Development and Evaluation of Fast Dissolving Film for Oro-Buccal Drug Delivery of Chlorpromazine

Abstract:

Objective: Objective was designed to prepare, develop and evaluate fast dissolving films (FDFs) for oro-buccal drug delivery of chlorpromazine. Background: The drug delivery through oro-buccal mucosa is very interesting one but it partially lacked oro-buccal delivery products in the market. Methods: FDFs of chlorpromazine were prepared by solvent casting method using polymers PVA, HPMCE-5, HPMCE-15 and were evaluated for film specific parameters. FDFs were also evaluated for dissolution and percentage drug release by in vitro and ex vivo dissolution or drug permeation study. Results: The prepared films DPF1, DHF2, DHF3, DHPF4 and DHPF5 were of smooth surface without bubbles and cracks; flexible and non-sticky; uniform in weight without any significant weight variation; around to neutral surface pH; unchanged folding endurance; 84-95 %mg drug content variation. Thickness of DPF1 was less compared to DHF2, DHF3, DHPF4 and DHPF5. DPF1 showed excellent elasticity and undergone disintegration in less time. Chlorpromazine was rapidly released in vitro from all formulations and release was found to be maximum 97.2% over a period of 150s in DPF1. Chlorpromazine was significantly more rapidly released ex vivo from DPF1 and release was found to be 85.10% over a period of 150s. Conclusion: The prepared FDFs of chlorpromazine were in accordance to the standard range of film specific parameters and comply it. FDF of chlorpromazine prepared with the polymer PVA is better than other prepared films with other polymers for oro-buccal drug delivery of chlorpromazine in buccal cavity for the treatment of either psychosis or emesis.

Key words: Chlorpromazine, Fast dissolving film, Oro-buccal drug delivery, in vitro, ex vivo.