Aptuit develops proprietary production screen to understand API and drug formulations

Aptuit, Inc., today announced that it has developed a proprietary production screen to enable a better understanding of active pharmaceutical ingredients (API) and drug formulations earlier in the product lifecycle. The production screen applies advanced theoretical developments in solid-state chemistry to address challenges at the most critical interfaces in the drug development process. Using this screen to provide an increased understanding of the characteristics of a drug compound, Aptuit is better able to offer data and insights that inform critical decisions, particularly around potential scale-up challenges, at both the development and production stages of drug development programs.

“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.”

“We’re continuously working to enhance our offering to meet the evolving challenges scientists face in advancing a drug candidate and bringing important new medicines to patients,” stated Timothy C. Tyson, chairman and chief executive officer at Aptuit. “This new production screen is a prime example of the unparalleled understanding of the science of drug development that our team applies to develop solutions for both individual client programs and broader industry-wide drug development challenges.”

The production screen examines and measures the effects of temperature, humidity, and other physical stresses on the solid form of a drug compound – the API, excipients, or the API/excipient form – and can be tailored to small molecules, large molecules and biologics. These data and early insights lead to better understanding of the solid-state material, including solubility and bioavailability properties, to optimize development and production processes and platforms; to strengthen patents and IP protection; and to inform regulatory discussions, particularly in relation to quality by design.

“Scale-up, in particular, introduces mechanical stresses to a compound which can create issues related to the stability and integrity of the drug,” commented Dr. Jan-Olav Henck, Senior Director of Scientific Operations and Site Director at Aptuit’s facility in West Lafayette, Indiana. “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.”