Synthesis and Formulation Development of Phenytoin by Inclusion Complexation.

Phenytoin is a classical anticonvulsant drug used in the treatment of epilepsy. It is a Biopharmaceutics classification system class II drug that has poor aqueous solubility, which affects dissolution rate. The main objective of this study was to enhance the dissolution rate of phenytoin and formulate the optimized chewable tablet. The phenytoin sodium was chemically synthesized and its solubility was enhanced with inclusion complexation by the kneading method using beta-cyclodextrin. This results in increased solubility of phenytoin sodium from 0.0150 to 0.0171 g/ml and solubility was found to be directly proportional to concentration beta-cyclodextrin. Further, 22 factorial design was used to optimize phenytoin sodium chewable tablet with enhanced solubility. In vitro evaluations were done for all 12 formulations to find out the optimized formulation. We found the significant increase in the percentage of drug release, at the end of 2 h, for formulation B6 (81.66 %) and C12 (92.76 %). Also, the pre-compressional and post-compressional properties of B6 and C12 formulations were found to be within the acceptable range of chewable tablets. In conclusion, the solubility of phenytoin sodium was enhanced and we successfully developed two (B6 and C12) optimized formulation of phenytoin sodium chewable tablet. [ABSTRACT FROM AUTHOR]