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Claims for Patent: 8,182,838

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Claims for Patent: 8,182,838

Title:Dry powder composition comprising co-jet milled particles for pulmonary inhalation
Abstract: The present invention relates to particles and to methods of making particles. In particular, the invention relates to methods of making composite active particles comprising a pharmaceutically active material for pulmonary inhalation, the method comprising a jet milling process.
Inventor(s): Morton; David (Chippenham, GB), Staniforth; John (Chippenham, GB)
Assignee: Vectura Limited (Chippenham, GB)
Application Number:10/571,146
Patent Claims: 1. A method for making a pharmaceutical composition comprising carrier particles and composite active particles for pulmonary inhalation, the method comprising the step of jet milling active particles in the presence of particles of additive material so that the additive material coats the active particles to form composite active particles, wherein the additive material is selected from the group consisting of: an amino acid, a metal stearate and a phospholipid, the method further comprising blending the carrier particles with the composite active particles.

2. The method as claimed in claim 1, wherein the additive material is selected from the group consisting of: leucine, isoleucine, lysine, valine, methionine, phenylalanine, and a combination of any of the foregoing.

3. The method as claimed in claim 2, wherein the additive material comprises one of the following: leucine and L-leucine.

4. The method as claimed in claim 1, wherein the additive material comprises magnesium stearate.

5. The method as claimed in claim 1, wherein the additive material comprises lecithin.

6. The method as claimed in claim 1, wherein the step of jet milling is carried out at an inlet pressure of between 0.1 and 3 bar.

7. The method as claimed in claim 1, wherein the step of jet milling is carried out at an inlet pressure of between 3 and 12 bar.

8. The method as claimed in claim 1, wherein at least 90% by volume of the active particles are less than 20 .mu.m in diameter prior to the step of jet milling.

9. The method as claimed in claim 1, wherein at least 90% by volume of the additive particles are less than 20 .mu.m in diameter prior to the step of jet milling.

10. The method as claimed in claim 1, wherein the step of jet milling is carried out at temperatures below room temperature.

11. The method as claimed in claim 10, wherein the step of jet milling is carried out at a temperature below 10.degree. C.

12. The method as claimed in claim 1, wherein the step of jet milling further comprises jet milling carrier particles with the active particles and the particles of additive material.

13. The method as claimed in claim 12, wherein the carrier particles have a particle size of at least 20 .mu.m.

14. The method as claimed in claim 12, wherein the carrier particles have a particle size of less than 30 .mu.m.

15. The method as claimed in claim 1, wherein the step of jet milling active particles is carried out in the presence of particles of additive material and one of the following: air, compressible gas and fluid.

16. The method according to claim 10, wherein the step of jet milling is carried out at a temperature below 0.degree. C.

17. The method as claimed in claim 12, wherein the carrier particles have a particle size of less than 20 .mu.m.

18. The method as claimed in claim 12, wherein the carrier particles have a particle size of less than 10 .mu.m.

19. A pharmaceutical composition comprising composite active particles prepared in accordance with the method as claimed in claim 1, blended with carrier particles.

20. The pharmaceutical composition of claim 19, wherein said composition is for pulmonary inhalation.

21. The pharmaceutical composition of claim 1, wherein the coating is a discontinuous coating.

22. The pharmaceutical composition of claim 1, wherein the coating of additive material is not more than 1 .mu.m in thickness.

23. The pharmaceutical composition of claim 19, wherein said composite active particles have an MMAD of not more than 10 .mu.m.

24. The pharmaceutical composition as claimed in claim 23, wherein said composite active particles have an MMAD of not more than 1 .mu.m.

25. The pharmaceutical composition of claim 23, wherein said composite active particles have an MMAD of not more than 5 .mu.m.

26. The pharmaceutical composition of claim 19, wherein at least 90% by weight of the composite active particles have a diameter of not more than 10 .mu.m.

27. The pharmaceutical composition as claimed in claim 26, wherein at least 90% by weight of the particles have a diameter of not more than 1 .mu.m.

28. The pharmaceutical composition of claim 26, wherein at least 90% by weight of the particles have a diameter of not more than 5 .mu.m.

29. The pharmaceutical composition as claimed in claim 19, wherein the pharmaceutical composition is a dry powder composition.

30. The pharmaceutical composition as claimed in claim 19, wherein the pharmaceutical composition has a FPF(ED) of at least 70%.

31. The pharmaceutical composition as claimed in claim 30, wherein the FPF(ED) is at least 80%.

32. The pharmaceutical composition as claimed in claim 19, wherein the pharmaceutical composition has a FPF(MD) of at least 60%.

33. The pharmaceutical composition as claimed in claim 30, wherein the FPF(MD) is at least 70%.

34. The pharmaceutical composition as claimed in claim 30, wherein the FPF(ED) is at least 90%.

35. The pharmaceutical composition as claimed in claim 30, wherein the FPF(ED) is at least 85%.

36. A dry powder inhaler containing a composition as claimed in claim 19.
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