WO2003061633B1 - Non-gelatin capsule shell formulation comprising iota-carrageenan and kappa-carrageenan - Google Patents

Non-gelatin capsule shell formulation comprising iota-carrageenan and kappa-carrageenan

Info

Publication number
WO2003061633B1
WO2003061633B1 PCT/US2003/001134 US0301134W WO03061633B1 WO 2003061633 B1 WO2003061633 B1 WO 2003061633B1 US 0301134 W US0301134 W US 0301134W WO 03061633 B1 WO03061633 B1 WO 03061633B1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
weight
amount
carrageenan
film
Prior art date
Application number
PCT/US2003/001134
Other languages
French (fr)
Other versions
WO2003061633A1 (en
Inventor
Linus G Fonkwe
Don A Archibald
Aristippos Gennadios
Original Assignee
Banner Pharmacaps Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Banner Pharmacaps Inc filed Critical Banner Pharmacaps Inc
Priority to JP2003561578A priority Critical patent/JP2005529066A/en
Priority to EP03731918A priority patent/EP1474115B1/en
Priority to AT03731918T priority patent/ATE459344T1/en
Priority to MXPA04006914A priority patent/MXPA04006914A/en
Priority to DE60331524T priority patent/DE60331524D1/en
Priority to CA2473312A priority patent/CA2473312C/en
Priority to AU2003237365A priority patent/AU2003237365B2/en
Publication of WO2003061633A1 publication Critical patent/WO2003061633A1/en
Publication of WO2003061633B1 publication Critical patent/WO2003061633B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material

Abstract

A film-forming hydrocolloid composition comprising kappa carrageenan, iota carrageenan, a bulking agent, plasticizer and water is described. The ratio of bulking agent to total carrageenan is from about 1:1 to 20:1. Kappa carrageenan is present in an amount of less than or equal to 50% by weight of total carrageenan present. To form the composition, all dry materials are mixed and added to a heated mixture of all liquid materials. The final mixture is heated until a composition free of particulate materials is formed. The formed composition can be cast or extruded into ribbons, films, sheets, tubes or the like, for encapsulating wet or dry materials including medicinal dosage forms, nutritional supplements, cosmetics, bath oils and gels, and paint balls.

