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首页> 外文期刊>journal of pharmaceutical innovation >A Gel-Free Reservoir System for Once-a-Day Ophthalmic Delivery of Timolol Maleate
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A Gel-Free Reservoir System for Once-a-Day Ophthalmic Delivery of Timolol Maleate

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Purpose This study aims to formulate an ophthalmic gel-free reservoir (GFR) system for once-a-day (OD) delivery of timolol maleate for the treatment of glaucoma. Methods The GFR system contains hydroxypropyl methylcellulose and polyvinylpyrrolidone mixed in ratios, HPMCconc/PVPconc = 0.1 to 2.0 with a total polymer concentration of similar to 1.0-4.0 providing a viscosity of similar to 30-65 cps. A formulation of timolol maleate was prepared by combining buffers (borate) and preservative cations (Zn+2) with GFR to form an anionic polymer interpenetrating network (IPN) which obstructs the diffusion of the cationic timolol maleate, thus providing sustained action. Results The GFR composition was optimized to impart physicochemical properties that were similar to artificial tear fluid, including clarity, with optical transmission of > 95, adjusted osmolality of similar to 300 mOsmol, pH range of 6.5-7.5, surface tension of 35-42 mN/s, and 40-45 mPas viscosity for ocular retention and retarding lacrimal drainage. The mucoadhesive index of similar to 9.0 which was more than conventional timolol maleate eye drops further helped in eye drop retention. The solution was weakly pseudoplastic having a calculated blink viscosity of < 33 mPas for ensuring maximum lubrication and precluding the feeling of drag to the eyelid blink or eyeball movement. The formulation tested on rabbit eyes showed low timolol plasma levels and comparable ocular tissue levels and intraocular pressure reduction compared to the different marketed OD ophthalmic formulations. Conclusion The results indicated the GFR composition imparted acceptable physicochemical properties similar to artificial tear fluid. In vivo study on rabbit eyes showed comparable aqueous humor levels compared to the commercial timolol OD formulations.

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