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1. (WO2002043700) PARTICULES SERVANT DANS UNE COMPOSITION PHARMACEUTIQUE
Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

Claims
1. A method of making a composition for inhalation which includes the step of mixing particles of additive material having a diameter of not more than 2μm with active particles, wherein the additive material is suitable for promoting the dispersal of active particles upon aerolisation of a dry powder in a dry powder inhaler.
2. A method as claimed in claim 1 in which the additive particles have a diameter of not more than 1.5μm.
3. A method as claimed in claim 1 or claim 2, wherein the additive material is also a hydrophobic material suitable for delaying the dissolution of an active substance in the lung. 4. A method as claimed in any of claims 1 to 3 , wherein the additive material comprises magnesium stearate.
5. A method as claimed in any of claims 1 to 4 , in which the additive material comprises a phospholipid.
6. A method as claimed in any of claims 1 to 5, in which the additive material comprises an amino acid.
7. A method as claimed in any of claims 1 to 6, in which the additive material is soft.
8. A method as claimed in any of claims 1 to 7 in which the additive particles are in the form of agglomerates.
9. A method as claimed in any of claims 1 to 8 in which the additive particles have a bulk density not more than
0.4gcm"3.
10. A method as claimed in any of claims 1 to 9 in which the additive particles are in the form of flakes having a
thickness of not more than 0.5μm.
11. A method as claimed in any of claims 1 to 10 which also includes the step of providing large particles of additive material having a MMAD of greater than 2μm and the step of reducing the size of those particles such that the MMAD of the resulting particles is less than 2μm.
12. A method as claimed in claim 11 in which the step of reducing the size of the particles of additive material involves the movement of the particles from a region of high pressure to a region of low pressure .
13. A method as claimed in claim 12 in which the step of reducing the size of the particles of additive material involves homogenisation.
14. A method as claimed in any of claims 11 to 13 which also includes, after the step of reducing the size of the
particles of additive material, a spray drying step.
15. A method as claimed in any of claims 11 to 14 in which the particles of active material are also present during the step of reducing the size of the particles of additive material .
16. A method as claimed in any of claims 1 to 15 which also involves the step of pressing the particles of additive material together with the active particles.
17. A composition for inhalation comprising particles of an active substance and additive particles, the composition being obtainable by a method as claimed in any of claims 1 to 16.
18. A composition as claimed in claim 17 which is a powder and is suitable for use in a dry powder inhaler.
19. A composition as claimed in claim 18 which comprises carrier particles .
20. A composition as claimed in claim 17 which comprises a propellant and is suitable for use in a pressurised metered dose inhaler.
21. A dry powder inhaler comprising a composition as claimed in claim 18 or claim 19.
22. A pressurised metered dose inhaler which comprises a composition as claimed in claim 20.
23. Use of particles of an additive material having a diameter of not more than 2μm, in a composition for
inhalation comprising active particles, to promote the dispersal of active particles upon actuation of an inhaler.
24. Use of particles of an additive material having a
diameter of not more than 2μm, in a composition for
inhalation comprising active particles, for delaying the

5 dissolution of the active particles in the lung.
25. A method of therapy comprising the step of administering a composition for inhalation as claimed in any of claims 17 to 20 to a human being or animal in need thereof.
26. Particles of an additive material substantially as
L0 described herein.
27. A method of producing particles of an additive material, the method being substantially as described herein.
28. A composition for inhalation, substantially as described herein.