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通过增材制造来定制高负荷无形固体分散物的释放

Carolina Alva¹, Elisa Goetzinger¹, Josip Matić²

¹Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Institute of Pharmaceutical Sciences, Department of Pharmaceutical Technology and Biopharmacy, University of Graz, Graz, Austria.

Journal of controlled release : official journal of the Controlled Release Society

|April 14, 2025

概括

这项研究使用HPMCAS.CAS开发了70%的伊特拉科纳无形固体分散 (ASD) 的3D打印平板电脑. 这些稳定的ASDs防止再结晶,并使药物释放量身定制,为个性化医疗铺平道路.

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
药物输送系统药物输送系统

背景情况:

提高难溶性活性药物成分 (API) 的生物可用性至关重要.
现在可以通过基于线程的3D打印 (3DP) 来定制API.
高负载的口服无形固体分散剂 (ASDs) 减少了药片负担,但面临着再结晶的挑战.

研究的目的:

开发含有高负载ASD (HPMCAS中的70%伊特拉科纳) 的紧型3D打印片.
通过热挤出 (HME) 和3DP研究ASD丝的可加工性.
为了评估3D打印的ASD片的稳定性和药物释放特性.

主要方法:

使用HME制造含有70%伊特拉科纳和HPMCAS的ASD丝.
导线属性的表征:固态,学和机械行为.
3D打印药片和评估药物释放动力学与可变充满模式.

主要成果:

稳定的ASD细丝通过HME和3DP成功制造和加工.
在ASD中没有观察到API再结晶,即使在储存六个月后.
保持了零顺序的药物释放,释放动力学可以通过3DP灌装模式调整.

结论:

3D打印的ASD平板提供了一个可行的方法来制备高负载,难溶的药物.
开发的系统表现出卓越的物理稳定性和受控的药物释放.
这项技术对个性化医疗和按需制造制药具有重大潜力.

关键词:

通过3D打印打印.增材制造增材制造是一种增材制造.无形固体的分散性固体.化沉积物的建模.高负载的高负载.热挤出方式

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