OUR SERVICES

NASAL SPRAY TESTING
Prevalere offers our clients comprehensive services for nasal spray products. These services include consulting and analytical work directed toward the optimization of nasal sprays, full service in-vitro bioequivalence testing according to the FDA Draft Guidance, "Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action" and release and stability testing.

Services offered include:

• Expert guidance in nasal spray
  development, optimization and
  characterization studies:
    Priming/repriming
    Temperature cycling
    Device robustness
    Tail-off
    Plume geometry
    Particle morphology
    Spray pattern
• Development/validation of analytical
  methods including:
    Dose delivery, including
    priming/repriming
    assessments and tail-off
    Particle size by cascade impaction
    Droplet size distribution (DSD) by
    dynamic
    laser light scattering
    Droplet size versus actuation force
    studies
    Mass balance studies
    Closure integrity
    Plume geometry by electronic imaging,
    using high speed video capture
• Preparation of testing protocols and ANDAs for generic nasal spray products.
• Development of protocols and
  development/validation of analytical
  methods for accelerated and long
   term stability studies:
    Dose delivery
    Moisture
    Particle size by cascade impaction
    Extractables
    Content uniformity
    Leachables
    Shot weight
    Leak rate
    Total drug content
    Microscopic evaluation
    Number of actuations
    Viscosity