US5266333A
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US
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Water dispersible and water soluble carbohydrate polymer compositions for parenteral administration of growth hormone
Assignee: Wyeth Holdings LLC
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Filing: 1989-08-30
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Granted: 1993-11-30
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Expires: 2009-08-30
Abstract
Abstract The present invention relates to compositions of water dispersible and water soluble carbohydrate polymers and biologically active macromolecules of growth hormones, somatomedins, growth factors, and other biologically active fragments which are suitable for parenteral administration. The present invention also relates to a method for increasing and for maintaining increased levels of growth hormone in the blood of treated animals for extended periods of time, increasing weight gains in animals, and increasing milk production of lactating animals by the administration of the compositions of the invention.
Inventors
- 👤 Susan M. Cady
- 👤 Richard Fishbein
- 👤 Ulf Schroder
- 👤 Hakan Eriksson
- 👤 Brenda L. Probasco
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-04 05:24
CPC Classifications
A; A61; A61K; A61K47/00; A61K47/30; A61K47/36; A61K47/50; A61K47/51; A61K47/56; A61K47/61; A61K9/00; A61K9/0012; A61K9/0019; Y; Y10; Y10S; Y10S530/00; Y10S530/81; Y10S530/812; Y10S530/813; Y10S530/814
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
112 words
A biologically active slow release composition which comprises a homogenous mixture of a water soluble carbohydrate polymer or a water dispersible carbohydrate polymer, a growth promoting effective amount or a milk production enhancing effective amount of a biologically active macromolecule and an aqueous or a pharmaceutically acceptable water miscible organie solvent; wherein said macromolecule is a growth hormone, a somatomedin or a biologically active fragment thereof; with the proviso that the weight ratio of the carbohydrate polymer to said macromolecule is in the range of 0.25:1.0 to 100:1.0 and the weight ration of the aqueous or pharmaceutically acceptable water miscible solvent to carbohydrate polymer is in the range of 0.83:1.0 to 50:1.0.
Claim 2
Dependent Claim
112 words
A biologically active slow release composition which comprises a homogenous mixture of a water soluble carbohydrate polymer or a water dispersible carbohydrate polymer, a growth promoting effective amount or a milk production enhancing effective amount of a biologically active macromolecule and an aqueous or a pharmaceutically acceptable water miscible organie solvent; wherein said macromolecule is a growth hormone, a somatomedin or a biologically active fragment thereof; with the proviso that the weight ratio of the carbohydrate polymer to said macromolecule is in the range of 0.25:1.0 to 100:1.0 and the weight ration of the aqueous or pharmaceutically acceptable water miscible solvent to carbohydrate polymer is in the range of 0.83:1.0 to 50:1.0.
Claim 3
Dependent Claim
20 words
The composition according to claim 1, wherein the biologically active macromolecule is bound to the carbohydrate polymer forming a complex.
Claim 4
Dependent Claim
20 words
The composition according to claim 2, wherein the mixture further contains a hydrophobic dissociating substance or a hydrophilic dissociating substance.
Claim 5
Dependent Claim
16 words
The composition according to claim 1, wherein the solvent is an aqueous buffered solution or saline.
Claim 6
Dependent Claim
16 words
The composition according to claim 2, 3 or 4, wherein the carbohydrate is starch or dextran.
Claim 7
Dependent Claim
60 words
The composition according to claim 4, wherein the carbohydrate polymer is dextran, dextrin, alginate, starch, fractionated starch, glycogen, pullullan, agarose, cellulose, chitosan, carrageenan, synthetic biopolymer, xanthan gum, guar gum, locust bean gum, gum arabic, tragacanth gum, karaya gum or a mixture thereof; and the growth hormone is bovine growth hormone, ovine growth hormone, equine growth hormone or porcine growth hormone.
Claim 8
Dependent Claim
29 words
The composition according to claim 6, wherein the carbohydrate polymer is dextrin; the growth hormone is bovine growth hormone and the solvent is water or an aqueous buffered solution.
Claim 9
Dependent Claim
29 words
The composition according to claim 6, wherein the carbohydrate polymer is a heteropolysaccharide of glucose, galactose, mannose, glucuronic acid and fucose and the growth hormone is bovine growth hormone.
Claim 10
Dependent Claim
24 words
The composition according to claim 6, wherein the mixture of carbohydrate polymers is a mixture of xanthan gum and locust bean gum and hormone.
Claim 11
Dependent Claim
102 words
A biologically active slow release composition which comprises an aqueous solution, a complex of a growth promoting effective amount or a milk production enhancing effective amount of a biologically active macromolecule selected from the group consisting of a growth hormone, a somatomedin and a biologically active fragment thereof bound to a water soluble or water dispersible carbohydrate polymer; with the proviso that the weight ratio of the carbohydrate polymer to said macromolecule is in the range of 0.25:1.0 to 100:1.0 and the weight ratio of the water of the aqueous solution to carbohydrate polymer is in the range of 0.83:1.0 to 50:1.0.
Claim 12
Dependent Claim
102 words
A biologically active slow release composition which comprises an aqueous solution, a complex of a growth promoting effective amount or a milk production enhancing effective amount of a biologically active macromolecule selected from the group consisting of a growth hormone, a somatomedin and a biologically active fragment thereof bound to a water soluble or water dispersible carbohydrate polymer; with the proviso that the weight ratio of the carbohydrate polymer to said macromolecule is in the range of 0.25:1.0 to 100:1.0 and the weight ratio of the water of the aqueous solution to carbohydrate polymer is in the range of 0.83:1.0 to 50:1.0.
Claim 13
Independent Claim
116 words
A method of preparing a biologically active slow release composition comprising mixing a growth promoting effective amount or a milk production enhancing effective amount of a biologically active macromolecule selected from the group consisting of a growth hormone, a somatomedin and a biologically active fragment thereof with a water soluble or water dispersible carbohydrate polymer in an aqueous solvent without forming a covalent bond between said biologically active macromolecule and said carbohydrate polymer, wherein the weight ratio of the carbohydrate polymer to said macromolecule is in the range of 0.25:1.0 to 100:1.0 and the weight ratio of the aqueous solvent to carbohydrate polymer is in the range of 0.83:1.0 to 50:1.0, thereby obtaining a homogenous mixture.
Claim 14
Independent Claim
116 words
A method of preparing a biologically active slow release composition comprising mixing a growth promoting effective amount or a milk production enhancing effective amount of a biologically active macromolecule selected from the group consisting of a growth hormone, a somatomedin and a biologically active fragment thereof with a water soluble or water dispersible carbohydrate polymer in an aqueous solvent without forming a covalent bond between said biologically active macromolecule and said carbohydrate polymer, wherein the weight ratio of the carbohydrate polymer to said macromolecule is in the range of 0.25:1.0 to 100:1.0 and the weight ratio of the aqueous solvent to carbohydrate polymer is in the range of 0.83:1.0 to 50:1.0, thereby obtaining a homogenous mixture.
Claim 15
Dependent Claim
42 words
The method according to claim 11, further comprising the step of adding a hydrophobic dissociating substance or a hydrophilic dissociating substance in the mixing step when said mixing step creates a noncovalent bond between the biologically active macromolecule and the carbohydrate polymer.
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| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1996-11-29 | 1997-05-31 | 1997-11-30 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2000-11-29 | 2001-05-31 | 2001-11-30 | $3760.00 | Window Closed / Lapsed |
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