22.04.2025

22.04.2025

New Whitepaper on Bioavailability Enhancement Strategies for Poorly Soluble Drugs

Starnberg, 22/04/2025

Aenova has published a new whitepaper addressing one of the pharmaceutical industry's most pressing R&D challenges: improving the bioavailability of poorly soluble drug candidates.

Titled “Acceleration development of poorly soluble drug candidates through quality-by-design,” the new whitepaper explores innovative approaches to enhance the solubility and bioavailability of difficult-to-formulate APIs.

With over 80% of new drug compounds falling into Biopharmaceutics Classification System (BCS) Class II and IV - categories characterized by poor aqueous solubility - there is a growing urgency to adopt advanced formulation strategies that can bring these therapies to market faster, especially in areas of high unmet medical need. Drug developers must therefore have a wide range of techniques to address solubility challenges presented by new generations of drug candidates.

Aenova presents a science-based, data-driven approach to formulation and recommends comprehensive pre-formulation programs that use active pharmaceutical ingredients (APIs) sparingly for technology screening to overcome the challenges of bringing new, poorly soluble drug candidates to clinic.

Quality-by-Design (QbD) is a structured pharmaceutical development approach that ensures quality is built into the product from the beginning by thoroughly understanding product properties and process controls. QbD is particularly valuable in the formulation development of poorly soluble drugs, helping developers identify key parameters influencing solubility and bioavailability. By incorporating a data-driven QbD approach, developers can mitigate the cost and time implications of late-stage setbacks.

The new whitepaper from Aenova describes several approaches, including how technologies such as hot melt extrusion and spray drying can be used to create amorphous solid dispersions with great success.

“These technologies are not only scientifically advanced but also scalable and economically viable, allowing for streamlined development even under accelerated timelines,” said Dr Klaus Pollinger, Group Director Global Product Development at Aenova. “Our latest whitepaper offers valuable insights for pharmaceutical developers seeking to overcome solubility barriers and deliver more effective therapies to patients.”

The whitepaper is available for download now.