Assessment of compatibility of rhIGF-1/rhIGFBP-3 with neonatal intravenous medications.

ABSTRACT:

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 a

SUBMITTER: Salamat-Miller N 

PROVIDER: S-EPMC9832074 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature