In conclusion
Laser diffraction and automated imaging combined with Raman spectroscopy are powerful, complementary techniques for nasal
spray product characterisation. Laser diffraction measurements relate to the formulation in its entirety and support the development
of formulation and device towards optimal dispersion. Laser diffraction studies are also required for routine quality control
and to determine in vitro bioequivalence. In contrast, automated image analysis in combination with Raman spectroscopy enables particle size analysis
of the API alone, an important variable with respect to bioavailiabilty. Both techniques are fast and efficient, with automated
imaging offering substantial advantage — quicker measurement, better reproducibility — compared with manual microscopy. Together
they promote the efficient commercialisation of new nasal spray products in accordance with the regulatory guidances.
Paul Kippax is Product Group Manager – Micrometrics, Malvern Instruments. paul.kippax@malvern.com
Deborah Huck is Product Technical Specialist – Morphological Imaging Systems, Malvern Instruments.
Carl Levoguer is Sales Specialist – Analytical Imaging Systems, Malvern Instruments.
Anne Virden is Product Technical Specialist – Diffraction, Malvern Instruments.
Julie Suman is President, NextBreath LLC.
References
1. FDA Guidance — Bioequivalance (BE) and bioavailability (BA) studies for nasal sprays and nasal aerosols for local action,
April 2003.
2. P. Kippax, et al., Pharm. Technol. Eur., 22(9), 58–65 (2010).
Further reading
In the September 2010 issue of Pharmaceutical Technology Europe,2
the authors discuss in more detail the value of laser diffraction in helping formulators achieve optimal nasal spray product
performance by enabling the capture of nasal droplet size data in real time.
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