US4816568A
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US
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Stabilization of growth hormones
Assignee: International Minerals and Chemical Corp
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Filing: 1986-05-16
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Granted: 1989-03-28
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Expires: 2006-05-16
Abstract
Abstract Growth hormones are admixed with various stabilizers to provide for the decreased formation of insolubles and preservation of the soluble bioactivity of the growth hormone in aqueous environments. Examples of such stabilizers include certain polyols, amino acids, polymers of amino acids having a charged side group at physiological PH, and choline salts.
Inventors
- 👤 Edwin J. Hamilton, Jr.
- 👤 Bruce D. Burleigh
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 17:08
CPC Classifications
A; A61; A61K; A61K47/00; A61K47/06; A61K47/16; A61K47/18; A61K47/183; A61K38/00; A61K38/16; A61K38/17; A61K38/22; A61K38/27; A61K47/186; A61K47/26; A61K47/30; A61K47/34
Claims Analysis
Total Claims: 36
Claim 1
Independent Claim
148 words
A method for the stabilization of an animal growth hormone which provides for the decreased formation of insolubles and preservation of the soluble bioactivity of the growth hormone in an aqueous environment comprising mixing a growth hormone with an effective amount of a stabilizer to provide a stabilized growth promoting formulation wherein the stabilizer is selected from one or more of the following: (a) an amino acid selected from the group consisting of glycine, sarcosine, lysine or salts thereof, serine, arginine or salts thereof, betaine, N,N-dimethylglycine, aspartic acid or salts thereof, glutamic acid or salts thereof, and mixtures thereof; (b) a polymer of an amino acid having a charged side group at physiological pH; and (c) a choline derivative selected from the group consisting of choline chloride, choline dihydrogen citrate, choline bitartrate, choline bicarbonate, tricholine citrate, choline ascorbate, choline borate, choline gluconate, choline phosphate, di(choline)sulfate and dicholine mucate.
Claim 2
Independent Claim
148 words
A method for the stabilization of an animal growth hormone which provides for the decreased formation of insolubles and preservation of the soluble bioactivity of the growth hormone in an aqueous environment comprising mixing a growth hormone with an effective amount of a stabilizer to provide a stabilized growth promoting formulation wherein the stabilizer is selected from one or more of the following: (a) an amino acid selected from the group consisting of glycine, sarcosine, lysine or salts thereof, serine, arginine or salts thereof, betaine, N,N-dimethylglycine, aspartic acid or salts thereof, glutamic acid or salts thereof, and mixtures thereof; (b) a polymer of an amino acid having a charged side group at physiological pH; and (c) a choline derivative selected from the group consisting of choline chloride, choline dihydrogen citrate, choline bitartrate, choline bicarbonate, tricholine citrate, choline ascorbate, choline borate, choline gluconate, choline phosphate, di(choline)sulfate and dicholine mucate.
Claim 3
Dependent Claim
25 words
The method of claim 1, wherein said growth hormone is selected from the group consisting of ovine, human, equine, avian, porcine and bovine growth hormones.
Claim 4
Dependent Claim
13 words
The method of claim 2, wherein said growth hormone is bovine growth hormone.
Claim 5
Dependent Claim
29 words
The method of claim 1, wherein said amino acid is present in amounts of from about 2.5 to about 99 percent by weight of the stabilized growth promoting formulation.
Claim 6
Dependent Claim
11 words
The method of claim 1, wherein said amino acid is sarcosine.
Claim 7
Dependent Claim
32 words
The method of claim 1, wherein said polymers of an amino acid is present in amounts of from about 2.5 to about 99 percent by weight of the stabilized growth promoting formulation.
Claim 8
Dependent Claim
36 words
The method of claim 1, wherein said polymers of an amino acid is a polyamino acid selected from the group consisting of polylysine, polyaspartic acid, polyglutamic acid, polyarginine, polyhistidine, polyornithine and salts of said polyamino acids.
Claim 9
Dependent Claim
14 words
The method of claim 7, wherein said polyamino acid salt is poly DL-lysine HBr.
Claim 10
Dependent Claim
29 words
The method of claim 1, wherein said choline derivative is present in amounts of from about 2.5 to about 99 percent by weight of the stabilized growth promoting formulation.
Claim 11
Dependent Claim
12 words
The method of claim 1, wherein said choline derivative is choline chloride.
Claim 12
Independent Claim
123 words
A method for effecting growth promotion in animals comprising administering to the animal an effective amount of a stabilized growth promoting formulation comprising a growth hormone with a stabilizing amount of a stabilizer selected from one or more of the following: (a) an amino acid selected from the group consisting of glycine, sarcosine, lysine or salts thereof, serine, arginine or salts thereof, betaine, N,N-dimethylglycine, aspartic acid or salts thereof, glutamic acid or salts thereof, (b) a polymer of an amino acid having a charged side group at physiological pH; and (c) a choline derivative selected from the group consisting of choline chloride, choline dihydrogen citrate, choline bitartrate, choline bicarbonate, tricholine citrate, choline ascorbate, choline borate, choline gluconate, choline phosphate, di(choline)sulfate and dicholine mucate.
Claim 13
Independent Claim
123 words
A method for effecting growth promotion in animals comprising administering to the animal an effective amount of a stabilized growth promoting formulation comprising a growth hormone with a stabilizing amount of a stabilizer selected from one or more of the following: (a) an amino acid selected from the group consisting of glycine, sarcosine, lysine or salts thereof, serine, arginine or salts thereof, betaine, N,N-dimethylglycine, aspartic acid or salts thereof, glutamic acid or salts thereof, (b) a polymer of an amino acid having a charged side group at physiological pH; and (c) a choline derivative selected from the group consisting of choline chloride, choline dihydrogen citrate, choline bitartrate, choline bicarbonate, tricholine citrate, choline ascorbate, choline borate, choline gluconate, choline phosphate, di(choline)sulfate and dicholine mucate.
