• Major, Ian
• Boyd, Peter
• Cohen, Jessica
• Malcolm, R. Karl
• Saxon, Gene
• Kilbourne-Brook, Maggie

Abstract

<p>Background: There is considerable interest in developing new multipurpose prevention technologies to address women's reproductive health needs. This study describes an innovative barrier contraceptive device - based on the SILCS diaphragm - that also provides long-term controlled release of the lead candidate anti-HIV microbicide dapivirine. Study Design: Diaphragm devices comprising various dapivirine-loaded polymer spring cores overmolded with a nonmedicated silicone elastomer sheath were fabricated by injection molding processes. In vitro release testing, thermal analysis and mechanical characterization were performed on the devices. Results: A diaphragm device containing a polyoxymethylene spring core loaded with 10% w/w dapivirine provided continuous and controlled release of dapivirine over a 6-month period, with a mean in vitro daily release rate of 174 mcg/day. The mechanical properties of the new diaphragm were closely matched to the SILCS diaphragm. Conclusions: The study demonstrates proof of concept for a dapivirine-releasing diaphragm with daily release quantities potentially capable of preventing HIV transmission. In discontinuous clinical use, release of dapivirine may be readily extended over 1 or more years.</p>

Topics

• impedance spectroscopy
• thermal analysis
• injection molding
• elastomer