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Claims for Patent: 4,275,063

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Claims for Patent: 4,275,063

Title: Pharmaceutical compositions
Abstract:A pharmaceutical composition useful for aiding regression and palliation of sarcoma, lymphosarcoma and leukaemia in mammals comprises a therapeutically effective amount of a compound of formula ##STR1## wherein R.sub.1 and R.sub.2 are each separately selected from hydrogen and methyl or together represent an ethylene bridging group, with the proviso that when both of the groups R.sub.1 and R.sub.2 are methyl they are disposed in the meso configuration, or a non-toxic salt thereof with a physiologically acceptable inorganic or organic acid, in combination with a physiologically acceptable diluent or carrier.
Inventor(s): Creighton; Andrew M. (London, GB2)
Assignee: National Research Development Corporation (GB2)
Application Number:05/768,287
Patent Claims: 1. A pharmaceutical composition useful for aiding regression and palliation of sarcoma, lymphosarcoma and leukaemia in humans which comprises an amount therapeutically effective in aiding said regression and pallition of dl, d or l 1,2-bis(3,5-dioxopiperazin-yl) propane, or an acid addition salt thereof with a physiologically acceptable inorganic or organic acid, in combination with a physiologically acceptable diluent which is sterile and pyrogen-free.

2. A pharmaceutical composition according to claim 1, wherein the propane compound is in the dl form.

3. A pharmaceutical composition according to claim 1, wherein the propane compound is in the d form.

4. A pharmaceutical composition according to claim 1, wherein the propane compound is in the l form.

5. A pharmaceutical composition according to claim 1, wherein the propane compound is in the form of the hydrochloride, isethionate, tartrate or methane sulphonate salt.

6. A pharmaceutical composition according to claim 1, in solution form.

7. A pharmaceutical composition according to claim 1, in suspension form.

8. A pharmaceutical composition according to claim 1, in unit dosage form.

9. A pharmaceutical composition according to claim 8, in which the therapeutically effective unit amount of 1,2-bis(3,5-dioxopiperazin-1-yl) propane is from about 500 milligrams to about 3 grams.

10. A pharmaceutical composition useful for aiding the regression and palliation of sarcoma, lymphosarcoma, and leukaemia in humans which comprises an amount therapeutically effective in aiding said regression and palliation of 1,2-bis(3,5-dioxopiperazin-1-yl) propane, or an acid addition salt thereof with a physiologically acceptable inorganic or organic acid, in the form of a physiologically acceptable, sterile injectable aqueous or oily solution, suspension or emulsion.

11. A pharmaceutical composition useful for aiding regression and palliation of one of the diseases cancer in humans which comprises a therapeutically effective amount sufficient to aid said regression and palliation of 1,2-bis(3,5-dioxopiperazin-1-yl) propane, or an acid addition salt thereof with a physiologically acceptable inorganic or organic acid, in a physiologically acceptable oily solution, suspension or emulsion.

12. A pharmaceutical composition useful for aiding regression and palliation of sarcoma, lymphosarcoma and leukaemia in humans which comprises an amount therapeutically effective in aiding said regression and palliation of dl, d or l 1,2-bis(3,5-dioxopiperazin-1-yl) propane, or an acid addition salt thereof with a physiologically acceptable inorganic or organic acid, in combination with a physiologically acceptable solid carrier.

13. A pharmaceutical composition according to claim 12, wherein the propane compound is in the dl form.

14. A pharmaceutical composition according to claim 12, wherein the propane compound is in the d form.

15. A pharmaceutical composition according to claim 12, wherein the propane compound is in the l form.

16. A pharmaceutical composition according to claim 12, wherein the propane compound is in the form of the hydrochloride, isethionate, tartrate or methane sulphonate salt.

17. A pharmaceutical composition according to claim 12, in tablet form.

18. A pharmaceutical composition according to claim 12, in unit dosage form.

19. A pharmaceutical composition according to claim 12, which comprises 1,2-bis(3,5-dioxopiperazin-1-yl) propane in a therapeutically effective amount of from about 250 milligrams to about 3 grams.

20. A pharmaceutical composition according to claim 12, wherein the therapeutically effective amount is from about 250 milligrams to about 1 gram.

21. A pharmaceutical composition useful for aiding regression and palliation of colorectal carcinoma, lymphosarcoma and leukaemia in humans which comprises an amount therapeutically effective in aiding said regression and palliation of dl, d or l 1,2-bis(3,5-dioxopiperazin-1-yl) propane, or an acid addition salt thereof with a physiologically acceptable inorganic or organic acid, in combination with a physiologically acceptable diluent which is sterile and pyrogen-free.

22. A method for aiding regression and palliation of sarcoma, lymphosarcoma and leukaemia in humans which comprises administering to a human afflicted therewith dl, d or l 1,2-bis(3,5-dioxopiperazin-1-yl) propane, or an acid addition salt thereof with a physiologically acceptable inorganic or organic acid, in combination with a physiologically acceptable diluent which is sterile and pyrogen-free or a physiologically acceptable solid carrier in an amount which is therapeutically effective until such regression and palliation are obtained.

23. A method according to claim 22, wherein the propane compound is in the dl form.

24. A method according to claim 22, wherein the propane compound is in the d form.

25. A method according to claim 22, wherein the propane compound is in the l form.

26. A method according to claim 22, wherein the propane compound is administered orally.

27. A method according to claim 22, wherein the propane compound is administered by injection.

28. A method according to claim 22, wherein the amount of the propane compound administered on each day of treatment is from about 250 milligrams to about 3 grams.

29. A method according to claim 28, wherein the amount is from about 250 milligrams to about 1 gram.

30. A method for aiding regression and palliation of cancer in humans which comprises administering to a human afflicted with sarcoma, a composition comprising a physiologically acceptable diluent and dl, d or l 1,2-bis(3,5-dioxopiperazin-1-yl) propane, or an acid addition salt thereof with a physiologically acceptable inorganic or organic acid, in an amount which is therapeutically effective until such regression and palliation are obtained.

31. A method according to claim 30, wherein the sarcoma is a soft tissue sarcoma.

32. A method for aiding regression and palliation of cancer in humans which comprises administering to a human afflicted with colorectal carcinoma, a composition comprising a physiologically acceptable diluent and dl, d or l 1,2-bis(3,5-dioxopiperazin-1-yl) propane, or an acid addition salt thereof with a physiologically acceptable inorganic or organic acid, in an amount which is therapeutically effective until such regression and palliation are obtained.
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