Claim 14
Dependent Claim
25 words
The method of claim 11, wherein said growth hormone is selected from the group consisting of ovine, equine, human, avian, porcine and bovine growth hormones.
Claim 15
Dependent Claim
13 words
The method of claim 12, wherein said growth hormone is bovine growth hormone.
Claim 16
Dependent Claim
29 words
The method of claim 11, wherein said amino acid is present in amounts of from about 2.5 to about 99 percent by weight of the stabilized growth promoting formulation.
Claim 17
Dependent Claim
11 words
The method of claim 11, wherein said amino acid is sarcosine.
Claim 18
Dependent Claim
32 words
The method of claim 11, wherein said polymer of an amino acid is present in amounts of from about 2.5 to about 99 percent by weight of the stabilized growth promoting formulation.
Claim 19
Dependent Claim
36 words
The method of claim 11, wherein said polymer of an amino acid is a polyamino acid selected from the group consisting of polylysine, polyaspartic acid, polyglutamic acid, polyarginine, polyhistidine, polyornithine and salts of said polyamino acids.
Claim 20
Dependent Claim
14 words
The method of claim 16, wherein said polyamino acid salt is poly DL-lysine HBr.
Claim 21
Dependent Claim
29 words
The method of claim 11, wherein said choline derivative is present in amounts of from about 2.5 to about 99 percent by weight of the stabilized growth promoting formulation.
Claim 22
Dependent Claim
12 words
The method of claim 13, wherein said choline derivative is choline chloride.
Claim 23
Dependent Claim
106 words
A stabilized growth promoting formulation comprising a growth hormone and a stabilizing amount of a stablizer selected from one or more of the following: (a) an amino acid selected from the group consisting of glycine, sarcosine, lysine or salts thereof, serine, arginine or salts thereof, betaine, N,N-dimethylglycine, aspartic acid or salts thereof, glutamic acid or salts thereof, (b) a polymer of an amino acid having a charged side group at physiological pH; and (c) a choline derivative selected from the group consisting of choline chloride, choline dihydrogen citrate, choline bitartrate, choline bicarbonate, tricholine citrate, choline ascorbate, choline borate, choline gluconate, choline phosphate, di(choline)sulfate and dicholine mucate.
Claim 24
Dependent Claim
106 words
A stabilized growth promoting formulation comprising a growth hormone and a stabilizing amount of a stablizer selected from one or more of the following: (a) an amino acid selected from the group consisting of glycine, sarcosine, lysine or salts thereof, serine, arginine or salts thereof, betaine, N,N-dimethylglycine, aspartic acid or salts thereof, glutamic acid or salts thereof, (b) a polymer of an amino acid having a charged side group at physiological pH; and (c) a choline derivative selected from the group consisting of choline chloride, choline dihydrogen citrate, choline bitartrate, choline bicarbonate, tricholine citrate, choline ascorbate, choline borate, choline gluconate, choline phosphate, di(choline)sulfate and dicholine mucate.
Claim 25
Dependent Claim
27 words
The stabilized growth formulation of claim 21, wherein said growth hormone is selected from the group consisting of ovine, porcine, equine, avian, human, and bovine growth hormones.
Claim 26
Dependent Claim
16 words
The stabilized growth promoting formulation of claim 21, wherein said growth hormone is bovine growth hormone.
Claim 27
Dependent Claim
32 words
The stabilized growth promoting formulation of claim 21, wherein said amino acid is present in amounts of from about 2.5 to about 99 percent by weight of the stabilized growth promoting formulation.
Claim 28
Dependent Claim
14 words
The stabilized growth promoting formulation of claim 21, wherein said amino acid is sarcosine.
Claim 29
Dependent Claim
35 words
The stabilized growth promoting formulation of claim 21, wherein said polymer of an amino acid is present in amounts of from about 2.5 to about 99 percent by weight of the stabilized growth promoting formulation.
Claim 30
Dependent Claim
39 words
The stabilized growth promoting formulation of claim 21, wherein said polymer of an amino acid is a polyamino and selected from the group consisting of polylysine, polyaspartic acid, polyglutamic acid, polyarginine, polyhistidine, polyornithine and salts of said polyamino acids.
Claim 31
Dependent Claim
17 words
The stabilized growth promoting formulation of claim 27, wherein said polyamino acid salt is poly DL-lysine HBr.
Claim 32
Dependent Claim
32 words
The stabilized growth promoting formulation of claim 21, wherein said choline derivative is present in amounts of from about 2.5 to about 99 percent by weight of the stabilized growth promoting formulation.
Claim 33
Dependent Claim
15 words
The stabilized growth promoting formulation of claim 21, wherein said choline derivative is choline chloride.
Claim 34
Dependent Claim
16 words
The stabilized growth promoting formulation of claim 21 wherein said formulation is in a dry state.
Claim 35
Dependent Claim
17 words
The stabilized growth promoting formulation of claim 21 wherein said formulation is dispersed in an aqueous solution.
Claim 36
Dependent Claim
17 words
The stabilized growth promoting formulation of claim 21 wherein said formulation is dissolved in an aqueous solution.
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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) | 1992-03-27 | 1992-09-26 | 1993-03-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-03-27 | 1996-09-26 | 1997-03-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-03-27 | 2000-09-26 | 2001-03-28 | $7700.00 | Window Closed / Lapsed |