US2008213241A1PendingUtilityA1

Protease composition and method for treating a digestive disorder

48
Individually held — no corporate assignee on recordPriority: Mar 28, 2003Filed: May 8, 2006Published: Sep 4, 2008
Est. expiryMar 28, 2023(expired)· nominal 20-yr term from priority
Inventors:John G. DavidsonRohit MedhekarJeremy D. MooreKen PaydonSteve Marr
A61K 31/4439A61K 38/48A61K 38/465A61K 33/10
48
PatentIndex Score
0
Cited by
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References
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Claims

Abstract

There is provided methods, kits, combinations, and compositions comprising protease enzymes and a lipase enzyme for treating a digestive disorder in a subject in need thereof. The methods, kits, combinations, and compositions may also be used along with an agent (or combination of agents) for raising the gastric pH, a digestive enzyme useful in enhancing digestive activity, a dietary supplement, or a pharmaceutical agent.

Claims

exact text as granted — not AI-modified
1 . A composition, comprising:
 (a) at least about 500 HUT of a microbial or plant protease enzyme;   (b) at least about 750 PC of a microbial or plant protease enzyme; and   (c) at least about 10 FCCLU of a microbial lipase enzyme.   
     
     
         2 . The composition of  claim 1 , wherein the microbial protease is selected from the group consisting of  Aspergillus, Rhizopus, Bacillus, Candida , and  Rhizomucor.    
     
     
         3 . The composition of  claim 2 , wherein the Aspergillus is selected from the group consisting of  Aspergillus niger, Aspergillus oryzae , and  Aspergillus melleus.    
     
     
         4 . The composition of  claim 2 , wherein the  Rhizopus  is selected from the group consisting of  Rhizopus niveus, Rhizopus delemar , and  Rhizopus oryzae.    
     
     
         5 . The composition of  claim 2 , wherein the  Bacillus  is selected from the group consisting of  Bacillus subtilis, Bacillus thermoproteolyticus, Bacillus licheniformis , and  Bacillus stearothermophilus.    
     
     
         6 . The composition of  claim 2 , wherein the  Candida  is selected from the group consisting of  Candida pseudotropicalis  and  Candida cylindracea.    
     
     
         7 . The composition of  claim 2 , wherein the  Rhizomucor  is  Rhizomucor miehei.    
     
     
         8 . The composition of  claim 1 , wherein the plant protease is selected from the group consisting of bromelain, papain, and ficin. 
     
     
         9 . The composition of  claim 1 , further comprising an agent selected from the group consisting of an antacid, a histamine H 2  receptor antagonist, and a proton pump inhibitor. 
     
     
         10 . The composition of  claim 9 , wherein the antacid is calcium carbonate. 
     
     
         11 . The composition of  claim 9 , wherein the histamine H 2  receptor antagonist is selected from the group consisting of ranitidine, cimetidine, famotidine, nizatidine, and roxatidine acetate. 
     
     
         12 . The composition of  claim 9 , wherein the proton pump inhibitor is selected from the group consisting of omeprazole, lansoprazole, and rabeprazole. 
     
     
         13 . The composition of  claim 1 , wherein the composition further comprises a digestive enzyme selected from the group consisting of a protease, a lipase, an amylase, and a cellulase. 
     
     
         14 . The composition of  claim 1 , wherein the composition comprises about 500 HUT to about 500,000 HUT of a microbial or plant protease enzyme. 
     
     
         15 . The composition of  claim 1 , wherein the composition comprises about 8,000 HUT of a microbial or plant protease enzyme. 
     
     
         16 . The composition of  claim 1 , wherein the composition comprises about 750 PC to about 750,000 PC of a microbial or plant protease enzyme. 
     
     
         17 . The composition of  claim 1 , wherein the composition comprises about 3,000 PC of a microbial or plant protease enzyme. 
     
     
         18 . The composition of  claim 1 , wherein the composition comprises about 10 FCCLU to about 20,000 FCCLU of a microbial lipase enzyme. 
     
     
         19 . The composition of  claim 1 , wherein the composition comprises about 100 FCCLU of a microbial lipase enzyme. 
     
