US4371523A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Reducing the aggregation of insulin in solution
Assignee: CALIFORNIA BERKELEY CALIF A CORPOF CALIF, University of, Regents of
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Filing: 1980-12-29
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Granted: 1983-02-01
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Expires: 2000-12-29
Abstract
Abstract A method for reducing aggregation of insulin within aqueous insulin solutions comprising including in said insulin solutions an anti-aggregation agent selected from pharmaceutically acceptable organic compounds having at least two carboxylic acid moieties and at least one amino, or amino derived, moiety. Such insulin solutions with the anti-aggregation agent are also maintained at pH's approximating the isoelectric point of the anti-aggregation agent. Glutamic acid or aspartic acid are especially preferred as the anti-aggregation agent. Relatively small quantities of such agents prevent, or greatly reduce aggregation of insulin even when such insulin solutions are maintained at elevated temperatures and under agitation for extended periods of time.
Inventors
- 👤 Gerold M. Grodsky
- 👤 Jacques Bringer
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-04 06:16
CPC Classifications
A; A61; A61K; A61K47/00; A61K47/06; A61K47/16; A61K47/18; A61K47/183; A61K38/00; A61K38/16; A61K38/17; A61K38/22; A61K38/28
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
75 words
A method of reducing the aggregation of insulin in a solution which is retained over extended periods of time in a reservoir under agitation and at about body temperature comprising admixing into said insulin solution an effective amount of an anti-aggregation agent having two carboxyl moieties and at least one amino or amino derivative moiety, and adjusting the pH of said insulin solution to a pH at about the isoelectric point of the anti-aggregation agent.
Claim 2
Independent Claim
75 words
A method of reducing the aggregation of insulin in a solution which is retained over extended periods of time in a reservoir under agitation and at about body temperature comprising admixing into said insulin solution an effective amount of an anti-aggregation agent having two carboxyl moieties and at least one amino or amino derivative moiety, and adjusting the pH of said insulin solution to a pH at about the isoelectric point of the anti-aggregation agent.
Claim 3
Dependent Claim
23 words
The method of claim 1 wherein said organic anti-aggregation agent is a di-carboxylic amino acid or a derivative of a di-carboxylic amino acid.
Claim 4
Dependent Claim
11 words
The method of claim 2 wherein said agent is glutamic acid.
Claim 5
Dependent Claim
11 words
The method of claim 2 wherein said agent is aspartic acid.
Claim 6
Dependent Claim
17 words
The method of claim 1 wherein the pH of said insulin solution is at an acid pH.
Claim 7
Dependent Claim
18 words
The method of claim 3 wherein the pH of said insulin solution is from about 3 to 3.5.
Claim 8
Dependent Claim
18 words
The method of claim 4 wherein the pH of said insulin solution is from about 3 to 3.5.
Claim 9
Dependent Claim
54 words
A stabilized insulin aqueous solution for use at about body temperature and under agitation consisting essentially of insulin, water, and an anti-aggregation agent having two carboxyl moieties and at least one amino or amino derivative moiety, the pH of said solution being within about the range of the isoelectric point of said anti-aggregation agent.
Claim 10
Dependent Claim
54 words
A stabilized insulin aqueous solution for use at about body temperature and under agitation consisting essentially of insulin, water, and an anti-aggregation agent having two carboxyl moieties and at least one amino or amino derivative moiety, the pH of said solution being within about the range of the isoelectric point of said anti-aggregation agent.
Claim 11
Dependent Claim
13 words
The stabilized solution of claim 8 wherein the anti-aggregation agent is glutamic acid.
Claim 12
Dependent Claim
13 words
The stabilized solution of claim 8 wherein the anti-aggregation agent is aspartic acid.
Claim 13
Dependent Claim
19 words
The stabilized solution of claim 9 wherein the solution is at a pH of from about 3 to 3.5.
Claim 14
Dependent Claim
19 words
The stabilized solution of claim 10 wherein the solution is at a pH of from about 3 to 3.5.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1986-01-31 | 1986-08-02 | 1987-02-01 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1990-01-31 | 1990-08-02 | 1991-02-01 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1994-01-31 | 1994-08-02 | 1995-02-01 | $7700.00 | Window Closed / Lapsed |