Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency
View Patent ↗Compositions of the present invention, comprising the combination of enterically coated and uncoated pancreatic enzyme-containing beads are useful for treating or preventing pancreatitis pain, and optionally disorders associated with digestive enzyme deficiencies.
1. A multi-particulate digestive enzyme composition consisting essentially of coated digestive enzyme-containing beads, and uncoated digestive enzyme-containing beads, wherein:
the enterically coated digestive enzyme-containing beads comprise a core and an enteric coating disposed over the core, wherein the core comprises a therapeutically effective amount of digestive enzymes, and the enteric coating comprises an enteric polymer; and
the uncoated digestive enzyme-containing beads comprise a therapeutically effective amount of digestive enzymes, and is substantially free of an enteric polymer coating; wherein
the digestive enzymes comprise lipase and protease, and the ratio of lipase and protease activities in the enterically coated digestive enzyme-containing beads to the lipase and protease activities in the uncoated digestive enzyme-containing beads ranges from about 5:95 to about 50:50.
2. The multi-particulate digestive enzyme composition of claim 1 , wherein the digestive enzymes comprise lipase and protease, and the ratio of lipase and protease activities in the enterically coated digestive enzyme-containing beads to the lipase and protease activities in the uncoated digestive enzyme-containing beads ranges from about 5:95 to about 25:75.
3. The multi-particulate digestive enzyme composition of claim 1 , wherein the digestive enzymes comprise lipase and protease, and each of the enterically coated and uncoated digestive enzyme-containing beads have substantially the same protease and lipase activity.
4. A dosage form comprising the multi-particulate digestive enzyme composition of claim 1 .
5. The dosage form of claim 4 , wherein the enterically coated digestive enzyme-containing beads have a total lipase activity ranging from about 2000 USP lipase units to about 10,000 USP lipase units.
6. The dosage form of claim 4 , wherein the enterically coated digestive enzyme-containing beads have a total protease activity ranging from about 6800 USP protease units to about 34,000 USP protease units.
7. The dosage form of claim 5 , wherein the enterically coated digestive enzyme-containing beads have a total protease activity ranging from about 6800 USP protease units to about 34,000 USP protease units.
8. The dosage form of claim 4 , wherein the uncoated digestive enzyme-containing beads have a total lipase activity ranging from about 10,000 USP lipase units to about 18,000 USP lipase units.
9. The dosage form of claim 4 , wherein the uncoated digestive enzyme-containing beads have a total protease activity ranging from about 34,000 USP protease units to about 62,000 USP protease units.
10. The dosage form of claim 8 , wherein the uncoated digestive enzyme-containing beads have a total protease activity ranging from about 34,000 USP protease units to about 62,000 USP protease units.
11. The dosage form of claim 4 , wherein the enterically coated digestive enzyme-containing beads have a total lipase activity ranging from about 2000 USP lipase units to about 4,000 USP lipase units.
12. The dosage form of claim 4 , wherein the enterically coated digestive enzyme-containing beads have a total protease activity ranging from about 6800 USP protease units to about 13,600 USP protease units.
13. The dosage form of claim 11 , wherein the enterically coated digestive enzyme-containing beads have a total protease activity ranging from about 6800 USP protease units to about 13,600 USP protease units.
14. The dosage form of claim 4 , wherein the uncoated digestive enzyme-containing beads have a total lipase activity ranging from about 14,000 USP lipase units to about 18,000 USP lipase units.
15. The dosage form of claim 4 , wherein the uncoated digestive enzyme-containing beads have a total protease activity ranging from about 47,000 USP protease units to about 62,000 USP protease units.
16. The dosage form of claim 14 , wherein the uncoated digestive enzyme-containing beads have a total protease activity ranging from about 47,000 USP protease units to about 62,000 USP protease units.
17. The dosage form of claim 4 , in the form of a capsule filled with the multi-particulate digestive enzyme composition.
18. A method of treating pancreatitis pain, comprising administering the composition of claim 1 to a patient in need thereof.
19. A method of treating pancreatitis pain and pancreatic insufficiency, comprising administering the composition of claim 1 to a patient in need thereof.
20. The method of claim 19 , wherein said administering comprises administering, per meal, an amount of multi-particulate digestive enzyme composition such that the lipase activity of the enterically coated digestive enzyme-containing beads ranges from about 8000 to about 40,000 USP lipase units, and the lipase activity of the uncoated digestive enzyme-containing beads ranges from about 40,000 to about 72,000 USP lipase units.
21. A method of treating pancreatic exocrine insufficiency, comprising administering to a patient in need thereof a therapeutically effective dose of an enterically coated digestive enzyme composition of claim 1 , wherein said dose ranges from about 100 to about 300 USP lipase units/kg/meal.
22. The method of claim 21 , wherein the daily dose of said enterically coated digestive enzyme ranges from about 35,000 to about 90,000 USP lipase units.
23. The method of claim 21 , wherein said the enterically coated digestive enzyme is in the form of a capsule comprising enterically coated digestive enzyme-containing beads;
wherein the enterically coated digestive enzyme-containing beads comprise a core and an enteric coating disposed over the core, wherein the core comprises a therapeutically effective amount of one or more digestive enzymes, and the enteric coating comprises an enteric polymer.