开发用于连续制药物质生产的先进制造技术
Daniel G Gregory1, Kaitlin E Kay1, Justin T Turnage1
1Department of Chemical and Life Science Engineering, Virginia Commonwealth University, 601 West Main St., Richmond, Virginia 23284, United States.
概括
这项研究详细介绍了一种先进的制造技术 (AMT),用于生产硫酸,一种喘药物. 该自动化系统旨在克服药物短缺并提高制药供应链的弹性.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 化学工程是化学工程的重要组成部分.
- 药物开发 药物开发
背景情况:
- 硫酸是喘治疗的关键支气管扩展剂.
- 目前的制造方法面临挑战,导致药物短缺.
- 美国食品和药物管理局将阿尔布醇硫酸盐列为缺乏药物的药物.
研究的目的:
- 描述一个候选先进制造技术 (AMT) 的早期概念发展.
- 为了实现硫酸的自动,连续生产.
- 解决目前的药物短缺问题,提高供应链的弹性.
主要方法:
- 开发一种新的合成途径,用于硫酸.
- 实现连续流的制造原理.
- 整合过程分析技术 (PAT) 进行实时监控.
- 使用HPLC,LC-MS,GC-FID和线性NMR进行分析性表征.
主要成果:
- 候选AMT系统的设计是为了自动生产超过2000毫克/小时的硫酸.
- 在1.0毫升/分钟的流速下达到78.4%的溶液产量.
- 经过轻微修改,证明了10倍吞吐量扩展的潜力.
结论:
- 开发的AMT提供了一个在液体药物配方生产中超越批量效率的策略.
- 这项技术有可能降低资本成本,消除药物短缺.
- 自动化连续制造的成功扩展加强了制药供应链的弹性.
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