US4496537A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Biologically stable alpha-interferon formulations
Assignee: Merck Sharp & Dohme LLC
•
Filing: 1983-09-16
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Granted: 1985-01-29
•
Expires: 2003-09-16
Abstract
Abstract The addition of glycine or alanine prior to lyophilization significantly improves the biological stability of alpha type interferon formulations.
Inventors
- 👤 Henry K. Kwan
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-02 17:06
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/16; A61K38/17; A61K38/19; A61K38/21; A61K38/212; A61K47/00; A61K47/06; A61K47/16; A61K47/18; A61K47/183; Y; Y10; Y10S; Y10S530/00; Y10S530/827; Y10S530/829
Claims Analysis
Total Claims: 8
Claim 1
Independent Claim
113 words
In a method for preparing a formulation of high specific activity alpha-type interferon having improved biological stability by lyophilizing a solution containing said alpha-type interferon to yield a reconstitutable lyophylizate, the improvement for further increasing said biological stability to a level such that the lyophilizate substantially retains its biological activity even when stored at 20° C. for at least six months which comprises: adding to said solution prior to lyophilization (a) a compatible buffer which will maintain the pH of the reconstituted solution within the range of about 6.5 to 8.0, and (b) glycine or alanine in an amount of 5 to 150 milligrams per milliliter of water to be added for reconstitution.
Claim 2
Dependent Claim
113 words
In a method for preparing a formulation of high specific activity alpha-type interferon having improved biological stability by lyophilizing a solution containing said alpha-type interferon to yield a reconstitutable lyophylizate, the improvement for further increasing said biological stability to a level such that the lyophilizate substantially retains its biological activity even when stored at 20° C. for at least six months which comprises: adding to said solution prior to lyophilization (a) a compatible buffer which will maintain the pH of the reconstituted solution within the range of about 6.5 to 8.0, and (b) glycine or alanine in an amount of 5 to 150 milligrams per milliliter of water to be added for reconstitution.
Claim 3
Dependent Claim
32 words
A method according to claim 1 wherein said solution to be lyophilized additionally contains up to 10 milligrams of human albumin for each milliliter of water that will be added during reconstitution.
Claim 4
Dependent Claim
15 words
A method according to claim 1 wherein the said alpha type interferon is alpha-2 interferon.
Claim 5
Dependent Claim
22 words
A method according to claim 1 wherein said compatible buffer maintains a pH at about 7.0 to 7.4 in the reconstituted solution.
Claim 6
Dependent Claim
32 words
A method according to claim 3 wherein about 5 to 25 mg of glycine is added for each 1×10 4 to 5×10 8 I.U. of the alpha-2 interferon mixture to be lyophilized.
Claim 7
Dependent Claim
32 words
A method according to claim 3 wherein about 5 to 25 mg of alanine is added for each 1×10 4 to 5×10 8 I.U. of the alpha-2 interferon mixture to be lyophilized.
Claim 8
Dependent Claim
15 words
A method according to claim 1 wherein the said alpha type interferon is alpha-1 interferon.
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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) | 1988-01-29 | 1988-07-30 | 1989-01-29 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-01-29 | 1992-07-30 | 1993-01-29 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-01-29 | 1996-07-30 | 1997-01-29 | $7700.00 | Window Closed / Lapsed |