Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament

  • US 7,309,707 B2
  • Filed: 03/10/2003
  • Issued: 12/18/2007
  • Est. Priority Date: 03/20/2002
  • Status: Active Grant
First Claim
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1. Crystalline tiotropium bromide micronisate, characterised by a particle size X50 of between 1.0 μ

  • m and 3.5 μ

    m at a Q(5.8) value of more than 60%, by a specific surface value in the range between 2 m2/g and 5 m2/g, by a specific heat of solution of more than 65 Ws/g and by a water content from about 1% to about 4.5%, wherein the crystalline tiotropium bromide micronisate is obtained from crystalline tiotropium bromide monohydrate, which crystalline tiotropium bromide monohydrate when thermally analysed by DSC has an endothermic maximum at 230±



    C. at a heating rate of 10K/min, has an IR spectrum which has bands inter alia at wavelengths 3570, 3410, 3105, 1730, 1260, 1035 and 720 cm

    1
    and which is characterised by a simple monoclinic cell with the following dimensions;

    a=18.0774 Å

    , b=11.9711 Å

    , c=9.9321 Å

    , β

    =102.691°

    , V=2096.96 Å

    3.

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