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Claims for Patent: 5,898,030

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Claims for Patent: 5,898,030

Title: hGH containing pharmaceutical compositions
Abstract:Pharmaceutical compositions containing hGH stabilized by means of saccharose. The formulation is particularly suitable for stabilizing a lyophilisate of recombinant hGH.
Inventor(s): Samaritani; Fabrizio (Rome, IT)
Assignee: Applied Research Systems Ars Holding N.V (NL)
Application Number:08/750,684
Patent Claims: 1. A pharmaceutical composition consisting essentially of a solid intimate mixture of human growth hormone (hGH) and a stabilizing amount of a stabilizer selected from the group consisting of saccharose and a combination of saccharose and mannitol.

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

3. A pharmaceutical composition according to claim 1, wherein the hGH is recombinant.

4. A pharmaceutical composition according to claim 1, containing 5 or 10 mg of hGH.

5. A pharmaceutical composition according to claim 1, wherein the stabilizer is saccharose.

6. A pharmaceutical composition according to claim 1, wherein the stabilizer is a combination of saccharose and mannitol.

7. A process for preparing a pharmaceutical composition according to claim 1 comprising providing an aqueous solution of human growth hormone and a stabilizing amount of saccharose, placing the aqueous solution in a container and lyophilizing the solution in the container.

8. The process according to claim 7, wherein the aqueous solution is a buffer solution selected from the group consisting of acetate buffer, succinate buffer and phosphate buffer.

9. The process according to claim 8, wherein the buffer solution is phosphate buffer.

10. The process according to claim 8, wherein the pH of the solution is within the range 6.0 to 8.0.

11. A process according to claim 8, wherein the pH of the solution is 7.5.

12. A solution comprising the pharmaceutical composition according to claim 1, reconstituted in a solvent or a solution for injectables.

13. A reconstituted solution, according to claim 12, comprising 5 or 10 mg/vial of hGH, 68.4 mg/vial of saccharose and phosphate buffer at pH 7.5.

14. A solution according to claim 13, wherein the solvent is a bacteriostatic solvent.

15. A solution according to claim 14, wherein the bacteriostatic solvent is 0.3% m-cresol.

16. A hermetically sealed sterile container containing the pharmaceutical composition of claim 1 therein.

17. A hermetically sealed sterile container according to claim 16 wherein the pharmaceutical composition is a lyophilisate.

18. A hermetically sealed sterile container according to claim 16 wherein the hGH is recombinant.

19. A hermetically sealed sterile container according to claim 16 containing 5-10 mg of hGH.

20. A pharmaceutical composition consisting of a solid intimate mixture of human growth hormone (hGH) and a stabilizing amount of a stabilizer selected from the group consisting of saccharose and a combination of saccharose and mannitol.
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