ABSTRACT:
The study mucoadhesive oral gels, releasing topical drugs in the oral cavity at a slow and predetermined rate, provide distinct advantages over traditional dosage forms for treatment of oral candidiasis. Miconazole nitrate (MN) is a broad spectrum antifungal agent preferred in the treatment of oral candidiasis. In the present study, mucoadhesive oral gels of MN were prepared with carbopol 934P in combination with sodium carboxy methyl cellulose, poloxamer 407, two different grades of hydroxy propyl methyl cellulose (50cps and 1500cps) and two different grades of hydroxy ethyl cellulose (145mPas and 270mPas). The prepared formulations were characterized in terms of drug content, pH, spreadability, viscosity, mucoadhesive strength, in vitro release and in vitro antifungal activity and compared with marketed MN gel. The surface pH values of all the gels were in the range of 6.59 ± 0.06 to 6.84 ± 0.07. All the formulations showed acceptable spreadability ranging from 4.56 ± 0.05 to 7.53 ± 0.25 cm and mucoadhesive strength of 3760.59 ± 3.2 to 6499.36 ± 4.7 dynes/cm2. The prepared gels exhibited shear thinning behaviour which is suitable for topical preparations. During in vitro drug release studies, formulations were successful in sustaining the release for 6h to more than 7h. Furthermore, the in vitro antifungal activity of the formulated mucoadhesive gels was significantly (p<0.05) higher to the reference marketed MN gel. The drug release mechanism was found to follow Fickian diffusion. On the basis of the obtained data, the mucoadhesive gel formulation which was prepared with 1% w/w hydroxy ethyl cellulose (270mPas) was determined as the most appropriate formulation for buccal application in means of possessing suitable physical properties, high mucoadhesion and favourable in vitro release pattern.