Immediate release eplerenone compositions
AssigneeG. D. Searle & Co.
InventorsShilpa S. Thosar, Rajeev D. Gokhale, Dwain S. Tolbert
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Abstract
The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
Claims72
A pharmaceutical composition comprising micronized eplerenone in an amount of about 10 mg to about 1000 mg and a pharmaceutically acceptable carrier material.
A pharmaceutical composition comprising micronized eplerenone and P-cyclodextrin in a liquid dosage form.
A pharmaceutical composition comprising micronized eplerenone and a pharmaceutical carrier material, wherein said composition is suitable for once or twice a day oral administration as an aldosterone receptor blocker.
A pharmaceutical composition comprising micronized eplerenone and a pharmaceutically acceptable carrier material, wherein said composition causes an average increase in blood serum renin concentrations in a human subject over an interval of about 12 to 24 hours after ingestion of the composition of at least about 10%.
A pharmaceutical composition comprising micronized eplerenone and a pharmaceutically acceptable carrier material, wherein said composition causes an average increase in blood serum aldosterone concentrations in a human subject over an interval of about 12 to 24 hours after ingestion of the composition of at least about 50%.
A pharmaceutical composition comprising micronized eplerenone and a pharmaceutically acceptable carrier material, wherein said composition causes an average decrease in diastolic blood pressure in a human subject over an interval of about 12 to 24 hours after ingestion of the composition of at least about 5%.
The method according to 57 wherein the condition or disorder is edema associated with liver insufficiency.
A method of preparing a pharmaceutical composition comprising eplerenone comprising:
- wet granulating micronized eplerenone and one or more carrier materials to form a wet granulated mixture;
- and
- preparing an oral dosage form of the pharmaceutical composition from the wet granulated mixture.
Use of micronized eplerenone and a cellulosic carrier material in the manufacture of a medicament for the treatment or prophylaxis of aldosterone mediated conditions or disorders.
A pharmaceutical composition comprising micronized eplerenone and a pharmaceutically acceptable carrier material, wherein said composition is an oral dosage form in which at least 50% of the eplerenone in the composition is released in vitro at least about 1.5 hours in 1% SDS.
A pharmaceutical composition comprising micronized eplerenone and a pharmaceutically acceptable carrier material, wherein said composition is an oral dosage form wherein at least 50% of the micronized eplerenone in the composition is released in vitro at least about 3.5 hours in 1% SDS.
A pharmaceutical composition comprising micronized eplerenone and a pharmaceutically acceptable carrier material, wherein said composition is an oral dosage form wherein at least 50% of the micronized eplerenone in the composition is released in vitro at least about 5.5 hours in 1% SDS.
Dependencies are inferred from the claim text.