Active pharmaceutical ingredients (APIs) can take a wide variety of solid-state forms, from pure crystals to hydrates and salts. Polymorphs of these forms further complexify solid-state screening, by increasing the difficulty of identifying crystalline variations that are both useful and unique. However, the field of solid-state screening is rapidly developing new solutions to address these challenges, in all three of the following areas:
1. Innovative screening technologies streamline polymorph identification.
Although x-ray Powder Diffraction (XPRD) remains the go-to technique for solid-state screening, many labs have also invested in infrared, Raman, and nuclear magnetic resonance (NMR) spectroscopy tools to enhance their identification capabilities.
2. An array of new techniques deliver deeper polymorph analysis.
A growing number of labs now use thermogravimetry, thermal scanning calorimetry and hot-stage microscopy, to analyze polymorphs’ structural stability, solvation and desolvation rates, and other mechanical properties.
3. High-throughput analytics provide polymorph screening at scale.
Labs are frequently contracted to identify 1,000 or more more crystallizations on a very tight deadline, using only three to five grams of material. Pharma companies and CMOs have responded with semi-automated analytical techniques that rapidly screen hundreds of polymorphs.
Solid-state screening techniques evolve every year. At VxP, we’re on top of all the latest developments.
