Method for reducing side effects from administration of phosphodiesterase-4 inhibitors
AssigneeArcutis Biotherapeutics, Inc.
InventorsHoward WELGUS, Archie W. THURSTON, JR., David W. Osborne
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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.
Claims23
A method for reducing gastrointestinal side effects in a patient suffering from gastrointestinal side effects or likely to suffer from gastrointestinal side effects due to administration of a PDE-4 (phosphodiesterase-4) inhibitor drug, comprising
- a) determining whether a patient is suffering from diarrhea, nausea, and/or abdominal pain or is likely to suffer from diarrhea, nausea, and/or abdominal pain due to administration of a PDE-4 inhibitor, and
- b) administering to said patient, a composition comprising a PDE-4 inhibitor drug at a concentration sufficient to provide a systemic effect of the drug in combination with a phosphate ester surfactant comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate.
A method for reducing a spike in Cmax resulting from administration of a PDE-4 (phosphodiesterase-4) inhibitor drug, comprising topically administering to said patient, a composition comprising a PDE-4 inhibitor drug at a concentration sufficient to provide a systemic effect of the drug in combination with a phosphate ester surfactant, wherein said phosphate ester surfactant comprises cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, wherein said PDE-4 inhibitor is selected from the group consisting of apremilast, cilomilast, crisaborole, ibudilast, piclamilast and rolipram.
A composition comprising a PDE-4 (phosphodiesterase-4) inhibitor drug in combination with a phosphate ester surfactant comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, wherein said PDE-4 inhibitor is selected from the group consisting of apremilast, cilomilast, crisaborole, ibudilast, piclamilast and rolipram.
Dependencies are inferred from the claim text.