World Journal of
Pharmaceutical and Life Sciences

FORMULATION AND EVALUATION OF NAPROXEN MOUTH DISSOLVING FILM FOR THE MANAGEMENT OF SEVERAL MENSTRUAL PAIN

Abhijit Daf*, Dr. Archana N. Mungle, Mr. Roshankumar Satsure, Ms. Ayushi S. Watkar, Mr. Sahil A. Mate, Mr. Shubham P. Navalkar, Mr. Manish M. Naik

ABSTRACT

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.

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