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Details for Patent: 5,773,024

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Details for Patent: 5,773,024

Title: Container with multi-phase composition for use in diagnostic and therapeutic applications
Abstract:A container comprising an aqueous lipid suspension and a gaseous phase substantially separate from the aqueous stabilizing phase, useful in diagnostic imaging such as ultrasound and magnetic resonance imaging and in therapeutic applications, is disclosed.
Inventor(s): Unger; Evan C. (Tucson, AZ), Matsunaga; Terry (Tucson, AZ), Yellowhair; David (Tucson, AZ)
Assignee: ImaRx Pharmaceutical Corp. (Tucson, AZ)
Filing Date:Sep 16, 1994
Application Number:08/307,305
Claims:1. A container which contains a composition comprising an aqueous phase and a gaseous phase substantially separate from said aqueous phase, wherein said aqueous phase comprises a lipid suspended therein and said gaseous phase comprises sulfur hexafluoride gas, and wherein said composition is capable of forming lipid spheres encapsulating the gas upon agitation of the container.

2. A container of claim 1 wherein said fluorinated gas further comprises a perfluorocarbon gas.

3. A container of claim 2 wherein said perfluorocarbon gas is selected from the group consisting of perfluoropropane, perfluorobutane, perfluorocyclobutane, perfluoroethane, perfluropentane, perfluorohexane and perfluoromethane.

4. A container of claim 3 wherein said perfluorocarbon gas is selected from the group consisting of perfluoropropane and perfluorobutane.

5. A container of claim 1 wherein said gaseous phase further comprises a paramagnetic gas.

6. A container of claim 5 wherein said paramagnetic gas is selected from the group consisting of oxygen, neon, xenon, and oxygen .sup.17 (.sup.17 O.sub.2).

7. A container of claim 1 wherein said gaseous phase further comprises a gas selected from the group consisting of air, nitrogen, oxygen, neon, helium, krypton, xenon, and oxygen .sup.17 (.sup.17 O.sub.2).

8. A container of claim 1 wherein said gaseous phase further comprises a gas selected from the group consisting of perfluoropropane, perfluorobutane, perfluorocyclobutane, perfluoromethane, perfluoroethane, perfluoropentane, and perfluorohexane, and a gas selected from the group consisting of air, nitrogen, oxygen, carbon dioxide neon, helium, krypton, xenon, and oxygen .sup.17 (.sup.17 O.sub.2).

9. A container of claim 1 wherein said gaseous phase further comprises a soluble gas.

10. A container of claim 9 wherein said soluble gas is selected from the group consisting of air, oxygen, carbon dioxide and nitrogen.

11. A container of claim 1 wherein said lipid which is suspended in said aqueous phase comprises a phospholipid.

12. A container of claim 11 wherein said phospholipid is selected from the group consisting of dipalmitoylphosphatidylcholine, dipalmitoylphosophatidic acid and dipalmitoylphosphatidylethanolamine.

13. A container of claim 1 wherein said aqueous phase further comprises a targeting ligand.

14. A container of claim 13 wherein said targeting ligand is polyethyleneglycol.

15. A container of claim 11 wherein said phospholipid is selected from the group consisting of dipalmitoylphosphatidylcholine, dipalmitoylphosophatidic acid and dipalmitoylphosphatidylethanolamine-PEG5000.

16. A container of claim 15 wherein said phospholipid is selected from the group consisting of dipalmitoylphosphatidylcholine, dipalmitoylphosophatidic acid and dipalmitoylphosphatidylethanolamine-PEG5000 in a mole percent ratio of about 82%:10%:8%.

17. A container of claim 1 wherein said aqueous phase further comprises a suspending agent.

18. A container of claim 1 wherein said aqueous phase further comprises a viscosity modifying agent.

19. A container of claim 18 wherein said viscosity modifying agent is selected from the group consisting of glycerol, proplylene glycol and polyvinylalcohol.

