公开(公告)号：US20080220061A1

公开(公告)日：2008-09-11

申请号：US11876153

申请日：2007-10-22

申请人： Wendy E. PRYCE LEWIS ,  Charles W. ROWE ,  Michael J. CIMA ,  Peter A. MATERNA

发明人： Wendy E. PRYCE LEWIS ,  Charles W. ROWE ,  Michael J. CIMA ,  Peter A. MATERNA

IPC分类号： A61K9/24

CPC分类号： A61K9/2893 ,  A61J3/10 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2054 ,  A61K9/209 ,  A61K9/2095 ,  B33Y70/00 ,  B33Y80/00

摘要： The present invention includes controlled release dosage forms and methods of designing and manufacturing dosage forms to obtain specific release profiles, for example, zero-order release profiles, escalating release profiles or decreasing release profiles. The dosage forms of the present invention can include spatial variation of API concentration in the dosage form and can include nested regions. Dosage forms according to the present invention may be manufactured by any appropriate method for obtaining the internal structure as disclosed herein for producing zero-order release profiles and increasing or decreasing release profiles. The invention further includes methods of manufacturing such dosage forms, such as by three-dimensional printing, possibly also including compression of the dosage form after three-dimensional printing. The invention further includes methods of designing such dosage forms. Release profiles from non-uniform distributions of API concentration may be predicted based on simple experiments with uniform-concentration dosage forms.

摘要翻译： 本发明包括控制释放剂型和设计和制造剂型以获得特定释放特征的方法，例如零级释放曲线，升级释放曲线或减少释放曲线。 本发明的剂型可以包括剂型中API浓度的空间变化，并且可以包括嵌套区域。 根据本发明的剂型可以通过用于获得本文公开的用于产生零级释放曲线和增加或减少释放曲线的内部结构的任何适当方法来制造。 本发明还包括制造这种剂型的方法，例如通过三维印刷，可能还包括在三维印刷后压制剂型。 本发明还包括设计这种剂型的方法。 可以基于使用均匀浓度剂型的简单实验来预测API浓度不均匀分布的释放曲线。