Abstract

Carbamazepine was complexed with β -cyclodextrin in an attempt to enhance the solubility features of the drug. Phase solubility studies revealed a linear relationship between carbamazepine solubility and b-cyclodextrin concentration. The value of the stability constant (405.42 M^-1sub ) calculated from the phase solubility diagram indicated that the complexes were adequately stable. Carbamazepine-β -cyclodextrin complex prepared by kneading method was used to produce dispersible tablets. A 2 ³sub factorial design was employed to investigate the effect of factors such as amount of binder, hardness and type of disintegrant on the tablet disintegration time and dissolution rate. Mathematical models containing only the significant factors influencing each response were generated using multiple linear regression and analysis of variance. The three main factors studied had a significant influence on both the response parameters. In addition to the main factors, the two-way interaction factors also showed a significant effect on the release rate. Type of disintegrant emerged as the main effect with the highest statistical significance affecting both the responses. Two formulations with a combination of factors within the experimental domain were developed and evaluated to validate the mathematical models. The predicted values were found to agree with the experimental values, confirming the forecasting ability of multi-linear regression and ANOVA.