Microparticles of a water-soluble material, which are smooth and spherical, and at least 90% of which have a mass median particle size of 1 to 10 μm, and which carry a therapeutic or diagnostic agent can successfully be used in dry powder inhalers to deliver the said agent.
대표청구항▼
1. A therapeutic composition for administration via the pulmonary airways comprising substantially dry, discrete microcapsules having a solid wall formed of a non-denatured, water-soluble wall-forming material, wherein the wall-forming material is a protein, peptide, or enzyme, and wherein said micr
1. A therapeutic composition for administration via the pulmonary airways comprising substantially dry, discrete microcapsules having a solid wall formed of a non-denatured, water-soluble wall-forming material, wherein the wall-forming material is a protein, peptide, or enzyme, and wherein said microcapsules have a mean size of between 1 and 10 μm, and a therapeutically effective amount of a therapeutic agent; wherein the wall forming material optionally is the therapeutic agent. 2. The composition according to claim 1, wherein said therapeutic agent is the sole component of the microcapsule. 3. The composition according to claim 1, wherein the particle size of said microcapsule is between 1 and 5 μm. 4. The composition according to claim 1, wherein said microcapsules have a maximum interquartile range of 3 μm. 5. The composition according to any of claims 1 to 4, which is sterile. 6. The composition according to claim 2, wherein the particle size of said microcapsule is between 1 and 5 μm. 7. The composition according to claim 2, wherein said microcapsules have a maximum interquartile range of 3 μm. 8. The composition according to claim 2, wherein said microcapsules have a maximum interquartile range of 2 μm. 9. The composition according to any of claims 6-8, which is sterile. 10. The composition according to claim 2, wherein said water-soluble material is a human protein or fragment or recombinant thereof. 11. The composition according to claim 2, wherein said water-soluble material is a protein with a NH, CO, OH or SH retained functional group. 12. The composition according to claim 1, wherein said microcapsules have a maximum interquartile range of 2 μm. 13. The composition according to claim 1, wherein said water-soluble material is a human protein or fragment or recombinant thereof. 14. The composition according to claim 1, wherein said water-soluble material is a protein with a NH, CO, OH or SH retained functional group. 15. A therapeutic or diagnostic composition for administration via the pulmonary airways comprising substantially dry, discrete microcapsules having a solid wall formed of a non-denatured, water-soluble wall-forming material, wherein the wall-forming material is an amino or polyamino acid, and wherein said microcapsules have a mean size of between 1 and 10 μm, and an effective amount of a therapeutic or diagnostic agent; wherein the wall forming material optionally is the therapeutic or diagnostic agent. 16. The composition according to claim 15, wherein said therapeutic or diagnostic agent is the sole component of the microcapsule. 17. The composition according to claim 15, wherein the particle size of said microcapsule is between 1 and 5 μm. 18. The composition according to claim 15, wherein said microcapsules have a maximum interquartile range of 3 μm. 19. The composition according to claim 15, wherein said microcapsules have a maximum interquartile range of 2 μm. 20. The composition according to claim 15, which is sterile.
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