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Title:
高分子担体含有医薬組成物の類縁物質分析方法
Document Type and Number:
Japanese Patent JP6625197
Kind Code:
B2
Abstract:
A method for analyzing related substances in a pharmaceutical composition containing an amphiphilic block copolymer comprising a hydrophilic block and a hydrophobic block as a polymeric drug carrier, related substances identified thereby, and a method for evaluating a pharmaceutical composition by using the same are provided. Preferably, the method comprises evaluating a polymeric micelle pharmaceutical composition, which comprises an amphiphilic block copolymer comprising a hydrophilic block (A) and a hydrophobic block (B), and paclitaxel or docetaxel as a poorly water-soluble drug, by using a compound represented by Chemical Formula 1, wherein the hydrophilic block (A) comprises one or more selected from the group consisting of polyethylene glycol or derivatives thereof, polyvinylpyrrolidone, polyvinyl alcohol, polyacrylamide and combinations thereof; and the hydrophobic block (B) is polylactide.

Inventors:
Kim Helim
Kim Ji Young
Min Pom Chan
Seo Min Hyo
Choi Ho Jun
Application Number:
JP2018504294A
Publication Date:
December 25, 2019
Filing Date:
July 28, 2016
Export Citation:
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Assignee:
SAMYANG BIOPHARMACEUTICALS CORPORATION
International Classes:
G01N30/88; B01J20/281; B01J20/283; B01J20/285; C07D305/14; G01N27/62; G01N30/60; G01N30/72; G01N30/74
Domestic Patent References:
JP2013516407A
JP2012513984A
JP2013541022A
JP2000507930A
Foreign References:
US20070112207
Other References:
Dana Ciutaru et al.,A HPLC validated assay of paclitaxel's related impurities in pharmaceutical forms containing Cremophor EL,Journal of Pharmaceutical and Biomedical Analysis,2004年,P493-499
Attorney, Agent or Firm:
Samejima Mutsumi
Yasushi Ochiai