Abstract

DESIGN, AND EVALUATION OF OCULAR INSERTS FOR CONTROLLED DRUG DELIVERY OF KETOROLAC TROMETHAMINE

*Appa Rao Potu, Veera Reddy Prabhakar Reddy

Abstract

Conventional ophthalmic dosage forms are easy to instill but needs to be applied very frequently and suffer from poor bioavailability and therapeutic response due to pre-corneal and, lacrimo-nasal drainage constraints. One of the novel classes of drug delivery systems, ocular inserts, are gaining worldwide popularity, release drugs at a preprogrammed rate for extended period by increasing the precorneal residence time. Ketorolac tromethamine is a potent non-narcotic analgesic with moderate anti-inflammatory activity. It is conventionally used in the short term management of seasonal allergic conjunctivitis, postoperative ocular pain and inflammation. The present study was undertaken mainly to develop a suitable ocular insert matrix system with the aim of increasing the contact time, achieving controlled release, reducing the frequency of administration, improving patient compliance. Different proportions of gelatin, hydroxyl propyl methyl cellulose, and ethyl cellulose (EC) were used along with the plasticizers and prepared by by film casting technique. Prepared inserts were subjected to different physicochemical evaluation tests. Formulation F18 is identified as the optimized one on the basis of in-vitro drug release data and other physic-mechanical characteristics. Release of drug from the optimized formula was found to be of first order model and non-fickian nature. Fourier transform infrared spectroscopic (FTIR) studies have indicated no interaction between the drug and polymers. Ocular irritation tests conducted in rabbit indicated no signs of toxicity.

Keywords: Ocular inserts, Postoperative ocular pain, Ketorolac tromethamine, Gelatin and Hydroxyl propyl methyl cellulose.