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US 12,685,727 B2Granted
Method for reducing side effects from administration of phosphodiesterase-4 inhibitors
AssigneeArcutis Biotherapeutics, Inc.
InventorDavid W. Osborne
Life of this patent
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Abstract
A method for altering the PK profile of a pharmaceutical formulation containing a PDE-4 inhibitor, such as roflumilast, to reduce the spike in Cmax. The spike in Cmax is reduced by topically administering the PDE-4 inhibitor in combination with one or more phosphate ester surfactants. Reducing the spike in Cmax will reduce gastrointestinal side effects and result in better patient compliance.
Claims22
A method of treating a patient suffering from an inflammatory dermatosis comprising:
- topically administering to said patient a cream once per day, wherein the cream comprises 0.05% w/w roflumilast, diethylene glycol monoethyl ether, and an emulsifier blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate,
- wherein roflumilast blood plasma concentration peak to trough ratio is less than 2 after 4 weeks of once-daily administration.
A method of treating a patient suffering from an inflammatory dermatosis comprising:
- topically administering to said patient a cream comprising a 0.05% w/w roflumilast, diethylene glycol monoethyl ether, and an emulsifier blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate,
- wherein the Cmax of roflumilast from the topical composition is reduced relative to an oral roflumilast formulation marketed under the trademark DALIRESP®.
Dependencies are inferred from the claim text.