Formulation and characterization of biodegradable medicated chewing gum delivery system for motion sickness using corn zein as gum former

Abstract

Purpose: To formulate and evaluate biodegradable corn zein as a base for diphenhydramine hydrochloride medicated chewing gum for effective management of motion sickness. Method: Corn zein gum formulations were prepared using a fixed concentration (35% w/w) of different plasticizer for each formulation. Substances used as plasticizer were triacetin, oleic acid, polyethylene glycol (PEG)-600, tributyl citrate, PEG-200, PEG-300, PEG-400, PEG-4000, triethyl citrate and castor oil. The gum formulations were characterized for the following parameters: texture profile analysis (TPA), biodegradation, in vitro drug release using a modified chewing apparatus, and sensory properties. Result: Formulations code MCG-5 and MCG-9 which incorporated glyceryl triacetate and castor oil as plasticizers, respectively, showed a biodegradation score of 2 and 1, respectively, indicating significant biodegradation. The formulation with castor oil as plasticizer showed hardness, gumminess, chewiness, and cohesiveness of 4228.87 g, 1002.52, 360.06 g and 0.237; these values are similar to that of the reference, Superpep® travel chewing gum. In vitro drug release of the drug was 95%, and showed uniform distribution of the drug in the gum matrix. Conclusion: Corn zein is suitable for use as a biodegradable gum base for the delivery of diphenhydramine hydrochloride, and can be developed as an alternative to currently used gum bases for commercial products.