Beyond bioavailability: from formulation to viable drug product

As the pharmaceutical industry gathered at CPHI Milan 2026 this week, formulation challenges associated with increasingly complex drug compounds were clearly part of the broader industry conversation.

Poor aqueous solubility remains one of the most persistent challenges in small molecule drug development. But the discussion around formulation is increasingly moving beyond the question of how to improve solubility or bioavailability alone.

Across the industry, there is growing recognition that formulation technologies also need to support the transition from early development to a viable commercial product. Scalability, manufacturing robustness, supply continuity and the practical requirements of downstream processing are becoming increasingly important parts of the equation.

At the same time, formulation choices can have consequences well beyond drug exposure. Drug loading, excipient burden, process complexity, solvent use and the size and convenience of the final dosage form can all influence both manufacturability and patient experience.

This points to a broader shift in how formulation technologies need to be evaluated.

Achieving strong dissolution or exposure is important, but it is not sufficient on its own. For companies developing challenging oral compounds, the question is no longer simply “Can we improve bioavailability?”, but also “Can we build a robust, scalable and patient-friendly product around it, with efficient manufacturing and limited solvent use?”

“Improving bioavailability is only part of the challenge. What ultimately matters is whether a formulation technology can also support efficient manufacturing, scale-up and a viable drug product. That broader perspective is very much at the heart of how we are developing Formulite®,” says Peter Åsberg, CEO of Disruptive Pharma.

Formulite® is based on stabilizing drug compounds in an amorphous state, supporting rapid drug release while retaining high drug loading and good powder processability. The platform is being developed with the downstream drug product in mind and is designed to work with established oral solid dosage processes, supporting development from early feasibility through scale-up and clinical and commercial manufacturing.

CPHI Milan provided a timely reminder that the next generation of formulation technologies will need to deliver more than a single performance benefit. For challenging oral drugs, the real value lies in combining drug performance with a practical path towards a manufacturable, scalable and patient-friendly product.