Chemometrics coupled to vibrational spectroscopy and spectroscopic imaging for the analysis of solid-phase pharmaceutical products: A brief review on non-destructive analytical methods

Abstract

This brief review reports on selected case studies aimed at verifying the authenticity of medicinal products, content uniformity of tablets and polymorphic forms in final products, and monitoring pharmaceutical cocrystallization processes. The studies combine chemometrics with vibrational spectroscopy or spectroscopic imaging, leading to non-destructive analytical methods. These methodologies allow one to analyze intact pharmaceutical formulations. Emphasis is directed to: (a) fighting against counterfeit pharmaceutical products, (b) spatial distribution of active pharmaceutical ingredients (API) in final products, (c) occurrence of polymorphic transitions in commercial tablets due to unsuitable storage conditions or excipient moisture, which could affect the apparent solubility, and (d) solubility enhancement of API polymorphic forms through a cocrystallization process.