Process performance of a new liquid medication dispensing robot

Abstract

Objectives: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: automation, packaging; liquid medication; tapering; validation studies.

Figure 1

Side view of the Nooddis rotary multi-pump head filling machine in our pharmacy lab testing unit (https://www.youtube.com/channel/UClUbsWMpJDshQ-oyApKANzw).

Figure 2

Inline checkweigher automatically drives each peristaltic pump head. Onfremovable amber glass laboratory bottles.

Figure 3

View of our software form for automatic tapering calculation.