Addition of Regular Insulin to Ternary Parenteral Nutrition: A Stability Study

Pharmaceutics

Pascal Pigny¹  David Seguy²  Patrice Maboudou³  Heloise Henry⁴  Pascal Odou⁴  Damien Lannoy⁴  Thierry Dine⁴ 

[1] Laboratoire de Biochimie & Hormonologie, Centre de Biologie Pathologie, CHU Lille, F-59000 Lille, France;Service Endocrinologie Diabétologie Maladies Métaboliques et Nutrition, CHU Lille, F-59000 Lille, France;Service de Biochimie Automatisée Protéines, CHU Lille, F-59000 Lille, France;ULR7365–GRITA–Groupe de Recherche sur les Formes Injectables et les Technologies Associées, University of Lille, F-59000 Lille, France;

关键词: regular insulin;    parenteral nutrition solutions;    stability;    immunoassay;   

DOI  :  10.3390/pharmaceutics13040458

来源: DOAJ

【 摘 要 】

Background: Parenteral nutrition (PN) is a complex medium in which added insulin can become unstable. The aim of this study is, therefore, to evaluate the stability of insulin in PN and to identify influencing factors. Methods: A total of 20 IU/L of regular insulin was added to PN in either glass or Ethylene Vinyl Acetate (EVA) containers. A 24 h stability study was performed via an electrochemiluminescence immunoassay in different media: A ternary PN admixture, separate compartments of the PN bag and a binary admixture. This study was repeated in the absence of zinc, with the addition of serum albumin or tween and with pH adjustment (3.6 or 6.3). Insulin concentration at t time was expressed as a percentage of the initial insulin concentration. Analysis of covariance (ANCOVA) was applied to determine the factors that influence insulin stability. Results: In all PN admixtures, the insulin concentration ratio decreased, stabilising at a 60% and then plateauing after 6 h. At pH 3.6, the ratio was above 90%, while at pH 6.3 it decreased, except in the amino acid solution. ANCOVA (r² = 0.68, p = 0.01) identified dextrose and pH as significant factors influencing insulin stability. Conclusion: A low pH level seems to stabilise insulin in PN admixtures. The influence of dextrose content suggests that insulin glycation may influence stability.

【 授权许可】

Unknown