US firm Aptuit has unveiled a new production screen that it claims will help speed up scale-up processes by enabling better understanding of active pharmaceutical ingredients (APIs) and drug formulations in the initial stages of the drug development process.
Built on advanced theoretical developments in solid-state chemistry, the proprietary screen examines and measures the effects of physical stresses including temperature and humidity on the solid form of a drug compound – the API, excipients, or the API / excipient form.
This data and early insights will help provide increased information on the material’s solubility and bioavailability properties, inform regulatory discussions, and strengthen patents and IP protection, according to Aptuit.
Indiana Aptuit facility senior director of scientific operations Dr Jan-Olav Henck said that scale-up, in particular, introduces mechanical stresses to a compound and can create issues related to the stability and integrity of the drug.
“The advanced scientific models and techniques we have developed in solid-state chemistry enable reproducible, predictable outcomes that ultimately help guide the development of safe and effective drugs,” Henck said.
The screen can be tailored to small molecules, large molecules and biologics.