Stabilized gonadotropin containing preparations

Details Stabilized gonadotropin containing preparations Stabilized gonadotropin containing preparations

1993-09-03

1995-01-24

Kishore, G. S.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

514 2, 514 8, 514 21, 514 23, 530398, 530399, 530852, A61K 914, A61K 3738

Patent

active

053841328

ABSTRACT:
Disclosed are lyophilized gonadotropin containing preparations containing a dicarboxylic acid salt stabilizer. The particular proteins (e.g. LH, TSH, FSH, or HCG) are in admixture with, and at least partially capable 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 disaccharide to increase the collapse temperature of the solution to be lyophilized. Methods of making the preparations in lyophilized form and the resulting injectable preparations are also disclosed.

REFERENCES:
patent: 3932943 (1976-01-01), Briggs et al.
patent: 4062942 (1977-12-01), Donini et al.
patent: 4457916 (1984-07-01), Hayashi et al.
patent: 4478829 (1984-10-01), Landaburu et al.
patent: 4623717 (1986-11-01), Fernandes et al.
patent: 4806524 (1989-02-01), Kawaguchi et al.
patent: 4812557 (1989-03-01), Yashushi et al.
patent: 4816568 (1989-03-01), Hamilton, Jr. et al.
patent: 4824938 (1989-04-01), Koyama et al.
Research Disclosure, No. 169, pp. 4-6, May 1978, Havant GB.

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