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Claims for Patent: 8,598,218

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Claims for Patent: 8,598,218

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, CH), 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:13/901,288
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 about 5 ml of an aqueous 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 said solution to a pH of from about 4.0 to about 6.0 prior to step (c), wherein the pharmaceutically stable solution comprises palonosetron hydrochloride in an amount of about 0.25 mg based on the weight of its 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 a pH adjusting agent.

3. The method of claim 1, wherein said solution has a pH of from 4.5 to 5.5, and wherein said solution further comprises mannitol.

4. A finished single unit dose vial of palonosetron or a pharmaceutically acceptable salt thereof manufactured by the method of claim 3.

5. The method of claim 1, wherein said solution further comprises a pH adjusting agent, a chelating agent, and mannitol.

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

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

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

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

10. A finished single unit dose vial of palonosetron or a pharmaceutically acceptable salt thereof manufactured by the method of claim 1.

11. 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 an aqueous pharmaceutically stable solution of palonosetron or a pharmaceutically acceptable salt thereof having a palonosetron concentration of 0.05 mg/mL based on the weight of its free base; c) sealing said filled containers; d) terminally sterilizing said sealed, filled containers; and e) optionally adjusting said solution to a pH of from about 4.0 to about 6.0 prior to step (c), wherein the pharmaceutically stable solution comprises palonosetron hydrochloride in a concentration of 0.05 mg/mL based on the weight of its 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.
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