Discriminatory dissolution test method in late development

Discriminatory dissolution test method in late development

Case study: Building discriminatory power into dissolution testing in late development – a key milestone for the fast product approval


Dissolution testing was introduced into pharmaceutical practice after the occurrence of serious side effects of phenytoin after calcium sulfate was replaced by lactose. As a result, the FDA introduced the USP Dissolution type 1 (Basket method) test as a QC test in 1971 followed by USP Dissolution type 2 (Paddle method) test in 1978. Over the years, FDA developed further guidance to advance in-vitro dissolution testing into an important tool for development, quality control and drug approval. Statistical methods were implemented to compare the similarity or dissimilarity between two dissolution profiles, bio-relevant media were requested for predicting IVIVC and more specific guidelines were release for immediate and modified release products as well as the solubility and permeability characteristics of the drugs according to the BCS drug classification. With the growing knowledge on biopharmaceutics and predictive in-silico tools, dissolution testing has evolved into a key element for drug development and regulatory assessments. This includes that the dissolution test method has to include clinically relevant dissolution specification and must have proven discriminating power between variations outside the acceptance criteria.

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