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Process For Preparing Crystalline Form A Of Lansoprazole

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اقرأ أكثر حفظ في قائمتي
  • Publication Date:
    January 15, 2009
  • معلومة اضافية
    • Document Number:
      20090018339
    • Appl. No:
      12/159922
    • Application Filed:
      January 04, 2007
    • نبذة مختصرة :
      The present invention relates to a process for preparing Crystalline Form A of Lansoprazole. Specifically, the present invention relates to a process for preparing highly pure Crystalline Form A of Lansoprazole in a large scale without any additional conversion step, even by using ethanol in which Crystalline Form B is easily formed.
    • Inventors:
      Moon, Seong Cheol (Gyeonggi-do, KR); Song, In Woong (Gyeonggi-do, KR); Kang, Doo Sung (Gyeonggi-do, KR); Oh, Seong Soo (Gyeonggi-do, KR); Lee, Sung Jae (Seoul, KR)
    • Assignees:
      Daewoong Pharmaceutical Co., Ltd. (Sungnam-si, Kyunggi-do, KR), Daewoong Chemical Co., Ltd. (Hwaseong-si, Gyeonggi-do, KR)
    • Claim:
      1. A process for preparing Crystalline Form A of Lansoprazole, which comprises dissolving Lansoprazole obtained by oxidation of 2-([3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]-methyl)thio-1H-benzimidazole in ethanol, adding water, stirring the mixture at the temperature range of from 15 to 40° C. for 0.5 to 4 hours, filtering, and drying.
    • Claim:
      2. The process of claim 1, wherein ethanol is used in an amount of 1 to 50 parts by weight per 1 part by weight of Lansoprazole.
    • Claim:
      3. The process of claim 1 or 2, wherein the used ethanol has a purity of 95 to 99%.
    • Claim:
      4. The process of claim 1, wherein the color of the solution is removed by using charcoal and sodium hydrosulfite (Na2S2O4) before water is added.
    • Claim:
      5. The process of claim 4, wherein the solution is adjusted to pH 8˜9 by using a base.
    • Claim:
      6. The process of claim 1, wherein water is used in an amount of 2 to 2.5 times by volume to ethanol.
    • Claim:
      7. The process of claim 1, wherein water is added dropwise over from 20 minutes to 1 hour.
    • Claim:
      8. The process of claim 1, wherein the stirring temperature is controlled to 18 to 22° C. after water is added.
    • Claim:
      9. The process of claim 1, wherein the stirring time is controlled to 1 to 2 hours after water is added.
    • Claim:
      10. The process of claim 1, wherein the drying is carried out under vacuum.
    • Claim:
      11. The process of claim 10, wherein vacuum drying is carried out for 4 to 24 hours at 35˜40° C.
    • Current U.S. Class:
      5462/737
    • Current International Class:
      07
    • الرقم المعرف:
      edspap.20090018339