|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 solution for reducing emesis or reducing the likelihood of emesis comprising: a) from 0.03 mg/mL to 0.2 mg/mL palonosetron hydrochloride, based
on the weight of the free base; b) a sterile injectable aqueous carrier at a pH of from 4 to 6; c) a tonicifying effective amount of mannitol; and d) from 0.005 mg/mL to 1.0 mg/mL EDTA.
2. A pharmaceutically stable solution for reducing emesis or reducing the likelihood of emesis comprising: a) 0.05 mg/mL palonosetron hydrochloride, based on the weight of the free base, in a sterile injectable aqueous carrier at a pH of from 4.5 to 5.5; b) from 0.005 mg/mL to 1.0 mg/mL EDTA; and c) mannitol in an amount sufficient to tonicify said solution, in a concentration of from about 10 mg/ml to about 80 mg/ml.
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