Cargando…

The stability of insulin solutions in syringes is improved by ensuring lower molecular weight silicone lubricants are absent

Protein drugs such as insulin are almost universally delivered via glass syringes lubricated with silicone oil. It is not uncommon for prefilled syringes (PFS) to become cloudy, which may affect bioavailability or total drug dose. To examine the role, if any, of the silicone oil lubricant in this pr...

Descripción completa

Detalles Bibliográficos
Autores principales: Nayef, Lamees, Khan, Madiha F., Brook, Michael A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5362151/
https://www.ncbi.nlm.nih.gov/pubmed/28367509
http://dx.doi.org/10.1016/j.heliyon.2017.e00264
_version_ 1782516909425557504
author Nayef, Lamees
Khan, Madiha F.
Brook, Michael A.
author_facet Nayef, Lamees
Khan, Madiha F.
Brook, Michael A.
author_sort Nayef, Lamees
collection PubMed
description Protein drugs such as insulin are almost universally delivered via glass syringes lubricated with silicone oil. It is not uncommon for prefilled syringes (PFS) to become cloudy, which may affect bioavailability or total drug dose. To examine the role, if any, of the silicone oil lubricant in this process, a systematic evaluation of the degree of insulin denaturation and aggregation as a function of silicone oils of different molecular weights was undertaken. The former was measured using fluorescence changes of aqueous insulin/silicone dispersions, while the latter examined changes in turbidity as a function of mixing and silicone oil type; the results were confirmed at two different insulin concentrations and agitation speeds. Lower molecular weight silicones led to the most rapid denaturation and aggregation, and when examined in blends of silicones at a fixed viscosity of 1000 cSt, commonly used for syringe lubrication, more rapid denaturation/aggregation was noted in blends of silicones containing the largest fractions of low molecular weight materials. As a consequence, the molecular weight profile of silicone lubricants should be established prior to the preparation of prefilled syringes.
format Online
Article
Text
id pubmed-5362151
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher Elsevier
record_format MEDLINE/PubMed
spelling pubmed-53621512017-03-31 The stability of insulin solutions in syringes is improved by ensuring lower molecular weight silicone lubricants are absent Nayef, Lamees Khan, Madiha F. Brook, Michael A. Heliyon Article Protein drugs such as insulin are almost universally delivered via glass syringes lubricated with silicone oil. It is not uncommon for prefilled syringes (PFS) to become cloudy, which may affect bioavailability or total drug dose. To examine the role, if any, of the silicone oil lubricant in this process, a systematic evaluation of the degree of insulin denaturation and aggregation as a function of silicone oils of different molecular weights was undertaken. The former was measured using fluorescence changes of aqueous insulin/silicone dispersions, while the latter examined changes in turbidity as a function of mixing and silicone oil type; the results were confirmed at two different insulin concentrations and agitation speeds. Lower molecular weight silicones led to the most rapid denaturation and aggregation, and when examined in blends of silicones at a fixed viscosity of 1000 cSt, commonly used for syringe lubrication, more rapid denaturation/aggregation was noted in blends of silicones containing the largest fractions of low molecular weight materials. As a consequence, the molecular weight profile of silicone lubricants should be established prior to the preparation of prefilled syringes. Elsevier 2017-03-20 /pmc/articles/PMC5362151/ /pubmed/28367509 http://dx.doi.org/10.1016/j.heliyon.2017.e00264 Text en © 2017 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Nayef, Lamees
Khan, Madiha F.
Brook, Michael A.
The stability of insulin solutions in syringes is improved by ensuring lower molecular weight silicone lubricants are absent
title The stability of insulin solutions in syringes is improved by ensuring lower molecular weight silicone lubricants are absent
title_full The stability of insulin solutions in syringes is improved by ensuring lower molecular weight silicone lubricants are absent
title_fullStr The stability of insulin solutions in syringes is improved by ensuring lower molecular weight silicone lubricants are absent
title_full_unstemmed The stability of insulin solutions in syringes is improved by ensuring lower molecular weight silicone lubricants are absent
title_short The stability of insulin solutions in syringes is improved by ensuring lower molecular weight silicone lubricants are absent
title_sort stability of insulin solutions in syringes is improved by ensuring lower molecular weight silicone lubricants are absent
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5362151/
https://www.ncbi.nlm.nih.gov/pubmed/28367509
http://dx.doi.org/10.1016/j.heliyon.2017.e00264
work_keys_str_mv AT nayeflamees thestabilityofinsulinsolutionsinsyringesisimprovedbyensuringlowermolecularweightsiliconelubricantsareabsent
AT khanmadihaf thestabilityofinsulinsolutionsinsyringesisimprovedbyensuringlowermolecularweightsiliconelubricantsareabsent
AT brookmichaela thestabilityofinsulinsolutionsinsyringesisimprovedbyensuringlowermolecularweightsiliconelubricantsareabsent
AT nayeflamees stabilityofinsulinsolutionsinsyringesisimprovedbyensuringlowermolecularweightsiliconelubricantsareabsent
AT khanmadihaf stabilityofinsulinsolutionsinsyringesisimprovedbyensuringlowermolecularweightsiliconelubricantsareabsent
AT brookmichaela stabilityofinsulinsolutionsinsyringesisimprovedbyensuringlowermolecularweightsiliconelubricantsareabsent