WO1994007467B1 - Calcium polycarbophil sprinkle - Google Patents
Calcium polycarbophil sprinkleInfo
- Publication number
- WO1994007467B1 WO1994007467B1 PCT/US1993/009139 US9309139W WO9407467B1 WO 1994007467 B1 WO1994007467 B1 WO 1994007467B1 US 9309139 W US9309139 W US 9309139W WO 9407467 B1 WO9407467 B1 WO 9407467B1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- calcium polycarbophil
- powder particles
- oral pharmaceutical
- pharmaceutical composition
- excipient
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
Abstract
This invention is directed to pharmaceutical compositions of calcium polycarbophil (CPC) sprinkles. The CPC sprinkles contain very fine calcium polycarbophil powder, with smooth particles, and are processed with one or more excipients to produce a flowable, dispersible composition. For pediatric dosing, the CPC sprinkles are premixed with food and when placed in the mouth, its smooth and creamy consistency makes it easy to ingest without leaving a gritty mouthfeel.
Claims
1. An oral pharmaceutical composition, comprising: very fine calcium polycarbophil powder particles, said particles having smooth edges; and one or more excipients, wherein said oral pharmaceutical composition does not contain alginic acid and said calcium polycarbophil powder particles are processed with said one or more excipients to product a flowable, dispersible composition.
2. An oral pharmaceutical composition, comprising: very fine calcium polycarbophil powder particles, said particles having smooth edges; and an binder solution, wherein said oral pharmaceutical composition does not contain alginic acid and said calcium polycarbophil powder particles are processed with said binder solution to produce a flowable, dispersible composition.
3. The oral pharmaceutical composition of claim 2, wherein said binder is a member selected from the group consisting of sucrose, dextrose, invert sugar, mannitol and sorbitol.
4. The oral pharmaceutical composition of any one of claims 2 or 3, wherein said composition further comprises a sweetener.
5. The oral pharmaceutical composition of claim 2, wherein said composition has a ratio of binder to calcium polycarbophil of between 50:50 to 5:95.
6. An oral pharmaceutical composition, comprising: very fine calcium polycarbophil powder particles, said particles having smooth edges; and a dry excipient, said excipient having a structure which entraps and holds said very fine calcium polycarbophil powder particles, wherein said oral pharmaceutical composition does not contain alginic acid and said calcium polycarbophil powder particles are processed with said dry excipient to form a flowable, dispersible composition.
7. The oral pharmaceutical composition of claim 6, wherein said dry excipient is one or more members select from the group consisting of: a monosaccharide, a disaccharide, a polysaccharide, and a glucose polymer derived from starch.
8. The oral pharmaceutical composition of claim 7, wherein said dry excipient is spray-dried sorbitol.
9. The oral pharmaceutical composition of claim 6, wherein the weight of said dry excipient to calcium polycarbophil is from 0.5 to 5 times the weight of said calcium polycarbophil.
10. The oral pharmaceutical composition of claim 6, further comprising one or more bulking and function modifying excipients which improve the flowability of the composition and reduce the absorbability of ambient moisture of the composition.
11. The oral pharmaceutical composition of claim 10, wherein said bulking and function modifying excipient may form up to 50 wt% of the formulation.
12. The oral pharmaceutical composition of claim 10, wherein said bulking and function modifying excipient is one or more members of selected from the group consisting of a monosaccharide, a disaccharide, a polysaccharide, and a glucose polymer derived from starch.
13. An oral pharmaceutical composition, consisting essentially of: a flowable, dispersible composition formed by blending together (1) very fine calcium polycarbophil powder particles produced by milling calcium polycarbophil using an attritor mill to produce very fine calcium polycarbophil powder particles having smooth edges, with (2) a binder component comprising one or more members selected from the group consisting of sucrose, dextrose, fructose, invert sugar, mannitol, sorbitol, saccharin, aspartame and cyclamates and optionally with (3) an electrolyte component comprising one or more members select from the group consisting of sodium chloride and potassium chloride, and wherein the ratio of said very fine calcium polycarbophil powder particles to said binder is about 80:20, and said very fine calcium polycarbophil powder particles (1) and said binder component (2) are blended for a length of time effective to granulate and coat said very fine calcium polycarbophil powder particles with binder.
14. An oral pharmaceutical composition, consisting essentially of: a flowable, dispersible composition formed by blending together (1) very fine calcium polycarbophil powder particles produced by milling calcium polycarbophil using an attritor mill to produce very fine calcium polycarbophil powder particles having smooth edges; with (2) an entrapping excipient comprising one or more members select from the group consisting of a monosaccharide, a disaccharide, a polysaccharide, and polymer of a monosaccharide, a polymer of a disaccharide and a ploymer of a polysaccharide, said entrapping excipient forming a mesh¬ like structure such that said very fine calcium polycarbophil powder particles are entrapped within said mesh-like structure; and then blending the resultant blended (1) and (2) with (3) a bulking and function modifying excipient comprising one or more members selected from the group consisting of a monosaccharide, a disaccharide, a polysaccharide, and a glucose polymer derived from starch, and optionally with (4) a sweetener component comprising one or more sweeteners selected from the group consisting of sucrose, dextrose, fructose, invert sugar, mannitol, saccharin, aspartame and cyclamates, and optionally with (5) an electrolyte component comprising one or more members select from the group consisting of sodium chloride and potassium chloride.
