为药物管理而使用平板电脑的分割和研磨的替代方法
Rajneesh Taneja1, Joseph Scarim2, Poonam G Pande3
1Global Alliance for TB Drug Development (TB Alliance), New York, New York.
International journal of pharmaceutical compounding
|June 2, 2023
概括
一个新的设备,XTEMP-R,有效地将药片转化为同质悬浮剂,用于无法吞药片的患者. 这种简单的方法可以确保为各种患者群体,包括儿科和老年人提供准确的药物.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 患者合规性 患者合规性
背景情况:
- 药片配方对患有吞困难的患者构成挑战,例如儿科和老年人群,以及那些需要通过食管服用药物的人群.
- 现有的给这些患者群体注射非液体药物的方法可能是低效或不准确的.
- 需要一种简单,可靠的设备来将固体口服剂型转化为可施用液体悬浮剂.
研究的目的:
- 开发和评估一种新型设备,XTEMP-R,用于将药片转化为同质悬浮液.
- 评估 XTEMP-R 装置在制备和分发药物悬浮剂中的效率,准确性和可重复性.
- 为了证明该设备与结核病治疗药物和常见的非处方药物的实用性.
主要方法:
- 设计了一种名为XTEMP-R的新设备,具有灵活的容器,紧紧的盖子和吸管杯底座.
- 药片 (结核病药物TBAJ-876,TBI-223和常见的药物,如乙氨基,安洛迪平,甲胺) 用水和悬浮剂分散在设备中.
- 通过视觉检查,颗粒大小分析 (子测试),药物总回收和小量剂量的可重复性,包括24小时后的再分散,评估了有效性.
主要成果:
- XTEMP-R成功地创建了没有大颗粒的视觉均悬浮,通过了#18 (<1000微米).
- 平均总药物恢复率很高 (TBAJ-876的99.2%,TBI-223的101.3%).
- 剂量可重复性为2毫升的位量是很好的 (98.9%-99.7%的TBI-223,102.6%-103.2%的TBAJ-876),在24小时后均的再分散.
结论:
- XTEMP-R装置提供了一种方便有效的方法,可以在不到10分钟的时间内准备均的药物悬浮液,而不会产生药物损失.
- 准确地从悬浮液中提取部分剂量是可行的.
- XTEMP-R是一种可行的工具,可以为无法吞药片的患者提供准确的药物.
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