COMPOSITIONS AND METHODS FOR TREATING PANCREATIC INSUFFICIENCY
The present invention relates to compositions for the treatment of conditions, including pancreatic insufficiency. The compositions of the present invention comprise lipase, protease and amylase in a particular ratio that provides beneficial results in patients, such as those afflicted with pancreatic insufficiency. This invention also relates to methods using such compositions for the treatment of pancreatic insufficiency.
1 - 34 . (canceled)
35 . A composition comprising lipase, protease, and amylase, wherein the ratio of lipase, protease and amylase in said composition is about 1:1:0.15 USP units.
36 . The composition of claim 35 , wherein the lipase is in the form of cross-linked crystals.
37 . The composition of claim 36 , wherein the lipase crystals are crosslinked with a multifunctional crosslinker.
38 . The composition of claim 37 , wherein the multifunctional crosslinker is bis(sulfosuccinimidyl) suberate.
39 . The composition of claim 35 , wherein the protease is in the form of protease crystals.
40 . The composition of claim 35 , wherein the amylase is in the form of amorphous amylase.
41 . The composition of claim 35 , wherein the lipase is a bacterial lipase, the protease is a fungal protease, and the amylase is a fungal amylase.
42 . The composition of claim 41 , wherein the bacterial lipase is a Burkholderia lipase.
43 . The composition of claim 41 , wherein the fungal protease is an Aspergillus protease.
44 . The composition of claim 43 , wherein the Aspergillus protease is an Aspergillus melleus protease.
45 . The composition of claim 41 , wherein the fungal amylase is an Aspergillus amylase.
46 . The composition of claim 45 , wherein the Aspergillus amylase is an Aspergillus oryzae amylase.
47 . The composition of claim 35 , wherein the lipase USP units are determined spectrophotometrically by monitoring hydrolysis of a p-nitrophenyl acetate substrate as follows:
(a) incubating lipase with p-nitrophenyl acetate in 0.2 M Tris;
(b) removing the lipase by centrifugation; and
(c) measuring absorbance at 400 nm.
48 . The composition of claim 35 , further comprising a pharmaceutically acceptable excipient.
49 . The composition of claim 35 , wherein the composition is in an oral dosage form selected from the group consisting of tablets, capsules, slurries, sachets, suspensions and dragees.
50 . A method for treating malabsorption in a mammal comprising the step of administering to said mammal a therapeutically effective amount of a composition of claim 35 .
51 . A method for treating pancreatic insufficiency in a mammal comprising the step of administering to said mammal a therapeutically effective amount of composition of claim 35 .
52 . The method of claim 50 , wherein the mammal suffers from cystic fibrosis.
53 . The method of claim 51 , wherein the mammal suffers from cystic fibrosis.