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Evaluation of performance testing and computer simulations for Quality by Design approaches of oral dosage forms Open Access


Other title
Quality by Design (QbD)
Rupture test
Disintegration test
BCS Classification
Type of item
Degree grantor
University of Alberta
Author or creator
Almukainzi, May
Supervisor and department
Löbenberg, Raimar (Pharmaceutical Sciences)
Examining committee member and department
Jamali, Fakhreddin (Pharmaceutical Sciences)
Tuszynski , Jack (Physics)
Faculty of Pharmacy and Pharmaceutical Sciences

Date accepted
Graduation date
Master of Sciences
Degree level
Performance testing and computer simulations have promising applications in Quality by Design approaches. The objectives of these studies were to investigate the performance of the disintegration test using different setups in addition to comparing the performance of the disintegration test with the rupture test using soft gelatin dietary supplements capsules. Classifying common herbs according to the Biopharmaceutical Classification System approach was also investigated using ADMET predictor TM. The final objective was evaluation the predictive power of computer simulations of in vitro dissolution in different media. The studies concluded that the disintegration test is robust only if firm specifications were applied. However, this test has no advantage over the rupture test. In silico methods can be used to classify herbs according to the BCS. Computer simulations of dissolution in vitro can be also a potential tool to estimate the dissolution behavior. These tools facilitate prediction of quality desired in a product.
License granted by May Almukainzi ( on 2011-04-12T17:30:47Z (GMT): Permission is hereby granted to the University of Alberta Libraries to reproduce single copies of this thesis and to lend or sell such copies for private, scholarly or scientific research purposes only. Where the thesis is converted to, or otherwise made available in digital form, the University of Alberta will advise potential users of the thesis of the above terms. The author reserves all other publication and other rights in association with the copyright in the thesis, and except as herein provided, neither the thesis nor any substantial portion thereof may be printed or otherwise reproduced in any material form whatsoever without the author's prior written permission.
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