Department of Pharmacy, Lab testing Unit (BSPharm, PhD,Technology Implementation Engineer), Pierre-Lôo Hospital, GHT58, La Charite-sur-Loire, France
Epitech and CSULB (IT Engineer), Le Kremlin-Bicetre Paris and Long Beach, CA, France and USA.
Eur J Hosp Pharm. 2023 Nov;30(6):340-346. doi: 10.1136/ejhpharm-2021-002811. Epub 2021 Dec 2.
Liquid medications provide an alternative to splitting pills and dosages by measuring an amount of liquid rather than crushing tablets or opening capsules. Special attention should also be paid to specific patient groups with swallowing difficulties or requiring enteral feeding administration. Liquid medicines are also often used to ease withdrawal symptoms for people suffering from addiction. Nevertheless, filling liquid medication cups with the right medication and precise doses may be difficult for healthcare professionals. The Nooddis ('Nominative Oral Dose Dispenser'-Pierre Lôo Hospital, France and Packinov, France) is a new robotic system for the automated filling of single dose liquid medications. Since the performance of such a complex piece of equipment depends on compliance of the service provider to our building guidelines, the process performance verification is a necessary prerequisite before starting routine production.
The performance of the Nooddis robot (accuracy, precision, and tapering calculation) and its ability to fill medicine cups was evaluated with 18 different liquid medications using an automatic in-line checkweigher. Microbiological testing was also performed.
648 sealed cups were prepared for qualification. The filling accuracy was within the limit of ±10% from 75 µL to 21.25 mL. The repeatability (% relative SD (%RSD) 0.05 to 4.93) and intermediate precision (%RSD 0.01 to 6.59) were validated for all preparations. All medicine cups met the requirements of USP and European Pharmacopoeia acceptance criteria for microbiological quality. Automated tapering calculations allowed for easy production of daily doses for the tapering periods chosen.
Since the system met the required quality standards, the Nooddis robot, with automatic in-line tapering system, is regarded as an accurate technology that can fill the exact amount of liquid oral medication in single dose cups. This may promote closer monitoring, which supports medication tapering as well as medication misuse prevention. With a packaging cost similar to current unit dose cup systems, it is a relevant alternative to fractioned or crushed tablets, as well as opened capsules. Further developments for some sterile liquid medications are yet to be studied.
与片剂分剂量或打开胶囊相比，液体制剂可通过测量液体剂量来提供替代方案。对于吞咽困难或需要管饲给药的特定患者群体，也应特别注意。液体制剂也常用于缓解成瘾者的戒断症状。然而，医护人员可能难以用正确的药物和精确剂量填充液体制剂杯。Nooddis（法国 Pierre Loo 医院的“提名口服剂量分配器”和法国 Packinov）是一种用于自动填充单剂量液体制剂的新型机器人系统。由于这种复杂设备的性能取决于服务提供商对我们建筑规范的遵守情况，因此在开始常规生产之前，对过程性能进行验证是必要的前提条件。
使用自动在线检重秤评估 Nooddis 机器人（准确性、精密度和锥形计算）及其填充药杯的能力，使用 18 种不同的液体制剂进行了测试。还进行了微生物测试。
为资格认证准备了 648 个密封杯。填充精度在从 75µL 到 21.25mL 的±10%范围内。所有制剂的重复性（%相对标准偏差（%RSD）0.05 至 4.93）和中间精密度（%RSD 0.01 至 6.59）均得到验证。所有药杯均符合 USP 和欧洲药典对微生物质量的验收标准。自动锥形计算可轻松生产所选锥形期的每日剂量。
由于该系统符合所需的质量标准，因此具有自动在线锥形系统的 Nooddis 机器人被认为是一种准确的技术，可以在单剂量杯中填充准确数量的液体制剂。这可以促进更密切的监测，支持药物减量以及防止药物滥用。与当前单位剂量杯系统的包装成本相似，它是片剂分剂量或打开胶囊的一种相关替代方案。还需要进一步研究一些无菌液体制剂的开发。
