US4447355A
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Method for stabilizing a tumor necrosis factor and a stable aqueous solution or powder containing the same
Assignee: Asahi Kasei Corp
•
Filing: 1983-03-23
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Granted: 1984-05-08
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Expires: 2003-03-23
Abstract
Abstract A method for stabilizing a Tumor Necrosis Factor (TNF), which comprises adding at least one member selected from the group consisting of an albumin, a gelatin, a globulin, a protamine and a salt of protamine to an aqueous solution or powder containing TNF, and a stable aqueous solution or powder which contains TNF and an effective amount of such a protein. The aqueous solution or powder containing TNF can be stored for a prolonged period of time without losing its activity, and is stable on freezing, thawing, lyophilization or the like.
Inventors
- 👤 Hajimu Sakamoto
- 👤 Takao Kiyota
- 👤 Hiroshi Hayashi
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-26 08:24
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/08; A61K38/00; A61K38/16; A61K38/17; A61K38/19; A61K38/191; A61K47/00; A61K47/30; A61K47/42
Claims Analysis
Total Claims: 49
Claim 1
Independent Claim
48 words
A method for stabilizing Tumor Necrosis Factor, which comprises adding to an aqueous solution or powder containing Tumor Necrosis Factor an effective amount of at least one stabilizing agent selected from the group consisting of an albumin, a gelatin, a globulin, a protamine and a salt of protamine.
Claim 2
Independent Claim
48 words
A method for stabilizing Tumor Necrosis Factor, which comprises adding to an aqueous solution or powder containing Tumor Necrosis Factor an effective amount of at least one stabilizing agent selected from the group consisting of an albumin, a gelatin, a globulin, a protamine and a salt of protamine.
Claim 3
Dependent Claim
22 words
A method according to claim 1, which further comprises subjecting to lyophilization the resulting aqueous solution having said stabilizing agent added thereto.
Claim 4
Dependent Claim
46 words
A method according to claim 1, wherein said stabilizing agent is added in an amount of about 10 μg to 50 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml.
Claim 5
Dependent Claim
22 words
A method according to claim 3, which further comprises subjecting to lyophilization the resulting aqueous solution having said stabilizing agent added thereto.
Claim 6
Dependent Claim
46 words
A method according to claim 3, wherein said stabilizing agent is added in an amount of about 100 μg to 10 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml.
Claim 7
Dependent Claim
22 words
A method according to claim 5, which further comprises subjecting to lyophilization the resulting aqueous solution having said stabilizing agent added thereto.
Claim 8
Dependent Claim
13 words
A method according to claim 1, wherein said stabilizing agent is an albumin.
Claim 9
Dependent Claim
13 words
A method according to claim 7, wherein said albumin is human serum albumin.
Claim 10
Dependent Claim
47 words
A method according to claim 8, wherein said human serum albumin is added in an amount of about 10 μg to 50 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml.
Claim 11
Dependent Claim
23 words
A method according to claim 9, which further comprises subjecting to lyophilization the resulting aqueous solution having the human serum albumin added thereto.
Claim 12
Dependent Claim
47 words
A method according to claim 9, wherein said human serum albumin is added in an amount of about 100 μg to 10 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml.
Claim 13
Dependent Claim
23 words
A method according to claim 11, which further comprises subjecting to lyophilization the resulting aqueous solution having the human serum albumin added thereto.
Claim 14
Dependent Claim
13 words
A method according to claim 1, wherein said stabilizing agent is a gelatin.
Claim 15
Dependent Claim
15 words
A method according to claim 13, wherein said gelatin is a water-soluble partially hydrolyzed gelatin.
Claim 16
Dependent Claim
48 words
A method according to claim 14, wherein said water-soluble partially hydrolyzed gelatin is added in an amount of about 10 μg to 50 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml.
Claim 17
Dependent Claim
24 words
A method according to claim 15, which further comprises subjecting to lyophilization the resulting aqueous solution having the water-soluble partially hydrolyzed gelatin added thereto.
