Advances in technology for rapid nanoparticle production -

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  • API-X needs to have a fast onset of action, dissolution velocity slow on currently marketed products.
  • NEW GRAPH Linear scale 10 to 1000
  • Both nano-suspension and spray dried forms showing complete dissolution with 2 minutes
  • Advances in technology for rapid nanoparticle production -

    1. 1. Non-confidential © Lena Nanoceutics Ltd. May 2010 Advances in technology for rapid nanoparticle production Lena Nanoceutics Ltd Webinar May 12th 2010
    2. 2. Company Overview • Company Established in 2007 • Partnership between Engineering specialists (Dena Technology Ltd) and Academic Institute focussed in the Pharmaceutical Sciences sector (Institute of Pharmaceutical Innovation, University of Bradford) • Exclusive license to exploit established Dena technologies for size reduction, mixing and homogenisation in Pharma/Healthcare applications Non-confidential © Lena Nanoceutics Ltd. May 2010
    3. 3. Technology Drivers • Low aqueous solubility has adversely impacted the performance of a multitude of candidate therapies – approx 50% of NMEs synthesised annually by big Pharma – Approx 10% of marketed therapies – 25% of the 61 drugs on the WHO list of essential medicines • Low and erratic bioavailability can impact safety and efficacy • Need to assess risk and address solubility and bioavailability issues as early as possible Non-confidential © Lena Nanoceutics Ltd. May 2010
    4. 4. Rising to the Challenge ‘Technology Solutions’ Solid dispersions Nanoparticles Complexing agents Liposomes Lipids Micelles Salts Micronisation Pro-drugs Non-confidential © Lena Nanoceutics Ltd. May 2010
    5. 5. Technology Solutions ‘Nanoparticles’ Non-confidential © Lena Nanoceutics Ltd. May 2010 • Ultrafine and sub-micron particles provide a number of attractions to the formulator for the enhanced delivery of drugs with low aqueous solubility – inc. marked increases in surface area to volume ratio • Versatility • Oral route – nanosuspensions and solid forms • Potential use in parenteral, ocular and OINDPs • Formulations do not require inclusion of large quantities of excipients
    6. 6. Technology Overview • In-line size reduction system • Product recirculated through size reduction chamber – narrow gap containing grinding media • Between 2 – 10 cycles can reduce range of materials from coarse sizes to sub-micron levels Non-confidential © Lena Nanoceutics Ltd. May2010 PCT/GB2006/003017
    7. 7. Sub-Micron Particles by Comminution 8 minutes processing 15 minutes processing 30 minutes processing Starting size >20 µmNon-confidential © Lena Nanoceutics Ltd. May 2010
    8. 8. Key features and benefits • Ability to process a range materials • Ability to process coarse starting materials (>100 µm) • Ability to process high solids contents (up to 40% w/v) • Consistent and rapid nano-particle processing • Physically and chemically stable product • Products with crystallinity maintained • Scalable process • Powder form through spray drying + in-house proprietary technology • Rapid dissolution • Improved bioavailability and speed of onset Non-confidential © Lena Nanoceutics Ltd. May 2010
    9. 9. Case study API with challenging physicomechanical properties which would benefit from reduced time for on-set SEM micrograph showing original particle size Crystals typically >100 microns across longest diameter Non-confidential © Lena Nanoceutics Ltd. May 2010
    10. 10. Case study Non-confidential © Lena Nanoceutics Ltd. April 2009 2% w/w solids content 15% w/w solids content
    11. 11. Case study TEM showing processed particle size Crystals typically 200 - 500 nm in length 1000 fold size reduction achieved in less than 1 hour Non-confidential © Lena Nanoceutics Ltd. May 2010
    12. 12. Case study 0 5 10 15 0.1 1 10 100 1000 10000 Intensity(%) Size (d.nm) Size Distribution by Intensity Record 720: 2% IBU, 1%PVP, 0.5% SLS, 10% MCT oil in water (250 mL). Stb chk 13/2 to 14/2.Size Distribution - 2% w/v material after 30 minutes Non-confidential © Lena Nanoceutics Ltd. May 2010
    13. 13. Case study Non-confidential © Lena Nanoceutics Ltd. May 2010 Nanoparticles isolated from suspension Starting material (API)
    14. 14. SEM of Spray-Dried Particles Aim to immobilise nano-particles within inert carrier matrix Drug loading of 50% w/v in carrier Spray dried particles approx <20 µm in diameter Rapid dissolution of crystalline drug Study conducted in collaboration with Kuecept Ltd Non-confidential © Lena Nanoceutics Ltd. May 2010
    15. 15. Case study Non-confidential © Lena Nanoceutics Ltd. May 2010 Inert Carrier Particles from Nanosuspension Spray-dried powder Starting material (API)
    16. 16. Case study Dissolution rate of spray-dried powder vs micronised commercial API Non-confidential © Lena Nanoceutics Ltd. May 2010
    17. 17. In vivo bioavailability In vivo data from client rat PK study Unidentified development compound Non-confidential © Lena Nanoceutics Ltd. May 2010
    18. 18. Partnering Options • Initial feasibility – Determine ability to generate nano- particles • Pre-clinical formulation development – For ADME, relative bioavailability or toxicology and pharmacology • Clinical concept formulations – Readily transferrable into cGMP facility (R5 Pharmaceuticals Ltd) • Commercial Formulation Development – Option for establishment of process at client company under license Non-confidential © Lena Nanoceutics Ltd. April 2010
    19. 19. Contact For more information contact Dr Angus Stewart-Liddon Business Development Manager Lena Nanoceutics Ltd Tel: +44 1274 235180 Email:angus.stewartliddon@lenanano. com Non-confidential © Lena Nanoceutics Ltd. May 2010
    20. 20. Innovative but Practical Technologies to Tame Difficult APIs Technology Showcase Richard Johnson of Upperton Pharmaceutical Spray-drying Marcel de Matas of Lena Nanoceutics Nano particle processing Steffen Mittwich & Rob Lammens of Atacama Labs Pneumatic Dry Granulation (PDG)

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