Therapeutic compositions comprising imidazole and imidazolium compounds
View Patent ↗Therapeutic compositions comprising substituted imidazole or imidazolium compounds may be used for a number of medical purposes, such as treatment of undesirable conditions or diseases, including disease or conditions related to bone, cancer, and/or pain.
1. A method of treating knee pain comprising orally administering a dosage form to a mammal in need thereof, wherein the dosage form comprises:
in an amount that is less than 0.1% w/w, and greater than 0% w/w; or
in an amount that is less than 0.1% w/w, and greater than 0% w/w;
wherein any amount in % w/w is based upon the total weight of Compound A, Compound B, and Compound C;
wherein each A is independently an acidic functional group;
wherein, if present, the bioavailability of zoledronic acid in the dosage form is from about 1.1% to about 4%.
2. A method of treating knee pain comprising orally administering a dosage form to a human being suffering from knee pain, wherein the dosage form comprises:
a) zoledronic acid; or
b) one of the following:
1) zoledronic acid and
in an amount that is less than 0.1% w/w and greater than 0% w/w;
2) zoledronic acid and
in an amount that is less than 0.1% w/w and greater than 0% w/w;
or
3) zoledronic acid and a combination of Compound 1 in an amount that is less than 0.1% w/w and greater than 0% w/w, and Compound 2 in an amount that is less than 0.1% w/w and greater than 0% w/w;
wherein the dosage form is free of therapeutically active agents that are not zoledronic acid, Compound 1, or Compound 2;
wherein any amount in % w/w is based upon the total weight of zoledronic acid, Compound 1, and Compound 2; and
wherein the bioavailability of zoledronic acid in the dosage form is from about 1.1% to about 4%.
3. The method of claim 2 , wherein the dosage form is administered in an amount and frequency that results in an AUC of zoledronic acid, over a four week period, that is about 100 ng·h/mL to about 2000 ng·h/mL.
4. The method of claim 2 , wherein the dosage form is administered in an amount that results in an AUC of zoledronic acid, over a twenty-four hour period, that is about 20 ng·h/mL to about 500 ng·h/mL.
5. The method of claim 2 , wherein the dosage form is administered in an amount such that a monthly dose of zoledronic acid is about 1 mg to about 600 mg.
6. The method of claim 2 , wherein the dosage form is administered in an amount such that a monthly dose of zoledronic acid is about 10 mg to about 600 mg.
7. The method of claim 2 , wherein the dosage form is administered in an amount such that a monthly dose of zoledronic acid is about 20 mg to about 500 mg.
8. The method of claim 2 , wherein the dosage form is administered in an amount such that a monthly dose of zoledronic acid is about 50 mg to about 300 mg.
9. The method of claim 2 , wherein the dosage form is administered in an amount such that a monthly dose of zoledronic acid is about 200 mg to about 300 mg.
10. The method of claim 2 , wherein the dosage form is administered once a day.
11. The method of claim 2 , wherein the dosage form is administered 1 to 5 times a month.
12. The method of claim 2 , wherein the dosage form is administered weekly.
13. The method of claim 2 , wherein the bioavailability of zoledronic acid in the dosage form is from about 1.3% to about 4%.
14. The method of claim 2 , wherein the bioavailability of zoledronic acid in the dosage form is from about 1.5% to about 4%.
15. The method of claim 2 , wherein the dosage form is orally administered to the human being after at least one hour of fasting.
16. The method of claim 2 , wherein the dosage form is solid.
17. A pharmaceutical dosage form comprising:
a) zoledronic acid; or
b) one of the following:
1) zoledronic acid and
in an amount that is less than 0.1% w/w and greater than 0% w/w;
2) zoledronic acid and
in an amount that is less than 0.1% w/w and greater than 0% w/w;
or
3) zoledronic acid and a combination of Compound 1 in an amount that is less than 0.1% w/w and greater than 0% w/w, and Compound 2 in an amount that is less than 0.1% w/w and greater than 0% w/w;
wherein the dosage form is free of therapeutically active agents that are not zoledronic acid, Compound 1, or Compound 2;
wherein any amount in % w/w is based upon the total weight of zoledronic acid, Compound 1, and Compound 2; and
wherein the bioavailability of zoledronic acid in the dosage form is from about 1.1% to about 4% in a human being.
18. The dosage form of claim 17 , comprising about 1 mg to about 600 mg of zoledronic acid.
19. The dosage form of claim 17 , comprising about 10 mg to about 300 mg of zoledronic acid.
20. The dosage form of claim 17 , comprising about 20 mg to about 50 mg of zoledronic acid.
21. The dosage form of claim 17 , comprising about 50 mg to about 100 mg of zoledronic acid.
22. The dosage form of claim 17 , comprising about 100 mg to about 200 mg of zoledronic acid.
23. The dosage form of claim 17 , wherein the dosage form is solid.
24. The dosage form of claim 17 , wherein the dosage form is orally administered.
25. The dosage form of claim 17 , wherein at least 10% of the weight of the dosage form is zoledronic acid.
26. The dosage form of claim 17 , wherein the dosage form is suitable for administration to a human being.
27. The dosage form of claim 17 , wherein the bioavailability of zoledronic acid in the dosage form is from about 1.3% to about 4% in a human being.
28. The dosage form of claim 17 , wherein the bioavailability of zoledronic acid in the dosage form is from about 1.5% to about 4% in a human being.
29. The dosage form of claim 17 , wherein the dosage form is a tablet.
30. The dosage form of claim 17 , wherein the dosage form is a capsule.