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Claims for Patent: 8,518,981

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Claims for Patent: 8,518,981

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 (Varese, IT), Cannella; Roberta (Varese, IT), Miksztal; Andrew (Palo Alto, CA), Malefyt; Thomas (Carmel Valley, CA), Lee; Kathleen (Palo Alto, CA)
Assignee: Helsinn Healthcare SA (Lugano/Pazzallo, CH) Roche Palo Alto LLC (Palo Alto, CA)
Application Number:13/087,012
Patent Claims: 1. A method of manufacturing and terminally sterilizing a finished single unit dose vial of palonosetron or a pharmaceutically acceptable salt thereof comprising: a) providing one or more sterile open containers; b) filling said containers with a pharmaceutically stable solution of palonosetron or a pharmaceutically acceptable salt thereof; c) sealing said filled containers; d) terminally sterilizing said sealed, filled containers; and e) optionally adjusting the pH of said solution using HCl or NaOH prior to step (c), wherein the pharmaceutically stable solution has a pH of from about 4.0 to about 6.0 and comprises palonosetron hydrochloride in a concentration of from about 0.03 mg/mL to about 0.2 mg/mL based on the weight of the free base, an aqueous carrier, and a tonicity agent, and wherein the pharmaceutically stable solution optionally comprises one or a combination of mannitol, a chelating agent, and a citrate buffer.

2. The method of claim 1, wherein said solution comprises 0.05 mg/ml of palonosetron hydrochloride based on the weight of the free base.

3. The method of claim 1, wherein said solution comprises HCl or NaOH as a pH adjusting agent.

4. The method of claim 1, wherein said solution has a pH of from 4.5 to 5.5, HCl or NaOH as a pH adjusting agent, and mannitol.

5. A single unit dose of palonosetron hydrochloride made by the method of claim 4.

6. The method of claim 1, wherein said solution has a pH of from 4.5 to 5.5, HCl or NaOH as a pH adjusting agent, a chelating agent and mannitol.

7. A single unit dose of palonosetron hydrochloric made by the method of claim 6.

8. The method of claim 1, wherein said solution comprises HCl or NaOH as a pH adjusting agent, a chelating agent and mannitol.

9. The method of claim 1, wherein said solution comprises a chelating agent and mannitol.

10. The method of claim 1, wherein said solution comprises a chelating agent.

11. The method of claim 1, wherein said solution comprises mannitol.

12. A single unit dose of palonosetron hydrochloride made by the method of claim 1.
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