Trudell Medical International (TMI) uses Malvern Spraytec in Novel Breath-Actuated Nebulizer Development

Researchers at Trudell Medical International (London ON, Canada), an established developer and manufacturer of aerosol delivery devices, are using the new Malvern Spraytec particle size analyzer in the study of nebulizer performance.

The Spraytec, equipped with an inhalation cell, allows the characterization of nebulizer sprays under conditions representative of their use. At TMI, the system is being used in the development of new products such as the AeroEclipse® II breath-actuated nebulizer (BAN).

The original AeroEclipse® BAN, introduced a few years ago, was the first mechanically-operated small volume BAN with dosimetric capability, providing a near constant delivery rate of medication from a variety of formulations and volume fills. This nebulizer required an inhalation flow rate close to 25 L/min to operate the breath-actuation mechanism. The second generation AeroEclipse® II BAN now actuates at flow rates as low as 15 L/min, making it potentially more suitable for younger patients.

According to Dr. Jolyon Mitchell, Scientific Director, the team had very clear reasons for selecting the new Spraytec system. “Based on initial testing with a widely used formulation, it may indeed be suitable for a wide range of pharmaceutical applications. Equally important for nebulizer studies is the inhalation cell which draws sample through the measurement zone at a rate designed to simulate the inhalation process. The cell on the Spraytec has proved to be especially easy to set up, use and clean.”

The Malvern Spraytec uses laser diffraction technology to deliver automated, in situ analysis of high concentration aerosols and sprays. .Its 10 kHz data acquisition rate, coupled with a 0.1 to 2000 micron dynamic range, enables accurate analysis of the dynamics of spray atomization.

The Spraytec's flexible design, completely sealed against moisture ingress, and a patented multiple scattering analysis yield robust, accurate measurements even when characterizing wide, high-volume spray plumes. Measurement synchronization is achieved using a series of triggering options ensuring that pulsed spray systems can be characterized effectively. The system's powerful software provides a frame-by frame analysis of each spray event and offers advanced data processing capabilities. Integrated Standard Operating Procedures (SOPs) simplify method definition and make reproducible measurements straightforward. IQ/OQs, full lifecycle documentation and a route to technical compliance to the requirements of 21 CFR Part 11 are provided for support of the pharmaceutical industry.