Christfort Juliane Fjelrad, Polhaus Chrysillis Judy Magaard, Bondegaard Pi Westi, Chang Tien-Jen, Hwu En Te, Hagner Nielsen Line, Zór Kinga, Boisen Anja
The Danish National Research Foundation and Villum Foundation's Center for Intelligent Drug Delivery and Sensing Using Microcontainers and Nanomechanics, Department of Health Technology, Technical University of Denmark, 2800 Kgs. Lyngby, Denmark.
The National Food Institute, Technical University of Denmark, 2800 Kgs. Lyngby, Denmark.
HardwareX. 2022 Feb 5;11:e00275. doi: 10.1016/j.ohx.2022.e00275. eCollection 2022 Apr.
release and dissolution models are widely used in the development phases of oral drug delivery systems to measure how an active pharmaceutical ingredient (API) is released from a dosage form. However, additional requirements for these models arise when evaluating probiotic dosage forms since they are often sensitive to temperature and oxygen levels. As a solution to this, we propose a custom-designed anaerobic release setup, made mainly by 3D printing and laser cutting, to function together with state-of-the-art pharmaceutical dissolution equipment - in this case, a microDISS Profiler™. The release model makes it possible to study the release rate of oxygen-sensitive probiotics in simulated intestinal conditions, while ensuring their survival due to the anaerobic conditions. This has not been possible so far since the available dissolution models have not been compatible with anaerobic conditions. With two different case studies, the developed model combined with a microDISS Profiler™ has proven capable of measuring the release of a probiotic and a small-molecule API from microdevices for oral drug delivery. Further, the model facilitated the survival of anaerobic bacteria present in the release medium.
释放和溶出模型在口服给药系统的开发阶段被广泛用于测定活性药物成分（API）从剂型中释放的情况。然而，在评估益生菌剂型时，对这些模型有额外的要求，因为它们通常对温度和氧气水平敏感。作为对此的一种解决方案，我们提出了一种定制设计的厌氧释放装置，主要由3D打印和激光切割制成，以便与最先进的药物溶出设备——在这种情况下是microDISS Profiler™——一起发挥作用。该释放模型使得在模拟肠道条件下研究对氧气敏感的益生菌的释放速率成为可能，同时由于厌氧条件确保了它们的存活。到目前为止这是不可能的，因为现有的溶出模型与厌氧条件不兼容。通过两个不同的案例研究，已证明所开发的模型与microDISS Profiler™相结合能够测量益生菌和小分子API从用于口服给药的微器件中的释放。此外，该模型促进了释放介质中厌氧细菌的存活。
