Dissolution Specifications for Ibuprofen Soft Gelatin Capsules: A Proposal

The aim of the present study was to propose a Q dissolution value as a quality control test for 400-mg ibuprofen soft gel capsules using the dissolution recommendations included in the FDA dissolution database. Two commercial batches of the reference product and two batches of three generic products were selected. Dissolution profiles were determined by using apparatus 1 at 150 rpm with 900 mL of phosphate buffer pH 7.2 as dissolution media. To determine the probability of passing the USP dissolution test, the R program with Burdick codes were used. Quality control tests including rupture time were also performed. Results showed that a Q dissolution value of 80% at 20 minutes could be recommended as a quality control test. A moderate correlation was found between rupture time and the percentage dissolved at 10 minutes.