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

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. / Pharmaceutical Sciences

Identiferoai:union.ndltd.org:LACETR/oai:collectionscanada.gc.ca:AEU.10048/1880
Date06 1900
CreatorsAlmukainzi, May
ContributorsLöbenberg, Raimar (Pharmaceutical Sciences), Jamali, Fakhreddin (Pharmaceutical Sciences), Tuszynski , Jack (Physics)
Source SetsLibrary and Archives Canada ETDs Repository / Centre d'archives des thèses électroniques de Bibliothèque et Archives Canada
LanguageEnglish
Detected LanguageEnglish
TypeThesis
Format1752447 bytes, application/pdf
RelationAlmukainzi M, Salehi M, Araci Bou-Chacra N, Löbenberg R. Investigation of the performance of the disintegration test for dietary supplements. AAPS Journal 2010;12(4):602-607, Almukainzi M, Salehi M, Araci Bou-Chacra N, Löbenberg R.Comparison of the Rupture and Disintegration Tests for Soft-Shell Capsules Dissiolution Technology, February, 2011; 18(1): 21-15

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