     
         20 . The composition of  claim 1 , wherein the composition is administered orally. 
     
     
         21 . The composition of  claim 1 , wherein the composition is in a dosage form comprising a tablet, capsule, cachet, lozenge, dispensable powder, granule, solution, suspension, or emulsion. 
     
     
         22 . A method for treating or reducing the risk of developing a digestive disorder in a subject in need thereof, comprising: administering to the subject an effective amount of a composition which comprises:
 (a) at least about 500 HUT of a microbial or plant protease enzyme;   (b) at least about 750 PC of a microbial or plant protease enzyme; and   (c) at least about 10 FCCLU of a microbial lipase enzyme.   
     
     
         23 . The composition of  claim 22 , wherein the microbial protease is selected from the group consisting of  Aspergillus, Rhizopus, Bacillus, Candida , and  Rhizomucor.    
     
     
         24 . The composition of  claim 23 , wherein the Aspergillus is selected from the group consisting of  Aspergillus niger, Aspergillus oryzae , and  Aspergillus melleus.    
     
     
         25 . The composition of  claim 23 , wherein the  Rhizopus  is selected from the group consisting of  Rhizopus niveus, Rhizopus delemar , and  Rhizopus oryzae.    
     
     
         26 . The composition of  claim 23 , wherein the  Bacillus  is selected from the group consisting of  Bacillus subtilis, Bacillus thernoproteolyticus, Bacillus licheniformis , and  Bacillus stearothermophilus.    
     
     
         27 . The composition of  claim 23 , wherein the  Candida  is selected from the group consisting of  Candida pseudotropicalis  and  Candida cylindracea.    
     
     
         28 . The composition of  claim 23 , wherein the  Rhizomucor  is  Rhizomucor miehei.    
     
     
         29 . The composition of  claim 22 , wherein the plant protease is selected from the group consisting of bromelain, papain, and ficin. 
     
     
         30 . The method of  claim 22 , further comprising an agent selected from the group consisting of an antacid, a histamine H 2  receptor antagonist, or a proton pump inhibitor. 
     
     
         31 . The method of  claim 30 , wherein the antacid is calcium carbonate. 
     
     
         32 . The method of  claim 30 , wherein the histamine H 2  receptor antagonist is selected from the group consisting of ranitidine, cimetidine, famotidine, nizatidine, and roxatidine acetate. 
     
     
         33 . The method of  claim 30 , wherein the proton pump inhibitor is selected from the group consisting of omeprazole, lansoprazole, and rabeprazole. 
     
     
         34 . The method of  claim 22 , wherein the composition further comprises a digestive enzyme selected from the group of a protease, a lipase, an amylase, and a cellulase. 
     
     
         35 . The method of  claim 22 , wherein the composition comprises about 500 HUT to about 500,000 HUT of a microbial or plant protease enzyme. 
     
     
         36 . The method of  claim 15 , wherein the composition comprises about 8,000 HUT of a microbial or plant protease enzyme. 
     
     
         37 . The method of  claim 22 , wherein the composition comprises about 750 PC to about 750,000 PC of a microbial or plant protease enzyme. 
     
     
         38 . The method of  claim 22 , wherein the composition comprises about 3,000 PC of a microbial or plant protease enzyme. 
     
     
         39 . The method of  claim 22 , wherein the composition comprises about 10 FCCLU to about 20,000 FCCLU of a microbial lipase enzyme. 
     
     
         40 . The method of  claim 22 , wherein the composition comprises about 100 FCCLU of a microbial lipase enzyme. 
     
     
         41 . A method for treating or reducing the risk of developing a digestive disorder in a subject in need thereof, comprising: administering to the subject in a combination therapy at least about 500 HUT of a microbial or plant protease enzyme, at least about 750 PC of a microbial or plant protease enzyme, at least about 10 FCCLU of a microbial lipase enzyme, and an agent selected from the group consisting of an antacid, an H 2  receptor antagonist, and a proton pump inhibitor. 
     
     
         42 . The method of  claim 41 , wherein the antacid is calcium carbonate. 
     
