Drug Formulation and Manufacturing


Thermo Scientific™ 挤出机和相关分析仪可解决药品生产中 API 溶解度、加工稳定性、掩味、肠溶和专用剂型等关键难题,提供从可行性研究到药物配方和生产的最短路径。


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Hot melt extrusion (HME) is a key technology that can produce alternative drug delivery systems such as subcutaneous, solid implants for controlled-release treatment in ophthamology and cancer (e.g., hormone) as well as extrusion of biocompatible or biodegradable polymer/drug formulations.

HME can be configured to create a fully-automated implant production line with small tolerances in diameter and length. This continuous manufacturing process is an ideal solution, offering high-precision control of implant dimensions, a small footprint for full containment and simple cleaning for aseptic requirements of FDA approved materials.

根据美国 FDA 的资料显示,连续制造过程减少了批处理过程中因启停造成的人为错误,更加安全可靠。在连续过程中,往往给进原料,将混合物送至下游生产。挤出机已用于湿法造粒多年;双螺杆挤出机如今在药物生产中发挥着核心作用。

流变学和光谱学在以挤出机为中心的药物制剂开发和生产中发挥着重要作用。现在,近红外(NIR)光谱在药物制剂活性成分分析中的应用广为人知。该技术无损、信噪比优良并可使用光纤将样品传输至过程中。NIR 光谱是监测热熔挤出机输出的理想选择。拉曼光谱在批量在线采样方面与 NIR 互补,采样显微成像分析片剂均匀性和共挤出。



ODFs made easy with HME

Orally disintegrating films (ODFs) allow safe, easy and exact dosage of active pharmaceutical ingredients (APIs). They also improve bioavailability of the API and help avoid the first pass effect. Hot-melt extrusion (HME) works well for manufacturing ODFs; it’s well-established, provides reproducible results, and doesn’t require solvents. Produce high-quality ODFs at lab- or production-scale.

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Continuous granulation

Hints to optimize pharma processes via continuous granulation

The switch from batch processing to continuous manufacturing of pharmaceuticals can really pay off with efficiencies and other savings. But how to set up a successful new continuous process - that's a challenge for everyone. We teamed up with Innopharma Technology to help.

Unique Advantages of Process Analytical Technology in Twin-Screw Granulation describes an experiment combining Thermo Scientific Twin-Screw Granulation (TSG) technology and Innopharma Process Analytical Technology (PAT). Read the results to learn which extruder parameters to adjust for the most impact on the continuous granulation process.

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Improve pharma and biotech manufacturing processes and help ensure patient safety

Save time, improve processes, protect brand integrity, and ensure patient safety, from raw material identification through the pharmaceutical manufacturing process, to finished and packaged pharmaceutical product inspection.

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