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 formulation comprising a pharmaceutical sterile aqueous intravenous solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises palonosetron or a pharmaceutically acceptable salt thereof in an amount of 0.25 mg and a concentration of from 0.03 mg/mL to 0.2 mg/mL based on the weight of the palonosetron free base.
2. The formulation of claim 1 , wherein said pharmaceutical sterile aqueous intravenous solution has a pH of from 4 to 6.
3. The formulation of claim 1 , wherein said pharmaceutical sterile aqueous intravenous solution has a pH of 5.0±0.5.
4. A method of manufacturing a finished container of a pharmaceutical formulation comprising palonosetron or a pharmaceutically acceptable salt thereof, said method comprising: a) providing an open container; b) filling said container with an aqueous intravenous solution comprising said palonosetron or pharmaceutically acceptable salt thereof in an amount of 0.25 mg and a concentration of from 0.03 mg/mL to 0.2 mg/mL based on the weight of the palonosetron free base; c) sealing said filled container; and d) terminally sterilizing said sealed, filled container to obtain said finished container.
5. The method of claim 4 , wherein said aqueous intravenous solution has a pH of from 4 to 6.
6. The method of claim 4 , wherein said aqueous intravenous solution has a pH of 5.0±0.5.
7. A finished container of palonosetron or a pharmaceutically acceptable salt thereof, manufactured and terminally sterilized by the process of claim 4 .
8. The finished container of claim 7 , wherein said aqueous intravenous solution has a pH of from 4 to 6.
9. The finished container of claim 7 , wherein said aqueous intravenous solution has a pH of 5.0±0.5.