Comparative assessment of cutaneous delivery of clobetasol propionate from two topical cream formulations using an in vitro Franz diffusion model

Abstract

Background: The therapeutic effectiveness of topical corticosteroids depends on their ability to achieve adequate skin retention while minimizing systemic absorption. This study compared the cutaneous delivery characteristics of two clobetasol propionate 0.05% cream formulations, clobetasol 0.05% cream and clobetasol 0.05% cream (innovator), using an in vitro Franz diffusion model.

Methods: Comparative skin permeation studies were conducted using excised swine skin mounted on Franz diffusion cells in accordance with OECD Test Guideline 428. A 100 mg dose of each formulation was applied to the skin surface and receptor fluid samples were collected over 12 hours. Clobetasol propionate concentrations were quantified using a validated HPLC method. Drug permeation, skin retention and surface residue were determined.

Results: Both formulations exhibited low transdermal permeation and substantial skin retention. At 12 hours, cumulative permeation was 2.52% for clobetasol 0.05% cream and 2.85% for clobetasol 0.05% cream (innovator). Skin retention was 59.25% and 52.67%, respectively, while the remaining drug was estimated as surface residue. Although minor differences in permeation kinetics were observed, the overall distribution profiles of clobetasol propionate were comparable between the two formulations.

Conclusions: Clobetasol 0.05% cream and clobetasol 0.05% cream (innovator) demonstrated comparable cutaneous delivery characteristics, with high skin retention and minimal transdermal permeation. The findings indicate that both formulations effectively localize clobetasol propionate within the skin, supporting their suitability for topical treatment of inflammatory dermatoses.