Claims

AMENDED CLAIMS
[received by the International Bureau on 10 September 2003 (10.09.03); original claims 1, 5, 17, 24, 26, 39, 46, 62, 70-72, 76, 77 and 84 amended; claims 4 and 25 cancelled; new claims 86-99 added; remaining claims unchanged
1. A film-forming composition comprising: a) iota carrageenan in an amount of from about 1% to about 15% by weight of the composition; b) kappa carrageenan in an amount less than 100% by weight of the iota carrageenan; c) a bulking agent, wherein the ratio of bulking agent to the combined total of iota and kappa carrageenan is from about 1 : 1 to about 20: 1 ; d) a plasticizer in an amount of from about 10% to about 50% by weight of the composition; and e) water.
2. The composition of claim 1 wherein the water is distilled.
3. The composition of claim 1, wherein the water is purified.
4. (Canceled)
5. The composition of claim 1 , wherein the total amount of all carrageenan is less than or equal to about 20% by weight of the composition.
6. The composition of claim 1, wherein the kappa carrageenan is present in an amount of from 0.1% to about 15% by weight of the composition.
7. The composition of claim 1, wherein the kappa carrageenan is present in an amount of from about 0.5% to about 7.5% by weight of the composition.
33
8. The composition of claim 1, wherein the iota carrageenan is present in an amount of between about 2.3% and about 10.0% by weight of the composition.
9. The composition of claim 1 , wherein the total amount of all carrageenan is less than or equal to about 20% by weight of the composition.
10. The composition of claim 1, wherein the total amount of all carrageenan is less than or equal to about 10% by weight of the composition.
11. The composition of claim 1, wherein the ratio of bulking agent to total carrageenan is from about 2:1 to about 15:1.
12. The composition of claim U wherein the water is presenting an amount of from about 10% to about 90% by weight of the composition.
13. The composition of claim 1, wherein the bulking agent is a modified starch.
14. The composition of claim 1, wherein the bulking agent is an esterified starch.
15. The composition of claim 1 wherein the plasticizer is selected from the group consisting of sorbitol, non-crystallizing sorbitol, maltitol, glycerin, polyethylene glycol, and combinations thereof.
16. The composition of claim 1, wherein the viscosity is from about 100 cP to about 1200 cP.
17. A wet ribbon comprising the film-forming composition of claim 1 having a moisture content of at least about 20%.
18. A dry ribbon comprising the film-forming composition of claim 1, having a moisture content of between about 5% and about 20%.
19. The dry ribbon of claim 18, wherein the tensile strength at rupture is between about 5 N and about 40 N.
34
20. The dry ribbon of claim 18, wherein the extensibility at rupture is from about 20 ram to about 80 mm.
21. The dry ribbon of claim 18, wherein the solids content if from about 80% to about 95% by weight of the dry ribbon.
22. A capsule made with the wet ribbon of claim 17.
23. A capsule made with the dry ribbon of claim 18.
24. A film-forming composition comprising: a) iota carrageenan in an amount of from about 1% to about 15% by weight of the composition; b) kappa carrageenan in an amount less than 100% by weight of the iota carrageenan; c) a bulking agent in an amount of from about 10% to about 60% by weight of the composition; d) a plasticizer in an amount of from about 10% to about 50% by weight of the composition; and e) water.
25. (Canceled)
26. (Amended) The composition of claim 24, wherein the total amount of all carrageenan is less than or equal to about 20% by weight of the composition.
27. The composition of claim 24, wherein the kappa carrageenan is present in an amount of from about 0.1% to about 15% by weight of the composition.
28. The composition of claim 24, wherein the kappa carrageenan is present in an amount of from about 0.5% to about 7.5% by weight of the composition.
29. The composition of claim 24, wherein the water is present in an amount of from about 10% to about 90% by weight of the composition.
30. The composition of claim 24, wherein the iota carrageenan is present in an amount of from about 2.3% to about 10% by weight of the composition.
31. The composition of claim 24, wherein the total amount of all carrageenan is less than or equal to about 20% by weight of the composition.
32. The composition of claim 24, wherein the total amount of all carrageenan is less than or equal to about 10% by weight of the composition.
33. The composition of claim 24, wherein the bulking agent is a modified starch.
34. The composition of claim 24, wherein the bulking agent is an esterified starch.
35. The composition of claim 24, wherein the plasticizer is selected from the group consisting of sorbitol, non-crystallizing sorbitol, maltitol, glycerin, polyethylene glycol, and combinations thereof.
36. The composition of claim 24, wherein the water is distilled.
37. The composition of claim 24, wherein the water is purified.
38. The composition of claim 24, wherein the viscosity is from about 100 cP to about 1200 cP.
39. A wet ribbon comprising the film-forming composition of claim 24 having a moisture content of at least about 20%.
36
85. A capsule made with the ribbon of claim 84.
86. A film-forming composition comprising from about 80% to about 95% by weight of solids and the remainder being about 20% to about 5% water, wherein the solids comprise by weight: iota carrageenan in an amount in the range of from about 2% to about 20% of the total composition; kappa carrageenan in an amount that is (i) in the range of from about 0.4% to about 20% of the total composition and (ii) less than 100% of the amount of the iota carrageenan; a bulking agent in an amount in the range of from about 10% to about 80% of the total composition; and a plasticizer in an amount in the range of from about 15% to about 40% of the total composition.
87. The film-forming composition of Claim 86 wherein the iota carrageenan is present in an amount in the range of from about 2.5% to about 10% of the total composition; the kappa carrageenan is present in an amount in the range of from about 0.5% to about 10% of the total composition; and the bulking agent is present in an amount in the range of from about 40% to about 70% of the total composition.
88. A capsule which comprises the film-forming composition of Claim 86.
89. The capsule of Claim 88, wherein the capsule is an encapsulated dosage form having a shell that comprises the film-forming composition, the encapsulated dosage form being selected from a softgel dosage form and a caplet dosage form.
37
90. The film-forming composition of Claim 86, wherein the plasticizer is selected from the group consisting of sorbitol, non-crystallizing sorbitol, maltitol, glycerin, polyethylene glycol, and combinations thereof.
91. The film-forming composition of Claim 86, wherein the bulking agent is a modified starch.
92. The film-forming composition of Claim 86, wherein the bulking agent is an esterified starch.
93. The method of Claim 76, wherein the mixture of iota carrageenan, kappa carrageenan, bulking agent, plasticizer and water are heated with stirring to a temperature of from about 85"C to about 95°C before adding them to the extruder.
94. A film-forming composition of Claim 1 in the form of a uniform dispersion in the shape of a film, ribbon, sheet or tube.
95. A film-forming composition of Claim 94, wherein said uniform dispersion has a solids content in the range of about 40% to about 90% by weight.
96. A film-forming composition of Claim 95, wherein said uniform dispersion has a solids content in the range of about 50% to about 80% by weight.
97. A film-forming composition of Claim 24 in the form of a uniform dispersion in the shape of a film, ribbon, sheet or tube.
98. A film-forming composition of Claim 97, wherein the uniform dispersion has a solids content in the range of about 40% to about 90% by weight.
99. A film-forming composition of Claim 98, wherein the uniform dispersion has a solids content in the range of about 50% to about 80% by weight.
38
PCT/US2003/001134 2002-01-18 2003-01-15 Non-gelatin capsule shell formulation comprising iota-carrageenan and kappa-carrageenan WO2003061633A1 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
JP2003561578A JP2005529066A (en) 2002-01-18 2003-01-15 Non-gelatin capsule skin composition containing iota carrageenan and kappa carrageenan
EP03731918A EP1474115B1 (en) 2002-01-18 2003-01-15 Process for preparing a formulatin for non-gelatin capsule shell comprising iota-carrageenan and kappa-carrageenan
AT03731918T ATE459344T1 (en) 2002-01-18 2003-01-15 METHOD FOR PRODUCING A GELATIN-FREE CAPSULE SHELL FORMULATION WITH IOTA-CARRAGEENAN AND KAPPA-CARRAGEENAN
MXPA04006914A MXPA04006914A (en) 2002-01-18 2003-01-15 Non-gelatin capsule shell formulation comprising iota-carrageenan and kappa-carrageenan.
DE60331524T DE60331524D1 (en) 2002-01-18 2003-01-15 METHOD FOR PRODUCING A GELATINE-FREE CAPSULE SHELL FORMULATION WITH IOTA CARRAGEENAN AND KAPPA CARRAGEENAN
CA2473312A CA2473312C (en) 2002-01-18 2003-01-15 Non-gelatin capsule shell formulation comprising iota-carrageenan and kappa-carrageenan
AU2003237365A AU2003237365B2 (en) 2002-01-18 2003-01-15 Non-gelatin capsule shell formulation comprising iota-carrageenan and kappa-carrageenan

