US4551177A
Expired / Lapsed
US
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Compressible starches as binders for tablets or capsules
Assignee: Ingredion Inc
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Filing: 1984-04-23
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Granted: 1985-11-05
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Expires: 2004-04-23
Abstract
Abstract A compressible starch, useful as a binder for tablets prepared by direct compression or dry granulation or as a binder-diluent for capsules, is prepared by treating a cold-water-insoluble, granular starch (e.g., corn or waxy corn starch) with an acid, and/or alpha-amylase enzyme at a temperature below the starch's gelatinization temperature. The treated starch is characterized by altered, weakened granules with a less dense interior and disrupted surface. The compressible starch when admixed with a wet granulation binder (e.g., pregelatinized starch) is useful as a binder for tablets prepared by wet granulation as well as direct compression or dry granulation or as a binder-diluent for capsules.
Inventors
- 👤 Paolo C. Trubiano
- 👤 James J. Kasica
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-09 21:55
CPC Classifications
C; C08; C08B; C08B30/00; C08B30/12; A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2022; A61K9/205; A61K9/2059; A61K9/48; A61K9/4841; A61K9/4866
Claims Analysis
Total Claims: 22
Claim 1
Independent Claim
111 words
A starch, useful as a binder for tablets prepared by direct compression or dry granulation or as a binder-diluent for capsules, which consists essentially of a free-flowing, compressible starch powder derived from a cold-water-insoluble, granular starch base by treatment with an acid, and/or alpha-amylase enzyme, the treatment of the starch base and recovery of the free-flowing, compressible starch powder being carried out at a temperature below the gelatinization temperature of the starch; the treated starch being characterized by altered, weakened non-gelatinized granules with a less dense interior and disrupted surface; the compressible starch powder being capable of forming, under direct compression, a tablet having a hardness of at least 5 kg.
Claim 2
Dependent Claim
111 words
A starch, useful as a binder for tablets prepared by direct compression or dry granulation or as a binder-diluent for capsules, which consists essentially of a free-flowing, compressible starch powder derived from a cold-water-insoluble, granular starch base by treatment with an acid, and/or alpha-amylase enzyme, the treatment of the starch base and recovery of the free-flowing, compressible starch powder being carried out at a temperature below the gelatinization temperature of the starch; the treated starch being characterized by altered, weakened non-gelatinized granules with a less dense interior and disrupted surface; the compressible starch powder being capable of forming, under direct compression, a tablet having a hardness of at least 5 kg.
Claim 3
Dependent Claim
29 words
The binder of claim 1, wherein the compressible starch powder is an acid and/or enzyme-treated corn, waxy corn, high amylose corn, potato, tapioca, rice, wheat, or waxy sorghum starch.
Claim 4
Dependent Claim
18 words
The binder of claim 2, wherein the compressible starch powder is an acid/enzyme-treated corn or waxy corn starch.
Claim 5
Dependent Claim
82 words
The binder of claim 2, wherein the acid-treated starch is a corn or waxy corn starch having a water fluidity of at least 60 WF, wherein the enzyme-treated starch is a corn or waxy corn starch which produces at least about 3.5% reducing sugars during the treatment, and wherein the acid/enzyme-treated starch or enzyme/acid-treated starch is a corn or waxy corn starch which has a water fluidity of at least 60 or produces at least about 3.5% reducing sugars during the treatment.
Claim 6
Dependent Claim
47 words
The binder of claim 4, wherein the production of at least about 3.5% reducing sugars in the enzyme treatment relates to a Brabender viscosity reduction of at least about 35% under the peak or final Brabender viscosity of the non-treated granular starch base, whichever reduction is greater.
Claim 7
Dependent Claim
64 words
The binder of claim 5, wherein the acid-treated starch has a water fluidity of about 80 or above, wherein the enzyme-treated starch has a Brabender viscosity about 45% less than that of the non-treated granular corn or waxy corn starch, and wherein the acid/enzyme-treated starch has a water fluidity of at least 80 or produces at least about 14% reducing sugars during the treatment.
Claim 8
Dependent Claim
28 words
The binder of claim 6, wherein the treated corn starch has a reduction in final viscosity and the treated waxy corn starch has a reduction in peak viscosity.
