DERMAL ABSORPTION OF FLUPREDNIDENE-21-ACETATE AND MICONAZOLE FROM A NEW TOPICAL PREPARATION IN PIGS

The dermal absorption of fluprednidene-21-acetate (CAS 1255-35-2) and miconazole nitrate (CAS 22832-87-7) of a new combination cream (Decode rm(R) tri) was studied in pigs after application of 0.5 cream/kg body weight under occlusive dressing for 5 h. H-3-labelled fluprednidene-21 -acetate and C-14-labelled miconazole nitrate were introduced into the base cream as single components or in combination. The three resultin g creams were tested in groups of 3 pigs each. To obtain a basis for t he assessment of the data after dermal application the two labelled dr ugs were also examined after intravenous injection. Based on the compa rison of the AUC of the radioactive labels an absorption of 4.4% for f luprednidene-21-acetate was calculated when administered alone and 2.4 % when administered in the combination cream. For miconazole a smaller absorbed fraction of the dermal dose of 0.5 and 0.8%, resp., was foun d. Since the differences between single and combined administration we re not significant, it follows that there is no relevant reciprocal in fluence of ht two compounds on their dermal absorption.