Abstract

SKIN IRRITATION, SKIN SENSITIZATION AND IN VIVO STUDIES OF SUMATRIPTAN SUCCINATE NEW LIPOSOMAL DRUG IN ADHESIVE PATCH FOR TRANSDERMAL DRUG DELIVERY

M. Srujan Kumar* and Anna Balaji

ABSTRACT

The present study focussed on skin irritation, skin sensitization and In Vivo studies for the prepared Lipo Drug-In-adhesive patch for transdermal drug delivery of sumatriptan succinate towards the pain management of migraine. Considering the unavailability of transdermal patches in the market, 100mg sumatriptan succinate tablets (Imitrex) were taken as reference products in order to determine the pharmacokinetic parameters from the plasma after administration of drug products. New chromatographic method with fluorescence detector was used for the determination of sumatriptan succinate in rabbit plasma using sulpiride as internal standard. The chromatograms showed absence of interference between the plasma and analyte. The pharmacokinetic parameters are calculated from the mean plasma concentration data and observed that patches of invention sumatriptan succinate Lipo-Drug-In-Adhesive patch delivered Cmax of 22.23 ng/ml at Tmax of 2.09 hours and prolonged plasma drug concentration of sumatriptan for 12 hours. The patches showed no evidence of skin irritation and skin sensitization based on scoring, primary irriation index and grade classification studies after 24 hours.

Keywords: Skin irritation, Skin sensitization, HPLC, Sumatriptan succinate, Sulpiride.