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Claims for Patent: 8,221,747

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Claims for Patent: 8,221,747

Title:Stable pancreatic enzyme compositions
Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.
Inventor(s): Ortenzi; Giovanni (Monza, IT), Marconi; Marco (Cinisello Balsamo, IT), Mapelli; Luigi (Milan, IT)
Assignee: Aptalis Pharma Limited (Wicklow, IE)
Application Number:12/034,488
Patent Claims: 1. A dosage form comprising a capsule, wherein the capsule comprises hydroxypropylmethylcellulose and a moisture content of about 4% or less, and wherein the capsule is filled with a pharmaceutical composition, said pharmaceutical composition comprising: a plurality of coated particles, said coated particles comprising a core comprising at least one digestive enzyme, and said coated particles coated with an enteric coating.

2. The dosage form of claim 1, wherein the coated particles have a moisture content of about 3% or less.

3. The dosage form of claim 1, wherein the coated particles have a moisture content of about 2% or less.

4. The dosage form of claim 1, wherein the coated particles exhibit a loss of digestive enzyme activity of no more than 25% after six months of accelerated stability testing.

5. The dosage form of claim 2, wherein the coated particles exhibit a loss of digestive enzyme activity of no more than 25% after six months of accelerated stability testing.

6. The dosage form of claim 2, wherein the coated particles exhibit a loss of digestive enzyme activity of no more than 15% after six months of accelerated stability testing.

7. The dosage form of claim 1, wherein the capsule was dried prior to filling with the plurality of coated particles.

8. The dosage form of claim 1, wherein the capsule has a moisture content of about 2% or less.

9. The dosage form of claim 1, wherein the enteric coating comprises at least one enteric polymer and 4-10 wt. % of at least one alkalinizing agent, and wherein each of said wt. % is based on the total weight of the coated particles.

10. The dosage form of claim 1, wherein the enteric coating comprises: 10-20 wt. % of at least one enteric polymer; and 4-10 wt. % of talc; and wherein each said wt. % is based on the total weight of the coated particles.

11. The dosage form of claim 10, wherein the enteric coating further comprises a plasticizer.

12. The dosage form of claim 11, wherein the plasticizer is selected from the group consisting of triacetin, tributyl citrate, tri-ethyl citrate, acetyl tri-n-butyl citrate, diethyl phthalate, dibutyl sebacate, polyethylene glycol, polypropylene glycol, castor oil, acetylated mono-glyceride, acetylated di-glyceride, and mixtures thereof.

13. The dosage form of claim 12, wherein the plasticizer is tri-ethyl citrate.

14. The dosage form of claim 1, wherein the size of the coated particles ranges from about 50-5000 .mu.m.

15. The dosage form of claim 1, wherein the nominal diameter of the coated particles ranges from about 2-5 mm.

16. The dosage form of claim 1, wherein the nominal diameter of the coated particles is less than about 2 mm.

17. The dosage form of claim 1, wherein the nominal diameter of the coated particles ranges from about 1-2 mm.

18. The dosage form of claim 10, wherein the enteric polymer is hydroxypropylmethylcellulose phthalate.

19. The dosage form of claim 18, wherein the enteric coating further comprises a plasticizer.

20. The dosage form of claim 18, wherein the coated particles have a moisture content of about 3% or less.

21. The dosage form of claim 20, wherein the digestive enzyme is porcine derived.

22. The dosage form of claim 21, wherein the digestive enzyme comprises pancrelipase.

23. The dosage form of claim 22, wherein the core further comprises at least one disintegrant and at least one polymeric binder.

24. The dosage form of claim 22, wherein the core further comprises a stabilizer, a binder, a plasticizer, and a disintegrant, wherein the stabilizer is colloidal silicon dioxide, the binder is microcrystalline cellulose, the plasticizer is hydrogenated castor oil, and the disintegrant is croscarmellose sodium.

25. The dosage form of claim 24, wherein the coated particles exhibit a loss of digestive enzyme activity of no more than 25% after six months of accelerated stability testing.

26. The dosage form of claim 24, wherein the coated particles exhibit a loss of digestive enzyme activity of no more than 15% after six months of accelerated stability testing.

27. The dosage form of claim 24, wherein the coated particles exhibit a loss of digestive enzyme activity of no more than 10% after six months of accelerated stability testing.

28. The dosage form of claim 25, wherein the nominal diameter of the coated particles ranges from about 2-5 mm.

29. The dosage form of claim 25, wherein the nominal diameter of the coated particles ranges from about 1-2 mm.

30. The dosage form of claim 1, wherein the core comprises: 60-90 wt. % of pancrelipase; 1-4 wt. % of at least one disintegrant; 0.5-1.0 wt. % of at least one plasticizer; 0.2-0.6 wt. % of at least one glidant; 2-6 wt. % of at least one polymeric binder; 0.2-0.6 wt. % of at least one lubricant; and wherein the coating comprises: 10-20 wt. % of at least one enteric polymer; 4-10 wt. % of at least one alkalinizing agent; and 1-2 wt. % of at least one plasticizer, wherein each of said wt. % is based on the total weight of the coated particles.
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