Strategies for successful manufacturing of highly potent oral solids

October 14, 2025

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Highly potent active pharmaceutical ingredients (HPAPIs) are increasingly prominent in drug development, but their poor solubility and low bioavailability present formulation challenges. To address these issues, manufacturers use enabling technologies such as micronization, spray drying, and hot melt extrusion to improve performance and downstream handling (Catalent, Outsourced Pharma).

The production of highly potent oral solids requires stringent containment, operator safety, and cross-contamination prevention. Contract development and manufacturing organizations (CDMOs) like Catalent provide the necessary infrastructure, expertise, and scalable capabilities to maintain product integrity.

Particle sizing and micronization are key to improving dissolution and bioavailability, but must be performed in isolators with proper densification to ensure safety (Catalent, Outsourced Pharma).

Robust containment measures, including glove boxes, isolators, and PPE, along with strict SOPs, protect workers and maintain safe manufacturing conditions. Continuous monitoring and maintenance of equipment ensure ongoing safety and compliance.

When outsourcing HPAPI manufacturing to a CDMO, sponsors should evaluate quality systems, experience, and capacity to ensure safe, efficient, and successful development of oral solids (Catalent, Outsourced Pharma).