Overcoming oral delivery challenges: The science behind scalable enteric capsules

Lonza has reimagined enteric delivery with Capsugel® Enprotect®, a bi-layer, ready-to-use capsule that integrates enteric functionality directly into its shell without the need for post-filling coating

- 

The pharma industry is witnessing an accelerating shift toward bio-logics, peptides, and other complex molecules that hold immense therapeutic promise, but their journey from lab to patient often hits a wall at the oral delivery stage.

While oral dosage forms remain the most patient-friendly route of administration, many advanced actives fail in the stomach, degraded by gastric acid or enzymes before they ever reach their target. This results in limited bioavailabil-ity, low efficacy, and the need for more invasive administration routes such as injections.

A 2022 NIH review estimates that more than 70 per cent of new drug molecules show poor oral bioavailability, especially peptides and macro-molecules. This not only increases R&D cost but also limits patient accessibility, particularly in chronic and large-scale therapies.

So the challenge is clear: how can pharma innovators make sensitive molecules orally viable, without adding layers of complexity, time, and cost?

Why traditional enteric coatings fall short

Conventional enteric coatings were designed to protect APIs from the gastric acid environment and release them in the intestine. While effective in principle, the process introduces several bottlenecks:

• Exposure to solvents, heat, or mechanical stress during coating can degrade sensitive APIs.

• Maintaining consistent coating thickness and release profiles adds complexity to scale-up.

• Additional equipment, formulation steps, and regulatory documentation prolong development timelines.

Each of these challenges compounds as drugs move from the R&D bench to commercial scale. In fast-paced development environments, formulators are looking for enteric solutions that are both scientifically robust and operationally simple.

The new generation of enteric delivery: built for science and scale