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A new long-acting contraceptive designed to be self-administered by women could offer a new family planning option, particularly in developing countries where access to health care may be limited, according to a recent study.
The contraceptive would be administered using microneedle skin patch technology, originally developed for the painless administration of vaccines.
In animal testing, a micropaper experimental contraceptive patch provided a therapeutic level of contraceptive hormone for more than one month with a single application to the skin.
When the patch is applied for several seconds, the microscopic needles break and stay below the surface of the skin, where biodegradable polymers slowly release the levonorgestrel contraceptive drug over time.
Originally designed to be used in areas of the world where access to health care is limited, the micro needle contraceptive could potentially offer a new family planning alternative to a broader population.
The research, published January 15 in the journal Nature Biomedical Engineering and copied to the Ghana News Agency, was supported by Family Health International (FHI 360), funded under a contract with the US Agency for International Development (USAID).
Professor Mark Prausnitz, Professor Regents at the Faculty of Chemical and Biomolecular Engineering at the Georgia Institute of Technology and the corresponding author of the paper m said"There is a lot of interest in providing more options for long – acting contraceptives.
"Our goal is for women to be able to self-administer long-acting contraceptives with the microneedle patch that would be applied to the skin for five seconds once a month."
According to the study, long-acting contraceptives are now available in formats such as patches to wear permanently, intrauterine devices (IUDs) that need to be placed by health professionals skilled and injected drugs with hypodermic needles. If the use of the microneedle contraceptive patch is finally approved, it could become the first self-administered, long-acting contraceptive that does not involve conventional needle injection.
Like other long-acting contraceptive techniques, the microneedle contraceptive patch would disrupt the menstrual cycles of women who use it.
Researchers led by Georgia Tech's postdoctoral researcher, Wei Li, have developed a technique that allows microneedles containing the drug to break free from the patch's backing material because small needles must remain in the skin for release. Hormone over time. . To achieve this, researchers mold small air bubbles in the top of the microneedles, creating structural weakness.
The resulting microneedles are strong enough to be pressed into the skin, but when the patch is then shifted to one side, the pure the force breaks the tiny structures of the skin. The backup patch can then be discarded.
Experimental patches designed to deliver a sufficient amount of the hormone for humans have been developed, but have not yet been tested, noted Professor Prausnitz, J. Erskine Love Chair. , Jr. in Chemical and Biomolecular Engineering at Georgia Tech.
Researchers are also studying whether a single patch could contain enough hormones to provide contraception for six months.
"The microneedle patch delivery platform developed by Professor Prausnitz and colleagues for contraception is an exciting breakthrough for women's health," said Gregory S. Kopf, Director of R & D at the University of California. contraceptive technology innovation at FHI 360.
"This long-acting, self-administered contraceptive will allow women to control their fertility in a discreet and convenient manner, which will have a positive impact on public health by reducing the number of unwanted and unwanted pregnancies."
The microneedles are mold from a mix of a biodegradable polymer, poly (lactic-co-glycolic acid) and poly (lactic acid), commonly used in resorbable sutures, said Steven Schwendeman, professor Ara Paul and director of the Department of Pharmaceutical Sciences at the University of Michigan, and collaborator of this project. Lactic and glycolic acids are naturally present in the body, contributing to the biocompatibility of the polymer material, he said.
"We have selected polymeric materials that meet specific design objectives, such as micro-needle resistance, biocompatibility, biodegradation and release time of the drug, as well as the stability of the formulation," explained the professor. Schwendeman.
"Our team then turns the polymer into microneedles by dissolving the polymer and the drug in an organic solvent, molding shape, then drying the solvent to create the microneedles. The polymer matrix when formed this way, can release slowly and safely the contraceptive hormone for weeks or months when it is placed in the body. "
Tests done on rats only evaluated blood levels of the hormone and did not attempt to determine whether this could prevent a pregnancy.
"The goal was to show that we could allow the levonorgestrel concentration to stay above the levels known to cause contraception in humans," explained Professor Prausnitz.
By developing the experimental micro-needle contraceptive patch, researchers have used earlier work on the dissolution of micro-needle patches designed to carry vaccines into the body. A Phase I clinical trial on influenza vaccination using fast dissolving microneedles was conducted in collaboration with Emory University.
This study suggests that microneedle patches could be used safely to administer the vaccine. Because the micro-needles are so small, they only penetrate the upper layers of the skin and have not been perceived as painful by the study participants.
"We do not yet know how micro-needle patches for contraceptives could work in humans," Prausnitz said.
"Because we use a well established contraceptive hormone, we are optimistic that the patch will be an effective means of contraception.We also expect that any skin irritation at the patch application site is minimal, but these expectations must be verified in clinical trials. "
Contraceptive patches tested on animals contained 100 microneedles. To give an adequate dose of levonorgestrel to a human, you will need a larger patch, manufactured but not yet tested. The researchers would like to develop a patch that can be applied once every six months.
"There is a lot of interest in minimizing the number of health care interventions needed," said Prof. Prausnitz.
"Therefore, a contraceptive patch lasting longer than a month is desirable, especially in countries where women's access to health care is limited." But, since the micro-needles are , by definition, small, the a lot of drugs can be incorporated into a microneedle patch. "
Although mbad production costs have not been determined, Prausnitz expects contraceptive patches to be economical enough to be used in developing countries.
In addition to those already mentioned, the research team included Richard N. Terry of Georgia Tech, as well as Jie Tang and Meihua R. Feng of the University of Michigan.
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