Preclinical stability evaluation of dapivirine and maraviroc release in vitro from combination silicone elastomer vaginal rings

摘要

Vaginal rings (VRs) loaded with microbicides may prove to be useful in the prevention of heterosexual transmission of HIV by providing sustained drug delivery over an extended period of time. Combinations of microbicides in VRs may result in increased efficacy of these products. In this study, silicone elastomer VRs loaded with the microbicide candidates dapivirine (a reverse transcriptase inhibitor) and maraviroc (a chemokine receptor antagonist) were assessed in a preclinical stability study. VRs were stored at 30°C/65% relative humidity (RH) or 40°C/75% RH and in vitro release of both drugs was assessed at TO, Tl, T2 and T3 months, in order to evaluate whether any significant changes in the release profiles occurred following storage at these conditions.