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首页> 外文期刊>Journal of Manufacturing Processes >Printing Pharmaceuticals by inkjet technology: Proof of concept for stand alone and continuous in-line printing on orodispersible films
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Printing Pharmaceuticals by inkjet technology: Proof of concept for stand alone and continuous in-line printing on orodispersible films

机译：通过喷墨技术印刷药品：在口分散膜上进行独立和连续在线印刷的概念证明

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Orodispersible films (ODFs) are promising dosage forms for special patient populations like paediatrics or elderly persons. By printing active pharmaceutical ingredients (APIs) onto orodispersible films, the flexibility of drug dosing is increased and therefore provides potential for personalized medicines. Until now, only small-scale experiments have been conducted, where continuous jetting was performed,but no continuous ODF production was realized. This study deals with the technology transfer from a small-scale inkjet printing system to a pilotscale process by incorporating the same print head assembly into a continuous ODF production process. ODFs made from hydroxypropylcellulose were non-continuously printed multiple times with test ink containing a blue colorant as model drug and were compared to continuously printed ODFs. To identify optimal manufacturing conditions, parameter settings like firing frequencies, resolution, voltage, etc. were varied and these effects were analysed by UV-Vis spectroscopy, image analysis and light microscopy. During continuous production, a linear correlation between firing frequency (100 to 600 Hz) and deposited colourant content could be observed (R = 0.999) as well as for the applied voltage (90-110 V) and the ink content (R = 0.998). A minor impact of the distance between the print head and the substrate was observed. By increasing the natural resolution (50 dpi) of the print head, the deposited ink amount could be doubled. A transfer from the non-continuous production (1 layer of 1 cm x 2 cm with a resolution of 750 dpi x 750 dpi) to the continuous production (corresponding to 380 Hz firing frequency on 6 cm(2) ODF) was successfully performed. Furthermore, image analysis was proven as useful tool for process analytical technology (PAT) of the continuously printed ODFs. The continuous ODF production with direct printing enabled various printing concepts, which may serve for individualized dosing in personalized medicine treatment in the near future.
机译：耳分散膜（ODF）是有希望的剂型，用于特殊的患者人群，例如儿科或老年人。通过将活性药物成分（API）印刷到口腔分散性薄膜上，药物剂量的灵活性得到了提高，因此为个性化药物提供了潜力。到目前为止，仅进行了小型实验，进行了连续喷射，但没有实现连续的ODF生产。这项研究通过将相同的打印头组件整合到连续的ODF生产过程中，解决了从小型喷墨打印系统到中试规模的技术转移。将由羟丙基纤维素制成的ODF与含有蓝色着色剂作为模型药物的测试油墨非连续印刷多次，并与连续印刷的ODF进行比较。为了确定最佳的制造条件，改变了诸如发射频率，分辨率，电压等参数设置，并通过紫外可见光谱，图像分析和光学显微镜分析了这些影响。在连续生产期间，可以观察到焙烧频率（100至600 Hz）与沉积的色料含量（R = 0.999）以及施加电压（90-110 V）和油墨含量（R = 0.998）之间的线性关系。 。观察到打印头和基材之间距离的轻微影响。通过增加打印头的自然分辨率（50 dpi），可以使沉积的墨水量增加一倍。成功地完成了从非连续生产（1层1 cm x 2 cm的分辨率为750 dpi x 750 dpi）到连续生产（与6 cm（2）ODF上的380 Hz发射频率相对应）的转换。此外，图像分析被证明是连续印刷ODF的过程分析技术（PAT）的有用工具。通过直接印刷进行连续ODF生产可以实现各种印刷概念，在不久的将来可用于个性化药物治疗中的个性化剂量。

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