a Department of Pharmaceutics and Drug Delivery , The University of Mississippi , Oxford , MS , USA.
b Pii Center for Pharmaceutical Technology , The University of Mississippi , Oxford , MS , USA.
Expert Opin Drug Deliv. 2019 May;16(5):539-550. doi: 10.1080/17425247.2019.1609448. Epub 2019 May 3.
Currently, hot melt extrusion (HME) is a promising technology in the pharmaceutical industry, as evidenced by its application to manufacture various FDA-approved commercial products in the market. HME is extensively researched for enhancing the solubility and bioavailability of poor water-soluble drugs, taste masking, and modifying release in drug delivery systems. Additionally, its other novel opportunities or pharmaceutical applications, and capability for continuous manufacturing are being investigated. This efficient, industrially scalable, solvent-free, continuous process can be easily automated and coupled with other novel platforms for continuous manufacturing of pharmaceutical products.
This review focuses on updates on solubility enhancement of poorly water-soluble drugs and process analytical tools such as UV/visible spectrophotometry; near-infrared spectroscopy; Raman spectroscopy; and rheometry for continuous manufacturing, with a special emphasis on fused deposition modeling 3D printing.
The strengths, weakness, opportunities, threats (SWOT) and availability of commercial products confirmed wide HME applicability in pharmaceutical research. Increased interest in continuous manufacturing processes makes HME a promising strategy for this application. However, there is a need for extensive research using process analytical tools to establish HME as a dependable continuous manufacturing process.
目前，热熔挤出（HME）是制药行业有前途的技术，其在市场上成功应用于制造各种 FDA 批准的商业产品就是证明。HME 广泛应用于提高水溶性差的药物的溶解度和生物利用度、掩味和药物传递系统中的释放控制。此外，还在研究其其他新的机会或药物应用，以及连续制造的能力。这种高效、工业可扩展、无溶剂、连续的工艺可以很容易地自动化，并与其他用于连续制造药物产品的新型平台相结合。
本综述重点介绍了用于提高水溶性差的药物溶解度的最新进展，以及过程分析工具，如紫外/可见分光光度法；近红外光谱；拉曼光谱；和用于连续制造的流变学，特别强调熔融沉积建模 3D 打印。
通过对强度、弱点、机会、威胁（SWOT）和商业产品的可用性的评估，确认了 HME 在制药研究中的广泛适用性。对连续制造工艺的兴趣增加使 HME 成为该应用的有前途的策略。然而，需要使用过程分析工具进行广泛的研究，以确立 HME 作为可靠的连续制造工艺的地位。
