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Claims for Patent: 5,270,057

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Claims for Patent: 5,270,057

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)
Application Number:07/914,227
Patent Claims: 1. A stabilized lyophilized FSH composition comprising:

1 part by weight FSH and

1to 10,000 parts by weight of at least one salt of an organic acid selected from the group consisting of salts or citric acid, tartaric acid, aspartic acid, isocitric acid, glutamic acid, and mixtures thereof, whereby a decrease in FSH activity over time is delayed.

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

3. The composition of claim 1, wherein said composition contains sufficient organic acid salt to form a solution having an ionic strength of at least 0.05 mol/l when said composition is reconstituted with water.

4. The composition of claim 1 wherein said organic acid salt is selected from the group consisting of salts of tartaric acid, aspartic acid, isocitric acid, glutamic acid, and mixtures thereof.

5. The composition of claim 2 wherein said non-reducing sugar is trehalose.

6. The composition of claim 2, wherein the non-reducing sugar is present in an amount of about three times by weight of the organic acid salt.

7. A lyophilized FSH composition comprising:

one part by weight of a FSH, said FSH being of recombinant source; and

200 to 10,000 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, glutamic acid and mixtures thereof.
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