Biowaiver Evidence for Ketorolac Tromethamine Immediate-Release Tablets

The dissolution profiles of 10 mg of ketorolac thrometamine from a marketed product and the innovator product were evaluated at 3 different pH values (1.2, 4.5, and 6.8), using apparatus 2 at 50 and 75 rpm and 900 mL of dissolution media. Results were related with those obtained in a bioequivalence study performed in 24 volunteers. In vitro data showed that at a stirring rate of 50 rpm, the dissolution of the innovator product was low at pH 1.2, however at 75 rpm the product complied with the very rapidly dissolving criteria. In vivo study showed that the products were bioequivalent. Our data indicate that for immediate release ketorolac tromethamine drug products, dissolution profiles using BCS (Biopharmaceutics Classification System) conditions could be used as a surrogate for bioequivalence studies using 900 mL of media and a stirring rate of 75 rpm.