Claims
- 1. A method of making a pharmaceutical composition of 117mSn(Sn4+) DTPA comprising the steps:
a) dissolving metallic 117Sn in a concentrated acid suspended in an aqueous medium to form a 117mSnCl2 solution; b) adding DTPA to the 117mSnCl2 solution in a molar concentration ratio of between about 1.0 to about 3.0 DTPA to 117mSnCl2; c) allowing the 117mSnCl2 to react with the DTPA to form a 117mSn(Sn2+)DTPA complex; d) oxidizing the 117m(Sn2+)DTPA to form a composition comprising 117mSn(Sn4+)DTPA; and e) removing the concentrated acid and water from the solution to form to form a resulting solid composition comprising 117m Sn(Sn4+)DTPA complex with a molar ratio of DTPA to 117m Sn(Sn4+) of about 1.0 to about 3.0.
- 2. A method according to claim 1 wherein said concentrated acid is hydrochloric acid.
- 3. A method according to claim 1 wherein the 117mSn has a specific activity from about 0.1 mCi/mg to about 80 Ci/mg.
- 4. A method according to claim 1 wherein the 117mSn has a specific activity from about 2 mCi/mg to about 80 Ci/mg.
- 5. A method according to claim 1 wherein the 117mSn has a specific activity from about 2 mCi/mg to about 20 mCi/mg.
- 6. A method according to claim 1 wherein the DTPA is added to the solution of 117mSnCl2 in a molar concentration of between about 1.0 to about 1.2 DTPA to 117mSnCl2.
- 7. A method according to claim 1 wherein the resulting solid composition comprises 117mSn(Sn4+)DTPA with a molar ratio of DTPA to 117mSn(Sn4+) of about 1.0 to about 1.2.
- 8. A method according to claim 1 wherein the acid and water are removed under vacuum.
- 9. A method according to claim 1 wherein said oxidizing step is performed by adding H2O2.
- 10. A method according to claim 1 wherein said oxidizing step is performed by exposing to open air.
- 11. A method of making a pharmaceutical composition of 117mSn(Sn4+) DTPA comprising the steps:
a) dissolving metallic 117Sn in a concentrated acid suspended in an aqueous medium to form a 117mSnCl2 solution under an inert atmosphere; b) adding DTPA to the 117mSnCl2 solution in a molar concentration ratio of between about 1.0 to about 3.0 DTPA to 117mSnCl2 in an inert atmosphere; c) removing the concentrated acid and water from the solution to form a solid residue comprising unchelated 117mSnCl2 and DTPA; d) dissolving the solid residue in an organic solvent to form an organic mixture; e) allowing the organic mixture to react sufficient to allow the formation of a 117mSn(Sn2+)DTPA complex; f) oxidizing the 117mSn(Sn2+)DTPA to form a resulting composition comprising 117mSn(Sn4+)DTPA with a molar ratio of DTPA to 117mSn(Sn4+) of about 1.0 to about 3.0.
- 12. A method according to claim 11 wherein said concentrated acid is hydrochloric acid.
- 13. A method according to claim 11 wherein the 117mSn has a specific activity from about 0.1 mCi/mg to about 80 Ci/mg.
- 14. A method according to claim 11 wherein the 117mSn has a specific activity from about 2 mCi/mg to about 80 Ci/mg.
- 15. A method according to claim 11 wherein the 117mSn has a specific activity from about 2 mCi/mg to about 20 mCi/mg.
- 16. A method according to claim 11 wherein said inert atmosphere is Ar or N2.
- 17. A method according to claim 11 wherein the DTPA is added to the solution of 117mSnCl2 in a molar concentration ratio of between about 1.0 to about 1.2 DTPA to 117mSnCl2.
- 18. A method according to claim 11 wherein the resulting composition comprises 117mSn(Sn4+)DTPA with a molar ratio of DTPA to 117mSn(Sn4+) of about 1.0 to about 1.2.
- 19. A method according to claim 11 wherein the acid and water are removed under vacuum.
- 20. A method according to claim 11 wherein the organic solvent is selected from the group consisting of methylene chloride or ethanol.
- 21. A method according to claim 20 wherein said organic solvent is methylene chloride.
- 22. A method according to claim 20 wherein said organic solvent is ethanol.
- 23. A method according to claim 11 wherein said organic mixture is allowed react from about 8 to about 24 hours.
- 24. A method according to claim 11 wherein said oxidizing step is performed adding H2O2.
- 25. A method according to claim 11 wherein said oxidizing step is performed by exposing to open air.
- 26. A pharmaceutical composition manufactured by the method of claim 1, wherein said pharmaceutical has a molar ratio of DTPA to 117mSn(Sn4+) of between about 1.0 to about 3.0.
- 27. A pharmaceutical according to claim 26 wherein said pharmaceutical has a molar ratio of DTPA to 117mSn(Sn4+) of between from about 1 to about 1.5.
- 28. A pharmaceutical according to claim 26 wherein said pharmaceutical has a molar ratio of DTPA to 117mSn(Sn4+) of between from about 1 to about 1.2.
- 29. A pharmaceutical composition manufactured by the method of claim 11, wherein said pharmaceutical has a molar ratio of DTPA to 117mSn(Sn4+) of between about 1.0 to about 3.0.
- 30. A pharmaceutical according to claim 29 wherein said pharmaceutical has a molar ratio of DTPA to 117mSn(Sn4+) of between from about 1 to about 1.5.
- 31. A pharmaceutical according to claim 29 wherein said pharmaceutical has a molar ratio of DTPA to 117mSn(Sn4+) of between from about 1 to about 1.2.
- 32. A method of treating a primary or metastatic tumor in skeletal bone of a mammal comprising the step of administering to the mammal a therapeutically effective amount of a pharmaceutical as set forth in claim 26.
- 33. A method according to claim 32 wherein said mammal is a human.
- 34. A method according to claim 33 wherein said effective amount is from about 10 mCi 117mSn(Sn4+) to about 1000 mCi 117mSn(Sn4+) per 70 kg body weight.
- 35. A method of treating a primary or metastatic tumor in skeletal bone of a mammal comprising the step of administering to the mammal a therapeutically effective amount of a pharmaceutical as set forth in claim 29.
- 36. A method according to claim 35 wherein said mammal is a human.
- 37. A method according to claim 36 wherein said effective amount is from about 10 mCi 117mSn(Sn4+) to about 1000 mCi 117mSn(Sn4+) per 70 kg body weight.
- 38. A method of treating bone pain associated with cancer in a mammal comprising the step of administering to said mammal a bone palliating amount of a pharmaceutical as set forth in claim 26.
- 39. A method according to claim 38 wherein said mammal is a human.
- 40. A method according to claim 39 wherein said effective amount is from about 6 mCi 117mSn(Sn4+) to about 50 mCi 117mSn(Sn4+) per 70 kg body weight.
- 41. A method of treating bone pain associated with cancer in a mammal comprising the step of administering to said mammal a bone palliating amount of a pharmaceutical as set forth in claim 29.
- 42. A method according to claim 41 wherein said mammal is a human.
- 43. A method according to claim 42 wherein said effective amount is from about 6 mCi 117mSn(Sn4+) to about 50 mCi 117mSn(Sn4+) per 70 kg body weight.
Government Interests
[0001] This invention was made with Government support under contract number DE-AC02-98CH10886, awarded by the U.S. Department of Energy. The Government has certain rights in the invention.