STABILIZED AMORPHOUS FORM OF IMATINIB MESYLATE

Title:

STABILIZED AMORPHOUS FORM OF IMATINIB MESYLATE

Document Type and Number:

Japanese Patent JP2013227324

Kind Code:

A

Abstract:

To provide a stabilized amorphous form of imatinib mesylate.

A pharmaceutical composition comprises a formulation principle that stabilizes an amorphous form of Imatinib mesylate and amorphous Imatinib mesylate, optionally together with a least one pharmaceutically acceptable carrier. The formulation principle is selected from solid dispersions, cyclodextrin complexes, co-milling with selected excipients. A capsule contains between an amount of stabilized amorphous Imatinib mesylate which corresponds to 50 mg and 200 mg of Imatinib mesylate, wherein the shell contains gelatine, titanium dioxide, or red iron oxide. The ratio of weight of capsule fill to capsule shell is between about 100:25 and 100:50. A tablet comprises an amount of stabilized amorphous Imatinib mesylate which corresponds to 100 mg, 400 mg or 800 mg of Imatinib mesylate.

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Inventors:

GONCALVES ELISABETE
KALB OSKAR
MUTZ MICHAEL
WIRTH WOLFGANG
LAKSHMAN JAY PARTHIBAN

Application Number:

JP2013128722A

Publication Date:

November 07, 2013

Filing Date:

June 19, 2013

Export Citation:

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Assignee:

NOVARTIS AG

International Classes:

A61K31/506; A61K9/20; A61K9/48; A61K47/02; A61K47/40; A61K47/42; A61P35/00; A61P35/02; A61P35/04

Domestic Patent References:

JP2000229887A	2000-08-22
JP2010521477A	2010-06-24

Foreign References:

WO2006133046A2	2006-12-14
WO2005123076A2	2005-12-29
WO2006121941A2	2006-11-16

Other References:

橋田充他, 経口投与製剤の設計と評価, vol. 株式会社薬業時報社, JPN6014023919, 10 February 1995 (1995-02-10), pages 172 - 179, ISSN: 0002830350
BENI,S. ET AL, EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 30, JPN6012043819, 2007, pages 167 - 174, ISSN: 0002830351

Attorney, Agent or Firm:

Aoyama Aoi
Takuji Yamada
Michiko Matsutani
Mitsutaka Iwasaki
Yasushi Ochiai

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