# US 11,998,511 B2 · Methods, compositions, and devices for supplying dietary fatty acid needs

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- Number: US 11,998,511 B2
- Document ID: US11998511B2
- Status: Granted
- Kind: B2
- Application number: 17/853,168
- Filed: 2022-06-29
- Published: 2022-10-20
- Granted: 2024-06-04
- Earliest claimed: 2012-02-17
- Assignees: Alcresta Therapeutics, Inc.
- Applicants: Alcresta Therapeutics, Inc.
- Inventors: Alexey L. Margolin; Robert Gallotto; Bhami Shenoy
- Web page: https://patentgrep.com/patent/US11998511B2

## CPC

- A61J 15/0092: {Valves on feeding tubes (tube valves A61M39/22)}
- A23D 7/011: {Compositions other than spreads}
- A23D 7/013: {Spread compositions}
- A23D 9/013: Other fatty acid esters, e.g. phosphatides
- A23K 20/158: Fatty acids; Fats; Products containing oils or fats
- A23K 50/30: for swines
- A23L 29/06: {Enzymes}
- A23L 33/115: Fatty acids or derivatives thereof; Fats or oils
- A23L 33/12: Fatty acids or derivatives thereof
- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A61J 15/0003: {Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth}
- A61J 15/0026: {Parts, details or accessories for feeding-tubes (external tubes from medical containers to a connector outside of the body A61M39/08)}
- A61K 9/0029: {Parenteral nutrition; Parenteral nutrition compositions as drug carriers}
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 38/465: {acting on ester bonds (3.1), e.g. lipases, ribonucleases}
- A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- A61P 3/06: Antihyperlipidemics
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- B65D 1/02: Bottles or similar containers with necks or like restricted apertures, designed for pouring contents (thermally-insulated containers B65D81/38, A47J41/00; {feeding-bottles A61J9/00})
- B65D 41/02: Caps or cap-like covers without lines of weakness, tearing strips, tags, or like opening or removal devices
- B65D 81/32: for packaging two or more different materials which must be maintained separate prior to use in admixture
- B65D 85/72: for edible or potable liquids, semiliquids, or plastic or pasty materials
- C12Y 301/00: Hydrolases acting on ester bonds (3.1)
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- C12Y 301/01: Carboxylic ester hydrolases (3.1.1)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A23D: EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS OR COOKING OILS (preservation thereof A23B20/00; production, refinement or preservation of animal or vegetable fats or oils C11B, C11C)
- A23K: FODDER
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- 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
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- C12Y: ENZYMES
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

Nutritional formulas comprising long-chain polyunsaturated fatty acids (LC-PUFAs) are provided, along with methods and devices for preparing and/or administering nutritional formulas. In some embodiments, a percentage of the LC-PUFAs in the nutritional formula are in the form of monoglycerides and/or free fatty acids. In some embodiments, the nutritional formulas do not comprise added lipase. Also provided are methods for providing nutrition to a subject, methods for improving fat absorption, methods for improving cognitive ability, methods for preventing chronic lung disease, and methods for reducing the length of time a patient requires total parenteral nutrition.

## Claims

### Claim 1

A method of providing a nutritional composition to a subject, the method comprising:
receiving a nutritional composition within an enteral feeding device;
exposing the nutritional composition to lipase immobilized within the enteral feeding device, wherein exposing the nutritional composition to the lipase hydrolyzes triglycerides and/or esters within the nutritional composition to form a hydrolyzed nutritional composition; and
delivering the hydrolyzed nutritional composition from the enteral feeding device to the subject,
wherein the method reduces a length of time the subject is on total parenteral nutrition.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject is diagnosed with at least one of: Alzheimer's disease, bipolar disorder, depression, sepsis, acute respiratory stress, cancer, cardiovascular disease, stroke, Parkinson's disease, schizophrenia, diabetes, multiple sclerosis, malnutrition, impaired GI function, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, short bowel syndrome, irritable bowel disorder, Systemic Inflammatory Response Syndrome, celiac disease, Crohn's disease, Cystic Fibrosis, Zollinger-Ellison syndrome, hypertriglyceridemia, neoplasms, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis, diarrhea, Shwachman's syndrome, trypsinogen deficiency, enterokinase deficiency, chylothorax, isolated deficiency of lipase, premature birth, pancreatic insufficiency, pancreatitis, malabsorption, compromised pancreatic output, a reduced ability to hydrolyze triglycerides or esters, or a reduced ability to absorb triglycerides or esters.

