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Claims for Patent: 9,173,942

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Claims for Patent: 9,173,942

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:13/901,830
Patent Claims: 1. A formulation comprising a pharmaceutical sterile aqueous intravenous solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises: palonosetron hydrochloride or another pharmaceutically acceptable salt of palonosetron at a concentration of 0.05 mg/mL based on the weight of the palonosetron free base; and from 10 mg/mL to 80 mg/mL mannitol; wherein the pharmaceutical sterile aqueous intravenous solution has a pH of 4.0 to 6.0.

2. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution comprises palonosetron hydrochloride or another pharmaceutically acceptable salt of palonosetron is in an amount of 0.25 mg.

3. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution comprises from 20 mg/mL to 60 mg/mL mannitol.

4. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution comprises from 40 mg/mL to 45 mg/mL mannitol.

5. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution comprises 41.5 mg/mL mannitol.

6. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution comprises a chelating agent.

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

8. The formulation of claim 7, wherein said pharmaceutical sterile aqueous intravenous solution comprises from 0.3 mg/mL to 0.7 mg/mL EDTA.

9. The formulation of claim 7, wherein said pharmaceutical sterile aqueous intravenous solution comprises 0.5 mg/mL EDTA.

10. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution has a pH of 5.0.+-.0.5.

11. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution comprises a citrate buffer.

12. A formulation comprising a pharmaceutical sterile aqueous intravenous solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises: palonosetron hydrochloride or another pharmaceutically acceptable salt of palonosetron at a concentration of 0.05 mg/mL based on the weight of the palonosetron free base; from 10 mg/mL to 80 mg/mL mannitol; and from 0.3 mg/mL to 0.7 mg/mL EDTA.

13. The formulation of claim 12, wherein said pharmaceutical sterile aqueous intravenous solution comprises palonosetron hydrochloride or another pharmaceutically acceptable salt of palonosetron is in an amount of 0.25 mg.

14. The formulation of claim 12, wherein said pharmaceutical sterile aqueous intravenous solution has a pH of 4.0 to 6.0.

15. The formulation of claim 12, wherein said pharmaceutical sterile aqueous intravenous solution has a pH of 5.0.+-.0.5.

16. The formulation of claim 12, wherein said pharmaceutical sterile aqueous intravenous solution comprises from 20 mg/mL to 60 mg/mL mannitol.

17. The formulation of claim 12, wherein said pharmaceutical sterile aqueous intravenous solution comprises from 40 mg/mL to 45 mg/mL mannitol.

18. The formulation of claim 12, wherein said pharmaceutical sterile aqueous intravenous solution comprises 41.5 mg/mL mannitol and 0.5 mg/mL EDTA.

19. The formulation of claim 12, wherein said pharmaceutical sterile aqueous intravenous solution comprises a citrate buffer.
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