可打印乳液凝和3D打印平板电脑的质量属性:朝着生产个性化剂型的方向
Jenny Johannesson1, Mingjun Wu1, Mathias Johansson2
1Department of Pharmacy, Uppsala University, SE 751 23 Uppsala, Sweden.
International journal of pharmaceutics
|September 19, 2023
概括
半固体挤出 (SSE) 3D打印使基于脂质的个性化剂型成为可能. 这项研究证实了3D打印平板电脑的质量和稳定性,用于准确的药物输送.
科学领域:
- 制药技术 制药技术 制药技术
- 药物输送系统 药物输送系统
- 在药品中使用3D打印.
背景情况:
- 3D打印提供了个性化的制药剂量形式.
- 小规模,按需3D打印的药物的质量控制是不发达的.
- 基于脂质的配方需要进行特定的质量评估.
研究的目的:
- 通过使用半固体挤出 (SSE) 来研究3D打印脂质片的关键质量属性.
- 评估可打印乳液凝和最终3D打印剂型的质量.
- 评估SSE3D打印在个性化药物递送方面的潜力.
主要方法:
- 半固体挤出 (SSE) 基于脂质的乳液凝的3D打印.
- 评估乳液凝印刷性和随时间推移的剂量准确性.
- 3D打印平板电脑的特征:重量,药物含量,均性和固态特性.
- 在储存后对脂质消化和药物释放的评估.
主要成果:
- 可打印的乳液凝在4°C下保持精确的剂量一个月.
- 在平板电脑的重量和药物含量之间发现了强烈的相关性 (R2=0.99).
- 3D打印的药片符合欧洲药典标准的质量和药物含量统一性.
- 没有观察到药物的结晶性,并且储存后的脂质消化/药物释放保持一致.
结论:
- SSE 3D 打印是一种可行的方法,可以生产基于脂质的个性化剂型.
- 成功评估了配方和打印产品的关键质量属性.
- 这项技术对量身定制的药物输送解决方案具有前景.
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