Salamat-Miller, Nazila, Turner, Mark A 
ORCID: 0000-0002-5299-8656, Bandekar, Amey, Dixit, Nitin, Jochim, Emily, Mangum, Barry, McPherson, Christopher, Tenjarla, Srini, Singh, Sukhjeet, Hwang, You Seok et al (show 1 more authors)
(2023)
Assessment of compatibility of rhIGF-1/rhIGFBP-3 with neonatal intravenous medications.
WORLD JOURNAL OF PEDIATRICS, 19 (1).
pp. 58-67.
Abstract
<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>In vitro physical compatibility was established for 11/19 medications: caffeine citrate, fentanyl, fluconazole, gentamicin, 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 solution), 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.<h4>Conclusion</h4>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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Chemical compatibility, Intravenous, Neonatal, Physical compatibility, rhIGF-1, rhIGFBP-3 |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 01 Feb 2023 11:08 |
| Last Modified: | 07 Feb 2023 20:43 |
| DOI: | 10.1007/s12519-022-00610-9 |
| Open Access URL: | https://doi.org/10.1007/s12519-022-00610-9 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3168060 |
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