IP Library › Granted Patent US 12,296,047
Granted Patent B2
US 12,296,047 · App. 18/943,310 · Granted May 13, 2025

Manufacturing of bupivacaine multivesicular liposomes

Inventors: Jeffrey S. Hall (San Diego, CA); David J. Turnbull (San Diego, CA); John J. Grigsby, Jr. (San Diego, CA); Soroush M. Ardekani (San Diego, CA); Kathleen D. A. Los (San Diego, CA)
Assignee: Pacira Pharmaceuticals, Inc.
A61K9/1277A61K31/451B01D61/146B01D61/147B01F23/4105B01F23/808B01D2315/10B01D2315/16B01F23/4144B01F23/4145B01F2101/22B01F2215/044B01F2215/0477B01F2215/0481
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Quick Facts
Patent No.
US 12,296,047
App. No.
18/943,310
Granted
May 13, 2025
Kind
B2
Abstract

Embodiments of the present application relate to compositions bupivacaine multivesicular liposomes (MVLs) prepared by a commercial manufacturing process with large particle diameter span.

Claims (48)

1. A batch comprising a composition of bupivacaine encapsulated multivesicular liposomes (MVLs) prepared by a process, the process comprising:

(a) mixing a first aqueous solution comprising phosphoric acid with a volatile water-immiscible solvent solution to form a first water-in-oil emulsion, wherein the volatile water-immiscible solvent solution comprises bupivacaine, 1,2-dierucoylphosphatidylcholine (DEPC), 1,2-dipalmitoyl-sn-glycero-3-phospho-rac-(1-glycerol) (DPPG), cholesterol, and tricaprylin;

(b) mixing the first water-in-oil emulsion with a second aqueous solution to form a second water-in-oil-in-water emulsion, wherein the second aqueous solution comprises lysine;

(c) removing the volatile water-immiscible solvent from the second water-in-oil-in-water emulsion to form a first aqueous suspension of bupivacaine encapsulated MVLs having a first volume;

(d) reducing the first volume of the first aqueous suspension of bupivacaine encapsulated MVLs by microfiltration to provide a second aqueous suspension of bupivacaine encapsulated MVLs having a second volume;

(e) exchanging the aqueous supernatant of the second aqueous suspension with a saline solution by diafiltration to provide a third aqueous suspension of bupivacaine encapsulated MVLs having a third volume; and

(f) further reducing the third volume of the third aqueous suspension by microfiltration to provide a final aqueous suspension of bupivacaine encapsulated MVLs having a bupivacaine concentration from about 11.3 mg/mL to about 17.0 mg/mL;

wherein the batch has a volume of 100 L to 250 L;

wherein the MVLs have an average d 90 particle diameter ranging from 54 μm to 65 μm and an average particle diameter span (d 90 -d 10 ) of 38 μm to 48 μm when measured after storage of the composition at 2 to 8° C. for less than 1 month; and

wherein the erucic acid concentration of the batch is about 105 μg/mL or less when measured after storage of the composition at about 25° C. for six months.

2. The batch of claim 1 , wherein the average d 90 particle diameter of the MVLs is from 54 μm to 58 μm when measured after storage of the composition at 2 to 8° C. for less than 1 month.

3. The batch of claim 1 , wherein the average particle diameter span of the MVLs is from m to 48 μm when measured after storage of the composition at 2 to 8° C. for less than 1 month.

4. The batch of claim 1 , wherein the erucic acid concentration of the batch is about 99 μg/mL or less when measured after storage of the composition at about 25° C. for six months.

5. The batch of claim 1 , wherein the composition of the batch comprises lysine encapsulated in the internal aqueous chambers of the MVLs, and the encapsulated lysine concentration in the composition is about 0.03 mg/mL.

6. The batch of claim 1 , wherein the composition of the batch comprises about 5% or less by weight of free bupivacaine.

7. The batch of claim 1 , wherein the internal pH of the bupivacaine encapsulated MVLs is about 5.5 when measured after storage of the composition at 2 to 8° C. for up to 9 months.

8. The batch of claim 1 , wherein the mixing in step (a) is performed using a mixer at a high shear speed from about 1100 rpm to about 1200 rpm for about 65 to about 75 minutes.

9. The batch of claim 1 , wherein the mixing in step (b) is performed using a mixer at a low shear speed from about 450 rpm to about 510 rpm for about 60 to about 65 seconds.

10. The batch of claim 1 , wherein the bupivacaine concentration in the composition of the batch is about 13.3 mg/mL.

11. The batch of claim 1 , wherein the batch has a volume of about 110 L to about 200 L.

12. A method of treating or ameliorating pain in a subject in need thereof, comprising administering a composition of the batch of claim 1 to the subject.

