Can improved water solubility
give API’s a new lease of life?
Dr. Jef Verplaetse
Managing Director/Owner
Laboratoria Smeet...
API Solubility: Importance
Solubility: Water solubility is important. Biological fluids are water-based
systems. Any biolo...
API Solubility: Techniques
Physical modification:
• Particle Size
• Crystalline structure modification
• Drug dispersion i...
API Solubility: Benefits
• Continuous granulation process and also
small batches possible
• Pharmaceutically acceptable ex...
API Solubility: Markets
Veterinary Market
• Medicated drinking water (antibiotics,
analgesics, monensin)
Human Market
• Wa...
API Solubility: Methods
Twin Screw Thermofisher 24mm
• Screw profile : two kneading blocks
• Separate entry for liquids.
B...
API Solubility: Conclusion
Continuous granulation creates new opportunities
Collaboration between Ghent University, Orotec...
Find Out More…
To learn more about API solubility please join our
FREE webinar on 17.10.13
http://bit.ly/17ggQLi
http://ww...
CONTACT
Kate Marston
WTG Webinars
www.wtgwebinars.com
+44 (0) 20 7202 7705
Kate.marston@wtgevents.com
http://www.wtgwebina...
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Can improved water solubility give APIs a new lease of life?

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The higher the dissolution rate, the higher an API’s effectiveness. Yet due to their chemical structure a large percentage of new and existing APIs are poorly water soluble.

This presentation examines whether a new granulation technique developed by Ghent University has the potential to improve dissolution rates and obtain supersaturated API solutions.

Published in: Business, Technology
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Can improved water solubility give APIs a new lease of life?

  1. 1. Can improved water solubility give API’s a new lease of life? Dr. Jef Verplaetse Managing Director/Owner Laboratoria Smeets http://www.wtgwebinar.com/pharma
  2. 2. API Solubility: Importance Solubility: Water solubility is important. Biological fluids are water-based systems. Any biological absorption happens in a water rich environment. Hence water is the solvent of choice for liquid pharmaceutical formulations. Rate of Dissolution: Important for practical reasons. If an API takes hours to dissolve, it is not practical mainly for administration via drinking water. Bioavailability: Essential for therapeutic effectiveness. http://www.wtgwebinar.com/pharma
  3. 3. API Solubility: Techniques Physical modification: • Particle Size • Crystalline structure modification • Drug dispersion in carriers • Use of surfactants Chemical modification: • pH – use of buffers • Salt formation • Chemical derivate Others: • Co-crystallisation http://www.wtgwebinar.com/pharma
  4. 4. API Solubility: Benefits • Continuous granulation process and also small batches possible • Pharmaceutically acceptable excipients • Low temperature operation • No up-scaling of production process necessary (Time is the only variable) • Drug loading: up to 60% http://www.wtgwebinar.com/pharma
  5. 5. API Solubility: Markets Veterinary Market • Medicated drinking water (antibiotics, analgesics, monensin) Human Market • Water soluble for oral delivery, improving bioavailability Potential For Old Molecules • New application enables new stage in life cycle http://www.wtgwebinar.com/pharma
  6. 6. API Solubility: Methods Twin Screw Thermofisher 24mm • Screw profile : two kneading blocks • Separate entry for liquids. Blending • Powder fraction : PEG 4000 (Melting point between 45.2 C - 67.2 C) • Maltodextrin • API • Liquid fraction • PEG 400 (Helps to lower melting point of the PEG 4000) • Tween Extrusion • First powder blend then liquid fed into the second kneading block. • Operating temperature max 50 C http://www.wtgwebinar.com/pharma
  7. 7. API Solubility: Conclusion Continuous granulation creates new opportunities Collaboration between Ghent University, Orotech and Laboratoria Smeets will lead to more innovative projects http://www.wtgwebinar.com/pharma
  8. 8. Find Out More… To learn more about API solubility please join our FREE webinar on 17.10.13 http://bit.ly/17ggQLi http://www.wtgwebinar.com/pharma
  9. 9. CONTACT Kate Marston WTG Webinars www.wtgwebinars.com +44 (0) 20 7202 7705 Kate.marston@wtgevents.com http://www.wtgwebinar.com/pharma

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