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Pharmaceutics
Volume 14
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10.3390/pharmaceutics14051081
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Article

Behavior of Regular Insulin in a Parenteral Nutrition Admixture: Validation of an LC/MS-MS Assay and the In Vitro Evaluation of Insulin Glycation

by
Heloise Henry
1,*,
Jean-François Goossens
1,
Mostafa Kouach
1,
Damien Lannoy
1,
David Seguy
2,
Thierry Dine
1,
Pascal Odou
1 and
Catherine Foulon
1
1
Univ. Lille, CHU Lille, ULR 7365-GRITA-Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France
2
Univ. Lille, Inserm, CHU Lille, U1286-INFINITE-Institute for Translational Research in Inflammation, F-59000 Lille, France
*
Author to whom correspondence should be addressed.
Pharmaceutics 2022, 14(5), 1081; https://doi.org/10.3390/pharmaceutics14051081
Submission received: 18 March 2022 / Revised: 14 May 2022 / Accepted: 17 May 2022 / Published: 18 May 2022
(This article belongs to the Special Issue Advances in Parenteral Formulations)
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Abstract

Parenteral-nutrition (PN)-induced hyperglycemia increases morbidity and mortality and must be treated with insulin. Unfortunately, the addition of insulin to a ternary PN admixture leads to a rapid decrease in insulin content. Our study’s objective was to determine the mechanistic basis of insulin’s disappearance. The literature data suggested the presence of a glycation reaction; we therefore validated an LC-MS/MS assay for insulin and glycated insulin. In a 24-h stability study, 20 IU/L of insulin was added to a binary PN admixture at pH 3.6 or 6.3. When the samples were diluted before analysis with a near-neutral diluent, insulin was fully stable at pH 3.6, while a loss of around 50% was observed at pH 6.3. Its disappearance was shown to be inversely correlated with the appearance of monoglycated insulin (probably a Schiff base adduct). Monoglycated insulin might also undergo a back-reaction to form insulin after acidic dilution. Furthermore, a second monoglycated insulin species appeared in the PN admixture after more than 24 h at high temperature (40 °C) and a high insulin concentration (1000 IU/L). It was stable at acidic pH and might be an Amadori product. The impact of insulin glycation under non-forced conditions on insulin’s bioactivity requires further investigation.
Keywords: regular insulin; drug stability study; parenteral nutrition admixture; glycation; LC-MS/MS regular insulin; drug stability study; parenteral nutrition admixture; glycation; LC-MS/MS
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MDPI and ACS Style

Henry, H.; Goossens, J.-F.; Kouach, M.; Lannoy, D.; Seguy, D.; Dine, T.; Odou, P.; Foulon, C. Behavior of Regular Insulin in a Parenteral Nutrition Admixture: Validation of an LC/MS-MS Assay and the In Vitro Evaluation of Insulin Glycation. Pharmaceutics 2022, 14, 1081. https://doi.org/10.3390/pharmaceutics14051081

AMA Style

Henry H, Goossens J-F, Kouach M, Lannoy D, Seguy D, Dine T, Odou P, Foulon C. Behavior of Regular Insulin in a Parenteral Nutrition Admixture: Validation of an LC/MS-MS Assay and the In Vitro Evaluation of Insulin Glycation. Pharmaceutics. 2022; 14(5):1081. https://doi.org/10.3390/pharmaceutics14051081

Chicago/Turabian Style

Henry, Heloise, Jean-François Goossens, Mostafa Kouach, Damien Lannoy, David Seguy, Thierry Dine, Pascal Odou, and Catherine Foulon. 2022. "Behavior of Regular Insulin in a Parenteral Nutrition Admixture: Validation of an LC/MS-MS Assay and the In Vitro Evaluation of Insulin Glycation" Pharmaceutics 14, no. 5: 1081. https://doi.org/10.3390/pharmaceutics14051081

APA Style

Henry, H., Goossens, J.-F., Kouach, M., Lannoy, D., Seguy, D., Dine, T., Odou, P., & Foulon, C. (2022). Behavior of Regular Insulin in a Parenteral Nutrition Admixture: Validation of an LC/MS-MS Assay and the In Vitro Evaluation of Insulin Glycation. Pharmaceutics, 14(5), 1081. https://doi.org/10.3390/pharmaceutics14051081

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