Process for the preparation of a solution of high...

A - Human Necessities – 61 – K

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167/103.33

A61K 38/49 (2006.01) A61K 47/18 (2006.01) A61L 2/00 (2006.01) C12N 9/96 (2006.01)

Patent

CA 1338698

In the preparation of parenteral solutions for the therapy and prophylaxis of thromboses and embolisms, because of the poor solubility of t-PA hitherto either the infusion of very large volumes has been necessary, or else a solu- tion with a low volume and a high t-PA concentration has been prepared at the expense of setting up a non- physiologically low pH of 2 to 5. Hence, the present invention relates to a process for the preparation of a solution of high con- centration of a protein having plasminogen activator activity, where an increase in stability and solubility is achieved by adding at least two substances from the group of D- and/or L-amino acids, their salts, derivatives or homologs. This invention also relates to a process for the pasteurization of a protein solution having t-PA acti- vity, and to a t-PA-containing solution prepared by the claimed process, and to the use of this solution as a fibrinolytic in human and veterinary medicine.

568464

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