Sunday 27 May 2012

Transdermal Drug Delivery

Cambridge Consultants glucose meter Cambridge Consultants Develop Concept Eco friendly Blood Glucose Meter

 



Tuesday 21st August, 2012

New eco-friendly breed of medical devices

Blood glucose monitor concept is easier to use and cuts environmental impact by two-thirds

A blood glucose monitor concept for diabetics that’s simpler to use, less cumbersome to carry and has a third of the environmental impact of traditional devices has been developed by Cambridge Consultants. The concept is the latest result of ‘Ecovation’ – an approach developed by the leading technology design and development firm to integrate environmental considerations into its radical concept generation process.
More than 346 million people worldwide have diabetes*, and monitoring glucose levels is a critical part of managing the condition and preventing long-term complications. Insulin-treated diabetics are advised to test blood glucose levels four times a day. Many existing blood glucose monitors require separate lancets, test strips, storage tubs for carrying these items, and sharps bins for disposal. This can mean the devices are fiddly to use, inconvenient to transport, and wasteful.
Applying the Ecovation process, Cambridge Consultants conducted a ‘life cycle assessment’ on a popular blood glucose monitor to identify which elements had the highest environmental impact and so should be the focus for innovation. It was identified that less than 5% of the environmental impact could be attributed to the monitor itself – with more than 70% due to the high number of single-use disposables that are consumed over the lifetime of the device.
Ideas generated to reduce the environmental impact ranged from efficient packing of unused and used components, to safe reuse of ‘single-use’ lancets and test strips. The winning concept achieved a 65% reduction in environmental impact by integrating the functionality of three previously discrete consumables and getting the device to do the handling – not the user. The final challenge was then to create a single consumable cartridge, which was both reliable and suitable for manufacturing.
For the user this novel concept has significant benefits. The integrated monitor design is easier to carry around, with fewer consumables requiring separate storage and transport. The cartridge design means the user only has to worry about loading the device once every 28 tests – and, by combining the lancets and test strips in the monitor itself, the glucose test is far easier to administer and more discreet for the user.
“What makes this concept so exciting is that, while it provides a sustainable alternative to the status quo, it also offers distinct usability advantages,” said Andy Pidgeon, of the Medical Technology division at Cambridge Consultants. “We have long championed combining the safety and reliability of the medical development framework with the broader lens of a consumer experience approach in order to create solutions that patients use both safely and willingly. Adding environmental considerations into the design process through Ecovation provides a framework for a new breed of superior medical devices.”
The approach employed in Ecovation can be applied to any type of product to reduce its overall environmental impact. For example, Cambridge Consultants previously demonstrated the methodology by producing an eco-vacuum concept that uses 43% less energy than the average vacuum cleaner.
“The Ecovation process, as demonstrated by our blood glucose monitor concept, has the potential to make a significant step change in reducing the eco-impact of almost any product,” said Gemma Evans, Senior Consultant in Innovation Management at Cambridge Consultants. “Applying Ecovation principles at the design stage needs to become standard practice if we are to reduce our carbon footprint. But making a product greener should never take away from its reliability or functionality and, as we have demonstrated, it can in fact improve its usability and the user experience while minimising its environmental impact.”






Iontophoresis with the Battery Built in

The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis.








Patients deserve faster access to safe and effective medical devices that address unmet public health needs. The FDA's Innovation Pathway is a new way of doing business within our existing regulatory framework that could yield significant benefits to patients in the U.S. by giving them first-in-the-world access to medical devices, including those with breakthrough technology.

The Innovation Pathway is an evolving system designed to help safe, breakthrough medical products reach patients in a timely manner. The Pathway ultimately aims to shorten the overall time and cost it takes for the development, assessment and review of medical devices, and to improve how FDA staff and innovators work together.

By engaging with innovators much earlier, more collaboratively, and in new ways, we believe we can reduce the time and cost of the entire process of bringing safe and effective technologies to patients more quickly.

On April 9, 2012, the FDA's Center for Devices and Radiological Health (CDRH) launched its second version of the Innovation Pathway, called "Innovation Pathway 2.0."

Innovation Pathway 2.0 offers new and modified tools and methods to deepen collaboration between the FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory process more efficient and timely.

