公开(公告)号：KR101390946B1

公开(公告)日：2014-05-02

申请号：KR1020120080062

申请日：2012-07-23

Applicant: 아주대학교산학협력단

Inventor： 이범진 ,  박준범

IPC: A61K31/5575 ,  A61K31/18 ,  A61K31/4015 ,  A61K9/16

Abstract: 본발명은녹는점이 70℃이하인중합체 100 중량부에약제학적활성성분 0.0001 내지 2 중량부를혼합하는단계; 상기혼합액을 30 내지 70℃에서고온-용융압출시켜압출물(extrudate)을형성하는단계; 및상기압출물을약제학적조성물로제제화하는단계를포함하는, 고온용융압출을이용한저함량약제학적조성물의제조방법에관한것이다. 본발명의제조방법에따르면, 일반적인활성성분에비해상대적으로낮은용융점을갖는중합체를사용하여중합체는고온-용융압출방법에의해녹고, 활성성분은녹지않는방식을통해활성성분의분해와변화를방지하며약물의제제화가가능하며, 이를통해대표적인저함량약물인리마프로스트, 탐슐로신, 글리메피리드등의함량균일성을유지하며제제화가가능하다. .

公开(公告)号：KR1020140021081A

公开(公告)日：2014-02-20

申请号：KR1020120080062

申请日：2012-07-23

Applicant: 아주대학교산학협력단

Inventor： 이범진 ,  박준범

IPC: A61K31/5575 ,  A61K31/18 ,  A61K31/4015 ,  A61K9/16

CPC classification number: A61K31/192 ,  A61K31/18 ,  A61K31/64 ,  A61K47/30

Abstract: The present invention relates to a preparation method of a low dose pharmaceutical composition using a hot melt extrusion method, which comprises the steps of: mixing 0.0001-2 parts by weight of pharmaceutically active ingredients with 100 parts by weight of polymers having 70°C or less of melting points; forming extrudates by hot melt extruding the mixed solution at 30-70°C; and formulating the extrudates in pharmaceutical compositions. According to the preparation method of the present invention, polymers are melted by the hot melt extrusion method by using polymers having a relatively lower melting point than the melting point of general active compositions; the active composition prevents decomposition and change of the active compositions through a non-melting method; and formulation of drugs is facilitated so that content uniformity of limaprost, tamsulosin, glimepiride, and the likes which are low dose drugs can be maintained and formulation can be facilitated.

Abstract translation: 本发明涉及使用热熔挤出法的低剂量药物组合物的制备方法，其包括以下步骤：将0.0001-2重量份的药物活性成分与100重量份的具有70℃的聚合物或 熔点少; 通过在30-70℃下热熔融挤出混合溶液形成挤出物; 并在药物组合物中配制挤出物。 根据本发明的制备方法，通过使用具有比一般活性组合物的熔点相对较低的熔点的聚合物，通过热熔融挤出方法熔融聚合物; 活性组合物通过非熔化方法防止活性组合物的分解和变化; 并且促进药物的配制，使得可以维持利马前列素，坦索罗辛，格列美脲等作为低剂量药物的含量均匀性，并且可以促进配制。