Intravaginal Devices for the Sustained Delivery of Tenofovir

In the past year we have made significant progress developing intravaginal reservoir devices for the sustained delivery of tenofovir (TFV). Over the past 12 months we successfully progressed the project and satisfied the proposed requirements and in preparation for human testing. Through the research and development process, we have continued to address several technical challenges that were not envisioned in the original research description. During the past year we have essentially solved many of these problems and have begun to transfer the technology to in vivo testing and manufacturing. The indication of this product is to prevent the acquisition of HIV through consistent use of this product over a women’s life. The route of administration is intravaginal and the dosage form is a reservoir thermoplastic polyurethane IVR to deliver TFV. The dosing schedule we are targeting is once per 90 days without removal for menstruation. The average dose over 90 days will be approximately 10 mg/day of tenofovir. The device will be composed of a hollow water swellable polyurethane tube that is loaded with a 62/36/2 (% w/w) TFV/glycerol/water paste. The tubing will be made by hot melt extrusion from a 75/25 blend (% w/w) of Lubrizol Tecophilic HP-60D-60 and Lubrizol Tecophilic HP-93A-100. The IVR dimensions will be approximately 5.5 mm in cross section and 55 mm outer diameter.