Pharmaceutical composition for the management of tumors

• US 20060281793A1
• Filed: 11/29/2005
• Published: 12/14/2006
• Est. Priority Date: 11/30/2004
• Status: Active Grant

• Current Assignee: Council of Scientific & Industrial Research
• Original Assignee: Council of Scientific & Industrial Research
• Inventors: Singh, Jaya, Gupta, Krishna Prabha
• Granted Patent: US 7,655,678 B2
• Time in Patent Office: Days
• US Class Current: 514/356
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/455 Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides

Abstract

The present invention relates to the effect of naturally occurring compounds on tumor development. As an example of proof, we used low; non-toxic doses of three compound e.g. Calcium D-glucarate, a naturally occurring Ca⁺⁺ salt of D-glucaric acid; Nicotinamide (NA), a naturally occurring vitamin and butyric acid (BA), a naturally occurring saturated short chain fatty acid. 7,12 dimethylbenzanthracene (DMBA), which is a very potent skin carcinogen and is an environmental pollutant, was used for skin tumor development. Experiment was performed upto 30 weeks. All the above-mentioned compounds were used either alone or concomitantly any two or all the three. In the positive control group 100% tumorigenesis was attained in 28 weeks, use of single compound led to the inhibition of DMBA induced tumorigenesis between 33 to 47%, use of two compounds resulted in the 73 to 80% reduction in tumorigenesis but the concomitant use of three compounds resulted into 100% inhibition of tumor development at the end of 30 weeks. This led us to conclude that the concomitant use of Cag, NA and BA in combination of two is useful for preventing skin tumor develoment for a sort or long period of time. But the concomitant use of all the three compounds, as described, exhibited the perfect synergistic effect in preventing the tumor development completely. This strategy should be equally effective in the management of benign and possibly malignant tumor in any organ caused by any mean.

Claims

1. A pharmaceutical composition for the management of tumors comprising salt of glucaric acid, salt of nicotinaminio acid, and butyric acid either in combination of any two or all of three compounds along with pharmaceutically acceptable excipients, diluents or carriers.

2. A composition as claimed in claim 1, comprising from 2-800 mg/100 μ

l/kg body wt of calcium glucarate or it'"'"'s isomers.

3. A composition as claimed in claim 1, comprising from 2-800 mg/100 μ

l/kg body wt of nicotinamide or it'"'"'s isomers.

4. A composition as claimed in claim 1, comprising from 1-20 mmoles/100 μ

l/kg body wt of butyric acid or it'"'"'s isomers.

5. A composition as claimed in claim 1, comprising about 0.05 mg to about 20 mg calcium glucarate, about 0.05 mg to about 20 mg NA and about 25 μ

moles to about 500 μ

moles BA.

6. A composition as claimed in claim 1, comprising about 6.0 mg calcium glucarate, about 6.0 mg NA and about 200 μ

moles BA.

7. A composition as claimed in claim 1, wherein the composition is administered topically.

8. A composition as claimed in claim 1, wherein the composition is in the form of a cream, a milk, a pomade, a salve, an impregnated pad, a gel, a spray, or a lotion.

9. A composition as claimed in claim 1, wherein the composition is used in treating or inhibiting tumor formation.

10. A composition as claimed in claim 1, wherein the composition is used in treating or inhibiting skin tumor formation.

25. A method as claimed in claim 1, comprising about 0.05 mg to about 20 mg calcium glucarate, about 0.05 mg to about 20 mg NA and about 25 μ

moles to about 500 μ

moles BA.

26. A method as claimed in claim 1, comprising about 6.0 mg calcium glucarate, about 6.0 mg NA and about 200 μ

moles BA.

11. Use of the pharmaceutical composition for the management of tumors comprising salt of glucaric acid, salt of nicotinamide acid, and butyric acid either in combination of two or all of three compounds along with pharmaceutically acceptable excipients, diluents or carriers.

12. Use as claimed in claim 11, comprising from 2-800 mg/100 μ

l/kg body wt of calcium glucarate or it'"'"'s isomers.

13. Use as claimed in claim 11, comprising from 2-800 mg/100 μ

l/kg body wt of nicotinamide or it'"'"'s isomers.

14. Use as claimed in claim 11, comprising from 1-20 mmoles/100 μ

l/kg body wt of butyric acid or it'"'"'s isomers.

15. Use as claimed in claim 11, wherein the composition comprises about 0.05 mg to about 20 mg calcium glucarate, about 0.05 mg to about 20 mg NA and about 25 μ

moles to about 500 μ

moles BA.

16. Use as claimed in claim 11, wherein the composition comprises about 6.0 mg calcium glucarate, about 6.0 mg NA and about 200 μ

moles BA.

17. Use as claimed in claim 11, wherein the composition is administered topically.

18. Use as claimed in claim 11, wherein the composition is in the form of a cream, a milk, a pomade, a salve, an impregnated pad, a gel, a spray, or a lotion.

19. Use as claimed in claim 11, wherein the composition is used in treating or inhibiting tumor formation.

20. Use as claimed in claim 11, wherein the composition is used in treating or inhibiting skin tumor formation.

21. A method for the management of tumors comprising administering to a subject suffering therefrom, a pharmaceutically effective amount of a pharmaceutical composition comprising salt of glucaric acid, salt of nicotinaminic acid, and butyric acid either in combination of two or all of three compounds along with pharmaceutically acceptable excipients, diluents or carriers.

22. A method as claimed in claim 21, comprising from 2-800 mg/100 μ

l/kg body wt of calcium glucarate or it'"'"'s isomers.

23. A method as claimed in claim 21, comprising from 2-800 mg/100 μ

l/kg body wt of nicotinamide or it'"'"'s isomers.

24. A method as claimed in claim 21, comprising from 1-20 mmoles/100 μ

l/kg body wt of butyric acid or it'"'"'s isomers.

27. A method as claimed in claim 21, wherein the composition is administered topically.

28. A method as claimed in claim 21, wherein the composition is in the form of a cream, a milk, a pomade, a salve, an impregnated pad, a gel, a spray, or a lotion.

29. A method as claimed in claim 21, wherein the composition is used in treating or inhibiting tumor formation.

30. A method as claimed in claim 21, wherein the composition is used in treating or inhibiting skin tumor formation.