Formulation and Evaluation of Naproxen Mouth Dissolving Film for the Management of Several Menstrual Pain

Menstrual pain (dysmenorrhea) significantly impacts women's quality of life, with non-steroidal anti-inflammatory drugs (NSAIDs) like naproxen as first-line therapy. Conventional naproxen tablets face challenges including delayed onset (30-60 minutes), gastrointestinal irritation, and swallowing difficulties during nausea episodes. This college project conducts a comparative study of naproxen-loaded mouth dissolving films (MDFs) versus standard tablets for rapid management of moderate-to-severe menstrual pain. MDFs were formulated using solvent casting technique with hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol (PVA), glycerol as plasticizer, and super disintegrants like croscarmellose sodium. Films (2x3 cm, 200 mg naproxen) were optimized for <60 seconds disintegration, >90% drug release in 5-30 minutes, uniform thickness (0.1-0.2 mm), and folding endurance (>300 folds). Physicochemical evaluations included weight variation, pH (5.8-6.8), drug content (95-102%) and in vitro dissolution in simulated saliva (pH 6.8). Comparative assessment simulated clinical use: MDFs achieved faster disintegration and dissolution than tablets, enhancing bioavailability by avoiding first-pass metabolism. Results demonstrate MDFs superior rapid onset (15-30 min relief onset vs. 45-60 min for tablets), improved patient compliance, and reduced side effects, positioning them as innovative orodispersible delivery for dysmenorrhea. This formulation addresses unmet needs in women's health, with scalability for commercial production. The study highlights solvent casting's simplicity for academic settings, providing a practical model for pharmacy students exploring novel drug delivery systems. Objective: To prepare mouth dissolving films containing naproxen using suitable film-forming polymers and excipients for Menstrual pain for rapid onset of action. Compare different formulations of naproxen mouth dissolving films for physical and pharmaceutical properties. Result: Formulate & evaluate films for thickness, weight uniformity, folding endurance, surface pH, drug content, disintegration time, and in vitro drug release & to assess the suitability of the optimized film for rapid onset of action in menstrual pain relief determine the patient compliance potential of the developed formulation for use in dysmenorrhea.