Preparation of active proteins, vaccines and pharmaceuticals as fine powders using supercritical or near-critical fluids.
Preparation of active proteins, vaccines and pharmaceuticals as fine powders using supercritical or near-critical fluids.
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DOI：
10.1007/s11095-008-9575-6
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发表时间：
2008-09
影响因子：
3.7
通讯作者：
Sievers, Robert E.
中科院分区：
文献类型：
--
作者：
Cape, Stephen P.;Villa, Joseph A.;Huang, Edward T. S.;Yang, Tzung-Horng;Carpenter, John F.;Sievers, Robert E.
关键词：
在过去十年左右的时间里，超临界或近临界流体产生微粒的过程引起了人们的极大关注，并在可溶于超临界流体或有机溶剂的物质方面取得了良好的成功。在本综述中，我们综述了它们在蛋白质颗粒生产中的应用。最近开发的一种称为气泡干燥器的二氧化碳辅助雾化(CAN-BD)的工艺已被证明对小分子和大分子物质(包括治疗性蛋白质)具有广泛的适用性。讨论了CAN-BD的原理，以及各种材料的稳定化、微粉化和干燥。对三种蛋白质进行了更详细的案例研究，其中两种具有治疗意义：抗cd4抗体(类风湿性关节炎)、α1-抗胰蛋白酶(囊性纤维化和肺气肿)和胰蛋白酶原(一种模型酶)。干燥的粉末被形成，在其中保持稳定和活动，并且足够细，可以被吸入并到达深层肺。在某些配方和工艺条件下，经CAN-BD处理后的表观活性也得到了提高。
Supercritical or near-critical fluid processes for generating microparticles have enjoyed considerable attention in the past decade or so, with good success for substances soluble in supercritical fluids or organic solvents. In this review, we survey their application to the production of protein particles. A recently developed process known as CO2-assisted nebulization with a Bubble Dryer® (CAN-BD) has been demonstrated to have broad applicability to small-molecule as well as macromolecule substances (including therapeutic proteins). The principles of CAN-BD are discussed as well as the stabilization, micronization and drying of a wide variety of materials. More detailed case studies are presented for three proteins, two of which are of therapeutic interest: anti-CD4 antibody (rheumatoid arthritis), α1-antitrypsin (cystic fibrosis and emphysema), and trypsinogen (a model enzyme). Dry powders were formed in which stability and activity are maintained and which are fine enough to be inhaled and reach the deep lung. Enhancement of apparent activity after CAN-BD processing was also observed in some formulation and processing conditions.
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影响因子：
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