Development of Inhalation
and Nasal Products
Metered Dose Inhalers, Dry Powder Inhalers,
Nasal Sprays, Nebulizers
Cirrus offers extensive expertise in the
development of aerosol products, including:
- Metered Dose Inhalers (MDI)
- Dry Powder Inhalers (DPI)
- Nasal Sprays
- Nebulizer Solutions and Suspensions
Services include physical and chemical characterization,
fine particle generation and characterization, formulation
development, device evaluation, stability testing, process
development, scale-up and technical transfer to clinical or
commercial manufacturing. Cirrus has expertise in developing
small molecules as well as proteins for inhalation and nasal
delivery.
Visit www.InhalationReport.com to get the latest news on inhalation product development.
Expertise in Inhalation Products
Cirrus was co-founded in 1997 by Dr. Tony
Hickey, a professor from the University of North Carolina
at Chapel Hill, who is sought globally for his expertise in
inhalation product development. Cirrus has grown over the
years to employ scientists who combine years of experience
to provide regulatory compliant product development services.
Specialized Instrumentation
Cirrus employs state of the art specialized
instrumentation for inhalation product development including:
- Andersen cascade impactors
- Next generation cascade impactor
- Laser Diffraction for particle size analysis
- Malvern Zetasizer for particle size analysis of nanoparticles
- Breathing Simulator
- Custom-built MDI waste-fire system
Our success is continually demonstrated.
For example, a metered dose inhaler (MDI) project was initiated
at Cirrus in 1999, the New Drug Application (NDA) was submitted
for the product in 2004, and the product was approved ten
months later after round one review by the FDA in 2005. This
was both a record for MDI product development time and for
FDA review time for an MDI product. Cirrus' contributions
to that program included analytical method development, micronization
optimization, salt selection, development of the HFA formulation,
packaging component selection, accelerated stability studies,
process development, scale-up, technical transfer and data
generation for the IND and NDA submissions.
Product Characterization
Cirrus has expertise in characterizing inhalation
and nasal products as required for regulatory submissions:
- Delivery volume/Shot weight
- Emitted dose and dose content uniformity
- Droplet/particle size distribution
- Spray pattern
- Cyr testing
- Fine particle fraction determination
- Priming and repriming
- Output rate
- Tail-off characteristics
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