Development and Evaluation of Medicated Chewing Gum Using Modified Gum Base

Abstract

The aim of the present work was to formulate a medicated chewing gum (MCG) using modified gum base containing model drug Miconazole Nitrate for the local treatment of oral candidiasis. MCG is novel drug delivery system containing pharmaceutically acceptable masticator gum, drug and other bulking ingredients. MCG offers better patient compliance, acceptability to all age group of patients and severs as mobile drug delivery. The availability of the directly compressible chewing gum base i.e. Health-In-Gum (Caffosa) has drastically increased the research on MCG. In the present investigation, the modified gum base was prepared using conventional gum base available in waxy nature. It was converted into the free flowing powder by freezing & pulverization and making suitable for direct compression method, which is easily adoptable approach by pharma industries. The chewing gum were prepared by direct compression and various formulation related parameters were studied. The optimization of the chewable mass, effect of temperature, effect of heating time, type and amount of softening agent, effect of combination of gum base, adsorbent, diluents, flavoring agent, etc. were studied as preliminary trials. The 3² full factorial design was applied to study the effect more significant factors - softening agent and heating temperature as an independent variable; while Carr’s Index, Peak Load, Chewiness and drug release were selected as dependent variables. The Peak load and chewiness were evaluated by using texture analyzer, and drug release was studied using chewing-gum assembly designed in-house. Chewing parameters were also compared with the marketed MCG as well as MCG formulated using health-in-gum base, and the results were found equivalent. In-vivo chewing study on human volunteers ensured that MCG possesses acceptable taste, mouth feel, Chewability, softness and negligible grittiness. Present study recommends application of modified gum base for MCG formulation with desired properties as economic and industrial adoptable approach