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Title:
安定な医薬製剤
Document Type and Number:
Japanese Patent JP2011520889
Kind Code:
A
Abstract:
Stable pharmaceutical formulations and methods of making same are provided. In a general embodiment, the present disclosure provides a method of making a stable pharmaceutical formulation comprising adding one or more vitrifying additives to an aqueous pharmaceutical solution to raise the glass transition temperature of the aqueous pharmaceutical solution. The aqueous pharmaceutical solution can be cooled to a temperature of about −50° C. to about −10° C. The vitrifying additive enhances the formation of a glass or amorphous solid of the aqueous pharmaceutical solution at cryogenic temperatures (−50 to −10° C.), and the pharmaceutical formulation can be thawed to liquid form and administered to a mammalian subject.

Inventors:
Kip, James E.
Wong, Joseph Sea. Tea.
Nea, lakshmi
Mirror, reagan
Rabinau, Barrett E.
Application Number:
JP2011509571A
Publication Date:
July 21, 2011
Filing Date:
May 08, 2009
Export Citation:
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Assignee:
BAXTER INTERNATIONAL INCORP0RATED
BAXTER HEALTHCARE S.A.
International Classes:
A61K31/407; A61K47/40; A61P31/04; A61P31/10
Domestic Patent References:
JPH0769887A1995-03-14
JPH051075A1993-01-08
JPH0920688A1997-01-21
Foreign References:
WO2006078066A12006-07-27
WO2007142212A12007-12-13
Other References:
JPN7013003634; メロペネム点滴静注用バッグ0.5g(NP)添付文書, 2011
Attorney, Agent or Firm:
Hidesaku Yamamoto
Takaaki Yasumura
Natsuki Morishita