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Claims for Patent: 7,011,848

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Claims for Patent: 7,011,848

Title:Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor
Abstract:An orally administered antihyperlipidemia composition according to the present invention includes from about 250 to about 3000 parts by weight of nicotinic acid, and from about 5 to about 50 parts by weight of hydroxypropyl methylcellulose. Also, a method of treating hyperlipidemia in a hyperlipidemic having a substantially periodic physiological loss of consciousness, includes the steps of forming a composition having an effective antihyperlipidemic amount of nicotinic acid and a time release sustaining amount of a swelling agent. The method also includes the step of orally administering the composition to the hyperlipidemic once per day "nocturnally," that is in the evening or at night.
Inventor(s): Bova; David J. (Hollywood, FL)
Assignee: KOS Pharmaceuticals, Inc. (Miami, FL)
Application Number:09/470,603
Patent Claims: 1. A method of treating hyperlipidemia in a hyperlipidemic comprising dosing the hyperlipidemic with an effective antihyperlipidemic amount of nicotinic acid or compound metabolized to nicotinic acid by the body, once per day in the evening or at night combined with pharmaceutically acceptable carriers, to produce a reduction in total and LDL cholesterol, triglycerides and Lp(a), with a significant increase in HDL cholesterol.

2. A method, as set forth in claim 1, wherein the hyperlipidemic is dosed with from about 250 parts to about 3000 parts by weight of nicotinic acid.

3. A method of claim 1, which causes minimum liver damage, uric acid increases or elevations in fasting glucose levels.

4. A method as set forth in claim 1 wherein the release rate of said nicotinic acid or compound metabolized by the body to nicotinic acid is from about 2.0% per hour to about 25% per hour.

5. A method as set forth in claim 1 wherein said nicotinic acid or compound metabolized to nicotinic acid by the body is prepared by formulating the active compound with from about 5% to about 50% parts by weight of hydroxypropyl methylcellulose per 100 parts by weight of tablet.

6. A method, as set forth in claim 1, wherein said nicotinic acid or compound metabolized to nicotinic acid by the body is dosed in he form of a sustained release formulation or tablet containing from about 1 to about 4 parts by weight of binder per 100 pats by weight of tablet.

7. A method, as set forth in claim 4, wherein said binder is a polymer having the repeating polymerization unit 1-ethenyl-2-pyrrolidone.

8. A method, as set forth in claim 1, wherein said nicotinic acid or compound metabolized to nicotinic acid by the body is dosed in the form of a sustained release formulation or tablet comprising from about 0.5 to about 2.5 parts by weight of a lubricating agent per 100 parts by weight of tablet.

9. A method, as set forth in claim 8, wherein said lubricating agent is selected from the group consisting of stearic acid and magnesium stearate.

10. A method, as set forth in claim 1, wherein the compound metabolized to nicotinic acid by the body to nicotinic acid is nicotinyl alcohol tartate.

11. A method, as set forth in claim 10, wherein the amount of nicotinyl alcohol tartrate is from about 100 milligrams to about 500 milligrams per dosage unit.

12. A method, as set forth in claim 1, wherein the compound metabolized to nicotinic acid by the body is selected from the group consisting of: d-glucitol hexanicotinate, aluminum nicotinate, and, 1-alpha-tocopheryl nicotinate.
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