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Amended Title Page Final - Ayub
Amended Title Page Final - Ayub
Scholar of the College of Pharmacy, University of Sargodha, hereby declare that this
thesis are the product of my own research and no part has been copied from any
/equations /formulas /protocols etc.). I further declare that this work has not been
submitted for award of any other degree /diploma. The University may take action if
Signature _____________________
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CERTIFICATE OF APPROVAL
This is to certify that this thesis entitled “Design and In-Situ Evaluation
of Taste Masked Orodispersible Tablets of Cyclobenzaprine
Hydrochloride” submitted by Mr. Muhammad Ayub Naveed is accepted in
its present form by the College of Pharmacy, University of Sargodha, Pakistan,
as satisfying the partial requirement for degree MASTER OF PHILOSOPHY
IN PHARMACEUTICS.
Internal Examiner:
____________________________
Prof. Dr. Humayun Riaz
Professor, Faculty of Pharmacy,
Lahore College of Pharmaceutical
Sciences
Co-Supervisor:
____________________________
Dr. Daulat Haleem Khan
Assistant Professor, Faculty of
Pharmacy, Lahore College of
Pharmaceutical Sciences
External Examiner:
____________________________
Dr. Fatima Rasool
Assistant Professor, College of
Pharmacy, University of the
Punjab, Lahore
Principal:
____________________________
Dr. Saira Azhar
Principal, College of Pharmacy,
University of Sargodha, Sargodha
Dean:
____________________________
Prof. Dr. Sajid Bashir
Dean, College of Pharmacy,
University of Sargodha, Sargodha
Student:
____________________________
Muhammad Ayub Naveed
14MPHIL(PHARM)14015
Registration No. 14F-US-36-08
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ACKNOWLEDGEMENTS
Foremost I bow to ALMIGHTY ALLAH, Who has enlightened our minds and
hearts with faith and guided us to the right path, the path of wisdom, perspicacity and
sophistication. All respects, blessings and love to the last Holy Prophet Hazrat
MUHAMMAD ﷺ, who enabled me to recognize Creator and His creations and
changed me from man to Muslim by teaching, “Seek knowledge from cradle to grave.”
I dedicate my all research and efforts to my Grandfather Muhammad Ashraf
Fazliah (late), a Sufi soul, Pharmacist by profession with the heart of an Engineer.
Without his support, encouragement and guidance I may not able to reach my goal. I
deem it a great honor and no word is too eloquent to express my sense of gratitude to
him.
I would like to express my gratitude to my supervisor Prof. Dr. Humayun Riaz
for his overall direction and ongoing support. His door is always open for discussions.
I am greatly appreciative of his expertise and guidance without which this project would
not have been possible.
I appreciate the affectionate and kind guidance of Prof. Dr. Sajid Bashir, Dean,
College of Pharmacy, University of Sargodha during entire studies and research work
right from topic selection till end.
I offer my sincerest gratitude to my co-supervisor, Mr. Daulat Haleem Khan,
Assistant Professor, Mr. Umair Ikram Dar, Assistant Professor, and Mr. Izaatullah
Khan, Assistant Professor Lahore College of Pharmaceutical sciences who has
supported me throughout my thesis with his patience and knowledge.
I have appreciated the collaboration of my colleagues, Rana Ihsan ul Haque
Ather, Muhammad Salman Azam, Sadia Altaf, Dr. Ghayour Ahmed, H.M. Asif Iqbal,
Saleem Mansoor, Ghazanfar Ali, Shaheer Butt, Arslan Tariq, Ahmad Raza Shahid and
Hamza Butt.
I express my heartfelt gratitude to my father Muhammad Naveed Ashraf,
mother, my brother Ibad-ur-Rehman, my sisters, my loving and caring wife, my son
and daughter & and all other family members. Their unlimited love and affection served
me a beacon of light. It is through their benevolent help and wholehearted prayers that
enabled me to complete my studies. I am also indebted to all those people who prayed
for my success.
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TABLE OF CONTENTS
iv
Serial No. Contents Page No
1. Chapter 1: Introduction 01
1.1 Introduction 02
3.1. Chemicals 20
3.2. Equipments 21
v
3.4.2.6. Wetting time 28
4. Chapter 4: Results 33
vi
5. Chapter 5: Discussion 60
6. Chapter 6: References 68
LIST OF FIGURES
Hydrochloride tablets
hydrochloride tablets
material
vii
4.10 HPLC Spectrograph of Cyclobenzaprine hydrochloride 44
hydrochloride tablet
4.14 51
Graphical comparison of active pharmaceutical ingredient
hydrochloride tablet
hydrochloride tablet
hydrochloride tablet
hydrochloride tablet
material
viii
4.20 XRD Diffracto-graph of Cyclobenzaprine hydrochloride 56
batch A4
batch A5
material at 5 µm Resolution.
at 50 µm resolution.
A4 at 5 µm resolution.
A4 at 5 µm resolution.
A5 at 10 µm resolution.
A5 at 20 µm resolution.
ix
LIST OF TABLES
dosage forms
HCl
HCl
Cyclobenzaprine HCl
Cyclobenzaprine HCl
x
4.8 Dissolution Test in phosphate buffer media performed at 48
Tablets
xi
Abstract
orodispersible tablets however, tablet compression is the most common technique adopted for
preparation of orodispersible tablets. The aim of the present research was to prepare taste
masked oral dispersible tablets by direct compression method. This was followed by
investigation of the effects of super disintegrants (Kyron-T314) and cross carmellose sodium
on the disintegration time, taste masking and percent release of a model drug from Kyron-t314
and cross carmellose sodium based formulations cyclobenzaprine hydrochloride was taken as
model drug for this study. Due to wetting action of sorbitol powder and super disintegrant
Kyron-t314, easy penetration of dissolution media was achieved for rapid release of drug.
Compatibility of formulation was checked by FTIR and XRD studies. The granules and tablets
were evaluated and found to be acceptable according to standard limits. In-vitro release studies
were performed using USP apparatus-II (paddle method) in 900ml of 0.1N HCl (pH 1.2) at
50rpm and 0.1 N phosphate buffer (pH 7.2). Kyron-t314 was found to cause a rapid
disintegration of orodispersible tablets within 28-43 seconds. The highest drug release was
obtained from A-5 (102.85 %). Finally, the overall study indicated a proper balance between
the taste masking and disintegration. The drug release profile of orodispersible tablets in the
xii
DESIGN AND IN-SITU EVALUATION OF TASTE
CYCLOBENZAPRINE HYDROCHLORIDE
By
MASTER OF PHILOSOPHY
IN
PHARMACEUTICS
xiii