Droplet size test methods for quality control

Researchers at Valois Pharmaceutical Division are using a Malvern Instruments Spraytec system to develop robust droplet size test methods for quality control and product development applications.

Researchers at Valois Pharmaceutical Division, a leader in the design and manufacture of spray delivery systems, are using a Malvern Instruments Spraytec system to develop robust droplet size test methods for quality control and product development applications.

The Spraytec provides a routine method of verifying the batch-to-batch product consistency of the different nasal pump delivery systems produced by Valois, in line with recently proposed FDA guidelines.

The design of new delivery systems can also be optimized.

Spray droplet data has been especially useful in the development and performance testing of Equadel, a new nasal spray pump designed to generate user-independent performance.

Spray droplet data collected using automated actuation stations illustrate how droplet size, a key variable in defining drug bioavailability, can vary with actuation profile.

Normally significant changes in pump output are observed as the actuation profile is changed.

However, data generated using the Spraytec confirms that Equadel pump system is insensitive to the applied actuation profile, as was the design intent.

This new design will therefore be more consistent, in terms of delivery performance, from patient-to-patient.

Spray characterization, such as spray droplet size measurement, has become routine in the testing of nasal spray products and devices.

For production quality control purposes FDA guidelines recommend that a certain number of devices from each batch are tested prior to despatch.

Spraytec, a laser diffraction system, specifically designed to meet industrial requirements for the efficient measurement of spray droplet size, is proving to be highly effective in this application.

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