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Physicochemical stability of extemporaneously prepared clonidine solutions for use in neonatal abstinence syndrome

Lu, D, Harmanjeet, H, Wanandy, T ORCID: 0000-0003-4703-0488, Paine, M, Peterson, GM ORCID: 0000-0002-6764-3882 and Patel, RP ORCID: 0000-0001-9344-1013 2019 , 'Physicochemical stability of extemporaneously prepared clonidine solutions for use in neonatal abstinence syndrome' , Journal of Clinical Pharmacy and Therapeutics , pp. 1-5 , doi: 10.1111/jcpt.13008.

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What is known and objective: Extemporaneously prepared clonidine admixture is increasingly used for the management of neonatal abstinence syndrome. However, itsstability beyond 15 minutes at room temperature is currently unknown. Therefore,healthcare professionals must prepare clonidine admixtures multiple times a daywhile the treatment is indicated, resulting in subsequent limitations and problems.The aim of this study was to investigate the physicochemical stability of clonidinein commonly used pharmaceutical diluents at clinically relevant concentrations andtemperatures.Methods: Glass bottles (n = 18) and plastic syringes (n = 18) containing 0.5 and 5 µg/mL of clonidine in either 5% glucose, 10% glucose or 0.9% normal saline were pre‐pared and stored at 4°C for 7 days and at 35°C for 24 hours, respectively. Aliquotswere withdrawn at predefined time points and analysed for the concentration ofclonidine, changes in pH and colour, and particle content.Results and discussion: No evidence of particle formation, or colour or pH changewas observed throughout the study period. Clonidine retained more than 98% of itsinitial concentration when stored in the tested diluents at 4°C for 7 days and at 35°Cfor 24 hours.What is new and conclusion: Our findings will allow healthcare professionals to pre‐pare weekly dose of clonidine in glass bottles for storage in a refrigerator. The dailyrequired dose of clonidine can be drawn aseptically from the glass bottle each dayand stored in a plastic syringe at room temperature. Clonidine present in a plasticsyringe can be administered via the nasogastric route 4‐6 times a day. This practicewould not only save nursing time and avoid delays in the timely administration ofclonidine, but also reduce the risk of potential medication errors as well as preparation‐associated costs.

Item Type: Article
Authors/Creators:Lu, D and Harmanjeet, H and Wanandy, T and Paine, M and Peterson, GM and Patel, RP
Keywords: stability, HPLC, clonidine, neonates
Journal or Publication Title: Journal of Clinical Pharmacy and Therapeutics
Publisher: Blackwell Publishing Ltd
ISSN: 0269-4727
DOI / ID Number: 10.1111/jcpt.13008
Copyright Information:

© 2019 John Wiley & Sons Ltd

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