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.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
Jason Bertola, executive director of Commercial Development for the Advanced Synthesis Platform at Lonza in North America, explains the demand for spray drying and the hurdles involved with scale up, in an interview with PharmTech.
The FDA has approved remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
The company is showcasing new development solutions and advanced digital technologies including its new OSD Express and Steriles Express solutions for drug development.
Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.
The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a enzymatic mRNA manufacturing technology, and a cell-free enzymatic biomanufacturing platform.
