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• W2012584090 abstract "Despite the fact that dissolution tests were first introduced to characterise the release profile of low solubility (< 1%) drugs in aqueous media, the emphasis is now to adopt dissolution tests in monographs of almost all oral solid dosage forms in most pharmacopoeias. This is attributable mainly to the growing demand by both regulatory authorities and pharmaceutical industries of more in vivo predictability of the release and absorption behaviours of drug(s) from the dosage form by means of in vitro tests, i.e. in vitro-in vivo correlation. Dissolution testing is also essential in various stages of formulation development for screening and proper assessment of different formulations. Although dissolution tests have been successfully implemented on conventional dosage forms, there are enormous difficulties in establishing proper dissolution test conditions and parameters for testing sustained or controlled release oral dosage forms because of prolonged gastrointestinal residence of the dosage form and variabilities in physiological conditions of the gastrointestinal tract. This review focuses on the challenges faced by formulation scientists and regulatory authorities in generalising the dissolution test conditions and parameters for testing sustained or controlled release dosage forms, and describes some recent trends and progress in overcoming some of these challenges." @default.
• W2012584090 created "2016-06-24" @default.
• W2012584090 creator A5005743738 @default.
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• W2012584090 date "1996-08-01" @default.
• W2012584090 modified "2023-10-16" @default.
• W2012584090 title "Dissolution testing for sustained or controlled release oral dosage forms and correlation with in vivo data: Challenges and opportunities" @default.
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• W2012584090 doi "https://doi.org/10.1016/0378-5173(96)04561-9" @default.
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