Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag

Megan A Rocchio, Caryn D Belisle, Bonnie C Greenwood, Michael C Cotugno, Paul M SzumitaDepartment of Pharmacy, Brigham and Women's Hospital, Boston, MA, USABackground: Regular human insulin 100 units added to a sufficient quantity of 0.9% sodium chloride, to yield a total volume of 100 mL wi...

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Autores principales:	Rocchio MA, Belisle CD, Greenwood BC, Cotugno MC, Szumita PM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/c730d0ef46584def9ee6aab03a342eec
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spelling	oai:doaj.org-article:c730d0ef46584def9ee6aab03a342eec2021-12-02T03:59:50ZEvaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag1178-7007https://doaj.org/article/c730d0ef46584def9ee6aab03a342eec2013-10-01T00:00:00Zhttp://www.dovepress.com/evaluation-of-the-maximum-beyond-use-date-stability-of-regular-human-i-a14662https://doaj.org/toc/1178-7007Megan A Rocchio, Caryn D Belisle, Bonnie C Greenwood, Michael C Cotugno, Paul M SzumitaDepartment of Pharmacy, Brigham and Women's Hospital, Boston, MA, USABackground: Regular human insulin 100 units added to a sufficient quantity of 0.9% sodium chloride, to yield a total volume of 100 mL within a polyvinylchloride bag, is accepted to be stable for 24 hours due to physical denaturation and chemical modification. The objective of this study was to evaluate the extended stability of such extemporaneously prepared regular human insulin, stored under refrigeration, to the maximum beyond-use-date allowed by United States Pharmacopeia chapter 797.Methods: At time “0” three admixtures of regular human insulin were prepared by withdrawing 1 mL of regular human insulin with a concentration of 100 units/mL and adding it to a sufficient quantity of 0.9% sodium chloride for injection in a polyvinylchloride bag to yield a total volume of 100 mL. The three admixtures were stored under refrigeration (2°C–8°C [36°F–46°F]), and one sample of each admixture was withdrawn and tested in duplicate at 0, 6, 24, 48, 72, 144, 168, 192, 216, 240, 312, and 336 hours. Utilizing high performance liquid chromatography, each sample underwent immediate testing. The time points were stable if the mean concentration of the samples exceeded 90% of the equilibrium concentration at 6 hours.Results: The equilibrium concentration was 0.89 units/mL. Time points were stable if the mean concentration was at least 0.80 units/mL. All time points retained at least 90% of the equilibrium concentration, with the exception of hour 168 (0.79 ± 0.03 units/mL). At 192 hours the mean concentration was 0.88 ± 0.03 units/mL. At 336 hours the mean concentration was 0.91 ± 0.02 units/mL.Conclusion: Based on these results, regular human insulin 100 units added to 0.9% sodium chloride for injection in a polyvinylchloride bag to yield a total volume of 100 mL is stable for up to 336 hours when stored at 2°C–8°C (36°F–46°F).Keywords: insulin, stability, storage, temperature, USP 797, sodium chloride, polyvinylchlorideRocchio MABelisle CDGreenwood BCCotugno MCSzumita PMDove Medical PressarticleSpecialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol 2013, Iss default, Pp 389-392 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Specialties of internal medicine RC581-951
spellingShingle	Specialties of internal medicine RC581-951 Rocchio MA Belisle CD Greenwood BC Cotugno MC Szumita PM Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag
description	Megan A Rocchio, Caryn D Belisle, Bonnie C Greenwood, Michael C Cotugno, Paul M SzumitaDepartment of Pharmacy, Brigham and Women's Hospital, Boston, MA, USABackground: Regular human insulin 100 units added to a sufficient quantity of 0.9% sodium chloride, to yield a total volume of 100 mL within a polyvinylchloride bag, is accepted to be stable for 24 hours due to physical denaturation and chemical modification. The objective of this study was to evaluate the extended stability of such extemporaneously prepared regular human insulin, stored under refrigeration, to the maximum beyond-use-date allowed by United States Pharmacopeia chapter 797.Methods: At time “0” three admixtures of regular human insulin were prepared by withdrawing 1 mL of regular human insulin with a concentration of 100 units/mL and adding it to a sufficient quantity of 0.9% sodium chloride for injection in a polyvinylchloride bag to yield a total volume of 100 mL. The three admixtures were stored under refrigeration (2°C–8°C [36°F–46°F]), and one sample of each admixture was withdrawn and tested in duplicate at 0, 6, 24, 48, 72, 144, 168, 192, 216, 240, 312, and 336 hours. Utilizing high performance liquid chromatography, each sample underwent immediate testing. The time points were stable if the mean concentration of the samples exceeded 90% of the equilibrium concentration at 6 hours.Results: The equilibrium concentration was 0.89 units/mL. Time points were stable if the mean concentration was at least 0.80 units/mL. All time points retained at least 90% of the equilibrium concentration, with the exception of hour 168 (0.79 ± 0.03 units/mL). At 192 hours the mean concentration was 0.88 ± 0.03 units/mL. At 336 hours the mean concentration was 0.91 ± 0.02 units/mL.Conclusion: Based on these results, regular human insulin 100 units added to 0.9% sodium chloride for injection in a polyvinylchloride bag to yield a total volume of 100 mL is stable for up to 336 hours when stored at 2°C–8°C (36°F–46°F).Keywords: insulin, stability, storage, temperature, USP 797, sodium chloride, polyvinylchloride
format	article
author	Rocchio MA Belisle CD Greenwood BC Cotugno MC Szumita PM
author_facet	Rocchio MA Belisle CD Greenwood BC Cotugno MC Szumita PM
author_sort	Rocchio MA
title	Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag
title_short	Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag
title_full	Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag
title_fullStr	Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag
title_full_unstemmed	Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag
title_sort	evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/c730d0ef46584def9ee6aab03a342eec
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Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag

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