Enteral feeding tubes (EFTs) are essential to use in cases where patients are unable to swallow oral dosage forms due to conditions such as dysphagia, neurological disorders, or critical illness. While this practice is common, it introduces significant formulation challenges that impact safety, efficacy, and outcomes in both adult and children patient populations.
An article published last year in Advanced Drug Delivery Reviews noted that medicines administered via EFTs to children, in particular, are often not licensed for use via EFTs and therefore subject to manipulation, such as crushing tablets or opening capsules, to administer. This leads to a greater risk of dosing errors, tube blockage, altered bioavailability, and safety issues due to agespecific physiological differences and narrow therapeutic windows. A lack of harmonised global regulatory guidance specific to paediatric EFT administration was also noted.
Pharma and biotech sponsors increasingly need early, data-driven in vitro testing to support EFT administration and avoid off-label use, making formulation design and testing strategy critical upstream activities. Draft guidance issued in 2021 from the US Food and Drug Administration (FDA) provided a framework for addressing these challenges, emphasising the importance of systematic testing and clear labelling.1 The FDA guidance was the first regulator-led attempt to formalise expectations for demonstrating whether oral drug products can be administered via EFTs using in vitro testing.
While it laid a foundation, the FDA guidance has left much to interpretation. More recently, the European Medicines Agency (EMA) have elaborated on requirements for studies that should be performed to demonstrate feasibility of EFT administration.2 The January 2026 guidance embeds EFT administration within broader quality and lifecycle management expectations. The EMA’s guidance is less exploratory and more operational, signalling that regulators will increasingly expect EFT feasibility to be designed in early drug development and clinical testing, instead of retrofitted later.
As regulations evolve, thoughtful drug product formulation design, excipient choice, and dose flexibility must be built in early and supported by data that demonstrates real-world tube compatibility. In this article, we look at factors involved in properly administering drug products through EFTs, including factors such as:
• Chemical compatibility and integrity
• Interaction with enteral feeding tube materials
• Physical stability and enteral feeding tube patency
• Labelling and instructions for use
