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首页> 美国卫生研究院文献>Pharmaceutics >Fundamental Investigations into Metoprolol Tartrate Deposition on Orodispersible Films by Inkjet Printing for Individualised Drug Dosing
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Fundamental Investigations into Metoprolol Tartrate Deposition on Orodispersible Films by Inkjet Printing for Individualised Drug Dosing

机译：通过喷墨印刷为个性化药物给药的喷墨印刷对甲金属托洛尔的基础调查

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摘要

Individualised medicine is continuously gaining attention in pharmaceutical research. New concepts and manufacturing technologies are required to realise this therapeutic approach. Off-label drugs used in paediatrics, such as metoprolol tartrate (MPT), are potential candidates for innovations in this context. Orodispersible films (ODFs) have been shown as an accepted alternative dosage form during the last years and inkjet printing is traded as seminal technology of precise deposition of active pharmaceutical ingredients (APIs). The objective of this study was to combine both technologies by developing imprinted ODFs based on hypromellose with therapeutically reasonable MPT single doses of 0.35 to 3.5 mg for paediatric use. After preselection, suitable ink compositions were analysed by confocal Raman microscopy regarding MPT distribution within the imprinted ODFs. Adjusted print settings, speed, print direction and angle, characterised the final ODF surface structure. The present investigations show that uniform dosages with acceptance values between 1 and 6 can be achieved. Nevertheless, changes in calibrated printed quantity due to nozzle aging have a significant effect on the final applied dose. At the lowest investigated quantity, the RSD was ±28% and at the highest, ±9%. This has to be considered for implementation of inkjet printing as a pharmaceutical production tool in the future.
机译：个性化药物在制药研究中不断受到关注。需要新的概念和制造技术来实现这种治疗方法。用于儿科（如美容洛尔洛尔（MPT））的非标签药物是在这种背景下的创新候选人。在过去几年中已显示出可接受的替代剂型（ODFS），并且喷墨印刷作为精确沉积活性药物成分（API）的精确沉积。本研究的目的是通过将基于杂种的ODFS在酸蛋白酶上开发印记的ODF，治疗合理的MPT单剂量为0.35至3.5mg进行儿科使用来结合。预选后，通过共焦拉曼显微镜分析有关印迹ODF内的MPT分布的合适的油墨组合物。调整后的打印设置，速度，打印方向和角度，表征了最终的ODF表面结构。本研究表明，可以实现具有1和6之间的均匀剂量的均匀剂量。然而，由于喷嘴老化引起的校准印刷量的变化对最终施用剂量具有显着影响。在最低调查的数量下，RSD为±28％，最高，±9％。这必须考虑在未来实施喷墨印刷作为药品生产工具。

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