IP Library › Patent Application 14052925
Patent Application
App. No. 14/052,925

LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON

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Quick Facts
Patent No.
US None
App. No.
14/052,925
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.

Claims (18)

1 - 55 . (canceled)

56 . A pharmaceutically stable solution for preventing or reducing emesis stored by the method of claim 57 , said solution 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;

c) from about 0.005 to about 1.0 mg/ml EDTA;

d) mannitol,

and wherein the pH of said stable solution is from about 4.0 to about 6.0.

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.