Claim 9
Dependent Claim
111 words
A starch-containing admixture, suitable as a binder for tablets prepared by direct compression, dry granulation, or wet granulation or as a binder-diluent for capsules, which consists essentially of an admixture of a compressible starch powder and an effective amount of a wet granulation binder; the compressible starch being an acid-, and/or alpha-amylase enzyme-treated starch powder derived from a cold-water-insoluble, granular starch base by treatment of the starch base and recovery of the free-flowing, compressible starch powder at a temperature below the gelatinization temperature of the starch, the compressible starch powder being characterized by altered, weakened non-gelatinized granules with a less dense interior and disrupted surface; the admixture effectively binding when compressed.
Claim 10
Dependent Claim
111 words
A starch-containing admixture, suitable as a binder for tablets prepared by direct compression, dry granulation, or wet granulation or as a binder-diluent for capsules, which consists essentially of an admixture of a compressible starch powder and an effective amount of a wet granulation binder; the compressible starch being an acid-, and/or alpha-amylase enzyme-treated starch powder derived from a cold-water-insoluble, granular starch base by treatment of the starch base and recovery of the free-flowing, compressible starch powder at a temperature below the gelatinization temperature of the starch, the compressible starch powder being characterized by altered, weakened non-gelatinized granules with a less dense interior and disrupted surface; the admixture effectively binding when compressed.
Claim 11
Dependent Claim
39 words
The admixture of claim 8, wherein the compressible starch powder is an acid and/or enzyme-treated corn, waxy corn, high amylose corn, potato, tapioca, rice, wheat, or waxy sorghum starch and wherein the wet granulation binder is a pregelatinized starch.
Claim 12
Dependent Claim
23 words
The admixture of claim 10, wherein the compressible starch is a corn or waxy corn starch and the pregelatinized starch is corn starch.
Claim 13
Dependent Claim
29 words
The admixture of claim 10, wherein the compressible starch is present in an amount of about 40-85% and the pregelatinized starch is present in an amount of about 15-60%.
Claim 14
Dependent Claim
29 words
The admixture of claim 11, wherein the compressible starch is present in an amount of about 75% and the pregelatinized starch is present in an amount of about 25%.
Claim 15
Dependent Claim
56 words
The admixture of claim 12, wherein the acid-treated starch has a water fluidity of at least 60, wherein the enzyme-treated starch produces at least about 3.5% reducing sugars during the treatment, and wherein acid/enzyme-treated or enzyme/acid-treated starch has a water fluidity of at least 60 or produces at least about 3.5% reducing sugars during the treatment.
Claim 16
Dependent Claim
47 words
The admixture of claim 13, wherein the production of at least about 3.5% reducing sugars in the enzyme treatment relates to a Brabender viscosity reduction of at least about 35% under the peak or final Brabender viscosity of the nontreated granular starch base, whichever reduction is greater.
Claim 17
Dependent Claim
60 words
The admixture of claim 14, wherein the acid-converted starch has a water fluidity of about 80 or above, wherein the enzyme-treated starch has a Brabender viscosity about 45% less than that of the non-treated granular starch, and wherein the acid/enzyme-treated starch has a water fluidity of at least 80 or produces at least about 14% reducing sugars during the treatment.
Claim 18
Dependent Claim
28 words
The admixture of claim 15, wherein the enzyme-treated corn starch has a reduction in final Brabender viscosity and the treated waxy corn has a reduction in peak viscosity.
Claim 19
Dependent Claim
32 words
The non-friable, hard tablet prepared by direct compression or dry granulation, which comprises a tabletting mixture of an active ingredient and an effective amount of the compressible starch binder of claim 1.
Claim 20
Dependent Claim
26 words
The capsule, which comprises plugs of a dry capsule mixture of an active ingredient and an effective amount of the compressible starch binder of claim 1.
Claim 21
Dependent Claim
32 words
The non-friable, hard tablet prepared by direct compression or dry or wet granulation, which comprises a tabletting mixture of an active ingredient and an effective amount of the admixture of claim 8.
Claim 22
Dependent Claim
24 words
The capsule, which comprises plugs of a dry capsule mixture of an active ingredient and an effective amount of the admixture of claim 8.
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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) | 1988-11-04 | 1989-05-06 | 1989-11-05 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-11-04 | 1993-05-06 | 1993-11-05 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-11-04 | 1997-05-06 | 1997-11-05 | $7700.00 | Window Closed / Lapsed |