Formulation Development and Characterization of Medicated Chewing Gum for Treatment of Oral Candidiasis

Abstract

The aim of the present investigation was to design and evaluate the medicated chewing gum containing fluconazole, mainly for the treatment of oral candidiasis and related conditions. Fluconazole is a triazole anti fungal drug and is used to treat especially candida infection of mouth, throat, bloodstream and vagina. Oral candidiasis is a mycosis (yeast/fungal infection) of candida species on the mucous membrane of the mouth. It is a fungal infection which affects many patients suffering from immuno-suppressed states including those with AIDS, denture stomatitis or the side-effects of cancer chemotherapy. Majority of the oral targeting is achieved by conventional dosage forms like buccal tablet, ointment, gel, sprays, mouth wash, etc. However, these exhibit demerits like patient noncompliance, rapid swallowing, drug loss, etc. To overcome above limitations, the newer formulation “Medicated Chewing Gum” is explored for targeting drug to oral cavity. For successful drug effect, 2 min contact time is require between drug and oral mucosa so need to sustained effect; the drug was coated with Eudragit EPO which also acts as a taste masking agent. MCG was developed by direct compression and various factors were studied. The drug was bitter in taste so taste masking was achieved with various approaches using Eudragit EPO, Sucralose and Xylitol and another factor like optimization of chewable mass, softening agent, effect of combination of gum base, particle size, and adsorbent were studied. A 32 full factorial design was incorporate to evaluate the combine effect of gum base concentration and softening agent as an independent variables while Peak Load, % Carr’s Index and Drug Release at 5 and 15 min were selected as a dependent variable. By using optimization technique % drug release was achieved as per the target product profile. Outcome of in vivo human study revealed that MCG prepared had good taste, chewablity and softness. Use of DOE helps in accurate optimization of formulation with minimum time, efforts and energy. Thus the Inclusion of drug in to Medicated chewing gum may prove to be superior in contrast to other conventional formulations treatment of Oral Candidiasis.