Sustained release ranolazine formulations
AssigneeCV Therapeutics, Inc.
InventorAndrew A. Wolff
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Abstract
A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 850 and 4000 ng base/mL.
Claims10
A method for treating a human patient suffering from a cardiovascular disease selected from arrhythmias, variant and exercise-induced angina, and myocardial infarction by administering a sustained release pharmaceutical dosage-form including at least 5.0% by weight ranolazine in no more than two tablets per dose to the human patient to maintain ranolazine plasma levels in the human patient at a minimum of 850 ng base/mL for at least 24 hours wherein the dose is administered at a frequency selected from once, twice and three times over 24 hours.
Dependencies are inferred from the claim text.