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Title:
NOVEL PHARMACEUTICAL FORMULATION CONTAINING BIGUANIDE AND THIAZOLIDINEDIONE DERIVATIVE
Document Type and Number:
Japanese Patent JP2013209426
Kind Code:
A
Abstract:

To provide a pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative.

A pharmaceutical dosage form comprises: a compressed tablet core comprising at least one pharmaceutically acceptable excipient and metformin hydrochloride; an osmotic tablet comprising a sustained release membrane surrounding the compressed tablet core, with which the metformin hydrochloride is released from the osmotic tablet so that the peak plasma level of the metformin is obtained between 6-12 hours after administration after meal; and an immediate release layer surrounding the sustained release membrane of the osmotic tablet, containing pioglitazone hydrochloride and a low-viscosity water-soluble binder, hydroxypropyl cellulose, that has a viscosity between 2 and 6 mPa.S when tested as a 2% aqueous solution at 20°C.


Inventors:
OKOCHI KAZUHIRO
NANGIA AVINASH
LODIN UNCHALEE
CARDINAL JACK R
Application Number:
JP2013129075A
Publication Date:
October 10, 2013
Filing Date:
June 19, 2013
Export Citation:
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Assignee:
ACTAVIS INC
TAKEDA CHEMICAL INDUSTRIES LTD
International Classes:
A61K31/155; A61K9/00; A61K9/20; A61K9/22; A61K9/24; A61K9/26; A61K9/28; A61K9/36; A61K31/425; A61K31/426; A61K31/4439; A61K45/06; A61K47/38; A61P3/10
Domestic Patent References:
JP2002326927A2002-11-15
JP2003514011A2003-04-15
Foreign References:
WO2004026241A22004-04-01
WO2002060448A12002-08-08
US20040161462A12004-08-19
Other References:
FUKUI, E. ET AL., JOURNAL OF CONTROLLED RELEASE, vol. 68, JPN6013005477, 2000, pages 215 - 223, ISSN: 0002852857
HANDBOOK OF PHARAMACEUTICAL EXCIPIENTS, vol. Fourth Edition, JPN6013051014, 2003, pages 289 - 293, ISSN: 0002852858
Attorney, Agent or Firm:
Kimura Mitsuru
Takuji Harada
Takanori Mamoru
Taiji Morikawa
Amamiya Yasuhito
Kei Sakurada
Mie Hideki