Liquid pharmaceutical formulations of palonosetron
AssigneesHelsinn Healthcare SA, Roche Palo Alto LLC
InventorsGiorgio Calderari, Daniele Bonadeo, Roberta Cannella, Alberto Macciocchi, Andrew Miksztal, Thomas Malefyt, Kathleen M Lee, Carmine Panuccio
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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.
Claims1
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.
Dependencies are inferred from the claim text.