Quality by design (QbD) in pharmaceuticals development : optimizing an age specific orally disintegrating tablets (ODTs) using direct compression method
Dissertant
Thesis advisor
University
Isra University
Faculty
Faculty of Pharmacy
University Country
Jordan
Degree
Master
Degree Date
2018
English Abstract
Introduction: Food and Drug Administration (FDA) and European Medicine Agency (EMA) regulations regarding pediatric dosage forms witnessed a paradigm shift in 2007, which was provoked by the demand for age appropriate dosage forms that meet safety, efficacy and quality specifications.
Orally disintegration tablets (ODTs) which combine the advantages of solid and liquid dosage forms, appeal to broader populations of patients and those experiencing swallowing difficulties like pediatrics, and are suitable option to meet this growing demand for novel age specific formulations that overcome the challenges encountered with liquid dosage forms.
Aim: this project aimed to develop ODTs using direct compression method and commonly used excipients in which cost-effective ODTs could be obtained using a potent and challenging model drug, cholecalciferol, in three different doses.
Materials and method: Mannitol, microcrystalline cellulose, Ac-Di-Sol and magnesium stearate were selected to be incorporated in this project as diluent, binder, superdisintigrant and lubricant, respectively.
The quantitative method by Uv/Vis spectrophotometry was validated according ICH guidelines.
That was followed by screening studies for ODTs development.
The produced ODTs were characterized for weight variation, thickness, hardness, friability and disintegration test in the initial screening studies to investigate the most suitable input and process parameters to take into an optimization study by employing QbD principles through Design of Experiment.
Results and discussion: The results revealed the positive effect of the superdisintigrant, and MCC as independent linear, interactive and quadratic factors on the production of ODTs with favorable properties that meet the criteria relating to disintegration time and mechanical strength.
Conclusion: Design space in QbD analysis showed that MCC in proportion ranging between 17-30% accompanied with Ac-Di-Sol proportion within 3-6.5% would results in efficient and cost-effective directly compressed cholecalciferol ODTs
Main Subjects
Topics
No. of Pages
87
Table of Contents
Table of contents.
Abstract.
Abstract in Arabic.
Chapter One : Introduction.
Chapter Two : Literature review.
Chapter Three : Materials and methods.
Chapter Four : Cholecalciferol analytical process validation.
Chapter Five : Screening studies for the development of cholecalciferol ODTS.
Chapter Six : Quality by design (QBD) for optimizing cholecalciferol ODTS.
Chapter Seven : Conclusion and future recommendations.
References.
American Psychological Association (APA)
Ifsisih, Hanadi Adil Ibrahim. (2018). Quality by design (QbD) in pharmaceuticals development : optimizing an age specific orally disintegrating tablets (ODTs) using direct compression method. (Master's theses Theses and Dissertations Master). Isra University, Jordan
https://search.emarefa.net/detail/BIM-837703
Modern Language Association (MLA)
Ifsisih, Hanadi Adil Ibrahim. Quality by design (QbD) in pharmaceuticals development : optimizing an age specific orally disintegrating tablets (ODTs) using direct compression method. (Master's theses Theses and Dissertations Master). Isra University. (2018).
https://search.emarefa.net/detail/BIM-837703
American Medical Association (AMA)
Ifsisih, Hanadi Adil Ibrahim. (2018). Quality by design (QbD) in pharmaceuticals development : optimizing an age specific orally disintegrating tablets (ODTs) using direct compression method. (Master's theses Theses and Dissertations Master). Isra University, Jordan
https://search.emarefa.net/detail/BIM-837703
Language
English
Data Type
Arab Theses
Record ID
BIM-837703
