Gueche Yanis A, Sanchez-Ballester Noelia M, Cailleaux Sylvain, Bataille Bernard, Soulairol Ian
ICGM, University Montpellier, CNRS, ENSCM, 34000 Montpellier, France.
Department of Pharmacy, Nîmes University Hospital, 30900 Nimes, France.
Pharmaceutics. 2021 Aug 6;13(8):1212. doi: 10.3390/pharmaceutics13081212.
3D printing is a new emerging technology in the pharmaceutical manufacturing landscape. Its potential advantages for personalized medicine have been widely explored and commented on in the literature over recent years. More recently, the selective laser sintering (SLS) technique has been investigated for oral drug-delivery applications. Thus, this article reviews the work that has been conducted on SLS 3D printing for the preparation of solid oral forms (SOFs) from 2017 to 2020 and discusses the opportunities and challenges for this state-of-the-art technology in precision medicine. Overall, the 14 research articles reviewed report the use of SLS printers equipped with a blue diode laser (445-450 nm). The review highlights that the printability of pharmaceutical materials, although an important aspect for understanding the sintering process has only been properly explored in one article. The modulation of the porosity of printed materials appears to be the most interesting outcome of this technology for pharmaceutical applications. Generally, SLS shows great potential to improve compliance within fragile populations. The inclusion of "Quality by Design" tools in studies could facilitate the deployment of SLS in clinical practice, particularly where Good Manufacturing Practices (GMPs) for 3D-printing processes do not currently exist. Nevertheless, drug stability and powder recycling remain particularly challenging in SLS. These hurdles could be overcome by collaboration between pharmaceutical industries and compounding pharmacies.
3D打印是制药生产领域中一项新兴的技术。近年来，其在个性化医疗方面的潜在优势已在文献中得到广泛探讨和评论。最近，选择性激光烧结（SLS）技术已被用于口服给药应用的研究。因此，本文综述了2017年至2020年期间利用SLS 3D打印制备固体口服制剂（SOFs）的相关工作，并讨论了这项先进技术在精准医疗中的机遇与挑战。总体而言，所综述的14篇研究文章报告了使用配备蓝色二极管激光器（445 - 450纳米）的SLS打印机的情况。该综述强调，尽管药物材料的可打印性是理解烧结过程的一个重要方面，但仅有一篇文章对其进行了恰当的探讨。对于药物应用而言，调节打印材料的孔隙率似乎是这项技术最引人关注的成果。一般来说，SLS在提高脆弱人群的顺应性方面显示出巨大潜力。在研究中纳入“质量源于设计”工具可以促进SLS在临床实践中的应用，尤其是在目前尚无3D打印工艺的药品生产质量管理规范（GMP）的情况下。然而，在SLS中，药物稳定性和粉末回收仍然极具挑战性。制药行业和配药药房之间的合作可以克服这些障碍。
