Primavessy Daniel, Büttner Sarah, Saaler-Reinhardt Sigrid
Midas Pharma GmbH, Rheinstrasse 49, 55218, Ingelheim am Rhein, Germany.
EDUMO Consulting, Professor-Neeb-Strasse 4, 55291, Saulheim, Germany.
Drug Deliv Transl Res. 2025 Jan;15(1):1-6. doi: 10.1007/s13346-024-01598-7. Epub 2024 May 4.
In this technical note we show with two simple experiments how Perfluorodecalin (PFD), an injectable perfluorocarbon, can be used as an agent for resuspending microparticulate suspensions in primary packaging containers for injection. Furthermore, we explain how this can be a substantial improvement regarding patient compliance in comparison to the commonly used gas headspace for resuspension. Our experiments are conducted with poly(lactic-co-glycolic acid) particles (often used in extended-release pharmaceutical formulations for injection) and in primary packaging that is commonly used in injection devices (glass cartridges). The results show that our method is feasible for resuspension and moreover even sediment solidification/caking is reduced. The differences between the two datasets collected are statistically significant with p < 0.01 in both cases.
在本技术说明中，我们通过两个简单实验展示了全氟萘烷（PFD），一种可注射的全氟化碳，如何用作在注射用初级包装容器中重新悬浮微粒悬浮液的试剂。此外，我们解释了与常用的用于重新悬浮的气体顶空相比，这在患者依从性方面如何能有实质性的改善。我们的实验使用聚（乳酸-乙醇酸）颗粒（常用于注射用缓释药物制剂）并在注射装置（玻璃药筒）中常用的初级包装中进行。结果表明，我们的方法对于重新悬浮是可行的，而且甚至能减少沉淀物固化/结块。所收集的两个数据集之间的差异在两种情况下均具有统计学显著性，p < 0.01。
