开发,药理动力学和抗疟疾评估剂量灵活的3D打印Dapsone的儿童患者
Adnan A Khan1, Tahir Khuroo2, Eman M Mohamed2
1School of Engineering Medicine, Texas A&M University, Houston, Texas, 77030, USA.
AAPS PharmSciTech
|September 17, 2024
概括
3D打印的达普森 (DDS) 打印片为儿科患者提供剂量灵活性. 这些打印纸显示了与传统药片相比的物理化学,稳定性和药物动力学特征,表明了临床互换性.
科学领域:
- 制药技术 制药技术 制药技术
- 3D打印应用 3D打印应用
- 药物输送系统 药物输送系统
背景情况:
- 达普森 (DDS) 对于治疗各种疾病至关重要,但儿科剂量需要灵活性.
- 传统的药片制造可能并不总是满足特定的儿科对剂量定制的需求.
研究的目的:
- 使用选择性激光烧结 (SLS) 3D打印制造剂量灵活的达 (DDS) 打印单.
- 为了评估DDS的物理化学,在使用中的稳定性和药理动力学特性.
- 为了比较DDS打印机与传统的DDS平板电脑,以获得临床互换性.
主要方法:
- 通过使用Kolicoat® IR,Eudragit® L-100-55和StarCap®作为辅助剂,创建了八种DDS打印的配方.
- 印刷品的硬度,分解,溶解和无形含量 (DSC,XRD) 进行了评估.
- 在Sprague Dawley大鼠中进行了使用中的稳定性和药理动力学研究.
主要成果:
- 打印纸硬度和分解时间在各种配方中各不相同.
- 达普在印刷品中是部分无形的,在20分钟内完全溶解 (>85%).
- 印刷品没有显示药物形式或储存后溶解的显著变化.
- 药物动力学参数 (Tmax,Cmax,AUC0-∞) 和疗效指标 (EC50,EC90) 在印刷品和药片配方之间统计上相似.
结论:
- 选择性激光烧结 (SLS) 3D打印成功生产了剂量灵活的达普森打印片.
- DDS印刷品表现出有利的物理化学,稳定性和药物动力学特征.
- 在临床上,DDS打印机与传统DDS平板相似,并且可以与其互换.
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