Enteral feeding tubes (EFTs) are crucial for adult and pediatric patient populations that are unable to swallow oral medicines due to conditions like dysphagia, neurological disorders, or critical illness.
Although widely used, EFTs present significant formulation challenges that impact safety and efficacy across both adult and pediatric populations.
Recent research in Advanced Drug Delivery Reviews highlights that medicines given to children via EFTs are often unlicensed for this route and must be manipulated, for example by crushing tablets. This adds risk for the patient that can range from dosing errors and tube blockages to altered bioavailability and safety concerns.
Pharmaceutical and biotech companies are increasingly adopting early, data-driven in vitro testing to support EFT administration and prevent off-label use, but a lack of harmonized regulatory guidance for pediatric EFT administration remains a challenge.
In 2021, the US Food and Drug Administration (FDA) issued draft guidance, providing a framework for systematic testing and labelling, formalizing expectations for demonstrating oral drug suitability for EFTs. However, this guidance left room for interpretation. More recently, the European Medicines Agency (EMA) has detailed requirements for studies confirming the feasibility of EFT administration. The EMA guidance, effective January 2026, integrates EFT considerations within broader quality and lifecycle management.
The EMA is signaling that regulators will increasingly expect EFT compatibility to be built in from the start, not added later. This progress in regulatory approaches, with clearer expectations on generating and documenting data, and labelling. Careful formulation design, excipient selection, and dose flexibility, all supported by robust data, will be key to meet evolving regulatory demands.
In our recent whitepaper, we review key factors for effective administration of drug products via EFTs for pediatric populations, highlighting chemical compatibility, interactions with tube materials, physical stability and tube patency, and clear labelling and instructions for use. Download our recent article to continue reading.