NICHIRIN CHEMICAL INDUSTRIES, LTD.;DAICEL CORPORATION
发明人:
HIRAMURA, TAKAHIRO,平邑隆弘,IKURA, KIYOSHI,以仓圣,以倉聖,ISHIKAWA, SAE,石川左枝,OKABAYASHI, TOMOHITO,冈林智仁,岡林智仁,HASHIKAWA, NAOHIRO,桥川尙弘,橋川尙弘,MORITA, TETSURO,森田哲郎,IKEDA, KIMIKO,池田君子,WAKAYAMA, HARU
申请号：
TW102111387
公开号：
TW201400145A
申请日:
2013.03.29
申请国别(地区):
TW
年份:
2014
代理人:
摘要：
The purpose of the present application is to provide an orally disintegrating tablet having excellent tablet hardness and disintegrating performance, a disintegrating particulate composition by which the orally disintegrating tablet is obtained with relatively low tablet compression force and which is able to impart excellent moldability, a method for producing the same, and the like. The present application pertains to: a method for producing a disintegrating particulate composition including the three components of a first disintegrating tablet component comprising acid-type carboxymethylcellulose, a second disintegrating tablet component, and an excipient, wherein the method includes a first wet granulation step for using any two components of the three components, and a second wet granulation step for using the granulated material obtained in the first wet granulation step and the remaining one component of the three components； a production method further including crystalline cellulose as a fourth component； a production method comprising a third step for mixing crystalline cellulose into the granulated material obtained in the second wet granulation step； disintegrating particulate compositions obtained by these production methods； and the like.本發明之目的在於提供一種具有優異之錠劑硬度及崩壞性之口腔內崩壞錠劑、及即便以相對較低之打錠壓縮力亦可獲得此種口腔內崩壞錠劑即亦可賦予優異之成形性之崩壞性粒子組成物及其製造方法等。本發明係關於一種崩壞性粒子組成物之製造方法，係包含由酸型羧甲基纖維素(acidic carboxymethyl cellulose)構成之第一崩壞劑成分、酸型羧甲基纖維素以外之第二崩壞劑成分及賦形劑的三成分之崩壞性粒子組成物的製造方法，其特徵在於包含：第一濕式造粒步驟，其使用該三成分中之任意二成分；及第二濕式造粒步驟，其至少使用經第一濕式造粒步驟獲得之造粒物與第一濕式造粒步驟中未使用之剩餘之一成分；本發明關於一種進而含有結晶纖維素作為第四成分之該製造方法、進而包含對經第二濕式造粒步驟獲得之造粒物中混合結晶纖維素之第三步驟的該製造方法、以及藉由該等製造方法獲得之崩壞性粒子組成物。
