Abstract

DESIGN AND EVALUATION OF CONTROLLED RELEASE OF BETAXOLOL HYDROCHLORIDE OCULAR INSERTS

Kulkarni K.B.*, Sirse Krantikumar, Nagoba Shivappa N, Ladde S.S

Abstract

The main aim of this study is to develop ocular drug delivery system for Betaxolol is a cardio selective (β1 adrenergic) receptor blocking agent. Ocular betaxolol may be especially useful in the treatment of glaucoma in patient with pulmonary disease. In the present study, an attempt was made to formulate ocular drug delivery system films for Betaxolol. In matrix, type formulations for Betaxolol containing 10%, 12%, and 14% w/v of Gelatin were Prepared by solvent casting method. And evaluated for their average weight variation, thickness, Drug content, In-vitro drug release and stability studies. An increase in average weight and thickness is due to increase in polymer concentration. IR spectral studies were performed to confirm the interaction of drug with excipients. IR spectrum revealed that there is no compatibility and no drug interaction. In vitro drug release Studies were performed by vial and pre hydrated cellophane membrane method. Gelatin F 09, (14%) w/v exhibited maximum average weight 15.16 mg and thickness of F 09 is 0.29 mm respectively .The drug content of F 09 is 99.48%. The In-vitro studies of selected formulations F1, F2, F3 containing 10% Gelatin shows the release of 96.16, 97.12 and 98.98% respectively, The formulation F4,F5, F6 containing 12% Gelatin shows the release of 95.18, 96.25, 97.73% respectively and the formulations F7, F8, F9 containing 14% Gelatin shows the release of 91.00, 97.79 and 99.23 % respectively. It showed that the gelatin films release of drug. Over 3hrs period was selected as an ideal formulation. In vitro diffusion studies of selected formulations i.e., lower and higher concentrations of Gelatin formulation F1 and F9 were 78.79 & 68.50% at 3hrs respectively. From the diffusion study it is concluded that as the concentration of polymer increases drug release from the formulation decreases. The addition of plasticizer like Glycerin shows flexibility more as the concentration increases Stability studies conducted for F 09 formulation. The formulation showed satisfactory physical stability at 250C and 400C at 60% and 75% RH respectively. The physical appearance had not changed considerably.

Keywords: Betaxolol Hydrochloride, ocular inserts, Gelatin.