Assessing nasal spray product performance - 5th April 2005

In 2003 the FDA issued its most recent draft guidance describing the process by which bioavailability and bioequivalence can be determined for nasal pump spray formulations. Within this, they outlined a series of in vivo tests which should be used to predict bioavailability, including the use of laser diffraction for particle sizing as well as over methods for plume geometry and pattern analysis. In this presentation the process of nasal spray pump characterisation will be discussed with reference to the FDA's guidance. Specific examples will be given, providing guidance regarding how users may assess performance differences between different pumps. The importance of using automated pump actuation stations to control the pump actuation profile will also be stressed, along with the need to ensure that the actuation profile selected for testing is realistic.

Type:	Laser Diffraction
Duration:	1 hour 4 minutes
Language:

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