Claim 18
Dependent Claim
48 words
A method according to claim 15, wherein said water-soluble partially hydrolyzed gelatin is added in an amount of about 100 μg to 10 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml.
Claim 19
Dependent Claim
24 words
A method according to claim 17, which further comprises subjecting to lyophilization the resulting aqueous solution having the water-soluble partially hydrolyzed gelatin added thereto.
Claim 20
Dependent Claim
13 words
A method according to claim 1, wherein said stabilizing agent is a globulin.
Claim 21
Dependent Claim
17 words
A method according to claim 19, wherein said globulin is human gamma globulin or a derivative thereof.
Claim 22
Dependent Claim
50 words
A method according to claim 20, wherein said human gamma globulin or derivative thereof is added in an amount of about 10 μg to 50 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml.
Claim 23
Dependent Claim
26 words
A method according to claim 21, which further comprises subjecting to lyophilization the resulting aqueous solution having the human gamma globulin or derivative thereof added thereto.
Claim 24
Dependent Claim
50 words
A method according to claim 21, wherein said human gamma globulin or derivative thereof is added in an amount of about 100 μg to 10 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml.
Claim 25
Dependent Claim
26 words
A method according to claim 23, which further comprises subjecting to lyophilization the resulting aqueous solution having the human gamma globulin or derivative thereof added thereto.
Claim 26
Dependent Claim
18 words
A method according to claim 1, wherein said stabilizing agent is a protamine or a salt of protamine.
Claim 27
Dependent Claim
49 words
A method according to claim 25, wherein said protamine or salt of protamine is added in an amount of about 10 μg to 50 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml.
Claim 28
Dependent Claim
25 words
A method according to claim 26, which further comprises subjecting to lyophilization the resulting aqueous solution having the protamine or salt of protamine added thereto.
Claim 29
Dependent Claim
49 words
A method according to claim 26, wherein said protamine or salt of protamine is added in an amount of about 100 μg to 10 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml.
Claim 30
Dependent Claim
25 words
A method according to claim 28, which further comprises subjecting to lyophilization the resulting aqueous solution having the protamine or salt of protamine added thereto.
Claim 31
Dependent Claim
40 words
A stable aqueous solution or powder which contains Tumor Necrosis Factor and an effective amount of at least one stabilizing agent selected from the group consisting of an albumin, a gelatin, a globulin, a protamine and a salt of protamine.
Claim 32
Dependent Claim
40 words
A stable aqueous solution or powder which contains Tumor Necrosis Factor and an effective amount of at least one stabilizing agent selected from the group consisting of an albumin, a gelatin, a globulin, a protamine and a salt of protamine.
Claim 33
Dependent Claim
93 words
A stable aqueous solution or powder according to claim 30, wherein said stabilizing agent is contained in an amount of about 10 μg to 50 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml, or is contained in an amount of about 10 μg to 50 mg per ml of an aqueous solution having a TNF activity of 10 2 to 10 9 units/ml which solution is one obtained by dissolving the powder containing Tumor Necrosis Factor.
Claim 34
Dependent Claim
93 words
A stable aqueous solution or powder according to claim 31, wherein said stabilizing agent is contained in an amount of about 100 μg to 10 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml, or is contained in an amount of about 100 μg to 10 mg per ml of an aqueous solution having a TNF activity of 10 2 to 10 9 units/ml which solution is one obtained by dissolving the powder containing Tumor Necrosis Factor.
Claim 35
Dependent Claim
17 words
A stable aqueous solution or powder according to claim 30, wherein said stabilizing agent is an albumin.
Claim 36
Dependent Claim
17 words
A stable aqueous solution or powder according to claim 33, wherein said albumin is human serum albumin.
Claim 37
Dependent Claim
94 words
A stable aqueous solution or powder according to claim 34, wherein said human serum albumin is contained in an amount of about 10 μg to 50 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml, or is contained in an amount of about 10 μg to 50 mg per ml of an aqueous solution having a TNF activity of 10 2 to 10 9 units/ml which solution is one obtained by dissolving the powder containing Tumor Necrosis Factor.
