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Claims for Patent: 4,626,531

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Claims for Patent: 4,626,531

Title: Prostaglandins and antigestagens for induction of labor and for abortion
Abstract:A pharmaceutical composition containing a prostaglandin and an antigestagen is suitable for induction of labor and for abortion.
Inventor(s): Elger; Walter (Berlin, DE), Beier; Sybille (Berlin, DE)
Assignee: Schering Aktiengesellschaft (Berlin and Bergkamen, DE)
Application Number:06/660,358
Patent Claims: 1. A pharmaceutical composition comprising a labor or abortion inducing prostaglandin and a labor or abortion inducing antigestagen, the total amount of the combination of the prostaglandin and the antigestagen being effective to induce labor or an abortion.

2. A pharmaceutical composition of claim 1 wherein the amount of the prostaglandin and the amount of the antigestagen are both lower than the amount at which each is effective to induce labor or abortion when used alone.

3. A pharmaceutical composition of claim 1, wherein at least one of the amount of the prostaglandin and the amount of the antigestagen is lower than the amount at which it is effective to induce labor or abortion when used alone.

4. A pharmaceutical composition of claim 1, wherein the prostaglandin and antigestagen are contained in a weight ratio of 1:20 to 1:6000.

5. A pharmaceutical composition of claim 1, wherein the prostaglandin and the antigestagen are contained in separate dosage units.

6. A pharmaceutical composition of claim 1, wherein the prostaglandin and the antigestagen are contained in the same dosage unit.

7. A pharmaceutical composition of claim 1, wherein the prostaglandin is 0.03-0.5 mg of 16-phenoxy-.omega.-17,18,19,20-tetranor-PGE.sub.2 -methylsulfonylamide or a biologically equivalent amount of another prostaglandin.

8. A pharmaceutical composition of claim 1, wherein the antigestagen is 10-200 mg of 11.beta.-[(4-N,N-dimethylaminophenyl]-17.beta.-hydroxy-17.alpha.-propinyl- 4,9(10)-estradien-3-one or a biologically equivalent amount of another antigestagen.

9. A pharmaceutical composition of claim 1, wherein the prostaglandin is prostaglandin E.sub.2, prostaglandin F.sub.2.sbsb..alpha. 16-phenoxy-.omega.-17,18,19,20-tetranor-PGE.sub.2 -methylsulfonylamide, 16,16-dimethyl-trans-.DELTA..sup.2 -PGE.sub.1 -methyl ester, 9-deoxo-16,16-dimethyl-9-methylene-PGE.sub.2, a prostaglandin F derivative, 15-methyl-PGF.sub.2.sbsb..alpha. -methyl ester, (5Z,13E)-(9R,11R,15R)-9-chloro-11,15-dihydroxy-16,16-dimethyl-5,13-prostad ienoic acid, (5Z,13E)-(9R,11R,15R)-11,15dihydroxy-9-fluoro-16-phenoxy-17,18,19,20-tetra nor-5,13-prostadienoic acid, (5Z,13E)-(9R,11R,15R)-11,15-dihydroxy-16,16-dimethyl-9-fluoro-5,13-prostad ienoic acid (DE-OS 31 26 924), (5Z,13E)-(9R,11R,15R)-9-bromo-11,15-dihydroxy-16-phenoxy-17,18,19,20-tetra nor-5,13-prostadienoic acid, or (5Z,13E)-(9R,11R,15R)-9-bromo-11,15-dihydroxy-16,16-dimethyl-5,13-prostadi enoic acid.

10. A pharmaceutical composition of claim 1, wherein the antigestagen is

11.beta.-[(4-N,N-dimethylamino)-phenyl]-17.beta.-hydroxy-17.alpha.-propinyl -4,9(10)-estradien-3-one,

11.beta.-[(4-N,N-dimethylamino)-phenyl]-17.beta.-hydroxy-18-methyl-17.alpha .-propinyl-4,9(10)-estradien-3-one,

11.beta.-[4-N,N-dimethylamino)-phenyl]-17a.beta.-hydroxy-17a.sbsb..alpha.-p ropinyl-D-homo-4,9(10),16-estratrien-3-one,

1.beta. -p-methoxyphenyl-17.beta.-hydroxy-17.alpha.-ethinyl-4,9(10)-estradi en-3-one, or

11.beta.-(4-dimethylaminophenyl)-17.alpha.-hydroxy-17.beta.-(3-hydroxypropy l)-13.alpha.-methyl-4,9-gonadien-3-one.

11. A pharmaceutical composition of claim 7 wherein the prostaglandin is 0.1 to 0.3 mg of 16-phenoxy-.omega.-17,18,19,20-tetranor-PGE.sub.2 -methylsulfonylamide or a biologically equivalent amount of another prostaglandin and the composition is adapted for i.m. or i.v. administration.

12. A pharmaceutical composition of claim 7 wherein the prostaglandin is 0.03 to 0.5 mg of 16-phenoxy-.omega.-17,18,19,20-tetranor-PGE.sub.2 -methylsulfonylamide or a biologically equivalent amount of another prostaglandin and the composition is adapted for local administration.

13. A pharmaceutical composition of claim 4, wherein the amount of antigestagen is 10-200 mg per dosage unit of 11.beta.-[(4-N,N-dimethylamino)-phenyl]-17.beta.-hydroxy-17.alpha.-propiny l-4,9(10)-estradine-3-one or a biologically equivalent amount of another antigestagen.

14. A method of inducing an abortion in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 1.

15. A method of inducing labor in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 1.

16. A method of claim 14, wherein the administration of the prostaglandin and the antigestagen is simultaneous.

17. A method of claim 14, wherein the administration of the prostaglandin and the antigestagen is sequential.

18. A method of claim 14, wherein the prostaglandin and the antigestagen are administered in separate dosage units.

19. A method of claim 15, wherein the administration of the prostaglandin and the antigestagen is simultaneous.

20. A method of claim 15, wherein the administration of the prostaglandin and the antigestagen is sequential.

21. A method of claim 15, wherein the prostaglandin and the antigestagen are administered in separate dosage units.

22. A method of inducing an abortion in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 3.

23. A method of inducing labor in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 3.

24. A method of inducing an abortion in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 7.

25. A method of inducing labor in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 7.

26. A method of inducing an abortion in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 8.

27. A method of inducing labor in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 8.

28. A method of inducing an abortion in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 9.

29. A method of inducing labor in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 9.

30. A method of inducing an abortion in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 10.

31. A method of inducing labor in a pregnant patient comprising administering to the patient an effective amount of a composition of claim 10.
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