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Overview Inhalation Oral Parenteral Topical & Transdermal
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INHALATION
Cirrus offers extensive expertise in the development of aerosol products, including:
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Metered Dose Inhalers (MDI)
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Dry Powder Inhalers (DPI) |
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Nasal Sprays
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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 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.
Cirrus employs state of the art specialized instrumentation for inhalation product development including:
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Andersen cascade impactors
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Next generation cascade impactor
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Laser Diffraction for particle size analysis
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Malvern Zetasizer for particle size analysis of nanoparticles
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Breathing Simulator |
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Custom-built MDI waste-fire system
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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.
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