A modified SILCS contraceptive diaphragm for long-term controlled release of the HIV microbicide dapivirine
Major, I.; Boyd, P.; Kilbourne-Brook, M.; Saxon, G.; Cohen, J.; Malcolm, R.K.
Contraception 88(1): 58-66
2013
ISSN/ISBN: 1879-0518 PMID: 23177261 DOI: 10.1016/j.contraception.2012.10.018Document Number: 571484
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. 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. 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. 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.
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