X-ray visible drug delivery device
View Patent ↗The subject invention provides an X-ray visible drug delivery device for subdermal administration of a contraceptive or hormone replacement therapy.
1. A drug delivery device for subdermal administration of a contraceptive or hormone replacement therapy comprising (i) a core comprising (a) crystalline desogestrel or 3-ketodesogestrel; (b) a thermoplastic polymer, wherein the percent weight of the thermoplastic polymer in the core is equal to or less than the percent weight of the desogestrel or 3-ketodesogestrel; and (c) about 4-30% by weight of a radio-opaque material, wherein substantially all the radio-opaque material is encapsulated in the thermoplastic polymer and not in the crystalline desogestrel or 3-ketodesogestrel; and (ii) a non-medicated thermoplastic polymer skin covering the core.
2. The drug delivery device according to claim 1 , wherein the radio-opaque material is about 6-20% by weight.
3. The drug delivery device according to claim 1 , wherein the radio-opaque material is about 8-15% by weight.
4. The drug delivery device according to claim 1 , wherein the radio-opaque material is barium sulphate.
5. The drug delivery device according to claim 1 , wherein the device is an implant.
6. The drug delivery device according to claim 1 , wherein the thermoplastic polymer in the core is ethylene-vinylacetate copolymer.
7. The drug delivery device of claim 4 , wherein the barium sulphate is about 8-15% by weight.
8. An implant consisting of a coaxial rod, the rod containing (i) a core comprising (a) crystalline desogestrel or 3-ketodesogestrel, (b) an ethylene-vinylacetate copolymer having a vinylacetate content of about 28%, wherein the percent weight of the ethylene-vinylacetate copolymer is equal to or less than the percent weight of the desogestrel or 3-ketodesogestrel, and (c) about 4-30% by weight of a radio-opaque material, wherein substantially all the radio-opaque material is encapsulated in the ethylene-vinylacetate copolymer; and (ii) a non-medicated ethylene-vinylacetate copolymer skin having a vinylacetate content of about 14%, covering the core.
9. The implant of claim 8 , wherein the radio-opaque material is barium sulphate.
10. The implant of claim 9 , wherein the barium sulphate is about 8-15% by weight.
11. The implant of claim 8 , wherein the rod has open ends.
12. The implant of claim 8 , wherein the implant has a length of 40 mm and a diameter of 2 mm.
13. The implant of claim 8 , wherein the amount of 3-ketodesogestrel is 68 mg.
14. A kit comprising:
a) the drug delivery device according to claim 4 ; and
b) an acrylonitrile-butadiene-styrene polymer applicator for inserting the implant.
15. A kit comprising:
a) the implant according to claim 9 ; and
b) an acrylonitrile-butadiene-styrene polymer applicator for inserting the implant.
16. An implant having a length of 40 mm and a diameter of 2 mm consisting of a coaxial rod, the rod comprising (i) a core comprising (a) 68 mg of crystalline 3-ketodesogestrel; (b) an ethylene-vinylacetate copolymer having a vinylacetate content of about 28%, wherein the percent weight of the ethylene-vinylacetate copolymer is equal to or less than the percent weight of the 3-ketodesogestrel; and (c) about 8-15% by weight of barium sulphate, wherein substantially all the radio-opaque material is encapsulated in the ethylene-vinylacetate copolymer; and (ii) a non-medicated ethylene-vinylacetate copolymer skin having a vinylacetate content of about 14% covering the core.
17. The implant of claim 16 , wherein the rod has open ends.
18. A kit comprising (a) the implant according to claim 16 , and (b) an acrylonitrile-butadiene-styrene polymer applicator consisting of a body, a plunger, a stainless steel needle and a polypropylene shield.
19. A drug delivery device for subdermal administration of a contraceptive or hormone replacement therapy comprising (i) a core comprising (a) crystalline desogestrel or 3-ketodesogestrel; (b) less than 50% by weight of a thermoplastic polymer; and (c) about 4-30% by weight radio-opaque material and substantially all the radio-opaque material is encapsulated in the thermoplastic polymer and (ii) a non-medicated thermoplastic polymer skin covering the core.
20. The drug delivery device according to claim 19 , wherein the radio-opaque material is about 6-20% by weight.
21. The drug delivery device according to claim 19 , wherein the radio-opaque material is about 8-15% by weight.
22. The drug delivery device according to claim 19 , wherein the radio-opaque material is barium sulphate.
23. The drug delivery device according to claim 19 , wherein the device is an implant.
24. The drug delivery device according to claim 19 , wherein the thermoplastic polymer in the core is ethylene-vinylacetate copolymer.