一个综合框架,简化制造高药载荷药片的制造
Eftychios Hadjittofis1, Selim Douieb1, Adam Hill2
1UCB S.A, Allée de la Recherche, 60, 1070 Brussels, Belgium.
International journal of pharmaceutics
|January 30, 2026
概括
本研究提出了一个新的工作流程,以加速生物制药行业的直接压缩 (DC) 配方开发. 它整合了粒子工程和配方设计,以获得高效的平板固体剂型.
科学领域:
- 制药科学 制药科学
- 化学工程是化学工程的重要组成部分.
- 材料科学 材料科学 材料科学
背景情况:
- 生物制药行业面临管道波动,并要求缩短平板固体剂型的开发时间.
- 传统的功能孤岛阻碍了有效的药物产品开发.
- 需要整合的工作流程来增强功能间的沟通和协同作用.
研究的目的:
- 提出和验证一个新的工作流程,以加速直接压缩 (DC) 的发展.
- 为了证明粒子工程和配方设计的整合.
- 为了提高平板固体剂型开发的效率.
主要方法:
- 利用CrystalGrower平台通过结晶策略进行粒子工程.
- 进行了小规模的实验,并使用了微型粉末表征工具.
- 采用EleGent平台进行高药载荷DC配方开发.
- 在平板电脑印刷机上验证的预测.
主要成果:
- 成功地绘制了粒子和粉末特性之间的关系.
- 确定了具有高药物负载的合适DC配方.
- 证明了使用具有挑战性的新化学实体 (NCE) 的工作流效率,Minzasolmin.
- 在平板印刷机上取得了成功的平板生产.
结论:
- 开发的工作流大大加速了DC开发.
- 综合的方法,结合粒子工程和配方,是有效的挑战API.
- 这个工作流显示了未来化学,制造和控制 (CMC) 开发活动的潜力.
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