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.
Claims19
A formulation comprising a pharmaceutical sterile aqueous intravenous solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises:
- palonosetron hydrochloride or another pharmaceutically acceptable salt of palonosetron at a concentration of 0.05 mg/mL based on the weight of the palonosetron free base;
- and
- from 10 mg/mL to 80 mg/mL mannitol;
- wherein the pharmaceutical sterile aqueous intravenous solution has a pH of 4.0 to 6.0.
A formulation comprising a pharmaceutical sterile aqueous intravenous solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises:
- palonosetron hydrochloride or another pharmaceutically acceptable salt of palonosetron at a concentration of 0.05 mg/mL based on the weight of the palonosetron free base;
- from 10 mg/mL to 80 mg/mL mannitol;
- and
- from 0.3 mg/mL to 0.7 mg/mL EDTA.
Dependencies are inferred from the claim text.