The Pathway also serves as a living laboratory to test new tools and methods for breakthrough devices that we may also apply to other technologies to enhance all of our device pre-market programs







 
 
 









3M Drug Delivery Systems 
Abbott Laboratories
Abeille Pharmaceuticals Inc
Acino AG
Acrux Ltd 
Adherex Technologies Inc
Agile Therapeutics Inc
AllTranz Inc
Amarin Technologies SA
An-eX Analytical Services Ltd  
Antares Pharma Inc
Apogee Biotechnology 
Apricus Biosciences Inc
Ascend Therapeutics Inc
Aveva Drug Delivery Systems 
Axogen Inc.
Auxilium Pharmaceuticals Inc
Bayer Pharma AG
BD (Becton, Dickinson and Company)
BHR Pharma LLC
Biochemics Inc.  
BioSante Pharmaceuticals Inc
Birch Point Medical (Ion Patch)
Capsulated Systems
Cellegy Pharmaceuticals Inc.
Celtic Pharma Management LP
Chrono Therapeutics Inc.
Corium International Inc
Corium International has been honored as P&G’s External Business Partner of the Year.

Crospon Ltd
Cyto Pulse Sciences Inc.
DBV Technologies    Dharma Therapeutics Inc
Dow Pharmaceutical Sciences
Durect Corporation  
Echo Therapeutics
Elan Corporation Plc
Embil Pharmaceuticals
Empi
Endo Pharmaceuticals Inc.
EpiCept Corporation
ESBA Laboratories Inc. 
Fuse Science 
Galderma
Genesis Medical Systems Ltd
GlaxoSmithKline
Gruenenthal GmbH
Recovery Healthcare Corporation    
Helix BioPharma Corporation
Hexal AG
Hisamitsu Pharmaceuticals  
Ichor Medical Systems Inc. 
Idea AG 
IGI Labs Inc. 
Imprimis Pharma (Transdel Pharmaceuticals)
Inovio Pharmaceuticals 
Intercell AG 
Janisys Ltd
Johnson & Johnson
Kowa Pharma
Laboratoires Pierre Fabre SA
Labtec Pharma
Lacer SA
Lavipharm Corporation
LTS Lohmann  
Medi-patch Clinic 
MedPharm Ltd
Merck KGaA
Micropoint Technologies
MIKA Pharma GmbH
Mylan Laboratories Inc.
NanoCyte Inc
NanoPass Technologies Ltd
Nemaura Pharma Limited
NeurogesX Inc
Nitto Denko Corporation
NOF Corporation
Nometics Inc
Novagali Pharma SA
Novartis  
Novavax Inc
Novel Therapeutic Technologies Ltd
Noven Pharmaceutical Inc.
NuPathe Inc. 
Nuvo Research Inc.
OBJ Limited
Optimags GmbH  
Pantec Biosolutions
Partners Against Pain (Purdue Pharma LP)   
Pfizer Pharmaceutical Group
Phosphagenics Ltd
Polytherapeutics Inc
Procter & Gamble Pharmaceuticals Inc.
ProStrakan Group plc
pSivida Corporation
Purdue Pharma LP
Rottapharm
Rx Safety Matters (Purdue Pharma LP)  
Schering-Plough Corporation (Merck) 
Sparsha Pharma 
Stiefel (GlaxoSmithKline)
Strategic Science and technologies 
Tapemark
Teikoku Pharma USA Inc.  
Teva Pharmaceuticals
Ther-Rx Corporation
Transcu Ltd
TransDerm Inc.
TransDermal Technologies Inc. 
TransPharma Medical Ltd
UCB Pharma
United Pharmaceuticals
Valeant Pharmaceuticals
Vaxin Inc.
Vyteris Inc.
Watson Pharmaceuticals
Zosano Pharma Inc (ALZA Corporation)  





Publications









FIGURE 2 Various modes of transdermal drug delivery. (A) Liquid-jet injections deliver drugs into intramuscular, subcutaneous, or intradermal regions. (B) Permeability-based methods of transdermal drug delivery: (i) delivery through hair follicles; (ii) tape-stripping removes the stratum corneum and facilitates drug absorption; (iii) thermal or radio frequency wave-mediated ablation of the stratum corneum creates micropores that enhance drug delivery; (iv) colloidal carriers, such as microemulsions and transfersomes, enhance the dermal absorption of topically applied drugs; (v) low-frequency ultrasound increases drug delivery by making the skin more permeable; (vi) chemical enhancers or peptides for drug delivery; (vii) electroporation of the stratum corneum enhances drug delivery into the epidermis; (viii) microneedles penetrate into the epidermis to deliver drugs. (C) Powder injection delivers dry drug powders into superficial skin layers (epidermis and superficial dermis). Source: Adapted from Mitragotri, 2005.


Needle-Free Drug Delivery

Frontiers of Engineering - The Bridge

Silk Microneedles Deliver Controlled-Release Drugs Painlessly

LTS - Transdermal Therapeutic Systems (TTS) 

Winning Strategies for Outsourcing Transdermal - pdf

SUCCESS THROUGH A DEEP UNDERSTANDING OF THE SKIN

FDA Guidance Residual Drug in Transdermal and Related Drug Delivery Systems 
Combination Products

FDA Bioequivalence Recommendations for Specific Products 




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