The objective of the study was to design a fast-dissolving film of cetirizine hydrochloride (CTZHCl) by the solvent casting method using various film-forming polymers like Hydroxyl propyl methylcellulose (HPMC K4M), Polyvinyl alcohol (PVA), Sodium alginate (Na-alg). Six different formulations were designed by varying the concentration of film-forming polymer. Acquired formulations were subjected to various physicochemical, physio-mechanical and in vitro drug release studies. All the films were homogenous, uniform and free from air bubbles and were in the pH range of 6.9 ± 0.01 to 7.2 ± 0.04. The physio-mechanical study suggests that the tensile strength of F2 was highest with 6.1 ± 0.63 N/cm2 and lowest in F6 with 2.48 ± 0.21 N/cm2. However, The %-elongation and folding endurance was highest in F6 with 89 ± 3.1 cm% and 126 ± 4 respectively. The lowest %-elongation and folding endurance was observed in F2 with the values of 66 ± 1.7 cm% and 78 ± 2 respectively. Content uniformity tests were performed in the films of 6 cm2. The drug contents were almost similar with all formulations. The disintegration time was observed to be maximum in F1 with 55 ± 4 seconds and minimum in F6 with 12 ± 1 seconds. The study suggests formulations having lower polymer concentration (F4, F5, F6) exhibits lower disintegration time; while formulations with higher polymer concentration (F1, F2, F3) showed good, clear and transparent film with increased disintegration time (DT). The in vitro drug dissolution study was performed in simulated saliva (pH 6.8) for all formulation. The cumulative in vitro drug release was maximum in F6 with 99.78 ± 2.81% and a minimum in F1 with 76.19 ± 2.64%. Drug release from the formulations were significantly different compared to pure drug CTZHCl (p<0.05). Data was analyzed using Tukey’s multiple comparison test and statistical significance was predefined at p<0.05.
Keywords: cetirizine, oral films, solvent casting