Formulation and characterization of caffeine biodegradable chewing gum delivery system for alertness using plasticized poly(D,L-lactic acid) as gum base

Abstract

Purpose: To formulate and evaluate biodegradable plasticized poly(D,L-lactic acid) as a base for caffeine-medicated chewing gums (MCGs) to increase alertness. Methods: Biodegradable plasticized poly(D,L-lactic acid) caffeine-MCGs were formulated with a fixed concentration (15 % w/w) of different plasticizers for different formulations. Substances used as plasticizers were triacetin, stearic acid, PEG-600, tributyl citrate, soya oil, sunflower oil, glycerol, triethyl citrate, PEG-4000, and castor oil. The characteristics of the gum formulations were examined using texture profile analysis (TPA), and also evaluated for biodegradation, microstructure`, in vitro drug release, and sensory features. Results: The MCG-1 and MCG-7 formulations with triacetin and glycerol as plasticizers, respectively, exhibited a biodegradation score of 1 and 2, respectively, indicating considerable biodegradation. The formulation with triacetin as a plasticizer exhibited TPA values of 3750.52 g, 1526.23, and 0.364 for hardness, adhesiveness, gumminess, chewiness, and cohesiveness, respectively; these values are similar to those of the Military Energy Gum. The microstructure of the gum base was characterized using scanning electron microscopy to determine surface properties. The in vitro drug release was determined as 97 % after a mean chewing time of 15 min by using a specially designed in vitro chewing machine. Conclusion: Plasticized poly(D,L-lactic acid) gum formulation is suitable for the delivery of caffeine and can be used as an alternative MCG for effective management of fatigue.