Biowaiver study of selected solid oral prednisolone products available in sri lanka: Recommendations for comparator product used in biowaiver testing

Abstract

This post-marketing study on prednisolone products in Sri Lanka was conducted using BCS-based biowaiver procedures for performing in vitro bioequivalence studies. The market leader product with the highest availability was selected as the comparator in the absence of the innovator product. A validated UV/Visible spectrophotometric method was used to quantify the drug dissolution. Cumulative drug release profiles were determined in dissolution media at pH 1.2, 4.5, and 6.8 using the paddle apparatus. Although the two test products and the comparator met pharmacopoeial requirements for quality, they failed to meet in vitro biowaiver criteria. Acceptability of biowaiver study results depends on the performance of the comparator product. Information on the comparator product's bioequivalence to the innovator product was not available. This study revealed the difficulties in low and middle-income countries (LMICs) when conducting biowaiver studies for regulatory submission and highlights the necessity to have bioequivalence data and excipient information for the comparator product for better decision making. The study supports having an international standard comparator product used by LMICs when manufacturing and registering generic drug products.