Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
Graz University of Technology, Institute of Fluid Mechanics and Heat Transfer, Graz, Austria.
Int J Pharm. 2018 Aug 25;547(1-2):169-180. doi: 10.1016/j.ijpharm.2018.05.041. Epub 2018 May 18.
In contact-less printing, such as piezo-electric drop on demand printing used in the study, the drop formation process is independent of the substrate. This means that having developed a printable formulation, printed pharmaceutical dosage forms can be obtained on any pharmaceutical grade substrate, such as polymer-based films. In this work we evaluated eight different oral films based on their suitability as printing substrates for sodium picosulfate. The different polymer films were compared regarding printed spot morphology, chemical stability and dissolution profile. The morphology of printed sodium picosulfate was investigated with scanning electron microscopy and optical coherence tomography. The spreading of the deposited drops was found to be governed by the contact angle of the ink with the substrate. The form of the sodium picosulfate drops changed on microcrystalline cellulose films at ambient conditions over 8 weeks and stayed unchanged on other tested substrates. Sodium picosulfate remained amorphous on all substrates according to small and wide angle X-ray scattering, differential scanning calorimetry and polarized light microscopy measurements. The absence of chemical interactions between the drug and substrates, as indicated by infrared spectroscopy, makes all tested substrates suitable for printing sodium picosulfate onto them.
在非接触式打印中，如研究中使用的压电按需滴液打印，液滴形成过程与基板无关。这意味着开发出可打印的制剂后，可以在任何药物级别的基板上获得打印的药物剂型，例如基于聚合物的薄膜。在这项工作中，我们评估了八种不同的口腔薄膜，以评估它们作为泊沙康唑打印基板的适用性。比较了不同的聚合物薄膜在打印斑点形态、化学稳定性和溶解性能方面的差异。用扫描电子显微镜和光学相干断层扫描研究了打印的泊沙康唑的形态。发现沉积液滴的铺展受油墨与基板之间接触角的控制。在微结晶纤维素薄膜上，泊沙康唑的形式在环境条件下 8 周后发生变化，而在其他测试的基板上保持不变。根据小角和广角 X 射线散射、差示扫描量热法和偏光显微镜测量，泊沙康唑在所有基板上均保持无定形。红外光谱表明药物和基板之间没有化学相互作用，这使得所有测试的基板都适合将泊沙康唑打印到它们上面。
