US4837381A
Expired / Lapsed
US
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Compositions for parenteral administration and their use
Assignee: Wyeth Holdings LLC
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Filing: 1987-07-31
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Granted: 1989-06-06
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Expires: 2007-07-31
Abstract
Abstract The invention is a microsphere composition of fat or wax or mixture thereof and a biologically active protein, peptide or polypeptide suitable for parenteral administration. The invention is also a slow release composition of fat or wax or mixture thereof and a biologically active protein, peptide or polypeptide suitable for parenteral administration. The invention also relates to methods for increasing and 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 compositions of the invention.
Inventors
- 👤 William Steber
- 👤 Richard Fishbein
- 👤 Susan M. Cady
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 01:13
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/14; A61K9/16; A61K9/1605; A61K9/1617; A23; A23K; A23K40/00; A23K40/30; A61K38/00; A61K38/16; A61K38/17; A61K38/22; A61K38/27
Claims Analysis
Total Claims: 34
Claim 1
Independent Claim
33 words
A microsphere composition comprising on a weight basis about 30% to 95% of a fat or wax or mixture thereof and about 2% to 70% of a biologically active protein, peptide or polypeptide.
Claim 2
Dependent Claim
33 words
A microsphere composition comprising on a weight basis about 30% to 95% of a fat or wax or mixture thereof and about 2% to 70% of a biologically active protein, peptide or polypeptide.
Claim 3
Dependent Claim
76 words
A microsphere composition according to claim 1 comprising on a weight basis about 40% to 95% of a wax or a fat or mixtures thereof; about 5% to 40% of a growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; 0% to about 20% of surfactant, preservative, stabilizer, salt, buffer or mixture thereof; wherein the weight average particle size of the microsphere composition is in a range of 25 microns to 300 microns.
Claim 4
Dependent Claim
18 words
A microsphere composition according to claim 2 wherein the growth hormone is bovine, porcine or avian growth hormone.
Claim 5
Dependent Claim
27 words
A microsphere composition according to claim 3 comprising on a weight basis about 20% to 40% of bovine growth hormone; and about 55% to 79% glyceryl tristearate.
Claim 6
Dependent Claim
21 words
A microsphere composition according to claim 4 for parenteral administration and slow release in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 7
Dependent Claim
40 words
A microsphere composition comprising on a weight basis about 20% to 40% bovine growth hormone; about 55% to 79% glyceryl tristearate; 0 to about 0.2% microbiological preservative; 0 to about 1% non-ionic surfactant; and 0 to about 2% sodium benzoate.
Claim 8
Dependent Claim
40 words
A microsphere composition comprising on a weight basis about 20% to 40% bovine growth hormone; about 55% to 79% glyceryl tristearate; 0 to about 0.2% microbiological preservative; 0 to about 1% non-ionic surfactant; and 0 to about 2% sodium benzoate.
Claim 9
Independent Claim
65 words
A method for increasing milk production in lactating animals comprising parenterally administering to the animal a microsphere composition comprising on a weight basis about 30% to 95% fat or wax or mixtures thereof; and about 2% to 70% of a growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; wherein the microsphere is dispersed in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 10
Independent Claim
65 words
A method for increasing milk production in lactating animals comprising parenterally administering to the animal a microsphere composition comprising on a weight basis about 30% to 95% fat or wax or mixtures thereof; and about 2% to 70% of a growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; wherein the microsphere is dispersed in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 11
Dependent Claim
66 words
A method according to claim 7 wherein the microsphere comprises on a weight basis about 40% to 95% of a wax or fat or mixtures thereof; about 5% to 40% of animal growth hormone, 0% to about 20% of surfactant, preservative, stabilizer, salt, buffer or mixture thereof and the weight average particle size of the microspheres is in a range of 25 microns to 300 microns.
Claim 12
Dependent Claim
42 words
A method according to claim 8 wherein the microsphere comprises on a weight basis about 20% to 40% of bovine growth hormone; about 55% to 79% glyceryl tristearate and the microsphere vehicle is a neutral mono-, di-, triglyceride liquid or mixtures thereof.
