Volume 19, Issue 44, July - December, 2025

Optimization of HPMC K4M and Glycerin Concentration in the Formulation of Orally Disintegrating Films of Chlorpheniramine Maleate Using the Solvent Casting Method

Febriyenti F^♦, Regina Andayani, Charrisca Syahyuning Kumalasari

Faculty of Pharmacy, Universitas Andalas, Kampus Limau Manis, Padang 25163, West Sumatera, Indonesia

^♦Corresponding author
Febriyenti F, Faculty of Pharmacy, Universitas Andalas, Kampus Limau Manis, Padang 25163, West Sumatera, Indonesia

ABSTRACT

Chlorpheniramine Maleate (CTM) is an alkylamine derivative and antihistamine. It has a relatively short half-life and requires frequent administration, approximately four to six times per day. Ensuring patient convenience in drug consumption is essential. Therefore, CTM was formulated into an Orally Disintegrating Film (ODF), which can be administered without the need for water. This study aimed to formulate CTM into an ODF dosage form using HPMC K4M as the polymer, glycerin as the plasticizer, and stevioside as the sweetener. The ODF was prepared using the solvent casting method. Four formulations were developed: F1 (2% HPMC K4M, 0.2% glycerin), F2 (2% HPMC K4M, 0.6% glycerin), F3 (4% HPMC K4M, 0.4% glycerin), and F4 (4% HPMC K4M, 1.2% glycerin). The pre-gel pH evaluation showed that all formulations met the requirements, with a pH range of 5.743 ± 0.005 to 5.817 ± 0.011. Organoleptic evaluation revealed that F1 and F2 formed whitish, wrinkled, and nonhomogeneous films, whereas F3 formed a clear, non-wrinkled, and relatively homogeneous film, and F4 formed a whitish, non-wrinkled, but non-homogeneous film. The results of the thickness and weight evaluation were only F3 qualified, with values of 0.075 ± 0.003 mm and 0.035 ± 0.001 g. Moisture content analysis showed compliance with the required range of 15.49 ± 3.35% to 21.81 ± 1.39%. The disintegration time met the requirement of being <60 seconds. The content uniformity evaluation met the required specifications, with an average content of 97.33 ± 4.63%, and an acceptance value of 12.28. Based on these results, F3 was determined to be the optimal ODF formulation for CTM.

Keywords: Orally Disintegrating Film, Chlorpheniramine Maleate, Solvent casting, HPMC, Stevioside

Drug Discovery, 2025, 19(44), e16dd2099

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Published: 18 August 2025