To achieve optimal product performance, nasal spray developers need to manipulate device and formulation parameters on the
basis of detailed understanding. Laser diffraction is a valuable technique for accessing relevant information because it captures
droplet size data in real time, enabling researchers to evaluate the impact of any change. The influence of formulation properties
such as viscosity and device parameters, including actuation profile, spray pump mechanism and actuator orifice size, can
be systematically studied to facilitate a knowledge-based approach, as the presented data show. The recommendation by the
regulators of laser diffraction as a measurement technique, relevant across the complete product lifecycle, from development
through to quality control, underlines its value.
Paul Kippax is Product Manager — Diffraction Products at Malvern Instruments Ltd., UK. Tel. +44 (0)1684 892 456 firstname.lastname@example.org
Julie Suman is President at NextBreath LLC, USA.
Gerallt Williams is Director, R&D Laboratory Services at AptarGroup SAS, France.
1. Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products — Chemistry, Manufacturing, and Controls Documentation (FDA, USA, July 2002).
2. Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (FDA, USA, April 2003).
3. Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products (European Medicines Agency, London, UK, June 2006).
4. Data on file at Malvern Instruments.