Services

Next Breath is a cGMP compliant (DEA license holder) full service laboratory for analytical testing throughout the drug development life cycle. Our services include method development and validation CMC studies, in vitro bioequivalence studies, batch release and stability studies. In addition, Next Breath provides support for 510(k) submissions for various drug delivery devices. We can also perform R&D studies for early stage projects. Our testing capabilities include:

DPIs, MDIs, Inhalation Solutions, Nebulizers and Spacers
o Aerodynamic particle size by inertial impaction (ACI and NGI)
o Dose content uniformity
o Shot weight
o Moisture content
o Particle size by microscopy
o Plume geometry
o Spray pattern
o Microbial limits
o Foreign particulate matter
o Number of metered doses
o Impaction force
o Electrostatics
o Priming and tail off studies
o Device Robustness

Chemistry
o Assay
o Impurities
o Degradation products

Nasal Sprays, Nasal Dry Powders and Topical Sprays
o Particle/droplet sizing by laser diffraction
o Particle size by microscopy
o Amount of drug in small particles by ACI
o Spray content uniformity
o Single actuation content uniformity
o Spray pattern
o Plume geometry
o Viscosity
o Osmolality
o Foreign particulate matter
o Number of metered doses
o Pump delivery/Shot weight
o Effect of dosing orientation

Summarized information sheets are available in the documents below:

* Nasal-Spray-Bioequivalence

* Nasal-Spray-CMC-Stability-and-Batch-Release

* DPI-Product-Development-and-CMC-Documentation

* MDI-CMC-Documentation

* Nebulizer-510K-Study

Next Breath Lab