Polymorph Characterization Using the Nicolet iS50 Raman Module

Solid dose drugs comprise a considerable segment of the pharmaceutical market. The solid dose form can offer long shelf life, convenient drug delivery, and can be packaged into capsules, tablets, gel caps, and patches. Polymorphism is the ability of a molecule to exist in more than one stable or meta-stable crystalline state. Distinct crystalline forms commonly exhibit differences in pharmacologically relevant properties of a single active pharmaceutical ingredient (API) in its solid dose form. These properties include bioavailability, solubility, rate of absorption, duration, stability, manufacturability, and processability. Manufacturing factors also can influence polymorphism and can include solvents used in product formulation, the rate of product recrystallization, salt selection, and temperature. Since polymorphism can have profound effects on an API’s pharmacodynamics and manufacturing process, it becomes critical to fully characterize and understand polymorphic behavior.