Stabilized pharmaceutical product
Use of an adsorbent and a sealed package (e.g. an overwrap) to protect a pharmaceutical product in a solid state in the presence of a reducing sugar.
1. A stable pharmaceutical product for treating a respiratory disease or disorder, comprising
i) a pharmaceutical composition in the solid state comprising a corticosteroid 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 adsorbent material are situated.
2. The stable pharmaceutical product of claim 1 , wherein the corticosteroid 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 corticosteroid 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 corticosteroid 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 corticosteroid 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.
21. The stable pharmaceutical product of claim 1 , wherein the corticosteroid is selected from the group consisting of mometasone furoate, triamcinolone acetonide, flunisolide, fluticasone propionate, budesonide, beclomethasone dipropionate, prednisone, betamethasone, cortisone, dexamethasone, hydrocortisone, methylprednisolone and prednisolone.