配方策略,制备方法和用于肺部输送生物制剂的装置
Kai Berkenfeld1, Simone Carneiro2, Carolina Corzo3
1Laboratory of Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmacy, University of Bonn, Gerhard-Domagk-Street 3, 53121 Bonn, Germany; Pharmaceutical Engineering and Technology Research Scientists (PETRS).
概括
肺部药物输送提供了一种非侵入性方法来管理生物药物,克服了与它们的大小相关的挑战. 干粉吸入器 (DPI) 和辅助剂使用方面的创新提高了稳定性和生物可用性,从而有效地提供治疗性蛋白质.
科学领域:
- 生物技术和制药科学 生物技术和制药科学
- 呼吸系统医学 呼吸系统医学
- 药物输送系统 药物输送系统
背景情况:
- 生物药物,如单克隆抗体,提供向疗法,但由于大分子大小而面临交付挑战.
- 肺部药物输送 (PDD) 为生物药物提供了一种非侵入性途径,使其能够快速吸收并避免第一通代谢.
研究的目的:
- 审查生物药物肺部药物输送方面的挑战和创新.
- 探索器件技术,粒子工程和助剂在PDD中的作用.
- 评估可吸入生物配方的干粉制造方法.
主要方法:
- 呼吸道解剖学和PDD的生理障碍的审查.
- 分析粒子大小效应,纳米粒子的使用,以及设备技术 (DPI,雾化器).
- 对生物制剂的辅助剂功能和干粉制造技术的检查.
主要成果:
- 肺部输送克服了生物障碍,并为生物药物提供了优势,而不是其他途径.
- 颗粒大小工程和二次颗粒使用对于优化药物沉积和生物可用性至关重要.
- 干粉吸入器 (DPI) 是适合生物制剂的格式,辅助剂和制造方法显著影响产品性能.
结论:
- 肺部药物输送是一种可行且有利的生物药物输送途径.
- 在DPI,粒子技术和配方方面的创新是成功的生物吸入疗法的关键.
- 了解制造方法对于吸入生物产品的临床转化至关重要.
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