HYDRALAZINE COMPOSITIONS AND METHODS
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.
1 - 20 . (canceled)
21 . 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,
wherein the co-solvent and the hydralazine and/or salt are provided at a 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.
22 . The composition according to claim 21 , wherein the co-solvent comprises ethylene glycol.
23 . The composition according to claim 21 , wherein the co-solvent comprises isopropanol.
24 . The composition according to claim 21 , wherein the co-solvent comprises ethanol.
25 . The composition according to claim 21 , wherein the co-solvent comprises vegetable oil.
26 . The composition according to claim 21 , wherein the weight ratio is no more than about 7.5:1.
27 . The composition according to claim 21 , wherein the weight ratio is between about 1:1 and 7.5:1.
28 . The composition according to claim 21 further comprising sodium hydroxide.
29 . The composition according to claim 21 , wherein the composition is provided in a bag.
30 . The composition according to claim 21 , wherein the composition is provided in a bottle.
31 . 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,
wherein the co-solvent and the hydralazine and/or salt are provided at a 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.
32 . The pre-filled syringe according to claim 31 , wherein the co-solvent comprises ethylene glycol.
33 . The pre-filled syringe according to claim 31 , wherein the co-solvent comprises isopropanol.
34 . The pre-filled syringe according to claim 31 , wherein the co-solvent comprises ethanol.
35 . The pre-filled syringe according to claim 31 , wherein the co-solvent comprises vegetable oil.
36 . 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,
wherein the co-solvent and the hydralazine and/or salt are provided at a 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.
37 . The method of claim 36 , wherein the co-solvent comprises ethylene glycol.
38 . The method of claim 36 , wherein the co-solvent comprises isopropanol.
39 . The method of claim 36 , wherein the co-solvent comprises ethanol.
40 . The method of claim 36 , wherein the co-solvent comprises vegetable oil.