Engineered Particles for Inhaled Biotherapeutics

Presented by Jeff Breit, Ph.D. and Devon DuBose
May 3, 2012

The number of pharmaceutical biological compounds in development and on the market is rapidly expanding, and this trend includes developing biotherapeutics to be delivered through inhalation. However, popular delivery systems, such as nebulizers, and often-used excipients, such as lactose, can present delivery, incompatibility, stability, and other issues. In response, spray drying has been used to manufacture and deliver inhalable engineered particles using excipients other than lactose.

In this presentation, we will outline important aspects of the spray-drying process and highlight formulation and process parameters that dictate a scalable, stable, and efficacious inhalable drug product.

Specific topics to be discussed include:

How spray drying can rapidly screen and minimize active pharmaceutical ingredient (API) use during formulation development, excipient screening, and manufacturing process determination.
Creating and testing inhalable spray-dried engineered particles for biotherapeutics with a focus on particle and protein stabilization during formulation design and manufacturing.
Importance of particle quality attributes including crystalline character, water content and water uptake.
How successful creation of spray dried particles with a mass median aerodynamic diameter (MMAD) suitable for inhalation and deposition into the lung is tied to the manufacturing process and API formulation
Tools used to screen and characterize powder particle properties