Granted Patent B2

US 8,029,811 · App. 12/771,557 · Granted Oct 4, 2011

Abstract

Claims (23)

1. A stable pharmaceutical product for treating a respiratory disease or disorder, comprising

i) a pharmaceutical composition in the solid state comprising ciclesonide and formoterol in a ratio of at least 5:1, and a reducing sugar;

ii) an effective amount of an adsorbent material; and

iii) a sealed package substantially impermeable to moisture having an enclosed volume within which the pharmaceutical composition and the absorbent material are situated.

2. The stable pharmaceutical product of claim 1 , wherein the ciclesonide and the formoterol have a particle size of about 0.1 μm to about 10 μm.

3. The stable pharmaceutical product of claim 1 , wherein greater than about 95% of the ciclesonide and the formoterol have a particle size of less than about 5 μm.

4. The stable pharmaceutical product of claim 1 , wherein the reducing sugar is selected from the group consisting of lactose, glucose, mannose, galactose, maltose, xylose, cellobiose, mellibiose, and maltotriose.

5. The stable pharmaceutical product of claim 1 , wherein the adsorbent material is selected from the group consisting of a molecular sieve, an activated clay, charcoal, an activated alumina, silica, a zeolite, a bauxite, and a mixture thereof.

6. The stable pharmaceutical product of claim 1 , wherein the adsorbent material is 10 Å (Angstrom) molecular sieves.

7. The stable pharmaceutical product of claim 1 , wherein the sealed package is a flexible laminate.

8. The stable pharmaceutical product of claim 1 , wherein the sealed package is hermetically sealed by heat-sealing, gluing, welding, brazing, mechanical closures, mechanical clamps, or compression.

9. The stable pharmaceutical product of claim 1 , wherein the effective amount of the adsorbent material is that amount to eliminate or reduce formation of Maillard products.

10. The stable pharmaceutical product of claim 1 , wherein the reducing sugar is lactose.

11. The stable pharmaceutical product of claim 1 , wherein the reducing sugar is lactose monohydrate.

12. The stable pharmaceutical product of claim 11 , wherein the lactose monohydrate is non-micronised.

13. The stable pharmaceutical product of claim 1 , wherein the pharmaceutical composition is housed within a dry powder inhaler.

14. The stable pharmaceutical product of claim 13 , wherein said adsorbent material is incorporated into a polymer mixture and manufactured into a plastic component of said dry powder inhaler.

15. The stable pharmaceutical product of claim 1 , wherein said adsorbent material is incorporated into an adhesive.

16. The stable pharmaceutical product of claim 1 , wherein said adsorbent material is in a porous sachet.

17. The stable pharmaceutical product of claim 1 , wherein the fine particle fraction of formoterol has a diameter of 6 μm or less.

18. The stable pharmaceutical product of claim 1 , wherein the ratio of ciclesonide to formoterol is from about 10:1 to about 100:1.

19. The stable pharmaceutical product of claim 17 , wherein greater than about 95% of the ciclesonide and the formoterol have a diameter of less than about 5 μm.

20. The stable pharmaceutical product of claim 1 , wherein the formoterol is formoterol fumarate dihydrate.

Assignments (17)