Abstract
Amlodipine base was prepared from its besylate salt and various physicochemical properties relevant to transdermal delivery determined. Permeation of the drug from a range of hydrophilic and hydrophobic bases through hairless mouse skin was studied and the influence of the penetration enhancers sodium lauryl sulphate 1% and propylene glycol 20% in a sodium carboxymethylcellulose 3% gel base was examined. The flux of drug could be further enhanced using variable percentage of ethanol in the donor phase. The influence of various rate controlling membranes and a contact adhesive on drug permeation was examined. In vivo studies using rabbits were performed to assess the suitability of a reservoir-type device. Employing data obtained from in vitro studies involving human abdominal skin, it was possible to predict the plasma profile resulting from the application of a similar device onto human skin over a period of 1 week and was found to be inadequate for clinical use. No adverse local effects in the animal model arising from the application of the transdermal device were observed.
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