Formulation and Evaluation of Orodispersible Film of Naproxen Using Natural Superdisintegrants

Abstract

This research work aimed to develop and evaluate an orodispersible film formulation of Naproxen using natural superdisintegrants. Naproxen is a non-selective nonsteroidal anti-inflammatory drug used to reduce pain, fever, and inflammation. Orodispersible films are thin polymeric strips that dissolve rapidly in the mouth without water requirement, offering quick drug delivery and improved patient compliance. The films were prepared by the solvent casting method using hydroxypropyl methylcellulose (HPMC) as the film-forming polymer, natural superdisintegrants for rapid disintegration, and polyethylene glycol as the plasticizer. A total of 10 formulation batches (F1-F10) were prepared with different polymer concentrations and plasticizer ratios. All formulations were evaluated for physical appearance, pH, thickness, weight variation, folding endurance, swelling property, transparency, drug content uniformity, in-vitro disintegration time, in-vitro dissolution studies, and drug release kinetics. The results showed that Naproxen films possessed uniform characteristics with thickness ranging from 0.7 -1.5 mm, good folding endurance, and rapid disintegration within 16-31 seconds. Drug content was uniform with relative standard deviation values below 6%. In-vitro dissolution studies demonstrated more than 90% drug release within 15 minutes for most formulations. The drug release followed zero-order, first-order, Higuchi, and Korsmeyer-Peppas models. These findings suggest that orodispersible Naproxen films represent a promising patient-friendly, fast-acting dosage form that can improve therapeutic effectiveness and patient compliance.

Keywords: Orodispersible film, Naproxen, Natural superdisintegrants, Solvent casting, Drug release kinetics.