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Title:
METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS
Document Type and Number:
Japanese Patent JP2015193668
Kind Code:
A
Abstract:
PROBLEM TO BE SOLVED: To provide methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans.SOLUTION: Methods for producing stabilized solid dosage form pharmaceutical compositions are provided. Specifically, methods for preparing protected granules containing morphinans, and solid dosage form pharmaceutical compositions produced using the morphinan-protected granules are provided. Another aspect of this disclosure provides granules that are substantially resistant to oxidative degradation of hydrocodone. The granules include an internal region that substantially contains hydrocodone and is surrounded by an external region that substantially contains at least one additive. The granules contain less than about 0.5% w/w, based on the total mass of hydrocodone, of a degradant selected from hydrocodone n-oxide and hydrocodone aldol dimer after being stored for 6 months at 40°C and 75% relative humidity.

Inventors:
PARK JAE HAN
TIFFANI EISENHAUER
ANISH DHANARAJAN
VISHAL K GUPTA
STEPHEN OVERHOLT
Application Number:
JP2015154715A
Publication Date:
November 05, 2015
Filing Date:
August 05, 2015
Export Citation:
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Assignee:
MALLINCKRODT LLC
International Classes:
A61K31/485; A61K9/16; A61K9/20; A61K9/24; A61K9/48; A61K9/54; A61K31/167; A61K45/00; A61K47/12; A61K47/18; A61K47/34; A61K47/36; A61K47/38; A61P25/04; A61P43/00
Domestic Patent References:
JP2009545560A2009-12-24
JP2009108083A2009-05-21
JP2009539761A2009-11-19
JP2009528328A2009-08-06
JP2007084568A2007-04-05
JP2008501750A2008-01-24
JP2007522196A2007-08-09
JP2007509979A2007-04-19
JP2008231110A2008-10-02
JP2004512354A2004-04-22
Foreign References:
WO2009035474A12009-03-19
WO2008033523A12008-03-20
Attorney, Agent or Firm:
Takeshi Oshio



 
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