Daiichi Sankyo Company, Limited

Makoto Kamada

Gaku Sekiguchi

Motonori Kidokoro

Hiroshi Nakagawa

Jin Maeda

A real-time release testing capable of constantly ensuring quality, a method for quality testing of a product using real-time release testing, a method for quality testing of an in-process product and/or an end product by real-time release testing, comprising the step of assessing the quality from design space established with only material attributes as inputs, and a manufacturing parameter-independent method for quality testing of a product using real-time release testing.

Product quality control method

It is desired to provide a pharmaceutical composition containing a compound represented by formula (I) or a pharmaceutically acceptable salt thereof, or a solvate thereof, which exhibits an inhibitory effect on activated blood coagulation factor X, and is useful as an agent for preventing and/or treating thrombosis, wherein the pharmaceutical composition exhibits favorable dissolution properties. The present invention provides a method for producing a pharmaceutical composition containing a compound represented by formula (I), comprising the step of mixing a compound represented by formula (I) or a pharmaceutically acceptable salt thereof, or a solvate thereof, one or more excipients selected from the group consisting of a sugar alcohol and a water-swelling additive, a disintegrant, and a binder under conditions for keeping the maximum water content of the granules during granulation at 10% or less.

Method for improving dissolution of anticoagulant agent

It is desired to provide a pharmaceutical composition containing a compound represented by formula (I) or a pharmacologically acceptable salt thereof, or a solvate thereof, which exhibits an inhibitory effect on activated blood coagulation factor X (FXa), and is useful as an agent for preventing and/or treating thrombosis, wherein the pharmaceutical composition exhibits favorable dissolution properties. The present invention relates to a solid pharmaceutical composition containing a compound represented by formula (I) or a pharmacologically acceptable salt thereof, or a solvate thereof, wherein the content of the compound represented by formula (I) is 0.5% by weight or more and less than 15% by weight with respect to the total weight of the pharmaceutical composition.

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Kanagawa, Japan

Makoto Kamada