Malvern Instruments Announces Alliance With Image Therm Engineering

Materials characterization company Malvern Instruments Ltd and Image Therm Engineering, Inc. have entered into an agreement whereby ImageTherm will manufacture and supply its SprayVIEW® NSx nasal spray actuation system for the Malvern Spraytec particle size analyzer.

The Spraytec system uses the technique of laser diffraction for high speed droplet size measurements in concentrated sprays and aerosols. It is being widely adopted within the pharmaceutical industry for the characterization of nasal sprays, inhalers and nebulizers. The alliance with ImageTherm adds significant new capabilities within the Spraytec product range, further enhancing the ability of manufacturers to meet the requirements set out in the FDA's draft guidance covering the testing of nasal aerosols and sprays.

Paul Kippax, Malvern's product manager for diffraction systems, is pleased to have secured the agreement with ImageTherm. He said, "The use of laser diffraction droplet sizing is becoming increasingly important in ensuring the complete characterization of nasal pump sprays in line with the FDA's regulatory guidance. Reproducible, automated actuation systems are a key requirement within this field. ImageTherm's expertise and reputation in the area of nasal and pulmonary pharmaceutical spray characterization were major factors in our decision to work with them, extending the ability of Malvern Instruments to meet the needs of our customers globally."

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 meainingful 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. In addition, an integration kit (the SprayVIEW NSx-MS) is available that allows accurate positioning of the actuator within the Spraytec's optical bench. This includes software feedback of the distance between the nasal spray nozzle and the laser diffraction measurement zone.

Dino Farina, President and founder of ImageTherm, stated that,"ImageTherm has always worked to provide innovative solutions for pharmaceutical product testing to our customers. Working with Malvern represents a significant opportunity for us to expand our business and provide better customer support to the global pharmaceutical product testing market. The integrated SprayVIEW NSx and Spraytec solution provides customers with a best of breed solution for efficient and reliable nasal spray characterization."

About Malvern Instruments
Malvern Instruments is a leading supplier of analytical solutions for particle characterization and rheological applications. Advanced technologies are combined with robust mechanical designs and comprehensive software to provide systems that measure material characterization data (size distribution, particle shape, zeta potential, molecular weight) and bulk material properties. On-line, at-line and off-line solutions are provided to meet QA/QC, control and development applications across a diverse range of industries. An extensive support service facilitates the optimal design and exploitation of any given system.

About ImageTherm
ImageTherm delivers innovative testing and development systems and services that are advancing the science of nasal and pulmonary spray delivery of pharmaceuticals. The privately-held company, founded in 1995, is headquartered in Sudbury, Mass. The company's products and methodologies enable 21 CFR Part 11 compliance and are ISO9001:2000 certified. ImageTherm's preferred, proven systems are in use by leading global pharmaceutical companies, including GlaxoSmithKline, AstraZeneca, Wyeth, IVAX, and the FDA.

Source: Malvern Instruments