Pharmaceutical formulations: salts of 8-[-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one and treatment methods using the same
AssigneeOPKO Health, Inc.
InventorsZhihui Qiu, Larisa Reyderman
Life of this patent
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Abstract
Pharmaceutical formulations containing salts of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl]-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one, represented by Formula I, are disclosed. Disclosed also are methods of treatment utilizing such dosage forms.
Claims13
1) A method of treating and/or preventing nausea and or emesis in a mammal comprising administering to the mammal a pharmaceutical formulation comprising a crystalline hydrochloride monohydrate salt of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl]-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one, lactose, microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, and magnesium stearate.
8) A method of providing therapy for delayed onset emesis and/or delayed onset nausea along with chemotherapy by contemporaneously or simultaneously administering a pharmaceutical formulation comprising a crystalline hydrochloride monohydrate salt of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl]-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one, lactose, microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, and magnesium stearate and a chemotherapeutic agent to a patient in need of chemotherapy.
Dependencies are inferred from the claim text.