Title:
MIRABEGRON-CONTAINING TABLET, METHOD FOR PRODUCING MIRABEGRON-CONTAINING PHARMACEUTICAL PREPARATION AND METHOD FOR PRODUCING MIRABEGRON-CONTAINING GRANULATED PRODUCT
Document Type and Number:
WIPO Patent Application WO/2017/038281
Kind Code:
A1
Abstract:
[Problem] To provide a mirabegron-containing tablet which retains the amorphous state of mirabegron after long-term storage; a mirabegron-containing pharmaceutical preparation capable of retaining mirabegron purity by preventing analog formation during storage; a method for producing a mirabegron-containing pharmaceutical preparation; and a method for producing a mirabegron-containing granulated product. [Solution] According to one embodiment of the present invention, provided is a mirabegron-containing pharmaceutical preparation, characterized in comprising mirabegron, and hypromellose and polyvinyl pyrrolidone. The mirabegron-containing pharmaceutical preparation may comprise a spray-dried granulated product comprising the mirabegron and the hypromellose and the polyvinyl pyrrolidone.
Inventors:
YANAGI TOSHIHIRO (JP)
NOZAWA KENJI (JP)
UMEMURA KAORI (JP)
ARIMURA MASATOSHI (JP)
TAKADA AKIKO (JP)
NOZAWA KENJI (JP)
UMEMURA KAORI (JP)
ARIMURA MASATOSHI (JP)
TAKADA AKIKO (JP)
Application Number:
PCT/JP2016/071140
Publication Date:
March 09, 2017
Filing Date:
July 19, 2016
Export Citation:
Assignee:
SAWAI SEIYAKU KK (JP)
International Classes:
A61K31/426; A61K9/14; A61K9/20; A61K47/32; A61K47/38; A61P13/10
Domestic Patent References:
| WO2010038690A1 | 2010-04-08 | |||
| WO2012156998A2 | 2012-11-22 | |||
| WO2011152297A1 | 2011-12-08 | |||
| WO2006064906A1 | 2006-06-22 |
Foreign References:
| JP2015515522A | 2015-05-28 | |||
| JP2014507449A | 2014-03-27 |
Other References:
KALARIYA, P.D. ET AL.: "Characterization of stress degradation products of mirabegron using UPLC-QTOF-MS/MS and in silico toxicity predictions of its degradation products", RSC ADV., vol. 5, no. 39, 26 March 2015 (2015-03-26), pages 31024 - 31038, XP055367752, ISSN: 2046-2069
See also references of EP 3345600A4
See also references of EP 3345600A4
Attorney, Agent or Firm:
TAKAHASHI, HAYASHI AND PARTNER PATENT ATTORNEYS, INC. (JP)
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