Systemic investigation of multiparticulate systems (MPS) for controlled release dosage forms employing quality by design (QbD) principles
Dissertant
Imriziq, Rua Ata Allah Imriziq
Thesis advisor
University
Isra University
Faculty
Faculty of Pharmacy
University Country
Jordan
Degree
Master
Degree Date
2018
English Abstract
Quality by design (QbD) is a key approach in pharmaceutical process development.
This study focused on the application of QbD principles to develop multiparticulate system (MPS) with controlled release profile.
Model drug, ibuprofen, was employed to develop the controlled release MPS using wet granulation method.
The project started with validation of quantitative analytical technique for ibuprofen using UV-spectrometry and based on the ICH guidelines in terms of specificity, accuracy, precision, linearity, limit of detection and limit of quantification.
To enable effective QbD project, initial screening studies were conducted.
The outcome of the screening studies set the boundaries for the QbD, where critical factors and product quality attributes were identified.
Granulation process was optimized and a range of analytical techniques were investigated during screening process to assess the quality of the produced granules.
Characterization included, granules size analysis, hardness test, moisture content analysis, coating process, flowability test, FTIR analysis and drug release studies.
The results were used to establish the boundaries of the design of experiment (DOE) using MODDE software to detect the relationship between factors (HPMC, Ibuprofen, ethylcellulose concentrations) and the critical quality attributes/ responses (dissolution of coarse and fine MPS, content uniformity and flowability of coarse and fine MPS).
The produced model was verified using multiple verification tools then the coefficient plots were used to understand the effect of factors on responses.
The outcome of this study was the determination of design space to specify the desirable range of input parameters for successful MPS.
Ethylcellulose concentration of 0.25%- 0.5% and HPMC concentration of 15%- 30% were the key factors affecting MPS performance.
The produced MPS could be further used to develop several dosage forms ranging from granules in sachets, capsules or compressed into orally disintegrating tablets which could be suitable for age specific population.
Main Subjects
Topics
No. of Pages
88
Table of Contents
Table of contents.
Abstract.
Abstract in Arabic.
Chapter One : Introduction.
Chapter Two : Literature review.
Chapter Three : Materials and methods.
Chapter Four : Quantitative analytical process validation.
Chapter Five : Screening studies for the development of ibuprofen multiparticulate system.
Chapter Six : Quality by design for optimisation of multiparticulate system.
Chapter Seven : Conclusions and future work.
References.
American Psychological Association (APA)
Imriziq, Rua Ata Allah Imriziq. (2018). Systemic investigation of multiparticulate systems (MPS) for controlled release dosage forms employing quality by design (QbD) principles. (Master's theses Theses and Dissertations Master). Isra University, Jordan
https://search.emarefa.net/detail/BIM-837728
Modern Language Association (MLA)
Imriziq, Rua Ata Allah Imriziq. Systemic investigation of multiparticulate systems (MPS) for controlled release dosage forms employing quality by design (QbD) principles. (Master's theses Theses and Dissertations Master). Isra University. (2018).
https://search.emarefa.net/detail/BIM-837728
American Medical Association (AMA)
Imriziq, Rua Ata Allah Imriziq. (2018). Systemic investigation of multiparticulate systems (MPS) for controlled release dosage forms employing quality by design (QbD) principles. (Master's theses Theses and Dissertations Master). Isra University, Jordan
https://search.emarefa.net/detail/BIM-837728
Language
English
Data Type
Arab Theses
Record ID
BIM-837728
