The new inhalation cell for Malvern Instruments' Spraytec laser diffraction particle size analyzer will be shown for the first time in the US at the forthcoming Respiratory Drug Delivery conference, RDD X. This took place in Boca Raton FL from April 23-27 2006. Practical experience with the Spraytec will be presented as part of the conference's Scientific Poster Session, with contributions from Malvern Instruments and from Trudell Medical International (Ontario), covering applications in nasal sprays and pulmonary drug delivery systems respectively. Researchers at Trudell are using the inhalation cell in the development of the AeroEclipse II ® BAN (Breath Activated Nebulizer), a second-generation device. The company has found the working range of the Spraytec and its sensitivity below one micron especially beneficial.
The Spraytec delivers real-time, high-speed particle size measurements for the complete characterization of continuous and pulsed spray events. With a data acquisition rate of 10 kHz in practice a 100-microsecond time resolution it allows highly accurate analysis of the dynamics of particle formation and dispersion, so that even the rapid changes in particle size that take place during inhaler and nasal spray operation can be followed.
The Spraytec's new cell is designed to support pharmaceutical development by enabling fast characterization of systems such as dry powder inhalers (DPIs), metered dose inhalers (MDIs) and nebulizers. If required, it can be used in-line with conventional impaction techniques and is fully compatible with the associated flow control systems, allowing correlation with traditional methods. However, the Spraytec offers significantly higher measurement rates - several hundred per day compared with six for conventional techniques - allowing the rapid screening of formulations for correct dispersion performance. Since laser diffraction measurements are independent of flow rate, the Spraytec with Inhalation Cell allows the measurement of particle size distributions during the operation of a device using model patient profiles, providing a more realistic mimic of real-life performance.
Exceptionally easy to use, the Spraytec has a built-in SOP wizard aiding method definition and transferability, and offering single-click operation. Full lifecycle documentation, following GAMP guidelines, provides complete design traceability; IQ/OQ documentation is provided for validation plans; and software provides technical compliance with the requirements of 21 CFR Part 11.
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