Next Generation Multipurpose Intravaginal Ring Technology Using Innovative CLIP 3D Printing

PROJECT SUMMARY
Globally, over 50% of those infected with HIV are women, and annually, ~50% of all pregnancies are unintended.
Therefore, there is a critical need to promote female-controlled methods of multipurpose prevention and delivery
strategies that can be disassociated from the sex act. Intravaginal rings are well tolerated by women, are
efficacious for contraception and hormone replacement therapy, and have high patient acceptability and
compliance 1-4. However, developing effective multipurpose IVRs is challenging due to the limitations of current
engineering processes 5-6, and differences in drug properties and release rates, thus mandating drug-specific
customized IVR designs. Our goal is to address these limitations by revolutionizing the engineering process of
intravaginal rings using a state-of-the-art 3D printing process known as the continuous liquid interface production
(CLIP™)7. Using CLIP, we can engineer IVRs with complex geometries that cannot be achieved with traditional
injection molding or extrusion. The complex geometries within the ring will allow us to precisely fine-tune diffusion
and release of drugs from the IVR, and achieve near complete release of drugs from the IVR. More importantly,
with CLIP, we can manufacture multipurpose IVRs that can integrate 2 or more drugs to prevent against
unintended pregnancies and STIs (HIV, HSV-2, HPV) in a rapid and cost effective single-step process. In this
NGM R01 grant and building on our existing data, we propose a comprehensive evaluation of this innovative
approach using highly relevant animal models as invaluable preclinical tools to assess the safety and
pharmacokinetic profiles of 3D CLIP MPT. This cutting edge combined approach will be utilized to evaluate the
scientific premise of our proposal in sheep and macaques to investigate the safety and efficacy of a unique and
highly innovative 3D printed multipurpose IVR technology.

Grant Number: 5R01AI150358-05
NIH Institute/Center: NIH
Principal Investigator: Soumya Benhabbour