Granted Patent B2

US 12,268,695 · App. 18/492,536 · Granted Apr 8, 2025

Inventors: John Ashleigh Watson (Walenstadt, CH); Sebastian Jäger (Wiernsheim, DE); Tobias Zahn (Pforzheim, DE)

Assignee: Amryt Pharmaceuticals Designated Activity Company

A61K31/56A61K31/045A61K36/185A61L15/44A61L26/0066A61K9/0014A61K9/06A61K9/107A61K9/122A61K45/06A61K2236/00A61L2300/30

Abstract

Claims (43)

1. A method of treating a wound associated with epidermolysis bullosa in a patient in need thereof, comprising topically administering a sterile oleogel to the wound,

wherein the oleogel comprises about 1 wt. % to about 20 wt. % of particles of a solid birch bark extract dispersed in one or more nonpolar liquids;

wherein the solid birch bark extract comprises at least about 70 wt. % betulin and one or more triterpenes selected from the group consisting of betulinic acid, oleanolic acid, erythrodiol, and lupeol; and

wherein the oleogel is sterilized by ionizing irradiation at doses ranging from about 11 to about 40 kGy.

2. The method of claim 1 , wherein the oleogel has a consistency ranging from about 300-3000 mN; wherein the consistency is the force (mN) needed to penetrate 1 cm into the oleogel as measured using a texture analyser with a 1.27 cm cylindrical penetrating object, and the speed of penetration is 0.4 mm/s.

3. The method of claim 1 , wherein the oleogel is prepared by a process comprising dispersing the about 1 wt. % to about 20 wt. % of a dried solid birch bark extract in the one or more non-polar liquids; and wherein the nonpolar liquid has a peroxide value less than about 3.

4. The method of claim 1 , wherein the oleogel is sterilized by ionizing irradiation at doses ranging from about 11 to about 20 kGy.

5. The method of claim 1 , wherein the ionizing radiation is X-ray or gamma radiation.

6. The method of claim 1 , wherein the dispersed solid birch bark extract particles are the only oleogel forming agent in the oleogel.

7. The method of claim 1 , wherein the oleogel comprises about 10 wt. % of particles of the solid birch bark extract.

8. The method of claim 1 , wherein the nonpolar liquid comprises one or more vegetable oils.

9. The method of claim 8 , wherein the nonpolar liquid is sunflower oil.

10. The method of claim 1 , wherein the oleogel is substantially free of solid birch bark extract particles having a size greater than about 50 μm.

11. A method of treating a wound associated with epidermolysis bullosa in a patient in need thereof, comprising:

(a) applying a sterile oleogel to the surface of a dressing and

(b) contacting the wound with the dressing such that the oleogel is in direct contact with the wound;

wherein the sterile oleogel comprises about 1 wt. % to about 20 wt. % of particles of a solid birch bark extract, dispersed in one or more nonpolar liquids;

wherein the solid birch bark extract comprises at least about 70 wt. % betulin and one or more triterpenes selected from the group consisting of betulinic acid, oleanolic acid, erythrodiol, and lupeol; and

wherein the oleogel is sterilized by ionizing irradiation at doses ranging from about 11 to about 40 kGy.

12. The method of claim 11 , wherein the oleogel has a consistency ranging from about 300-3000 mN; wherein the consistency is the force (mN) needed to penetrate 1 cm into the oleogel as measured using a texture analyser with a 1.27 cm cylindrical penetrating object, and the speed of penetration is 0.4 mm/s.

13. The method of claim 11 , wherein the oleogel is prepared by a process comprising dispersing the about 1 wt. % to about 20 wt. % of a dried solid birch bark extract in the one or more non-polar liquids; and wherein the nonpolar liquid has a peroxide value less than about 3.

14. The method of claim 11 , wherein the oleogel is sterilized by ionizing irradiation at doses ranging from about 11 to about 20 kGy.

15. The method of claim 11 , wherein the ionizing radiation is X-ray or gamma radiation.

16. The method of claim 11 , wherein the dispersed solid birch bark extract particles are the only oleogel forming agent in the oleogel.

17. The method of claim 11 , wherein the oleogel comprises about 10 wt. % of particles of the solid birch bark extract.

18. The method of claim 11 , wherein the nonpolar liquid comprises one or more vegetable oils.

19. The method of claim 18 , wherein the nonpolar liquid is sunflower oil.

20. The method of claim 11 , wherein the oleogel is substantially free of solid birch bark extract particles having a size greater than about 50 μm.

21. A method of treating a wound associated with epidermolysis bullosa in a patient in need thereof, comprising:

(a) applying a sterile oleogel to the wound and

(b) covering the wound with a dressing;

wherein the sterile oleogel comprises about 1 wt. % to about 20 wt. % of particles of a solid birch bark extract, dispersed in one or more nonpolar liquids;

wherein the solid birch bark extract comprises at least about 70 wt. % betulin and one or more triterpenes selected from the group consisting of betulinic acid, oleanolic acid, erythrodiol, and lupeol; and

wherein the oleogel is sterilized by ionizing irradiation at doses ranging from about 11 to about 40 kGy.

22. The method of claim 21 , wherein the oleogel has a consistency ranging from about 300-3000 mN; wherein the consistency is the force (mN) needed to penetrate 1 cm into the oleogel as measured using a texture analyser with a 1.27 cm cylindrical penetrating object, and the speed of penetration is 0.4 mm/s.

23. The method of claim 21 , wherein the oleogel is prepared by a process comprising dispersing the about 1 wt. % to about 20 wt. % of a dried solid birch bark extract in the one or more non-polar liquids; and wherein the nonpolar liquid has a peroxide value less than about 3.

24. The method of claim 21 , wherein the oleogel is sterilized by ionizing irradiation at doses ranging from about 11 to about 20 kGy.

25. The method of claim 21 , wherein the ionizing radiation is X-ray or gamma radiation.

26. The method of claim 21 , wherein the dispersed solid birch bark extract particles are the only oleogel forming agent in the oleogel.

27. The method of claim 21 , wherein the oleogel comprises about 10 wt. % of particles of the solid birch bark extract.

28. The method of claim 21 , wherein the nonpolar liquid comprises one or more vegetable oils.

29. The method of claim 28 , wherein the nonpolar liquid is sunflower oil.

30. The method of claim 21 , wherein the oleogel is substantially free of solid birch bark extract particles having a size greater than about 50 μm.

Assignments (2)

Continuity (6)

References Cited (174)