Formulation Development and Evaluation of Ketorolac Tromethamine Gel for Topical Application in Pain Management

In today's world, pain and inflammation has been a matter of concern in day to day life. For the slightest disorder of pain and inflammation; patients want quick symptomatic relief. Hence there is a wide scope for delivery of analgesic, anti-inflammatory drugs through all possible routes of administration. Topical drug delivery system has been considered as fastest, easiest and safest mode of treating local inflammation. In conventional topical formulation, it was found that the drug release was for a shorter period of time. Hence there was a need for enhancing the release for an extended period of time. In present study topical formulation with penetration enhancer were used to study the effect of the drug release. For patient acceptability and quick relief from pain, development of topical gel of ketorolac tromethamine was formulated. An Experimental design of 4 formulations was set up to study influence of gelling polymer-Noveon AA-1 USP Polycarbophil with added penetration enhancers on drug delivery, to provide effective therapy to evoke a desired pharmacological effect for pain management. The effect of the above on the performance and physicochemical characteristics of formulations were assessed. The gels were evaluated based on appearance, consistency, drug content uniformity, pH, viscosity, spreadability, in vitro permeation studies and stability studies. Gels were physically and chemically sound with respect to their quality parameters. Developed topical gel formulation of ketorolac tromethamine was found to be an innovative approach to provide an effective therapy to evoke a desired pharmacological effect within the targeted tissues and ensuring the drugs availability in therapeutic concentration for drug release over a 5 hour period.