In vitro Dissolution Profile Comparison:A Tool for Biowaivers Based on BCS

Dissolution testing has been recognized as an important tool in drug development and assessment of quality of pharmaceutical products both in case of novel drug product and interchangeability drug products. In vitro dissolution testing is one of the primary United States Pharmacopoeia/National Formulary (USP/ NF) test, which is performed to ensure that a drug product meet the USP/NF standards of identity, strength, quality, purity, stability and bioequivalence in case of interchangeable drug products. In vitro dissolution profile comparison of drug release can be used as a surrogate in formulation development and in vivo bioequivalence testing. The comparison of dissolution profiles is considered to be critical test for assessing the performance of a drug product. In the present study, in vitro dissolution profile of two in-house batches, containing Biopharmaceutical Classification System (BCS) class 1 API (Zidovudine) was compared with reference product (Retrovir) by model independent approach to meet the requirements for biowaiver. Batch 2 of in-house formulation is considered to be similar to reference product and could be interchangeable.