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Claims for Patent: 9,066,980

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Claims for Patent: 9,066,980

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 (Lugano/Pazzallo, CH) Roche Palo Alto LLC (Palo Alto, CA)
Application Number:13/902,299
Patent Claims: 1. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous solution, said solution comprising: a) palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base, b) optionally a chelating agent, and c) a tonicifying agent in an amount sufficient to make said solution isotonic, wherein said formulation is stable at 24 months when stored at room temperature.

2. The pharmaceutical formulation of claim 1, wherein said solution is buffered at a pH of 5.0.+-.0.5.

3. The pharmaceutical formulation of claim 1, wherein said tonicifying agent is mannitol.

4. The pharmaceutical formulation of claim 3, wherein said mannitol is in an amount from 10 mg/mL to 80 mg/mL.

5. The pharmaceutical formulation of claim 4, wherein said mannitol is in an amount of 41.5 mg/mL.

6. The pharmaceutical formulation of claim 1, wherein said formulation comprises a chelating agent.

7. The pharmaceutical formulation of claim 6, wherein said chelating agent is EDTA.

8. The pharmaceutical formulation of claim 7, wherein said EDTA is in an amount of from 0.005 mg/mL to 1.0 mg/mL.

9. The pharmaceutical formulation of claim 8, wherein said EDTA is in an amount of 0.5 mg/mL.

10. The pharmaceutical formulation of claim 1, wherein said solution further comprises a citrate buffer.

11. The pharmaceutical formulation of claim 10, wherein said citrate buffer is at a concentration of 20 millimolar.

12. A method for reducing the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising intravenously administering to a human in need thereof the pharmaceutical formulation of claim 1, wherein said intravenous administration to said human occurs before the start of the cancer chemotherapy.

13. The method of claim 12, wherein said intravenous administration to said human occurs over a period of time of 10 to 60 seconds.

14. The method of claim 12, wherein said intravenous administration reduces the likelihood of acute nausea and vomiting in said human.

15. The method of claim 12, wherein said intravenous administration reduces the likelihood of delayed nausea and vomiting in said human.

16. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous solution, said solution comprising: a) palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base, b) optionally a chelating agent, and c) a tonicifying agent in an amount sufficient to make said solution isotonic, wherein said formulation is stable at 18 months when stored at room temperature.
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