FORMULATIONS OF BENDAMUSTINE

  • US 20110184036A1
  • Filed: 01/28/2011
  • Published: 07/28/2011
  • Est. Priority Date: 01/28/2010
  • Status: Active Grant
First Claim
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1. A long term storage stable bendamustine-containing composition, comprising:

  • a) bendamustine or a pharmaceutically acceptable salt thereof; and

    b) a pharmaceutically acceptable fluid comprisingi) a member of the group consisting of polyethylene glycol, propylene glycol and mixtures thereof; and

    ii) a stabilizing amount of an antioxidant;

    said bendamustine-containing composition having less than about 5% total impurities, on a normalized peak area response (“

    PAR”

    ) basis as determined by high performance liquid chromatography (“

    HPLC”

    ) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5°

    C. to about 25°

    C.

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