Patent US5096714A successfully refreshed from Google Patents.
US5096714A
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Prolonged release drug tablet formulations
Assignee: Cibus Pharmaceutical Inc
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Filing: 1989-11-22
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Granted: 1992-03-17
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Expires: 2009-11-22
Abstract
Abstract A prolonged-release unit dosage formulation or pharmaceutical composition, preferably in tablet form, is described. The composition consists essentially of a gel-forming dietary fiber, a biologically-absorbable drug or other active therapeutic agent, and certain specific disintegrants, namely, a physiologically-acceptable edible acid and a mineral salt which releases a physiologically-acceptable gas upon ingestion, preferably carbon dioxide, e.g., a mineral carbonate or bicarbonate, and advantageously dextrose or like soluble sugar. The dietary fiber-containing composition, when compressed into a tablet together with the drug and the specific disintegrants, provides a unique and efficient prolonged-action drug-delivery system.
Inventors
- 👤 Eric H. Kuhrts
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-04 21:38
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0087; A61K9/0095; A61K31/00; A61K31/70; A61K31/715; A61K33/00; A61K33/06; A61K33/10; A61K36/00; A61K36/18; A61K36/185; A61K36/48; A61K36/481; A61K36/483; A61K36/68; A61K47/00; A61K47/06; A61K47/08; A61K47/12
Claims Analysis
Total Claims: 68
Claim 1
Independent Claim
153 words
A solid prolonged-release oral unit dosage composition for oral administration and ingestion in solid form, and intended to be swallowed as such, which consists essentially of a solid admixture of an effective dose of a biologically-absorbable therapeutic agent or drug, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:05 and 1:1.5.
Claim 2
Dependent Claim
153 words
A solid prolonged-release oral unit dosage composition for oral administration and ingestion in solid form, and intended to be swallowed as such, which consists essentially of a solid admixture of an effective dose of a biologically-absorbable therapeutic agent or drug, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:05 and 1:1.5.
Claim 3
Dependent Claim
12 words
The composition of claim 1, wherein the gas released is carbon dioxide.
Claim 4
Dependent Claim
15 words
The composition of claim 2, wherein the mineral salt is a mineral carbonate or bicarbonate.
Claim 5
Dependent Claim
25 words
The composition of claim 3, wherein the mineral salt is calcium carbonate, magnesium carbonate, magnesium bicarbonate, sodium carbonate, sodium bicarbonate, potassium carbonate, or potassium bicarbonate.
Claim 6
Dependent Claim
16 words
The compostion of claim 1, wherein the acid is a food-grade organic acid or phosphoric acid.
Claim 7
Dependent Claim
157 words
A solid prolonged-release oral unit dosage composition for oral administration and ingestion in solid form, and intended to be swallowed as such, which consists essentially of a solid admixture of an effective dose of a biologically-absorbable therapeutic agent or drug, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, and a soluble sugar, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 8
Dependent Claim
157 words
A solid prolonged-release oral unit dosage composition for oral administration and ingestion in solid form, and intended to be swallowed as such, which consists essentially of a solid admixture of an effective dose of a biologically-absorbable therapeutic agent or drug, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, and a soluble sugar, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 9
Dependent Claim
18 words
The composition of claim 1, wherein the gel-forming dietary fiber comprises about 50% by weight of the composition.
Claim 10
Dependent Claim
17 words
The composition of claim 1, wherein the physiologically-acceptable acid comprises about 5% by weight of the composition.
Claim 11
Dependent Claim
17 words
The composition of claim 1, wherein the mineral salt comprises about 15% by weight of the composition.
Claim 12
Dependent Claim
56 words
The composition of claim 1, wherein the gel-forming dietary fiber comprises about 50% by weight, the physiologically-acceptable acid comprises about 5% by weight, the mineral salt comprises about 15% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:05 and 1:1.5.
