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对使用双螺丝湿颗粒制剂连续制造奎酸即时释放片的工艺参数的评估
Tejaswini Naguboyina1, Preethi Lakkala1, Siva Ram Munnangi1,2
1Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS, 38677, USA.
Pharmaceutical research
|April 14, 2025
概括
双螺旋湿颗粒化 (TSWG) 优化了奎氨酸烟酸片的生产. 这种连续制造方法提高了颗粒的均性和平板质量,为传统批量工艺提供了强大的替代方案.
科学领域:
- 制药技术 制药技术 制药技术
- 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:
- 颗粒对于固体剂型质量至关重要,增强了诸如流量,可压缩性和药物均性等特性.
- 传统的批量颗粒化正在被连续制造取代,以提高效率和可扩展性.
- 双螺丝颗粒机为先进的颗粒加工过程提供了一个强大的,多功能平台.
研究的目的:
- 调查双螺丝湿颗粒剂 (TSWG) 对于立即释放的奎胺酸盐 (QTF) 片的应用.
- 评估工艺参数 (螺丝配置,L/S比) 和结合剂 (HPC,PVP) 对颗粒特性的影响.
- 评估颗粒的质量属性和产生的片的性能.
主要方法:
- 双螺旋湿颗粒剂 (TSWG) 用于生产奎胺烟酸盐颗粒.
- 过程参数包括螺丝配置和液体与固体 (L/S) 的比率被系统地变化.
- 评估了颗粒的特性 (颗粒大小分布,流量) 和片的特性 (硬度,易碎性,分解性,溶解性).
主要成果:
- 与单个混合区相比,三组混合区螺丝配置产生了更均的颗粒,添加的液体较少.
- 由TSWG颗粒制成的药片表现出优异的硬度,低脆性,快速分解,并在0.1 N HCl中5分钟内释放约95%的药物.
- 奎氨酸烟酸的高溶解度和颗粒孔隙性有助于快速释放药物.
结论:
- 在TSWG中优化过程参数是实现所需颗粒和平板电脑属性的关键.
- TSWG提出了一种可行的连续制造方法,用于立即释放药片.
- 了解参数-属性关系有助于开发固体剂型的稳健连续制造工艺.
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