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Details for Patent: 5,384,132

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Details for Patent: 5,384,132

Title: Stabilized gonadotropin containing preparations
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.
Inventor(s): De Meere; Andreas L. J. (Waspik, NL), De Ruiter; Marinus A. (Oss, NL)
Assignee: Akzo N.V. (Arnhem, NL)
Filing Date:Sep 03, 1993
Application Number:08/116,420
Claims:1. A stabilized, lyophilized human chorionic gonadotropin (HCG) composition comprising:

one part by weight HCG and

one to ten thousand parts by weight of at least one salt of an organic acid selected from the group consisting of salts of citric acid, tartaric acid, aspartic acid, isocitric acid and glutamic acid.

2. The stabilized HCG composition of claim 1, further comprising a non-reducing sugar selected from the group consisting of sucrose and trehalose, wherein the non-reducing sugar is present in an amount three to fifty times the amount by weight of the organic acid salt.

3. The stabilized HCG composition of claim 1, further comprising a non-ionic surfactant.

4. The stabilized HCG composition of claim 1, further comprising a second, non-HCG gonadotropin capable of stabilization by said organic acid salt.

5. A stabilized, lyophilized HCG composition comprising:

one part by weight HCG; and

two hundred to ten thousand parts by weigh of at least one salt of an organic acid selected from the group consisting of salts of citric acid, tartaric acid, aspartic acid, isocitric acid and glutamic acid.

6. A method of making a stabilized HCG composition comprising:

admixing in an aqueous solution, HCG with an amount of at least one salt of an organic acid selected from the group consisting of salts of citric acid, tartaric acid, aspartic acid, isocitric acid and glutamic acid, to adjust the ionic strength of said solution to between 0.050 and 0.350; and

dissolving a non-reducing sugar selected from the group consisting of sucrose and trehalose in said admixture in an amount of about three to fifty times the amount, by weight, of the organic acid salt; and

freeze-drying said admixture at a temperature greater than -35.degree. centigrade to form said stabilized HCG composition.
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