A team of researchers from the Brigham and Women's Hospital and MIT is designing a new method to help improve adherence and reduce the risk of pregnancy by offering an oral contraceptive that could be taken once a month.
The study has been published in the 'Science Translational Medicine Journal'.
"Our capsule represents a major advancement toward providing women with a once-a-month contraceptive. For many, this may be hard to believe. But our preclinical data is encouraging us along that road," said co-corresponding author Giovanni Traverso, MD, PhD, a gastroenterologist and physician-researcher at Brigham and MIT.
"We began our work on extended drug release by working with treatments for malaria, tuberculosis and HIV. But early on, we were having conversations about the potential impact that extended drug release could have on family planning. We wanted to help empower women with respect to fertility control and are pleased to report our progress toward that goal," Traverso added.
The team designed a drug-delivery vehicle that consists of six arms joined by an elastic-coated core. The arms were loaded with the oral contraceptive drug levonorgestrel and folded up into a capsule that can be swallowed. Once in the stomach, the arms unfold and have a span that is larger than the opening of the human pylorus, helping the system stay in the stomach where it can release the drug over time.
The research team tested the concentration of oral contraceptives over time in a pig model and measured the presence of the drug in the bloodstream for animals that had been given the extended-release form versus an immediate-release tablet. For the tablet, dosage tapered off after six hours. For the extended-release form, the team observed concentrations of the drug for up to 29 days.
Work is now underway to bring the extended-release pill closer to human trials. The next steps will include scaling up manufacturing processes and safety evaluations.
Co-authors of this work included Ameya R. Kirtane, Tiffany Hua, Alison Hayward, Ambika Bajpayee, Aniket Wahane, Aaron Lopes, Taylor Bensel, Lihong Ma, Frank Z. Stanczyk, Sierra Brooks, Declan Gwynne, Jacob Wainer, Joy Collins, Siid Tamang, and Robert Langer.
This work was funded by the Bill and Melinda Gates Foundation Grant No. OPP1139927. Traverso, Langer and Kirtane are co-inventors on patents describing the use of gastric retentive drug delivery systems. Traverso and Langer have a financial interest in Lyndra Therapeutics, a biotechnology company focused on the development of oral drug delivery for long drug release. Hayward is a consultant for Lyndra Therapeutics.
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