PT  - JOURNAL ARTICLE
AU  - Tri-Hung Nguyen
AU  - Peter Lambert
AU  - Rajpreet Singh Minhas
AU  - Claire McEvoy
AU  - Kim Deadman
AU  - Philip Wright
AU  - Richard J Prankerd
AU  - Seloi Mogatle
AU  - Michelle P McIntosh
TI  - Temperature stability of oxytocin ampoules labelled for storage at 2°C–8°C and below 25°C: an observational assessment under controlled accelerated and temperature cycling conditions
AID  - 10.1136/bmjopen-2019-029083
DP  - 2019 Jul 01
TA  - BMJ Open
PG  - e029083
VI  - 9
IP  - 7
4099  - http://bmjopen.bmj.com/content/9/7/e029083.short
4100  - http://bmjopen.bmj.com/content/9/7/e029083.full
SO  - BMJ Open2019 Jul 01; 9
AB  - Introduction Oxytocin, administered via injection, is recommended by WHO for the prevention and treatment of postpartum haemorrhage. However, the susceptibility of oxytocin injection to thermal degradation has led WHO and UNICEF to recommend cold-chain storage of all oxytocin products. Nevertheless, some oxytocin products supplied to the global market are labelled for storage at ≤25°C, often with a shorter shelf-life relative to products labelled for refrigeration. Differences in labelled storage requirements can lead to uncertainties among stakeholders around the relative stability of oxytocin products and specifically whether ≤25°C products are more resistant to degradation. Such confusion can potentially influence policies associated with procurement, distribution, storage and the use of oxytocin in resource-poor settings.Objectives To compare the stability of oxytocin injection ampoules formulated for storage at ≤25°C with those labelled for refrigerated storage.Design Accelerated and temperature cycling stability studies were performed with oxytocin ampoules procured by the United Nations Population Fund (UNFPA) from four manufacturers.Method Using oxytocin ampoules procured by UNFPA, accelerated stability (up to 120 days) and temperature cycling (up to 135 days between elevated and refrigerated temperatures) studies were performed at 30°C, 40°C and 50°C. Oxytocin content was quantified using a validated HPLC-UV method.Results All ampoules evaluated exhibited similar stability profiles under accelerated degradation conditions with the exception of one product formulated for ≤25°C storage, where the rate of degradation increased at 50°C relative to other formulations. Similar degradation trends at elevated temperatures were observed during temperature cycling, while no significant degradation was observed during refrigerated periods of the study.Conclusion Oxytocin ampoules formulated for non-refrigerated storage demonstrated comparable stability to those labelled for refrigerated storage and should not be interpreted by stakeholders as offering a more stable alternative. Furthermore, these products should not be procured for use in territories with high ambient temperatures, where all oxytocin injection products should be supplied and stored under refrigerated conditions.