15. The oral pharmaceutical composition of claim 14,
. . . ® wherein said entrapping excipient is SORBITOL INSTANT , and said bulking and function modifying excipient is
® ® maltodextrin M550 and CANTAB .
16. The oral pharmaceutical of claim 15, wherein said SORBITOL INSTANT ® i.s present m an amount from 0.5 to 5 times the weight of said very fine calcium polycarbophil powder particles.
17. A method for preparing an oral pharmaceutical composition, comprising: (a) mixing very fine calcium polycarbophil powder particles having smooth edges with a binder in a ratio of binder to calcium polycarbophil of between 50:50 to 5:95 for a time sufficient to granulate said calcium polycarbophil to form granulated polycarbophil powder particles; (b) passing said granulated calcium polycarbophil powder particles through a first screen having a first mesh size to form screened calcium polycarbophil powder particles;
(c) drying said screened calcium polycarbophil powder particles; and
(d) passing said dried calcium polycarbophil powder particles through a second screen having a second mesh size which is smaller than said first screen mesh size, wherein said calcium polycarbophil powder particles are not reacted with alginic acid.
W ©ED SHEET (ARTICLE 19)
18. A method for preparing an oral pharmaceutical composition, comprising: dry-blending very fine calcium polycarbophil powder particles having smooth edges, with a dry excipient having a structure which entraps and holds
5 said very fine calcium polycarbophil powder particles to form a flowable, dispersible composition.
19. The method of any one of claims 17 or 18, wherein said very fine calcium polycarbophil powder particles are
10 produced by first milling calcium polycarbophil using a attritor mill.
20. The method the claim 17, wherein said ratio of binder to calcium polycarbophil is 20:80.
15
21. The method of claim 17 wherein said drying step is conducted at a temperature of between 20 *C to about 50 °C for a period of up to 48 hours.
20 22. The method of claim 17, wherein said binder is selected from the group consisting of sucrose, dextrose, invert sugar, mannitol and sorbitol.
23. The method of claim 18, wherein said in bulking an 25 function modifying excipient are one or more members selected from the group consisting of: a monosaccharide, a disaccharide, a polysaccharide, and a glucose polymer derived from starch.
30 24. The method of claim 21, wherein said dry excipient is one or more members selected from the group consisting of: a monosaccharide, a disaccharide, a polysaccharide, a glucose polymer derived from starch, a polymer of a monosaccharide, a polymer of dissacharide and a polymer of a
35 polysaccarhide.
25. The method of claim 18, wherein said excipient of spray-dried sorbitol.
26. The method of claim 18 wherein the weight of said dry excipient to calcium polycarbophil is from 0.5 to 5 times the weight of said calcium polycarbophil.
27. The method of claim 18, further comprising: mixing the blend of calcium polycarbophil and dry excipient with one or more bulking and function modifying excipients which improve the flowability of the composition and reduce the absorbability of ambient moisture of the composition.
28. The method of claim 27, wherein said excipients may form up to 50 wt% percent of the formulation.
29. A method for treating a patient afflicted with diarrhea, comprising administering to said patient a therapeutically effective amount of the oral pharmaceutical composition of anyone of claims 1, 2, 6, 13 or 14.
STATEMENT UNDER ARTICLE 19
The substitute sheets present 29 claims, each of which is fully supported in the specification as filed, and none of which introduces new matter. The claims are now identical to the claims pending in corresponding U.S. Patent Application Serial No. 07/953,055. Original claims 2, 6, 10, 16, 17, 23 and 26 have been cancelled and rewritten. The remaining claims have been rewritten to correct claim dependencies and to more clearly set forth the present invention. Again, no new matter has been added.
