Title:
CRYSTALLINE POLYMORPHIC FORM OF ULIPRISTAL ACETATE
Document Type and Number:
WIPO Patent Application WO/2014/050106
Kind Code:
A1
Abstract:
A novel crystalline polymorphic form of ulipristal acetate useful as an agent for preventing and/or treating uterine leiomyoma and as a contraceptive, and a process for producing the crystalline polymorphic form are provided. The novel crystalline polymorphic form of ulipristal acetate is obtained by dissolving an isopropanol-solvated crystal of ulipristal acetate in a mixed solvent containing ethanol and water, and crystallizing an ulipristal acetate from the solution without addition of a seed crystal to the solution.
Inventors:
IWASHITA SHIGEKI (JP)
HAYASHI HIROYUKI (JP)
MIYAZAKI KOICHI (JP)
HAYASHI HIROYUKI (JP)
MIYAZAKI KOICHI (JP)
Application Number:
PCT/JP2013/005709
Publication Date:
April 03, 2014
Filing Date:
September 26, 2013
Export Citation:
Assignee:
ASKA PHARM CO LTD (JP)
International Classes:
C07J41/00; A61K31/58; A61P5/36
Domestic Patent References:
| WO1996030390A2 | 1996-10-03 | |||
| WO2007144674A1 | 2007-12-21 | |||
| WO1989012448A1 | 1989-12-28 | |||
| WO1996030390A2 | 1996-10-03 | |||
| WO2010119029A1 | 2010-10-21 |
Foreign References:
| EP1602662A1 | 2005-12-07 | |||
| JP2953725B2 | 1999-09-27 | |||
| JP2006519255A | 2006-08-24 | |||
| JP2006515869A | 2006-06-08 | |||
| JP2009539964A | 2009-11-19 |
Other References:
DATABASE CA [online] CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; LUO, JUNZHI ET AL: "Ulipristal acetate with polymorph and preparation method thereof", XP002718838, retrieved from STN Database accession no. 2012:1391254
RAO P N ET AL: "A practical large-scale synthesis of 17alpha-acetoxy-11beta-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-di one (CDB-2914)", STEROIDS, ELSEVIER SCIENCE PUBLISHERS, NEW YORK, NY, US, vol. 65, no. 7, 1 July 2000 (2000-07-01), pages 395 - 400, XP004222665, ISSN: 0039-128X, DOI: 10.1016/S0039-128X(00)00100-8
DATABASE CA [online] CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; TIAN, WEIXUE ET AL: "New crystal structure for steroidal compound and manufacture method thereof", XP002718880, retrieved from STN Database accession no. 2013:1074939
"Handbook of Pharmaceutical Excipients", 1989, MARUZEN COMPANY, LTD.
"Japanese Pharmaceutical Excipients Dictionary 2007", July 2007, YAKUJI NIPPO LTD.
"Pharmaceutics", 1997, NANKODO, CO., LTD.
"Japanese Pharmaceutical Excipients 2003", August 2003, YAKUJI NIPPO LTD.
RAO P N ET AL: "A practical large-scale synthesis of 17alpha-acetoxy-11beta-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-di one (CDB-2914)", STEROIDS, ELSEVIER SCIENCE PUBLISHERS, NEW YORK, NY, US, vol. 65, no. 7, 1 July 2000 (2000-07-01), pages 395 - 400, XP004222665, ISSN: 0039-128X, DOI: 10.1016/S0039-128X(00)00100-8
DATABASE CA [online] CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; TIAN, WEIXUE ET AL: "New crystal structure for steroidal compound and manufacture method thereof", XP002718880, retrieved from STN Database accession no. 2013:1074939
"Handbook of Pharmaceutical Excipients", 1989, MARUZEN COMPANY, LTD.
"Japanese Pharmaceutical Excipients Dictionary 2007", July 2007, YAKUJI NIPPO LTD.
"Pharmaceutics", 1997, NANKODO, CO., LTD.
"Japanese Pharmaceutical Excipients 2003", August 2003, YAKUJI NIPPO LTD.
Attorney, Agent or Firm:
KUWATA, Mitsuo (6th Floor Minato Umeda Building, 3-17, Nishitemma 6-chome, Kita-ku, Osaka-sh, Osaka 47, JP)
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