t-PA solution of high concentration and use of the solution in h

Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing – Stabilized enzymes or enzymes complexed with nonenzyme

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424 9463, 424 9464, 435212, 435215, 435236, A61K 37547, A61K 3754, C12N 964, C12N 972

Patent

active

050681060

ABSTRACT:
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 solution 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 concentration 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 activity, 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.

REFERENCES:
patent: 4258030 (1981-03-01), Sasaki et al.
patent: 4440679 (1984-04-01), Fernandes et al.
patent: 4568544 (1986-02-01), Hasegawa et al.
Ranby et al, Progress in Fibrinolysis, vol. 5 (1981), pp. 233-235.

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