FORMULATION AND DEVELOPMENT OF CONTROLLED RELEASE OCULAR INSERTS OF TIMOLOL MALEATE AND DORZOLAMIDE HYDROCHLORIDE FOR TREATMENT OF GLAUCOMA

Abstract

The goal of present investigation was to formulate and evaluate ocular insert of Timolol maleate and Dorzolamide hydrochloride for the treatment of glaucoma. Glaucoma is a chronic progressive ocular disorder characterized by optic nerve damage and visual loss with increased intraocular pressure i.e. IOP is a major risk factor. The insert of timolol maleate and dorzolamide hydrochloride were prepared by using different polymers HPMC K4M, propylene glycol, polyvinyl alcohol by solvent casting method with an objective reducing frequencies of administration, increasing contact time, achieving controlled release and improving therapeutic efficacy. The formulations were evaluated for physical characteristics, thickness, folding endurance, drug content, surface pH, swelling, in-vitro drug release, sterility, stability and ocular tolerance. Drug content ranged from approximately 96.25% to 98.95%, with F3 showing 98.95 ± 0.03%. The goat cornea was used for Ex-vivo trans corneal permeability study of timolol maleate and dorzolamide ocular insert. The stability study was carried out for three months of optimized ocular insert. Then the inserts were sterilized by gamma radiation. For this study alternative thioglycolate medium and soyabean casein digest medium were used to analyse presence of bacteria and fungi.