Pharmaceutical development of a generic corticoid semisolid formulation

The development of bioequivalent topical products is still a challenge, partly due to a lack of general methods available to perform this assessment. Several tests are proposed to fulfil this objective, such as dermatopharmacokinetic and pharmacodynamic evaluation. The aim of this study is the evaluation of a topical corticoid emulsion as a candidate to undergo further skin blanching tests. 0.1% mometasone furoate pickering emulsion was produced and evaluated regarding appearance, pH, viscosity assay and impurity D values, under three experimental conditions, 25 degrees C/60% HR, 30 degrees C/65% HR and 40 degrees C/75% HR., in vitro drug release and ex vivo skin absorption profiles have also been studied. All the parameters evaluated remained within specifications in time. Based on impurity D levels, expected shelf life is over five years for formulations stored at 25 degrees C and three years for formulations stored at 30 degrees C. A moderate range of viscosity (16785-94611 mPa s) was found between batches, but this variability did not lead to statistical differences in Higuchi's release constants. Mometasone skin absorption parameters were found to be statistically equivalent to the reference formulation (elocom (R) emulsion), therefore, the present formulation is a good candidate for skin blanching tests. (C) 2017 Elsevier B.V. All rights reserved.