持续喷射可吸入的生物药物产品:新的配方和制造技术
Saeed Najafian1,2, Yu Lei2,3, Da Hye Yang1
1Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT, USA.
Pharmaceutical research
|March 11, 2026
概括
一个新的电喷连续制造平台有效地生产稳定,生物加载的干粉吸入配方. 这种方法保留了蛋白质结构,为吸入生物输送提供了传统批量工艺的有希望的替代方案.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 生物技术是生物技术.
- 材料科学 材料科学 材料科学
背景情况:
- 传统的批量制药制造面临诸多挑战,包括停机时间,高碳足迹,污染风险和成本增加.
- 由于生物制剂的降解和消化肠道吸收不良,口服生物制剂受到阻碍,需要使用替代的输送方法.
研究的目的:
- 开发和评估使用电喷涂的连续制造平台.
- 使用这个平台生产生物制剂的干粉吸入 (DPI) 配方.
主要方法:
- 设计了一种连续电喷系统,以创建可生物降解的PLGA核心外微粒,封装牛血清白蛋白 (BSA) 和胰岛素.
- 使用输送带收集装置,微粒被粘附在乳糖载体上.
- 分析了粒子形态,蛋白质分布,二次结构,形态稳定性,封装效率和体外释放.
主要成果:
- 电喷成功产生了4-20微米的PLGA核心外微粒,均地附着在乳糖载体上.
- 蛋白质结构在加工过程中变化最小,FTIR和CD分析证实了这一点.
- 该配方在12小时内表现出78.16%的封装效率和72%的累积蛋白质释放率.
结论:
- 基于电子喷涂的连续制造平台显示出可扩展生产稳定,生物载荷DPI配方的巨大潜力.
- 这种方法有效地封装敏感蛋白质,同时保持结构完整性,表明未来可吸入生物传递应用的前景.
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