Liquid pharmaceutical formulations of palonosetron

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.

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.