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

Authors

  • Nattawan Promadej-Lanier,

    1.  Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV, STD, TB Prevention, CCID, Centers for Disease Control and Prevention, Atlanta, GA, USA
    Search for more papers by this author
    • *

      These two authors contributed equally to this work.

  • James M. Smith,

    1.  Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV, STD, TB Prevention, CCID, Centers for Disease Control and Prevention, Atlanta, GA, USA
    Search for more papers by this author
    • *

      These two authors contributed equally to this work.

  • Priya Srinivasan,

    1.  Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV, STD, TB Prevention, CCID, Centers for Disease Control and Prevention, Atlanta, GA, USA
    Search for more papers by this author
  • Clare F. McCoy,

    1.  School of Pharmacy, Medical Biology Centre, Queen’s University Belfast, Belfast, UK
    Search for more papers by this author
  • Sal Butera,

    1.  Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV, STD, TB Prevention, CCID, Centers for Disease Control and Prevention, Atlanta, GA, USA
    Search for more papers by this author
  • A. David Woolfson,

    1.  School of Pharmacy, Medical Biology Centre, Queen’s University Belfast, Belfast, UK
    Search for more papers by this author
  • R. Karl Malcolm,

    1.  School of Pharmacy, Medical Biology Centre, Queen’s University Belfast, Belfast, UK
    Search for more papers by this author
  • Ron A. Otten

    1.  Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV, STD, TB Prevention, CCID, Centers for Disease Control and Prevention, Atlanta, GA, USA
    Search for more papers by this author

Ron A. Otten, PhD, Laboratory Branch, DHAP, NCHSTP, CCID, CDC Mailstop G-19, 1600 Clifton Road, Atlanta, GA 30333, USA.
Tel.: +1 (404) 639 1018;
fax: +1 (404) 639 1174;
e-mail: rxo1@cdc.gov

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 × 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.

Ancillary