High potency dihydroergotamine compositions
AssigneePozen Inc.
InventorsJohn R. Plachetka, Donna Gilbert
Life of this patent
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Abstract
The present invention is directed to improved formulations for dihydroergotamine in which the drug is present at a concentration of at least 2.9 mM. The invention encompasses methods for using these formulations in treating patients for migraine headaches and the packaging of formulation into prefilled syringes for self-administration by patients.
Claims33
A pharmaceutical composition in unit dose form, comprising:
- a) dihydroergotamine (DHE) in an amount such that one or more unit doses of said composition are effective in the symptomatic treatment of migraine headache when administered to a patient;
- and
- b) a pharmaceutically acceptable liquid vehicle in which said DHE is dissolved at a concentration of at least 2.9 mM.
In a unit dose pharmaceutical composition containing a solution of DHE and indicated for use in the treatment of migraine, the improvement which comprises:
- a concentration of DHE in said composition of at least 2 mg/ml and carbon dioxide and/or nitrogen dissolved in said composition at a concentration sufficient to retard oxidative degradation of said composition.
A pharmaceutical composition in unit dose form, comprising:
- (a) dihydroergotamine (DHE) in an amount such that one or more unit doses of said composition are effective in the symptomatic treatment migraine headache when administered to a patient;
- (b) a pharmaceutically acceptable liquid vehicle in which said DHE is dissolved at a concentration of at least 2.9 mM;
- and
- (c) caffeine at between a 0.1:1 and 10:1 weight ratio with DHE.
In a unit dose pharmaceutical composition containing a solution of DHE and indicated for use in treatment of migraine headache, the improvement which comprises:
- (a) a concentration of DHE in said composition of at least 2 mg/ml;
- (b) carbon dioxide and/or nitrogen dissolved in said composition at a concentration sufficient to retard oxidative degradation of said composition;
- and
- (c) caffeine at between a 0.1:1 and 10:1 weight ratio with DHE.
Dependencies are inferred from the claim text.