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Drug Delivery Trends, Challenges   Cambridge Consultants Ltd
                                   Science Park, Milton Road,
and Opportunities                  Cambridge, England CB4 0DW


                                   Tel: + 44 (0)1223 420024
                                   Fax: + 44 (0)1223 423373
                                   www.CambridgeConsultants.com
Drug Delivery Trends, Challenges and Opportunities : The patients’ choice

Trends, Challenges & Opportunities


 •   New therapies
 •   New compounds
 •   Patents expiring (or being overturned!)
 •   Third world markets
 •   New technologies
 •   Better design
Drug Delivery Trends, Challenges and Opportunities : The patients’ choice

Drug delivery the route forwards?
Drug Delivery Trends, Challenges and Opportunities : Tablets

    The oral drug delivery route is nearly perfect



      Why?                                                             Why not?


•    Simple user                                                   •   Side effects
     steps
                                                                   •   Non-specific
•    Fool proof                                                        delivery site
•    Discrete                                                      •   Poor absorption
•    Cheap                                                         •   Drug release
                                                                       profile
•    Patient familiarity
                                                                   •   Slow acting
Drug Delivery Trends, Challenges and Opportunities : Devices

    The main alternatives to tablets and capsules are devices such as
    inhalers, injectors, nebulisers and infusion pumps


     Why?                                                              Why not?


•    Fast acting                                                   •   High cost
•    Targeted delivery                                             •   Training required
•    Minimal side                                                  •   Poor technique
     effects                                                           affects treatment
•    Can incorporate                                               •   Bulky
     safety features
                                                                   •   Unfamiliar
•    Product
     differentiation                                               •   Patient suspicion
Drug Delivery Trends, Challenges and Opportunities : User steps

The challenge with many existing devices is exemplified by looking at
the patient steps involved in their use.




Tablet user steps
 •   Push tablet out of blister pack
 •   Place tablet in mouth
 •   Drink water
 •   Swallow tablet with water
Drug Delivery Trends, Challenges and Opportunities : Reducing user steps

Even though there are only four user steps, advances have been made
to reduce this.




Reduced tablet user steps
 •   Push tablet out of blister
     pack
 •   Put tablet (or powder)
     in mouth
 •   Swallow (or chew)
Drug Delivery Trends, Challenges and Opportunities : Device user steps

Drug delivery devices typically have a higher number of user steps and
a greater risk of patient or carer error

Metered dose inhaler user steps
 •   Remove mouthpiece cover
 •   Shake inhaler
 •   Hold inhaler upright
 •   Breath out
 •   Place inhaler in mouth
 •   Slowly start to breathe in
 •   Depress canister
 •   Remove inhaler from mouth
 •   Hold breath for a few seconds
 •   Replace mouthpiece cover
Drug Delivery Trends, Challenges and Opportunities : Convergence

This leads to two routes forward to produce more effective drug delivery



               Tablets need to evolve to achieve

               the benefits of devices




                         Devices need to be designed to achieve the

                         patient and clinician acceptability of tablets
Drug Delivery Trends, Challenges and Opportunities : Convergence




                         Devices need to be designed to achieve the

                         patient and clinician acceptability of tablets




To achieve the simplicity of tablets, devices require technology to be
implemented in appropriate designs.

It sounds simple but is rarely achieved.
Drug Delivery Trends, Challenges and Opportunities : Implementing technologies

Technology implementation does not have to look like this:
Drug Delivery Trends, Challenges and Opportunities : Implementing technologies

Iontophoretic patches offer affordable discrete drug delivery solutions


 •   Simple to use
 •   Completely discrete
 •   Low cost (in volume)
Drug Delivery Trends, Challenges and Opportunities : Implementing technologies

Smart pills and implantables
Drug Delivery Trends, Challenges and Opportunities : Electronic opportunities

The use of electronics opens up new possibilities in the area of drug
delivery.


 •   Active feedback systems
 •   Implantable devices
 •   Programmable drug release profile
 •   Improved ease of use
 •   Greater clinician and patient feedback
 •   Clinical trials compliance monitoring




 Sounds good but will it not cost too much?
Drug Delivery Trends, Challenges and Opportunities : Electronic opportunities

Many are put off incorporating electronics into devices due to the
increased cost of goods.


 •   10 cents can buy you a microprocessor
     with more processing power than the
     first lunar landing module
 •   Replacing mechanical components
     with electronic components often
     reduces cost and improves reliability




To quantify this, an electronic counter for an MDI could be designed to
cost less than 50 cents in volume
Drug Delivery Trends, Challenges and Opportunities : Appropriate design

Appropriate design does not necessarily look like this:
Drug Delivery Trends, Challenges and Opportunities : Appropriate design

Increasing useful feedback to user
Drug Delivery Trends, Challenges and Opportunities : Appropriate design

Improving accuracy
Drug Delivery Trends, Challenges and Opportunities : Appropriate design

A two-part syringe concept for the reconstitution of lyophilised drugs


 •   Eliminates complex patient steps
 •   Reduced opportunity for drug mix up
 •   Cost savings through
     reduced drug wastage
Drug Delivery Trends, Challenges and Opportunities : Conclusions




                  •   Patients prefer the oral delivery route
                  •   Tablet technology is continually
                      improving to address the inherent
                      weaknesses in the oral route
                  •   Devices need to embrace technological
                      opportunities without forgetting the end
                      user.
                  •   Electronics will play an increasing role in
                      drug delivery as low cost, low power,
                      miniature electronics become fully utilised.


