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Last Updated: September 22, 2021

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Claims for Patent: 4,496,537

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Summary for Patent: 4,496,537
Title: Biologically stable alpha-interferon formulations
Abstract:The addition of glycine or alanine prior to lyophilization significantly improves the biological stability of alpha type interferon formulations.
Inventor(s): Kwan; Henry K. (Summit, NJ)
Assignee: Schering Corporation (Madison, NJ)
Application Number:06/532,886
Patent Claims:1. 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.degree. 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.

2. 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.

3. A method according to claim 1 wherein the said alpha type interferon is alpha-2 interferon.

4. A method according to claim 1 wherein said compatible buffer maintains a pH at about 7.0 to 7.4 in the reconstituted solution.

5. A method according to claim 3 wherein about 5 to 25 mg of glycine is added for each 1.times.10.sup.4 to 5.times.10.sup.8 I.U. of the alpha-2 interferon mixture to be lyophilized.

6. A method according to claim 3 wherein about 5 to 25 mg of alanine is added for each 1.times.10.sup.4 to 5.times.10.sup.8 I.U. of the alpha-2 interferon mixture to be lyophilized.

7. A method according to claim 1 wherein the said alpha type interferon is alpha-1 interferon.

Summary for Patent: ⤷  Free Forever Trial

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
South Africa82/8580Nov 19, 1982
82111665.4Dec 15, 1982

Details for Patent 4,496,537

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Schering INTRON A interferon alfa-2b VIAL 103132 001 1986-06-04 ⤷  Free Forever Trial Schering Corporation (Madison, NJ) 2002-11-19 RX company
Schering INTRON A interferon alfa-2b VIAL 103132 002 1986-06-04 ⤷  Free Forever Trial Schering Corporation (Madison, NJ) 2002-11-19 RX company
Schering INTRON A interferon alfa-2b VIAL 103132 003 1986-06-04 ⤷  Free Forever Trial Schering Corporation (Madison, NJ) 2002-11-19 RX company
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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