Claim 13
Independent Claim
64 words
A method for increasing weight gains in animals comprising parenterally administering to the animal a microsphere composition comprising on a weight basis about 30% to 95% fat or wax or mixtures thereof; and about 2% to 70% of a growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; wherein the microsphere is dispersed in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 14
Independent Claim
64 words
A method for increasing weight gains in animals comprising parenterally administering to the animal a microsphere composition comprising on a weight basis about 30% to 95% fat or wax or mixtures thereof; and about 2% to 70% of a growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; wherein the microsphere is dispersed in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 15
Dependent Claim
64 words
A method according to claim 10 wherein the microsphere comprises on a weight basis about 40% to 95% of fat or wax or mixtures thereof; about 5% to 40% of animal growth hormone; 0% to about 20% surfactant, preservative, stabilizer, salt, buffer or mixture thereof; and the weight average particle size of the microspheres is in a range of 25 microns to 300 microns.
Claim 16
Dependent Claim
43 words
A method according to claim 11 wherein the microsphere comprises on a weight basis about 20% to 40% of bovine growth hormone; about 55% to 79% glyceryl tristearate; and the microsphere vehicle is a neutral mono-, di-, or triglyceride liquid or mixtures thereof.
Claim 17
Independent Claim
95 words
A method for elevating and maintaining elevated blood levels of a biologically active protein, peptide or polypeptide, improving feed efficiency, increasing growth rate, increasing muscle size, decreasing body fat and improving lean meat to fat ratio in an animal comprising parenterally administering to the animal a microsphere composition comprising on a weight basis about 30% to 95% fat or wax or mixtures thereof; and about 2% to 70% of a growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; wherein the microsphere is dispersed in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 18
Independent Claim
95 words
A method for elevating and maintaining elevated blood levels of a biologically active protein, peptide or polypeptide, improving feed efficiency, increasing growth rate, increasing muscle size, decreasing body fat and improving lean meat to fat ratio in an animal comprising parenterally administering to the animal a microsphere composition comprising on a weight basis about 30% to 95% fat or wax or mixtures thereof; and about 2% to 70% of a growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; wherein the microsphere is dispersed in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 19
Dependent Claim
67 words
A method according to claim 13 wherein the microsphere comprises on a weight basis about 40% to 95% of a wax or a fat or mixtures thereof; about 5% to 40% of animal growth hormone; 0% to about 20% of surfactant preservative, stabilizer, salt, buffer or mixture thereof and the weight average particle size of the microspheres is in a range of 25 microns to 300 microns.
Claim 20
Dependent Claim
43 words
A method according to claim 14 wherein the microsphere comprises on a weight basis about 20% to 40% of bovine growth hormone; about 55% to 79% glyceryl tristearate; and the microsphere vehicle is a neutral mono-, di-, or triglyceride liquid or mixtures thereof.
Claim 21
Dependent Claim
29 words
A slow release composition comprising a fat or wax or mixture thereof and a biologically active protein, peptide or polypeptide dispersed in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 22
Dependent Claim
29 words
A slow release composition comprising a fat or wax or mixture thereof and a biologically active protein, peptide or polypeptide dispersed in a pharmaceutically and pharmacologically acceptable liquid vehicle.
Claim 23
Dependent Claim
72 words
A composition according to claim 16 characterized by heating about 1% to 30% of growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; about 5% to 60% of fat or wax or mixtures thereof; 0% to about 15% of surfactant, preservative, stabilizer, salt, buffer or mixture thereof; and sufficient oil to total 100% to obtain a homogeneous mixture; and cooling said mixture to ambient temperature to form said composition.
Claim 24
Dependent Claim
17 words
A composition according to claim 17 wherein the growth hormone is bovine, porcine or avian growth hormone.
Claim 25
Dependent Claim
53 words
A composition according to claim 18 comprising on a weight basis about 5% to 27% of bovine growth hormone; about 10% to 48% of glyceryl tristearate; 0% to about 0.2% microbiological preservative and 0% to about 1% non-ionic surfactant; and sufficient neutral mono-, di-, or triglyceride liquid or mixtures thereof to total 100%.
Claim 26
Independent Claim
87 words
A method for increasing milk production in lactating animals comprising parenterally administering to the animal a biologically active slow release composition characterized by heating about 1% to 30% of growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; about 5% to 60% of fat or wax or mixtures thereof; 0% to about 15% of surfactant, preservative, stabilizer, salt, buffer or mixture thereof; and sufficient oil to total 100% to obtain a homogeneous mixture; and cooling said mixture to ambient temperature to form said composition.
