| abstract |
A novel crystalline form (Form L) of the aldosterone receptor antagonist dru g eplerenone is provided having relatively hich physical stability at normal temperatures of storage and use. Pharmaceutical compositions are also provid ed comprising Form L eplerenone, optionally accompanied by one or more other solid state forms of eplerenone, in a total unit dosage amount of eplerenone of about 10 to about 1000 mg, and further comprising one or more pharmaceutically acceptable excipients. Processes are provided for preparing Form L eplerenone and for preparing compositions comprising Form L eplerenon e. A method for prophylaxis and/or treatment of an aldosterone-mediated conditi on or disorder is also provided, comprising administering to a subject a therapeutically effective amount of eplerenone, wherein at least a fraction of the eplerenone present is Form L eplerenone. |