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Last Updated: November 28, 2020

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Claims for Patent: 9,457,020

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Summary for Patent: 9,457,020
Title: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.
Inventor(s): Calderari; Giorgio (Rancate, CH), Bonadeo; Daniele (Casalzuigno, CH), Cannella; Roberta (Varese, IT), Miksztal; Andrew (Palo Alto, CA), Malefyt; Thomas (Carmel Valley, CA), Lee; Kathleen M (Palo Alto, CA)
Assignee: Helsinn Healthcare SA (Lugano, Pazzallo, CH)
Application Number:14/855,564
Patent Claims: 1. 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 ten degrees Celsius; 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 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 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.

2. A pharmaceutically stable solution for preventing or reducing emesis stored by the method of claim 1, said solution comprising a) from 0.01 to about 5.0 mg/ml palonosetron or a pharmaceutically acceptable salt thereof; b) from 10 to about 100 millimoles citrate buffer; c) from 0.005 to about 1.0 mg/ml EDTA; d) mannitol, and wherein the pH of said stable solution is from 4.0 to about 6.0.

3. 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 0.01 mg/mL to about 5.0 mg/mL, (ii) the pH of the solution is from 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 10 to about 100 millimoles citrate buffer and from 0.005 to about 1.0 mg/ml EDTA, (iv) the solution comprises mannitol, or (v) the solution comprises from 10 to about 100 milliMoles of a citrate buffer.

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
AstraZeneca
Johnson and Johnson
McKesson
Boehringer Ingelheim

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