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Claims for Patent: 8,956,661

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Claims for Patent: 8,956,661

Title:Method of making composite particles for use in pharmaceutical compositions and composite particles and compositions thereof
Abstract: The invention relates to a method for making composite active particles for use in a pharmaceutical composition for pulmonary administration, the method comprising a milling step in which particles of active material are milled in the presence of particles of an additive material which is suitable for the promotion of the dispersal of the composite active particles upon actuation of an inhaler. The invention also relates to compositions for inhalation prepared by the method.
Inventor(s): Staniforth; John Nicholas (Bath, GB), Green; Matthew Michael James (Surrey, GB), Morton; David Alexander Vodden (Bath, GB)
Assignee: Vectura Limited (Chippenham, Wiltshire, GB)
Application Number:13/623,326
Patent Claims: 1. A method for making composite active particles for use in a pharmaceutical composition for pulmonary administration, the method comprising a milling step in which particles of active material are milled in the presence of particles of an additive material which is suitable for the promotion of the dispersal of the composite active particles upon actuation of an inhaler wherein the mass median aerodynamic diameter of the composite active particles is not more than 10 .mu.m after milling.

2. A method as claimed in claim 1, in which the milling step is carried out in the presence of a liquid.

3. A method as claimed in claim 2, in which the liquid comprises a propellant suitable for use in a pressurised metered dose inhaler device.

4. A method as claimed in claim 2, which also comprises, after the milling step, a processing step in which the degree of aggregation of the composite active particles is changed.

5. A method as claimed in claim 4, in which the processing step is an agglomeration step.

6. A method as claimed in claim 4, in which the processing step is a deagglomeration step.

7. A method as claimed in claim 1, which comprises, after the milling step, a drying step in which a mixture of the composite active particles and a liquid is dried to remove the liquid.

8. A method as claimed in claim 7, which the liquid is added after the milling step.

9. A method according to claim 7, during which, in the drying step, the composite active particles agglomerate to form agglomerated composite active particles.

10. A method as claimed in claim 7, in which the drying step is a spray drying step.

11. A method as claimed in claim 7, in which in the drying step the liquid is evaporated slowly.

12. A method as claimed in claim 7, in which the drying steep is a freeze drying step.

13. A method as claimed in claim 1, in which the additive material comprises an amino acid.

14. A method as claimed in claim 1, in which the additive material comprises a phospholipid.

15. A method as claimed in claim 1, in which the additive material comprises a metal stearate.

16. A method according to claim 1 in which the milling step involves ball milling.

17. A method according to claim 1 in which the milling step involves passing a mixture of particles of additive material and particles of active material, in a liquid, through a constriction under pressure.

18. A method according to claim 1 in which the milling step involves compressing a mixture of the active particles and additive particles in a gap of predetermined width.

19. A method as claimed in claim 18 in which the gap is not more than 10 mm wide.

20. Composite active particles for use in a pharmaceutical composition as made by the method of claim 1.

21. Composite active particles for use in a pharmaceutical composition for pulmonary administration, each composite active particle comprising a particle of active material and particulate additive material on the surface of that particle of active material, the composite active particles having a mass median aerodynamic diameter of not more than 9 .mu.m and the additive material being suitable for the promotion of the dispersal of the composite active particles upon actuation of a delivery device.

22. Composite active particles as claimed in claim 21, which are in the form of agglomerated composite active particles.

23. Composite particles as claimed in claim 21 in which the additive particles form a coating on the surfaces of the particles of active material.

24. Composite active particles as claimed in claim 23 in which the coating is a discontinuous coating.

25. Composite active particles as claimed in claim 23 in which the coating is not more than 1 .mu.m thick.

26. A pharmaceutical composition comprising composite active particles as made by a method according to claim 1.

27. A pharmaceutical composition as claimed in claim 26, which is a dry powder and is suitable for use in a dry powder inhaler.

28. A pharmaceutical composition, as claimed in claim 26, which comprises a propellant and is suitable for use in a pressurised metered dose inhaler.

29. A method for milling an active material using an additive material as a milling aid, comprising milling particles of active material in the presence of particles of an additive material which is suitable for the promotion of the dispersal of the composite active particles upon actuation of an inhaler wherein the mass median aerodynamic diameter of the composite active particles is not more than 10 .mu.m after milling.

30. A method as claimed in claim 1, which also comprises, after the milling step, a processing step in which the degree of aggregation of the composite active particles is changed.

31. A method as claimed in claim 30, in which the processing step is an agglomeration step.

32. A method as claimed in claim 30, in which the processing step is a deagglomeration step.
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