Clobetasol Propionate and Pramoxine Hydrochloride Loaded Nanolipid Carrier Gel for the Treatment of Atopic Dermatitis

Abstract

Aim: To prepare and evaluate Clobetasol Propionate(CP) and Pramoxine Hydrochloride (PH) loaded nanolipid carrier (NLC) based gel for improved skin permeation for the treatment of Atopic Dermatitis. Methodology: (CP) and (PH) loaded NLCs were prepared by melt emulsification ultra-sonication technique. In vitro, ex vivo and In vivo studies in atopic dermatitis animal model of formulated drug loaded NLC (DNLC) gel were evaluated. Dermal pharmacokinetic parameters were evaluated by Phoenix Winnonlin software. Results and discussions: DNLC gel was prepared successfully. Skin permeation and retentive property of DNLC gel showed CP from DNLC had a permeability flux of 5.88 μg/cm2/h and enhancement ratio of 1.92 compared to CP drug solution, while PH from DNLC gel had a permeability flux of 9.52 μg/cm2/h and enhancement ratio of 1.62 compared to PH drug solution. Dermal pharmacokinetic parameters were determined using WinNonlin software. CP retained at 24h in stratum corneum, epidermis, and dermis was 4.25 ± 0.02μg, 75.77 ± 0.01μg and 32.04±0.012μg, respectively, while PH retained at 24h was 11.82 ± 0.003μg, 344.0± 0.05μg and 172.85± 0.040μg, respectively. More CP was retained from DNLC gel than marketed CP cream. In vivo animal studies confirmed DNLC gel's effectiveness in treating atopic dermatitis compared to commercial cream and individual drug-loaded DNLC gel, decreasing induced disease on par with marketed CP cream. Epidermal thickness, IgE, and AEC showed greatest reduction in the DNLC gel treatment group.