Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency

Abstract

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.

We claim: 
     
         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.