### Claim 3 (depends on 1)

The method of claim 1, wherein the nutritional composition is exposed to the immobilized lipase for at least one minute, prior to delivering the hydrolyzed nutritional composition to the subject.

### Claim 4 (depends on 1)

The method of claim 1, wherein the nutritional composition is exposed to the immobilized lipase for no more than thirty seconds, prior to delivering the hydrolyzed nutritional composition to the subject.

### Claim 5 (depends on 1)

The method of claim 1, wherein the nutritional composition is exposed to the immobilized lipase for no more than one minute, prior to delivering the hydrolyzed nutritional composition to the subject.

### Claim 6 (depends on 1)

The method of claim 1, wherein the nutritional composition is exposed to the immobilized lipase for no more than five minutes, prior to delivering the hydrolyzed nutritional composition to the subject.

### Claim 7 (depends on 1)

The method of claim 1, wherein the nutritional composition is exposed to the immobilized lipase for no more than sixty minutes, prior to delivering the hydrolyzed nutritional composition to the subject.

### Claim 8 (depends on 1)

The method of claim 1, wherein exposing the nutritional composition to the immobilized lipase causes the hydrolyzed nutritional composition to comprise more free fatty acids than monoglycerides.

### Claim 9 (depends on 1)

The method of claim 1, wherein the enteral feeding device includes a syringe.

### Claim 10 (depends on 1)

The method of claim 1, wherein the method further reduces gut atrophy in the subject.

### Claim 11

A method of providing a nutritional composition to a subject, the method comprising:
receiving a nutritional composition within an enteral feeding device;
exposing the nutritional composition to lipase immobilized within the enteral feeding device, wherein exposing the nutritional composition to the lipase hydrolyzes triglycerides and/or esters within the nutritional composition into monoglycerides and free fatty acids to form a hydrolyzed nutritional composition; and
delivering the hydrolyzed nutritional composition from the enteral feeding device and to the subject,
wherein the method reduces gut atrophy in the subject.

### Claim 12 (depends on 11)

The method of claim 11, wherein the subject is diagnosed with at least one of: Alzheimer's disease, bipolar disorder, depression, sepsis, acute respiratory stress, cancer, cardiovascular disease, stroke, Parkinson's disease, schizophrenia, diabetes, multiple sclerosis, malnutrition, impaired GI function, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, short bowel syndrome, irritable bowel disorder, Systemic Inflammatory Response Syndrome, celiac disease, Crohn's disease, Cystic Fibrosis, Zollinger-Ellison syndrome, hypertriglyceridemia, neoplasms, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis, diarrhea, Shwachman's syndrome, trypsinogen deficiency, enterokinase deficiency, chylothorax, isolated deficiency of lipase, premature birth, pancreatic insufficiency, pancreatitis, malabsorption, compromised pancreatic output, a reduced ability to hydrolyze triglycerides or esters, or a reduced ability to absorb triglycerides or esters.

### Claim 13 (depends on 11)

The method of claim 11, wherein the hydrolyzed nutritional composition is delivered to the subject via a feeding tube.

### Claim 14 (depends on 11)

The method of claim 11, wherein exposing the nutritional composition to the immobilized lipase causes the hydrolyzed nutritional composition to comprise more free fatty acids than monoglycerides.

### Claim 15 (depends on 11)

The method of claim 11, wherein the nutritional composition is exposed to the immobilized lipase for at least one minute, prior to delivering the hydrolyzed nutritional composition to the subject.

### Claim 16 (depends on 11)

The method of claim 11, wherein the nutritional composition is exposed to the immobilized lipase for no more than five minutes, prior to delivering the hydrolyzed nutritional composition to the subject.

### Claim 17 (depends on 11)

The method of claim 11, wherein the nutritional composition is exposed to the immobilized lipase for no more than sixty minutes, prior to delivering the hydrolyzed nutritional composition to the subject.

### Claim 18 (depends on 11)

The method of claim 11, wherein the method further reduces a length of time the subject is on total parenteral nutrition.