PANCREATIC ENZYME COMPOSITIONS AND METHODS FOR TREATING PANCREATITIS AND PANCREATIC INSUFFICIENCY
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 comprising enterically 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.
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 50:50.
3 . 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.
4 . 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.
5 . A dosage form comprising the multi-particulate digestive enzyme composition of claim 1 .
6 . The dosage form of claim 5 , 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.
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 6 , 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.
9 . The dosage form of claim 5 , 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.
10 . The dosage form of claim 5 , 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 9 , 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.
12 . The dosage form of claim 5 , 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
13 . 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 13,600 USP protease units.
14 . The dosage form of claim 12 , 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.
15 . The dosage form of claim 5 , 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.
16 . The dosage form of claim 5 , 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 15 , 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.
18 . The dosage form of claim 5 , in the form of a capsule filled with the multi-particulate digestive enzyme composition.
19 . A method of treating pancreatitis pain, comprising administering the composition of claim 1 to a patient in need thereof.
20 . A method of treating pancreatitis pain and pancreatic insufficiency, comprising administering the composition of claim 1 to a patient in need thereof.
21 . The method of claim 20 , 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.
22 . 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, wherein said dose ranges from about 100 to about 300 USP lipase units/kg/meal.
23 . The method of claim 22 , wherein the daily dose of said enterically coated digestive enzyme ranges from about 35,000 to about 90,000 USP lipase units.
24 . The method of claim 22 , 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.