I-Corps: From Compacts to Integrated Systems: A New Paradigm for the Design and Manufacture of Pharmaceuticals

拟议的团队为药物剂型的设计和制造引入了一种新的范例。新的平台技术3D集成制药(3D IP)的灵感来自于3D IC(3D集成电路)模型实现的令人印象深刻的进步。拟议方法的基本概念是将制药产品视为集成系统，这对制药业来说是新的。使用3D IP，剂型是由预制的工作组件根据预先确定的蓝图组装而成，而不是通过混合和压缩粉末。结果是一种相对简单的方法来制造具有定制形状、物理尺寸以及最重要的药物释放曲线的药物产品。3D IP是一个专注于生产药物口服剂型的新型平台。类似于3D集成电路的设计，通过多种功能组件的3D层叠构建，3D IP剂型通过堆叠活性成分载体、增溶功能、ID/防伪、防篡改等预制功能组件来组装。3D IP技术在需要针对目标或活性化合物进行定制释放的领域具有应用，这些领域不仅限于口服药物，还延伸到透皮市场、智能贴片、农用化学品、营养食品和个人护理产品。

The proposed team introduces a new paradigm for the design and manufacture of pharmaceutical dosage forms. The new platform technology, 3D Integrated Pharmaceuticals (3D IP), is inspired after the impressive progress realized by the 3D IC (3D Integrated Circuits) model. The underlying concept of the proposed approach, novel to the pharmaceutical industry, consists in looking at pharmaceutical products as integrated systems. With 3D IP, dosage forms are assembled from pre-fabricated working components, according to a pre-established blueprint instead of by blending and compressing powders. The result is a comparatively simple means of making pharmaceutical products with customized shape, physical dimensions, and most importantly, drug release profile. 3D IP is a novel platform that has focused on producing pharmaceutical oral dosage forms. Analogous to the design of 3D integrated circuits, built by the 3D layer stacking of multiple functional components, 3D IP dosage forms are assembled by stacking pre-fabricated functional components such as active ingredient carrier, solubilizing function, ID/anti-counterfeiting, and tamper prevention. The 3D IP technology has applications in areas where customizable release for a target or active compound is needed, which extend beyond oral pharmaceuticals, into transdermal markets, smart patches, agrochemicals, nutraceuticals and personal care products.