A modified SILCS contraceptive diaphragm for long-term controlled release of the HIV microbicide dapivirine

作者：Major Ian; Boyd Peter; Kilboume Brook Maggie; Saxon Gene; Cohen Jessica; Malcolm R Karl^*

来源：Contraception, 2013, 88(1): 58-66.

DOI：10.1016/j.contraception.2012.10.018

• HIV microbicide
• Multipurpose prevention technology
• Contraceptive diaphragm
• SILCS
• Vaginal drug delivery
• Dapivirine
• Controlled release

Background: There is considerable interest in developing new multipurpose prevention technologies to address women%26apos;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. %26lt;br%26gt;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. %26lt;br%26gt;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. %26lt;br%26gt;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.

• 出版日期2013-7