The future of drug delivery may be a programmable, wirelessly controlled microchip implanted in a patient's body.
A team of researchers at Massachusetts Institute of Technology conceived the idea 15 years ago, helped form a company called MicroCHIPS to explore commercialization, and recently announced results of a successful in-body test.
"You could literally have a pharmacy on a chip," says Langer, a professor and longtime plastics expert at MIT who cofounded MicroCHIPS. "You can do remote control delivery; you can do pulsatile drug delivery; and you can deliver multiple drugs." Langer tells PlasticsToday that metals are used as seals in the chip that was tested, but biodegradable chips made from polylactic-co-glycolic acid (PLGA) have also been studied. There are other small plastic parts in the device that the company declined to identify.
In the new study, the programmable implants delivered an osteoporosis drug called teriparatide to seven women aged 65 to 70. The device delivered dosages comparable to injections, and there were no adverse side effects.
"Patients with chronic diseases, regular pain-management needs or other conditions that require frequent or daily injections could benefit from this technology," says Robert Farra, president and chief operating officer at MicroCHIPS.
In 1999, the MIT team that included Langer and MIT Professor Micahel Cima published its initial findings in Nature, and MicroCHIPS was founded and licensed the microchip technology from MIT. The company refined the chips, including adding a hermetic seal and a release system that works reliably in living tissue.
"Compliance is very important in a lot of drug regimens, and it can be very difficult to get patients to accept a drug regimen where they have to give themselves injections," says Cima. "This avoids the compliance issue completely, and points to a future where you have fully automated drug regimens."
Human clinical trials began in Denmark last year. Chips were implanted during a 30-minute procedure at a doctor's office using local anesthetic, and remained in the patients for four months. Patients said they often forgot they even had the implant, Cima says.
Chips used in the study stored 20 doses of teriparatide, individually sealed in tiny reservoirs about the size of
MIT Professors Cima (left) and Langer developed idea for an implantable lab on a chip. Photo: MIT
a pinprick. The reservoirs are capped with a thin layer of platinum and titanium that melts when a small electrical current is applied, releasing the drug inside. MicroCHIPS is now working on developing implants that can carry hundreds of drug doses per chip.
Dosages can be scheduled in advance or triggered remotely by radio communication over a special frequency called Medical Implant Communication Service (MICS). Implantable microchip devices can also provide real-time dose schedule tracking, and as part of a network, physicians can remotely adjust treatment schedules as necessary.
MicroCHIPS expects that it will take up to four years for its first product to be on the market. During this time, the company tells PlasticsToday it will refine the product design for a microchip implant that can deliver drug for one year or more, and complete the clinical studies for approval by regulatory authorities.
Langer adds: "The convergence of drug delivery and electronic technologies gives physicians a real-time connection to their patient's health, and patients are freed from the daily reminder, or burden, of disease by eliminating the need for regular injections."
MicroCHIPS was founded by John Santini, Cima and Langer of the Massachusetts Institute of Technology, and Terry McGuire of Polaris Venture Partners. Investors include: Polaris Venture Partners, Flybridge Capital Partners, Medtronic, Novartis Venture Fund, CSK Ventures, Intersouth Partners, Saints Capital, Care Capital and Boston University.