Abstract

The aim of this study was the formulation and evaluation of medicated chewing gum of EGCG (epigallocatechin gallate) enriched extract of camellia sinensis. The extraction of marketed lipton green tea was done by infusion method and antibacterial activities of extract were done against P. gingivalis and S. mutan by well diffusion method. Chewing gum was prepared by softening of gum bases and then mixing with other formulation ingredients and optimization of the formulation by screening of different excipients. Performance evaluation was carried out by evaluating hardness, fracturability, adhesiveness, elasticity, cohesiveness, stringiness, chewiness, gumminess, in vivo drug release study. Precentage yield of extract in first step and second step were found to be 9.43, 11.65 respectively by infusion method. The EGCG obtained with second step of two step method was found significantly greater. In antibacterial activities, the glucan synthesis by the bacterial S. mutan glucosyl transferase was strongly inhibited by (-)-epigallocatechin gallate (EGCG) at concentrations of 50-200ug/ml, the main components of the green tea polyphenols and completely inhibited the growth and adherence of P. gingivalis onto the buccal epithelial cells. Optimized formulations MCG-6 showed hardness, adhesiveness, elasticity, gumminess, chewiness, resilience and cohesiveness values are similar to that of the reference (Nicogum). In vitro drug released of optimized formulation was found to be 77% within 15 min. The developed formulation of medicated chewing gum can be a better alternative to mouth dissolving and conventional tablet formulation. It may be proved as a promising approach to improve the bioavailability as well as to improve patient compliance.

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