开发一个模块化的连续制药产品制造系统,以实时质量保证,用于生产制药迷你片
Varun Sundarkumar1, Wanning Wang1, Madeline Mills1
1Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, USA.
Journal of pharmaceutical sciences
|October 3, 2023
概括
这项研究开发了一个模块化制造系统,使用按需下降 (DoD) 打印用于个性化的固体口服药物. 该原型成功生产了儿科迷你平板电脑,展示了敏捷和灵活的制药生产能力.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 药物输送系统是药物输送系统.
- 工艺工程是过程工程.
背景情况:
- 制药行业寻求敏捷,小规模的模块化制造,以在危机期间快速生产药物.
- 开发用于固体口服药品的模块化设施面临着挑战.
- 需要针对个性化医疗和紧急药物供应提供灵活的制造解决方案.
研究的目的:
- 开发一个原型模块化系统,用于个性化的固体口服药物生产,使用按需 (DoD) 打印.
- 为了证明该系统在制造儿科迷你平板电脑方面的能力.
- 整合关键质量属性和过程参数的实时过程监控.
主要方法:
- 使用需求点滴 (DoD) 打印机创建化配方滴.
- 固化液滴成迷你片,然后进行集成提取,洗和干燥.
- 集成的过程监控工具,可实时跟踪关键质量属性和过程参数.
- 在连续和半批量模式下运行系统.
主要成果:
- 成功开发并演示了用于固体口服药物制造的原型模块化系统.
- 使用DoD打印在连续和半批量模式制造的儿科迷你平板电脑.
- 集成下游加工 (过,干燥) 与印刷机组.
- 实现关键过程参数和产品质量的实时监控.
结论:
- 开发的原型展示了灵活,个性化的固体口服药物制造的可行平台.
- 该系统为生产儿科配方和潜在的其他固体剂型提供了灵活性.
- 未来的创新可以增强先进药物制造系统的原型.
相关概念视频
Factors Influencing Drug Absorption: Pharmaceutical Parameters
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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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The selection of a drug's delivery route depends upon its physicochemical properties, including lipid or water solubility and ionization, as well as the therapeutic requirement, such as immediate or sustained effect. These routes can be divided into three primary categories: enteral, parenteral, and topical.
Enteral delivery involves administering drugs directly through swallowing, sublingual placement, or buccal application. Orally administered drugs predominantly navigate the...
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