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Last Updated: April 26, 2024

Claims for Patent: 8,722,037


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Summary for Patent: 8,722,037
Title:X-ray visible drug delivery device
Abstract: The subject invention provides an X-ray visible drug delivery device for subdermal administration of a contraceptive or hormone replacement therapy.
Inventor(s): Veenstra; Harm (Oss, NL), De Graaff; Wouter (Oss, NL)
Assignee: Meck Sharp & Dohme B.V. (BN Harleem, NL)
Application Number:10/592,725
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,722,037
Patent Claims: 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.

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