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Advanced Microparticle Characterization Methods to Support Respiratory Product Development

Lechuga-Ballesteros D, D'Sa D, Hoe S, Vehring R.

Respiratory Drug Delivery 2016. Volume 1, 2016: 63-70.

Abstract:

Application of the quality by design (QbD) approach to the development of inhalation products relies on the identification of critical quality attributes (CQA) of formulation components and their implications on manufacturing processes and inhaler performance. The QbD approach places emphasis on process and product understanding during development stages, which enable fast identification of root cause failures and more comprehensive implementation of solutions, when quality issues arise. Identification of active pharmaceutical ingredient CQAs, such as particle size and crystallinity, can guide micronization, conditioning, and blending process optimization during the development of lactose blends for a DPI. Likewise, drug solubility in propellant can affect pMDI suspension physical stability. Surface properties of microparticles, such as surface rugosity, surface area, and surface energy may drive suspension stability in a pMDI or aerosol performance in a DPI. Furthermore, water content in a formulation or exposure to environmental conditions can determine physical stability of drug microparticles. Advances in characterization technologies that facilitate the identification of microparticle CQAs to support the QbD approach to development of inhalation products are discussed further in this paper.