Project BriefOpen Competition 3 - BiotechnologyMicrojet Patch for Transdermal Drug DeliveryDevelop a novel wearable transdermal drug delivery system using programmable arrays of high-energy microjets for painless, and precisely controlled and timed administration of any drug, including injectibles. Sponsor: StrataGent Life Sciences, Inc.16301 Withey RoadLos Gatos, CA 95030
The way a drug is delivered, such as by injection or in an oral pill, can have a huge impact on the effectiveness of a treatment, or even its viability. Pills seem to take forever to start working, and shots hurt. Both can cause unpleasant side effects to be more severe since they deliver a higher dose than necessary when they do start to work. They have other challenges too - you have to remember to take the right dose at the right time. Simple forgetfulness or other problems can cause patients to miss doses even with easy once-a-day pills. The overall problem of missed medications or taking the wrong dose is called "non-compliance," and by some estimates it costs the United States an extra $10 billion a year in healthcare costs and lost productivity, not to mention 150,000 deaths. One of the easiest drug-delivery mechanisms (from the patient's point of view) and hence one of the best methods of beating non-compliance is the transdermal "patch" that delivers a continuous, steady dose of medication through the patient's skin. Ease of use is not the sole attraction - in delivering continuous doses these patches also can optimize drug levels in the bloodstream and minimize the impact of side effects. Moreover, since the drug goes almost directly into the bloodstream, it sidesteps several other problems associated with oral medications. The problem with transdermal patches is that only a handful of drugs, typically small molecules, can be usefully absorbed through the skin - skin, after all, evolved to keep foreign molecules out of the body. This precludes the use of patches for the new and promising protein-based drugs. Patches also take even longer than pills to start working, which further limits their usefulness. StrataGent Life Sciences proposes a radical departure in transdermal patches. Rather than rely on slow passive diffusion of the drug through the skin, the StrataGent patch will use an array of "microjets" to proactively inject the drug through the tough stratum corneum, the outer layer of the skin that poses the most significant barrier. Such a patch can quickly deliver therapeutic dosages of a wide variety of macromolecular drugs that currently can be delivered only by injection, or any other drug for that matter. Controlled by an integrated microprocessor, the StrataGent patch could be programmed to specific drug delivery profiles, a significant improvement over today's passive transdermal patches. The original microjet design has been studied for use as a hand-held microsurgery tool. To transform it into the envisioned microjet patch, StrataGent faces several significant technical challenges, including assuring dosage volume control, system reliability, possible problems with drug stability because of the high-energy microjets, and miniaturizing and packaging the device. The company plans to work with the University of California at Santa Barbara (UCSB) for animal studies and with Case Western Reserve University (CWRU) (Cleveland, Ohio) on preclinical development. StrataGent is a small start-up that lacks the resources to pursue the project on its own. Sources of conventional R&D funding consider it too risky. If it is successful, a mere 1 percent improvement in patient compliance would save $360 million a year in the cost of direct healthcare, lost productivity, and premature death. The microjet patch would enable a new, rapid-onset, needle-free, highly customizable drug-delivery system for a host of drugs with applications in hormone therapy, immunotherapy, pain management, and the treatment of arthritis, cancer, cardiovascular disease, diabetes, and other chronic conditions. It might even enable new drugs to be developed that would not otherwise be feasible - pharmaceutical companies shelve drugs that require too frequent injection as unmarketable.
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