US4396608A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Intravenously injectable immune serum globulin
Assignee: Bayer Corp
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Filing: 1981-08-24
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Granted: 1983-08-02
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Expires: 2001-08-24
Abstract
Abstract A composition is disclosed which comprises a solution in a pharmaceutically acceptable carrier of an immune serum globulin, said solution having an ionic strength and a pH to maintain the monomer content and the actual and latent anticomplement activity of the immune serum globulin such that the composition is intravenously injectable. Novel methods are disclosed for preparing the above composition.
Inventors
- 👤 Robert A. Tenold
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-07 23:53
CPC Classifications
A; A61; A61K; A61K39/00; A61K39/395; A61K39/39591
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
51 words
A stable, sterile, intravenously injectable pharmaceutical composition comprising an aqueous solution of a therapeutic amount of an immune serum globulin, said solution having an ionic strength such that the solution at 5% protein concentration has a nephelometric reading less than 15 NTU, a pH of about 3.5-5.0, and a physiologically-acceptable tonicity.
Claim 2
Dependent Claim
51 words
A stable, sterile, intravenously injectable pharmaceutical composition comprising an aqueous solution of a therapeutic amount of an immune serum globulin, said solution having an ionic strength such that the solution at 5% protein concentration has a nephelometric reading less than 15 NTU, a pH of about 3.5-5.0, and a physiologically-acceptable tonicity.
Claim 3
Dependent Claim
11 words
The composition of claim 1 which further includes other blood products.
Claim 4
Dependent Claim
32 words
The composition of claim 1 which includes a material selected from the group consisting of carbohydrates, sugar alcohols, and amino acids in an amount sufficient to render physiologically-acceptable tonicity to the solution.
Claim 5
Dependent Claim
10 words
The composition of claim 3 wherein the carbohydrate is maltose.
Claim 6
Dependent Claim
11 words
The composition of claim 3 wherein the amino acid is glycine.
Claim 7
Independent Claim
95 words
A method for treating immune serum globulin which comprises (a) forming an aqueous solution of an immune serum globulin, (b) adjusting the pH of said solution to about 3.5-5.0 by addition of a physiologically acceptable acid, (c) treating the solution to reduce its ionic strength (Γ/2) while maintaining the pH of said solution at 5% protein concentration has a nephelometric reading less than 15 NTU, and (d) adjusting the tonicity of the solution to a physiologically acceptable level by addition of an agent selected from the group consisting of amino acids, carbohydrates, and sugar alcohols.
Claim 8
Independent Claim
95 words
A method for treating immune serum globulin which comprises (a) forming an aqueous solution of an immune serum globulin, (b) adjusting the pH of said solution to about 3.5-5.0 by addition of a physiologically acceptable acid, (c) treating the solution to reduce its ionic strength (Γ/2) while maintaining the pH of said solution at 5% protein concentration has a nephelometric reading less than 15 NTU, and (d) adjusting the tonicity of the solution to a physiologically acceptable level by addition of an agent selected from the group consisting of amino acids, carbohydrates, and sugar alcohols.
Claim 9
Dependent Claim
20 words
The method of claim 6 wherein the solution in Step a has a protein concentration of about 0.5-20% by weight.
Claim 10
Dependent Claim
22 words
The method of claim 6 wherein the pH is adjusted to about 3.8-4.2 in Step b and maintained thereat in Step c.
Claim 11
Dependent Claim
13 words
The method of claim 6 wherein the solution is diafiltered in Step c.
Claim 12
Dependent Claim
15 words
The method of claim 6 which further includes the step of (e) sterilizing the solution.
Claim 13
Dependent Claim
8 words
A composition comprising the product of claim 6.
Claim 14
Dependent Claim
17 words
The method of claim 6 which further includes the step of lyophilizing the solution of Step c.
Claim 15
Dependent Claim
8 words
A composition comprising the product of claim 12.
Claim 16
Dependent Claim
40 words
A dry composition comprising immune serum globulin which upon solution in water has a pH of about 3.5-5.0 and an ionic strength (Γ/2) such that the solution at 5% protein concentration has a nephelometric reading less than about 15 NTU.
Claim 17
Dependent Claim
40 words
A dry composition comprising immune serum globulin which upon solution in water has a pH of about 3.5-5.0 and an ionic strength (Γ/2) such that the solution at 5% protein concentration has a nephelometric reading less than about 15 NTU.
References Cited (Backward Citations)
US4093606A
Cited
US4186192A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1986-08-01 | 1987-01-31 | 1987-08-02 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1990-08-01 | 1991-01-31 | 1991-08-02 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1994-08-01 | 1995-01-31 | 1995-08-02 | $7700.00 | Window Closed / Lapsed |