Particle size distribution significantly impacts drug product efficacy, which makes ingredient specific particle sizing a requirement for today's regulatory environment.
The size of the particles present within a drug product, including both the active pharmaceutical ingredient (API) and excipients, can significantly affect bioavailability and efficacy. Therefore, it is important to understand particle size distribution of ingredients to fully assess a pharmaceutical product and influence formulation development. This is especially true for generic drug developers, where bioequivalence studies can expedite marketing approval decisions from the FDA.
Gateway Analytical provides particle size distribution testing that allows our customers to obtain ingredient specific size information for nasal sprays, inhalable drugs administered through metered dose inhalers (MDI) and dry powder inhalers (DPI), creams, gels, ointments, and more. The information provided can be used to compare expected uptake, mode of action, and effect between two drug preparations, such as an innovator formulation and a generic challenger.
Our experts perform this service in two phases: Feasibility and Full Testing. During Feasibility, we assess the ability to distinguish specific ingredients. This is determined using Raman spectroscopy (RCI, SPE-Raman, or manual confocal Raman) to build a spectra reference library of the pure components comprising the drug product. Once established, we conduct Full Testing to determine ingredient specific particle size distribution, conduct statistical analyses, and collect representative particle images and spectra.
These types of analyses are crucial during the development of generics, proving bioequivalence, and in reverse-engineering of innovator drugs. Contact us today and learn how we can work together on your next project.