In the present study, buccal discs of fluconazole were prepared by direct compression method employing Mimosa pudica seed mucilage as bucoadhesive polymer. The formulation of buccal discs was optimised using 3-factor, 3-level central composite design, using polymer/excipient ratio, drug concentration and compression force as the independent variables and bioadhesion time and percentage release as dependent variables. The results revealed that polymer/excipient ratio and compression force are the significant factors affecting the bioadhesion time and percentage release, with the effect of polymer/excipient ratio being more pronounced. A quadratic model with backward elimination fitted to the data was used to predict the responses in the optimal region. The optimised formulation of buccal discs provided bioadhesion time and percentage release close to the predicted values. The proposed mathematical model is found to be robust and accurate for optimisation of buccal discs of fluconazole, consistent with the goals of bioadhesion time of 10 h and more than 85% release in 10 h.
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http://dx.doi.org/10.1248/yakushi.130.937 | DOI Listing |
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