Title : Pharmaceutical polymorphs: Advanced strategies for solid-state characterization and optimization
Abstract:
The solid-state form of active pharmaceutical ingredients (APIs) exerts a decisive influence on critical quality attributes such as bioavailability, stability, and manufacturability. Among these, polymorphic transitions are particularly pivotal, as distinct crystalline modifications can exhibit divergent physicochemical behaviors, thereby necessitating rigorous analytical control throughout the drug development lifecycle.
This presentation delves into advanced methodologies for the comprehensive elucidation of pharmaceutical polymorphs, spotlighting Raman spectroscopy as a cornerstone in solid-state characterization. Owing to its intrinsic sensitivity to molecular vibrations and non-destructive nature, Raman spectroscopy provides unparalleled insight into lattice dynamics and intramolecular interactions, enabling precise differentiation between polymorphic species—even in complex matrices and at minimal sample volumes.
Additionally, the strategic deployment of Raman mapping allows for the spatial resolution of polymorph distribution within solid dosage forms, offering critical insights into heterogeneity and phase purity. The regulatory ramifications of these analytical advancements are equally substantial, as precise polymorph identification underpins intellectual property (IP) protection and ensures compliance with increasingly stringent quality guidelines.
Case studies presented herein will underscore the operational synergy between Raman spectroscopy and complementary techniques in unraveling the complexities of polymorphic systems, underscoring its role as a linchpin in contemporary pharmaceutical crystallography.
