IN-VITRO COMPARATIVE-STUDIES OF TRANSDERMAL NICOTINE DELIVERY SYSTEMS

In vitro release rates of nicotine from three trandsermal systems avai lable in the Portuguese and Spanish markets have been compared in vitr o by methods based on recently proposed USP release tests and assay, a nd using Franz diffusion cells with membranes of 'full-thickness' porc ine ear or human breast skin. No significant differences were found be tween the release profiles obtained by the different release test meth ods for each device and it may be possible and desirable to further st andardise testing recommendations. Total nicotine content could not be determined for one device at modest agitation speeds by methanol extr action. Some simple approaches to comparing animal models and release tests with human skin experiments in vitro are discussed in relation t o potential applications to quality control of TDS and traditional top ical products. (C) 1997 Elsevier Science B.V.