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Claims for Patent: 4,957,939

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Claims for Patent: 4,957,939

Title: Sterile pharmaceutical compositions of gadolinium chelates useful enhancing NMR imaging
Abstract:Pharmaceutical compositions comprising gadolinium chelates are useful for enhancing NMR images.
Inventor(s): Gries; Heinz (Berlin, DE), Rosenberg; Douwe (Berlin, DE), Weinmann; Hanns-Joachim (Berlin, DE)
Assignee: Schering Aktiengesellschaft (Berlin and Bergkamen, DE)
Application Number:06/876,497
Patent Claims: 1. A pharmaceutical composition for enhancement of NMR imaging comprising a physiologically compatible gadolinium chelate complex and a pharmaceutically acceptable carrier, wherein said composition is sterile.

2. A composition according to claim 1, wherein gadolinium is chelated by an open-chain or cyclic complexing agent containing organic nitrogen, phosphorous, oxygen or sulfur.

3. A composition according to claim 1, wherein gadolinium is chelated by an open-chain chelating agent.

4. A composition according to claim 1, wherein gadolinium is chelated by a cyclic chelating agent.

5. A composition according to claim 1, wherein gadolinium is chelated by an aminopolycarboxylic acid.

6. A pharmaceutical composition according to claim 1, wherein gadolinium is chelated by nitrilotriacetic acid (NTA), N,N,N',N'-ethylenediaminetetraacetic acid (EDTA), N-hydroxyethyl-N,N',N'-ethylenediaminetriacetic acid (HEDTA), N,N,N',N",N"-diethylenetriaminepentaacetic acid (DTPA), or N-hydroxyethyliminodiacetic acid.

7. A composition according to claim 1, wherein gadolinium is chelated by an amine of the formula ##STR9## wherein R.sub.1 and R.sub.1 ', being identical or different, are H or alkyl of 1 to 4 C atoms and n is a number from 0 to 4.

8. A composition according to claim 1, wherein gadolinium is chelated by ethylenediamine, diethylenetriamine, triethylenetetraamine, tetraethylenepentaamine, or pentaethylenehexaamine.

9. A composition according to claim 1, wherein gadolinium is chelated by a macrocyclic compound of the formula ##STR10## wherein R.sub.2 is H, a hydrocarbon radical or an alkoxycarbonyl radical or both radicals R.sub.2 together form a group of subformula ##STR11## A is in each case a hydrocarbon radical; X is in each case N or P;

D is in each case O, S, a group of formula ##STR12## wherein R is H or a hydrocarbon radial, or a hydrocarbon radical; and m, n and p are whole numbers from 0 to 5; with the proviso that at least two of the D groups are O,

S, or a group of formula ##STR13## and in cases in which each R.sub.2 radical is a hydrogen atom, a hydrocarbon radical or an alkoxycarbonyl radical and X is a N atom, one of these two radicals or atoms which D represents, is an O or S atom and the other radical is an O atom or a group of formula ##STR14##

10. A composition according to claim 1, wherein no free acid or free base groups are present in the chelate complex.

11. A composition according to claim 1, wherein a free acid or a free base group is present in the chelate complex.

12. A composition of claim 1, wherein a free acid or a free base group of the chelate complex is in the form of a salt thereof with an inorganic or organic base or acid.

13. A composition according to claim 1, wherein said chelate complex is both a salt of gadolinium and the chelating agent thereof, and also a salt with an inorganic or organic base or acid.

14. A composition according to claim 1, wherein said chelate complex is only a salt of gadolinium and the chelating agent thereof and not also a salt with an inorganic or organic base or acid.

15. A composition according to claim 1, wherein the chelating agent which forms said chelate complex is diethylenetriaminepentaacetic acid.

16. A composition according to claim 1, wherein said chelate complex consists of a single gadolinium chelated by a chelating agent which optionally is a salt with an organic or inorganic acid or base.

17. A composition according to claim 13, wherein said inorganic or organic acid or base is hydrochloric acid, sulfuric acid, acetic acid, citric acid, aspartic acid, glutamic acid, sodium hydroxide, glucamine, N-methylglucamine, N,N-dimethylglucamine, ethanolamine, diethanolamine, morpholine, lysine, ornithine or arginine.

18. A composition according to claim 1, further comprising a conventional galenic stabilizer.

19. A composition according to claim 1, further comprising sodium chloride.

20. A pharmaceutical composition according to claim 1, comprising said chelate complex dissolved in water.

21. A composition according to claim 1, which is an aqueous solution containing 5-250 mmole/l of said chelate complex.

22. A composition according to claim 1, which is an aqueous solution having a pH of 6.5-8.0.

23. A composition according to claim 1, which is physiologically suitable for oral administration.

24. A composition according to claim 1, which is physiologically suitable for neural administration.

25. A composition according to claim 1, which is physiologically suitable for intravascular administration.

26. A composition according to claim 1, which is an aqueous solution isotonic with respect to blood.

27. A composition according to claim 1, wherein said chelate complex is the di-N-methyl glucamine salt of gadolinium(III)-diethylenetriaminepentaacetic acid.

28. A pharmaceutical composition of claim 1, with the proviso that the gadolinium chelate is not a gadolinium citrate or a gadolinium edetate.

29. A composition according to claim 1, wherein said chelate complex is nonionic.

30. A composition according to claim 3, wherein said chelate complex is nonionic.

31. A composition according to claim 4, wherein said chelate complex is nonionic.

32. A composition according to claim 28, wherein said chelate complex is nonionic.
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