Abstract
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.
Keywords
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Article Info
Publication History
Published online: November 23, 2012
Accepted:
October 17,
2012
Received in revised form:
October 5,
2012
Received:
August 27,
2012
Footnotes
���Sources of support: USAID .
Identification
Copyright
© 2013 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