Claim 27
Independent Claim
87 words
A method for increasing milk production in lactating animals comprising parenterally administering to the animal a biologically active slow release composition characterized by heating about 1% to 30% of growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; about 5% to 60% of fat or wax or mixtures thereof; 0% to about 15% of surfactant, preservative, stabilizer, salt, buffer or mixture thereof; and sufficient oil to total 100% to obtain a homogeneous mixture; and cooling said mixture to ambient temperature to form said composition.
Claim 28
Dependent Claim
60 words
A method for increasing milk production in animals according to claim 20 wherein the composition comprises on a weight basis about 5% to 27% bovine growth hormone; about 10% to 48% glyceryl tristearate; 0% to about 0.2% microbiological preservative and 0% to about 1% non-ionic surfactant; and sufficient neutral mono-, di-, or triglyceride liquid or mixtures thereof to total 100%.
Claim 29
Independent Claim
84 words
A method for increasing weight gains comprising parenterally administering to the animal a biologically active slow release composition characterized by heating about 1% to 30% of growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; about 5% to 60% of fat or wax or mixtures thereof; 0% to about 15% of surfactant, preservative, stabilizer, salt, buffer or mixture thereof; and sufficient oil to total 100% to obtain a homogeneous mixture; and cooling said mixture to ambient temperature to form said composition.
Claim 30
Independent Claim
84 words
A method for increasing weight gains comprising parenterally administering to the animal a biologically active slow release composition characterized by heating about 1% to 30% of growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; about 5% to 60% of fat or wax or mixtures thereof; 0% to about 15% of surfactant, preservative, stabilizer, salt, buffer or mixture thereof; and sufficient oil to total 100% to obtain a homogeneous mixture; and cooling said mixture to ambient temperature to form said composition.
Claim 31
Dependent Claim
55 words
A method according to claim 22 wherein the composition comprises on a weight basis about 5% to 27% bovine growth hormone; about 10% to 48% of glyceryl tristearate; 0% to about 0.2% microbiological preservative and 0% to about 1% non-ionic surfactant; and sufficient neutral mono-, di, or triglyceride liquid or mixtures thereof to total 100%.
Claim 32
Independent Claim
117 words
A method for elevating and maintaining elevated blood levels of a biologically active protein, peptide or polypeptide, improving feed efficiency, increasing growth rate, increasing muscle size, decreasing body fat and improving lean meat to fat ratio in an animal comprising parenterally administering to the animal a biologically active slow release composition characterized by heating about 1% to 30% of growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; about 5% to 60% of fat or wax or mixtures thereof; 0% to about 15% of surfactant, preservative, stabilizer, salt, buffer or mixture thereof; and sufficient oil to total 100% to obtain a homogeneous mixture; and cooling said mixture to ambient temperature to form said composition.
Claim 33
Independent Claim
117 words
A method for elevating and maintaining elevated blood levels of a biologically active protein, peptide or polypeptide, improving feed efficiency, increasing growth rate, increasing muscle size, decreasing body fat and improving lean meat to fat ratio in an animal comprising parenterally administering to the animal a biologically active slow release composition characterized by heating about 1% to 30% of growth hormone, somatomedin, growth factor or biologically active fragment or derivative thereof; about 5% to 60% of fat or wax or mixtures thereof; 0% to about 15% of surfactant, preservative, stabilizer, salt, buffer or mixture thereof; and sufficient oil to total 100% to obtain a homogeneous mixture; and cooling said mixture to ambient temperature to form said composition.
Claim 34
Dependent Claim
55 words
A method according to claim 24 wherein the composition comprises on a weight basis about 5% to 27% bovine growth hormone; about 10% to 48% of glyceryl tristearate; 0% to about 0.2% microbiological preservative and 0% to about 1% non-ionic surfactant; and sufficient neutral mono-, di-, or triglyceride liquid or mixtures thereof to total 100%.
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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) | 1992-06-05 | 1992-12-05 | 1993-06-06 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-06-05 | 1996-12-05 | 1997-06-06 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-06-05 | 2000-12-05 | 2001-06-06 | $7700.00 | Window Closed / Lapsed |