記録された日時: December 10 2017

Detailed particle characterization, including shape and size analysis and chemical identification, enables thorough understanding of drug formulations. This level of knowledge creates confidence and control in optimized development and manufacture processes.In this webinar, we will focus on the orthogonal application of particle characterization tools for the development of both innovator and generic dry powder inhalers (DPIs).

DPIs are an increasingly popular means of delivering a therapeutic dose to the respiratory system for local action. DPI formulations typically consist of finely micronized drug particles, which are either co-agglomerated to form soft pellets, or, more traditionally, blended with coarse excipient particles to improve the overall flow properties of the powder and to aid metering of the low dosagestypically required for local drug action.The complexity of these particle interactions within a DPI formulation governs aerosol dispersion and regional deposition and disposition of the aerosolized dose within the airways.

A principal challenge fordevelopers of both innovator and generic DPIs is understanding the relationship between in vitro dosing parameters and the fate of the inhaled dose in vivo. Investigations into the state of aggregation for both the formulated blend contained within a unit dose blister, capsule or reservoir DPI device and the resulting arrangement of the dispersed dose are therefore of increasing interest.

In this webinar, we examine the orthogonal use of Morphologically-Directed Raman Spectroscopy (MDRS)and UniDose-enabled dissolution testing to characterize the microstructure of DPI formulations and improve inhaled drug delivery profiles.