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Claims for Patent: 6,582,678

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Claims for Patent: 6,582,678

Title: Carrier particles for use in dry powder inhalers
Abstract:In a method of producing particles suitable for use as carrier particles in dry powder inhalers, particles (1) of a size suitable for use as carrier particles in dry powder inhalers are treated so as to dislodge small grains from the surface of the particles, without substantially changing the size of the particles during the treatment. The treatment gives improved efficiency of redispersion of active particles from the surfaces of carrier particles.
Inventor(s): Staniforth; John Nicholas (Bath, GB)
Assignee: Vectura Limited (London, GB)
Application Number:09/841,055
Patent Claims: 1. A method of producing carrier particles for use in dry powder inhalers, comprising: milling particles, wherein milling dislodges small grains from the surfaces of said particles, wherein said milling does not substantially change the size of said particles, and wherein said particles to be milled are of a size suitable for use as carrier particles in dry powder inhalers.

2. A method according to claim 1 wherein the small grains become reattached to the surfaces of the carrier particles.

3. A method according to claim 1 wherein the milling step is performed in a ball mill.

4. A method according to claim 3 wherein the carrier particles are milled using plastics balls.

5. A method according to claim 3 wherein the mill is rotated at a speed of less than about 20 revolutions per minute.

6. A method according to claim 3 wherein the mill is rotated at a speed of about six revolutions per minute.

7. A method according to claim 1 wherein the carrier particles are milled for at least one hour.

8. A method according to claim 1 wherein the carrier particles are milled for about six hours.

9. A method according to claim 1 wherein the carrier particles are crystalline sugar particles.

10. A method according to claim 9 wherein the carrier particles are lactose particles.

11. A method according claim 1 wherein the diameter of the carrier particles lies between 50 .mu.m and 125 .mu.m.

12. A method according to claim 11 wherein the diameter of the carrier particles lies between 90 .mu.m and 125 .mu.m.

13. A method according to claim 1 wherein the method further includes the step of selecting an advantageous range of size of carrier particles prior to the milling step.

14. A method according to claim 13 wherein the step of selecting an advantageous range of size is a sieving step.

15. A method of producing a dry powder for use in dry powder inhalers, comprising milling carrier particles, wherein milling dislodges small grains from the surfaces of said carrier particles wherein said milling does not substantially change the size of said carrier particles; and mixing said milled carrier particles with active particles such that active particles adhere to the surfaces of said carrier particles.

16. A method according to claim 15, wherein the small grains become reattached to the surfaces of the carrier particles.

17. A method of producing a dry powder for use in dry powder inhalers, the method including the steps of milling carrier particles according to claim 1, and mixing the milled carrier particles with the active particles such that active particles adhere to the surfaces of carrier particles.

18. A method according to claim 16 wherein the carrier particles and the active particles are mixed in a container made from a plastics material.

19. A method according to claim 16 wherein the carrier particles and the active particles are mixed for at least five minutes.

20. A method according to claim 19 wherein the carrier particles and the active particles are mixed for thirty minutes.

21. A method according to claim 19 wherein the mixing is interrupted and the mixture of carrier particles and active particles is sieved.

22. A method according to claim 21 wherein the sieve mesh size is about 250 .mu.m.

23. A method according to claim 16 wherein the carrier particles and active particles are mixed in a ratio by weight of 125 to 1.

24. A method according to claim 16 wherein the diameter of the active particles is between 0.1 .mu.m and 3 .mu.m.

25. A method according to claim 16 wherein the active particles include a .beta..sub.2 -agonist.

26. A method according to claim 25 wherein the active particles include terbutaline, a salt of terbutaline or a combination thereof.

27. A method according to claim 25 wherein the active particles include salbutamol, a salt of salbutamol or a combination thereof.

28. A method according to claim 27 wherein the active particles include salbutamol sulphate.

29. Particles suitable for use as carrier particles in a dry powder inhaler, the particles consisting of small grains and large particles wherein the small grains are attached to the surfaces of the large particles.

30. Particles according to claim 29 wherein the small grains have a diameter between 1 .mu.m and 5 .mu.m.

31. Particles according to claim 29 wherein large particles have a diameter between 50 .mu.m and 1000 .mu.m.

32. Particles according to claim 31, wherein at least a substantial proportion of the large particles have a diameter between 60 .mu.m and 250 .mu.m.

33. Particles according to claim 29, wherein the large particles are crystalline sugar particles.

34. Particles according to claim 29 wherein the large particles are particles of lactose.

35. Particles suitable for use as carrier particles in a dry powder inhaler wherein the particles are made by a method according to claim 1.

36. A method of producing particles according to claim 29, the method including the step of treating large particles such that small grains adhere to the surfaces of the large particles.

37. A method according to claim 36 wherein the small grains are of substantially the same material as that of the large particles.

38. A method according to claim 36 wherein the treatment step is a mixing step.

39. A method according to claim 36 wherein the small grains are the product of milling large particles.

40. A method according to claim 39 wherein the large particles and small grains are mixed in a ratio by weight of at least one part of large particles to each part of small grains.

41. Particles suitable for use as carrier particles in a dry powder inhaler wherein the particles are made by a method according to claim 36.

42. A dry powder suitable for use in a dry powder inhaler including carrier particles according to claim 29 and active particles, wherein active particles adhere to the surfaces of carrier particles.
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