IP Library Granted Patent US 11,413,319
Granted Patent B2
US 11,413,319 · App. 17/088,899 · Granted Aug 16, 2022

Microencapsulation of bacteriophages and related products

Inventors: Nancy Tawil (Cantley, CA); Edwige Caroline Rebecca Arnold (Montreal, CA); Ramaz Katsarava (Tbilisi, GE); David Tugushi (Tbilisi, GE); Vakhtang Beridze (Tbilisi, GE)
Assignee: PHAGELUX (CANADA) INC.
A61K35/76A61K9/5031A61K9/7015A61K47/183A61K47/32A61K47/34
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Quick Facts
Patent No.
US 11,413,319
App. No.
17/088,899
Granted
Aug 16, 2022
Kind
B2
Abstract

An encapsulated bacteriophage formulation and a method for encapsulating bacteriophages and bacteriophage-related products in polymeric microcapsules is provided. Some embodiments of the method of producing the encapsulated bacteriophages involves a water-in-oil-in-water double emulsion.

Claims (38)

1. A composition comprising:

polymer microcapsules; and

active bacteriophages encapsulated in the polymer microcapsules;

wherein the polymer microcapsules include an amino-acid based polymer and the active bacteriophages are dispersed in the polymer microcapsules;

wherein the amino-acid based polymer is a poly (ester amide urea) comprising the following two blocks with random distribution thereof

wherein

the ratio of l:m ranges from 0.05:0.95 to 0.95:0.05, l+m=1,

R 1 is chosen from C 2 -C 12 alkylenes optionally interrupted by at least one oxygen, C 3 -C 8 cycloalkylenes, C 3 -C 10 cycloalkylalkylenes,

R 3 is C 2 -C 12 alkylene,

R 2 and R 4 are independently chosen from the side chains of L- and D- amino acids so that the carbon to which R 2 or R 4 is attached has L or D chirality.

2. The composition as defined in claim 1 , wherein the amino-acid based polymer defines a hollow structure in which a first aqueous suspension is encapsulated in at least some of the polymer microcapsules, at least some of the active bacteriophages being suspended in the first aqueous suspension.

3. The composition as defined in claim 2 , wherein at least some of the active bacteriophages are dispersed in the amino-acid based polymer.

4. The composition as defined in claim 2 , wherein the first aqueous suspension includes polyvinyl alcohol.

5. The composition as defined in claim 4 , wherein the first aqueous suspension includes between 0.1% and 10% w/v of the polyvinyl alcohol and wherein the polyvinyl alcohol has a mean molecular weight of between 10 kDa and 400 kDa.

6. The composition as defined in claim 5 , wherein the polyvinyl alcohol has a mean molecular weight of between 65 kDa and 90 kDa.

7. The composition as defined in claim 5 , wherein the polyvinyl alcohol has a mean molecular weight of between 10 kDa and 35 kDa.

8. The composition as defined in claim 2 , wherein the polymer microcapsules are in a second aqueous suspension, and wherein the second aqueous suspension also includes polyvinyl alcohol.

9. The composition as defined in claim 8 , wherein the second aqueous suspension includes between 1% and 5% w/v of the polyvinyl alcohol.

10. The composition as defined in claim 8 , wherein the polyvinyl alcohol is in a higher concentration in the second aqueous solution than in the first aqueous solution.

11. The composition as defined in claim 1 , wherein the polymer microcapsules have a mean size between 20 μm and 100 μm and an upper limit size of 250 μm or less.

12. The composition as defined in claim 2 , wherein a thickness of the polymer enclosing the first aqueous solution in the microcapsules is between 3% and 15% of a mean size of the microcapsules.

13. The composition as defined in claim 1 , wherein the microcapsules further include at least one product selected from the group consisting of endolysins, lysostaphins, phage proteins, phage enzymatic formulations.

14. The composition as defined in claim 1 , wherein the ratio of l:m ranges from 0.25:0.75 to 0.75:0.25, l+m=1.

15. The composition as defined in claim 1 , wherein R 1 is —(CH 2 ) 6 —, R 3 is —(CH 2 ) 8 — and both R 2 and R 4 are the side chain of L-leucine.

16. The composition as defined in claim 1 , wherein the amino-acid based polymer has a polydispersity of 1.15 or less.

17. The composition as defined in claim 1 , wherein the amino-acid based polymer has a molecular weight between 15 kDa and 30 kDa and is amorphous.

18. The composition as defined in claim 1 , wherein the active bacteriophages include at least two different strains of bacteriophages from different families.

19. The composition as defined in claim 1 , wherein the composition is in liquid form.

20. The composition as defined in claim 19 , wherein the composition has a viscosity small enough to allow pulverization through a nozzle.

21. The composition as defined in claim 19 , wherein the polymer microcapsules are suspended in a solution including a poloxamer.

22. The composition as defined in claim 21 , wherein the poloxamer is poloxamer 407 having a mean molecular weight of between 9500 kDa and 15000 kDa and in a concentration of between 10 and 30 percent.

23. The composition as defined in claim 1 , wherein the composition is powder form.

24. The composition as defined in claim 1 , wherein the composition is in gel form.

25. The composition as defined in claim 1 , wherein the polymer microcapsules contain on average more than 4 active bacteriophages.

26. The composition as defined in claim 1 , wherein the polymer microcapsules contain on average more than 100 active bacteriophages.

27. The composition as defined in claim 1 , wherein the composition further includes active bacteriophages outside of the polymer microcapsules.

28. The composition as defined in claim 1 , further comprising a drug selected from the set consisting of antibiotics, pain killer and hemostatic drug.

29. The composition as defined in claim 1 , wherein the composition has a stability such that at least 1% of the active bacteriophages remain active after storage of the composition for one year at 4° C.

Assignments (4)
NUNC PRO TUNC ASSIGNMENT Recorded Mar 8, 2024
From: PRECISIOBIOTIX TECHNOLOGIES INC.
To: PRECISIO BIOTIX THERAPEUTICS, INC.
Reel/Frame 066704/0012 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2023
From: PHAGELUX (CANADA) INC.
To: PRECISIOBIOTIX TECHNOLOGIES INC.
Reel/Frame 063307/0637 →
NUNC PRO TUNC ASSIGNMENT Recorded Apr 21, 2021
From: TAWIL, NANCY; ARNOLD, EDWIGE CAROLINE REBECCA
To: PHAGELUX (CANADA) INC.
Reel/Frame 055994/0732 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2021
From: KATSARAVA, RAMAZ; TUGUSHI, DAVID; BERIDZE, VAKHTANG
To: PHAGELUX (CANADA) INC.
Reel/Frame 055998/0363 →
Continuity (3)
Continuation In Part 16310732
Provisional Application 62353658 · Jun 23, 2016
Related Publication 20210046132A1 · Feb 18, 2021
Cited By (1)
US 12,611,435