A Biopharmaceutical Classification System Approach to Dissolution: Mechanisms and Strategies
Dissolution testing is a common characterization method employed by the pharmaceutical industry to design formulations and assess product quality. It is a required performance test by many regulatory authorities for solid oral dosage forms, transdermal patches, stents, and oral suspensions. Dissolution testing is unique in that it is the only finished product test method in routine use that measures the effect of the formulation and physical properties of the active pharmaceutical ingredient (API) on the in vitro rate of drug solubilization. As a result, dissolution testing is the only test that monitors the impact of environmental storage conditions and manufacturing process upon the rate of drug release from the dosage form. These sensitivities have led to the use of the dissolution test as a measure of formulation bioperformance.
KeywordsDrug Release Quality Attribute Immediate Release Release Dosage Form Tablet Disintegration
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