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Claims for Patent: 6,706,681

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Claims for Patent: 6,706,681

Title: HCG liquid formulations
Abstract:The invention refers to liquid pharmaceutical compositions containing hCG stabilised with a polyalcohol or a non-reducing sugar. Preferably, the compositions are stabilised with mannitol. In the preferred embodiments such compositions are aqueous solutions in a phosphate buffer at pH 7. Such compositions are ready to be injected and, therefore, the step of reconstitution of the lyophilised powder is avoided, thus simplifying the way of use.
Inventor(s): Samaritani; Fabrizio (Rome, IT), Natale; Patrizia (Rome, IT)
Assignee: Applied Research System ARS Holding N.V. (Antilles, NL)
Application Number:08/913,748
Patent Claims: 1. A stable, liquid pharmaceutical composition comprising recombinant human Chorionic Gonadotropin and a stabilizing amount of mannitol.

2. A liquid pharmaceutical composition according to claim 1, wherein the solution is a buffered aqueous solution.

3. A liquid pharmaceutical composition according to claim 2, wherein the buffer solution is selected from the group consisting of acetate, succinate and phosphate buffer.

4. A liquid pharmaceutical composition according to claim 3, wherein the buffer is phosphate buffer.

5. A liquid pharmaceutical according to claim 2, wherein the buffer solution is at pH 7.0.

6. A liquid pharmaceutical composition according to claim 2, wherein the buffer solution is 0.01 M.

7. A liquid pharmaceutical composition according to claim 1, comprising from 1,000 to 40,000 IU/ml of rhCG and from 10 to 180 mg/l of mannitol in a 0.01 M phosphate buffer at pH 7.0.

8. A process for the preparation of a liquid pharmaceutical composition according to claim 1, comprising diluting a rhCG bulk solution in a buffer solution containing exipients.

9. The liquid pharmaceutical composition of claim 1 hermetically closed in a sterile condition in a container suitable for the storage before use.

10. A liquid pharmaceutical composition according to claim 3, wherein the buffer solution is at pH 7.0.

11. A liquid pharmaceutical composition according to claim 4, wherein the buffer solution is at pH 7.0.

12. A liquid pharmaceutical composition according to claim 3, wherein the buffer solution is 0.01 M.

13. A liquid pharmaceutical composition according to claim 4, wherein the buffer solution is 0.01 M.

14. A liquid pharmaceutical composition according to claim 5, wherein the buffer solution is 0.01 M.

15. A liquid pharmaceutical composition according to claim 10, wherein the buffer solution is 0.01 M.

16. A liquid pharmaceutical composition according to claim 11, wherein the buffer solution is 0.01 M.
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