CAO, LINQIU,凯欧霖秋,凱歐霖秋,LANGRIDGE, JOHN RICHARD,连圭居约翰理查,連圭居約翰理查,VAN GESSEL, ALEXANDER WILHELMUS,格赛尔亚历山大威浩缪思,格賽爾亞歷山大威浩繆思
申请号：
TW096147757
公开号：
TWI413532B
申请日:
2007.12.13
申请国别(地区):
TW
年份:
2013
代理人:
摘要：
The invention pertains to controlled release excipient composition suitable in formulation of a slow or extended release tablet, wherein the composition contains a synergistic mixture of substantially uncross-linked carboxymethyl starch, or sodium starch glycolate (SSG), and a hydrophilic, non-ionic cellulose ether, preferably hydroxypropylmethylcellulose. Whether or not a SSG in the mixture is sufficiently uncross-linked in the context of the invention can be determined by means of sedimentation: 0.25 g of the formulation in 100 ml deionized water after 24 hours at, if subjected to centrifugation at 6080 G at 25 ℃ for 15 minutes, should exhibit a sedimentation volume of more than 60 ml.本發明係關於控制釋放之賦形劑組合物,其適用於一緩慢或延長釋放之片劑配方,其中所述之組合物包含一實質上無交聯之羧甲基澱粉或澱粉乙醇酸鈉(SSG)及一親水性、非離子性之纖維素醚,且以羥丙基甲基纖維素醚為佳。在本發明文中,混合物中之一SSG是否充分無交聯,可用沈降的方法決定:0.25公克之配方於25℃下在100毫升去離子水中經過24小時後,如果於25℃下接受6080G離心15分鐘,應展現出大於60毫升之沈降體積。
