Storage stable eplerenone formulation
OwnerPornanong Aramwit, Hong Qi +1inventors
InventorsPornanong Aramwit, Hong Qi, Leonard J. Ferro
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Abstract
There is provided a parenterally deliverable pharmaceutical composition comprising eplerenone and a solvent liquid having the eplerenone in solution therein. Compositions of the invention are storage stable.
Claims43
A parenterally deliverable pharmaceutical composition comprising a solvent liquid and eplerenone, wherein at least a substantial portion of the eplerenone is present in the solvent liquid in dissolved and/or solubilized form and the composition has a pH of about 3.5 to about 6.0.
A parenterally deliverable pharmaceutical composition comprising a solvent liquid and eplerenone, wherein at least a substantial portion of the eplerenone is present in the solvent liquid in dissolved and/or solubilized form, the composition has a pH of about 4.0 to about 5.5, and upon storage in a closed container maintained at 25° C. for a period of at least 180 days, said eplerenone constitutes at least about 96%, by weight, of eplerenone originally present in the composition.
A parenterally deliverable pharmaceutical composition comprising eplerenone in an amount of about 2.5 mg/ml to about 20 mg/ml, hydroxypropyl-β-cyclodextrin in an amount of about 10 mg/ml to about 110 mg/ml, at least one pharmaceutically acceptable buffering agent, at least one pharmaceutically acceptable isotonic agent, and water;
- wherein at least a substantial portion the eplerenone is present in dissolved and/or solubilized form and the composition has a pH of about 3.5 to about 6.0.
Dependencies are inferred from the claim text.