Formulation In Vitro and In Vivo Evaluation of Ketorolac Topical Hydrogel

Abstract

Non-steroidal anti-inflammatory drugs (NSAIDs) like Ketorolac Tromethamine are frequently prescribed to alleviate pain associated with osteoarthritis, ankylosing spondylitis, acute sciatica, rheumatoid arthritis, and low back pain. Hydrogels are polymeric three-dimensional networks that are able to consume significant volumes of water and remain insoluble in water due to their physical and chemical crosslinking. They respond to temperature, pH and ionic strength. They can be prepared by using natural polymers such as dextran, pectin, alginate, or synthetic polymers such as polyvinyl alcohol, polyethylene oxide, and poly–hydroxy ethyl methacrylate. Hydrogels are used to deliver several drugs. Today, hydrogels have found a wide range of applications due to their non-toxic nature and low cost. The purpose of the current research was to formulate and assess a topical gel based on hydrogel that contained Ketorolac Tromethamine to treat inflammation and pain while reducing the gastrointestinal side effects associated with oral treatment. According to the FTIR analysis, Ketorolac Tromethamine doesn't interact with other excipients in a significant way. The physical characteristics, pH level, extrudability, spreadability, swelling property, in-vitro drug release study of hydrogel formulations were assessed. Using a dialysis membrane and a phosphate buffer solution with a pH of 7.4, in vitro and ex vivo release studies were conducted on the Franz diffusion cell. Among all formulations, HF4 showed high spreadability of 25.2 ±0.3 gm./cm/sec, extrudability, swelling index, in vitro drug release, and ex vivo drug diffusion. HF4 hydrogel showed no signs of skin irritation. The final formulation HF4 hydrogel shows an equal analgesic and anti-inflammatory effect as standard Ketorolac gel. It was found from the drug release kinetics that the Topical Ketorolac hydrogel HF4 drug release mechanism follows the Higuchi model and zero order.