US4565651A
Expired / Lapsed
US
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Method of lyophilizing cold insoluble globulin
Assignee: Tanabe Pharma Corp
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Filing: 1983-10-03
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Granted: 1986-01-21
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Expires: 2003-10-03
Abstract
Abstract A lyophylized cold insoluble globulin preparation can be prepared in stable condition and in short time by lyophylizing an aqueous solution of a cold insoluble globulin in the presence of albumin and a neutral amino acid, a monosaccharide, a disaccharide or a sugar alcohol. The preparation dissolves in water without occurrence of turbidity and is usable for injection.
Inventors
- 👤 Takao Ohmura
- 👤 Yutaka Hirao
- 👤 Takuji Hanamura
- 👤 Akimasa Ohmizu
- 👤 Satoshi Funakoshi
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-28 20:31
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/16; A61K38/17; A61K38/39
Claims Analysis
Total Claims: 13
Claim 1
Independent Claim
104 words
A method of lyophilizing an aqueous solution of a cold insoluble globulin containing from about 0.1 to 10% w/v cold insoluble globulin which has been purified by heat treatment to a pharmaceutically acceptable degree, said method comprising lyophilizing the aqueous solution to which from about 0.25 to 5% w/v albumin and from about 1 to 10% w/v of at least one stabilizer selected from the group consisting of neutral amino acids, monosaccharides, disaccharides, and sugar alcohols have been added, the amounts of albumin and the stabilizer being sufficient for preventing the occurrence of turbidity when the lyophilized cold insoluble globulin is dissolved in water.
Claim 2
Independent Claim
104 words
A method of lyophilizing an aqueous solution of a cold insoluble globulin containing from about 0.1 to 10% w/v cold insoluble globulin which has been purified by heat treatment to a pharmaceutically acceptable degree, said method comprising lyophilizing the aqueous solution to which from about 0.25 to 5% w/v albumin and from about 1 to 10% w/v of at least one stabilizer selected from the group consisting of neutral amino acids, monosaccharides, disaccharides, and sugar alcohols have been added, the amounts of albumin and the stabilizer being sufficient for preventing the occurrence of turbidity when the lyophilized cold insoluble globulin is dissolved in water.
Claim 3
Dependent Claim
23 words
The method according to claim 1, wherein the aqueous solution contains the cold insoluble globulin in a concentration of 0.1 to 10% W/V.
Claim 4
Dependent Claim
32 words
A lyophylized cold insoluble globulin composition which contains a cold insoluble globulin, albumin and at least one member selected from the group consisting of neutral amino acids, monosaccharides, disaccharides and sugar alcohols.
Claim 5
Dependent Claim
32 words
A lyophylized cold insoluble globulin composition which contains a cold insoluble globulin, albumin and at least one member selected from the group consisting of neutral amino acids, monosaccharides, disaccharides and sugar alcohols.
Claim 6
Dependent Claim
13 words
A lyophylized cold insoluble globulin composition prepared by the method of claim 1.
Claim 7
Dependent Claim
22 words
The method according to claim 1, wherein the stabilizer is a neutral amino acid and is glycine, alanine, valine, leucine or isoleucine.
Claim 8
Dependent Claim
19 words
The method according to claim 1, wherein the stabilizer is a monosaccharide and is glucose, mannose, galactose or fructose.
Claim 9
Dependent Claim
18 words
The method according to claim 1, wherein the stabilizer is a disaccharide and is sucrose, maltose or lactose.
Claim 10
Dependent Claim
19 words
The method according to claim 1, wherein the stabilizer is a sugar alcohol and is mannitol, sorbitol or xylitol.
Claim 11
Dependent Claim
22 words
The method according to claim 1, wherein the amount of albumin is in the range of about 0.5 to about 1.0% w/v.
Claim 12
Dependent Claim
93 words
In a method of lyophilizing an aqueous solution of a cold insoluble globulin comprising lyophilizing the solution in the presence of at least one stabilizer selected from the group consisting of neutral amino acids, monosaccharides, disaccharides, and sugar alcohols, the improvement comprising including in the solution to be lyophilized from about 0.25 to 5% w/v of albumin and from about 1 to 10% w/v of said stabilizer, provided that the amounts of albumin and stabilizer are sufficient for preventing the occurrence of turbidity when the lyophilized cold insoluble globulin is dissolved in water.
Claim 13
Dependent Claim
93 words
In a method of lyophilizing an aqueous solution of a cold insoluble globulin comprising lyophilizing the solution in the presence of at least one stabilizer selected from the group consisting of neutral amino acids, monosaccharides, disaccharides, and sugar alcohols, the improvement comprising including in the solution to be lyophilized from about 0.25 to 5% w/v of albumin and from about 1 to 10% w/v of said stabilizer, provided that the amounts of albumin and stabilizer are sufficient for preventing the occurrence of turbidity when the lyophilized cold insoluble globulin is dissolved in water.
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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) | 1989-01-20 | 1989-07-22 | 1990-01-21 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1993-01-20 | 1993-07-22 | 1994-01-21 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1997-01-20 | 1997-07-22 | 1998-01-21 | $7700.00 | Window Closed / Lapsed |