Patent US5268181A successfully refreshed from Google Patents.
US5268181A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method of using niacin to control nocturnal cholesterol synthesis
Assignee: Kos Pharmaceuticals Inc
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Filing: 1992-06-29
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Granted: 1993-12-07
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Expires: 2012-06-29
Abstract
Abstract The invention provides a therapeutic method to treat hyperlipidemia by administering to a human patient a single daily dose of a prolonged release dosage form of niacin, so that nocturnal cholesterol synthesis is effectively suppressed.
Inventors
- 👤 Victoria A. O'Neill
- 👤 Kenneth L. Evenstad
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-03 20:59
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2013; A61K31/00; A61K31/33; A61K31/395; A61K31/435; A61K31/44; A61K31/455; A61K9/2022; A61K9/205; A61K9/2054
Claims Analysis
Total Claims: 12
Claim 1
Independent Claim
133 words
A therapeutic method for lowering serum lipids or lipid components consisting essentially of administering to a human in need of such treatment an amount of a single daily dose of niacin which is effective to lower the nocturnal levels of a serum lipid or lipid component selected from the group consisting of total serum cholesterol, total triglycerides, lipoprotein a and low-density lipoprotein-cholesterol (LDL-C), wherein said dose of niacin is administered by ingestion of at least one controlled release tablet comprising, in admixture, about 5-30 % high viscosity hydroxypropyl methyl cellulose having a nominal viscosity, 2% aqueous solution, of at least about 10,000 cps, a methoxyl content of about 7-30% and a hydroxypropyl content of about 7-20%, about 2-15% of a water-soluble pharmaceutical binder, about 2-20% of a hydrophobic component and about 30-90% niacin.
Claim 2
Dependent Claim
133 words
A therapeutic method for lowering serum lipids or lipid components consisting essentially of administering to a human in need of such treatment an amount of a single daily dose of niacin which is effective to lower the nocturnal levels of a serum lipid or lipid component selected from the group consisting of total serum cholesterol, total triglycerides, lipoprotein a and low-density lipoprotein-cholesterol (LDL-C), wherein said dose of niacin is administered by ingestion of at least one controlled release tablet comprising, in admixture, about 5-30 % high viscosity hydroxypropyl methyl cellulose having a nominal viscosity, 2% aqueous solution, of at least about 10,000 cps, a methoxyl content of about 7-30% and a hydroxypropyl content of about 7-20%, about 2-15% of a water-soluble pharmaceutical binder, about 2-20% of a hydrophobic component and about 30-90% niacin.
Claim 3
Dependent Claim
18 words
The method of claim 1 wherein said treatment also raises the levels of high density lipoprotein cholesterol (HDL-C).
Claim 4
Dependent Claim
31 words
The method of claim 1 wherein the single dose of niacin is administered with the evening meal of said human or after the evening meal of said human but before bedtime.
Claim 5
Dependent Claim
16 words
The method of claim 1 wherein the tablet further comprises a coating comprising a water-swellable polymer.
Claim 6
Dependent Claim
18 words
The method of claim 4 wherein the coating of the water-swellable polymer is overcoated with an enteric coating.
Claim 7
Dependent Claim
12 words
The method of claim 1 wherein the tablet comprises about 50-85% niacin.
Claim 8
Dependent Claim
12 words
The method of claim 1 wherein the hydrophobic component comprises a wax.
Claim 9
Dependent Claim
22 words
The method of claim 1 wherein the hydroxypropyl methyl cellulose has a nominal viscosity, 2 percent aqueous solution, of about 50,000-100,000 cps.
Claim 10
Dependent Claim
49 words
The method of claim 8 wherein the hydroxypropylmethyl cellulose has a nominal viscosity, two percent solution, of about 100,000 cps, a methoxyl content of about 19-24%, a hydroxypropyl content of about 7-12 percent, and a particle size where at least ninety percent passes through a USS 100 mesh screen.
Claim 11
Dependent Claim
42 words
The method of claim 1 wherein the water-soluble pharmaceutical binder is selected form the group consisting low-viscosity hydroxypropyl methylcellulose which has a nominal viscosity, two percent solution, of less than about 100 cps, polyvinyl pyrollidone, methyl cellulose, gelatin, starch, sucrose and lactose.
Claim 12
Dependent Claim
24 words
The method of claim 1 wherein the tablet is a 250 mg tablet, a 500 mg tablet, a 750 mg tablet or mixtures thereof.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1996-12-06 | 1997-06-07 | 1997-12-07 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2000-12-06 | 2001-06-07 | 2001-12-07 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2004-12-06 | 2005-06-07 | 2005-12-07 | $7700.00 | Window Closed / Lapsed |