干层乳糖作为脆脆的辅助剂对多组分混合物的可加工性的影响
Zhixing Lin1, Bian Cabello1, Rajesh N Davé1
1New Jersey Center for Engineered Particulates, New Jersey Institute of Technology, Newark, NJ 07102, USA.
International journal of pharmaceutics
|February 21, 2024
概括
干涂层易碎的辅助剂,如Pharmatose,可以改善粉末的流量和药片的强度,以便直接压缩. 这种方法提高了凝聚性活性药物成分混合物的可加工性.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
背景情况:
- 干涂层微晶纤维素 (MCC) 通过提高流动性来增强直接压缩 (DC).
- 易碎的辅助剂往往表现出不良的流动性和紧缩性,限制了它们在DC平板电脑制造中的使用.
研究的目的:
- 为了评估干涂脆的辅助剂 (Pharmatose 450和350) 与二氧化的直接压缩能力.
- 评估干涂层对多组分凝聚性活性药物成分 (API) 混合物的影响.
主要方法:
- 在Pharmatose 450 (P450) 和Pharmatose 350 (P350) 中使用二氧化 (A200或R972P) 进行干涂.
- 评估涂层辅助剂和API混合物的流动性,散装密度和抗拉强度.
- 多组分混合物的配方与乙氨基和布洛芬混合.
主要成果:
- 干涂P450和P350表现出极好的流动性,高散密度和增强的抗拉强度.
- 性A200比性R972P提高了拉伸强度.
- 在乙氨基混合物中观察到改善的散装密度和流动性,最小的干涂P450.
- 对于使用18%重量%的干涂P450.0的布洛芬混合物,实现了更好的可加工性和DC能力.
结论:
- 干涂层易碎的Pharmatose助剂显著提高了它们用于直接压缩的性能.
- 这种方法克服了脆弱的辅助剂的局限性,使凝聚性API混合物的DC成为可能.
- 优化的干涂层策略可以提高平板电脑制造效率和性能.
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