Future contraceptive? Microchip may be option
Science is looking at a wireless microchip implant, with remote drug delivery control, that is designed to last up to 16 years. Now in the very early stages of testing, such a device would provide long-lasting contraception — nearly half of a woman’s reproductive life — and could be deactivated without a trip to the clinic and an outpatient procedure.
EXECUTIVE SUMMARY
Science is looking at a wireless microchip implant, with remote drug delivery control, that is designed to last up to 16 years.
- The proposed contraceptive microchip measures 20 by 20 by 7 mm and is designed to be implanted under the skin of the buttocks, upper arm, or abdomen. Scientists look for the microchip to release a daily dose of 30 mcg levonorgestrel.
- A hermetic titanium and platinum seal on reservoirs in the chip is activated each day through an internal battery to release the daily drug dose.
MicroCHIPS of Lexington, MA, a developer of implantable drug delivery devices and biosensors, is aiming for testing of the contraceptive chip in 2015, with trials beginning in 2016, says Robert Farra, MSME, MicroCHIPS president.
The proposed contraceptive microchip measures 20 by 20 by 7 mm. It is designed to be implanted under the skin of the buttocks, upper arm, or abdomen. Scientists look to use a daily dose of 30 mcg of levonorgestrel as the contraceptive. Tiny reservoirs holding 16 years of drug doses fit on a microchip 1.5 cm wide inside the device. A hermetic titanium and platinum seal on the reservoirs is activated each day through an internal battery to release a daily dose of the contraceptive. Components of the original microchip technology, such as the array of micro reservoirs used to contain drug and the first microchip opening mechanism, were developed at the Massachusetts Institute of Technology and licensed to MicroCHIPS.
Levonorgestrel has been widely used in oral contraceptives, intrauterine devices, and subdermal implants, says Farra. It has a well-understood and safe profile. "The chip stores discrete doses, providing long-term stability, and dosing can be turned on or off without an additional procedure to remove the device," notes Farra. "It provides women with additional choices helping them plan their family. It also simplifies a woman’s life in that she doesn’t need to remember to take a pill."
Technology under review
MicroCHIPS began looking at the contraceptive microchip after its work with a similar chip designed to deliver an osteoporosis drug, teriparatide. In its trial, postmenopausal women diagnosed with osteoporosis received daily doses of the drug through microchip delivery rather than daily injection. The drug released from the implanted microchip demonstrated similar measures of safety and therapeutic levels in blood compared to standard subcutaneous injections.1
To conduct the study, seven osteoporotic postmenopausal patients between 65 and 70 received the microchip-based implant. The primary objective of the trial was to assess the pharmacokinetics of the released drug from the implanted devices. Safety measures included evaluation of the biological response to the implant and monitoring indicators of toxicity.
The device and drug combination were found to be biocompatible with no adverse immune reaction. The pharmacokinetic profiles from the implant were comparable to and had less variation than the profiles of multiple, recommended subcutaneous injections of the drug. The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals.1
MicroCHIPS received a $4.6 million grant from the Bill & Melinda Gates Foundation in January 2014 to advance its work on the contraceptive chip.
Despite the current variety of contraceptives, there still are existing gaps in the method mix, says Laneta Dorflinger, PhD, distinguished scientist and director of the Contraceptive Technology Innovation program at FHI 360, a global nonprofit human development organization based in Durham, NC. There is a need for new contraceptive options that will fill these gaps and increase choices for women, notes Dorflinger. However, in recent decades, there has been limited investment in contraceptive research and development.
"Recently, the Bill & Melinda Gates Foundation has taken a leadership position making a variety of medium and longer-term investments in innovative contraceptive product development," states Dorflinger. "Through FHI 360’s Contraceptive Technology Innovation Initiative, which is funded by the Gates Foundation, we are working to develop innovative, long-acting contraceptives to help expand choice and access for women most in need in low-income countries."
The FHI 360 Initiative is building on projects now underway to develop a longer-acting injectable contraceptive and a new biodegradable contraceptive implant. The program also is looking to advance the Sino-implant (II), a highly effective, low-cost, subdermal contraceptive implant composed of two thin, flexible, silicone rods, with each rod filled with 75 mg of levonorgestrel.2 Program officials hope to ensure the implant is affordable and accessible to women in the poorest countries.
- Farra R, Sheppard NF Jr, McCabe L, et al. First-in-human testing of a wirelessly controlled drug delivery microchip. Sci Transl Med 2012; doi: 10.1126/scitranslmed.3003276.
- Lendvay A, Otieno-Masaba R, Azmat SK, et al. Effectiveness, safety and acceptability of Sino-implant (II) during the first year of use: results from Kenya and Pakistan. Contraception 2014; 89(3):197-203.
