IP Library › Granted Patent US 9,700,570
Granted Patent B2
US 9,700,570 · App. 15/348,808 · Granted Jul 11, 2017

Compositions for oral administration of zoledronic acid or related compounds for treating complex regional pain syndrome

View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 9,700,570
App. No.
15/348,808
Granted
Jul 11, 2017
Kind
B2
Abstract

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 such as complex regional pain syndrome.

Claims (45)

1. A method of treating complex regional pain syndrome comprising orally administering a dosage form to a human being in need thereof, wherein the dosage form comprises:

in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w; or

in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w;

wherein each A is independently an acidic functional group;

wherein, if present, the bioavailability of Compound A in the dosage form is from about 1.1% to about 4%.

2. A method of treating complex regional pain syndrome comprising orally administering a dosage form to a human being in need thereof, wherein the dosage form comprises:

a) zoledronic acid; or

b) one of the following:

1) zoledronic acid and

in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w; or

2) zoledronic acid and

in a salt form, 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 Ion 1 in a salt form, in an amount that is less than 0.1% w/w and greater than 0% w/w, and Ion 2 in a salt form, 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 in a salt form or in an acid form, Ion 1 in a salt form, or Ion 2 in a salt form;

wherein any amount in % w/w is based upon the total weight of zoledronic acid, Ion 1, Ion 2, and any corresponding counter ions; and

wherein the bioavailability of zoledronic acid in the dosage form is about 1.2% to about 4%;

wherein oral administration of the dosage form in a fasted state results in an area under the plasma concentration curve (AUC) of zoledronic acid of about 50 ng·hr/mL to about 500 ng·hr/mL, measured over a 24 hour period.

3. The method of claim 2 , wherein the zoledronic acid is in a disodium salt form.

4. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 50 ng·hr/mL to about 100 ng·hr/mL, measured over a 24 hour period.

5. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 100 ng·hr/mL to about 200 ng·hr/mL, measured over a 24 hour period.

6. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 130 ng·h/mL to about 180 ng·hr/mL, measured over a 24 hour period.

7. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 130 ng·h/mL to about 150 ng·hr/mL, measured over a 24 hour period.

8. The method of claim 3 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 130 ng·h/mL to about 140 ng·hr/mL, measured over a 24 hour period.

9. The method of claim 3 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 140 ng·h/mL to about 150 ng·hr/mL, measured over a 24 hour period.

10. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 150 ng·hr/mL to about 200 ng·hr/mL, measured over a 24 hour period.

11. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 200 ng·hr/mL to about 300 ng·hr/mL, measured over a 24 hour period.

12. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 250 ng·hr/mL to about 300 ng·hr/mL, measured over a 24 hour period.

13. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 300 ng·hr/mL to about 400 ng·hr/mL, measured over a 24 hour period.

14. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 300 ng·hr/mL to about 350 ng·hr/mL, measured over a 24 hour period.

15. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 400 ng·hr/mL to about 500 ng·hr/mL, measured over a 24 hour period.

16. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 350 ng·hr/mL to about 400 ng·hr/mL, measured over a 24 hour period.

17. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 450 ng·hr/mL to about 500 ng·hr/mL, measured over a 24 hour period.

18. The method of claim 3 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 130 ng·hr/mL to about 160 ng·hr/mL, measured over a 24 hour period.

19. The method of claim 3 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 300 ng·hr/mL to about 350 ng·hr/mL, measured over a 24 hour period.

20. The method of claim 3 , wherein oral administration of the dosage form in a fasted state results in an AUC of zoledronic acid of about 405 ng·hr/mL to about 450 ng·hr/mL, measured over a 24 hour period.

21. The method of claim 2 , wherein the dosage form contains about 40 mg to about 150 mg of zoledronic acid.

22. The method of claim 3 , wherein the dosage form contains about 50 mg to about 200 mg of zoledronic acid in the disodium salt form.

23. The method of claim 2 , wherein the dosage form contains about 150 mg to about 200 mg of zoledronic acid.

24. The method of claim 3 , wherein the dosage form contains about 50 mg of zoledronic acid in the disodium salt form.

25. The method of claim 3 , wherein the dosage form contains about 150 mg of zoledronic acid in the disodium salt form.

26. The method of claim 2 , wherein the dosage form is orally administered daily, weekly, biweekly, monthly, every two or three months, once a year, or twice a year.

27. The method of claim 24 , wherein the dosage form is orally administered weekly for 6 weeks.

28. The method of claim 25 , wherein the dosage form is orally administered biweekly 3 times within a period of about one month.

29. The method of claim 24 , wherein oral administration of the dosage form in a fasted state results in an C max of zoledronic acid of about 30 ng/mL to about 40 ng/mL.

30. The method of claim 2 , wherein oral administration of the dosage form in a fasted state results in an C max of zoledronic acid of about 20 ng/mL to about 50 ng/mL.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 1, 2017
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 041144/0468 →