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Claims for Patent: 7,582,727

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Claims for Patent: 7,582,727

Title:Pharmaceutical formulations of bivalirudin and processes of making the same
Abstract:Pharmaceutical batch(es) or pharmaceutical formulation(s) comprising bivalirudin as the active ingredient, and a method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s). The pharmaceutical batch(es) or pharmaceutical formulation(s) may have a maximum impurity level of Asp.sup.9-bivalirudin that does not exceed about 0.6%. Also, the pharmaceutical batch(es) or pharmaceutical formulation(s) may have a reconstitution time that does not exceed about 42 seconds. The method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s) may comprise dissolving bivalirudin in a solvent to form a first solution, efficiently mixing a pH-adjusting solution with the first solution to form a second solution in which the pH-adjusting solution may comprise a pH-adjusting solution solvent, and removing the solvent and the pH-adjusting solution solvent from the second solution.
Inventor(s): Krishna; Gopal (Parsippany, NJ), Musso; Gary (Parsippany, NJ)
Assignee: The Medicinces Company (Parsippany, NJ)
Application Number:12/180,553
Patent Claims: 1. Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and a pharmaceutically acceptable carrier for use as an anticoagulant in a subject in need thereof, wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum impurity level of Asp.sup.9-bivalirudin that does not exceed about 0.6% as measured by HPLC.

2. The pharmaceutical batches of claim 1, wherein the maximum impurity level of Asp.sup.9-bivalirudin does not exceed about 0.4% as measured by HPLC.

3. The pharmaceutical batches of claim 2, wherein the maximum impurity level of Asp.sup.9-bivalirudin does not exceed about 0.3% as measured by HPLC.

4. The pharmaceutical batches of claim 1, wherein the batches have a maximum total impurity level that does not exceed about 2% as measured by HPLC.

5. The pharmaceutical batches of claim 4, wherein the maximum total impurity level does not exceed about 1% as measured by HPLC.

6. The pharmaceutical batches of claim 5, wherein the maximum total impurity level does not exceed about 0.5% as measured by HPLC.

7. The pharmaceutical batches of claim 1, wherein the batches have a maximum level of D-Phe.sup.12-bivalirudin that does not exceed about 2.5% as measured by HPLC.

8. The pharmaceutical batches of claim 1, wherein the pharmaceutically acceptable carrier comprises one or more of a bulking agent or a stabilizing agent.

9. The pharmaceutical batches of claim 8, wherein the bulking agent is a sugar.

10. The pharmaceutical batches of claim 9, wherein the sugar is mannitol.

11. Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and a pharmaceutically acceptable carrier for use as an anticoagulant in a subject in need thereof, wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum reconstitution time that does not exceed about 42 seconds and a maximum total impurity level that does not exceed about 2% as measured by HPLC.

12. The pharmaceutical batches of claim 11, wherein the maximum reconstitution time does not exceed about 30 seconds.

13. The pharmaceutical batches of claim 12, wherein the maximum reconstitution time does not exceed about 21 seconds.

14. The pharmaceutical batches of claim 11, wherein the pharmaceutically acceptable carrier comprises one or more of a bulking agent or a stabilizing agent.

15. The pharmaceutical batches of claim 14, wherein the bulking agent is a sugar.

16. The pharmaceutical batches of claim 15, wherein the sugar is mannitol.

17. The pharmaceutical batches of claim 1, wherein the base is sodium hydroxide.

18. The pharmaceutical batches of claim 11, wherein the base is sodium hydroxide.

19. Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and mannitol for use as an anticoagulant in a subject in need thereof, wherein the batches have a pH adjusted by sodium hydroxide, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum reconstitution time that does not exceed about 42 seconds and a maximum total impurity level that does not exceed about 2% as measured by HPLC.

20. The pharmaceutical batches of claim 19, wherein the batches have a maximum impurity level of Asp.sup.9-bivalirudin that does not exceed about 0.6% as measured by HPLC.
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