基于挤出的自动分发:用于儿科护理的克洛皮多格雷尔片的个性化剂量和质量控制
Farnaz Shokraneh1, Anne M Filppula2, Aleksi Tornio3
1Pharmaceutical Sciences Laboratory, Science and Engineering, Åbo Akademi University, BioCity, Tykistökatu 6A, Turku FI-20520, Finland; CurifyLabs Oy, Salmisaarenaukio 1, Helsinki FI-00180, Finland.
概括
3D打印技术使得个性化的儿科克洛皮多格雷尔二硫酸盐片成为可能. 这项研究证明了半固体挤出3D打印的适用性,用于生产稳定,快速溶解的克洛皮多格雷尔片用于临床使用.
科学领域:
- 制药技术 制药技术 制药技术
- 个性化医疗是个性化的医疗.
- 添加剂制造 添加剂制造 添加剂制造
背景情况:
- 传统的制药化合物在精确的儿科剂量方面面临挑战.
- 三维 (3D) 打印提供了定制药物的潜力.
- 半固体挤出是一种在复合药房中成熟的3D打印技术.
研究的目的:
- 开发和评估使用半固体挤出3D打印的克洛皮多格雷尔二硫酸盐片.
- 评估这些药片适合于小儿使用,剂量可变.
- 描述关键的质量属性,包括药物含量,释放,分解和稳定性.
主要方法:
- 开发了两个克洛皮多格雷尔凝片 (1%和2%度) 的配方.
- 采用基于半固体挤出的沉积技术来制造平板电脑.
- 评估的药片特性:质量变化,含量均性,体外药物释放,分解和稳定性 (3个月),使用XRD和FTIR等技术.
主要成果:
- 打印片 (200-500毫克) 在药典限制内表现出可接受的重量变化和内容均性.
- 这两种配方均表现出快速的体外药物释放 (满足USP目标) 并符合分解规格.
- 稳定性研究在三个月内证实了一致的物理和化学特性,并通过XRD和FTIR进行验证.
结论:
- 半固体挤出3D打印是一种可行的技术,用于生产儿科用克洛皮多格雷尔二硫酸盐片.
- 开发的克洛皮多格雷尔片符合临床应用的关键质量属性.
- 这种自动化技术支持为个性化儿科医学提供即时复合.
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