Quality by Design: Concept for Product Development of Dry‐powder Inhalers

This review discusses recent developments in the manufacture of inhalable dry powder formulations. Pulmonary drugs have distinct advantages compared with other drug administration routes. However, requirements of drugs properties complicate the manufacture. Control over crystallization to make particles with the desired properties in a single step is often infeasible, which calls for micronization techniques. Although spray drying produces particles in the desired size range, a stable solid state may not be attainable. Supercritical fluids may be used as a solvent or antisolvent, which significantly reduces solvent waste. Future directions include application areas such as biopharmaceuticals for dry powder inhalers and new processing strategies to improve the control over particle formation such as continuous manufacturing with in-line process analytical technologies.

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Quality by Design: Concept for Product Development of Dry‐powder Inhalers

Cited by 2 publications

References 88 publications

Design of Experiments for the Development of Inhalational Products

Design of Experiments for the Development of Inhalational Products

A Review on Recent Technologies for the Manufacture of Pulmonary Drugs

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