Future drugdelivery

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Cambridge Consultants Ltd Science Park, Milton Road, Cambridge, England CB4 0DW Tel: + 44 (0)1223 420024 Fax: + 44 (0)1223 423373 www.CambridgeConsultants.com Drug Delivery Trends, Challenges and Opportunities

Transcript of Future drugdelivery

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Cambridge Consultants LtdScience Park, Milton Road,Cambridge, England CB4 0DW

Tel: + 44 (0)1223 420024Fax: + 44 (0)1223 423373www.CambridgeConsultants.com

Drug Delivery Trends, Challenges and Opportunities

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• New technologies

• Better design

Trends, Challenges & Opportunities

• New therapies

• New compounds

• Patents expiring (or being overturned!)

• Third world markets

Drug Delivery Trends, Challenges and Opportunities : The patients’ choice

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Drug delivery the route forwards?

Drug Delivery Trends, Challenges and Opportunities : The patients’ choice

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The oral drug delivery route is nearly perfect

Drug Delivery Trends, Challenges and Opportunities : Tablets

Why?

• Simple user steps

• Fool proof

• Discrete

• Cheap

• Patient familiarity

Why not?

• Side effects

• Non-specific delivery site

• Poor absorption

• Drug release profile

• Slow acting

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

Drug Delivery Trends, Challenges and Opportunities : Devices

Why not?

• High cost

• Training required

• Poor technique affects treatment

• Bulky

• Unfamiliar

• Patient suspicion

Why?

• Fast acting

• Targeted delivery

• Minimal side effects

• Can incorporate safety features

• Product differentiation

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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 : User steps

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

Reduced tablet user steps

• Push tablet out of blisterpack

• Put tablet (or powder)in mouth

• Swallow (or chew)

Drug Delivery Trends, Challenges and Opportunities : Reducing user steps

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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 : Device user steps

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

Drug Delivery Trends, Challenges and Opportunities : Convergence

Tablets need to evolve to achieve

the benefits of devices

Devices need to be designed to achieve the

patient and clinician acceptability of tablets

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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 : Convergence

Devices need to be designed to achieve the

patient and clinician acceptability of tablets

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Technology implementation does not have to look like this:

Drug Delivery Trends, Challenges and Opportunities : Implementing technologies

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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

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Smart pills and implantables

Drug Delivery Trends, Challenges and Opportunities : Implementing technologies

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Sounds good but will it not cost too much?

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

Drug Delivery Trends, Challenges and Opportunities : Electronic opportunities

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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 : Electronic opportunities

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Appropriate design does not necessarily look like this:

Drug Delivery Trends, Challenges and Opportunities : Appropriate design

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Increasing useful feedback to user

Drug Delivery Trends, Challenges and Opportunities : Appropriate design

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Improving accuracy

Drug Delivery Trends, Challenges and Opportunities : Appropriate design

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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 : Appropriate design

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“Technology without design is like a bird without wings”

• 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.

Drug Delivery Trends, Challenges and Opportunities : Conclusions

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

Concorde - only 20 manufactured Boeing 747 - over 1300 manufactured

Drug Delivery Trends, Challenges and Opportunities : Conclusions