Granted Patent B2

US 8,288,445 · App. 12/951,608 · Granted Oct 16, 2012

Abstract

Claims (24)

1. A stable pharmaceutical product comprising:

a) a pharmaceutical composition comprising:

(i) R,R-formoterol L-tartrate salt; and

(ii) ciclesonide;

b) an article which comprises a material that leaches a substance that is capable of causing degradation of the R,R-formoterol L-tartrate salt;

c) an effective amount of a sorbent material; and

d) a sealed package having an enclosed volume within which said pharmaceutical composition, said article and said sorbent material are situated.

2. The stable pharmaceutical product of claim 1 , wherein said R,R-formoterol L-tartrate salt is crystalline R,R-formoterol L-tartrate salt.

3. The stable pharmaceutical product of claim 1 , wherein said material is polyoxymethylene.

4. The stable pharmaceutical product of claim 1 , wherein said substance is formaldehyde.

5. The stable pharmaceutical product according to claim 1 , wherein said article is a dry powder inhalation device.

6. The stable pharmaceutical product of claim 5 , wherein said dry powder inhalation device comprises a multi-dose reservoir that contains said pharmaceutical composition.

7. The stable pharmaceutical product of claim 5 , wherein said sorbent material is housed within said dry powder inhalation device.

8. The stable pharmaceutical product of claim 5 , wherein said sorbent material is incorporated into a polymer mixture and manufactured into a component of said dry powder inhalation device.

9. The stable pharmaceutical product of claim 5 , wherein said sorbent material is incorporated into plastic sheeting used in packaging said dry powder inhalation device.

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

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

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

13. The stable pharmaceutical product of claim 1 , wherein said sorbent material is 10 Å molecular sieves.

14. The stable pharmaceutical product of claim 1 , wherein said R,R-formoterol L-tartrate salt has a particle size of about 0.1 μm to about 10 μm.

15. The stable pharmaceutical product of claim 1 , wherein greater than 95% or about 95% of said R,R-formoterol L-tartrate salt has a particle size of less than 5 μm or about 5 μm.

16. The stable pharmaceutical product of claim 1 , wherein said pharmaceutical composition further comprises a pharmaceutically acceptable carrier.

17. The stable pharmaceutical product of claim 16 , wherein said pharmaceutical composition comprises about 2969 μg to about 3016 μg of said pharmaceutically acceptable carrier per about 0.5 μg to about 4 μg of R,R-formoterol L-tartrate salt.

18. The stable pharmaceutical product of claim 16 , wherein said pharmaceutical composition comprises about 2969 μg to about 3016 μg of said pharmaceutically acceptable carrier per about 1 μg to about 2 μg of R,R-formoterol L-tartrate salt.

Assignments (17)