Claim 13
Dependent Claim
170 words
A solid prolonged-release oral unit dosage composition for oral administration and ingestion in solid form, and intended to be swallowed as such, which consists essentially of a solid admixture of an effective dose of a biologically-absorbable therapeutic agent or drug, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, and a soluble sugar in an amount between 1% and about 30% by weight of the composition, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:05 and 1:1.5.
Claim 14
Dependent Claim
170 words
A solid prolonged-release oral unit dosage composition for oral administration and ingestion in solid form, and intended to be swallowed as such, which consists essentially of a solid admixture of an effective dose of a biologically-absorbable therapeutic agent or drug, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, and a soluble sugar in an amount between 1% and about 30% by weight of the composition, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:05 and 1:1.5.
Claim 15
Dependent Claim
25 words
The composition of claim 11, wherein a soluble sugar is present in an amount between about 3% AND about 12% by weight of the composition.
Claim 16
Dependent Claim
13 words
The composition of claim 1, wherein the drug or therapeutic agent is niacin.
Claim 17
Dependent Claim
172 words
A solid prolonged-release oral unit dosage composition for oral administration and ingestion in solid form, and intended to be swallowed as such, which consists essentially of a solid admixture of an effective does of a biologically-absorbable therapeutic agent or drug, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, wherein the drug or therapeutic agent is niacin in granular form, with a cellulose coating about the granules thereof, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 18
Dependent Claim
172 words
A solid prolonged-release oral unit dosage composition for oral administration and ingestion in solid form, and intended to be swallowed as such, which consists essentially of a solid admixture of an effective does of a biologically-absorbable therapeutic agent or drug, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, wherein the drug or therapeutic agent is niacin in granular form, with a cellulose coating about the granules thereof, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 19
Dependent Claim
22 words
The composition of claim 13, wherein the niacin is present in amount between about 100 and about 200 mg/per unit dosage form.
Claim 20
Dependent Claim
8 words
The composition of claim 15, in tablet form.
Claim 21
Dependent Claim
89 words
A prolonged-release unit dosage composition consisting essentially of an effective dose of niacin, a gel-forming dietary fiber in an amount of about 25% to about 85% by weight of the composition, a physiologically-acceptable edible acid in an amount of about 2% to about 50% by weight, and a mineral salt which releases a physiologically-acceptable gas upon ingestion in an amount of about 5% to about 75% by weight, and wherein the ratio of the weight of the gel-forming fiber to the niacin is between about 1,000:0.5 and about 1:1.5.
Claim 22
Dependent Claim
89 words
A prolonged-release unit dosage composition consisting essentially of an effective dose of niacin, a gel-forming dietary fiber in an amount of about 25% to about 85% by weight of the composition, a physiologically-acceptable edible acid in an amount of about 2% to about 50% by weight, and a mineral salt which releases a physiologically-acceptable gas upon ingestion in an amount of about 5% to about 75% by weight, and wherein the ratio of the weight of the gel-forming fiber to the niacin is between about 1,000:0.5 and about 1:1.5.
Claim 23
Dependent Claim
8 words
The composition of claim 17, in tablet form.
Claim 24
Dependent Claim
21 words
The composition of claim 17, wherein the amount of the niacin is between about 100 mg and about 200 mg per
Claim 25
Dependent Claim
100 words
A prolonged-release unit dosage composition consisting essentially of an effective dose of niacin, in granular form, the granules being coated with a cellulose coating, a gel-forming dietary fiber in an amount of about 25% to about 85% by weight of the composition, a physiologically-acceptable edible acid in an amount of about 2% to about 50% by weight, and a mineral salt which releases a physiologically-acceptable gas upon ingestion in an amount of about 5% to about 75% by weight, and wherein the ratio of the weight of the gel-forming fiber to the niacin is between about 1,000:0.5 and about 1.1:5.
Claim 26
Dependent Claim
100 words
A prolonged-release unit dosage composition consisting essentially of an effective dose of niacin, in granular form, the granules being coated with a cellulose coating, a gel-forming dietary fiber in an amount of about 25% to about 85% by weight of the composition, a physiologically-acceptable edible acid in an amount of about 2% to about 50% by weight, and a mineral salt which releases a physiologically-acceptable gas upon ingestion in an amount of about 5% to about 75% by weight, and wherein the ratio of the weight of the gel-forming fiber to the niacin is between about 1,000:0.5 and about 1.1:5.
