[Studies on the skin surface dosage of dermatopharmaceutical preparations]

In human volunteers presenting with normal skin an investigation has been carried out to determine the specific skin surface dose, the actual application volume, and the theoretical surface film thickness resulting from thin and thick layer inunction of 4 common corticosteroid topicals. The findings obtained indicate that the skin surface dose provides the most suitable criterion for the terrain saturation behaviour exhibited by different formulation types of semi-solid topical preparations (inunguenda). Various aspects of the surface dosage concept are discussed with regard to the active agents and forms of application of external skin remedies. Predicative clinical determinations of the skin surface doses of topicals relating to special therapeutic and assessment procedures are believed to be a valuable complement to experimental (predictive) determinations of this parameter; some problems involved are pointed out by reference to a clinical trial example. Data on the application dosage of topicals--either by skin surface dose or by volume or layer thickness quantification--have been extracted from the dermatological literature and are reviewed with the aim of furnishing a basis for comparative estimation of our experimental results.