|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)|
1. A pharmaceutically stable isotonic intravenous solution of palonosetron hydrochloride for reducing emesis or reducing the likelihood of emesis comprising a) from about
0.03 mg/mL to about 0.2 mg/mL palonosetron as palonosetron hydrochloride, b) a sterile pharmaceutically acceptable aqueous carrier comprising mannitol as a tonicity agent, at a pH of from 4.0 to 6.0, and c) EDTA in an amount of from 0.005 to 1.0 mg/mL.
2. The solution of claim 1 wherein the palonosetron is in a concentration of about 0.05 mg/mL as palonosetron hydrochloride.
3. The solution of claim 1 wherein the pH is from 4.5 to 5.5.
4. The solution of claim 1 wherein the pharmaceutically acceptable carrier further comprises citric acid.
5. The solution of claim 1 wherein: a) said palonosetron is present in a concentration of 0.05 mg/ml, as palonosetron hydrochloride; and b) said EDTA is present in a concentration of from 0.005 to 1.0 mg/ml.
6. The solution of claim 5 wherein said pH is from 4.5 to 5.5.