STMicroelectronics (ST) and Debiotech, which are based in Lausanne and Geneva respectively, have completed the production of an evaluation prototype of their insulin Nanopump.
The device, which is based on microfluidic micro-electro-mechanical system (MEMS) chip technology, can be mounted on a disposable skin patch that the companies hope will improve drug availability, therapeutic efficacy and enhance the quality of life of diabetes sufferers.
Michael Markowitz, director of technical media relations at ST told in-PharmaTechnologist.com that: "while we have completed the industrialization of the Nanopump, we still need to build a network of marketing partners and collect regulatory approvals; this could take a couple of years."
Continuous subcutaneous insulin infusion (CSII) is an increasingly attractive alternative to injectable treatments that must be administered several times a day. The programmability of such systems means that they can be tailored to the patient's individual requirements.
According to a report by industry analysts RNCOS the insulin market is currently undergoing double-digit growth as a result of the increasing prevalence of diabetes. While injectable delivery systems dominate the sector, the pain and inconvenience of these methods mean that there is strong demand for alternatives, particularly given the failure of inhalable insulin products like Pfizer's Exubera and Eli Lilly's AIR.
"The success of the initial prototype tests has moved the revolutionary insulin Nanopump a step closer to market availability," said Benedetto Vigna, Group Vice President of ST's MEMS and Healthcare, RF transceiver and sensors division.
"Working with our key partner Debiotech, we are readying a tiny piece of silicon that can make a huge difference to millions of diabetes patients around the world."
Debiotech's CEO, Frederic Neftel, explained that successful tests are a "key achievement toward the successful launch of a new drug delivery device, combining the highest level of reliability and performance with a previously unmet level of convenience and safety for the patient."
Dr Neftel added that: "The collaboration with ST has proven to be extremely efficient in time and achievements, allowing us to now concentrate on a future partnership with a leading medical device company who will be responsible to introduce the product on the market."
MEMS chip technology
The Nanopump consists of a volumetric membrane pump and a pair of check valves combined on a MEMS chip system. The chip is a stack of three layers bonded together a silicon on insulator (SOI) plate with micromachined pump-structures and two Pyrex cover plates with through-holes.
The system controls delivery through displacement of the pumping membrane between two mechanical stops. As a result, it can provide a linear flow rate that is unaffected by inlet/outlet pressure, actuation voltage, temperature, viscosity and aging.
The versatility of MEMS chip technology means that it can be applied to a wide range of liquid micro-dosing applications that require high performance and accuracy of delivery. In addition, because several chips can be produced in parallel on a single silicon wafer, manufacturing costs are low.