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For characterizing nebulizers, Spraytec offers real-time droplet size and concentration measurement independent of flow rate. Nebulizer mist droplet size dictates deposition behavior in the respiratory tract. Concentration influences the rate of drug delivery.

Good agreement between laser diffraction and cascade impaction data encourages the use of Spraytec to accelerate product development and performance testing. It is suitable for both breath-triggered and continuous systems. The results support the rapid and efficient specification of nebulizer device and formulation for different patient groups.

Case Studies

Comparing laser diffraction and cascade impaction data Scientists at Catalent Pharma Solutions have shown that laser diffraction and cascade impaction give closely comparable fine particle fraction (fraction < 5 microns) data for nebulizer solutions. A cross-validation study compares Spraytec data with those from a Next Generation Impactor (NGI) for two solutions, nebulized using two commercial devices. The study confirms laser diffraction as a fast and efficient way to generate the information needed for nebulizer screening and development.

The impact of breathing profile on nebuliser output Spraytec was used successfully to track changes in droplet size and concentration induced by variation in breathing profile and nebulizer operating conditions. The nebulizer assessed was air-driven and breath-assisted. A breath simulator (Copley Scientific, UK) provided sinusoidal air flow of varying frequency to reflect the inhalation pattern of different patient groups. The results inform selection of the best device/formulation combination for a given user group and parameters such as treatment duration.

Formulation and device optimization Studies emphasise the complementary nature of imaging analysis and laser diffraction for optimizing nebulizer device and formulations. The Morphologi G3 imaging system (Malvern Instruments – Link) detects and classifies over-sized particles in a nebulizer formulation for better manufacture. Spraytec quantifies the influence of parameters such as driving air flow for optimizing device performance.

Spraytec Inhalation cell for DPI, MDI and Nebuliser measurements The Spraytec Inhalation cell is specified for DPI, MDI and nebulizer testing. It simplifies experimentation under controlled air flow conditions, in accordance with routine testing protocols. Using the Inhalation cell Spraytec can be set up in line with a cascade Impactor to streamline data acquisition.

 
 
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