13. The method of claim 12 , wherein the administration is via local infiltration to provide local analgesia.

14. The method of claim 12 , wherein the administration is via a nerve block to provide regional analgesia.

15. The method of claim 12 , wherein the composition has a volume of 10 mL or 20 mL for a single-dose administration.

16. Batches comprising compositions of bupivacaine encapsulated multivesicular liposomes (MVLs) prepared by a process, the process of preparing a batch comprising:

(a) mixing a first aqueous solution comprising phosphoric acid with a volatile water-immiscible solvent solution to form a first water-in-oil emulsion, wherein the volatile water-immiscible solvent solution comprises bupivacaine, 1,2-dierucoylphosphatidylcholine (DEPC), 1,2-dipalmitoyl-sn-glycero-3-phospho-rac-(1-glycerol) (DPPG), cholesterol, and tricaprylin;

(b) mixing the first water-in-oil emulsion with a second aqueous solution to form a second water-in-oil-in-water emulsion, wherein the second aqueous solution comprises lysine;

(c) removing the volatile water-immiscible solvent from the second water-in-oil-in-water emulsion to form a first aqueous suspension of bupivacaine encapsulated MVLs having a first volume;

(d) reducing the first volume of the first aqueous suspension of bupivacaine encapsulated MVLs by microfiltration to provide a second aqueous suspension of bupivacaine encapsulated MVLs having a second volume;

(e) exchanging the aqueous supernatant of the second aqueous suspension with a saline solution by diafiltration to provide a third aqueous suspension of bupivacaine encapsulated MVLs having a third volume; and

(f) further reducing the third volume of the third aqueous suspension by microfiltration to provide a final aqueous suspension of bupivacaine encapsulated MVLs having a bupivacaine concentration from about 11.3 mg/mL to about 17.0 mg/mL;

wherein each batch has a volume of 100 L to 250 L;

wherein the MVLs of each batch have an average d 90 particle diameter ranging from 54 μm to 65 μm and an average particle diameter span (d 90 -d 10 ) of 38 μm to 48 m when measured after storage of the composition at 2 to 8° C. for less than 1 month; and

wherein an average erucic acid concentration of three batches prepared by the process is about 105 μg/mL or less when measured after storage of compositions of the batches at about 25° C. for six months.

17. The batches of claim 16 , wherein the average d 90 particle diameter of the MVLs of each batch is from 54 μm to 58 μm when measured after storage of the composition of the batch at 2 to 8° C. for less than 1 month.

18. The batch of claim 16 , wherein the average particle diameter span of the MVLs of each batch is from 40 μm to 48 μm when measured after storage of the composition of the batch at 2 to 8° C. for less than 1 month.

19. The batches of claim 16 , wherein the average erucic acid concentration of three batches prepared by the process is about 99 μg/mL or less when measured after storage of the compositions of the batches at about 25° C. for six months.

20. The batches of claim 16 , wherein the average erucic acid concentration of three batches prepared by the process is greater than 53 μg/mL when measured after storage of the compositions of the batches at about 25° C. for six months.

21. The batches of claim 19 , wherein the average erucic acid concentration of three batches prepared by the process is greater than 53 μg/mL when measured after storage of the compositions of the batches at about 25° C. for six months.

22. The batches of claim 16 , wherein the composition of each batch comprises about 5% or less by weight of free bupivacaine.

23. The batches of claim 16 , wherein the mixing in step (a) is performed using a mixer at a high shear speed from about 1100 rpm to about 1200 rpm for about 65 to 75 minutes.

24. The batches of claim 16 , wherein the mixing in step (b) is performed using a mixer at a low shear speed from about 450 rpm to about 510 rpm for about 60 to 65 seconds.

25. The batches of claim 16 , wherein the bupivacaine concentration in the composition of each batch is about 13.3 mg/mL.

26. The batches of claim 16 , wherein each batch has a volume of about 110 L to about 200 L.

27. A method of treating or ameliorating pain in a subject in need thereof, comprising administering a composition of a batch of claim 16 to the subject.

28. The method of claim 27 , wherein the administration is via local infiltration to provide local analgesia.

29. The method of claim 27 , wherein the administration is via a nerve block to provide regional analgesia.

30. The method of claim 27 , wherein the composition has a volume of 10 mL or 20 mL for a single-dose administration.

Assignments (2)
SECURITY INTEREST Recorded Jul 4, 2025
From: PACIRA PHARMACEUTICALS, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
Reel/Frame 071814/0792 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 11, 2025
From: HALL, JEFFREY S.; TURNBULL, DAVID J.; GRIGSBY, JOHN J., JR.; ARDEKANI, SOROUSH M.; LOS, KATHLEEN D. A.
To: PACIRA PHARMACEUTICALS, INC.
Reel/Frame 070815/0403 →
Continuity (6)
Continuation 17840104 · Jun 14, 2022
Continuation In Part 17719716 · Apr 13, 2022
Continuation 17536516 · Nov 29, 2021
Continuation 17319591 · May 13, 2021
Continuation 17156400 · Jan 22, 2021
Related Publication 20250064742A1 · Feb 27, 2025
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