Inhibition of crystal growth of roflumilast
AssigneeArcutis Biotherapeutics, Inc.
InventorDavid W. OSBORNE
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Abstract
Roflumilast crystals have been shown to increase in size during storage. The size of the roflumilast crystals can affect the bioavailability and efficacy of a pharmaceutical composition. The growth of roflumilast crystals can be inhibited during storage by including hexylene glycol in the composition. The resulting composition has improved bioavailability and efficacy and can be used to inhibit phosphodiesterase 4 in a patient in need of such treatment.
Claims22
A topical pharmaceutical composition comprising roflumilast in an amount of 0.05%-1% w/w, hexylene glycol, and water, wherein the hexylene glycol is in an amount sufficient to inhibit crystal growth of roflumilast in the composition for at least six weeks of storage at 15° C.-26° C., wherein the composition is in the form of a cream or foam, and wherein said composition has a shelf life.
A topical pharmaceutical composition comprising roflumilast in an amount of 0.05%-1% w/w, hexylene glycol, water, and one or more pharmaceutically acceptable excipients, wherein the hexylene glycol is in an amount sufficient to inhibit crystal growth of the roflumilast, and wherein any precipitated roflumilast returns to a dissolved state when the formulation returns to 15° C.-26° C. following exposure to a temperature below 15° C.
Dependencies are inferred from the claim text.