EP0177478B1
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Prolonged release of biologically active somatotropins
Assignee: Monsanto Co
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Filing: 1985-10-03
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Granted: 1991-04-17
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Expires: 2005-10-03
Abstract
Abstract Non-aq. compsn. comprises at least 10wt.% of a biologically active polypeptide (I) and, as a continuous phase of the compsn., a biocompatible oil (II). Also claimed is a non-aq. compsn. of 15-40wt.% of a bovine somatotropin (Ia) chemically associated with zinc, 2-5wt.% of an aluminium mono- or di-stearate (IIIa) and, as a continuous phase of the compsn., a biocompatible vegetable oil. (Ia) has a particulate median vol. dia. of no greater than 5 microns and is present in a wt. ratio to the stearate of at least about 3. (Ia) chemically associated with non-toxic polyvalent metal is also new, pref. 0.3-2wt.% zinc.
Inventors
- 👤 James William Mitchell
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-30 04:56
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/16; A61K47/00; A61K47/06; A61K47/08; A61K47/12; A61K38/17; A61K38/22; A61K38/27; A61K47/44; A61K9/00; A61K9/0012; A61K9/0019
Claims Analysis
Total Claims: 41
Claim 1
Independent Claim
43 words
A substantially non-aqueous composition comprising a biologically active somatotropin and, as a continuous phase of said composition, a biocompatible oil, characterised in that the composition is for parenteral administration and the amount of somatotropin is at least 10% by weight of the composition.
Claim 2
Dependent Claim
43 words
A substantially non-aqueous composition comprising a biologically active somatotropin and, as a continuous phase of said composition, a biocompatible oil, characterised in that the composition is for parenteral administration and the amount of somatotropin is at least 10% by weight of the composition.
Claim 3
Dependent Claim
13 words
A composition of Claim 1 in which the somatotropin is a bovine somatotropin.
Claim 4
Dependent Claim
13 words
A composition of Claim 1 in which the somatotropin is a porcine somatotropin.
Claim 5
Dependent Claim
17 words
A composition of any of the previous claims in which the composition comprises at least 15% somatotropin.
Claim 6
Dependent Claim
18 words
A composition of any of the previous claims in which the composition comprises from 15% to 42% somatotropin.
Claim 7
Dependent Claim
17 words
A composition of any of the previous claims in which the composition comprises at least 20% somatotropin.
Claim 8
Dependent Claim
24 words
A composition of any of the previous claims in which the composition further comprises at least 1 % by weight of an antihydration agent.
Claim 9
Dependent Claim
27 words
A composition of Claim 7 in which the antihydration agent is an aluminum, calcium or magnesium salt of a fatty acid with from 8 to 22 carbons.
Claim 10
Dependent Claim
22 words
A composition of Claim 8 in which the fatty acid is selected from stearic acid, palmitic acid, lauric acid, and mixtures thereof.
Claim 11
Dependent Claim
23 words
A composition of Claim, 8 or 9 in which the weight ratio of the somatotropin to the antihydration agent is at least 1.
Claim 12
Dependent Claim
19 words
A composition of any of the previous claims in which the somatotropin is associated with a non-toxic metal ion.
Claim 13
Dependent Claim
27 words
A composition of Claim 11 in which the metal is selected from zinc, sodium, potassium, iron, calcium, bismuth, barium, magnesium, manganese, aluminum, copper, cobalt, nickel, and cadmium.
Claim 14
Dependent Claim
11 words
A composition of Claim 12 in which the metal is zinc.
Claim 15
Dependent Claim
13 words
A composition of Claim 12 in which the metal is sodium or potassium.
Claim 16
Dependent Claim
67 words
A composition of any of the previous claims having a syringeability of at least 0.03 milliliters per second, the syringeabilty being the volume of the composition in millilitres passing through a hyperdermic needle having an internal diameter of 0.838 mm and a length of 4 cm in one second when a pressure of 1193 kPa is applied to the composition in a syringe fitted with the needle.
Claim 17
Dependent Claim
23 words
A composition of any of the previous claims in which the somatotropin has a particulate median volume diameter no greater than 15 micrometres.
Claim 18
Dependent Claim
23 words
A composition of any of the previous claims in which the somatotropin has a particulate median volume diameter no greater than 10 micrometres.
Claim 19
Dependent Claim
36 words
A composition of any of the previous claims in which the oil is selected from corn oil, peanut oil, sesame oil, olive oil, palm oil, safflower oil, soybean oil, cottonseed oil, rapeseed oil, and mixtures thereof.
Claim 20
Dependent Claim
69 words
A substantially non-aqueous composition for parenteral administration comprising between 15% and 42% by weight of a bovine somatotropin; between 2% and 5% by weight of an aluminum mono- or distearate and, as a continuous phase of the composition, a biocompatible vegetable oil, said somatotropin having a particulate median volume diameter no greater than 10 micrometres and being present in a weight ratio to said stearate of at least 3.