20. A container of claim 1 wherein said aqueous phase further comprises a therapeutic or diagnostic agent.

21. A container of claim 20 wherein said diagnostic agent is an MRI contrast enhancing agent.

22. A container of claim 21 wherein said MRI contrast enhancing agent is a paramagnetic ion.

23. A container of claim 1 wherein said aqueous phase further comprises a polymer.

24. A container of claim 1 wherein said container is sterilized.

25. A container which contains a composition for use in diagnostic imaging, wherein the composition comprises an aqueous phase and a gaseous phase which comprises sulfur hexafluoride, wherein said aqueous phase includes a lipid suspended therein and the composition is capable of forming lipid spheres encapsulating the gas upon agitation of the container.

26. A container of claim 25 wherein said gaseous phase further comprises a perfluorocarbon gas.

27. A container of claim 26 wherein said perfluorocarbon gas is selected from the group consisting of perfluoropropane, perfluorobutane, perfluorocyclobutane, perfluoroethane, perfluoropentane, perfluorohexane and perfluoromethane.

28. A container of claim 27 wherein said perfluorocarbon gas is selected from the group consisting of perfluoropropane and perfluorobutane.

29. A container of claim 25 wherein said gaseous phase further comprises a paramagnetic gas.

30. A container of claim 29 wherein said paramagnetic gas is selected from the group consisting of oxygen, neon, xenon, and oxygen .sup.17 (.sup.17 O.sub.2).

31. A container of claim 25 wherein said gaseous phase further comprises a gas selected from the group consisting of air, nitrogen, oxygen, neon, helium, krypton, xenon, and oxygen .sup.17 (.sup.17 O.sub.2).

32. A container of claim 25 wherein said lipid comprises a phospholipid.

33. A container of claim 32 wherein said phospholipid is selected from the group consisting of dipalmitoylphosphatidylcholine, dipalmitoylphosophatidic acid and dipalmitoylphosphatidylethanolamine-PEG5000.

34. A container of claim 33 wherein said dipalmitoylphosphatidylcholine, dipalmitoylphosophatidic acid and dipalmitoylphosphatidylethanolamine-PEG5000 are present in a mole percent ratio of about 82%:10%:8%.

35. A container of claim 25 wherein said diagnostic imaging is selected from the group consisting of ultrasound imaging and magnetic resonance imaging.

36. A container of claim 25 wherein said lipid in said lipid sphere is in the form of a monolayer.

37. A container of claim 36 wherein said lipid is a phospholipid.

38. A container of claim 37 wherein polyethyleneglycol is conjugated to at least a portion of said lipid.

39. A container of claim 36 wherein said lipid is a phospholipid and said gaseous phase further comprises perfluoropentane.

40. A container of claim 36 wherein said lipid is a phospholipid and said gaseous phase further comprises perfluoropropane.

41. A container of claim 25 wherein said lipid in said lipid sphere is in the form of one or more bilayers.

42. A container of claim 41 wherein said lipid is a phospholipid.

43. A container of claim 42 wherein polyethyleneglycol is conjugated to at least a portion of said lipid.

44. A container of claim 41 wherein said lipid is a phospholipid and said gaseous phase further comprises perfluoropentane.

45. A container of claim 41 wherein said lipid is a phospholipid and said gaseous phase further comprises perfluoropropane.

46. A container of claim 25 wherein said diagnostic imaging is selected from the group consisting of ultrasound imaging and magnetic resonance imaging.

47. A container which contains a composition for use in diagnostic imaging, wherein the composition comprises an aqueous phase and a substantially separate gaseous phase, said aqueous phase comprising lipid suspended therein and said gaseous phase comprising a substantially insoluble gas in combination with a soluble gas, wherein the composition is capable of forming lipid spheres encapsulating the gas upon agitation of the container.

48. A container of claim 47 wherein said substantially insoluble gas comprises a fluorinated gas.

49. A container of claim 48 wherein said fluorinated gas is selected from the group consisting of sulfur hexafluoride and a perfluorocarbon.

50. A container of claim 47 wherein said soluble gas is selected from the group consisting of air, nitrogen, oxygen, carbon dioxide, neon, helium, krypton, xenon, and oxygen .sup.17 (.sup.17 O.sub.2).

51. A container of claim 50 wherein said soluble gas is selected from the group consisting of air, nitrogen, oxygen and carbon dioxide.
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