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


Lu, D and Harmanjeet, H and Wanandy, T and Paine, M and Peterson, GM and Patel, RP, Physicochemical stability of extemporaneously prepared clonidine solutions for use in neonatal abstinence syndrome, Journal of Clinical Pharmacy and Therapeutics, 44, (6) pp. 883-887. ISSN 0269-4727 (2019) [Refereed Article]

Copyright Statement

2019 John Wiley & Sons Ltd

DOI: doi:10.1111/jcpt.13008


What is known and objective: Extemporaneously prepared clonidine admixture is increasingly used for the management of neonatal abstinence syndrome. However, its stability beyond 15 minutes at room temperature is currently unknown. Therefore, healthcare professionals must prepare clonidine admixtures multiple times a day while the treatment is indicated, resulting in subsequent limitations and problems. The aim of this study was to investigate the physicochemical stability of clonidine in commonly used pharmaceutical diluents at clinically relevant concentrations and temperatures.

Methods: Glass bottles (n = 18) and plastic syringes (n = 18) containing 0.5 and 5 g/ mL of clonidine in either 5% glucose, 10% glucose or 0.9% normal saline were pre‐ pared and stored at 4C for 7 days and at 35C for 24 hours, respectively. Aliquots were withdrawn at predefined time points and analysed for the concentration of clonidine, changes in pH and colour, and particle content.

Results and discussion: No evidence of particle formation, or colour or pH change was observed throughout the study period. Clonidine retained more than 98% of its initial concentration when stored in the tested diluents at 4C for 7 days and at 35C for 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 daily required dose of clonidine can be drawn aseptically from the glass bottle each day and stored in a plastic syringe at room temperature. Clonidine present in a plastic syringe can be administered via the nasogastric route 4‐6 times a day. This practice would not only save nursing time and avoid delays in the timely administration of clonidine, but also reduce the risk of potential medication errors as well as preparation‐associated costs.

Item Details

Item Type:Refereed Article
Keywords:stability, HPLC, clonidine, neonates
Research Division:Health Sciences
Research Group:Health services and systems
Research Field:Primary health care
Objective Division:Health
Objective Group:Provision of health and support services
Objective Field:Provision of health and support services not elsewhere classified
UTAS Author:Lu, D (Mr Danqi Lu)
UTAS Author:Harmanjeet, H (Mr Harmanjeet Harmanjeet)
UTAS Author:Wanandy, T (Mr Troy Wanandy)
UTAS Author:Peterson, GM (Professor Gregory Peterson)
UTAS Author:Patel, RP (Dr Rahul Patel)
ID Code:134350
Year Published:2019
Deposited By:Pharmacy
Deposited On:2019-08-08
Last Modified:2022-07-06

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