Department of Chemical Engineering, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA 02139, USA.
Department of Chemical Engineering, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA 02139, USA.
Int J Pharm. 2018 Mar 25;539(1-2):157-164. doi: 10.1016/j.ijpharm.2018.01.027. Epub 2018 Jan 31.
Due to the complex nature of the pharmaceutical supply chain, the industry faces several major challenges when it comes to ensuring an adequate supply of quality drug products. These challenges are not only the causes of supply chain disruptions and financial loss, but can also prevent underserved and remote areas from receiving life-saving drugs. As a preliminary demonstration to mitigate all these challenges, at MIT we have developed active pharmaceutical ingredients manufacturing in a miniature platform. However, manufacturing of final oral solid dosage as tablets from drug substances had not been demonstrated. In this study, a compact, portable, re-configurable, and automated tablet manufacturing system, roughly the size of a North American household oven, [72.4 cm (length) × 53.3 cm (width) × 134.6 cm (height)] was designed, built and demonstrated. This miniature system is able to manufacture on-demand tablets from drug crystals on a scale of hundreds to thousands per day. Ibuprofen and Diazepam, each having different drug loading, were manufactured using this miniature system and meet U.S. Pharmacopeia standards. We foresee this flexible, miniature, plug-and-play pharmaceutical solids dosage manufacturing system advancing on-demand ready-to-use pharmaceuticals enabling future treatment of human diseases at the point-of-care.
由于药物供应链的复杂性,该行业在确保高质量药物产品的充足供应方面面临着几个重大挑战。这些挑战不仅是供应链中断和财务损失的原因,还可能导致服务不足和偏远地区无法获得救命药物。作为缓解所有这些挑战的初步示范,我们麻省理工学院已经在微型平台上开发了活性药物成分的制造。然而,尚未证明从药物物质制造最终的口服固体制剂(如片剂)。在这项研究中,设计、构建并演示了一种紧凑、便携、可重新配置和自动化的片剂制造系统,大约有一个北美家庭烤箱那么大,[72.4 厘米(长)×53.3 厘米(宽)×134.6 厘米(高)]。这个微型系统能够每天按需制造数百到数千片药物晶体的片剂。布洛芬和地西泮,每种药物的负载量都不同,都使用这个微型系统制造,并符合美国药典标准。我们预计这种灵活的、微型的、即插即用的药物固体制剂制造系统将推进按需即用的药物的发展,从而能够在医疗点对人类疾病进行未来的治疗。