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Details for Patent: 4,233,284

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Details for Patent: 4,233,284

Title: Stabilized radiographic scanning agents
Abstract:Stable compositions, useful as technetium-99m-based scintigraphic agents, comprise gentisic acid or a pharmaceutically-acceptable salt or ester thereof in combination with a pertechnetate reducing agent or dissolved in pertechnetate-99m (.sup.99m TcO.sub.4.sup.-) solution. The compositions are especially useful in combination with a phosphate or phosphonate material which carries the radionuclide to bone, thus providing a skeletal imaging agent.
Inventor(s): Fawzi; Mahdi B. (Cincinnati, OH)
Assignee: The Procter & Gamble Company (Cincinnati, OH)
Filing Date:Mar 31, 1978
Application Number:05/892,245
Claims:1. A stable composition, useful in the preparation of technetium-99m-based radiographic scanning agents, comprising: a pertechnetate reducing agent; and a stabilizing amount of a gentisate stabilizer selected from gentisic acid and the soluble, pharmaceutically-acceptable salts and esters thereof.

2. A composition according to claim 1, comprising a weight ratio of gentisate stabilizer to reducing agent in the range of about 20:1 to about 1:20.

3. A composition according to claim 2, wherein the ratio of stabilizer to reducing agent is in the range of from about 10:1 to about 1:1.

4. A composition according to claim 3, wherein the gentisate stabilizer is selected from gentisic acid or a pharmaceutically-acceptable salt thereof.

5. A composition according to claim 1, wherein the pertechnetate reducing agent is selected from the group consisting of the soluble stannous, chromous and ferrous salts.

6. A composition according to claim 5 wherein the pertechnetate reducing agent is selected from the group consisting of stannous chloride, chromous chloride and ferrous sulfate.

7. A composition according to claim 1 wherein the reducing agent is stannous chloride, the gentisate is gentisic acid or sodium gentisate, and the weight ratio of gentisate:SnCl.sub.2 is about 5:1 to about 1:1.

8. A composition according to claim 1, additionally comprising an organ-specific carrier.

9. A composition according to claim 8 wherein the organ-specific carrier is an organophosphonate.

10. A composition according to claim 9 wherein the organophosphonate is selected from the group consisting of ethane-1-hydroxy-1,1-diphosphonic acid, methanediphosphonic acid, dichloromethanediphosphonic acid, methanehydroxydiphosphonic acid, and the soluble salts and esters thereof.

11. A composition according to claim 10 wherein the pertechnetate reducing agent is stannous chloride, the organ-specific carrier is a sodium salt form of ethane-1-hydroxy-1,1-diphosphonic acid, and the gentisate stabilizer is sodium gentisate or gentisic acid.

12. A composition according to claim 10 wherein the pertechnetate reducing agent is stannous chloride, the organ-specific carrier is a sodium salt form of methanediphosphonic acid, and the gentisate stabilizer is sodium gentisate or gentisic acid.

13. A composition according to claim 10 wherein the pertechnetate reducing agent is stannous chloride, the organ-specific carrier is a sodium salt form of dichloromethanediphosphonic acid, and the gentisate stabilizer is sodium gentisate or gentisic acid.

14. A composition according to claim 10 wherein the pertechnetate reducing agent is stannous chloride, the organ-specific carrier is a sodium salt form of methanehydroxydiphosphonic acid, and the gentisate stabilizer is sodium gentisate or gentisic acid.

15. A composition according to claim 9 wherein the organophosphonate is a 3-aminopropane-1-hydroxy-1,1-diphosphonate.

16. A composition according to claim 8 wherein the organ-specific carrier is a water-soluble inorganic phosphate.

17. A composition according to claim 16 wherein the inorganic phosphate is a sodium pyrophosphate.

18. A composition useful in the preparation of technetium-99m-based radiographic scanning agents, comprising: and oxidized pertechnetate solution having dissolved therein a stabilizing amount of a gentisate stabilizer selected from gentisic acid or a pharmaceutically-acceptable salt or ester thereof.

19. A composition according to claim 18, comprising an oxidized pertechnetate solution having dissolved therein no more than about 0.1% by weight of a gentisate stabilizer.

20. A composition according to claim 19, comprising an oxidized pertechnetate solution having dissolved therein no more than about 0.1%, by weight, of sodium gentisate or gentisic acid.

21. A method of preparing a stabilized technetium-99m-based scanning agent, comprising codissolving a stabilizing amount of a gentisate stabilizer selected from gentisic acid or a pharmaceutically-acceptable salt or ester thereof with an aqueous solution of radioactive technetium in the +3, +4 or +5 valence state.

22. A method according to claim 21 wherein an organ-seeking carrier is included in the solution.
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