Dissolution and In-Vitro Release Testing
Dissolution and In-Vitro Release Testing contains 3 topic pages in Pharmaceutical Quality Assurance.
Dissolution testing measures the rate and extent to which an active pharmaceutical ingredient is released from a solid oral dosage form into solution under standardised experimental conditions, and serves as a critical quality control tool and a surrogate predictor of in vivo drug absorption. This chapter examines the compendial dissolution apparatus, the principles governing dissolution method development, the biopharmaceutics classification system, and the concept of in vitro-in vivo correlation.
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Compendial Dissolution Apparatus
Apparatus Types and Their Applications The United States Pharmacopeia describes several standardised dissolution apparatus configurations, of which the...
Dissolution Method Development
Selection of Dissolution Medium and Conditions Dissolution method development requires careful selection of an appropriate dissolution medium, generally...
Biopharmaceutics Classification System and In Vitro-In Vivo Correlation
The Biopharmaceutics Classification System The biopharmaceutics classification system categorises drug substances into four classes according to their...