Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF pH TRIGGERED IN SITU OPHTHALMIC GEL OF FEXOFENADINE HYDROCHLORIDE

Sumedha R. Dani*, Smita S. Aher and Rishikesh S. Bacchav

ABSTRACT

The aim of the present work was to formulation and evaluation of pH Triggered in-situ Ophthalmic Gel of Fexofenadine Hydrochloride to overcome the drawbacks obtained by conventional eye drop. There are two independent variables were used i.e. Carbopol 934 and HPMC K100. Carbopol 934 was used as gelling agent and HPMC K100 were used as bioadhesive polymer. Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. H1 receptor is responsible for mediating allergic reactions. The in situ gelling system involves sol-to-gel transition in the cul-de-sac upon instillation to avoid pre corneal elimination. The formulations were prepared by 32 factorial design. The prepared formulations were evaluated for clarity, pH, and viscosity, Bioadhesive strength of gel, gel strength gel, Drug Content, In-vitro Drug Release Study, Isotonicity Evaluation, HET-CAM Test and stability studies. The drug content was in the range of 97-99.57 %. Formulation F4 selected as optimized on the basis of evaluation. It shows highest drug release up to 8 hrs. The optimized formulation was isotonic with blood cells. It passes sterility test. The optimized formulation passes the ocular irritancy test i.e. HET-CAM Test. The formulation kept for the stability study for 3 months.

Keywords: pH Triggered, bioadhesive polymer, Carbopol 934, HPMC K100, HET-CAM Test, Bioadhesive Strength.