液体负载水平和粘合剂类型对中孔基液态固体的可平板性的影响
Jan Appelhaus1, Kristina E Steffens1, Karl G Wagner2
1Department of Pharmaceutics, University of Bonn, Gerhard-Domagk-Str. 3, 53121, Bonn, Germany.
AAPS PharmSciTech
|October 21, 2024
概括
片剂中孔 (Syloid® XDP 3050) 需要特定的填充剂/粘合剂,以提高结合能力. 最佳配方平衡液体负载和填充剂类型,以成功生产液态固体片.
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:
- 半孔二氧化促进了液体到固体的转化,具有高负荷和溶解.
- 由于结合能力差,特别是药物负载高时,中孔的平板电脑压缩受到阻碍.
研究的目的:
- 调查半孔二氧化的压缩机制和可分片性.
- 评估液体负载和填充剂/粘合剂类型对片剂性能的影响.
主要方法:
- 用Vivapur® 101,FlowLac® 90,Pearlitol® 200 SD或酸四水合物制备的Syloid® XDP 3050的二元混合物,在各种液体负载水平下制备.
- 使用StylOne® Classic 105 ML压缩模拟器分析了压缩特性.
- 总体液体负载 (OLL) 被定义为一个关键的质量属性.
主要成果:
- 填充剂/粘合剂的高可塑性和结合能力对于成功的高液体负载片配方至关重要.
- 30%的Vivapur® 101和70%的0.75mL/g加载的Syloid® XDP 3050混合物实现了36-41%的[v/v]总体液体负载.
- 最佳的混合物与各种液体载体保持了1.5N/mm2的抗拉强度.
结论:
- 填充剂/粘合剂的选择和液体负载的优化是中孔二氧化液态固体可平板性的关键.
- 定义的整体液体负载 (OLL) 为配方开发提供了有价值的指标.
- 成功的药片配方需要具有强大的结合能力和高可塑性的辅助剂.
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