Novel Approaches in the Development of Mouth Dissolving Formulation for Analgesic and Anti-Inflammatory Drugs

Abstract

The present investigation was undertaken to develop and evaluate a novel mouth dissolving formulation of analgesic and anti-inflammatory drugs with the objective of improving patient compliance, enhancing dissolution characteristics, and achieving rapid therapeutic action. Conventional oral solid dosage forms frequently present swallowing difficulties, particularly among pediatric, geriatric, and dysphagic patient populations, thereby limiting treatment adherence and therapeutic effectiveness. Mouth dissolving tablets (MDTs) have emerged as a promising drug delivery platform capable of rapidly disintegrating in the oral cavity without the requirement for water, facilitating improved convenience and patient acceptability. In the current study, Tolperisone hydrochloride, a centrally acting muscle relaxant, and Celecoxib, a selective cyclooxygenase-2 inhibitor, were selected as model analgesic and anti-inflammatory agents for formulation development. Novel formulation strategies employing superdisintegrants, including crospovidone and sodium starch glycolate, were utilized to promote rapid tablet disintegration and enhance drug dissolution. Comprehensive pre- compression characterization of powder blends was performed through the determination of bulk density, tapped density, Carr's compressibility index, and Hausner ratio to assess flow properties and compressibility behavior. The prepared formulations were further evaluated for post-compression quality attributes, including hardness, friability, weight variation, thickness, wetting time, disintegration time, drug content uniformity, and in vitro dissolution performance. The optimized formulation demonstrated acceptable physicochemical characteristics, satisfactory mechanical integrity, rapid disintegration behavior, and enhanced drug release profiles compared with conventional oral dosage forms. Furthermore, accelerated stability studies conducted in accordance with international regulatory guidelines confirmed the stability and integrity of the optimized formulation under stressed storage conditions. The findings of the present study suggest that the developed mouth dissolving formulation constitutes an effective and patient centric drug delivery system with the potential to improve bioavailability, therapeutic efficacy, and treatment compliance in the management of pain and inflammatory disorders.