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Claims for Patent: 6,479,496

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Claims for Patent: 6,479,496

Title: Methods for treating angina with ranolazine
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:09/520,932
Patent Claims: 1. A method for treating a human patient suffering from variant and exercise-induced angina by administering a sustained release pharmaceutical dosage form including at least 50% 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.

2. The method of claim 1 wherein the maximum plasma ranolazine level is about 4000 ng base/mL.

3. The method of claim 1 wherein the pharmaceutical dosage form is administered to the human patient at a frequency selected from once and twice over 24 hours.

4. The method of claim 1 wherein the pharmaceutical dosage form is administered to the human patient in two doses over 24 hours wherein each dose consists of two tablets.

5. The method of claim 1 wherein the pharmaceutical dosage form includes between about 50% to about 95% by weight ranolazine.

6. The method of claim 1 wherein the pharmaceutical dosage form includes from about 70% to about 80% by weight ranolazine.

7. The method of claim 1 wherein the peak to trough human patient plasma ranolazine levels is less than 4:1 over a 24 hour period.

8. The method of claim 1 wherein the peak to trough human patient plasma ranolazine levels is less than 3:1 over a 24 hour period.

9. The method of claim 1 wherein the peak to trough human patient plasma ranolazine levels is less than 2:1 over a 24 hour period.

10. The method of claim 1 wherein the dose includes from about 500 to 1500 mg ranolazine.
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