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Claims for Patent: 7,947,724

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Claims for Patent: 7,947,724

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), Braglia; Enrico (Pazzallo, CH), Braglia; Riccardo (Pazzallo, CH), Miksztal; Andrew (Palo Alto, CA), Malefyt; Thomas (Carmel Valley, CA), Lee; Kathleen M. (Palo Alto, CA)
Assignee: Helsinn Healthcare S.A. (Lugano, CH) Roche Palo Alto LLC (Palo Alto, CA)
Application Number:11/186,311
Patent Claims: 1. A pharmaceutically stable intravenous solution for reducing emesis or reducing the likelihood of emesis comprising: a) from 0.03 mg/ml to 0.2 mg/ml palonosetron or a pharmaceutically acceptable salt thereof, buffered at a pH of from 4.0 to 6.0; and b) a pharmaceutically acceptable sterile aqueous carrier including a tonicifying effective amount of mannitol and from 0.005 mg/ml to 1.0 mg/ml EDTA.

2. The solution of claim 1 wherein the palonosetron or pharmaceutically acceptable salt thereof is in concentration of about 0.05 mg/ml.

3. The solution of claim 1 comprising palonosetron hydrochloride.

4. The solution of claim 1 wherein the pH is from 4.5 to 5.5.

5. The solution of claim 1 wherein the pharmaceutically acceptable carrier comprises from 10 to 100 millimoles of a citrate buffer.

6. The solution of claim 1 comprising 0.3 to 0.7 mg/ml EDTA, and from 10 to 40 millimoles of a citrate buffer.

7. The solution of claim 1 comprising 0.3 to 0.7 mg/ml EDTA, from 10.0 to 80.0 mg/ml mannitol, and from 10 to 40 millimoles of a citrate buffer.

8. A pharmaceutically stable isotonic intravenous solution for reducing emesis or reducing the likelihood of emesis comprising: a) from 0.01 mg/ml to 5 mg/ml palonosetron or a pharmaceutically acceptable salt thereof, at a pH of from 4.0 to 6.0; and b) an aqueous pharmaceutically acceptable carrier including a chelating agent.

9. The solution of claim 8 wherein the palonosetron or pharmaceutically acceptable salt thereof is in concentration of about 0.05 mg/ml.

10. The solution of claim 8 comprising palonosetron hydrochloride.

11. The solution of claim 8 wherein the pH is from 4.5 to 5.5.

12. The solution of claim 8 wherein the pharmaceutically acceptable carrier comprises from 0.005 mg/ml to 1.0 mg/ml EDTA.

13. The solution of claim 8 wherein the pharmaceutically acceptable carrier comprises mannitol.

14. The solution of claim 8 adapted for intravenous administration.
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