Birth control pills in their present form need to be taken once a day each day for the whole menstrual cycle. Other options such as Intra-Uterine devices (IUDs) or implanted progesterone offer a longer coverage, but most women prefer the pills due to their reliability and cheaper, easier and safer usage profile.
Daily oral contraceptive pills. Image credit: areeya_ann / Shutterstock
Studies and surveys have shown that nine percent of women annually in the United States miss their pill and eventually get pregnant. This pill failure could be curbed if daily regimen of the pill was altered to a weekly or monthly gap feel researchers.
Researchers from the Brigham and Women’s Hospital and MIT have developed a formulation that makes a pill resist the acidic environment of the stomach and release the hormones within it in a slow and steady manner.
In animal studies in the pigs they managed to make the pill release the hormones for up to 29 days. This means that a pill designed with this coating, could be used once a month and provide contraception to the user.
The results of the study with the new formulation of the birth control pill was published in the latest issue of the Science Translational Medicine this week.
Giovanni Traverso, co-author of the study and a gastroenterologist and biomedical engineer at Brigham and Women’s and MIT said, “From an engineering aspect, the key novelty is the ability to deliver a drug for a month after a single ingestion event.”
According to Traverso, the new formulation has a six-armed face within a cylinder. Each of the arms of the pill contains a silicone polymer within which is embedded the hormone levonorgestrel.
At the centre of the arms is an elastic core and all arms fold to fit into a capsule that can be swallowed. Within the stomach the capsule coating dissolves and the arms open up like a starfish, explained Traverso.
When open the pill is 2 cm wide and sits at the opening between the stomach and intestines called the pyloric sphincter.
The pill then releases the hormone slowly which passes onto the intestines and is absorbed in the blood stream.
In the pigs the capsule when administered, released the drug for up to 30 days. X rays showed the location of the pill.
Over time only two of the arms detached among the total 18 arms in 3 pigs. Despite breaking off, the arms kept releasing the hormone as predicted say the researchers.
He explained that the pill in its new avatar was being commercially developed by Lyndra Therapeutics based in Boston. Traverso is one of the founders of the company with MIT bioengineer Robert Langer in 2015.
The Gates Foundation this year in July provided the much needed funds to the tune of $13 million to the company so that it could develop the monthly pill for human use. The duo believes that this pill could help low- and middle-income countries where population control is a major public health problem. Lyndra’s CEO, Patricia Hurter, explained that they would be starting human clinical trials in 2021. She added that this contraption could also help develop medications against other common diseases such as malaria, HIV, tuberculosis and schizophrenia.