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Claims for Patent: 5,650,390

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Claims for Patent: 5,650,390

Title: Gonadotropin containing pharmaceutical compositions with sucrose stabilizer
Abstract:Pharmaceutical compositions containing FSH, LH or hCG stabilized by means of a combination of sucrose and glycine. The formulation is particularly suitable for stabilizing a lyophilisate of recombinant gonadotropins.
Inventor(s): Samaritani; Fabrizio (Rome, IT), Natale; Patrizia (Rome, IT)
Assignee: Applied Research Systems ARS Holding N. V. (Curacao, AN)
Application Number:08/244,575
Patent Claims: 1. A pharmaceutical composition comprising a solid intimate mixture of gonadotropin and a stabilizing amount of sucrose in combination with glycine.

2. A pharmaceutical composition according to claim 1 wherein the sucrose is between 20 and 50 mg per unit dosage.

3. A pharmaceutical composition according to claim 1, wherein the solid intimate mixture is a lyophilisate.

4. A pharmaceutical composition according to claim 3, wherein the gonadotropin is FSH, or LH or hCG.

5. A pharmaceutical composition according to claim 1, wherein the gonadotropin is recombinant.

6. A pharmaceutical composition according to claim 1, containing 75 or 150 I.U. of FSH, 30 mg of sucrose, and an effective amount of glycine.

7. A pharmaceutical composition according to claim 1, containing 75 or 150 I.U. of LH, 47.75 mg of sucrose, and an effective amount of glycine.

8. A pharmaceutical composition according to claim 4, wherein the gonadotropin is recombinant.

9. A process for preparing a pharmaceutical composition according to claim 1 comprising preparing an aqueous solution of the components, distributing the components within containers, and drying or lyophilizing the solution within the containers.

10. A process according to claim 9, wherein the pH of the solution is within the range 6.5-8.5.

11. A process according to claim 10, wherein the pH of the solution is 7 for the FSH formulation and 8 for the LH formulation.

12. Forms of presentation of said pharmaceutical composition consisting essentially of the solid mixture according to claim 1, hermetically closed in a sterile condition in a container suited for storage before use and reconstitution of the mixture in a solvent or a solution for injectables.

13. A solution comprising the solid mixture according to claim 12, reconstituted in a solvent or a solution for injectables.

14. Forms of presentation of said pharmaceutical composition comprising the solid mixture according to claim 8, hermetically closed in a sterile condition in a container suited for storage before use and reconstitution of the mixture in a solvent or a solution for injectables.

15. Forms of presentation of said pharmaceutical composition comprising the solid mixture according to claim 1, hermetically closed in a sterile condition in a container suited for storage before use and reconstitution of the mixture in a solvent or a solution for injectables.

16. Forms of presentation of said pharmaceutical composition comprising the solid mixture according to claim 1, hermetically closed in a sterile condition in a container suited for storage before use and reconstitution of the mixture in a solvent or a solution for injectables, wherein the gonadotropin is FSH, LH or hCG.
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