IP Library Granted Patent US 12,178,785
Granted Patent B2
US 12,178,785 · App. 18/502,995 · Granted Dec 31, 2024

Methods, compositions, and devices for supplying dietary fatty acid needs

Inventors: Alexey L. Margolin (Newton, MA); Robert Gallotto (Newton, MA); Bhami Shenoy (South Grafton, MA)
Assignee: Alcresta Therapeutics, Inc.
A61J15/0092A23D7/011A23D7/013A23D9/013A23K20/158A23K50/30A23L29/06A23L33/115A23L33/12A23L33/40A61J15/0003A61J15/0026A61K9/0029A61K31/202A61K38/465B65D1/02B65D41/02B65D81/32B65D85/72C12Y301/00A23V2002/00C12Y301/01
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Quick Facts
Patent No.
US 12,178,785
App. No.
18/502,995
Granted
Dec 31, 2024
Kind
B2
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 monogiycerides 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 (48)

1. A device comprising:

a container for receiving a nutritional composition;

a first opening in the container, wherein the first opening is configured for connecting the container to a feeding tube;

a second opening in the container; and

a lipase immobilized within the container so that the nutritional composition is exposed to the lipase when the nutritional composition is received within the container,

wherein the lipase is configured to hydrolyze fats within the nutritional composition to form a nutritional formula.

2. The device of claim 1 , wherein the lipase is immobilized such that when the nutritional formula passes through the container the immobilized lipase remains in the container.

3. The device of claim 1 , wherein the lipase is immobilized to an inner surface of the container.

4. The device of claim 1 , wherein the lipase is immobilized to a structure within the container.

5. The device of claim 4 , wherein the structure comprises balls or beads within the container.

6. The device of claim 1 , wherein the first opening includes a connector for connecting to the feeding tube.

7. The device of claim 1 , wherein the container is a first container, and the second opening is configured to facilitate transferring the nutritional composition to a second container.

8. The device of claim 1 , wherein the container is a first container, and the second opening includes a connector for connecting to a second container.

9. The device of claim 1 , wherein the feeding tube is a nasogastric tube or a nasojejunal tube.

10. The device of claim 1 , wherein the lipase is immobilized by one or more of adsorption, ionic binding, covalent binding, cross-linking, encapsulation, or entrapment.

11. The device of claim 1 , wherein the lipase is selected from a group consisting of Chromobacterium viscosum lipase, Pseudomonas fluorescens lipase, and Rhizopus oryzae lipase.

12. The device of claim 1 , further comprising a filter located at the first opening, the second opening, or both the first opening and the second opening of the container.

13. The device of claim 1 , wherein immobilization of the lipase limits the amount of lipase that enters into the nutritional composition to no more than 0.1 milligram of lipase per milligram of triglycerides exposed to the lipase.

14. A method of preparing a nutritional formula, the method comprising:

passing a nutritional composition comprising triglycerides through the device of claim 1 to expose the nutritional composition to the immobilized lipase to at least partially hydrolyze at least a portion of the triglycerides to form the nutritional formula,

wherein, after exposure to the lipase, the nutritional formula contains less triglycerides and more monoglycerides and free fatty acids than before exposure to the lipase.

15. The method of claim 14 , wherein the nutritional formula is provided to a preterm infant or a subject having at least one of:

impaired gastrointestinal function;

fat malabsorption;

short bowel syndrome; or

cystic fibrosis.

16. The method of claim 14 , wherein the nutritional formula comprises more free fatty acids than monoglycerides after the nutritional composition is exposed to the lipase.

17. The method of claim 14 , wherein the nutritional formula is provided to a subject, and wherein the nutritional composition is exposed to the lipase for at least one minute, prior to ingestion by the subject.

18. The method of claim 14 , wherein the nutritional formula is provided to a subject, and wherein the nutritional composition is exposed to the lipase for at least 30 seconds, prior to ingestion by the subject.

19. The method of claim 14 , wherein the nutritional formula is provided to a subject, and wherein the nutritional composition is exposed to the lipase for no more than one minute, prior to ingestion by the subject.

20. The method of claim 14 , wherein the nutritional formula is provided to a subject, and wherein the nutritional composition is exposed to the lipase for no more than five minutes, prior to ingestion by the subject.

21. The method of claim 14 , wherein the nutritional formula is provided to a subject, and wherein the nutritional composition is exposed to the lipase for no more than 60 minutes, prior to ingestion by the subject.

22. A method of providing a nutritional formula, the method comprising:

flowing at least one of milk, infant formula, or enteral formula into the container of device 26 ;

hydrolyzing fats in the at least one of milk, infant formula, or enteral formula to form the nutritional formula by exposing the milk, infant formula, or enteral formula to immobilized lipase contained within the container of the device; and

outputting the nutritional formula from the device and into a feeding tube for ingestion by a subject.

23. The method of claim 22 , wherein the feeding tube is a nasogastric tube or a nasojejunal tube.

24. The method of claim 22 , wherein the lipase is immobilized to an inner surface of the container.

25. The method of claim 22 , wherein the lipase is immobilized to a structure within the container.

26. The method of claim 25 , wherein the structure comprises balls or beads within the container.

27. The method of claim 22 , wherein the lipase is immobilized to particles contained within the container.

28. The method of claim 22 , wherein the lipase is immobilized to limit the amount of lipase that enters the nutritional formula.

29. The method of claim 22 , wherein the nutritional formula output from the device comprises more free fatty acids than monoglycerides.

30. The method of claim 22 , wherein the nutritional formula is provided to a preterm infant or a subject having at least one of:

impaired gastrointestinal function;

fat malabsorption;

short bowel syndrome; or

cystic fibrosis.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 4, 2026
From: MARGOLIN, ALEXEY L.; GALLOTTO, ROBERT; SHENOY, BHAMI
To: ALCRESTA, INC.
Reel/Frame 074554/0257 →
SECURITY INTEREST Recorded Mar 12, 2024
From: ALCRESTA THERAPEUTICS, INC.
To: TWIN BROOK CAPITAL PARTNERS, LLC, AS AGENT
Reel/Frame 066742/0319 →
CHANGE OF NAME Recorded Nov 8, 2023
From: ALCRESTA, INC.
To: ALCRESTA THERAPEUTICS, INC.
Reel/Frame 065571/0839 →
Continuity (9)
Continuation 17211487 · Mar 24, 2021
Continuation 16000327 · Jun 5, 2018
Continuation 15684430 · Aug 23, 2017
Continuation 15587513 · May 5, 2017
Continuation 15240596 · Aug 18, 2016
Continuation 14378856
Provisional Application 61719173 · Oct 26, 2012
Provisional Application 61600207 · Feb 17, 2012
Related Publication 20240065943A1 · Feb 29, 2024