Nasal Pulmonary (available in June 2008)
West offers GMP-compliant analytical testing of nasal spray, oral sprays, metered dose inhaler (MDI), dry powder inhaler (DPI) and inhalation by nebulizer for CMC studies, in vitro bioavailability/bioequivalence (BA/BE) studies, in-use tests and long-term stability studies, (both developmental and validation / biobatches), including studies of potent compound products. Method development and method validation is offered for all testing.

Results are reported on a Certificate of Analysis (CoA), using a format consistent with the CMC Section of an Annual Report.

Testing Capabilities:

• Appearance and color
• Identification
• Microbial limits
• MDI: Moisture content, alcohol content, pressure testing, leak rate
• Net content (fill) weight
• Drug content (assay)
• Impurities and degradation products
• Dose content uniformity and DCU through container life
• Particle size distribution (cascade impaction with mass balance)
• Microscopic evaluation
• Spray pattern
• Dose delivery (ex device and ex valve for MDI)
• Net content (fill) weight (DPI device-metered)
• Nasal inhalation: pH, specific gravity, osmolality, viscosity
• Droplet size distribution (DSD) (multiple parameters)
• Pump delivery and number. of doses (nasal)
• Weight loss
• Foreign particle count
• Profiling of sprays near container exhaustion (nasal)

Characterization / In-use Tests:

• Priming and repriming in various orientations
• Effect of resting time
• Temperature cycling
• In vitro dose proportionality
• Cleaning instructions
• Device robustness

Bioavailability / BioEquivalence (BA/BE)

• BA/BE characterization
• Consultation on population bioequivalence

TEST	EVALUATION FOR BE
Single Actuation Content Through Container Life	PBE (population bioequivalence)
Droplet Size Distribution by Laser Diffraction	PBE
Drug in Small Particles/Droplets by Cascade Impactor	PBE modified to be one-sided with respect to the mean comparison
Particle/Droplet Size Distribution by Cascade Impactor	Profile analysis
Drug Particle Size Distribution by Microscopy for Suspensions	Report
Spray Pattern	PBE for area and ovality ratio (automated analysis)
Plume Geometry	Point estimates
Priming and Repriming	Point estimate relative to label claim if in precursor product (R) labeling

Please click here to contact us by email to discuss your needs for nasal pulmonary testing.