Indiana pharma research group to present crystallinity research at Basel synchrotron workshop

Improved Pharma, the West Lafayette-based pharmaceutical research and consulting group, will present new work on detecting crystalline impurities in amorphous drug formulations at the Spring Pharmaceutical Synchrotron-XRPD Workshop in Basel next month, as the industry continues to grapple with one of the more persistent shelf-life risks in modern drug development.

Dr Pam Smith, the company's chief operating officer, and researcher Ruba Alajlouni, will deliver a presentation comparing the performance of several orthogonal analytical techniques — Raman spectroscopy and hot-stage polarised microscopy — against synchrotron X-ray powder diffraction coupled with pair distribution function analysis, as tools for identifying micro-domains of crystallinity in amorphous dispersions. The workshop, hosted by Excelsus, runs from 6 to 8 May.

The subject matter has meaningful commercial stakes. Amorphous solid dispersions have become an increasingly important formulation strategy for the pharmaceutical industry, particularly for poorly soluble drug candidates — a category that accounts for a growing share of pipeline assets. But unintended crystallisation during storage can compromise bioavailability, shorten shelf life and, in regulatory terms, undermine the product specifications on which marketing authorisations depend. Detecting low levels of crystallinity reliably is therefore a persistent challenge for formulation scientists and regulators alike.

"We are thrilled to be able to participate again at SPS-XRPD in efforts to openly exchange our ideas with experts in both pharmaceutical and synchrotron communities," Dr Smith said, adding that continued research in the area would "have a positive impact on advancing the development of pharmaceutical drugs".

Improved Pharma, founded in 2006 by Stephen and Sarah Byrn — who previously established SSCI, a solid-state chemistry services business later acquired by Aptuit — offers solid-state form studies, formulation design, analytical testing and expert consulting, including intellectual property support. The firm's pitch to its clients rests on the intersection of pharmaceutical formulation science and increasingly sophisticated synchrotron-based analytical techniques, an area that has attracted greater attention from drug developers, contract research organisations and generics manufacturers seeking to defend or challenge patents around solid-state drug forms.