Claim 27
Dependent Claim
19 words
The composition of claim 20, wherein the coating is a combination of a carboxymethylcellulose coating and an ethylcellulose coating.
Claim 28
Dependent Claim
16 words
The composition of claim 17, wherein the gel-forming fiber is psyllium husk powder or guar gum.
Claim 29
Dependent Claim
16 words
The composition of claim 17, wherein the acid is a food-grade organic acid or phosphoric acid,
Claim 30
Dependent Claim
11 words
The composition of claim 23, wherein the acid is citric acid.
Claim 31
Dependent Claim
14 words
The composition of claim 17, wherein the mineral salt is a carbonate or bicarbonate.
Claim 32
Dependent Claim
12 words
The composition of claim 25, wherein the mineral salt is calcium carbonate.
Claim 33
Independent Claim
171 words
A method for prolonging the release of a drug or active therapeutic agent upon oral ingestion by a human being, comprising the step of orally administering to the said human being a prolonged-release unit dosage oral composition in solid form which consists essentially of a solid admixture of an effective dose of a biologically-absorbable drug or therapeutic agent, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 34
Independent Claim
171 words
A method for prolonging the release of a drug or active therapeutic agent upon oral ingestion by a human being, comprising the step of orally administering to the said human being a prolonged-release unit dosage oral composition in solid form which consists essentially of a solid admixture of an effective dose of a biologically-absorbable drug or therapeutic agent, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 35
Dependent Claim
12 words
The method of claim 27, wherein the gas released is carbon dioxide.
Claim 36
Dependent Claim
15 words
The method of claim 28, wherein the mineral salt is a mineral carbonate or bicarbonate.
Claim 37
Dependent Claim
25 words
The method of claim 29, wherein the mineral salt is calcium carbonate, magnesium carbonate, magnesium bicarbonate, sodium carbonate, sodium bicarbonate, potassium carbonate, or potassium bicarbonate.
Claim 38
Dependent Claim
16 words
The method of claim 27, wherein the acid is a food-grade organic acid or phosphoric acid.
Claim 39
Independent Claim
176 words
A method for prolonging the release of a drug or active therapeutic agent upon oral ingestion by a human being, comprising the step of orally administering to the said human being a prolonged-release unit dosage oral composition in solid form which consists essentially of a solid admixture of an effective does of a biologically-absorbable drug or therapeutic agent, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, and a soluble sugar, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises a about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 40
Independent Claim
176 words
A method for prolonging the release of a drug or active therapeutic agent upon oral ingestion by a human being, comprising the step of orally administering to the said human being a prolonged-release unit dosage oral composition in solid form which consists essentially of a solid admixture of an effective does of a biologically-absorbable drug or therapeutic agent, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, and a soluble sugar, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises a about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 41
Dependent Claim
18 words
The method of claim 27, wherein the gel-forming dietary fiber comprises about 50% by weight of the composition.
Claim 42
Dependent Claim
17 words
The method of claim 27, wherein the physiologically-acceptable acid comprises about 5% by weight of the composition.
Claim 43
Dependent Claim
17 words
The method of claim 27, wherein the mineral salt comprises about 15% by weight of the composition.
