Method for evaluating lipid a analog-containing injections
AssigneeEisai Co., Ltd.
InventorsKazuhiro Kaneko, Tomohiro Watanabe, Yasuyuki Asai, Yoshihisa Sano, Kiyomi Kikuchi, Ikuo Kushida, Kazuhide Ashizawa
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Abstract
The present invention provides an evaluation method and preparation process of injection containing a lipid A analog. Specifically, it provides, in an injection preparation containing a lipid A analog or a pharmacologically acceptable salt thereof, forecasting and evaluating methods of the pharmacokinetics of the lipid A analog, and quality evaluating method and preparation process of the injection, which each comprises measuring membrane fluidity and/or circular dichroism.
Claims22
A method of forecasting a pharmacokinetic parameter of a lipid A analog as an aggregate structure in solution or in an injection preparation, wherein said aggregate structure in solution or injection preparation contains a lipid A analog or a pharmacologically acceptable salt thereof, said method comprising
- measuring at least one of membrane fluidity and circular dichroism of the solution or the injection preparation;
- preparing a plurality of lots of solutions, each solution having a unique, known value of said pharmacokinetic parameter;
- measuring the membrane fluidity or circular dichroism of said plurality of lots of solutions;
- preparing a graphical correlation for said plurality of lots of solutions, said correlation being between the
- membrane fluidity or circular dichroism and said unique, known value of said pharmacokinetic parameter.
A method of forecasting a pharmacokinetic parameter of a lipid A analog as an aggregate structure in solution or in an injection preparation, wherein said aggregate structure in solution or injection preparation contains a lipid A analog or a pharmacologically acceptable salt thereof, said method comprising
- measuring at least one of membrane fluidity and circular dichroism of the solution or the injection preparation;
- preparing a plurality of lots of solutions, each solution having a unique, known value of said membrane fluidity or circular dichroism;
- measuring the pharmacokinetic parameter of said plurality of lots of solutions;
- preparing a graphical correlation for said plurality of lots of solutions, said correlation being between the pharmacokinetic parameter and said unique, known value of membrane fluidity or circular dichroism.
Dependencies are inferred from the claim text.