Researchers have developed a microarray patch that may give young women and girls in resource-limited areas a discreet option for receiving pre-exposure prophylaxis and contraceptives, according to recent research from IDWeek 2019 in Washington, DC.
“The purpose of this research is to develop a microarray patch (MAP; also known as a microneedle patch) for delivery of long-acting cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) and co-delivery of long-acting CAB LA and a hormonal contraceptive to enable a future multipurpose prevention technology,” Annie Rein-Weston, MPH, Technical Officer at PATH in Seattle, and colleagues wrote in their study abstract.
“MAPs could provide a discreet delivery system that enables self-administration, which could be particularly important for HIV prevention and contraception for young women and girls in low-resource settings,” they said.
Rein-Weston and her colleagues presented preclinical pharmacokinetic results of the MAP, which delivers CAB LA and a hormonal contraceptive intradermally on a baseplate with an array of micron-scale projections less than 1 mm high. To prepare a MAP for phase 1 study, the researchers are currently looking at how to make the patch easy to self-administer in a form factor not unlike transdermal patches available on the market (with a size range of 20 cm2 to 140 cm2). The MAP would also have a low wear time of under 24 hours with an ideal wear time of 20 minuter, and would be administered either weekly or monthly.
“The purpose of this three-year, USAID-funded project is to develop a MAP for delivery of long-acting HIV PrEP through to the point of Phase I clinical readiness,” Rein-Weston and colleagues said.
Currently, the researchers have loaded 5.86 mg CAB LA per 1 cm2 MAP, which has remained stable for 6 months in foil packaging using accelerated aging techniques. When applied, a MAP “readily pierce[s] the skin, and rapidly dissolve[s],” the researchers said. An experiment on rats showed MAP had achieved therapeutic targets of 4xPA-IC90 for 28 days but had lower bioavailability than intramuscular or intradermal injections. In a phosphate-buffered solution, a MAP projection fully dissolved within 25 minutes, the researchers noted.
“Additional development work is warranted, including optimizing bioavailability, evaluating MAPs as a maintenance dose in vivo, conducting cost of manufacturing and cost of delivery analyses, and assessing potential end-user acceptability,” Rein-Weston and colleagues concluded.
Rein-Weston A, et al. Abstract LB8. IDWeek; Oct. 2-6, 2019; Washington, DC.