US4525345A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Constant order release, solid dosage indomethacin formulation and method of treating arthritis and other inflammatory conditions
Assignee: Verex Laboratories Inc
•
Filing: 1984-08-06
•
Granted: 1985-06-25
•
Expires: 2004-08-06
Abstract
Abstract A constant release rate indomethacin formulation in tablet unit dosage form, said tablet comprising an intimate admixture of from 50 to 200 mg of indomethacin, from about 1.7 to 3.7 weight percent of a slow-dissolving, water-insoluble cellulose derivative, from about 1.5 to 5.0 weight percent of a tabletting disintegrant, and from about 40 to 80 weight percent of a pharmaceutically acceptable bulking agent or diluent.
Inventors
- 👤 James M. Dunn
- 👤 Ronald T. Haas
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 11:14
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2022; A61K9/205; A61K9/2054
Claims Analysis
Total Claims: 28
Claim 1
Independent Claim
93 words
A constant release rate indomethacin formulation in tablet unit dosage form, said tablet comprising an intimate screened, solvent wet-granulated admixture of from 50 to 200 mg of indomethacin, from about 1.7 to 3.7 weight percent of a slow-dissolving water-insoluble cellulose derivative selected from the group consisting of cellulose acetate phthalate and ethyl cellulose, dissolved in the wet-granulation solvent, the wet granulation being completely dried before screening, from about 1.5 to 5.0 weight percent of a tabletting disintegrant, and from about 40 to 80 weight percent of a pharmaceutically acceptable bulking agent or diluent.
Claim 2
Dependent Claim
93 words
A constant release rate indomethacin formulation in tablet unit dosage form, said tablet comprising an intimate screened, solvent wet-granulated admixture of from 50 to 200 mg of indomethacin, from about 1.7 to 3.7 weight percent of a slow-dissolving water-insoluble cellulose derivative selected from the group consisting of cellulose acetate phthalate and ethyl cellulose, dissolved in the wet-granulation solvent, the wet granulation being completely dried before screening, from about 1.5 to 5.0 weight percent of a tabletting disintegrant, and from about 40 to 80 weight percent of a pharmaceutically acceptable bulking agent or diluent.
Claim 3
Dependent Claim
15 words
The indomethacin tablet of claim 1 wherein said water-insoluble cellulose derivative is cellulose acetate phthalate.
Claim 4
Dependent Claim
21 words
The indomethacin tablet of claim 1 wherein said water-insoluble cellulose derivative is a mixture of cellulose acetate phthalate and ethyl cellulose.
Claim 5
Dependent Claim
12 words
The indomethacin tablet of claim 1 wherein said disintegrant is corn starch.
Claim 6
Dependent Claim
12 words
The indomethacin tablet of claim 2 wherein said disintegrant is corn starch.
Claim 7
Dependent Claim
12 words
The indomethacin tablet of claim 3 wherein said disintegrant is corn starch.
Claim 8
Dependent Claim
22 words
The indomethacin tablet of claim 1 wherein said disintegrant is a saccharide selected from the group consisting of lactose, maltose and fructose.
Claim 9
Dependent Claim
22 words
The indomethacin tablet of claim 2 wherein said disintegrant is a saccharide selected from the group consisting of lactose, maltose and fructose.
Claim 10
Dependent Claim
22 words
The indomethacin tablet of claim 3 wherein said disintegrant is a saccharide selected from the group consisting of lactose, maltose and fructose.
Claim 11
Dependent Claim
14 words
The indomethacin tablet of claim 1 wherein said bulking agent is dibasic calcium phosphate.
Claim 12
Dependent Claim
14 words
The indomethacin tablet of claim 2 wherein said bulking agent is dibasic calcium phosphate.
Claim 13
Dependent Claim
14 words
The indomethacin tablet of claim 3 wherein said bulking agent is dibasic calcium phosphate.
Claim 14
Dependent Claim
14 words
The indomethacin tablet of claim 4 wherein said bulking agent is dibasic calcium phosphate.
Claim 15
Dependent Claim
14 words
The indomethacin tablet of claim 5 wherein said bulking agent is dibasic calcium phosphate.
Claim 16
Dependent Claim
14 words
The indomethacin tablet of claim 6 wherein said bulking agent is dibasic calcium phosphate.