          “Technology without design is like a bird without wings”
Drug Delivery Trends, Challenges and Opportunities : Conclusions

Technology or design alone do not make a successful product. Technology
needs to be implemented in an appropriate design




Concorde - only 20 manufactured                     Boeing 747 - over 1300 manufactured

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Future drugdelivery

  • 1. Drug Delivery Trends, Challenges Cambridge Consultants Ltd Science Park, Milton Road, and Opportunities Cambridge, England CB4 0DW Tel: + 44 (0)1223 420024 Fax: + 44 (0)1223 423373 www.CambridgeConsultants.com
  • 2. Drug Delivery Trends, Challenges and Opportunities : The patients’ choice Trends, Challenges & Opportunities • New therapies • New compounds • Patents expiring (or being overturned!) • Third world markets • New technologies • Better design
  • 3. Drug Delivery Trends, Challenges and Opportunities : The patients’ choice Drug delivery the route forwards?
  • 4. Drug Delivery Trends, Challenges and Opportunities : Tablets The oral drug delivery route is nearly perfect Why? Why not? • Simple user • Side effects steps • Non-specific • Fool proof delivery site • Discrete • Poor absorption • Cheap • Drug release profile • Patient familiarity • Slow acting
  • 5. Drug Delivery Trends, Challenges and Opportunities : Devices The main alternatives to tablets and capsules are devices such as inhalers, injectors, nebulisers and infusion pumps Why? Why not? • Fast acting • High cost • Targeted delivery • Training required • Minimal side • Poor technique effects affects treatment • Can incorporate • Bulky safety features • Unfamiliar • Product differentiation • Patient suspicion
  • 6. Drug Delivery Trends, Challenges and Opportunities : User steps The challenge with many existing devices is exemplified by looking at the patient steps involved in their use. Tablet user steps • Push tablet out of blister pack • Place tablet in mouth • Drink water • Swallow tablet with water
  • 7. Drug Delivery Trends, Challenges and Opportunities : Reducing user steps Even though there are only four user steps, advances have been made to reduce this. Reduced tablet user steps • Push tablet out of blister pack • Put tablet (or powder) in mouth • Swallow (or chew)
  • 8. Drug Delivery Trends, Challenges and Opportunities : Device user steps Drug delivery devices typically have a higher number of user steps and a greater risk of patient or carer error Metered dose inhaler user steps • Remove mouthpiece cover • Shake inhaler • Hold inhaler upright • Breath out • Place inhaler in mouth • Slowly start to breathe in • Depress canister • Remove inhaler from mouth • Hold breath for a few seconds • Replace mouthpiece cover
  • 9. Drug Delivery Trends, Challenges and Opportunities : Convergence This leads to two routes forward to produce more effective drug delivery Tablets need to evolve to achieve the benefits of devices Devices need to be designed to achieve the patient and clinician acceptability of tablets
  • 10. Drug Delivery Trends, Challenges and Opportunities : Convergence Devices need to be designed to achieve the patient and clinician acceptability of tablets To achieve the simplicity of tablets, devices require technology to be implemented in appropriate designs. It sounds simple but is rarely achieved.
  • 11. Drug Delivery Trends, Challenges and Opportunities : Implementing technologies Technology implementation does not have to look like this:
  • 12. Drug Delivery Trends, Challenges and Opportunities : Implementing technologies Iontophoretic patches offer affordable discrete drug delivery solutions • Simple to use • Completely discrete • Low cost (in volume)
  • 13. Drug Delivery Trends, Challenges and Opportunities : Implementing technologies Smart pills and implantables
  • 14. Drug Delivery Trends, Challenges and Opportunities : Electronic opportunities The use of electronics opens up new possibilities in the area of drug delivery. • Active feedback systems • Implantable devices • Programmable drug release profile • Improved ease of use • Greater clinician and patient feedback • Clinical trials compliance monitoring Sounds good but will it not cost too much?
  • 15. Drug Delivery Trends, Challenges and Opportunities : Electronic opportunities Many are put off incorporating electronics into devices due to the increased cost of goods. • 10 cents can buy you a microprocessor with more processing power than the first lunar landing module • Replacing mechanical components with electronic components often reduces cost and improves reliability To quantify this, an electronic counter for an MDI could be designed to cost less than 50 cents in volume
  • 16. Drug Delivery Trends, Challenges and Opportunities : Appropriate design Appropriate design does not necessarily look like this:
  • 17. Drug Delivery Trends, Challenges and Opportunities : Appropriate design Increasing useful feedback to user
  • 18. Drug Delivery Trends, Challenges and Opportunities : Appropriate design Improving accuracy
  • 19. Drug Delivery Trends, Challenges and Opportunities : Appropriate design A two-part syringe concept for the reconstitution of lyophilised drugs • Eliminates complex patient steps • Reduced opportunity for drug mix up • Cost savings through reduced drug wastage
  • 20. Drug Delivery Trends, Challenges and Opportunities : Conclusions • Patients prefer the oral delivery route • Tablet technology is continually improving to address the inherent weaknesses in the oral route • Devices need to embrace technological opportunities without forgetting the end user. • Electronics will play an increasing role in drug delivery as low cost, low power, miniature electronics become fully utilised. “Technology without design is like a bird without wings”
  • 21. Drug Delivery Trends, Challenges and Opportunities : Conclusions Technology or design alone do not make a successful product. Technology needs to be implemented in an appropriate design Concorde - only 20 manufactured Boeing 747 - over 1300 manufactured