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Claims for Patent: 6,852,724

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Claims for Patent: 6,852,724

Title: Sustained release ranolazine formulations
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.
Inventor(s): Wolff; Andrew A. (San Francisco, CA)
Assignee: CV Therapeutics, Inc. (Palo Alto, CA)
Application Number:10/382,266
Patent Claims: 1. A method for treating a human patient suffering from variant and exercise-induced angina by administering a sustained release ranolazine pharmaceutical dosage form, wherein the dosage form comprises at least 50% by weight ranolazine, said dosage form when administered at least once over a 24 hour period provides a peak to trough plasma ranolazine level ratio that does not exceed 3:1 over a 24 hour period.

2. A method for treating a human patient suffering from variant and exercise-induced angina by administering a sustained release ranolazine pharmaceutical dosage form, wherein the dosage form when administered at least once over a 24 hour period provides a peak to trough plasma ranolazine level that does not exceed 4:1 over a 24 hour period.

3. A method for treating a human patient suffering from intermittent claudication by administering a sustained release ranolazine pharmaceutical dosage form, wherein said dosage form when administered at least once over a 24 hour period provides a peak to trough plasma ranolazine level ratio that does not exceed 4:1 over a 24 hour period.

4. A method for treating a human patient suffering from myocardial infarction by administering a sustained release ranolazine pharmaceutical dosage form, wherein said dosage form when administered at least over a 24 hour period provides a peak to trough plasma ranolazine level ration that does not exceed 4:1 over a 24 hour period.

5. A method for treating a human patient suffering from a cardiovascular disease by administering a sustained release ranolazine pharmaceutical dosage form, wherein said dosage form when administered over a 24 hour period maintains plasma ranolazine levels close to minimal effective levels without peak fluctuations.

6. A method for treating angina in a mammal comprising administration of at least one sustained release pharmaceutical dosage form comprising at least 50% by weight ranolazine.

7. A method for treating a cardiovascular disease in a mammal comprising administration of an immediate release formulation of ranolazine followed by or in combination with at least one sustained release pharmaceutical dosage form comprising at least 50% by weight ranolazine.

8. A method for treating a cardiovascular disease in a mammal comprising IV administration of an immediate release formulation of ranolazine followed by at least one sustained release pharmaceutical dosage form comprising at least 50% by weight ranolazine.

9. A method for treating angina in a mammal comprising administration of an immediate release formulation of ranolazine followed by or in combination with at least one sustained release pharmaceutical dosage form comprising at least 50% by weight ranolazine.

10. A method for treating angina in a mammal comprising IV administration of an immediate release formulation of ranolazine followed by or in combination with at least one sustained release pharmaceutical dosage form comprising at least 50% by weight ranolazine.

11. A method for treating angina in a mammal comprising IV administration of an immediate release formulation of ranolazine followed by at least one sustained release pharmaceutical dosage form of ranolazine, wherein the sustained release dosage form maintains a trough plasma ranolazine level minimim of about 850 ng base/mL over a 24 hour period.

12. A method for treating a cardiovascular disease in a mammal comprising administration of at least one sustained release pharmaceutical dosage form of ranolazine wherein said dosage form comprises ranolazine free base, at least one pH-dependent binder and optional excipients.

13. The method of claim 12 wherein said dosage form also comprises at least one pH independent binder.

14. The method of claim 12 wherein said optional excipients comprise one or more of the following: fillers, coloring agents, flavoring agents, plasticizers, or film-forming agents.

15. A method for treating arrhythmias in a mammal comprising administration of an immediate release formulation of ranolazine followed by or in combination with at least one sustained release pharmaceutical dosage form comprising at least 50% by weight ranolazine.

16. A method for treating arrhythxnias in a mammal comprising IV administration of an immediate release formulation of ranolazine followed by or in combination with at least one sustained release pharmaceutical dosage form comprising at least 50% by weight ranolazine.

17. A method for treating arrhythmias in a mammal comprising IV administration of an immediate release formulation of ranolazine followed by at least one sustained release pharmaceutical dosage form of ranolazine, wherein the sustained release dosage form maintains a trough plasma ranolazine level minimum of about 850 ng base/mL over a 24 hour period.
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