In Vitro Drug Release Testing Method For Nepafenac Ophthalmic Suspension

Abstract

In vitro release test (IVRT) method is important to monitor batch-to-batch quality variations during pharmaceutical manufacturing and also to show the pharmaceutical equivalence of a generic product with the innovator. To fulfil regulatory requirements for approval of a generic ophthalmic suspension product, in vitro release study is required. No compendial or non-compendial method is available for IVRT of nepafenac ophthalmic suspension. Current research is aimed to screen various approaches using different conventional and non-conventional instruments to suggest the most suitable technique appropriate for nepafenac ophthalmic suspension followed by optimization of method parameters and validation. The trials used the paddle apparatus (USP Type-2) with dialysis sacs, the flow-through cell apparatus (USP Type-4), the rotating bottle apparatus, and the Franz diffusion cell apparatus. With the USP Type-4 apparatus drug release was found to be ∼ 83% in the simulated tear fluid (STF) of pH 7.4 in 120 min that increased to ∼ 97% upon the addition of surfactant sodium lauryl sulfate (SLS). With USP Type-2 and Franz diffusion cell apparatus, the drug release was either slow or not reaching close to the complete release. Whereas, in the case of the rotating bottle apparatus, a burst release profile was observed. The estimation of the drug release was done by the HPLC method and all the method validation parameters like specificity, accuracy, linearity, and precision were found to be within acceptance criteria.