Abstract
Creams and lotions use emulsifiers to create a physically stable vehicle for topically applied dosage forms. The minimum temperature required for an anionic emulsifier to form micelles, which can cause lipid extraction from skin and result in irritation, is known as the Krafft temperature (TK). A cream or lotion formulated with emulsifiers having a TK above safe water exposure temperatures (approximately 50°C) cannot irritate skin due to epidermal lipid extraction. Roflumilast cream, a novel, once-daily, topical formulation of a highly potent phosphodiesterase-4 inhibitor in development for treatment of several dermatologic conditions, demonstrated favorable tolerability in clinical trials.
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