低用量タクロリムス分包品の調製方法の確立

Abstract

Doses of tacrolimus less than the standard dose (0.5mg) have often been prescribed for pediatric transplantpatients. When preparing 0.1mg tacrolimus in a package, 13mg (contain 0.1mg tacrolimus) was used with a 0.5mg Prograf® capsule (the total amount of 65mg), and then it was packaged by hand. However, it is difficult to prepare such drugs for many transplant patients, since this method is very complicated. Therefore, we examined how to prepare low dose packages of tacrolimus package easily and correctly without making any packaging errors. To reduce any preparation errors, the bulk of tacrolimus was increased by mixing it with lactose. The contents of tacrolimus in the prepared package and the blood of patient were measured using the microparticle enzyme immunoassay (IMX). When mixing the medicine and lactose, the mixing errors using a sieve were fewer than when using a mortar and pestle. Regarding package errors (CV), packaging by hand resulted in fewer errors than when using an automatic packaging machine. Moreover, the preparation time of packaging significantly decreased when using this method, in comparison to the conventional method, and no difference was found in the blood concentration of tacrolimus in pediatric liver transplant patients, who took the medicine prepared by both conventional and the present methods. Therefore, when drugs need to be packaged at doses lower than the standard doses, such drugs should be mixed by a sieve and then be packed by hand to reduce preparation errors.