Claim 44
Dependent Claim
55 words
The method of claim 27, wherein the gel-forming dietary fiber comprises about 50% by weight, the physiologically-acceptable acid comprises about 5% by weight, the mineral salt comprises about 15% by weight, and the ratio of the weight of gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 45
Independent Claim
189 words
A method for prolonging the release of a drug or active therapeutic agent upon oral ingestion by a human being, comprising the step of orally administering to the said human being a prolonged-release unit dosage oral composition in solid form which consists essentially of a solid admixture of an effective does of a biologically-absorbable drug or therapeutic agent, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, and a soluble sugar in an amount between about 1% and about 30% by weight of the composition, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 46
Independent Claim
189 words
A method for prolonging the release of a drug or active therapeutic agent upon oral ingestion by a human being, comprising the step of orally administering to the said human being a prolonged-release unit dosage oral composition in solid form which consists essentially of a solid admixture of an effective does of a biologically-absorbable drug or therapeutic agent, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, and a soluble sugar in an amount between about 1% and about 30% by weight of the composition, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, the mineral salt comprises about 5% to about 75% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 47
Dependent Claim
24 words
The method of claim 37, wherein a soluble sugar is present in an amount between 3% and about 12% by weight of the composition.
Claim 48
Independent Claim
172 words
A method for prolonging the release of a drug or active therapeutic agent upon oral ingestion by a human being, comprising the step of orally administering to the said human being a prolonged-release unit dosage oral composition in solid form which consists essentially of a solid admixture of an effective dose of a biologically-absorbable drug or therapeutic agent, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, and between about 1% and about 30% of a soluble sugar wherein the gel-forming dietary fiber comprises about 50% by weight, the physiologically-acceptable acid comprises about 5% by weight, the mineral salt comprises about 15% by weight, and the ratio of the weight of gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids.
Claim 49
Independent Claim
172 words
A method for prolonging the release of a drug or active therapeutic agent upon oral ingestion by a human being, comprising the step of orally administering to the said human being a prolonged-release unit dosage oral composition in solid form which consists essentially of a solid admixture of an effective dose of a biologically-absorbable drug or therapeutic agent, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, and between about 1% and about 30% of a soluble sugar wherein the gel-forming dietary fiber comprises about 50% by weight, the physiologically-acceptable acid comprises about 5% by weight, the mineral salt comprises about 15% by weight, and the ratio of the weight of gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids.
Claim 50
Dependent Claim
13 words
The method of claim 27, wherein the drug or therapeutic agent is niacin.
Claim 51
Independent Claim
179 words
A method for prolonging the release of a drug or active therapeutic agent upon oral ingestion by a human being, comprising the step of orally administering to the said human being a prolonged-release unit dosage oral composition in solid form which consists essentially of a solid admixture of an effective dose of a biologically-absorbable drug or therapeutic agent, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, wherein the drug or therapeutic agent is niacin in granular form, with a cellulose coating about the granules thereof, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 52
Independent Claim
179 words
A method for prolonging the release of a drug or active therapeutic agent upon oral ingestion by a human being, comprising the step of orally administering to the said human being a prolonged-release unit dosage oral composition in solid form which consists essentially of a solid admixture of an effective dose of a biologically-absorbable drug or therapeutic agent, a gel-forming dietary fiber, a physiologically-acceptable acid, and a mineral salt which releases a physiologically-acceptable gas upon ingestion, wherein the drug or therapeutic agent is niacin in granular form, with a cellulose coating about the granules thereof, the combination of the fiber, acid, and salt providing amounts thereof which effect prolonged but effective release of the drug or therapeutic agent upon oral ingestion and exposure of the solid composition to biological fluids, wherein the gel-forming dietary fiber comprises about 25% to about 85% by weight, the physiologically-acceptable acid comprises about 2% to about 50% by weight, and the ratio of the weight of the gel-forming fiber to the weight of the drug or therapeutic agent is between about 1,000:0.5 and 1:1.5.
Claim 53
Dependent Claim
23 words
The method of claim 40, wherein the niacin is present in an amount between about 100 and about 200 mg/per unit dosage form.
Claim 54
Dependent Claim
12 words
The method of claim 42, wherein the dosage unit is a tablet.
Claim 55
Independent Claim
118 words
A method for prolonging release of a drug or active therapeutic agent upon administration to a human being, comprising the step of administering to the said human being a prolonged-release unit dosage composition which consists essentially of an effective dose of niacin, a gel-forming dietary fiber in an amount of about 25% to about 85% by weight of the composition, a physiologically-acceptable edible acid in an amount between about 2% and about 50% by weight, and a mineral salt which releases a physiologically-acceptable gas upon ingestion in an amount of about 5% to about 75% by weight, and wherein the ratio of the weight of the gel-forming fiber to the niacin is between about 1,000:05 and about 1:1.5.
