Device for delivery of once-a-month contraceptives (Tiffany Hua, MIT)
5 Dec. 2019. A contraceptive capsule is shown in tests with pigs to release and maintain detectable levels of birth control drugs in the blood stream for up to 29 days. Researchers from Massachusetts Institute of Technology and other institutions describe the drug-delivery technology in yesterday’s issue of the journal Science Translational Medicine.
A team from the biomedical engineering and materials science labs of Giovanni Traverso and Robert Langer at MIT are seeking better methods for family planning that help overcome obstacles of access, convenience, and acceptance. The most common form of birth control for women is a daily contraceptive pill, because of its ease of use and rapid reversal to fertility when desired. The authors point out, however, that up to half of respondents in a multi-national survey say they missed at least one dose of daily contraceptives, or reported taking the pill at the wrong time. As a result, women taking daily contraceptives have a 1 in 11, or 9 percent, chance of becoming pregnant.
The Bill and Melinda Gates Foundation funded the project to find a safe but longer-term solution for family planning, with the ease of oral contraceptives. Traverso and Langer are developing solutions that provide extended delivery of drugs to improve adherence by patients. Much of their work focuses on bio-compatible and degradable polymer materials that can be folded into ingestible capsules and withstand the stomach’s acidic environment. Once in the stomach, the devices unfold and release their medication over extended periods.
Following this model, the team led by postdoctoral researcher Ameya Kirtane and technical associate Tiffany Hua, now at Lux Research, built a snowflake-shaped device with six arms, made of the polymers polydimethylsiloxane and polysebacic anhydride, bio-compatible materials employed in medical devices and tissue engineering. The researchers loaded the device with the contraceptive drug levonorgestrel, used in intrauterine devices, as well as emergency pregnancy-protection drugs (e.g., Plan B). Bench tests in the lab show changing the mix of polymers in the device could alter the release of levonorgestrel in the stomach.
The team tested the device by folding the arms of the device into an ingestible gelatin capsule, given to three female pigs through a feeding tube. Pigs have organs similar in size and function to humans. Blood tests of the pigs show detectable concentrations of levonorgestrel in the pigs for up to 29 days. By comparison, concentrations of levonorgestrel given as tablets diminished quickly in the first two days. In addition, X-rays show the devices largely remain in the pigs’ stomachs over the 29 days, although two of the arms detached and were passed by the animals.
In 2015, Langer, Traverso, and entrepreneur Amy Schulman founded the company Lyndra Therpeutics Inc. in Watertown, Massachusetts to license and commercialize the extended release drug-delivery technology. As reported in Science & Enterprise in July, Lyndra Therapeutics also received a Gates Foundation grant to further develop a contraceptive capsule that works for weeks at a time.
“Through the development of these technologies,” says Traverso in an MIT statement, “we aim to transform people’s experience with taking medications by making it easier, with more infrequent dosing in the first once-a-month, orally delivered drug system.”
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