Dissolution testing of tablet and capsule dosage forms
Anil C. Mehta
Abstract
Anil C. Mehta
Abstract
Dissolution testing has become the major in vitro test for determining the quality of oral dosage forms. Although correlation between in vitro test and in vivo bioavailability of a drug may not be automatically assumed, it is nevertheless widely accepted that failure of a product to meet the dissolution requirement may be indicative of a potential bioavailability problem. In dissolution testing modern analytical techniques play an important part. This paper discusses the present status of dissolution tests for tablets and capsules and assesses some of the analytical techniques used in such tests.
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Dissolution testing has become the major in vitro test for determining the quality of oral dosage forms. Although correlation between in vitro test and in vivo bioavailability of a drug may not be automatically assumed, it is nevertheless widely accepted that failure of a product to meet the dissolution requirement may be indicative of a potential bioavailability problem. In dissolution testing modern analytical techniques play an important part. This paper discusses the present status of dissolution tests for tablets and capsules and assesses some of the analytical techniques used in such tests.
Key concepts: Dissolution, Bioavailability, Dissolution testing, Dosage form, Bioequivalence, Capsule, In vivo, Pharmacology