Claims for Patent: 11,135,215

Summary for Patent: 11,135,215

Title:	Opioid formulations
Abstract:	A depot precursor formulation comprising:
Inventor(s):	Tiberg Fredrik, Harwigsson Ian, Johnsson Markus
Assignee:	Camurus AB
Application Number:	US17142723
Patent Claims:	1. A pre-filled syringe containing a composition , the composition comprising:about 5% by weight of buprenorphine;about 10% by weight of ethanol;about 42% by weight of a phosphatidylcholine; andabout 42% by weight of glycerol dioleate.2. The pre-filled syringe of claim 1 , wherein the pre-filled syringe contains less than 5 mL of the composition.3. The pre-filled syringe of claim 2 , wherein the pre-filled syringe contains less than 2 mL of the composition.4. The pre-filled syringe of claim 3 , wherein the pre-filled syringe contains less than 1 mL of the composition.5. The pre-filled syringe of claim 1 , wherein the composition comprises about 3 mg to about 40 mg of buprenorphine (calculated as buprenorphine free base).6. The pre-filled syringe of claim 5 , wherein the composition comprises about 5 mg to about 30 mg of buprenorphine (calculated as buprenorphine free base).7. The pre-filled syringe of claim 1 , wherein the composition has a viscosity that is about 1 to about 1000 mPas at 20° C. claim 1 , as measured with a CarriMed CSL 100 rheometer equipped with automatic gap setting.8. The pre-filled syringe of claim 7 , wherein the composition has a viscosity that is about 100 mPas to about 500 mPas at 20° C. claim 7 , as measured with a CarriMed CSL 100 rheometer equipped with automatic gap setting.9. The pre-filled syringe of claim 1 , wherein the pre-filled syringe further comprises a needle stick prevention safety device.10. The pre-filled syringe of claim 1 , wherein the pre-filled syringe further comprises an auto injector.11. The pre-filled syringe of claim 1 , wherein the pre-filled syringe is disposable.12. The pre-filled syringe of claim 1 , wherein the pre-filled syringe comprises a needle having a gauge greater than 18 G.13. The pre-filled syringe of claim 12 , wherein the pre-filled syringe comprises a needle having a gauge greater than 20 G.14. The pre-filled syringe of claim 13 , wherein the pre-filled syringe comprises a needle having a gauge greater than 22 G.15. The pre-filled syringe of claim 14 , wherein the pre-filled syringe comprises a needle having a gauge higher than 23 G.16. The pre-filled syringe of claim 15 , wherein the pre-filled syringe comprises a needle having a gauge higher than 25 G.17. The pre-filled syringe of claim 1 , wherein the pre-filled syringe has a capacity of about 1 mL.18. The pre-filled syringe of claim 1 , wherein the composition is storage stable at 25° C./60% relative humidity.19. The pre-filled syringe of claim 1 , wherein the composition is storage stable at 40° C./75% relative humidity.20. The pre-filled syringe of claim 1 , characterized in that the composition claim 1 , when administered to a subject claim 1 , exhibits a variation between Cmin and Cmax of buprenorphine at steady-state administration that is between 0.4 ng/mL and 10 ng/mL.21. The pre-filled syringe of claim 20 , characterized in that the composition claim 20 , when administered to a subject claim 20 , exhibits a variation between Cmin and Cmax of buprenorphine at steady-state administration that is between 0.5 ng/mL and 8 ng/mL.22. The pre-filled syringe of claim 1 , characterized in that the composition claim 1 , when administered to a subject claim 1 , provides a Cmax of buprenorphine of no more than 0.3 ng/mL per mg of administered buprenorphine after a single administration.23. The pre-filled syringe of claim 1 , wherein the composition claim 1 , after contact with an aqueous fluid claim 1 , forms a liquid crystalline phase structure.24. The pre-filled syringe of claim 23 , wherein the liquid crystalline phase structure is a non-lamellar crystalline phase structure.25. A pre-filled syringe containing a composition claim 23 , the composition comprising:about 5.29% by weight of buprenorphine;about 10% by weight of ethanol;about 42.36% by weight of a phosphatidylcholine; andabout 42.36% by weight of glycerol dioleate.26. The pre-filled syringe of claim 25 , wherein the pre-filled syringe contains less than 1 mL of the composition.27. The pre-filled syringe of claim 25 , wherein the composition comprises about 3 mg to about 40 mg of buprenorphine (calculated as buprenorphine free base).28. The pre-filled syringe of claim 27 , wherein the composition comprises about 5 mg to about 30 mg of buprenorphine (calculated as buprenorphine free base).29. The pre-filled syringe of claim 25 , wherein the composition has a viscosity that is about 1 to about 1000 mPas at 20° C. claim 25 , as measured with a CarriMed CSL 100 rheometer equipped with automatic gap setting.30. The pre-filled syringe of claim 25 , wherein the pre-filled syringe is disposable.