSA KANAKAL
CO SUPERVISOR: MR. KHAIRULANWAR HUSAIN

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OUTLINES
• Introduction
• Background of the study/Review of literature
• Problem statement
• Aim & objectives of the study
• Significance of the study
• Methodology
• references
INTRODUCTION:
• Due to the differences in development in terms of physiology, cognitive
and motor skills infants requires specifically designed formulations as
compared to other paediatric patients

• Advantages that provided by oral liquid dosage forms that makes it very
popular for infants due to ease of swallowing (Gerrard et al., 2019)

• Lack of commercially available specialized oral liquid dosage forms for

infants leads to use of off label medicines for these group of patients
There are several problems associated with off label use of
products

 Lack of access to off label formulation stability data such as chemical, physical &
microbiological
 Lack of information on off label medications’ shelf life (Brion et al., 2003) (Giam
and McLachlan, 2010) (Pai and Nahata, 2001) (Standing and Tuleu, 2005).
 Carry risk of lack of proof of dose uniformity (Costello et al., 2007)
 Microbiological contamination in multidose off label preparations (Ghulam et
al., 2007)
 Difficult to assess off label medication’s safety due to presence of unknown
excipients (Conroy S., 2008)
 Significant difference in bioavailability between specialized preparations for
infants and off label preparations(Stevenson J., 2008).
 BACKGROUND OF STUDY
• List of Common Symptoms Among Infants for Various
Disease Conditions are as follows:

 Fever
 Respiratory related Symptoms
 Diarrhea
 Vomiting
 Common Symptoms in Various Disease Conditions
Medical Explanation Reference
Issue
Fever Sign of mild or more serious illness and causes of (Purssell, 2010)
fever in infants include colds, flu, mumps,
chickenpox, urinary and kidney infections, measles
and teething
Concern to many parents and may indicate more (Van Den Bruel et
severe diseases such as bacterial infections like al., 2006)
meningitis, septicaemia and urinary tract infection
Most common complaint in paediatric emergency (Armon et al., 2001)
department, accounting nearly 20% of paediatric
emergency department visits
Symptoms Explanation Reference
Pneumonia-Becomes the cause for about 30-60% 0f hospital visits (Mitra NK., 2001)
around the world as well as 20-30% of hospital admission for
children

Children with pneumonia were have chief complaints such as fever, (Shaheen et al., 2017)
cough, runny nose, and sore throat and about 62.7% of paediatric
Respiratory patients had more than one respiratory symptoms
related
Symptoms Asthma-One of the chronic diseases in paediatrics & it more (Kudzyte, J., Griska, E., & Bojarskas,
prevalent among paediatrics compared to adults J., 2008)
(Ghaffari & Aarabi, 2013)
An increase in evidence that paediatrics are inappropriately treated (Mahashur, 2015)
for asthma based on cough as the solitary symptom
Cough-Common medical problem in paediatric patient and most (Paramesh H., 2017)
common paediatric problem managed by physicians
Symptoms Explanation Reference
Diarrhea Diarrhea during early infancy (children less than 2 (Thiagarajah et al., 2018)
years of age) is relatively common, generally mild,
and often self-limited

Causes of Diarrhea (Thiagarajah et al., 2018)

• Enteric viral or bacterial infections (Johnston et al., 2016)
• Allergic disorders induced by exposure to food
allergens, such as cow’s milk protein
• Antibiotic induced diarrhea
Vomiting Vomiting is a common symptom of numerous (Shields & Lightdale, 2018)
underlying conditions for which
children frequently present for healthcare

Causes of Vomiting (Shields & Lightdale, 2018)

• Viral gastroenteritis (Deborah M., 2020)
• Gastroesophageal reflux disease
• Food poisoning
• Bowel obstruction
Commonly Used Medicines for Infant Related Disease Symptoms
Class of Drug Drug Indication Reference
Antipyretic Paracetamol Fever, pain Venkateswaramurthy et al., 2017
Ithnin et al., 2018
BOTZENHARDT et Al., 2016

NSAIDs Ibuprofen Fever, pain BOTZENHARDT et Al., 2016

Palanisamy et al., 2012

Antibiotics Amoxicillin Pneumonia, Tonsilitis Tea MH, 2016 Venkateswaramurthy

Erythromycin et al., 2017
Shaheen et al., 2017
Ithnin et al., 2018
Meesala, 2017
Bronchodilators Salbutamol Asthma, cough Venkateswaramurthy et al., 2017
Ithnin et al., 2018
Palanisamy et al., 2012

Antihistamine Diphenhydramine Cough, common cold Pasupathi S., 2016

Chlorpheniramine Palanisamy et al., 2012
Mohamad et al., 2014
Cetrizine
Oral Formulations for Infants
• Available in the form of ready-to-use or require manipulation and
multiuse or single use (Strickley, 2019)
• Ready-to-use formulations
• Oral solution, oral suspensions
• Formulations Require Manipulations
• Sprinkle capsule, powder for oral solution, powder for oral suspension,
granules for oral suspension, oral powder oral granules,
 Excipients Used in Paediatric Oral Formulations
• Functions of Excipients in pharmaceutical dosage forms
• Facilitate the manufacturing processes
• Improve the stability of the preparations (Burgess, 2017)
• To enhance organoleptic properties of preparations (Van Riet-Nales et al., 2013)
• Impact of excipients on infants
• Infants are not able to metabolize all the excipients due to immatured physiological
conditions(Burgess, 2017)

• Preservatives are not recommended for infant formulations due to safety

reasons(Oishi S.,2004)
Global Regulations & Guidelines for Paediatric Drug Development
In 2007, World Health
Organization (WHO)
• To increase awareness for child
specific medicines
• Development aspects of
paediatric medicines such as;
dosage form, flexible dosage
form, formulation design, safe
use of excipients and many
others (Ch, Rasekaran, K, &
Asamy, 2018)
In 2007, in Europe Peadiatric protocol kkm
Paediatric regulation was
implemented for the
development of paediatric
specific drug products
10 year market exclusivity can
be under Paediatric use
Marketing Authorization
(PUMA) and 6 months of
extension to Supplementary
Protection Certificate (SPC) for
paediatric drug products upon
approval of Paediatric
oughInvestigation Plan (PIP) in
Europe (Walsh, 2017).
Problem Statement
• Lack of specialized formulations for infants has resulted in
increased use of off-label preparations, which maybe harmful
to infants

• Infants have limited capacity to swallow oral liquid

preparations

• Challenges to formulate concentrated low volume

preparations using solid dosage forms
Aim & Objective

Aim of the Study

• Systematic review study on commonly used infant medications in Malaysia.

Objectives of the Study

• To identify common medical issues among infants in Malaysia.

• To identify management of common medical issues among infants in Malaysia.
• To identify pharmaceutical preparations for infants in Malaysia.
Significance of Study

• Will provide insight on oral medication practices for common

medical issues for infants in Malaysia

• Will provide selection of suitable oral preparations for

management of common medical issues for infants in Malaysia

• The study will highlight the need for specialized oral

medications for infants in Malaysia
Research Methodology
• Identification of commonly prescribed drugs for infants for common medical
issues as per Ministry of Health, Malaysia official guidelines

• Prescribing information will be obtained from various official sources from

Ministry of Health, Malaysia and various research publications

• The availability of registered dosage forms of drugs used in infants will be

obtained from National Pharmaceutical Regulatory Agency (NPRA) official
website.
• The availability of infant dosage forms across the globe will be obtained from
various sources such as MIMS, CIMS, BNF-Paediatrics, and other various drug
databases.
References