Method Development and Validation of in Vitro Release Test for Fluorometholone Ophthalmic Suspension using Franz Diffusion Cell System

Abstract

The in Vitro release method to be used must have dissolution conditions capable of distinguishing even small changes in the formulation or production process required to develop the generic product. It should measure the amount of active substance released during the in Vitro release test in an accurate, robust and repeatable manner. The aim of the study is to demonstrate the similarity by comparing the test and reference product for Ophthalmic Suspensions containing Fluorometholone (FLU) with the Bootstrap F2 method. In the experiment, pH 7.4 ATF / STF (Artificial / Simulated Tear Fluid) medium was used. Since the FLU molecule is not soluble in water, 2% Sodium dodecyl sulphate was applied as a surfactant to increase the solubility of FLU. By Franz Diffusion Cell method, using Nylon Membrane Disc Filter an in Vitro release profile of 48 hours at 37°C at 750 rpm rotation speed was performed. Last but not the least, a selective and validated HPLC method was used for the analysis of released drug molecules .