Entry of the claims is respectfully requested.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP6509213A JPH08502073A (en) | 1992-09-30 | 1993-09-30 | Calcium polycarbophil sprinkle |
| EP93922397A EP0662821A4 (en) | 1992-09-30 | 1993-09-30 | Calcium polycarbophil sprinkle. |
| AU51408/93A AU5140893A (en) | 1992-09-30 | 1993-09-30 | Calcium polycarbophil sprinkle |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US95305592A | 1992-09-30 | 1992-09-30 | |
| US07/953,055 | 1992-09-30 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO1994007467A1 WO1994007467A1 (en) | 1994-04-14 |
| WO1994007467B1 true WO1994007467B1 (en) | 1994-04-28 |
Family
ID=25493510
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US1993/009139 Ceased WO1994007467A1 (en) | 1992-09-30 | 1993-09-30 | Calcium polycarbophil sprinkle |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US5618527A (en) |
| EP (1) | EP0662821A4 (en) |
| JP (1) | JPH08502073A (en) |
| AU (1) | AU5140893A (en) |
| WO (1) | WO1994007467A1 (en) |
| ZA (1) | ZA937277B (en) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6916495B2 (en) * | 1999-02-24 | 2005-07-12 | Allan Taylor | Preparation for regulating lower bowel function |
| US7914811B2 (en) | 2001-06-29 | 2011-03-29 | Mcneil-Ppc, Inc. | Brittle-coating, soft core dosage form |
| TW200404557A (en) * | 2002-06-26 | 2004-04-01 | Fuji Yakuhin Co Ltd | A pharmaceutical composition for preventive and/or therepeutic treatment of constipation and symptom resulting from constipation |
| US20040180868A1 (en) * | 2003-03-12 | 2004-09-16 | Mullally John P. | Composition and method for treating inflammations by reducing C-reactive protein |
| US7207505B2 (en) * | 2004-06-04 | 2007-04-24 | Bender Martin P | Method for producing small granules |
| EP1845950A2 (en) * | 2005-02-03 | 2007-10-24 | Nycomed Pharma AS | Fast wet-massing method for the preparation of calcium-containing compositions |
| US20070048373A1 (en) * | 2005-08-30 | 2007-03-01 | Cima Labs Inc. | Dried milled granulate and methods |
| US9056050B2 (en) * | 2009-04-13 | 2015-06-16 | Curemark Llc | Enzyme delivery systems and methods of preparation and use |
| CN109258963A (en) * | 2018-09-18 | 2019-01-25 | 浙江汇能生物股份有限公司 | A kind of calcium polycarbophil stomach floating particle and the application on livestock and poultry |
| WO2021156184A1 (en) * | 2020-02-07 | 2021-08-12 | Dsm Ip Assets B.V. | New formulation of a plant extract |
| CN114767652B (en) * | 2022-04-22 | 2024-05-10 | 苏州中化药品工业有限公司 | Polycarbofil calcium dry suspension and preparation method and application thereof |
| CN115462506A (en) * | 2022-09-16 | 2022-12-13 | 郑州瑞普生物工程有限公司 | Soybean milk powder, preparation method thereof and application thereof in foods suitable for people with high blood pressure, high blood sugar and high blood sugar |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB709091A (en) * | 1952-08-14 | 1954-05-12 | Rohm & Haas | Improvements in or relating to dusting powders |
| US2909462A (en) * | 1955-12-08 | 1959-10-20 | Bristol Myers Co | Acrylic acid polymer laxative compositions |
| US3085936A (en) * | 1962-01-12 | 1963-04-16 | S B Penick & Company | Gastro-enteritis-diarrheal syndrome treatment |
| US3202577A (en) * | 1962-05-25 | 1965-08-24 | White Lab Inc | Process of treating diarrhea with resins |
| EP0273209B1 (en) * | 1986-12-30 | 1992-01-15 | American Cyanamid Company | Composition of matter containing polycarbophil |
| US5084278A (en) * | 1989-06-02 | 1992-01-28 | Nortec Development Associates, Inc. | Taste-masked pharmaceutical compositions |
| FR2661611B1 (en) * | 1990-05-04 | 1994-11-18 | Theramex | NOVEL PHARMACEUTICAL COMPOSITIONS BASED ON POLYCARBOPHIL AND PROCESS FOR OBTAINING SAME. |
| US5110605A (en) * | 1990-08-21 | 1992-05-05 | Oramed, Inc. | Calcium polycarbophil-alginate controlled release composition and method |
| JP2609022B2 (en) * | 1990-11-29 | 1997-05-14 | 北陸製薬株式会社 | Polycarbophil calcium-containing preparation |
| US5336486A (en) * | 1991-03-28 | 1994-08-09 | Theratech, Inc. | Appetite control method |
| DE9212938U1 (en) * | 1992-09-25 | 1992-11-26 | Boehringer Ingelheim Gmbh, 6507 Ingelheim | Calcium polycarbophil preparation for taking high doses of active ingredients |
-
1993
- 1993-09-30 WO PCT/US1993/009139 patent/WO1994007467A1/en not_active Ceased
- 1993-09-30 EP EP93922397A patent/EP0662821A4/en not_active Withdrawn
- 1993-09-30 AU AU51408/93A patent/AU5140893A/en not_active Abandoned
- 1993-09-30 ZA ZA937277A patent/ZA937277B/en unknown
- 1993-09-30 JP JP6509213A patent/JPH08502073A/en active Pending
-
1994
- 1994-05-11 US US08/240,820 patent/US5618527A/en not_active Expired - Fee Related
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