One of the challenges in developing three-dimensional printed medicines is related to their stability due to the manufacturing conditions involving high temperatures. This work proposed a new protocol for preformulation studies simulating thermal processing and aging of the printed medicines, tested regarding their morphology and thermal, crystallographic, and spectroscopic profiles. Generally, despite the strong drug-polymer interactions observed, the chemical stability of the model drugs was preserved under such conditions. In fact, in the metoprolol and Soluplus® composition, the drug's solubilization in the polymer produced a delay in the drug decomposition, suggesting a protective effect of the matrix. Paracetamol and polyvinyl alcohol mixture, in turn, showed unmistakable signs of thermal instability and chemical decomposition, in addition to physical changes. In the presented context, establishing protocols that simulate processing and storage conditions may be decisive for obtaining stable pharmaceutical dosage forms using three-dimensional printing technology.

由于涉及高温的制造条件，开发 3D 打印药物的挑战之一与它们的稳定性有关。这项工作为模拟印刷药物的热加工和老化的预制剂研究提出了一种新协议，并对其形态和热、晶体学和光谱学特征进行了测试。通常，尽管观察到强烈的药物-聚合物相互作用，但模型药物的化学稳定性在这种条件下得以保持。事实上，在美托洛尔和 Soluplus® 组合物中，药物在聚合物中的溶解会导致药物分解延迟，这表明基质具有保护作用。反过来，对乙酰氨基酚和聚乙烯醇混合物显示出明显的热不稳定性和化学分解迹象，除了身体上的变化。在目前的情况下，建立模拟加工和储存条件的协议对于使用 3D 打印技术获得稳定的药物剂型可能是决定性的。