FORMULATION AND IN VITRO EVALUATION OF SODIUM NAPROXEN PATCH

• Main Author: Amanda, Yovita
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/81100
• Institution: Institut Teknologi Bandung

Naproxen works by inhibiting the COX non-selectively, causing gastrointestinal side effects when taken orally. Therefore, this study aimed to create a topical sodium naproxen patch to minimize these side effects. This research involved determining the final formula, making and evaluating the gel, and creating and evaluating the patch. The determination of the final formula began with selecting the polymer, followed by choosing the ethanol-water mixture ratio for gel production. The gel was made with the final formula comprising sodium naproxen (?1% naproxen), low viscosity HPMC (9%), propylene glycol (20% HPMC), methylparaben (0.18%), propylparaben (0.02%), ethanol (13.33%), and water. Based on organoleptic, pH, and viscosity evaluations, a clear, non-foaming gel was obtained with a pH of 6.92 ± 0.009 and viscosity of 1153.667 ± 16.905 cP. The patch was created by drying the gel using an oven, followed by pouring an adhesive solution onto it. The produced patch underwent evaluations for weight variation, thickness, moisture content, folding resistance, mechanical strength, content uniformity, and in vitro permeation. The resulting patch was clear and non-bubbly, with a weight of 412.7 ± 1.453 mg, thickness of 0.150 ± 0.003 mm, moisture content of 7.777 ± 0.732%, folding resistance >200 times, tensile strength of 5.17 ± 0.73 MPa, elongation percentage of 13.05 ± 1.48%, and sodium naproxen content of 101.021 ± 0.009%. The in vitro permeation of sodium naproxen after 24 hours was 20.31 ± 7.39%. The low in vitro permeation could be attributed to the hydrophilic and polar nature of sodium naproxen, its ionized form being less permeable, and the limited penetration-enhancing ability of propylene glycol. The release kinetics of sodium naproxen from the patch closely resembled the Korsmeyer-Peppas release kinetics.