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. A monolithic implant drug delivery system comprising between 30% and 50% by weight of 4′-ethynyl-2-fluoro-2′-deoxyadenosine, a radiopaque material and ethylene vinyl acetate copolymer, wherein the 4′-ethynyl-2-fluoro-2′-deoxyadenosine is dispersed or dissolved in the ethylene vinyl acetate copolymer, and wherein said implant drug delivery system is implanted subdermally and 4′-ethynyl-2-fluoro-2′-deoxyadenosine is continually released in vivo at a rate resulting in a plasma concentration between 0.02 ng/mL and 300.0 ng/mL.
2. The implant drug delivery system of claim 1 wherein the 4′-ethynyl-2-fluoro-2′-deoxyadenosine plasma concentration is between 0.02 ng/mL and 30.0 ng/mL.
3. The implant drug delivery system of claim 2 wherein the 4′-ethynyl-2-fluoro-2′-deoxyadenosine the plasma concentration is between 0.02 ng/mL and 8.0 ng/mL.
4. The implant drug delivery system of claim 1 wherein the ethylene vinyl acetate copolymer is selected from the group consisting ethylene vinyl acetate copolymer (9% vinyl acetate), ethylene vinyl acetate copolymer (15% vinyl acetate), ethylene vinyl acetate copolymer (28% vinyl acetate), and ethylene vinyl acetate copolymer (33% vinyl acetate).
5. The implant drug delivery system of claim 4 wherein the ethylene vinyl acetate copolymer is ethylene vinyl acetate copolymer (9% vinyl acetate).
6. The implant drug delivery system of claim 4 wherein the ethylene vinyl acetate copolymer is ethylene vinyl acetate copolymer (15% vinyl acetate).
7. The implant drug delivery system of claim 1 comprising between 1% and 20% by weight of a radiopaque material.
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 three months and thirty-six months.
9. The implant drug delivery system of claim 1 wherein the 4′-ethynyl-2-fluoro-2′-deoxyadenosine is released at prophylactic concentrations for a duration from between three months and thirty-six months.