CHARACTERIZATION AND EX-VIVO SKIN PERMEATION STUDY OF DOMPERIDONE MALEATE TRANSDERMAL PATCH

The present study was designed to develop a suitable matrix type transdermal drug delivery system (TDDS) of domperidone maleate using blends of three different polymeric combinations of polyvinylpyrrolidone (PVP) and ethylcellulose (EC). Physical studies including moisture content, moisture uptake and flatness to study the stability of the formulations were performed. In-vitro dissolution as well as ex-vivo skin permeation studies of the experimental formulations were also performed. Ex-vivo skin permeation study was conducted across the depilated rat abdominal skin using a modified Franz’s diffusion cell. Drug-excipient interaction studies were carried out using TLC (Thin Layer Chromatography) method. All the formulations were found to be suitable for formulating in terms of physicochemical characteristics and there was no significant interaction noticed between the drug and polymers used. It was observed that as the concentration of the hydrophilic polymer (PVP) increased in the formulation, the rate of dissolution increased subsequently and the best result found for the polymer ratio PVP:EC, 3:5. From the study of release mechanism, it was found that the Higuchi plot showed reasonably straight line with high correlation coefficient. Ex-vivo skin permeation study also shows that the permeation of the drug (Domperidone maleate) through the depilated rat abdominal skin was reasonably better in the formulation where PVP concentration was high. It was also found that there was no significant reaction developed during the contact of patch with the dermis. Hence, it can be reasonably concluded that domperidone maleate can be formulated into the transdermal matrix type patches to sustain its release characteristics and the polymeric composition (PVP:EC, 3:5) was found to be the best choice for manufacturing transdermal patches of domperidone maleate among the formulations studied.