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Inhalable Drug Powders of Premium Performance Janne Raula Aalto University Teicos Pharma Oy UMK Day 22.4.2010. Requirements for pharmaceutical dry powders Easy handling Reproducible and uniform dosing Stable during storage Chemical and physical Safe to use.
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Inhalable Drug Powders of Premium Performance JanneRaula Aalto University TeicosPharmaOy UMK Day 22.4.2010
Requirements for pharmaceutical dry powders • Easy handling • Reproducible and uniform dosing • Stable during storage • Chemical and physical • Safe to use
Additional requirements for inhalable dry powders • Good flowability • Efficient emission of drug powder from an inhaler • Good dispersibility • Efficient deep lung penetration of drug particles
Powder delivery via inhalation An inhalation driven,multidose dry powder inhaler (DPI) Air Flow In Complex Flow & Turbulence Drug & Carrier Thoratic 4-10 µm Suspension (Aerosolization) Respirable ≤5 µm (1-2 µm) Re-deposition Drug-Carrier Break-up
Factors influencing particulate properties • Particle shape • Surface texture • Surface roughness • Size and size distribution • Surface energy • Hygroscopicity • Relative humidity • Electrical properties CONTACT AREA DECREASES
Comparison of powders Commercial powder 1-2% of drug + 98-99% of carrier particles Our powder 90-99% of drug + 1-10% L-leucine 5 mm 5 mm • Low adhesion -> flows well • No need for carrier particles for powder dosing • Very cohesive • Needs large carrier particles for powder dosing
Q: How do we do that ? A: Gas-phase coating of solid particles Introducing L-leucine vapor Particles coated by L-leucine nanocrystals Solute droplets Particle drying Drug(s) in droplets Well-flowable & dispersible powder Precursor solution
Control over L-leucine coating layer • Saturation vapor pressure and concentration of L-leucine
Carrier-free inhalation experiments Coated drug powder • High emitted dose • High deep lung deposition • Independent on inhalation • Low dose variation Emitted dose from inhaler Lung deposition, d<5µm
Comparison of technologies Commercial milling process Our aerosol process Any pharmaceutical solids Many steps to get micron-sized drug particles Single-step process Suitable only for crystalline and stable molecules Micro and nanoparticles can be coated Needs large carrier particles for accurate dosing No need for carrier particles for accurate dosing
INNOVATION PATENT APPL. COMPANY SUPPORT
SUPPORT is very important RunarBäckström’s foundation Academic and industrial collaboration
Spin-off: TeicosPharmaOy • Business • Production and sales of a new class of inhalable API (active pharmaceutical ingredient) powders for dry powder inhalers (DPI) based on a novel coating and encapsulation technology.
Visit our web pages for further info TeicosPharmaOy www.teicospharma.com Aalto University tfy.tkk.fi/nanomat