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Title:
ORALLY ADMINISTERED MEDICAL COMPOSITION
Document Type and Number:
WIPO Patent Application WO/2014/034860
Kind Code:
A1
Abstract:
In order to provide to clinical practices a single pharmaceutical preparation having a controlled release part including mirabegron or a pharmaceutically acceptable salt thereof and a rapid release part including solifenacin or a pharmaceutically acceptable salt thereof: (1) provided is a single pharmaceutical preparation wherein the elution profile of each medication is unchanged from conventional pharmaceutical preparations; and (2) provided is a single pharmaceutical preparation having a maximum medication elution rate of at least 90% for each medication and exhibiting a similar bioavailability to conventional pharmaceutical preparations. Furthermore, (3) a single pharmaceutical preparation is provided that exhibits good productivity whereby tableting problems are suppressed and exhibits good storage stability whereby coloration of the rapid release part thereof is suppressed.　This orally administered medical composition contains (1) a controlled release part including mirabegron or a pharmaceutically acceptable salt thereof and (2) a rapid release part including solifenacin or a pharmaceutically acceptable salt thereof and calcium stearate.

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Inventors:
TSUTSUI YUUKI (JP)
TOYOTA HIROYASU (JP)
HAKOMORI TADASHI (JP)
Application Number:
PCT/JP2013/073351
Publication Date:
March 06, 2014
Filing Date:
August 30, 2013
Export Citation:
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Assignee:
ASTELLAS PHARMA INC (JP)
International Classes:
A61K31/4725; A61K9/24; A61K31/426; A61K47/12; A61K47/32; A61K47/34; A61K47/38; A61P13/00
Domestic Patent References:
WO2012018773A12012-02-09
WO2010038690A12010-04-08
WO2010090172A12010-08-12
WO2013129644A12013-09-06
WO2004041276A12004-05-21
WO1999020607A11999-04-29
WO2003037881A12003-05-08
WO2010038690A12010-04-08
WO1996020194A11996-07-04
WO2009057685A12009-05-07
WO2010090172A12010-08-12
Foreign References:
US6017927A2000-01-25
Other References:
TAKASHI MAKIMURA: "Stearic Acid Calcium no Kino to Shokuhin Bun'ya eno Oyo", FOOD CHEMICALS, vol. 22, no. 8, 2006, pages 38 - 43, XP008178663
YUICHIRO OGAWA ET AL.: "Josei OAB Kanja ni Taisuru Solifenacin Heiyo Mirabegron no Yukosei no Rinshoteki Kento", LUTS: LOWER URINARY TRACT SYMPTOMS 1757-5664, vol. 23, no. 1, 10 August 2012 (2012-08-10), pages 233, O-112, XP008178667
See also references of EP 2891493A4
Attorney, Agent or Firm:
MORITA Kenichi et al. (JP)
Ken-ichi Morita (JP)
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