Granted Patent B2

US 10,172,849 · App. 15/060,184 · Granted Jan 8, 2019

Abstract

Claims (27)

1. A method for treating opioid dependence or pain in a patient in need thereof, the method comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising buprenorphine particles suspended in an aqueous solution comprising:

(i) polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, a poloxamer, a phospholipid, or a combination of two or more thereof; and

(ii) a polyethylene glycol polymer;

wherein (i) and (ii) are dissolved in the aqueous solution; wherein the buprenorphine particles are buprenorphine free base particles or a pharmaceutically acceptable salt of buprenorphine particles; wherein the buprenorphine particles have an average particle size of less than 100 μm; and wherein the composition does not comprise a polylactide polymer, a polyglycolide polymer, or a copolymer of polylactide and polyglycolide.

2. The method of claim 1 , wherein the composition comprises about 5 wt % to about 20 wt % buprenorphine free base particles; wherein the buprenorphine free base particles have an average particle size of less than 50 μm; and wherein (i) comprises polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, or the combination thereof; and (ii) comprises the polyethylene glycol polymer.

3. The method of claim 2 , wherein the polyethylene glycol polymer has a molecular weight between 1,000 and 10,000.

4. The method of claim 1 , wherein the buprenorphine particles have an average particle size of less than 20 μm.

5. The method of claim 1 , wherein the aqueous solution further comprises a pharmaceutically acceptable salt, a pharmaceutically acceptable sugar, a preservative, or a combination of two or more thereof.

6. The method of claim 1 for treating opioid dependence.

7. The method of claim 1 for treating pain.

8. The method of claim 1 , wherein the pharmaceutical composition is administered parenterally and extravascularly to the patient.

9. The method of claim 1 , wherein the pharmaceutical composition is administered subcutaneously to the patient.

10. The method of claim 1 , wherein the pharmaceutical composition is administered to the patient from about once every 7 days to about once every 30 days.

11. The method of claim 1 , wherein the therapeutically effective amount of buprenorphine is from about 0.1 mg to about 10 mg per day.

12. A method for treating opioid dependence or pain in a patient in need thereof, the method comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition to treat the opioid dependence or pain, wherein the pharmaceutical composition comprises buprenorphine particles suspended in an aqueous solution comprising:

(i) polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, a poloxamer, a phospholipid, or a combination thereof; and

(ii) a polyethylene glycol polymer, a carboxymethylcellulose, a polyvinylpyrrolidone, a polyvinylalcohol, a dextran, or a combination thereof;

wherein (i) and (ii) are dissolved in the aqueous solution; wherein the buprenorphine particles are buprenorphine free base particles or a pharmaceutically acceptable salt of buprenorphine particles; wherein the buprenorphine particles have an average particle size of less than 100 μm; and wherein the composition does not comprise a polylactide polymer, a polyglycolide polymer, or a copolymer of polylactide and polyglycolide.

13. A method for treating opioid dependence in a patient in need thereof comprising subcutaneously administering to the patient an aqueous composition to treat the opioid dependence, wherein the aqueous composition comprises about 5 wt % to about 20 wt % of buprenorphine free base particles suspended in an aqueous solution comprising:

(i) polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, or a combination thereof; and

(ii) a polyethylene glycol polymer;

wherein (i) and (ii) are dissolved in the aqueous solution; wherein the buprenorphine free base particles have an average particle size of less than 50 μm; and wherein the composition does not comprise a polylactide polymer, a polyglycolide polymer, or a copolymer of polylactide and polyglycolide.

14. The method of claim 13 , wherein (ii) is polyoxyethylene (20) sorbitan monooleate.

15. The method of claim 13 , wherein the buprenorphine free base particles have an average particle size of less than 20 μm.

16. The method of claim 13 , wherein the polyethylene glycol polymer has a molecular weight between 1,000 and 10,000.

17. The method of claim 13 , wherein the polyethylene glycol polymer has a molecular weight of about 3350.

18. The method of claim 12 to treat opioid dependence.

Assignments (7)