Assessment of Dissolution Performance of Immediate Release Ibuprofen Products:Screening of Products Available on the Palestinian Market

Abstract

Dissolution testing has emerged as an essential quality-control tool to monitor batch-to-batch consistency during drug development. The aim of this study was to assess the dissolution performance of drug products containing ibuprofen as active pharmaceutical ingredient available on the Palestinian market. Ibuprofen is one of the most widely used analgesic, antipyretic and anti-inflammatory over the counter (OTC) medication. Dissolution tests were performed using simulated intestinal fluid (pH 7.2) in accordance to the specifications in the United States Pharmacopoeia (USP). In vitro dissolution profiles of nine immediate-release ibuprofen formulations (A-I) were evaluated and compared. Percent of drug released was determined by spectrophotometric method. Comparison of dissolution profiles was done using similarity (f 2) and difference (f 1) factors. In the present work dissolution in basic media (7.2 phosphate buffer) was tested using a rotating paddle apparatus. The results obtained showed that the average drug release after 60 minutes of products A-I exceeded 90%. All of the tested products passed the dissolution test and met specifications in the USP. The results were above the Q value = 80 + 5% which is recommended in the USP. Similarity and difference factors-when applied for both dosage forms tablets and liquid capsules-showed that there were no significant differences of all tested products compared to branded version of ibuprofen except product A (local tablet dosage form) compared to its counterpart brand. Pertaining pharmacoeconomic aspects, our data revealed that customer prices of ibuprofen products varied widely.