Claim 17
Dependent Claim
108 words
A constant release rate solid oral dosage indomethacin formulation in tablet unit dosage form comprising an intimate screened, solvent wet-granulated admixture of a therapeutically effective amount of indomethacin, from about 1.7 to 3.7 weight percent of a water-insoluble cellulose derivative selected from the group consisting of cellulose acetate phthalate and ethyl cellulose, dissolved in the wet-granulation solvent, the wet granulation being completely dried before screening, from about 1.5 to 5.0 weight percent of a tabletting disintegrant selected from the group consisting of corn starch or lactose and from about 40 to 80 weight percent of dibasic calcium phosphate and from 0.3 to 1.5 weight percent of a lubricant.
Claim 18
Dependent Claim
108 words
A constant release rate solid oral dosage indomethacin formulation in tablet unit dosage form comprising an intimate screened, solvent wet-granulated admixture of a therapeutically effective amount of indomethacin, from about 1.7 to 3.7 weight percent of a water-insoluble cellulose derivative selected from the group consisting of cellulose acetate phthalate and ethyl cellulose, dissolved in the wet-granulation solvent, the wet granulation being completely dried before screening, from about 1.5 to 5.0 weight percent of a tabletting disintegrant selected from the group consisting of corn starch or lactose and from about 40 to 80 weight percent of dibasic calcium phosphate and from 0.3 to 1.5 weight percent of a lubricant.
Claim 19
Dependent Claim
26 words
A constant release rate indomethacin formulation of claim 16 wherein said water-insoluble cellulose derivative is present in an amount of from 2.0 to 3.0 weight percent.
Claim 20
Dependent Claim
24 words
The constant release rate indomethacin formulation of claim 16 wherein said disintegrant is present in an amount of from 1.9 to 3.2 weight percent.
Claim 21
Dependent Claim
25 words
The constant release rate indomethacin formulation of claim 16 wherein said bulking agent is present in amounts of from about 55 to 75 weight percent.
Claim 22
Dependent Claim
105 words
A constant release rate solid oral dosage indomethacin tablet composition adapted to be administered to a patient suffering from arthritis once or twice a day, said tablet comprising: an intimate admixture of from 50-200 mg per tablet of indomethacin, from 1.5 to 5.0 weight percent of a water-insoluble cellulose derivative selected from the group consisting of cellulose acetate phthalate and ethyl cellulose, dissolved in the wet-granulation solvent, the wet granulation being completely dried before screening, from 1.5 to 5.0 weight percent of a tabletting disintegrant, from 40 to 80 weight percent of a bulking agent and from 0.3 to 1.5 weight percent of a lubricant.
Claim 23
Dependent Claim
105 words
A constant release rate solid oral dosage indomethacin tablet composition adapted to be administered to a patient suffering from arthritis once or twice a day, said tablet comprising: an intimate admixture of from 50-200 mg per tablet of indomethacin, from 1.5 to 5.0 weight percent of a water-insoluble cellulose derivative selected from the group consisting of cellulose acetate phthalate and ethyl cellulose, dissolved in the wet-granulation solvent, the wet granulation being completely dried before screening, from 1.5 to 5.0 weight percent of a tabletting disintegrant, from 40 to 80 weight percent of a bulking agent and from 0.3 to 1.5 weight percent of a lubricant.
Claim 24
Dependent Claim
28 words
The indomethacin tablet of claim 20 wherein said water-insoluble cellulose derivative is cellulose acetate phthalate, said disintegrant is corn starch and said bulking agent is dibasic calcium phosphate.
Claim 25
Dependent Claim
21 words
The indomethacin tablet of claim 20 wherein said water-insoluble cellulose derivative is a mixture of cellulose acetate phthalate and ethyl cellulose.
Claim 26
Dependent Claim
11 words
The indomethacin tablet of claim 20 wherein said disintegrant is lactose.
Claim 27
Dependent Claim
66 words
The indomethacin tablet of claim 21 wherein said cellulose derivative is present in an amount of from 2.0 to 3.0 weight percent, said disintegrant is present in an amount of from 1.9 to 3.2 weight percent, said bulking agent is present in an amount of from 55 to 75 weight percent and said lubricant is present in an amount of from 0.5 to 0.9 weight percent.
Claim 28
Dependent Claim
37 words
A method of treating the symptoms of arthritis and other inflammatory diseases comprising the steps of administering the tablet of claim 20 to a patient suffering from arthritis or another inflammatory disease once or twice a day.
References Cited (Backward Citations)
US3557279A
Cited
US4343789A
Cited
CA1146866A
Cited
WO1981001652A1
Cited
US4308251A
Cited
JPS58144316A
Cited
JPS58170712A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1988-06-24 | 1988-12-24 | 1989-06-25 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-06-24 | 1992-12-24 | 1993-06-25 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-06-24 | 1996-12-24 | 1997-06-25 | $7700.00 | Window Closed / Lapsed |