     
         43 . The method of  claim 41 , wherein the histamine H 2  receptor antagonist is selected from the group consisting of ranitidine, cimetidine, famotidine, nizatidine, and roxatidine acetate. 
     
     
         44 . The method of  claim 41 , wherein the proton pump inhibitor is selected from the group consisting of omeprazole, lansoprazole, and rabeprazole. 
     
     
         45 . The method of  claim 41 , wherein the composition further comprises a protease, a lipase, an amylase, and a cellulase. 
     
     
         46 . The method of  claim 41 , wherein the composition comprises about 500 HUT to about 500,000 HUT of a microbial or plant protease enzyme. 
     
     
         47 . The method of  claim 41 , wherein the composition comprises about 8,000 HUT of a microbial or plant protease enzyme. 
     
     
         48 . The method of  claim 41 , wherein the composition comprises about 750 PC to about 750,000 PC of a microbial or plant protease enzyme. 
     
     
         49 . The method of  claim 41 , wherein the composition comprises about 3,000 PC of a microbial or plant protease enzyme. 
     
     
         50 . The method of  claim 41 , wherein the composition comprises about 10 FCCLU to about 20,000 FCCLU of a microbial lipase enzyme. 
     
     
         51 . The method of  claim 41 , wherein the composition comprises about 100 FCCLU of a microbial lipase enzyme. 
     
     
         52 . The method of  claim 41 , wherein the protease enzymes and the lipase enzyme are formulated in a single composition. 
     
     
         53 . The method of  claim 41 , wherein the protease enzymes and the lipase enzyme are provided as a separate component of a kit. 
     
     
         54 . The method of  claim 41 , wherein the protease enzymes and the lipase enzyme are administered in a sequential manner. 
     
     
         55 . The method of  claim 41 , wherein the protease enzymes and the lipase enzyme are administered in a substantially simultaneous manner. 
     
     
         56 . The method according to  claim 41 , wherein the digestive disorder is selected from the group consisting of upper gastrointestinal tract distress, inflammatory bowel disease, gastritis, irritable bowel syndrome, ulcerative colitis, dairy intolerance, gallbladder stress, malabsorption, intestinal toxemia, food allergies, sugar intolerance, hyperglycemia, hypoglycemia, hypertension, kidney disease, adult onset diabetes, liver problems, fibromyalgia, migraine headaches, postmenstrual syndrome, and hyperactivity in children. 
     
     
         57 . The method composition of  claim 41 , wherein the microbial protease is selected from the group consisting of  Aspergillus, Rhizopus, Bacillus, Candida , and  Rhizomucor.    
     
     
         58 . The method composition of  claim 41 , wherein the Aspergillus is selected from the group consisting of  Aspergillus niger, Aspergillus oryzae , and  Aspergillus melleus.    
     
     
         59 . The method composition of  claim 41 , wherein the  Rhizopus  is selected from the group consisting of  Rhizopus niveus, Rhizopus delemar , and  Rhizopus oryzae.    
     
     
         60 . The method composition of  claim 41 , wherein the Bacillus is selected from the group consisting of  Bacillus subtilis, Bacillus thermoproeolyticus, Bacillus licheniformis , and  Bacillus stearothermophilus.    
     
     
         61 . The method composition of  claim 41 , wherein the  Candida  is selected from the group consisting of  Candida pseudotropicalis  and  Candida cylindracea.    
     
     
         62 . The method composition of  claim 41 , wherein the  Rhizomucor  is  Rhizomucar miehei.    
     
     
         63 . The method composition of  claim 41 , wherein the plant protease is selected from the group consisting of bromelain, papain, and ficin. 
     
     
         64 . A composition made by combining a digestive-disorder-effective amount of the compound of  claim 1  and a pharmaceutically acceptable carrier, excipient, adjuvant, and/or vehicle. 
     
     
         65 . A method for making a composition, comprising: combining a digestive-disorder-effective amount of the compound of  claim 1  and a pharmaceutically acceptable carrier, excipient, adjuvant, and/or vehicle.

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