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
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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.
Claims16
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 5 mL sterile aqueous solution, said solution comprising:
- a) palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base,
- b) optionally a chelating agent, and
- c) a tonicifying agent in an amount sufficient to make said solution isotonic, wherein said formulation is stable at 24 months when stored at room temperature.
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 5 mL sterile aqueous solution, said solution comprising:
- a) palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base,
- b) optionally a chelating agent, and
- c) a tonicifying agent in an amount sufficient to make said solution isotonic, wherein said formulation is stable at 18 months when stored at room temperature.
Dependencies are inferred from the claim text.