For inquiries please call 1-919-321-4047 email: bizdev@cirruspharm.com

www.cirruspharm.com

Capabilities in Particle Size AnalysisCirrus Pharmaceuticals, Inc. is a contract product development organization providing services to the pharmaceutical and biotech industries.

Projects range from sample-based services to feasibility studies to full-scale product development.

Cirrus Pharmaceuticals, Inc. is registered with the United States Food and Drug Administration and is a cGMP compliant facility.

Characterizing particles is more than just reporting a mean and a standard deviation. Particle shape and morphology can also profoundly impact product performance as can the breadth and shape of the particle size distribution. Cirrus scientists have the experience and depth of knowledge to unravel the complexities of particle characterization and assist sponsors in understanding how results affect their products.

Particle sizing and characterization services offered by Cirrus range from singlesample analyses to full method development, validation and commercialproduct release testing to comprehensive product characterization studies.

Product Development

•PulmonaryDelivery •TabletsandCapsules • EmulsionsandSuspensions •NanoparticulateSystems

Optimization of:

•Bioavailability • WettingProperties •DissolutionRate •Stability •FlowCharacteristics

Process Development

•In-lineMonitoringofManufacturingProcess • StabilityStudies • BatchRelease

Laser Diffraction Particle Sizing

Laser diffraction is a rapid and highly reproducible means of determining the particle size distribution of powders, emulsions, suspensions, and sprays over a range of 0.1 µm to 1000 µm. A wide range of accessories and lenses allow us to sensitively measure particle and droplet size distributions of bulk powders and particulate products as well as emitted doses from devices such as metered dose inhalers, nasalsprays,andnebulizers.Withdrydispersionaswellasaqueousandnon-aqueouswetdispersioncapabilities,wehaveawiderange ofoptionsinoptimizingamethodforyourproductorin-processsamples.Wehavealsoperfectedtechniquesforreducingsamplesizeto thelowmilligramrangeforpreciousmaterials.Withcorrectlyoptimizedsampledispersion,methodprecisionistypicallyinthe1%range.

Inertial Impaction

Inertial impaction methods are widely used to determine the aerodynamic particle size distribution of aerosols. Aerosol particles with sufficient inertia impact upon the collection stage while smaller particles follow the airflow out of the impaction region. Since each stage represents a discrete particle size range, a size distribution can be determined by assaying the drug particles collected on each stage.

Our extensive experience in the development of fast and highly sensitive HPLC/MSD assays enables us to accurately determine particle size distributions from single doses of highly potent drugs, as well as to reduce run times and increase throughput.

Photon Correlation Spectroscopy

Photoncorrelationspectroscopy,knownalsoasdynamiclightscattering,isatechniquewhichmeasurestheBrownian motion of particles to determine their particle size. It is used to determine the size distribution of nanosuspensions, emulsions,proteins,polymers,andotherparticlesinthesubmicronrange.TheMalvernZetasizerNanousedbyCirrus has a nominal range of 0.6 µm to 6 µm.

Microscopy

Microscopy can be used as a stand-alone particle sizing method or as a complement to other methods. As an absolute method, it can be used to verify results from other methods, to differentiate between primary particles and aggregates, and to provide information on particle shape and morphology.

Instrumentation

SympatecHELOSLaserDiffractionParticleSizeAnalyzer:

•RODOSDryPowderDisperser •SUCELLLiquidDispersionUnit •6-mLCuvetteforLiquidDispersion •VIBRIPowderDeliveryDevice •50-mLCuvetteforLiquidDispersion •FullSetofLensesforDifferentSizeRanges •SprayAdaptor

MalvernZetasizer

•NIBSPhotonCorrelationAlgorithm •StandardandMicroSampleCells(Downto12µL)

InertialTechniques

•AndersonCascadeImpaction • NextGenerationImpactor •LiquidImpinger

•Solution

Capabilities in Particle Size Analysis