Claim 56
Independent Claim
118 words
A method for prolonging release of a drug or active therapeutic agent upon administration to a human being, comprising the step of administering to the said human being a prolonged-release unit dosage composition which consists essentially of an effective dose of niacin, a gel-forming dietary fiber in an amount of about 25% to about 85% by weight of the composition, a physiologically-acceptable edible acid in an amount between about 2% and about 50% by weight, and a mineral salt which releases a physiologically-acceptable gas upon ingestion in an amount of about 5% to about 75% by weight, and wherein the ratio of the weight of the gel-forming fiber to the niacin is between about 1,000:05 and about 1:1.5.
Claim 57
Dependent Claim
12 words
The method of claim 44, wherein the dosage unit is a tablet.
Claim 58
Dependent Claim
22 words
The method of claim 45, wherein the amount of the niacin is between about 100 mg and about 200 mg per tablet.
Claim 59
Independent Claim
129 words
A method for prolonging release of a drug or active therapeutic agent upon administration to a human being, comprising the step of administering to the said human being a prolonged-release unit dosage composition which consists essentially of an effective dose of niacin in granular form, the granules being coated with a cellulose coating, a gel-forming dietary fiber in an amount of about 25% to about 85% by weight of the composition, a physiologically-acceptable edible acid in an amount between about 2% and about 50% by weight, and a mineral salt which releases a physiologically-acceptable gas upon ingestion in an amount of about 5% to about 75% by weight, and wherein the ratio of the weight of the gel-forming fiber to the niacin is between about 1,000:05 and about 1:1.5.
Claim 60
Independent Claim
129 words
A method for prolonging release of a drug or active therapeutic agent upon administration to a human being, comprising the step of administering to the said human being a prolonged-release unit dosage composition which consists essentially of an effective dose of niacin in granular form, the granules being coated with a cellulose coating, a gel-forming dietary fiber in an amount of about 25% to about 85% by weight of the composition, a physiologically-acceptable edible acid in an amount between about 2% and about 50% by weight, and a mineral salt which releases a physiologically-acceptable gas upon ingestion in an amount of about 5% to about 75% by weight, and wherein the ratio of the weight of the gel-forming fiber to the niacin is between about 1,000:05 and about 1:1.5.
Claim 61
Dependent Claim
19 words
The method of claim 47, wherein the coating is a combination of a carboxymethylcellulose coating and an ethylcellulose coating.
Claim 62
Dependent Claim
16 words
The method of claim 44, wherein the gel-forming fiber is psyllium husk powder or guar gum.
Claim 63
Dependent Claim
16 words
The method of claim 44, wherein the acid is a food-grade organic acid or phosphoric acid.
Claim 64
Dependent Claim
11 words
The method of claim 50, wherein the acid is citric acid.
Claim 65
Dependent Claim
14 words
The method of claim 44, wherein the mineral salt is a carbonate or bicarbonate.
Claim 66
Dependent Claim
12 words
The method of claim 52, wherein the mineral salt is calcium carbonate.
Claim 67
Dependent Claim
27 words
The composition of claim 1, wherein the drug or therapeutic agent is an analgesic, an antihypercholesterolemic, a vitamin, a stimulant, an appetite suppressant, or a mineral supplement.
Claim 68
Dependent Claim
27 words
The method of claim 27, wherein the drug or therapeutic agent is an analgesic, an antihypercholesterolemic, a vitamin, a stimulant, an appetite suppressant, or a mineral supplement.
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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) | 1995-03-17 | 1995-09-16 | 1996-03-17 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-03-17 | 1999-09-16 | 2000-03-17 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-03-17 | 2003-09-16 | 2004-03-17 | $7700.00 | Window Closed / Lapsed |