液态固体作为大麻片制剂的平台
Jan Appelhaus1, Karl G Wagner1, Kristina E Steffens1
1Department of Pharmaceutics, University of Bonn, Germany, Gerhard-Domagk-Str. 3, 53121 Bonn, Germany.
International journal of pharmaceutics: X
|March 5, 2026
概括
半孔性二氧化液固体将粘性大麻提取物转化为用于药片配方的粉末. 优化的辅助剂和压缩参数产生了强大,稳定的大麻片,具有高液体负载.
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:
- 半孔性二氧化液体固体使液体/粘性活性物质如大麻提取物的粉末配方成为可能.
- 传统的大麻配方仅限于液体或软凝囊.
- 药片液体固体存在诸如低抗拉强度和封装等挑战.
研究的目的:
- 开发稳定,高品质的大麻液固体片,THC剂量为10毫克.
- 为了优化液态固体配方的辅助剂选择和片剂参数.
- 评估配方大麻片的物理性质和稳定性.
主要方法:
- 使用了65/35比的Syloid® XDP 3050和Vivapur® 101粘合剂/填充剂.
- 确定了Kollidon® CL-F (4%) 和酸 (0.5%) 的最佳度.
- 采用StylOne®压缩模拟器,优化了压缩前和主要压缩压力.
主要成果:
- 实现了1.58N/mm2的抗拉强度和38.4% (V/V) 的总体液体负荷.
- 通过在主压缩压力的一半的预压缩来最大限度地提高平板的速度,从而最大限度地减少缺陷.
- 药片显示了可接受的分解,脆性和溶解概况.
结论:
- 优化的大麻液体固体配方为传统的输送方法提供了可行的替代方案.
- 开发的配方显示出出色的物理性能和稳定性.
- 药片在40°C/0%湿度下稳定30天,预计在冷藏下稳定>3年.
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