US4439421A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Stabilized gamma globulin concentrate
Assignee: Baxter International Inc
•
Filing: 1982-08-30
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Granted: 1984-03-27
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Expires: 2002-08-30
Abstract
Abstract Gamma globulin concentrates are stabilized against anticomplement activity generation during lyophilization by inclusion in the concentrate of a physiologically acceptable, substantially nonsurface-active hydrophilic macromolecule. The improved concentrates may be safely administered to patients. The main additives to the gamma globulin are a substantially nonsurface-active hydrophilic macromolecule, a protein and a polyol.
Inventors
- 👤 John A. Hooper
- 👤 Samia Mankarious
- 👤 Catherine R. Liu-Rash
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-04 15:53
CPC Classifications
C; C07; C07K; C07K16/00; C07K16/06; C07K16/065; A; A61; A61K; A61K38/00
Claims Analysis
Total Claims: 29
Claim 1
Independent Claim
97 words
A stabilized gamma globulin concentrate comprising gamma globulin (a) a water soluble, physiologically acceptable, substantially nonsurface-active hydrophilic macromolecule having a molecular weight greater than about 1000 Daltons, (b) a water soluble, physiologically acceptable protein other than gamma globulin and (c) a water soluble, physiologically acceptable polyol having a molecular weight less than the average molecular weight of the hydrophilic macromolecule, said macromolecule, protein and polyol being present, respectively, in a weight ratio to total protein in the concentrate of (a) about from 0.0075:1 to 0.062:1, (b) about from 0.01:1 to 0.125:1 and (c) about from 0.05:1 1.25:1.
Claim 2
Dependent Claim
97 words
A stabilized gamma globulin concentrate comprising gamma globulin (a) a water soluble, physiologically acceptable, substantially nonsurface-active hydrophilic macromolecule having a molecular weight greater than about 1000 Daltons, (b) a water soluble, physiologically acceptable protein other than gamma globulin and (c) a water soluble, physiologically acceptable polyol having a molecular weight less than the average molecular weight of the hydrophilic macromolecule, said macromolecule, protein and polyol being present, respectively, in a weight ratio to total protein in the concentrate of (a) about from 0.0075:1 to 0.062:1, (b) about from 0.01:1 to 0.125:1 and (c) about from 0.05:1 1.25:1.
Claim 3
Dependent Claim
8 words
The concentrate of claim 1 which is dry.
Claim 4
Dependent Claim
18 words
The concentrate of claim 1 which additionally comprises a gamma globulin stabilizing amount of the amino acid glycine.
Claim 5
Dependent Claim
18 words
The concentrate of claim 1 wherein the macromolecule has an average molecular weight greater than about 1000 Daltons.
Claim 6
Dependent Claim
14 words
The concentrate of claim 1 wherein the macromolecule is a polyether or polyhydroxy compound.
Claim 7
Dependent Claim
13 words
The concentrate of claim 5 wherein the macromolecule is a hydrophilic vinyl polymer.
Claim 8
Dependent Claim
11 words
The concentrate of claim 5 wherein the macromolecule is a polysaccharide.
Claim 9
Dependent Claim
10 words
The concentrate of claim 7 wherein the macromolecule is polyglucose.
Claim 10
Dependent Claim
11 words
The concentrate of claim 5 wherein the macromolecule is polyethylene glycol.
Claim 11
Dependent Claim
18 words
The concentrate of claim 9 wherein the polyethylene glycol has an average molecular weight of about 4000 Daltons.
Claim 12
Dependent Claim
11 words
The concentrate of claim 1 wherein the macromolecule is substantially nonpolar.
Claim 13
Dependent Claim
24 words
The concentrate of claim 1 wherein the macromolecule is present in a ratio to total protein of about from 0.01 to 0.05 by weight.
Claim 14
Dependent Claim
12 words
The concentrate of claim 1 wherein the protein is human serum albumin.
Claim 15
Dependent Claim
24 words
The concentrate of claim 1 wherein the protein is present in a ratio to total protein of about from 0.01 to 0.05 by weight.
Claim 16
Dependent Claim
16 words
The concentrate of claim 1 wherein the polyol has a molecular weight below about 1000 Daltons.
Claim 17
Dependent Claim
15 words
The concentrate of claim 1 wherein the polyol contains less than about seven hydroxyl groups.
Claim 18
Dependent Claim
21 words
The concentrate of claim 1 wherein the polyol is a sugar, sugar alcohol or oligomer thereof containing less than four monomers.
Claim 19
Dependent Claim
12 words
The concentrate of claim 17 wherein the polyol is a nonreducing sugar.
Claim 20
Dependent Claim
10 words
The concentrate of claim 17 wherein the polyol is glucose.
Claim 21
Dependent Claim
24 words
The concentrate of claim 1 wherein the polyol is present in a ratio to total protein of about from 0.1 to 0.5 by weight.
Claim 22
Dependent Claim
11 words
The concentrate of claim 20 wherein the ratio is about 0.5.
Claim 23
Dependent Claim
24 words
The concentrate of claim 1 wherein the concentrate is in aqueous solution at a concentration of about from 40 to 100 mg gamma globulin/ml.
Claim 24
Dependent Claim
10 words
The concentrate of claim 1 in a hermetically sealed container.
Claim 25
Dependent Claim
8 words
The concentrate of claim 1 which is sterile.
Claim 26
Dependent Claim
12 words
The concentrate of claim 1 which is substantially free of nonionic surfactant.
Claim 27
Dependent Claim
18 words
The concentrate of claim 1 which is free of the block copolymer of polypropylene glycol and polyethylene glycol.
Claim 28
Dependent Claim
89 words
A stabilized gamma globulin concentrate comprising gamma globulin (a) polyethylene glycol of a molecular weight greater then about 1000 daltons, (b) a water soluble, physiologically acceptable protein other than gamma globulin and (c) a water soluble, physiologically acceptable polyol selected from the group of sugars, sugar alcohols or oligomers thereof, the polyethylene glycol, protein and polyol being present, respectively, in a weight ratio to total protein in the concentrate of (a) about from 0.0075:1 to 0.062:1, (b) about from 0.01:1 to 0.125:1 and (c) about from 0.05:1 to 1.25:1.
Claim 29
Dependent Claim
89 words
A stabilized gamma globulin concentrate comprising gamma globulin (a) polyethylene glycol of a molecular weight greater then about 1000 daltons, (b) a water soluble, physiologically acceptable protein other than gamma globulin and (c) a water soluble, physiologically acceptable polyol selected from the group of sugars, sugar alcohols or oligomers thereof, the polyethylene glycol, protein and polyol being present, respectively, in a weight ratio to total protein in the concentrate of (a) about from 0.0075:1 to 0.062:1, (b) about from 0.01:1 to 0.125:1 and (c) about from 0.05:1 to 1.25:1.
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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) | 1987-03-27 | 1987-09-26 | 1988-03-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-03-27 | 1991-09-26 | 1992-03-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-03-27 | 1995-09-26 | 1996-03-27 | $7700.00 | Window Closed / Lapsed |