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US4571333A Expired / Lapsed US ⏱️ 0.0 years remaining

Controlled release naproxen and naproxen sodium tablets

Assignee: Syntex Pharmaceuticals International Ltd
•
Filing: 1983-06-14
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Granted: 1986-02-18
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Expires: 2003-06-14
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Abstract

Abstract A controlled release tablet for once-daily oral administration of about 500-1200 mg of naproxen or naproxen sodium, said tablet being a homogeneous matrix comprising about 4-9 weight percent of hydroxypropylmethylcellulose having a number average molecular weight in the range of from about 80,000 to about 130,000, about 81-96 weight percent naproxen or naproxen sodium, 0.1 to about 2 weight percent of a pharmacetucailly acceptable lubricating agent, and 0 to about 8 weight percent of other pharmaceutically acceptable excipients.

Inventors

  • 👤 Charles H. Hsiao
  • 👤 John S. Kent

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-01 11:43
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2022; A61K9/205; A61K9/2054; A61K31/00; A61K31/185; A61K31/19

Claims Analysis

Total Claims: 30
Claim 1
Independent Claim 64 words
A controlled release tablet for once-daily oral administration of about 500-1200 mg of naproxen or naproxen sodium, which tablet comprises a homogenous matrix comprising: about 4-6 weight percent of hydroxypropylmethylcellulose having a number average molecular weight in the range of from about 80,000 to about 130,000, about 81-96 weight percent of naproxen or naproxen sodium in an amount effective for once daily oral administration,
Claim 2
Dependent Claim 64 words
A controlled release tablet for once-daily oral administration of about 500-1200 mg of naproxen or naproxen sodium, which tablet comprises a homogenous matrix comprising: about 4-6 weight percent of hydroxypropylmethylcellulose having a number average molecular weight in the range of from about 80,000 to about 130,000, about 81-96 weight percent of naproxen or naproxen sodium in an amount effective for once daily oral administration,
Claim 3
Dependent Claim 24 words
1 to about 2 weight percent of a pharamaceutically acceptable lubricating agent, and 0 to about 8 weight percent of other pharmaceutically acceptable excipients.
Claim 4
Dependent Claim 24 words
1 to about 2 weight percent of a pharamaceutically acceptable lubricating agent, and 0 to about 8 weight percent of other pharmaceutically acceptable excipients.
Claim 5
Dependent Claim 10 words
The controlled release tablet of claim 1 which contains naproxen.
Claim 6
Dependent Claim 19 words
The controlled release tablet of claim 2 wherein the hydroxypropylmethylcellulose has a number average molecular weight of about 120,000-130,000.
Claim 7
Dependent Claim 41 words
The controlled release tablet of claim 3 which comprises: about 5 weight percent of the hydroxypropylmethylcellulose, about 92-95 weight percent naproxen, 0.1 to about 2 weight percent magnesium stearate, and 0 to about 1 weight percent of a pharmaceutically acceptable colorant.
Claim 8
Dependent Claim 15 words
The controlled release tablet of claim 4 wherein the amount of naproxen is 500 mg.
Claim 9
Dependent Claim 16 words
The controlled release tablet of claim 5 which contains about 0.01-0.05 weight percent FD&C Yellow #6.
Claim 10
Dependent Claim 15 words
The controlled release tablet of claim 4 wherein the amount of naproxen is 750 mg.
Claim 11
Dependent Claim 14 words
The controlled release tablet of claim 7 which contains 0.01-0.05 mg FD&C Yellow #6.
Claim 12
Dependent Claim 15 words
The controlled release tablet of claim 4 wherein the amount of naproxen is 1000 mg.
Claim 13
Dependent Claim 15 words
The controlled release tablet of claim 9 which contains about 0.01-0.05 mg. FD&C Yellow #6.
Claim 14
Dependent Claim 19 words
The controlled release tablet of claim 1 wherein the hydroxypropylmethylcellulose has a number average molecular weight of about 120,000-130,000.
Claim 15
Dependent Claim 43 words
The controlled release tablet of claim 11 which comprises: about 5 weight percent of the hydroxypropylmethylcellulose, about 85-95 weight percent naproxen or naproxen sodium, 0.1 to about 2 weight percent lubricating agent, and 0 to about 8 weight percent other pharmaceutically acceptable excipients.
Claim 16
Dependent Claim 19 words
The controlled release tablet of claim 12 wherein the amount of naproxen or naproxen sodium is about 500-550 mg.
Claim 17
Dependent Claim 19 words
The controlled release tablet of claim 12 wherein the amount of naproxen or naproxen sodium is about 750-800 mg.
Claim 18
Dependent Claim 18 words
The controlled release tablet of claim 12 wherein the amount of naproxen or naproxen sodium is 1000-1100 mg.
Claim 19
Dependent Claim 19 words
The controlled release tablet of claim 1 wherein the hydroxypropylmethylcellulose has a number average molecular weight of about 85,000-95,000.
Claim 20
Dependent Claim 19 words
The controlled release tablet of claim 16 wherein the amount of naproxen or naproxen sodium is about 500-550 mg.
Claim 21
Dependent Claim 19 words
The controlled release tablet of claim 16 wherein the amount of naproxen or naproxen sodium is about 750-800 mg.
Claim 22
Dependent Claim 19 words
The controlled release tablet of claim 16 wherein the amount of naproxen or naproxen sodium is about 1000-1100 mg.
Claim 23
Dependent Claim 11 words
The controlled release tablet of claim 1 which contains naproxen sodium.
Claim 24
Dependent Claim 61 words
The controlled release tablet of claim 20 which comprises: about 6 weight percent of hydroxypropylmethylcellulose having a number average molecular weight in the range of about 120,000-130,000, about 82-90 weight percent naproxen sodium, 0.1 to about 2 weight percent lubricating agent, about 4-6 weight percent of a pharmaceutically acceptable glident, and 0 to about 2 weight percent other pharmaceutically acceptable excipients.
Claim 25
Dependent Claim 17 words
The controlled release tablet of claim 21 wherein the amount of naproxen sodium is about 550 mg.
Claim 26
Dependent Claim 17 words
The controlled release table of claim 21 wherein the amount of naproxen sodium is about 1100 mg.
Claim 27
Dependent Claim 14 words
The controlled release tablet of claim 1 wherein the lubricating agent in magnesium stearate.
Claim 28
Dependent Claim 16 words
The controlled release tablet of claim 2 wherein the amount of naproxen is about 500 mg.
Claim 29
Dependent Claim 16 words
The controlled release tablet of claim 2 wherein the amount of naproxen is about 750 mg.
Claim 30
Dependent Claim 16 words
The controlled release tablet of claim 2 wherein the amount of naproxen is about 1000 mg.

References Cited (Backward Citations)

US3065143A Cited
US3424842A Cited
US3807790A Cited
US4226849A Cited
US4369172A Cited
US4389393A Cited
US4389393B1 Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1989-02-17 1989-08-19 1990-02-18 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1993-02-17 1993-08-19 1994-02-18 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1997-02-17 1997-08-19 1998-02-18 $7700.00 Window Closed / Lapsed

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