Johannesson Jenny, Wu Mingjun, Johansson Mathias, Bergström Christel A S
Department of Pharmacy, Uppsala University, SE 751 23 Uppsala, Sweden.
Department of Molecular Sciences, Swedish University of Agricultural Sciences (SLU), SE 750 07 Uppsala, Sweden.
Int J Pharm. 2023 Nov 5;646:123413. doi: 10.1016/j.ijpharm.2023.123413. Epub 2023 Sep 17.
3D-printing technology offers a flexible manufacturing platform with the potential to address the need of personalized dosage forms. However, quality aspects of such small-scale, on-demand production of pharmaceutical products intended for personalization is still limited. The aim of this study was therefore to study critical quality control attributes of lipid tablets produced by semi-solid extrusion (SSE) 3D printing from emulsion gels incorporating a poorly water-soluble drug. Quality attributes for both the printable emulsion gel and the printed dosage forms were assessed. The emulsion gel was shown to be printable with accurate dosing for at least one month of storage at 4 °C. Tablets were 3D printed in different sizes and a correlation, R value of 0.99, was found between the weight and the drug content. The 3D-printed tablets complied with the mass and drug content uniformity requirements described in the European Pharmacopoeia.. Solid-state characterization of the tablets during short-term storage revealed no signs of crystallinity of the drug. Lastly, the lipid digestion and drug release were unchanged after short-term storage of the tablets. This study demonstrates the potential of SSE 3D printing for personalized dosing of a lipid-based formulation strategy and discusses central quality attributes for the printable formulation and the 3D-printed dosage form.
3D打印技术提供了一个灵活的制造平台，有潜力满足个性化剂型的需求。然而，这种用于个性化的药品小批量按需生产的质量方面仍然有限。因此，本研究的目的是研究由包含难溶性药物的乳液凝胶通过半固体挤出（SSE）3D打印生产的脂质片的关键质量控制属性。评估了可打印乳液凝胶和打印剂型的质量属性。结果表明，乳液凝胶可打印，在4℃下储存至少一个月时剂量准确。以不同尺寸3D打印片剂，发现重量与药物含量之间存在相关性，R值为0.99。3D打印片剂符合欧洲药典中所述的质量和药物含量均匀性要求。片剂在短期储存期间的固态表征未显示药物结晶迹象。最后，片剂短期储存后脂质消化和药物释放未发生变化。本研究证明了SSE 3D打印用于基于脂质的制剂策略个性化给药的潜力，并讨论了可打印制剂和3D打印剂型的核心质量属性。
