A brief review of the FDA dissolution methods database

Abstract

The FDA Dissolution Database was reviewed using the following criteria: dosage forms, apparatus, rotation/pulsation speed, dissolution media, sampling time points, and trends for special dosage forms. In July 2015, there were 1084 drug products in the database, more than 50% thereof in tablet form. The paddle (Apparatus 2) is the most common apparatus in the database and is recommended for 488 products (45%). Rotation speeds listed in the database are 35-200 rpm for Apparatus 1 and 25-200 rpm for Apparatus 2. Deaerated or degassed water is recommended for 114 methods. The pH values for the most commonly cited dissolution media are in the range of 1-7.5; however, several dissolution methods have pH values that are out of physiological range (pH 12 for celecoxib capsules, pH 9.5 for glyburide tablets, pH 8.0 for Rabeprazole Sodium Tablets, pH 7.8 for Glimepiride Tablets).