Optimization of HPMC-Based Oral Fast Dissolving Film of Cetirizine Dihydrochloride

Abstract

There are challenges involved in improving the convenience of cetirizine dihydrochloride (CTZ) administration for geriatric and pediatric patients with allergic asthma. Due to the ease of swallowing, oral fast-dissolving films (OFDFs) have been identified as a potential solution. This study aimed to prepare hydroxypropyl methylcellulose (HPMC)-based OFDFs of CTZ using the solvent casting method. Film compositions, including the amounts of HPMC and glycerin, were optimized using a face-centered central composite design based on film thickness, folding endurance (FE), and disintegration time (DT). Nine prepared films were found to be transparent and clear in appearance, demonstrating the homogeneity of the films. The weights and thicknesses of all films were in the ranges of 57-109 mg and 22 - 40 µm. The FE of the prepared films was determined to be 42-156, 30-124, and 17-70 times for 3%, 4%, and 5% (w/w) HPMC-based films, respectively. The DT of the films ranged from 99 ± 13 to 478 ± 21 s as their compositions were altered in terms of the HPMC contents and the amount of glycerin. The film fabricated from 3 % (w/w) HPMC and 10% (w/w polymer mass) glycerin (F3) was identified as optimal due to achieving the highest FE and the least DT. Moreover, regression analysis demonstrated a significant effect of the HPMC and glycerin amounts on the film properties. After adding CTZ in F3 (the optimized film), the CTZ content in the films was 0.84 ± 0.14 mg/cm2. The optimized film could be evaluated further for drug release and drug permeation. Keywords: Cetirizine dihydrochloride, Film former, Folding endurance, HPMC-based film, Plasticizer