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Matrix and reservoir-type multipurpose vaginal rings for controlled release of dapivirine and levonorgestrel.

Matrix and reservoir-type multipurpose vaginal rings for controlled release of dapivirine and levonorgestrel.
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Boyd P, Fetherston SM, McCoy CF, Major I, Murphy DJ, Kumar S, Holt J, Brimer A, Blanda W, Devlin B, Malcolm RK,


Boyd P, Fetherston SM, McCoy CF, Major I, Murphy DJ, Kumar S, Holt J, Brimer A, Blanda W, Devlin B, Malcolm RK, (click to view)

Boyd P, Fetherston SM, McCoy CF, Major I, Murphy DJ, Kumar S, Holt J, Brimer A, Blanda W, Devlin B, Malcolm RK,

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International journal of pharmaceutics 2016 07 26511(1) 619-29 doi 10.1016/j.ijpharm.2016.07.051

Abstract

A matrix-type silicone elastomer vaginal ring providing 28-day continuous release of dapivirine (DPV) – a lead candidate human immunodeficiency virus type 1 (HIV-1) microbicide compound – has recently demonstrated moderate levels of protection in two Phase III clinical studies. Here, next-generation matrix and reservoir-type silicone elastomer vaginal rings are reported for the first time offering simultaneous and continuous in vitro release of DPV and the contraceptive progestin levonorgestrel (LNG) over a period of between 60 and 180days. For matrix-type vaginal rings comprising initial drug loadings of 100, 150 or 200mg DPV and 0, 16 or 32mg LNG, Day 1 daily DPV release values were between 4132 and 6113μg while Day 60 values ranged from 284 to 454μg. Daily LNG release ranged from 129 to 684μg on Day 1 and 2-91μg on Day 60. Core-type rings comprising one or two drug-loaded cores provided extended duration of in vitro release out to 180days, and maintained daily drug release rates within much narrower windows (either 75-131μg/day or 37-66μg/day for DPV, and either 96-150μg/day or 37-57μg/day for LNG, depending on core ring configuration and ignoring initial lag release effect for LNG) compared with matrix-type rings. The data support the continued development of these devices as multi-purpose prevention technologies (MPTs) for HIV prevention and long-acting contraception.

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