FORMULATION, DEVELOPMENT AND EVALUATION OF KETOROLAC TROMETHAMINE ORAL MUCOADHESIVE GEL

ABSTRACT: The present study focuses on the formulation and evaluation of an oral mucoadhesive gel containing Ketorolac Tromethamine, a potent non-steroidal anti-inflammatory drug (NSAID), with the aim of enhancing local and systemic drug availability while minimizing first-pass hepatic metabolism. Mucoadhesive gels were prepared using Carbopol 934P, Hydroxypropyl Methylcellulose (HPMC), Sodium Alginate, and Chitosan in optimized ratios to obtain suitable viscosity, spreadability, and adhesive strength. The drug was uniformly incorporated into the polymeric matrix under controlled conditions to ensure homogeneity and consistent dosing. The prepared formulations were assessed for physicochemical parameters including appearance, pH, viscosity, gel strength, spreadability, drug content uniformity, and mucoadhesive strength. In-vitro diffusion studies were carried out to evaluate drug release behavior. Stability studies were conducted at 40°C ± 2°C/75% ± 5% RH for one month to examine formulation integrity under accelerated conditions. FTIR analysis was performed to investigate possible drug–polymer interactions. Among six developed batches, formulation F3 demonstrated optimal characteristics with a pH of 7.01, viscosity of 1400 cps, and 100% drug content. The optimized formulation showed sustained drug release of 98.91% over 6 hours and satisfactory mucoadhesive properties, indicating prolonged retention at the site of application. Stability studies revealed no significant changes in physical appearance or drug content. Overall, the developed oral mucoadhesive gel of Ketorolac Tromethamine presents a promising alternative to conventional dosage forms by offering controlled release, improved residence time, enhanced therapeutic effectiveness, and better patient compliance. Keywords: Ketorolac tromethamine, Oral mucoadhesive gel, Muco-adhesion, Controlled release, Local drug delivery, NSAID, Buccal drug delivery.