Abstract

FORMULATION AND EVALUATION OF IN-SITU OPTHALMIC GEL OF KETOROLAC TROMETHAMINE

*Sumegha Meshram, Surendra Kumar Jain, Nishiprakash Jain

Sagar Institute of Research & Technology - Pharmacy, Bhopal, India.

ABSTRACT

The poor bioavailability and therapeutic response exhibited by conventional ophthalmic solutions due to rapid precorneal elimination of drug may be overcome by the use of in-situ gel-forming systems that are instilled as drops into the eye and undergo a sol-gel transition.The aim of the present work was formulation and evaluation of in-situ gelling system of ketorolac tromethamine. Ketorolac tromethamine is an non-steroidal anti-inflammatory agent. The developed formulation can be used as an in-situ gelling vehicle to enhance ocular bioavailability. Carbopol 940 was used as the gelling agent in combination with HPMC K4M which acted as a viscosity enhancing agent. The prepared formulations were evaluated for pH, clarity, gelling capacity, in-vitro drug release, drug-excipient interactions (FTIR), and Short-term stability studies (40±2° C/75±5% RH for 3 months). IR spectroscopic studies indicated that there are no drug-excipient interactions. In-vitro drug release data of optimized formulation (K27) was treated according to Zero, First, Korsmeyer Peppas and Higuchi kinetics to access the mechanism of drug release. Eye irritation test using the HET-CAM test data of optimized formulation (K27) and calculated S value. The gel provided sustained drug release over an 9 hour period and the reduced frequency of instillation resulting in better patient acceptance.

Keywords: In-situ gel; Carbopol 940; Ketorolac tromethamine; HET-CAM test.