Effect of exposure of the 25 mg dapivirine vaginal ring to cleaning solutions and personal lubricants

Diarmaid Murphy, Clare F. McCoy, Peter Boyd, Tiffany Derrick, Patrick Spence, Brid Devlin, Robert Malcolm

Research output: Contribution to conferencePoster

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Abstract

Background: During use, vaginal rings may be exposed to various cleaning agents or personal lubricants which have the potential to extract drug from the ring, cause ring discoloration, and/or cause degradation of the drug substance within the ring. Here, we tested exposure of the 25 mg dapivirine (DPV) vaginal ring to a range of such agents.

Methods: 25 mg DPV vaginal rings were supplied by QPharma (Malmö, Sweden). Rings were exposed for different time periods to solutions of household bleach (Domestos), a surfactant-based liquid soap (Fairy Liquid), three different bath salts (Revive, Sols, DeWitt ́s), and three different personal lubricants (aqueous, mineral oil or silicone-based; Replens, Super Slik Lube and Sliquid Silver). Water, SVF+Tween, and no exposure were used as controls. Rings were rinsed, sectioned and extracted with acetone. Extraction solutions were analysed by HPLC for DPV content and degradation products using gradient HPLC. All peaks identified as equivalent to greater than 0.1% w/w were investigated and a plausible explanation for peak appearance was determined.

Results: For all test treatments, mean DPV ring assay was 99.1- 103.5% of the mean batch assay value (24.4 mg). Ring discolouration was observed with only one commercially available bath salt (Sols); this discolouration was not removed on rinsing and was not associated with a change in DPV assay or the development of any observable degradation products. For all treatments, the total degradation products were comparable to control rings extracted without treatment.

Conclusions: No substantial impact on the DPV assay value of 25 mg vaginal rings was observed upon exposure to a range of wash, lubricant or bath salt solutions. No new degradation peaks greater than 0.1% w/w which could only be attributed to the wash or bath salt solutions were identified.
Original languageEnglish
Number of pages1
Publication statusPublished - 25 Oct 2018
EventHIV Research for Prevention 2018 - Madrid Marriott Auditorium Hotel, Madrid, Spain
Duration: 21 Oct 201825 Oct 2018
http://www.hivr4p.org

Conference

ConferenceHIV Research for Prevention 2018
Abbreviated titleHIVR4P 2018
CountrySpain
CityMadrid
Period21/10/201825/10/2018
Internet address

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