Drug delivery system for the delivery of antiviral agents
This invention relates to novel implant drug delivery systems for long-acting delivery of antiviral drugs. These compositions are useful for the treatment or prevention of human immunodeficiency virus (HIV) infection.
1. An implant drug delivery system for subcutaneous implantation consisting essentially of one or more polyurethane coated tablets in the form of a capsule or tube, wherein the one or more tablets consist essentially of 4′-ethynyl-2-fluoro-2′-deoxyadenosine, and optionally a diluent and/or a lubricant, wherein said 4′-ethynyl-2-fluoro-2′-deoxyadenosine is continually released in vivo at a rate resulting in a plasma concentration between 0.1 ng/mL and 25.0 ng/mL.
2. The pharmaceutical composition of claim 1 wherein the optional diluent is lactose and the optional lubricant is magnesium stearate.
3. The implant drug delivery system of claim 1 wherein the plasma concentration is between 0.1 ng/mL and 5.0 ng/mL.
4. The implant drug delivery system of claim 3 wherein the plasma concentration is between 0.1 ng/mL and 1.0 ng/mL.
5. The polyurethane of claim 1 selected from the group consisting of hydrophilic polyurethane and hydrophobic polyurethane.
6. The polyurethane of claim 1 which is hydrophilic polyurethane.
7. The implant drug delivery system of claim 1 wherein the 4′-ethynyl-2-fluoro-2′-deoxyadenosine is released at therapeutic concentrations for a duration from between three months and thirty-six months.
8. The implant drug delivery system of claim 1 wherein the 4′-ethynyl-2-fluoro-2′-deoxyadenosine is released at therapeutic concentrations for a duration from between six months and twelve months.
9. A method of treating HIV infection with an implant drug delivery system according to claim 1 comprising implanting the implant drug delivery system of claim 1 in a patient in need thereof.
10. A method of preventing HIV infection with an implant drug delivery system according to claim 1 comprising implanting the implant drug delivery system of claim 1 in a patient in need thereof.
11. The implant drug delivery system of claim 1 wherein the implantable device is 2 mm to 6 mm in diameter and 2 cm to 5 cm in length.
12. The implant drug delivery system of claim 11 wherein one or more implants can be used to achieve the desired therapeutic dose for durations up to 2 years.