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Claims for Patent: 8,729,094

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Claims for Patent: 8,729,094

Title:Liquid pharmaceutical formulations of palonosetron
Abstract: The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
Inventor(s): Calderari; Giorgio (Rancate, CH), Bonadeo; Daniele (Casalzuigno, IT), Cannella; Roberta (Varese, IT), Macciocchi; Alberto (Melide, CH), Miksztal; Andrew (Palo Alto, CA), Malefyt; Thomas (Carmel Valley, CA), Lee; Kathleen M (Palo Alto, CA)
Assignee: Helsinn Healthcare SA (Pambio-Noranco, CH) Roche Palo Alto LLC (Palo Alto, CA)
Application Number:13/902,132
Patent Claims: 1. A method for reducing the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising intravenously administering to a human in need thereof a pharmaceutical single-use, unit-dose formulation comprising a 5 mL sterile aqueous isotonic solution buffered at a pH of about 5.0.+-.0.5, said solution comprising: about 0.05 mg/mL palonosetron hydrochloride based on the weight of its free base; about 41.5 mg/mL mannitol; about 0.5 mg/mL EDTA; and a citrate buffer, wherein said formulation is stable at 24 months when stored at room temperature, and wherein said intravenous administration to said human occurs before the start of the cancer chemotherapy.

2. The method of claim 1, wherein said intravenous administration to said human occurs over a period of time of 10 to 60 seconds.

3. The method of claim 1, wherein said intravenous administration reduces the likelihood of acute nausea and vomiting in said human.

4. The method of claim 1, wherein said intravenous administration reduces the likelihood of delayed nausea and vomiting in said human.

5. A method for reducing the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising intravenously administering to a human in need thereof a pharmaceutical single-use, unit-dose formulation comprising a 5 mL sterile aqueous isotonic solution buffered at a pH of about 5.0.+-.0.5, said solution comprising: about 0.05 mg/mL palonosetron hydrochloride based on the weight of its free base; from about 10 mg/mL to about 80 mg/mL mannitol; and from about 0.3 mg/mL to about 0.7 mg/mL EDTA; wherein said solution optionally comprises a citrate buffer, wherein said formulation is stable at 24 months when stored at room temperature, and wherein said intravenous administration to said human occurs before the start of the cancer chemotherapy.

6. The method of claim 5, wherein said intravenous administration to said human occurs over a period of time of 10 to 60 seconds.

7. The method of claim 5, wherein said intravenous administration reduces the likelihood of acute nausea and vomiting in said human.

8. The method of claim 5, wherein said intravenous administration reduces the likelihood of delayed nausea and vomiting in said human.

9. The method of claim 5, wherein said solution comprises from about 20 mg/mL to about 60 mg/mL mannitol.

10. The method of claim 9, wherein said solution comprises from about 40 mg/mL to about 45 mg/mL mannitol.

11. The method of claim 10, wherein said solution comprises about 41.5 mg/mL mannitol and about 0.5 mg/mL EDTA.

12. The method of claim 5, wherein said solution comprises a citrate buffer.

13. A method for reducing the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising intravenously administering to a human in need thereof a pharmaceutical single-use, unit-dose formulation comprising a 5 mL sterile aqueous isotonic solution, said solution comprising: about 0.05 mg/mL palonosetron hydrochloride based on the weight of its free base; a tonicifying effective amount of mannitol; and from about 0.3 mg/mL to about 0.7 mg/mL EDTA; wherein said solution optionally comprises a citrate buffer and optionally has a pH of from about 5.0.+-.0.5, wherein said formulation is stable at 24 months when stored at room temperature, and wherein said intravenous administration to said human occurs before the start of the cancer chemotherapy.

14. The method of claim 13, wherein said intravenous administration to said human occurs over a period of time of 10 to 60 seconds.

15. The method of claim 13, wherein said intravenous administration reduces the likelihood of acute nausea and vomiting in said human.

16. The method of claim 13, wherein said intravenous administration reduces the likelihood of delayed nausea and vomiting in said human.

17. The method of claim 13, wherein said solution comprises a citrate buffer.

18. The method of claim 13, wherein said solution is buffered at a pH of about 5.0.+-.0.5.

19. The method of claim 13, wherein said solution comprises from about 10 mg/mL to about 80 mg/mL mannitol.

20. The method of claim 19, wherein said solution comprises from about 20 mg/mL to about 60 mg/mL mannitol.

21. The method of claim 20, wherein said solution comprises about 41.5 mg/mL mannitol and about 0.5 mg/mL EDTA.

22. A method for reducing the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising intravenously administering to a human in need thereof a pharmaceutical single-use, unit-dose formulation comprising a 5 mL sterile aqueous isotonic solution buffered at a pH of about 5.0.+-.0.5, said solution comprising: about 0.05 mg/mL palonosetron hydrochloride based on the weight of its free base; and a tonicifying effective amount of mannitol; wherein said solution optionally comprises one or a combination of a citrate buffer and a chelating agent, wherein said formulation is stable at 24 months when stored at room temperature, and wherein said intravenous administration to said human occurs before the start of the cancer chemotherapy.

23. The method of claim 22, wherein said intravenous administration to said human occurs over a period of time of 10 to 60 seconds.

24. The method of claim 22, wherein said intravenous administration reduces the likelihood of acute nausea and vomiting in said human.

25. The method of claim 22, wherein said intravenous administration reduces the likelihood of delayed nausea and vomiting in said human.

26. The method of claim 22, wherein said solution comprises a citrate buffer.

27. The method of claim 22, wherein said solution comprises a chelating agent.

28. The method of claim 27, wherein said chelating agent is EDTA.

29. The method of claim 28, wherein said solution comprises from about 0.3 mg/mL to about 0.7 mg/mL EDTA.

30. The method of claim 22, wherein said solution comprises from about 10 mg/mL to about 80 mg/mL mannitol.
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