Liquid pharmaceutical formulations of palonosetron
AssigneeHelsinn Healthcare SA
InventorsGiorgio Calderari, Daniele Bonadeo, Roberta Cannella, Enrico Braglia, Riccardo Braglia
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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.
Claims58
1) A pharmaceutically stable solution for preventing or reducing emesis comprising
- a) palonosetron or a pharmaceutically acceptable salt thereof and
- b) a pharmaceutically acceptable carrier,
- wherein the pharmaceutically acceptable carrier comprises mannitol.
32) A pharmaceutically stable solution for preventing or reducing emesis comprising:
- a) from about 0.03 mg/mL to about 0.2 mg/mL palonosetron or a pharmaceutically acceptable salt thereof;
- and
- b) a pharmaceutically acceptable carrier.
42) A pharmaceutically stable intravenous solution for preventing or reducing emesis comprising:
- a) from about 0.01 mg/mL to about 5 mg/mL palonosetron or a pharmaceutically acceptable salt thereof;
- and
- b) a pharmaceutically acceptable carrier.
51) A pharmaceutically stable solution for preventing or reducing emesis comprising:
- a) palonosetron or a pharmaceutically acceptable salt thereof;
- and
- b) a pharmaceutically acceptable carrier,
- at a pH from about 4.0 to about 6.0.
53) A pharmaceutically stable solution for preventing or reducing drug induced emesis comprising
- a) palonosetron or a pharmaceutically acceptable salt thereof and
- b) a pharmaceutically acceptable carrier,
- wherein the pharmaceutically acceptable carrier comprises from about 10 to about 100 milliMoles of a citrate buffer.
56) A pharmaceutically stable solution for preventing or reducing emesis comprising
- a) from about 0.01 to about 5.0 mg/ml palonosetron or a pharmaceutically acceptable salt thereof;
- b) from about 10 to about 100 millimoles citrate buffer;
- and
- c) from about 0.005 to about 1.0 mg/ml EDTA.
57) A method of storing one or more containers in which are contained a solution of palonosetron or a pharmaceutically acceptable salt thereof comprising:
- a) providing a room comprising said one or more containers;
- b) adjusting or maintaining the temperature of the room at greater than about ten degrees celcius;
- c) storing said containers in said room for one month or more,
- wherein (i) the palonosetron or pharmaceutical salt thereof is present in an intravenous formulation at a concentration of from about 0.01 mg/mL to about 5.0 mg/mL, (ii) the pH of the solution is from about 4.0 to about 6.0, (iii) the solution comprises from about 0.01 to about 5.0 mg/ml palonosetron or a pharmaceutically acceptable salt thereof, from about 10 to about 100 millimoles citrate buffer and from about 0.005 to about 1.0 mg/ml EDTA, (iv) the solution comprises mannitol, or (v) the solution comprises from about 10 to about 100 milliMoles of a citrate buffer.
58) A method of filling a container in which is contained a solution of palonosetron or a pharmaceutically acceptable salt thereof comprising:
- a) providing one or more sterile open containers;
- b) filling said containers with a solution of palonosetron in a non-aseptic environment
- c) sealing said filled containers;
- and
- d) sterilizing said sealed, filled containers,
- wherein (i) the palonosetron or pharmaceutical salt thereof is present in an intravenous formulation at a concentration of from about 0.01 mg/mL to about 5.0 mg/mL, (ii) the pH of the solution is from about 4.0 to about 6.0, (iii) the solution comprises from about 0.01 to about 5.0 mg/ml palonosetron or a pharmaceutically acceptable salt thereof, from about 10 to about 100 millimoles citrate buffer and from about 0.005 to about 1.0 mg/ml EDTA, (iv) the solution comprises mannitol, or (v) the solution comprises from about 10 to about 100 milliMoles of a citrate buffer.
Dependencies are inferred from the claim text.