开发3D打印的双释放固定剂量组合,通过双融挤压
1College of Pharmacy, Sahmyook University, Seoul 01795, Republic of Korea.
International journal of pharmaceutics
|July 2, 2024
概括
这项研究开发了一种3D打印的平板电脑,使用双融挤出技术打印了两种药物. 该技术成功地创造了一种双释放的固定剂量组合药片,具有不同的药物释放配置文件.
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:
- 固定剂量组合 (FDC) 药片提供了改善的患者服药性和治疗疗效.
- 开发具有差异性药物释放配置文件的FDC给制造业带来了挑战.
- 3D打印技术可以实现具有复杂内部结构的定制药物输送系统.
研究的目的:
- 开发一种3D打印的FDC平板,使用双融挤出 (DME) 来分别释放乙氨基 (持续) 和布洛芬 (溶解).
- 调查DME的可行性,以创建适合3D打印的纤维,并将不同的药物纳入其中.
- 描述开发的3D打印FDC平板电脑的物理化学特性和药物释放行为.
主要方法:
- 双融挤出 (DME) 工艺在两个步骤中创建一个含有持续释放乙氨基和溶解布洛芬的单一丝.
- 在不同的温度下使用特定的聚合物 (Eudragit® S100,HPC-LF,Eudragit® EPO) 进行热挤出 (HME).
- 从制造的发光线中3D打印圆柱状平板.
- 在模拟的胃肠道条件下使用pH跳跃方法进行体外溶解试验.
- 使用TGA,DSC,PXRD,FTIR,SEM和CLSM进行物理化学表征.
主要成果:
- 通过使用DME,成功制造了一根含有持续释放乙氨基和溶解布洛芬的单一光纤.
- 制作一个9毫米圆柱形3D打印的FDC平板电脑,其中包含了不同的药物.
- 溶解试验证实了10小时内对乙氨基和布洛芬的分离释放概况.
- 物理化学分析证实了药物的稳定性,无形状态转化和药物在线索和片内独立分离.
- SEM和CLSM证实,在发光线内存在持续释放的乙氨基颗粒.
结论:
- 双化挤出 (DME) 技术有效地用于为3D打印的固剂组合 (FDC) 平板电脑制造细丝.
- 开发的方法允许对乙氨基和布洛芬进行独立的结合和差异性释放.
- 这种方法为制造具有定制药物释放特性的先进3D打印FDC平板电脑提供了一个有前途的战略.
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