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J Med Primatol. 2009 Aug;38(4):263-71. doi: 10.1111/j.1600-0684.2009.00354.x. Epub 2009 May 19.

Development and evaluation of a vaginal ring device for sustained delivery of HIV microbicides to non-human primates.

Author information

1
Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV, STD, TB Prevention, CCID, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.

Abstract

BACKGROUND:

There is considerable interest in developing coitally independent, sustained release formulations for long-term administration of HIV microbicides. Vaginal ring devices are at the forefront of this formulation strategy.

METHODS:

Non-medicated silicone elastomer vaginal rings were prepared having a range of appropriate dimensions for testing vaginal fit in pig-tailed and Chinese rhesus macaques. Cervicovaginal proinflammatory markers were evaluated. Compression testing was performed to compare the relative flexibility of various macaque and commercial human rings.

RESULTS:

All rings remained in place during the study period and no tissue irritation or significant induction of cervicovaginal proinflammatory markers or signs of physical discomfort were observed during the 8-week study period.

CONCLUSIONS:

Qualitative evaluation suggests that the 25 x 5-mm ring provided optimal fit in both macaque species. Based on the results presented here, low-consistency silicone elastomers do not cause irritation in macaques and are proposed as suitable materials for the manufacture of microbicide-loaded vaginal rings.

[Indexed for MEDLINE]

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