Claim 38
Dependent Claim
94 words
A stable aqueous solution or powder according to claim 35, wherein said human serum albumin is contained in an amount of about 100 μg to 10 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml, or is contained in an amount of about 100 μg to 10 mg per ml of an aqueous solution having a TNF activity of 10 2 to 10 9 units/ml which solution is one obtained by dissolving the powder containing Tumor Necrosis Factor.
Claim 39
Dependent Claim
17 words
A stable aqueous solution or powder according to claim 30, wherein said stabilizing agent is a gelatin.
Claim 40
Dependent Claim
19 words
A stable aqueous solution or powder according to claim 37, wherein said gelatin is a water-soluble partially hydrolyzed gelatin.
Claim 41
Dependent Claim
95 words
A stable aqueous solution or powder according to claim 38, wherein said water-soluble partially hydrolyzed gelatin is contained in an amount of about 10 μg to 50 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml, or is contained in an amount of about 10 μg to 50 mg per ml of an aqueous solution having a TNF activity of 10 2 to 10 9 units/ml which solution is one obtained by dissolving the powder containing Tumor Necrosis Factor.
Claim 42
Dependent Claim
95 words
A stable aqueous solution or powder according to claim 39, wherein said water-soluble partially hydrolyzed gelatin is contained in an amount of about 100 μg to 10 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml, or is contained in an amount of about 100 μg to 10 mg per ml of an aqueous solution having a TNF activity of 10 2 to 10 9 units/ml which solution is one obtained by dissolving the powder containing Tumor Necrosis Factor.
Claim 43
Dependent Claim
17 words
A stable aqueous solution or powder according to claim 30, wherein said stabilizing agent is a globulin.
Claim 44
Dependent Claim
21 words
A stable aqueous solution or powder according to claim 41, wherein said globulin is human gamma globulin or a derivative thereof.
Claim 45
Dependent Claim
97 words
A stable aqueous solution or powder according to claim 42, wherein said human gamma globulin or derivative thereof is contained in an amount of about 10 μg to 50 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml, or is contained in an amount of about 10 μg to 50 mg per ml of an aqueous solution having a TNF activity of 10 2 to 10 9 units/ml which solution is one obtained by dissolving the powder containing Tumor Necrosis Factor.
Claim 46
Dependent Claim
97 words
A stable aqueous solution or powder according to claim 43, wherein said human gamma globulin or derivative thereof is contained in an amount of about 100 μg to 10 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml, or is contained in an amount of about 100 μg to 10 mg per ml of an aqueous solution having a TNF activity of 10 2 to 10 9 units/ml which solution is one obtained by dissolving the powder containing Tumor Necrosis Factor.
Claim 47
Dependent Claim
22 words
A stable aqueous solution or powder according to claim 30, wherein said stabilizing agent is a protamine or a salt of protamine.
Claim 48
Dependent Claim
96 words
A stable aqueous solution or powder according to claim 45, wherein said protamine or salt of protamine is contained in an amount of about 10 μg to 50 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml, or is contained in an amount of about 10 μg to 50 mg per ml of an aqueous solution having a TNF activity of 10 2 to 10 9 units/ml which solution is one obtained by dissolving the powder containing Tumor Necrosis Factor.
Claim 49
Dependent Claim
96 words
A stable aqueous solution or powder according to claim 46, wherein said protamine or salt of protamine is contained in an amount of about 100 μg to 10 mg per ml of the aqueous solution containing Tumor Necrosis Factor, said aqueous solution having a TNF activity of 10 2 to 10 9 units/ml, or is contained in an amount of about 100 μg to 10 mg per ml of an aqueous solution having a TNF activity of 10 2 to 10 9 units/ml which solution is one obtained by dissolving the powder containing Tumor Necrosis Factor.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1987-05-08 | 1987-11-07 | 1988-05-08 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-05-08 | 1991-11-07 | 1992-05-08 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-05-08 | 1995-11-07 | 1996-05-08 | $7700.00 | Window Closed / Lapsed |