10 December 2009: Aptuit, Inc. today announced the publication of new research in the December issue of the European Journal of Pharmaceutical Sciences, the official journal of the European Federation for Pharmaceutical Sciences (EUFEPS), which describes the solid-state characterisation of three forms of finasteride. The study, conducted by researchers at SSCI, a Division of Aptuit, outlines a systematic approach to characterising a set of solvated active pharmaceutical ingredients (APIs) and evaluating the solid-state behavior of each. The research uncovered previously uncharacterised API forms within an existing family of finasteride solvates, demonstrating that Aptuit’s approach to applying solid-state chemistry may lead to the early identification of new API forms with improved pharmaceutical properties.

“Interestingly, in our initial efforts to determine the approximate solubility for subsequent solid-form screens on finasteride, we noticed unique recrystallisation properties that prompted this study. We then set forth in generating, characterising and investigating the solid-state behavior of three finasteride solvates,” explained Nathan Schultheiss, PhD, research investigator at SSCI, a Division of Aptuit, and lead investigator of the published study. “Through our work, we gained unparalleled insight into the crystallographic and thermoanalytical behavior of the compound.”

Findings from the study, “Three isostructural solvates of finasteride and their solid-state characterisation,” showed that the newly observed finasteride forms were isostructural members to an already existing family of isostructural, finasteride solvates, and determined how each of the solvated forms could be converted to other forms through standard manufacturing processes. Studies such as this can help to elucidate new API forms, aid in the discovery and selection of lead candidates, and inform manufacturing processes to ensure that selected API forms remain consistent throughout the development process.

“This study highlights the scientific expertise that our teams at Aptuit apply to the challenges our clients face in evaluating drug candidates and developing viable commercial drug products. The ability not only to discover and manufacture API solid forms, but also to continually monitor them, is a unique service that we are able to offer to the drug development innovators that partner with and entrust their programs to us,” said Jan-Olav Henck, Senior Director, Scientific Operations. “In doing this, we’re enabling the success of our clients’ programs with information that allows for safer, more consistent, and reproducible results throughout the drug development process.”