ACG Flags Dosage Form Design as a Primary Driver of Medication Non-Adherence in Elderly Patients

Formulation decisions made at the bench are reaching patients as adherence failures at the bedside, and ACG is pressing pharma R&D and manufacturing teams to treat dosage form design as a clinical variable, not an afterthought. The argument is grounded in population data: polypharmacy affects 45% of elderly outpatients and rises to 71% in hospital settings, while adherence rates for common chronic therapies, oral antidiabetics, antihyperlipidemics, antiosteoporotics, sit between 35% and 60%.

Dosing frequency compounds the problem. Adherence drops from 79% at once-daily regimens to 51% at four-times-daily schedules. Fixed-dose combinations (FDCs) address frequency burden and have demonstrated a 26% improvement in adherence rates, but they introduce formulation complexity around API compatibility and differential release profiles that process development teams must account for during process validation.

Dysphagia is a structural gap in current prescribing and formulation practice. Approximately 30% of elderly patients experience swallowing difficulties, rising to 58% in nursing home populations, yet nearly 70% report never being assessed for the condition before a regimen is prescribed. The downstream consequence is significant: up to 67% of medicines in geriatric care facilities are crushed or split, directly compromising the integrity of modified-release and enteric dosage forms, a GMP-relevant outcome that quality teams cannot ignore.

Alternative dosage forms, orally disintegrating tablets (ODTs), effervescent tablets, multiple unit pellet systems (MUPS), and sprinkle capsules, eliminate the intact-swallow requirement, but each carries manufacturing trade-offs. Pellet integrity, coating uniformity, and product stability under varied administration conditions introduce quality control checkpoints that require robust process design. The FDA guidance recommending tablets below 22 mm and capsules no larger than size 00 provides a dimensional benchmark, but size reduction often demands higher-density formulations or full reformulation, raising the bar for analytical and process development work.

Simpler interventions, film coating, smoother capsule shells, ovular tablet geometry, offer incremental gains with lower manufacturing overhead and merit evaluation before committing to platform changes. Packaging remains a parallel failure point: push-and-twist closures and standard child-resistant blisters can exceed the grip and torque capacity of elderly patients, making access itself a barrier to adherence regardless of formulation quality.

As regulatory agencies and payers increase scrutiny of real-world outcomes, formulation teams that document adherence-by-design rationale within their development dossiers will be better positioned to defend product decisions through the lifecycle.

Source: ACG via acg-world.com, 19 May 2026.