公开(公告)号：US06552024B1

公开(公告)日：2003-04-22

申请号：US09434878

申请日：1999-11-05

申请人： Li-Lan H. Chen ,  William R. Pfister ,  Donald W. Renn ,  Thitiwan Buranachokpaisan ,  James Osborne ,  Hock Seng Tan ,  Li Tao

发明人： Li-Lan H. Chen ,  William R. Pfister ,  Donald W. Renn ,  Thitiwan Buranachokpaisan ,  James Osborne ,  Hock Seng Tan ,  Li Tao

IPC分类号： A61K31495

CPC分类号： A61K9/0007 ,  A61K9/0031 ,  A61K9/0034 ,  A61K9/0043 ,  A61K9/0056 ,  A61K9/006 ,  A61K9/145 ,  A61K9/1623 ,  A61K9/7007 ,  A61K9/7015 ,  A61K31/495 ,  A61K31/505

摘要： Mucosal surface-coat-forming film dosage units containing a water-soluble hydrocolloid, an effective dose of an active agent and a mucosal adhesion enhancer; wherein the active agent is encapsulated within a polymer which is chemically or physically distinct from the hydocolloid; wherein the mucosal adhesion enhancer is a starch graft copolymer; wherein the film exhibits a dry tack value of less than 3.5 g, a wet tack of greater than 35 g, a gelation temperature that is greater than 70° C. for a 2% polymer solution, a dry film thickness of less than 20 mil, a water content of 0.5 to 10%, a tensile strength greater than 1500 psi, a modulus in the range of 35,000 to 300,000 psi, a % elongation of less than 20%, a tear probagation resistance of 0.001 to 1 N, and a dissolution time in the range of 1 to 600 seconds upon application to an oral mucosal surface.

摘要翻译： 含有水溶性水胶体的粘膜表面涂膜形成膜剂量单位，有效剂量的活性剂和粘膜粘附增强剂; 其中所述活性剂包封在化学或物理上不同于所述液体胶体的聚合物内; 其中粘膜粘附增强剂是淀粉接枝共聚物; 其中所述膜的干粘度值小于3.5g，湿粘性大于35g，对于2％聚合物溶液的凝胶化温度大于70℃，干膜厚度小于20密耳 ，水含量为0.5〜10％，拉伸强度大于1500psi，模量为35,000〜300,000psi，％伸长率小于20％，耐撕裂概率为0.001〜1N， 施用于口腔粘膜表面后的溶出时间为1至600秒。

公开(公告)号：US09017718B2

公开(公告)日：2015-04-28

申请号：US13060325

申请日：2010-04-22

申请人： Hock Seng Tan ,  Siew Lian Chung

发明人： Hock Seng Tan ,  Siew Lian Chung

IPC分类号： A61M35/00 ,  A61K47/32 ,  A61K47/34 ,  A61K9/00 ,  A61K9/70

CPC分类号： A61M35/00 ,  A61K9/0056 ,  A61K9/006 ,  A61K9/7007 ,  A61K47/32 ,  A61K47/34

摘要： Provided is a dual-release, dual-adhesiveness flexible thin film dosage form comprising: a quick-release subfilm comprising an admixture of polymer, which comprises predominantly highly water-soluble polymer(s), and a bioactive agent, the polymers and other components of the quick-release subfilm adapted to provide 20 minutes or less erodibility for the quick-release subfilm; and laminated against the quick-release subfilm, a sustained-release subfilm comprising an admixture of polymer, which comprises predominantly hydrophilic, bioadhesive polymer(s), and a second bioactive agent, which can be the same as the first, the polymers and other components of the sustained-release subfilm adapted to provide erodibility of 1 hour or more and 20 hours or less for the sustained-release subfilm, the dosage form having a thickness of 30 mil or less, and being more adhesive on the sustained-release side.

摘要翻译： 提供了一种双重释放双重粘合性柔性薄膜剂型，其包含：快速释放子膜，其包含聚合物的混合物，所述聚合物主要包含高度水溶性聚合物和生物活性剂，所述聚合物和其它组分 的快速释放子膜适于为快速释放子膜提供20分钟或更短的可蚀刻性; 并且与快速释放子膜层压，包含主要包含亲水性生物粘附聚合物的聚合物混合物和第二生物活性剂的缓释亚膜，其可以与第一种聚合物和其它物质相同 持续释放亚膜的组分适于为持续释放亚膜提供1小时或更长和20小时以下的可蚀刻性，剂型具有30密耳或更小的厚度，并且在持续释放侧上更粘合 。

公开(公告)号：US20110280925A1

公开(公告)日：2011-11-17

申请号：US13060325

申请日：2010-04-22

申请人： Hock Seng Tan ,  Siew Lian Chung

发明人： Hock Seng Tan ,  Siew Lian Chung

IPC分类号： A61K9/70 ,  A61P1/08 ,  A61K31/445 ,  A61K31/439 ,  A61K31/465 ,  A61K31/485

CPC分类号： A61M35/00 ,  A61K9/0056 ,  A61K9/006 ,  A61K9/7007 ,  A61K47/32 ,  A61K47/34

摘要： Provided is a dual-release, dual-adhesiveness flexible thin film dosage form comprising: a quick-release subfilm comprising an admixture of polymer, which comprises predominantly highly water-soluble polymer(s), and a bioactive agent, the polymers and other components of the quick-release subfilm adapted to provide 20 minute or less erodibility for the quick-release subfilm; and laminated against the quick-release subfilm, a sustained-release subfilm comprising an admixture of polymer, which comprises predominantly hydrophilic, bioadhesive polymer(s), and a second bioactive agent, which can be the same as the first, the polymers and other components of the sustained-release subfilm adapted to provide erodibility of 1 hours or more and 20 hours or less for the sustained-release subfilm, the dosage form having a thickness of 30 mil or less, and being more adhesive on the sustained-release side.

摘要翻译： 提供了一种双重释放双重粘合性柔性薄膜剂型，其包含：快速释放子膜，其包含聚合物的混合物，所述聚合物主要包含高度水溶性聚合物和生物活性剂，所述聚合物和其它组分 的快速释放子膜适于为快速释放子膜提供20分钟或更短的可蚀性; 并且与快速释放子膜层压，包含主要包含亲水性生物粘附聚合物的聚合物混合物和第二生物活性剂的缓释亚膜，其可以与第一种聚合物和其它物质相同 持续释放亚膜的组分适于为持续释放亚膜提供1小时或更长和20小时以下的可蚀刻性，所述剂型具有30密耳或更小的厚度，并且在持续释放侧上更粘合 。