Claims for Patent: 7,947,724

Summary 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 Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,947,724
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.