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Dedicated needle-free injection solution

Extending the capabilities of an innovative needle-free, single use injector to meet full customisation needs, very high volume manufacturing, minimum time to market delays and very high safety levels.

Combining space and medical technologies, the DENIS partners have developed an original and innovative easy to use pre-filled and single-use, low-cost needle-free injector for liquid medicines. To effectively meet public health issues like eliminating contamination risks, relieving patient stress, maximising treatment compliance and safety and minimising global costs, specific solutions have to be provided for each therapeutic area, taking into account the drug to be injected (doses, viscosity), the injection sites (tissue, depth) and other practical criterions (sensations, potential drug side effects, etc.). Customisation to therapeutic applications is allowed first by a modular approach and, second, from the natural adaptability of the gas generation technique used: * A 100% pharmaceutical compatible drug capsule is first adapted to the drug to be injected (dimensions adapted to drug dose, evaluation of elastomer closures formulations that are already validated for the drug to be integrated); as this adaptation is independent from the rest of the optimization process, it is possible to offer reduced risks regarding shelf life specifications. * A nozzle is then specifically designed regarding functional specifications or constraints: number, diameter and shape of orifices, depending on drug dose or viscosity, penetration depth, target tissues (Identifier (ID), Suspension Concentrate (SC) or IM), etc. As it is made of plastic and is independent from the primary packaging, nozzle adaptation can be efficient while staying cost effective. * A versatile, high power, gas generator allows the final tuning of the configuration for optimal performances. This gas generator is directly inspired from airbag safety devices technology; it is made of a small amount of energetic material stored at atmospheric pressure in the device; at the precise moment the device is triggered for injection, the energetic material starts to burn, generating the amount of gas necessary to perform the injection. The nature and amount of energetic material can be easily chosen to provide the best pressure profile for each specific configuration. To offer pharmaceutical companies fast and reliable customised devices, the DENIS programme will deal with: * Extending the initial range of configuration to key representative configurations that will be starting points for full customisation. * Putting in place investigation tools and models that will allow a deep understanding of injection mechanisms and internal behaviour of devices for fast and efficient customisation. * Putting in place validation tools that will prove biological efficacy and safety of each configuration. * Improving and demonstrating intrinsic safety of devices (taking into account conception and manufacturing) to fit with very high volumes (more than 100 million units/year). * Putting in place pilot manufacturing tools to validate high volume manufacturing processes and allow clinical investigations. * Managing the multiple regulation certification process. Keywords: needle-free, injection, pharmaceutical.
Acronym: 
DENIS
Project ID: 
3 026
Start date: 
01-02-2003
Project Duration: 
36months
Project costs: 
24 500 000.00€
Technological Area: 
Medical devices technology (instrumentation, medical imaging, radiology)
Market Area: 

Raising the productivity and competitiveness of European businesses through technology. Boosting national economies on the international market, and strengthening the basis for sustainable prosperity and employment.