June 04, 2013
Authored by Oksana Olkhovyk, Ph.D., at Gateway Analytical , this poster presents new qualitative and semi-qualitative methods for the examination of size and polymorph drug particle identification in finished products. Specifically, its benefits for BA/BE testing is described using the model of fluticasone-containing nasal spray suspension formulation.
Polymorphs are chemicals of identical molecular structure with different crystal lattice formations. Screening for polymorphs is crucial for drug research and development, since the crystal form of the active pharmaceutical ingredient (API) directly correlates with its pharmacokinetic properties. Polymorphism can also affect the quality, safety and efficacy of the drug product and ability to manufacture the drug substance with desired product stability and bioavailability (BA).
Ingredient-specific particle sizing (ISPS) analysis, in conjunction with polymorph identification analysis of drug-only particles in OINDPs based on Raman spectroscopy and imaging, can address challenges in evaluating drug products, from both the BA/BE and physical perspectives.