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Title:
STABILIZED PHARMACEUTICAL COMPOSITION
Document Type and Number:
WIPO Patent Application WO/2008/023807
Kind Code:
A1
Abstract:
[PROBLEMS] To provide a stabilized liquid pharmaceutical composition comprising 1-(2-methoxyethyl)-2-methyl-4,9-dioxo-3-(pyrazin-2-ylmethyl)-4,9-dihydro-1H-naphtho[2,3-d]imidazol-3-ium or a pharmaceutically acceptable salt thereof, in which the degradation of the compound over time can be prevented when the pharmaceutical composition is applied to clinical practice, and also provide a method for stabilizing the liquid pharmaceutical composition. [MEANS FOR SOLVING PROBLEMS] A stabilized liquid pharmaceutical composition comprising 1-(2-methoxyethyl)-2-methyl-4,9-dioxo-3-(pyrazin-2-ylmethyl)-4,9-dihydro-1H-naphtho[2,3-d]imidazol-3-ium or a pharmaceutically acceptable salt thereof, characterized by further containing at least one member selected from the group consisting of carbazochrome sodium sulfonate and a derivative thereof, vitamin C, butyl hydroxyanisole, vitamin E, vitamin P, gallic acid, propyl gallate, alpha-thioglycerin and cysteine hydrochloride; a lyophilized product of the pharmaceutical composition; and a method for stabilizing the pharmaceutical composition.

Inventors:
MURAI MAKOTO (JP)
YONEMOCHI YUICHI (JP)
SHAKUSHIRO KOHSUKE (JP)
KASAI AKIHIRO (JP)
Application Number:
PCT/JP2007/066495
Publication Date:
February 28, 2008
Filing Date:
August 24, 2007
Export Citation:
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Assignee:
ASTELLAS PHARMA INC (JP)
MURAI MAKOTO (JP)
YONEMOCHI YUICHI (JP)
SHAKUSHIRO KOHSUKE (JP)
KASAI AKIHIRO (JP)
International Classes:
A61K31/497; A61K9/08; A61K47/10; A61K47/12; A61K47/14; A61K47/18; A61K47/20; A61K47/22
Domestic Patent References:
WO2004092160A12004-10-28
WO2001060803A12001-08-23
WO2004092160A12004-10-28
WO2001080858A12001-11-01
Foreign References:
JPH07126017A1995-05-16
JP2003128548A2003-05-08
JPH07126017A1995-05-16
JPH11193233A1999-07-21
Other References:
OKANO S.: "Shin. Yakuzaigaku Soron", vol. 3RD ED., 10 April 1987, HAKKO, NANKODO CO., LTD., pages: 359 - 361, XP003020285
KOSHIRO A.: "Cefotiam no Haigoekichu ni Okeru Anteisei", JOURNAL OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY, JAPAN, vol. 42, no. 4, 1982, pages 370 - 376, XP003020286
YAMAJI A.: "Stability of ritodrine hydrochloride in infusion solution", JAPANESE JOURNAL OF PHARMACEUTICAL HEALTH AND CARE AND SCIENCES, vol. 13, no. 5, 1987, pages 298 - 303, XP003020287
DATABASE CAPLUS [online] GOTO K.: "Characteristics changes of injection formulations. 4. Incompatibility of latamoxef sodium injection", XP003020288, Database accession no. (1984:428158)
TAKEUCHI TOKUO ET AL.: "Studies on the DPPH Radical Scavenging ability of Miso", BULLETIN OF GIFU WOMEN'S COLLEGE, vol. 33, 2004, pages 115 - 122
Attorney, Agent or Firm:
MORITA, Hiroshi et al. (3-11 Nihonbashi-Honcho 2-chom, Chuo-ku Tokyo 11, JP)
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