Formulation and Quality – Chemical
2019 PharmSci 360
Advanced physical and chemical imaging tools are critical to develop well-understood therapeutics. Product Characterization Studies are accelerated stability studies that evaluate drug product CQAs as function of temperature and humidity. Product elegance issues can arise as failure modes. Diversified imaging technologies has enabled product elegance investigation.
• Tablet cracking – XRCT imaging and MSI demonstrated that deliquesce of an acidifier led to micro crack expansion at high humidity. Controlled humidity or removal of the acidifier will mitigate the issue of tablet cracking.
• Surface Roughness – MALDI-MS Imaging demonstrated that moisture will induce the deformation of super disintegrant at the tablet surface and cause surface roughness.
• Tablet pinholes – LA-ICP-MS revealed that interaction between film coating and acidifier caused the pin hole formation.
Root Cause evaluation of pharmaceutical tablet appearance defects under accelerated stability are guided by different imaging and chemical analysis. Sound mechanistic understanding of product elegance issue will lead to more robust market formulations.