Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Patent
1992-07-13
1993-12-14
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
514 2, 514 8, 514 21, 514 22, 530398, 530399, 530850, A61K 914, A61K 3738
Patent
active
052700577
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.
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Research Disclosure, No. 169, May 1978 Havant GB pp. 4-6.
De Meere Andreas L. J.
De Ruiter Marinus A.
Akzo N.V.
Blackstone William M.
Kishore G. S.
Page Thurman K.
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