CLOTRIMAZOLE TOPICAL FORMULATIONS IVIVC

The interest in in vivo/in vitro correlations in the dermal field of research has increased steadily. This study was designed to demonstrate the rate of release of Clotrimazole from two different, marketed topical cream formulations ; by performing In vitro and in vivo experiments. For In Vitro study the penetration of Clotrimazole from two different formulatio ns was evaluated using human cadaver skin in a Franz Diffusion cell setup. The release rate of Clotrimazole from two different formulations in the receptor phase through human cadaver skin was monitored chromatographically. Whereas in In Vivo experiment the pharmacokinetic study of two marketed formulations of Clotrimazole was performed by Dermatopharmacokinetic method using 12 healthy Indian male subjects. Pharmacokinetic parameters of Clotrimazole were calculated as Cmax, Tmax, AUC (0-t) and AUC (0-∞). Clotrimazole was estimated in Stratum Corneum using a validated chromatographic method. Different release profiles of Clotrimazole were observed in both the formulations for both the studie s. In conclusion, the linear In Vitro – In Vivo correlation for the release rate of Clotrimazole was observed for both the two Formulations. But the In Vitro experiments using the cadaver skin is more time consuming than the In Vivo Dermatopharmacokinetic absorption experiments.