Characterizing A Nasal Spray Formulation From Droplet To API Particle Size - Pharmaceutical Technology

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PharmTech Europe

Characterizing A Nasal Spray Formulation From Droplet To API Particle Size
Regulatory guidance for nasal spray products recognises the effect on drug delivery of the particle size of both the delivered droplets and the suspended active. Here we examine the application of laser diffraction and automated image analysis combined with Raman spectroscopy in this context, highlighting the role these techniques can play in fast and efficient nasal spray characterisation.

Pharmaceutical Technology Europe
Volume 23, Issue 2

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.

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.


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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