Abstract
Semisolid systems (creams, gels etc.) for dermal application get more and more importance in pharmaceutical and cosmetic industry. However the number of methodologies for their physico-chemical characterization have been increasing; development of methods for the measurement of the active agent’s release onto the skin surface is still a challenging task. Beside measuring the amount of the active agent reaching the skin; dissolution testing (also called release testing) can be also a good indicator of product composition changes, therefore it can be used as quality control methodology. The purpose of this study was to investigate the in vitro drug release of active agents from hydrogels, organogels, o/w and w/o creams, emulgels and w/o/w multiple emulsions for dermal use by means of the vertical diffusion cell methodology, for quality control purposes.
Highlights
1 Introduction Dissolution studies are developed and are available mainly for solid dosage forms; different methodologies validated for these forms are detailed in the main Pharmacopoeias [1,2]
There is no compulsory method in any Pharmacopoeia for semisolid dosage forms; only two guidelines are available suggesting equipment for the measurement of drug release from these preparations
The experimental conditions in drug release testing such as receptor phases, membrane-types, usage of different animal skin-models etc. depend on the purpose of the experiments; whether the aim is quality control or so called bioavailability testing in order to decrease the number of animal testing or eliminating them [7,8]
Summary
Dissolution studies are developed and are available mainly for solid dosage forms (tablets, capsules); different methodologies validated for these forms are detailed in the main Pharmacopoeias [1,2]. There is no compulsory method in any Pharmacopoeia for semisolid dosage forms; only two guidelines are available suggesting equipment for the measurement of drug release from these preparations. According to these guidelines and based on literature data, drug release has been extensively investigated by means of the Franz cell diffusion system with a synthetic membrane [3,4,5,6]. The experimental conditions in drug release testing such as receptor phases, membrane-types, usage of different animal skin-models etc. Predicting the practical applicability or changes within a given system with mathematical modelling [10,11] or different
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