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Title:
ORALLY DISINTEGRATING SUSTAINED RELEASE TABLET CONTAINING AMBROXOL HYDROCHLORIDE
Document Type and Number:
Japanese Patent JP2014101332
Kind Code:
A
Abstract:

To provide an orally disintegrating sustained release tablet containing ambroxol hydrochloride.

An orally disintegrating sustained release tablet is manufactured by: mixing controlled-release fine particles comprising (1) core particles containing ambroxol hydrochloride and a binding agent, (2) a release-controlled layer obtained by mixing a water insoluble polymer and a water soluble polymer which covers the core particles, (3) a protecting layer which is provided outside of the release-controlled layer and contains a water soluble wax type polymer, and (4) controlled-release fine particles composed of an adhesion protecting layer which is provided outside the protecting layer and contains powder that is not dissolved and swelled in the water insoluble polymer and/or water, with quick-release fine particles obtained by covering the core particles containing ambroxol hydrochloride and the binding agent with only the water insoluble polymer or the mixture of the water insoluble polymer and the water soluble polymer so that at least part of ambroxol hydrochloride is released in the stomach; and adding at least a disintegrating agent and a lubricant to the obtained mixture and then compressing and molding.


Inventors:
YAMAZAKI JUNJI
ONISHI HARUMASA
OSAKI MIYUKI
NAKANO YOSHIO
HAYASHIDA TOMOHIRO
Application Number:
JP2012255855A
Publication Date:
June 05, 2014
Filing Date:
November 22, 2012
Export Citation:
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Assignee:
ZENSEI YAKUHIN KOGYO KK
International Classes:
A61K31/137; A61K9/26; A61K47/04; A61K47/12; A61K47/34; A61K47/38; A61P11/06; A61P11/08; A61P11/10
Domestic Patent References:
JP2007153887A2007-06-21
JP2012005181A2012-01-05
JP2012153724A2012-08-16
JP2009524698A2009-07-02
JP2007153887A2007-06-21
JP2012005181A2012-01-05
JP2012153724A2012-08-16
JP2009524698A2009-07-02
Foreign References:
WO2012063257A22012-05-18
WO2012051333A12012-04-19
WO2011066289A12011-06-03
WO2012063257A22012-05-18
WO2012051333A12012-04-19
WO2011066289A12011-06-03
Attorney, Agent or Firm:
Akaoka Michio
Kazuo Akaoka
Akiko Yoshioka