# US 2023/0118104 A1 · Compositions and methods for treating pancreatic enzyme deficiencies in mammals > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2023/0118104 A1 - Document ID: US20230118104A1 - Status: Published application - Kind: A1 - Application number: 18/071,857 - Filed: 2022-11-30 - Published: 2023-04-20 - Earliest claimed: 2018-08-23 - Assignees: Vets Plus, Inc. - Applicants: Vets Plus, Inc. - Inventors: Daniel J. DuBourdieu; Jamil Talukder; Rajiv Lall - Web page: https://patentgrep.com/patent/US20230118104A1 ## CPC - A61K 38/48: acting on peptide bonds (3.4) - A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) - A61K 38/465: {acting on ester bonds (3.1), e.g. lipases, ribonucleases} - A61K 38/47: acting on glycosyl compounds (3.2), e.g. cellulases, lactases - A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes - A61P 5/48: of the pancreatic hormones - C12Y 301/01003: Triacylglycerol lipase (3.1.1.3) - C12Y 302/01001: Alpha-amylase (3.2.1.1) - C12Y 304/24028: Bacillolysin (3.4.24.28) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C12Y: ENZYMES ## Abstract A composition containing enzymes, L-arginine, and other components for treating exocrine pancreatic enzyme insufficiencies and gastrointestinal disorders in mammals. The compositions replace pancreatic enzymes while concurrently treating the side effects of small intestinal bacterial overgrowth and gastrointestinal mucosal degeneration that occurs with pancreatic enzyme loss. The composition can be mixed into animal feeds or sprayed onto extruded feeds prior to consumption. ## Claims ### Claim 1 An oral ingestible composition for treating exocrine pancreatic insufficiency and a secondary gastrointestinal disorder thereof in a mammal, the composition comprising active ingredients in an inert carrier base, wherein the active ingredients comprise: a protease; a lipase; an amylase; and L-arginine. ### Claim 2 (depends on 1) The composition of claim 1, wherein: the protease is present in the composition an amount from about 200,000 USP Units/g to about 800,000 USP Units/g; the lipase is present in the composition in an amount from about 35,000 USP Units/g to about 140,000 USP Units/g; the amylase is present in the composition in an amount from about 230,000 USP Units/g to about 920,000 USP Units/g; and the L-arginine is present in the composition in an amount from about 2.5% w/w to about 10% w/w. ### Claim 3 (depends on 1) The composition of claim 1, wherein the protease, the lipase, and the amylase are all microbial enzymes. ### Claim 4 (depends on 1) The composition of claim 1, wherein the protease, the lipase, and the amylase are all microbially produced. ### Claim 5 (depends on 1) The composition of claim 1, wherein: the protease comprises an enzyme with an International Union of Biochemistry (IUB) classification of 3.4.24.28; the lipase comprises an enzyme with an International Union of Biochemistry (IUB) classification of 3.1.1.3; and the amylase comprises an enzyme with an International Union of Biochemistry (IUB) classification of 3.2.1.1. ### Claim 6 (depends on 1) The composition of claim 1, wherein the active ingredients further comprise vitamin B12. ### Claim 7 (depends on 6) The composition of claim 6, wherein the vitamin B12 is present in the composition in an amount of about 0.01% w/w to about 0.05% w/w. ### Claim 8 (depends on 1) The composition of claim 1, wherein the active ingredients further comprise a non-heme, iron-binding glycoprotein. ### Claim 9 (depends on 8) The composition of claim 8, wherein the non-heme, iron-binding glycoprotein is selected from the group consisting of ferritin, lactoferrin, transferrin, and ovotransferrin. ### Claim 10 (depends on 8) The composition of claim 8, wherein the non-heme, iron-binding glycoprotein is at least partially present in apo form. ### Claim 11 (depends on 8) The composition of claim 8, wherein non-heme, iron-binding glycoprotein is present in the composition in an amount from about 2.5% w/w to about 10% w/w. ### Claim 12 (depends on 1) The composition of claim 1, wherein the inert carrier base is present in the composition in an amount from about 12.5% w/w to about 50% w/w. ### Claim 13 (depends on 1) The composition of claim 1, wherein the oral ingestible composition is in a powder form. ### Claim 14 (depends on 1) The composition of claim 1, wherein: the protease: is a microbially produced enzyme; is a microbial enzyme; comprises an enzyme with an International Union of Biochemistry (IUB) classification of 3.4.24.28; and is present in the composition an amount of about 200,000 USP Units/g to about 800,000 Units/g; the lipase: is a microbially produced enzyme; is a microbial enzyme; an enzyme with an International Union of Biochemistry (IUB) classification of 3.1.1.3; and is present in the composition in an amount of about 35,000 USP Units/g to about 140,000 USP Units/g; the amylase: is a microbially produced enzyme; is a microbial enzyme; comprises an enzyme with an International Union of Biochemistry (IUB) classification of 3.2.1.1; and is present in the composition in an amount of about 230,000 USP Units/g to about 920,000 USP Units/g; the L-arginine is present in the composition in an amount from about from about 2.5% w/w to about 10% w/w; the active ingredients further comprise vitamin B12 present in the composition in an amount of about 0.01% w/w to about 0.05% w/w; the active ingredients further comprise a non-heme, iron-binding glycoprotein selected from the group consisting of ferritin, lactoferrin, transferrin, and ovotransferrin at least partially present in apo form and present in the composition in an amount from about 2.5% w/w to about 10% w/w; the inert carrier base is present in the composition in an amount from about 12.5% w/w to about 50% w/w; and the oral ingestible composition is in a powder form. ### Claim 15 (depends on 1) A method for treating exocrine pancreatic insufficiency and a secondary gastrointestinal disorder thereof in a mammal, the method comprising administering the composition of claim 1 to the mammal. ### Claim 16 (depends on 15) The method of claim 15, wherein the composition is in a powder form, the composition is added in powder form to or mixed with food prior to the administering to thereby form a composition-supplemented food, and the administering comprises feeding the composition-supplemented food to the mammal. ### Claim 17 (depends on 15) The method of claim 15, wherein the composition is in a powder form, the composition in powder form is mixed with a liquid to thereby form a composition-supplemented liquid, the composition-supplemented liquid is added to or mixed with food prior to the administering to thereby form a composition-supplemented food, and the administering comprises feeding the composition-supplemented food to the mammal. ### Claim 18 (depends on 15) The method of claim 15, wherein the composition is administered to the mammal in an amount and for a time effective to elicit at least one of the following effects: a normalization of fasting blood cobalamin levels; a normalization of fasting blood folate levels; a normalization of fasting blood trypsin-like immunoreactivity levels; a normalization of dysbiosis index; and an increase in weight. ### Claim 19 (depends on 15) The method of claim 15, wherein the secondary disorder of the exocrine pancreatic insufficiency comprises small intestinal bacterial overgrowth, gastroenteritis, and mucositis.