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1. (WO2014207956) PRODUCTION METHOD FOR MEDICINAL PREPARATION, AND MEDICINAL PREPARATION KIT

Pub. No.:    WO/2014/207956    International Application No.:    PCT/JP2013/081190
Publication Date: Thu Jan 01 00:59:59 CET 2015 International Filing Date: Wed Nov 20 00:59:59 CET 2013
IPC: A61K 38/00
A61K 9/08
A61K 39/12
A61K 39/395
A61K 48/00
Applicants: YASUI Kiyotada
安井 清忠
Inventors: YASUI Kiyotada
安井 清忠
Title: PRODUCTION METHOD FOR MEDICINAL PREPARATION, AND MEDICINAL PREPARATION KIT
Abstract:
Provided is a production method for a medicinal preparation comprising a first preparation component and a second preparation component, wherein the method includes: a step of preparing a first preparation component that is an active pharmaceutical ingredient previously demonstrated in non-clinical studies to be stable, effective, and safe, and that comprises an effective component and a solvent only, the effective component being either a protein preparation component, a nucleic acid preparation component, or a vaccine preparation component; a step of preparing a second preparation component which, in the event that the effective component is a protein preparation component or a nucleic acid preparation component, contains at least one type of preparation additive, or in the event that the effective component is a vaccine preparation component, contains at least one type of adjuvant and/or preparation additive; a step in which an adsorption preventive agent is filtered through a filtration sterilization filter to effect adsorption preventive treatment of the filtration sterilization filter; a step of filtration sterilization of the first preparation component through the filtration -sterilization filter; and a step of formulation through mixing the filtration-sterilized first preparation component and the second preparation component in any proportion, making possible administration without the need to evaluate stability in clinical studies.