Abstract

A RESEARCH ON FORMULATION, DEVELOPMENT, AND EVALUATION OF AN OPHTHALMIC IN SITU GEL BY USING CENEGERMIN

*Prasad Kailas Gaikawad, Nandini A. Patil and Dr. Megha T. Salve

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Abstract

The present study focuses on the formulation, development, and evaluation of an ophthalmic in situ gel containing Cenegermin (Oxervate), a recombinant human nerve growth factor (rhNGF) approved for the treatment of neurotrophic keratitis. In situ gels offer significant advantages in ocular drug delivery by providing prolonged contact time with the ocular surface, enhanced bioavailability, and reduced frequency of administration. Cenegermin was incorporated into a thermosensitive polymer-based in situ gel using polymers such as Poloxamer 407 and Carbopol 934P. The formulation was optimized for parameters including gelation temperature, clarity, viscosity, pH, drug content, sterility, and in vitro drug release. The optimized formulation demonstrated rapid sol-to-gel transition at physiological temperatures, suitable viscosity for ocular application, and sustained drug release over a 24-hour period. The results suggest that the developed in situ gel is a promising carrier for effective ocular delivery of Cenegermin, potentially improving patient compliance and therapeutic outcomes in the treatment of neurotrophic keratitis.

Keywords: Cenegermin, Oxervate, Ophthalmic in situ gel, Neurotrophic keratitis, Thermosensitive polymers, Poloxamer 407, Carbopol 934P, Sustained release, Ocular drug delivery, Recombinant human nerve growth factor (rhNGF).