The results of recent research suggest it is possible that women could have access to an intravaginal ring that can serve both as a contraceptive and as HIV prevention.1
The ring would be created through 3D printing technology. So far, it has been tested for safety in sheep, and it could be several years before clinical trials are underway.
“The most exciting part is the technology works, and we need to get funding to advance it as quickly as possible,” says S. Rahima Benhabbour, MSc, PhD, an associate professor at UNC/NCSU Joint Department of Biomedical Engineering. Benhabbour also is an adjunct associate professor at the University of North Carolina Eschelman School of Pharmacy and a member of the Center for Nanotechnology in Drug Delivery at UNC Chapel Hill.
Discreet Protection
If the contraceptive continues to progress through clinical trials and ultimately receives FDA approval, it could be the first device since the invention of condoms to prevent both HIV and unintended pregnancy.
“That’s the most important part of all, and it’s why we’re doing all this work,” Benhabbour says. “It’s for empowering young, adolescent women in low- and middle-income countries where the prevalence of HIV is highest and there’s pregnancy risk, as well.”
Many women around the world have no way of independently and discreetly protecting themselves from HIV infection. For this reason, the contraceptive device could appeal to women anywhere in the world.
“This is women-controlled, and I think that the ultimate goal is to empower women who have no power over protecting themselves,” Benhabbour says.
The main benefit of the new 3D-printed technology for the intravaginal ring is that it holds the promise of implementing design within the ring. “It allows us to control those rings and tailor them to particular drugs and indications,” Benhabbour explains. “The ring, for instance, is intended to incorporate three drugs — active pharmaceutical ingredients.”
One of the drugs is an antiretroviral drug, and the other two are part of a hormonal contraceptive combination like in the NuvaRing. “We chose that strategically because it’s highly potent,” Benhabbour says. “To accelerate approval, we chose a hormonal regimen that was already approved in a ring.”
Focus Groups Drive Design
Investigators have conducted focus group studies to learn what women want in an intravaginal ring as far as color, size, and feel.
“We have the ability to change the look and feel of the ring to tailor it to end users’ preferences,” Benhabbour explains. “We asked women to look at different colors, different designs within the ring, and found out what they like and dislike. We have the ability to prototype very fast, and we conducted the next focus group study using input from the earlier one to change the color. Then, we honed in on the top three designs that were most liked by women.”
The end product will have one design and one color. But it will have been developed to what women are most likely to find acceptable because of the use of 3D printing in the contraceptive’s development.
“Real-time input from women who could be end users is one of the major advantages of 3D printing,” Benhabbour notes. “The other advantage is to independently control how the drug is released from the ring. The compression force of the ring is dictated by its size and the material used in traditional manufacturing processes.”
User factors include how easily they can compress the ring and insert it. “We can make them more squishable, which is the main parameter that women associate with administration and comfort,” Benhabbour explains. “A stiffer ring is associated with less comfort, and it’s harder to administer, whereas a squishier ring is seen by end users as easier to administer and more comfortable.”
Theoretically, a manufacturer could adjust the 3D printer to make a contraceptive ring with the exact features a person would like. But for reasons related to the complexity of regulatory approval, researchers have used focus groups to create one design that may appeal to the most end users.
“If you change a color from one to another, the agency has to approve it,” Benhabbour explains. “It’s important to hone in on those characteristics early in the development, before you get all the way to the regulatory stage.”
The contraceptive device’s efficacy and safety are the most important features. “If the product is safe and it does what we want it to do to protect against HIV and unintended pregnancy, that’s the end goal,” she says. “But we also need to make these devices something women want to use.”
3D Printing Is Cost-Effective
If the device receives approval from the FDA, the next stage is to manufacture it. 3D printers can work well and cost-effectively, Benhabbour says. A manufacturer would make the devices according to the approved design, and the medication would be incorporated after the 3D printing process. The medication is not exposed to high heat or pressure that occurs with injection molding.
“We have done a cost analysis, and it’s cheaper to use 3D printers at manufacturing scale than injection molders,” Benhabbour adds.
Everything is fund-dependent because it takes millions of dollars to advance technologies through the regulatory path and clinical trials.
“We are academia, and we’re moving as fast as we can, but if all the funding is there, it’d take three to five years to get to a Phase I clinical trial,” Benhabbour says.
REFERENCE
- Young IC, Srinivasan P, Shrivastava R, et al. Next generation 3D-printed intravaginal ring for prevention of HIV and unintended pregnancy. Biomaterials 2023;301:122260.
The results of recent research suggest it is possible that women could have access to an intravaginal ring that can serve both as a contraceptive and as HIV prevention. The ring would be created through 3D printing technology. So far, it has been tested for safety in sheep, and it could be several years before clinical trials are underway.
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