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Assessment of compatibility of rhlGF-1/rhlGFBP-3 with neonatal intravenous medications

World Journal of Pediatrics 2023年第1期19卷 58-67页

作者： Nazila Salamat-Miller Mark A.Turner Amey Bandekar Nitin Dixit Emily Jochim Barry Mangum Christopher McPherson Srini Tenjarla sukhjeet singh You Seok Hwang Norman Barton Takeda 200 Shire WayLexingtonMA 02421USA Institute of Translational Medicine University of LiverpoolLiverpoolUK Paidion Research DurhamNCUSA Washington University St.LouisMOUSA

Background Recombinant human(rh)IGF-1/IGFBP-3 protein complex,administered as a continuous intravenous infusion in preterm infants,is being studied for the prevention of complications of prematurity.Methods We conducted in vitro studies to evaluate the physical and chemical compatibility of rhIGF-1/IGFBP-3 with medications routinely administered to preterm neonates.In vitro mixing of rhIGF-1/IGFBP-3 drug product with small-molecule test medications plus corresponding controls was performed.Physical compatibility was defined as no color change,precipitation,turbidity,gas evolution,no clinically relevant change in pH/osmolality or loss in medication content.Chemical compatibility of small molecules was assessed using liquid chromatography(e.g.,reverse-phase HPLC and ion chromatography),with incompatibility defined as loss of concentration of≥10%.A risk evaluation was conducted for each medication based on in vitro compatibility data and potential for chemical modification.Results In vitro physical compatibility was established for 11/19 medications:caffeine citrate,fentanyl,fluconazole,gen-tamicin,insulin,intravenous fat emulsion,midazolam,morphine sulfate,custom-mixed parenteral nutrition solution(with/without electrolytes),parenteral nutrition solution+intravenous fat emulsion,and vancomycin(dosed from a 5 mg/mL solu-tion),but not for 8/19 medications:amikacin,ampicillin,dopamine,dobutamine,furosemide,meropenem,norepinephrine,and penicillin G,largely owing to changes in pH after mixing.Small-molecule compatibility was unaffected post-mixing,with no loss of small-molecule content.For physically compatible medications,risk analyses confirmed low probability and severity of a risk event.Conclusion Co-administration of rhIGF-1/rhIGFBP-3 drug product with various medications was assessed by in vitro studies using case-by-case risk analyses to determine the suitability of the products for co-administration.

关键词： Chemical compatibility Intravenous Neonatal Physical compatibility rhIGF-1/rhIGFBP-3

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