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, -51.13 g.s, 1580.88, 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.
Highlights
Chewing gums are considered as one of the popular drug delivery methods because they are easy to use, do not require water, have a good taste, and are liked by children
A medicated chewing gum (MCG) is defined by European Pharmacopeia [1] as a ‘solid single dose preparation with a base mainly consisting of gum, which is intended to be chewed but not swallowed [2]’
The present study evaluated plasticized poly(D,L-lactic acid) biodegradable caffeine MCG for effectively managing fatigue
Summary
Chewing gums are considered as one of the popular drug delivery methods because they are easy to use, do not require water, have a good taste, and are liked by children. Conventional chewing gums are formulated using synthetic or natural elastomers. The synthetic or natural elastomers in gum cuds have an adhesive-like character, which enables them to adhere to any surface if not properly discarded. To overcome the stickiness problem, biodegradable chewing gums based on poly(lactic acid-co-caprolactone) elastomers and plasticized poly(D,L-lactic acid) have been formulated in US Patent no.5672367 [5] and 6613363 [6], respectively. Such MCGs are currently widely accepted in oral healthcare [7]
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