An established commercial product sensitive to oxygen and moisture had to be transferred to a new lyophilizer with the option to load on pre-cooled shelves
Dapivirine Vaginal Ring (25 mg) provides topical delivery of the microbicide,
dapivirine, to the vagina. There is the potential of drug-drug interactions between
dapivirine and other co-administered vaginal products. Clotrimazole, an imidazole
derivative with a broad spectrum of antimycotic activity, is widely used in
HIV prevention methods should consider circumstances of non-adherence to evaluate effectiveness. The effect of multiple removals and (re-)insertions of Dapivirine Vaginal Ring at different time points during a 28-day period on local and systemic dapivirine exposure and dapivirine residual levels in used rings was evaluated to simulate possible scenarios of product non-adherence by women in Phase III clinical trials.