Project: Injection System for Transderm Administration of dRugs

_x000D_The objective is to bring on the market a new drug delivery device accepted by the medical authorities and the patient, solving public health issues like eliminating risks of contamination or injuries, relieving patient stress (needle phobia), maximizing the treatment efficiency, useful in emergency or crisis situation and complying with regulation imposing safer injections._x000D__x000D_The proposed solution is a needle free pre-filled drug injection device based on the following innovating concept: _x000D_ -in order to inject drugs into the skin without a needle, the liquid medicine is pushed at high pressure through a nozzle fitted with one or more orifices; the resulting jets become very fast and go through the skin without needing a needle._x000D_ -to be the most efficient and adaptive, a gas generator coming from airbag and space technologies is used as actuator to provide the requested gas pressure to push the drug at the right place_x000D__x000D_This project objective is to design, test and validate on human skin a such kind of needle free injector ready to be industrialized and put rapidly on the market with better performance than a syringe equipped with a needle or than the already drug delivery devices in development:_x000D_ -easy to use: pre-filled, ergonomic, to be handled by all the people including disabled population_x000D_ -safe: reliable in terms of functioning, single use_x000D_ -efficient in terms of injection sites or tissue depth, allowing proper subcutaneous, intramuscular, intradermic injections_x000D_ -cost effective_x000D__x000D_The targeted market for the participants represents a volume up to 150 M injectors /year (6% of the whole possible market) reached in a period of time of 10 years and dealing with more than 10 therapeutic classes favouring the high value drugs like hormones, interferon, EPO, emergency drugs, vaccines, to minimize the cost ratio of the injector._x000D__x000D_This also is a way to promote innovative therapies like new molecules from biotechnologies or gene therapy which are growing and cannot be delivered by oral way. _x000D__x000D_The market organization deals with agreements with pharmaceutical laboratories consisting in license sales and the supply of ready to be filled devices ; revenues as high as 15 M Euros to 20 M Euros in 2010 and 100 M Euros in 2013 are expected for the participants._x000D__x000D_Preliminary trials have been already successfully performed by the applicant and led to the proof of concept in terms of:_x000D_ - device definition: test and validation with prototypes _x000D_ -glass tube design and test: it contains the drug and is submit to high pressures during the injection phase; it has been optimized and resists at the requested pressures (~250bars)_x000D_ - clinical subcutaneous tests were made on volunteers in the frame of an agreement with a big pharmaceutical laboratory ; the tests were passed successfully_x000D__x000D_The objective is now to industrialize the device, to manufacture it in mass production and to put it on the market._x000D_The up to now lab prototypes successfully tested are not designed in an economic way and suffer from a lack of reliability, so:_x000D_ - the help of a P specialized in mass production of small devices including pyrotechnic actuators is requested; this is the Austrian Company Hirtenberger Automotive Safety (short: HAS) as participant in the project; they have skills in reliable mass production of automotive safety devices and their components; the injector is close to this kind of technology_x000D_ - additional work has to be conducted on this new design: understanding of the injection phase to improve the reliability, validation on human skin injection, extension of the injection application to intra muscular_x000D__x000D_The ISTAR project items are:_x000D_ -reduce the dispersion of the injection by a deep understanding of the phenomena involved during the initial phase of injection _x000D_ -extent the injection application to intramuscular which is deeper, the most experiments made up to now were subcutaneous_x000D_ -design and realize a reliable environmental friendly and cost effective actuator compatible with mass manufacturing_x000D_ -design and realize the pharmaceutical sub-assembly adapted to the actuator to improve reliability and safety of the final system_x000D_ -validate the performances of the new designed device through tests on human skin_x000D_ -address the management, quality, regulation, industrial proprietary issues in the frame of the organization between the Ps_x000D_ -design the pilot manufacturing lines _x000D__x000D_The project consortium will consist of :_x000D_ -Crossject a SME as CO P responsible for the project, in charge of injection understanding, human skin tests, reliability of the final system: actuator+pharmaceutical sub-assembly, to be provided to the pharmaceutical customer _x000D_ -Hirtenberger (HAS) as P, a large company responsible for conception and mass production of a reliable actuator _x000D__x000D_ _x000D_

Acronym	ISTAR (Reference Number: 4258)
Duration	01/06/2008 - 30/09/2009
Project Topic	Design,test and validate on human skin a needle free drug delivery injector ready to be produced and put on the market in 2010 with the advantages: easy to use, safe, efficient in terms of injection, no contamination, no fear from needle._x000D_ The growing market of new drugs like biologics is targeted
Project Results (after finalisation)	The CO results concern the Research phase and the Development phases:_x000D_Research phase_x000D_ -better understanding of the phenomena occured during the injection allowing a better control and liability of the drug injection_x000D_ -extension of the injection to intramuscular applications with deeper depths, besides the sub-cutaneous allowing an extension of the drugs to be delivered by this way; intradermal injection was not taken into account in this program; has to be considered in a further project._x000D_Development phase_x000D_ -design and development of a new actuator performing the gas generation to push the drug through the skin, lighter, more liable and able to be industrialized_x000D_ -design and development of an improved pharmaceutical sub- assembly designed for drug storage and delivery when activated_x000D_ -validation of the complete device (actuator + pharmaceutical sub-assembly) on human skin injection tests_x000D_ -improvement of the project management, the quality and the intellectual property _x000D_ -design of the actuator assembly chain for further industrialization
Network	Eurostars
Call	Eurostars Cut-Off 1

Project partner

Number	Name	Role	Country
2	CROSSJECT	Coordinator	France
2	HIRTENBERGER AUTOMOTIVE SAFETY GmbH & Co KG	Partner	Austria