Formulation, Development, Evaluation of Calcitriol and Clobetasol Propionate Ointment

Abstract

Psoriasis vulgaris is a common skin disorder characterized by focal formation of inflamed, raised plaques that constantly shed scales derived from excessive growth of skin epithelial cells. Prevalence of Psoriasis is 2-3 % in general population. Currently, Topical Corticosteroids remain a pivotal Treatment due to their effective anti-inflammatory properties; however potential adverse effects associated with chronic application limit long-term continuous therapy. Vitamin D analogues provide another mechanism of action reducing lesions through effects on keratinocytes and on cytokine environment. A topical combination of corticosteroid & Vitamin D derivative appears to provide a balanced approach to psoriasis treatment. When Calcitriol is used in combination with topical steroids, Psoriasis improves more than one agent alone. The main side effect of Calcitriol is skin irritation. Topical steroids Clobetasol used in conjunction with Calcitriol may lessen skin irritation. Combination reduces hazards associated with long term use of topical Corticosteroids (atrophy and rebound) as well as irritation associated with Calcipotriol. Various formulations of Calcitriol (0.0003%) and Clobetasol Propionate (0.05%) were taken for optimization in relation to ointment base, consistency, ointment stability, stability with antioxidant, stability with different preservatives, and effect of temperature of Calcitriol phase addition to bulk white petrolatum base of ointment. Observations of all formulations for physical characterization and drug release profile had shown that, all comply with the specifications of official pharmacopeias and or standard reference. It was observed that, formulation batch- F12 selected as optimized formulation of Ointment, as it fulfills all requirements of Topical ointment.