Poorly-soluble APIs present formulation and development challenges. Excipient selection and manufacturing process development are crucial. Continuous twin-screw granulation is gaining acceptance as a manufacturing technology to address issues presented by these APIs and is offering high production capacity in a small footprint.
In this dedicated dialogue, solubility enhancement expert Andreas Gryczke from BASF will answer additional questions that have been posed in our recent webinar on Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.