L(9) orthogonal design assisted formulation and evaluation of chitosan-based buccoadhesive films of miconazole nitrate.

The present study was aimed to prepare and evaluate buccoadhesive films of miconazole nitrate (MCZ). The films based on chitosan were prepared by solvent casting method using L(9) orthogonal array design to release the drug above its minimum inhibitory concentration (MIC) for a prolonged period of time so as to reduce its frequency of administration. As per the experimental design, guar gum, HPMC K15M and HEC were added at three different levels to control the drug release. Films showed smooth, uniform and non-sticky surface with good flexibility and folding endurance. Thickness and weight-variation data showed no significant difference among the batches, indicating that the polymeric blend possessed a good film forming ability and its desired properties could easily be achieved by varying the composition of the casting solution. Films composed of chitosan with guar gum appeared to be tougher; comparatively more bioadhesive in vitro, resided to an appropriate time interval and swelled at a more reasonable rate than those containing HPMC and HEC, suggesting the superiority of guar gum over other polymers. In vitro drug release studies conducted on all batches and microbiological studies done on the statistically optimized formulation demonstrated that the films had ability to sustain the drug concentration above its MIC for 6 hrs, despite the incorporation of a smaller dose (2.5 mg/cm(2) of the film). Films, except CF2 and CF3, followed Fickian diffusion of release mechanism. FT-IR spectra revealed no interactions between the drug and polymers.