Journal
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 39, Issue 4, Pages 203-212Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ejps.2009.11.007
Keywords
Intravaginal ring; Anti-HIV drug; Polyurethane; Microbicide; Dual delivery; Controlled release
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Funding
- The International Partnership for Microbicides
- U.S. Department of Energy [DE-FG02-05ER64026]
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Dual segment polyurethane intravaginal rings (IVRs) were fabricated to enable sustained release of anti retroviral agents dapivirine and tenofovir to prevent the male to female sexual transmission of the human immunodeficiency virus. Due to the contrasting hydrophilicity of the two drugs, dapivirine and tenofovir were separately formulated into polymers with matching hydrophilicity via solvent casting and hot melt extrusion. The resultant drug loaded rods were then joined together to form dual segment IVRs. Compression testing of the IVRs revealed that they are mechanically comparable to the widely accepted NuvaRing (R) IVR. Physical characterization of the individual IVR segments using wide angle X-ray scattering and differential scanning calorimetry determined that dapivirine and tenofovir are amorphous and crystalline within their polymeric segments, respectively. In vitro release of tenofovir from the dual segment IVR was sustained over 30 days while dapivirine exhibited linear release over the time period. A 90 day accelerated stability study confirmed that dapivirine and tenofovir are stable in the IVR formulation. Altogether, these results suggest that multisegment polyurethane IVRs are an attractive formulation for the sustained vaginal delivery of drugs with contrasting hydrophilicity such as dapivirine and tenofovir. (C) 2009 Elsevier B.V. All rights reserved.
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