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为个性化儿科使用的半固体挤出片:肠道管中药物的开发,质量控制和体外评估
Mahsa Bahman1, Niklas Sandler Topelius1, Tapani Viitala2
1Pharmaceutical Sciences Laboratory, Åbo Akademi University, Artillerigatan 6A, 02520 Turku, Finland; Curifylabs Oy, Salmisaarenaukio 1, 00180 Helsinki, Finland.
概括
使用半固体挤出 (SSE) 的简化3D打印为创建个性化儿科药物提供了有前途的方法. 这种方法确保了准确的剂量,稳定性和快速的药物释放,克服了儿童传统药物化合物的局限性.
科学领域:
- 制药技术 制药技术 制药技术
- 儿科药物输送 儿科药物输送
- 添加剂制造 添加剂制造 添加剂制造
背景情况:
- 药物复合在儿科医学中是必不可少的,因为缺乏合适的商业剂量形式.
- 半固体挤出 (SSE) 3D打印显示了个性化儿科医学的潜力.
- 传统的平板电脑3D打印可能很慢,阻碍了大量个性化剂量的生产.
研究的目的:
- 评估一种简化的SSE3D打印方法,用于制造个性化的儿科平板电脑.
- 评估含有普罗普兰诺洛尔,斯皮罗诺拉克和普雷迪尼索隆的打印片的质量控制,稳定性和溶解概况.
- 确定这些配方适用于儿科的适用性,包括度和鼻胃管恢复.
主要方法:
- 开发了一种简化的SSE3D打印方法,用于兰,螺旋和普雷迪尼索隆片.
- 建立了HPLC药物定量方法,并进行了质量控制测试 (质量,含量均性,稳定性,溶解).
- 通过鼻胃管评估药片度,并进行药物回收测试.
主要成果:
- 印刷片 (每片n=144) 显示出很好的质量均性和同质性 (AV<15).
- 配方表现出长达9个月的稳定性,并满足USP立即释放溶解的标准.
- 药片度明显低于儿科配方建议,鼻胃管恢复显示药物损失变化 (4-36%).
结论:
- 简化的SSE3D打印方法是生产个性化儿科药物的可行和有前途的方法.
- 这种技术可以准确地制造为儿科患者量身定制的剂型.
- 需要进一步优化鼻胃管的恢复,但整体研究结果支持儿童个性化医学的SSE.
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