Next generation pharmaceutical impactor (a new impactor for pharmaceutical inhaler testing). Part I: Design

Area of Science:

• Pharmaceutical Sciences
• Aerosol Science and Technology
• Mechanical Engineering

Background:

• Accurate characterization of particle size distribution is critical for the efficacy of pharmaceutical inhalers.
• Existing impactor designs may have limitations in flow rate flexibility, sample handling, and collection efficiency for very fine particles.

Purpose of the Study:

• To introduce and describe the design and capabilities of the Next Generation Pharmaceutical Impactor (NGI).
• To highlight the NGI's suitability for pharmaceutical inhaler testing across a range of flow rates.
• To detail features enhancing usability and particle collection efficiency.

Main Methods:

• Design and aerodynamic modeling of a seven-stage cascade impactor.
• Evaluation of particle size fractionation across a flow rate range of 30-100 L/min.
• Incorporation of novel features such as removable collection cups and a micro-orifice collector (MOC).

Main Results:

• The NGI provides confident particle size fractionation behavior from 0.24 to 11.7 microm aerodynamic diameter.
• Operates effectively across a wide flow rate range (30-100 L/min).
• Features facilitate rapid sample processing and efficient collection of ultra-fine particles via the MOC.

Conclusions:

• The Next Generation Pharmaceutical Impactor (NGI) is a versatile and user-friendly device for pharmaceutical inhaler testing.
• Its aerodynamic design and novel features meet the needs of the inhaler testing community.
• The NGI enables precise particle size analysis, contributing to the development of effective inhalation therapies.