Development of Solid Dispersion-Based Dapagliflozin In-Situ Gel for Ocular Delivery in Dry Eye Disease

Abstract

Rapid precorneal elimination of ocular drugs results in low bioavailability and poor therapeutic response. This limitation can be overcome through novel ophthalmic drug delivery systems. The present study aims to develop and evaluate pH-triggered in-situ gels of Dapagliflozin for prolonged corneal residence and sustained drug release in the treatment of Dry Eye Disease (DED). Formulations were prepared using Carbopol 940 as a pH-sensitive gelling agent and HPMC K4M as a viscosity enhancer. Solid dispersion of Dapagliflozin with PEG 6000 was used to enhance the drug’s aqueous solubility. The prepared formulations were evaluated for parameters such as physical appearance, clarity, pH, viscosity, gelling capacity, drug content, sterility, and in-vitro drug release. The optimized formulation demonstrated desirable clarity, pH near physiological range, acceptable viscosity with shear-thinning behavior, and sustained drug release for up to 10 hours. It followed Zero-order kinetics, indicating a controlled release profile. The developed Dapagliflozin in-situ gel is a promising alternative to conventional eye drops, offering improved bioavailability, reduced dosing frequency, and enhanced patient compliance.