淺析bcs分類與制劑的聯(lián)系-文庫吧
2025-03-25 02:19 本頁面
【正文】 etermined to be 85 percent or more of an administered dose based on a mass balance determination (along with evidence showing stability of the drug in the GI tract) or in parison to an intravenous reference dose.FDA于2017年進(jìn)行了更新，但對高溶解性和高滲透性的定義上沒有變化。CFDA是以劑量判斷溶解性，而FDA是以規(guī)格來判斷。3）EMA判斷The drug substance is consideredhighly solubleif thehighest single doseadministered as immediate release formulation(s) is pletely dissolvedin 250 ml of buffers within the range of pH at 37177。1oC.This demonstration requires the investigation in at leastthree buffers within this range (preferably at pH , and ) and inaddition at the pKa, if it is within the specified pH range.與CFDA、FDA不同的是，、同時(shí)加上pH=pKa(如果pka在該范圍內(nèi))。For this purpose plete absorption is considered to be established where measured extent of absorption is ≥85%. Complete absorption is generally related to high permeability. 即藥物的吸收程度≥85%即認(rèn)為藥物為完全吸收
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