Particle sizer improved for aerosol drugs
ImageTherm Engineering to develop a new version of an instrument
used to measure the size of droplets in concentrated spray and
aerosols.
The system, based on Malvern's Spraytec particle size analyser, will use a nasal spray actuation system developed by ImageTherm to improve the system's ability to generate particle size data on this type of product.
The alliance is particularly timely, as the US Food and Drug Administration (FDA) has just drawn up new draft guidance covering the testing of nasal aerosols and sprays, according to Malvern.
The Spraytec system uses the technique of laser diffraction for high speed droplet size measurements in concentrated sprays and aerosols.It is already being used within the pharmaceutical industry for the characterisation of nasal sprays, inhalers and nebulisers.
Paul Kippax, Malvern's product manager for diffraction systems, said: "The use of laser diffraction droplet sizing is becoming increasingly important in ensuring the complete characterisation of nasal pump sprays in line with the FDA's regulatory guidance.
Reproducible, automated actuation systems are a key requirement within this field, he added.
In Europe, the regulatory authorities are also in the process of updating their guidance on inhaled drugs, as the current regulations no longer reflect the realities in the marketplace for these products.
The SprayView NSx actuator provides researchers with a precise means of controlling the actuation of nasal pump sprays during product testing, eliminating user bias and ensuring that meaningful product comparisons can be made.
The system allows users to specify both the velocity and acceleration of actuation, providing a realistic mimic of how a patient may use a given device.
