Stabilized gonadotropin containing preparations

Details Stabilized gonadotropin containing preparations Stabilized gonadotropin containing preparations

A - Human Necessities

61

K

A61K 38/24 (2006.01) A61K 9/19 (2006.01) A61K 47/12 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2037884

Disclosed are lyophilized gonadotropin containing preparations containing a dicarboxylic acid salt stabi- lizer. The particular proteins (e.g. LH, TSH, FSH, or HCG) are in admixture with, and at least partially capa- ble of stabilization by, the particular stabilizer in lyophilized form. The preparations contain a sufficient amount of dicarboxylic acid salt to stabilize the protein in freeze-dried form for a desired time at a desired temperature. Typical dicarboxylic acid salts disclosed are the salts of citric, tartaric, and aspartic acids. The preparations preferably include a non-reducing disac- charide to increase the collapse temperature of the solu- tion to be lyophilized. Methods of making the prepara- tions in lyophilized form and the resulting injectable preparations are also disclosed.

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