Low hygroscopic aripiprazole drug substance and processes for the preparation thereof

  • US 9,359,302 B2
  • Filed: 10/09/2013
  • Issued: 06/07/2016
  • Est. Priority Date: 09/25/2001
  • Status: Active Grant
First Claim
Patent Images

1. Anhydrous aripiprazole crystals having low hygroscopicity, wherein said low hygroscopicity is defined as a moisture content of 0.40% or less when the anhydrous aripiprazole crystals are placed for 24 hours in a dessicator maintained at a temperature of 60°

  • C. and a humidity level of 100%,wherein the anhydrous aripiprazole crystals have one or more of the following properties;

    a powder x-ray diffraction spectrum comprising characteristic peaks at 2θ

    =11.0°

    , 16.6°

    , 19.3°

    , 20.3°

    , and 22.1°

    , using a Cu Kα

    x-ray;

    an infrared absorption spectrum comprising infrared absorption bands at 2945, 2812, 1678, 1627, 1448, 1377, 1173, 960, and 779 cm

    1
    on the IR (KBr) spectrum;

    an endothermic curve comprising an endothermic peak at about 141.5°

    C. in a thermogravimetric or differential thermal analysis (heating rate 5°

    C./min); and

    an endothermic curve comprising an endothermic peak at about 140.7°

    C. in a differential scanning calorimetry analysis (heating rate 5°

    C./min).

View all claims
    ×
    ×

    Thank you for your feedback

    ×
    ×