{
  "abstract": "Aim To assess the long-term physico-chemical stability of intravenous (IV) drug preparations commonly used in neonatal intensive care units (NICUs), with the goal of identifying candidates suitable for standardised, ready-to-administer (RTA) formulations. This synthesis supports objectives outlined in the Neonatal and Paediatric Pharmacy Group (NPPG) framework for standardising intravenous infusion concentrations in children, 1 which advocates for RTA formulations to enhance safety and efficiency across the NHS.Methods Six independent rapid reviews were conducted by fourth year pharmacy undergraduate students, collectively evaluating the stability of 22 drugs named in the NPPG framework across various therapeutic classes, including catecholamines, sedatives, analgesics, anticoagulants, antiarrhythmics, neuromuscular blockers, and insulin. Literature searches were performed using databases such as Medline, Embase, and Scopus. Inclusion criteria focused on studies employing validated high-performance liquid chromatography (HPLC) or ultra-performance liquid chromatography (UPLC) assays to assess chemical stability. Stability was defined as maintaining 95–105% of the initial drug concentration. Studies were critically appraised using modified CASP checklists and benchmarked against NHS Pharmaceutical Quality Assurance Committee (PQAC) gold standards. 2 Results Morphine and midazolam consistently demonstrated long-term stability, with shelf lives of up to 36 months when stored in polyolefin or polypropylene containers under ambient or refrigerated conditions. Catecholamines such as noradrenaline and dopamine showed promising stability profiles in certain container types, with noradrenaline stable for up to 12 months and dopamine for up to 6 months under refrigerated or frozen conditions. Dobutamine and adrenaline exhibited extended stability, particularly when stabilising excipients were used. Clonidine and furosemide were also found to be chemically stable for 24 months and 35 days, respectively. In contrast, dinoprostone, octreotide, glucagon, atracurium, and rocuronium lacked sufficient or consistent long-term data.Across all studies, key factors influencing stability included temperature, light exposure, container material, and excipient use. Polypropylene and polyolefin containers were preferred over polyvinyl chloride (PVC) due to reduced permeability and better compatibility with autoclaving. However, many of the studies did not meet NHS gold standards, particularly in assessing sterility, sub-visible particles, and degradation products.Conclusion Morphine, midazolam, noradrenaline, dopamine, and clonidine are strong candidates for standardised RTA formulations based on current stability data, and indeed a licensed dopamine formulation is already coming to market with a shelf life of 2 years in a glass container. 3 These findings support the feasibility of transitioning to mass-manufactured, pre-filled injectables in neonatal care. However, further research is required to validate these results under NHS gold-standard protocols and to address data gaps for drugs such as dinoprostone, octreotide, and glucagon. Attention should be paid to the need for stability data which examines degradation products, microbiological sterility and whether stabilising excipients are appropriate for the neonatal population.This synthesis provides a foundational reference for future formulation development and contributes to the broader goal of improving neonatal medication safety through standardisation. This work supports the transition from bespoke, ward-based preparation to safer, standardised intravenous infusions, reducing the risk of dosing errors and contamination in neonatal care.References NPPG. Standardising intravenous infusion concentrations for neonates and children in the UK – framework. 2024 Available from: https://www.rcpch.ac.uk/resources/standardising-intravenous-infusion-concentrations-neonates-children-uk-framework Date accessed: 3/6/2025.NHS Pharmaceutical Quality Assurance Committee. A standard protocol for deriving and assessment of stability – Part 1: Aseptic preparation. SPS 2019 Available from: https://www.sps.nhs.uk/articles/a-standard-protocol-for-deriving-and-assessment-of-stability-part-1-aseptic-preparation/Date accessed: 3/6/2025.European Medicines Agency. Neoatricon. EMA 2024; Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/neoatricon Date accessed: 3/6/2025.",
  "authors": [
    {
      "affiliations": [
        "University Hospital Of UK"
      ],
      "name": "Thomas Wyllie"
    },
    {
      "affiliations": [
        "Cardiff University, UK"
      ],
      "name": "Allan Cosslett"
    }
  ],
  "title": "P23 Evaluating injectable drug stability to support standardisation of neonatal infusions",
  "uid": "31ac3843-ed18-5e92-8a3a-a7ab7cd3ff0f"
}