Topical compositions to treat circulatory disorders

1. A pharmaceutical composition comprising nifedipine, pentoxifylline, ketamine hydrochloride, gabapentin, lidocaine or pharmaceutically acceptable salt thereof, and prilocaine or pharmaceutically acceptable salts thereof,

wherein lidocaine or a pharmaceutically acceptable salt thereof is present in an amount of about 0.1% to about 5%, wherein prilocaine or a pharmaceutically acceptable salt thereof is present in an amount of about 0.1% to about 5%, wherein the ratio of nifedipine to pentoxifylline is ≧1:1, and wherein the composition does not contain clonidine.

2. The pharmaceutical composition of claim 1 , wherein the ratio of nifedipine to pentoxifylline is ≧2:1.

3. The pharmaceutical composition of claim 1 , wherein the composition is formulated as a topical composition.

4. The pharmaceutical composition of claim 1 , wherein the composition is incorporated into a formulation selected from the group consisting of: cream, lotion, gel, oil, and ointment.

5. The pharmaceutical composition of claim 1 , wherein the composition is in a 60 gram, 90 gram, or 120 gram quantity.

6. The pharmaceutical composition of claim 1 , wherein the composition is formulated in up to a 4 gram dose.

7. The pharmaceutical composition of claim 1 , wherein the composition is formulated in a pharmaceutically acceptable carrier.

8. The pharmaceutical composition of claim 7 , wherein the pharmaceutically acceptable carrier is present in an amount of about 55% to about 65%.

9. The pharmaceutical composition of claim 1 , wherein nifedipine is present in an amount of about 1% to about 25%.

10. The pharmaceutical composition of claim 1 , wherein nifedipine is present in an amount of about 5% to about 15%.

11. The pharmaceutical composition of claim 1 , wherein nifedipine is present in an amount of about 10%.

12. The pharmaceutical composition of claim 1 , wherein pentoxifylline is present in an amount of about 1% to about 25%.

13. The pharmaceutical composition of claim 1 , wherein pentoxifylline is present in an amount of about 1% to about 10%.

14. The pharmaceutical composition of claim 1 , wherein pentoxifylline is present in an amount of about 5%.

15. The pharmaceutical composition of claim 1 , wherein ketamine hydrochloride is present in an amount of about 5% to about 15%.

16. The pharmaceutical composition of claim 1 , wherein ketamine hydrochloride is present in an amount of about 10%.

17. The pharmaceutical composition of claim 1 , wherein gabapentin is present in an amount of about 1% to about 30%.

18. The pharmaceutical composition of claim 1 , wherein gabapentin is present in an amount of about 1% to about 10%.

19. The pharmaceutical composition of claim 1 , wherein gabapentin is present in an amount of about 6%.

20. The pharmaceutical composition of claim 1 , wherein the lidocaine is lidocaine hydrochloride monohydrate and is present in an amount of about 3.7%.

21. The pharmaceutical composition of claim 1 , wherein the prilocaine is prilocalne hydrochloride and is present in an amount of about 3.5%.

22. A pharmaceutical composition comprising:

a) nifedipine in an amount of about 1% to about 25%;

b) pentoxifylline in an amount of about 1% to about 25%;

c) ketamine hydrochloride in an amount of about 5% to about 50%;

d) gabapentin in an amount of about 1% to about 30%;

e) lidocaine or a pharmaceutically acceptable salt thereof in an amount of about 0.1% to about 5%; and

f) prilocaine or a pharmaceutically acceptable salt thereof in an amount of about 0.1% to about 5%;

wherein the ratio of nifedipine to pentoxifylline is ≧1:1, and wherein the composition does not contain clonidine.

23. The pharmaceutical composition of claim 22 wherein:

a) nifedipine is present in an amount of about 10%;

b) pentoxifylline is present in an amount of about 5%;

c) ketamine hydrochloride is present in an amount of about 10%;

d) gabapentin is present in an amount of about 6%;

e) the lidocaine is lidocaine hydrochloride monohydrate and is present in an amount of about 3.7%; and

f) the prilocaine is prilocalne hydrochloride and is present in an amount of about 3.5%.

24. A method of treating peripheral neuropathy comprising administering to a patient in need thereof a pharmaceutical composition comprising:

a) nifedipine in an amount of about 1% to about 25%;

b) pentoxifylline in an amount of about 1% to about 25%;

c) ketamine hydrochloride in an amount of about 5% to about 50%;

d) gabapentin in an amount of about 1% to about 30%;

e) lidocaine or a pharmaceutically acceptable salt thereof in an amount of about 0.1% to about 5%, and

f) prilocaine or a pharmaceutically acceptable salt thereof in an amount of about 0.1% to about 5%, and wherein the composition does not contain clonidine.

25. The method of claim 24 wherein the peripheral neuropathy is selected from the group consisting of diabetic neuropathy, non-diabetic neuropathy, HIV associated neuropathy, B 12 -deficiency associated neuropathy, cranial nerve palsies, drug-induced neuropathy, industrial neuropathy; lymphomatous neuropathy; myelomatous neuropathy; multi-focal motor neuropathy, chronic idiopathic sensory neuropathy, carcinomatous neuropathy, acute pan autonomic neuropathy, alcoholic neuropathy, compressive neuropathy, and vasculitic/ischaemic neuropathy.

26. The method of claim 24 further comprising applying heat to a treatment area a first time, applying the pharmaceutical composition to the treatment area, and applying heat to the treatment area a second time.

27. The method of claim 26 further comprising removing excess pharmaceutical composition after applying heat to the treatment area a second time.

28. The method of claim 24 wherein the pharmaceutical composition is administered three times a day.

29. The method of claim 24 , wherein the pharmaceutical composition is administered in a 4 gram dose, wherein the 4 gram dose comprises:

a) 0.4 grams nifedipine;

b) 0.2 grams pentoxifylline;

c) 0.4 grams ketamine hydrochloride;

d) 0.24 grams gabapentin;

e) 0.15 grams lidocaine hydrochloride monohydrate;

f) 0.14 grams prilocaine hydrochloride;

g) 0.04 grams vitamin E acetate;

h) 0.002 grams sodium metabisulfite;

i) 0.002 grams butylated hydroxytoluene; and

j) 2.43 grams of a pharmaceutically acceptable carrier.