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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)|
|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
|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|
|Country||Patent Number||Estimated Expiration|
|Austria||12073||⤷ Free Forever Trial|
|Australia||558966||⤷ Free Forever Trial|
|Australia||9168882||⤷ Free Forever Trial|
|Canada||1207665||⤷ Free Forever Trial|
|Germany||3262575||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
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