Effects of microemulsions on the stratum corneum and hydrocortisone penetration.

We tested a high-water-content hydrophilic microemulsion (ME 1) and a low-water-content lipophilic microemulsion (ME 2) for their suitability for use in dermatology, in general, and as alternative hydrocortisone (HC) vehicles, in particular. The lipophilic component of both study products was isopropyl myristate. The surfactant/cosurfactant system of ME 1 consisted of two sucrose esters and that of ME 2 was a mixture of Tagat S and Plurololeat. Both MEs showed no in vitro irritability in the hen's egg test on chorioallantoic membranes. In 14 subjects, stratum corneum water content was determined by corneometry and transepidermal water loss (TEWL) by the Tewameter before and after 3 days use of ME 1 or ME 2 as well as on two untreated control sites. ME 1 produced dehydration and increased TEWL as evidence of barrier compromise. ME 2 also produced an increase in TEWL but had no dehydrating effect. Subjects then underwent standardized washing with a surfactant solution. Under these conditions, pretreatment with ME 2 also produced dehydration, but to a lesser extent than did pretreatment with ME 1. In the same subjects, the impact of the two MEs on HC penetration (0.5%, 24h occlusion) was evaluated in terms of the chromameter-determined blanching effect compared with that on a site treated only with an occlusive film dressing. The comparator was an ambiphilic cream (Basiscreme (BC) Deutscher Arzneimittel Codex (German Formulary)). Irritative skin redness produced by ME 1 was significant and that produced by ME 2 was slight but visible, compared with BC. HC penetration was demonstrable from all the study products via the blanching effect and was significantly greater from ME 1 and slightly greater from ME 2 than from BC. However, neither ME would improve HC therapy because the irritative effects were so great that the blanching effect of HC formulated in ME 1 was significantly smaller and that of HC in ME 2 slightly smaller than that of HC formulated in BC.