Development And Validation of In-Vitro Release Test (IVRT) Method for Topical Complex Generic - Ganciclovir Ophthalmic Gel

Background: The in-vitro release test (IVRT) is a tool to measure the amount and the release rate of active pharmaceutical compounds released from topical semisolid dosage forms. The IVRT provides significant information for product performance assessment and evaluation. It is also used to assess the bioequivalence study (biowaivers) for topical semisolid products. Objective: The study aims to develop and validate the IVRT method for qualitative and quantitative estimation of ganciclovir topical products and to demonstrate the similarity between the marketed reference product and the in-house test product of ganciclovir ophthalmic gel. Method: The method was developed using a vertical diffusion cell with a synthetic cellulose membrane, simulated tear fluid as the receiver media, and UV detection. The IVRT study was performed at 100rpm and 32oC for 6hr. The marketed formulation containing 0.15%w/w ganciclovir was used as a reference. Result: The in-house test product of ganciclovir met all characterization criteria. The analytical method was optimized and validated with a concentration range of 2-14μg/ml and a regression coefficient of 0.9997 as per the ICH guideline. The developed IVRT method was simple, economical, linear, robust, reproducible, sensitive, specific, and selective to evaluate the drug release from the formulation. The %recovery at 6hr was found to be 84.43% and 78.68% for reference and test product of ganciclovir ophthalmic gel with correlation coefficient R2 0.9947 and 0.9921, respectively, this value justified the biowaivers between the reference and test formulation. Conclusion: This method can be utilized to check topical semisolid product quality, product performance, and product uniformity. Additionally, it can also be used to waive the requirement for bioequivalency studies for ganciclovir ophthalmic gel.