Claim 21
Dependent Claim
69 words
A substantially non-aqueous composition for parenteral administration comprising between 15% and 42% by weight of a bovine somatotropin; between 2% and 5% by weight of an aluminum mono- or distearate and, as a continuous phase of the composition, a biocompatible vegetable oil, said somatotropin having a particulate median volume diameter no greater than 10 micrometres and being present in a weight ratio to said stearate of at least 3.
Claim 22
Dependent Claim
14 words
A composition of Claim 19 in which the somatotropin is chemically associated with zinc.
Claim 23
Dependent Claim
20 words
A composition of Claim 20 or 21 in which the particulate median volume diameter is no greater than 5 micrometres.
Claim 24
Dependent Claim
37 words
A composition of any of the previous claims for use in a method for achieving prolonged release of a biologically active somatotropin to the circulatory system of an animal to which the composition has been parenterally administered.
Claim 25
Dependent Claim
33 words
A composition of any of the previous claims for use in a method for enhancing lean-to-fat ratio, feed efficiency or milk production of an animal to which the composition has been parenterally administered.
Claim 26
Dependent Claim
19 words
A composition of Claim 22 or 23 in which the animal is selected from cattle, sheep, goats and swine.
Claim 27
Independent Claim
35 words
A method for achieving prolonged release of a biologically active somatotropin into the circulatory system of an animal which comprises parenteral administration to said animal of a composition of any of Claims 1 to 21.
Claim 28
Independent Claim
31 words
A method for enhancing lean-to-fat ratio, feed efficiency or milk production of an animal which comprises parenteral administration to said animal of a composition of any of Claims 1 to 21.
Claim 29
Independent Claim
47 words
A method of maintaining in a lactating cow an average plasma somatotropin concentration of at least 12 nanograms per milliliter for at least 7 days which comprises parenteral administration of a composition of any of Claims 1, 2 or 4 to 21 which contains a bovine somatotropin.
Claim 30
Independent Claim
19 words
A method of Claims 25 or 26 in which the animal is selected from cattle, sheep, goats and swine.
Claim 31
Independent Claim
90 words
A method for preparing a non-aqueous somatotropin composition comprising dispersing finely-divided, discrete particles of the somatotropin in a biocompatible oil in proportions such that the oil forms a continuous phase of the resulting dispersion and said dispersion contains at least 10% by weight of said somatotropin, and under conditions such that the resulting dispersion is substantially nonaqueous and the somatotropin in the resulting dispersion has a particulate median volume diameter not greater than 15 micrometres, said dispersing being carried out at temperatures compatible with the biological activity of the somatotropin.
Claim 32
Independent Claim
90 words
A method for preparing a non-aqueous somatotropin composition comprising dispersing finely-divided, discrete particles of the somatotropin in a biocompatible oil in proportions such that the oil forms a continuous phase of the resulting dispersion and said dispersion contains at least 10% by weight of said somatotropin, and under conditions such that the resulting dispersion is substantially nonaqueous and the somatotropin in the resulting dispersion has a particulate median volume diameter not greater than 15 micrometres, said dispersing being carried out at temperatures compatible with the biological activity of the somatotropin.
Claim 33
Dependent Claim
56 words
A method of Claim 29 wherein an antihydration agent is present in the oil in the range from 1 % to 5% by weight of the oil and antihydration agent, said antihydration agent comprising a metal salt of a fatty acid having from 8 to 22 carbon atoms, said metal selected from aluminum, calcium and magnesium.
Claim 34
Dependent Claim
34 words
A method of Claim 29 or 30 wherein said oil is selected from corn oil, peanut oil, sesame oil, olive oil, palm oil, safflower oil, soybean oil, cottonseed oil, rapeseed oil, and mixtures thereof.
Claim 35
Dependent Claim
22 words
A method of Claim 30 in which the fatty acid is selected from stearic acid, palmitic acid, lauric acid, and mixtures thereof.
Claim 36
Independent Claim
21 words
A method of any of Claims 29 to 32 wherein the dispersing is carried out between 4 C and 125 C.
Claim 37
Independent Claim
16 words
A method of any of Claims 29 to 33 wherein the somatotropin is bovine or porcine.
Claim 38
Dependent Claim
53 words
Use of an animal somatotropin in the manufacture of a composition for enhancing lean-to-fat ratio, feed efficiency or milk production of an animal, said composition comprising as a continuous phase, a biocompatible oil and, as a discontinuous phase, the animal somatotropin in an amount not less than 10% by weight of the composition,
Claim 39
Dependent Claim
53 words
Use of an animal somatotropin in the manufacture of a composition for enhancing lean-to-fat ratio, feed efficiency or milk production of an animal, said composition comprising as a continuous phase, a biocompatible oil and, as a discontinuous phase, the animal somatotropin in an amount not less than 10% by weight of the composition,
Claim 40
Dependent Claim
28 words
The use of an animal somatotropin according to Claim 35 in which the composition includes the features of any of Claims 1 to 3 and 4 to 21.
Claim 41
Dependent Claim
24 words
The use of an animal somatotropin according to Claim 35 or 36 in which the animal is selected from cattle, sheep, goats and swine.
References Cited (Backward Citations)
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