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/051,201 2002-01-18
US10/051,201 US6949256B2 (en) 2002-01-18 2002-01-18 Non-gelatin capsule shell formulation

Publications (2)

Publication Number Publication Date
WO2003061633A1 WO2003061633A1 (en) 2003-07-31
WO2003061633B1 true WO2003061633B1 (en) 2003-12-18

Family

ID=21969929

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/001134 WO2003061633A1 (en) 2002-01-18 2003-01-15 Non-gelatin capsule shell formulation comprising iota-carrageenan and kappa-carrageenan

Country Status (10)

Country Link
US (2) US6949256B2 (en)
EP (1) EP1474115B1 (en)
JP (1) JP2005529066A (en)
CN (1) CN100467065C (en)
AT (1) ATE459344T1 (en)
AU (1) AU2003237365B2 (en)
CA (1) CA2473312C (en)
DE (1) DE60331524D1 (en)
MX (1) MXPA04006914A (en)
WO (1) WO2003061633A1 (en)

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CN100467065C (en) 2009-03-11
US20030138482A1 (en) 2003-07-24
ATE459344T1 (en) 2010-03-15
US6949256B2 (en) 2005-09-27
CA2473312C (en) 2010-02-23
MXPA04006914A (en) 2006-03-16
JP2005529066A (en) 2005-09-29
CA2473312A1 (en) 2003-07-31
DE60331524D1 (en) 2010-04-15
WO2003061633A1 (en) 2003-07-31
AU2003237365B2 (en) 2007-05-31
US20060029660A1 (en) 2006-02-09
EP1474115A1 (en) 2004-11-10
EP1474115B1 (en) 2010-03-03

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