Hydralazine compositions and methods
AssigneeEndo Operations Limited
InventorsKumaresh Soppimath, Tushar Hingorani, Hari A. Attluri, Harshil H. Jain
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Abstract
A sterile, ready-to-use pharmaceutical composition having hydralazine and/or a salt thereof at a concentration of less than about 20 mg/mL and a solvent comprising an organic co-solvent, wherein the hydralazine and/or salt thereof and the organic co-solvent are provided at a first weight ratio sufficient for the hydralazine and/or salt thereof to have a change in concentration of no more than about 10% after 2 months of storage at 60° C. Also described are methods of making and using the composition.
Claims18
A sterile, ready-to-use pharmaceutical composition comprising:
- hydralazine and/or a salt thereof at a concentration of about 10 mg/mL, and
- a solvent comprising a co-solvent, wherein the solvent comprises water and the co-solvent comprises propylene glycol,
- wherein the co-solvent and the hydralazine and/or salt thereof are provided at a weight ratio of no more than about 7.5:1, and wherein the hydralazine and/or salt thereof has a change in concentration of no more than about 10% after 2 months of storage at 60° C.
A pre-filled syringe comprising a sterile, ready-to-use pharmaceutical composition, the composition comprising:
- hydralazine and/or a salt thereof at a concentration of about 10 mg/mL, and
- a solvent comprising a co-solvent, wherein the solvent comprises water and the co-solvent comprises propylene glycol,
- wherein the co-solvent and the hydralazine and/or salt thereof are provided at a weight ratio of no more than about 7.5:1, and wherein the hydralazine and/or salt thereof has a change in concentration of no more than about 10% after 2 months of storage at 60° C.
A method of treating hypertension comprising administering to a subject in need thereof a sterile, ready-to-use pharmaceutical composition, the composition comprising:
- hydralazine and/or a salt thereof at a concentration of about 10 mg/mL, and
- a solvent comprising a co-solvent, wherein the solvent comprises water and the co-solvent comprises propylene glycol,
- wherein the co-solvent and the hydralazine and/or salt thereof are provided at a weight ratio of no more than about 7.5:1, and wherein the hydralazine and/or salt thereof has a change in concentration of no more than about 10% after 2 months of storage at 60° C.
Dependencies are inferred from the claim text.