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Claims for Patent: 7,658,918

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Claims for Patent: 7,658,918

Title:Stable digestive 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: Eurand Pharmaceuticals Ltd. (County Wicklow, IE)
Application Number:12/576,930
Patent Claims: 1. A dosage form comprising a plurality of coated particles, said particles comprising a core coated with an enteric coating; wherein the core comprises: 68-90 wt. % of pancrelipase; the enteric coating comprises: 10-20 wt. % of at least one enteric polymer; and 4-10 wt. % of talc; wherein each said wt. % is based on the total weight of the coated particles, wherein the combined lipase, protease, and amylase activities of the dosage form is: 4,500-5,500 IU of lipase activity, 8,000-34,000 IU of protease activity, and 8,000-45,000 IU of amylase activity; or 9,000-11,000 IU of lipase activity, 17,000-67,000 IU of protease activity, and 17,000-90,000 IU of amylase activity; or 13,500-16,500 IU of lipase activity, 26,000-100,000 IU of protease activity, and 26,000-135,000 IU of amylase activity; or 18,000-22,000 IU of lipase activity, 35,000-134,000 IU of protease activity, and 35,000-180,000 IU of amylase activity; wherein said coated particles have a moisture content of about 2% or less, and exhibit a loss of pancrelipase activity of no more than 25% after six months of accelerated stability testing.

2. The dosage form of claim 1, wherein the core further comprises 1-4 wt. % of at least one disintegrant; 0.2-0.6 wt. % of at least one glidant; 2-6 wt. % of at least one polymeric binder; and 0.2-0.6 wt. % of at least one lubricant, based on the total weight of the coated particles.

3. The dosage form of claim 2, wherein the at least one disintegrant is croscarmellose sodium, the at least one glidant is colloidal silicon dioxide, the at least one polymeric binder is microcrystalline cellulose, the at least one lubricant is magnesium stearate, and the enteric polymer is hydroxypropylmethylcellulose phthalate.

4. The dosage form of claim 2, wherein the core further comprises 0.5-1.0 wt. % of at least one plasticizer, based on the total weight of the coated particles.

5. The dosage form of claim 4, wherein the at least one plasticizer is hydrogenated castor oil.

6. The dosage form of claim 1, wherein the pancrelipase is porcine derived.

7. The dosage form of claim 1, wherein the coating further comprises 1-2 wt. % of at least one plasticizer, based on the total weight of the coated particles.

8. The dosage form of claim 7, wherein the at least one plasticizer is triethyl citrate.

9. The dosage form of claim 1, wherein the coated particles exhibit a loss of pancrelipase activity of no more than 15% after six months of accelerated stability testing.

10. The dosage form of claim 1, in the form of a capsule comprised of hydroxypropylmethylcellulose, filled with said plurality of coated particles.

11. The dosage form of claim 1, wherein the ratio of protease to lipase activity is from about 1.8-6.2.

12. The dosage form of claim 1, wherein the ratio of protease to lipase activity is from about 2.0-6.1.

13. The dosage form of claim 1, wherein the ratio of amylase to lipase activity is from about 1.8-8.2.

14. The dosage form of claim 1, wherein the ratio of amylase to lipase activity is from about 2.0-8.2.

15. The dosage form of claim 1, wherein the ratio of lipase:protease:amylase activities ranges from about 1:10:10 to about 10:1:1.
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