New System Reflects Growing Importance of Impaction Force in Characterising Pharmaceutical Sprays

Copley Scientific Ltd has launched the Copley Spray Force Tester SFT 1000. The new system reflects increasing recognition by both the US Food & Drug Administration (FDA) and the pharmaceutical industry of the importance of impaction force as a parameter for spray characterisation. Simple to operate, the SFT 1000 is a cost-effective option for the measurement of maximum spray force, for both nasal sprays and metered dose inhalers (MDIs). It is highly suitable for quality control and research and development applications.

Recent work by the FDA highlights the application of spray impaction force for in vitro equivalence studies, and raises the possibility of using maximum force measurements at different distances from the mouthpiece for quality control purposes. Of all the variables that can be used to characterise a spray, impaction force is the one most noticeable to the patient and is also closely correlated with aerosol deposition behaviour.

The SFT1000's highly sensitive load cell permits accurate measurement of maximum impaction force (+/- 2.5 mN) during the spray event. The distance between the test device and impaction plate can be simply set and/or varied using the precision slide rails with integral lock, and the impaction plate is easily removed for cleaning. The unit can be operated either vertically or horizontally for the representative testing of nasal sprays or metered dose inhalers respectively and the calibration can be easily verified, in the lab, by the user.