Liquid pharmaceutical formulations of palonosetron
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.
1. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 50 mL sterile isotonic solution buffered at a pH of 4.8±0.5 comprising:
palonosetron hydrochloride in an amount of 0.75 mg based on the weight of its free base;
450.0 mg sodium chloride;
2.5 mg EDTA;
18.5 mg sodium citrate; and
7.8 mg citric acid monohydrate,
wherein said formulation is contained in a polyethylene multilayer film infusion bag comprising an isoprene rubber stopper.