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Claims for Patent: 5,929,028

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Claims for Patent: 5,929,028

Title: Liquid gonadotropin containing formulations
Abstract:The invention concerns a liquid gonadotropin-containing formulation characterised in that the formulation comprises a gonadotropin and stabilising amounts of a polycarboxylic acid or a salt thereof and of a thioether compound. The particular proteins (e.g. LH, TSH, FSH, or HCG) are in admixture with the particular stabilizers in an aqueous solution. The preparations contain a sufficient amount of the polycarboxylic acid or a salt thereof, preferably sodium citrate, and a sufficient amount of the thioether compound, preferably methionine, to stabilize the protein. The preparations preferably also include a nonreducing disaccharide like sucrose, and a non-ionic surfactant.
Inventor(s): Skrabanja; Arnold Titus Philip (An Nijmegen, NL), van den Oetelaar; Petrus Johannes Maria (Et Heesch, NL)
Assignee: Akzo Nobel, N.V. (Arnhem, NL)
Application Number:09/006,812
Patent Claims: 1. A stabilized liquid gonadotropin-containing formulation contained in a closed cartridge suited for storage, said formulation comprising a gonadotropin and stabilizing amounts of a polycarboxylic acid or salt thereof and of a thioether compound.

2. The liquid gonadotropin-containing formulation of claim 1, wherein the thioether compound is the amino acid methionine.

3. The liquid gonadotropin-containing formulation of claim 1 or 2, wherein the polycarboxylic acid is citric acid or the sodium salt thereof.

4. The liquid gonadotropin-containing formulation of claim 3, wherein the concentration of sodium citrate is 25-100 mM and the concentration of methionine is 1-10 mM.

5. The liquid gonadotropin-containing formulation of claim 1, further comprising a non-reducing sugar.

6. The liquid gonadotropin-containing formulation of claim 5, wherein the non-reducing sugar is sucrose in a concentration of 25-300 mM.

7. The liquid gonadotropin-containing formulation of claim 1, further comprising a non-ionic surfactant.

8. The liquid gonadotropin-containing formulation of claim 1, wherein the pH of the formulation is between 6.5 and 7.2.

9. The liquid gonadotropin-containing formulation of claim 1, wherein the gonadotropin is selected from luteinizing hormone (LH), human chorionic gonadotropin (hCG), follicle stimulating hormone (FSH), or derivatives thereof, and mixtures thereof.

10. The liquid gonadotropin-containing formulation of claim 9, wherein the gonadotropin is recombinant human FSH (recFSH) or recombinant FSH-CTP.

11. A method for preparing a stabilized liquid gonadotropin formulation comprising:

admixing, in an aqueous solution, at least one gonadotropin with a stabilizing amount of a polycarboxylic acid or a salt thereof, and a stabilizing amount of a thioether compound;

optionally dissolving an amount of a nonreducing disaccharide in the resulting admixture and optionally dissolving a nonionic surfactant in said admixture;

adjusting the pH of the resulting solution to a value between 6.5 and 7.2; and

sealing the pH adjusted solution in a cartridge suited for storage.

12. A method for preparing a stabilized liquid gonadotropin formulation comprising:

admixing, in an aqueous solution, at least one gonadotropin with an amount of sodium citrate to a concentration of 25-100 mM, and an amount of methionine to a concentration of 1-10 mM;

optionally dissolving an amount of sucrose in the resulting admixture to a concentration of 25-300 mM and optionally dissolving a surfactant in said admixture;

adjusting the pH of the resulting solution to a value between 6.5 and 7.2; and

sealing the pH adjusted solution in a cartridge suited for storage.

13. A method for treating infertility of a patient, comprising administering to the patient an effective amount of a formulation according to claim 1.

14. The liquid gonadotropin-containing formulation of claim 8, wherein the pH is 7.
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