IP Library Granted Patent US 11,298,332
Granted Patent B2
US 11,298,332 · App. 16/446,192 · Granted Apr 12, 2022

Compositions for therapy and health containing amino acids with bitter taste

Inventors: Thomas Hanlon (Concord, MA); Andrew M. Wood (Newtown, PA)
Assignee: AXCELLA HEALTH INC.
A61K31/198A23L27/33A23L27/84A23L27/88A23L29/055A23L29/27A23L33/175A61K31/205A61K31/405A61K31/4172A61K47/12A61K47/22A61K47/26A61K47/36
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Quick Facts
Patent No.
US 11,298,332
App. No.
16/446,192
Granted
Apr 12, 2022
Kind
B2
Abstract

This disclosure provides a dry powder formulation of free amino acids with an acceptable and even good taste profile.

Claims (36)

1. A dry blended preparation comprising at least three amino acid entities and an excipient formulation, wherein the dry blended preparation is suitable for oral administration, wherein at least one amino acid entity has a bitter taste and the dry blended preparation has an acceptable taste, wherein the excipient formulation has fewer than eleven (11) ingredients, wherein the amino acid entities are not part of a peptide longer than 20 amino acids long, wherein the bitter tasting amino acid is arginine, valine, leucine, isoleucine, tryptophan, or phenylalanine; and one or both of:

the excipient formulation comprises acesulfame, and acesulfame is present in the dry blended preparation at a level less than 1% (w/w); or

the excipient formulation comprises sucralose, and sucralose is present in the dry blended preparation at a level less than 3.9% (w/w).

2. The dry blended preparation of claim 1 , wherein the at least three amino acid entities comprise:

(i) leucine, isoleucine, valine, lysine, histidine, threonine, and L-ornithine-L-aspartate;

(ii) leucine, isoleucine, valine, acetylcysteine (NAC), and acetyl-L-carnitine (ALCAR);

(iii) leucine, isoleucine, valine, arginine, histidine, and phenylalanine; or

(iv) leucine, isoleucine, valine, and arginine.

3. The dry blended preparation of claim 1 , which is: i) free of lecithin, ii) free of a bitterness masking agent, or iii) free of a rapid onset sweetener.

4. The dry blended preparation of claim 1 , wherein the excipient formulation comprises Xanthan Gum.

5. The dry blended preparation of claim 1 , wherein the excipient formulation comprises a pH modifying agent comprising citric acid.

6. The dry blended preparation of claim 1 , wherein the excipient formulation comprises a single flavor agent comprising an orange citrus flavor.

7. The dry blended preparation of claim 1 , wherein the excipient formulation comprises a vanilla custard aroma flavor agent.

8. The dry blended preparation of claim 1 , wherein the excipient formulation comprises an orange coloring agent (colorant).

9. The dry blended preparation of claim 1 , wherein the excipient formulation comprises a sweetener, a thickening agent, a pH modifying agent, a single flavor agent, an aroma flavor agent, and a coloring agent.

10. The dry blended preparation of claim 1 , wherein the excipient consists of a sweetener, a thickening agent, a pH modifying agent, a single flavor agent, an aroma flavor agent, and a coloring agent.

11. The dry blended preparation of claim 9 , wherein the sweetener is sucralose, wherein the thickening agent is Xanthan Gum, the pH modifying agent is citric acid, the flavor agent is an orange citrus flavor, the aroma flavor agent is vanilla custard, and the coloring agent is orange.

12. The dry blended preparation of claim 1 , wherein the excipient formulation comprises sucralose, Xanthan Gum, citric acid for modifying pH, an orange citrus flavor agent, a vanilla custard aroma flavor agent, and an orange coloring agent.

13. The dry blended preparation of claim 1 , wherein the excipient formulation consists of sucralose, Xanthan Gum, citric acid for modifying pH, an orange citrus flavor agent, a vanilla custard aroma flavor agent, and an orange coloring agent.

14. The dry blended preparation of claim 9 , which is: i) free of lecithin, ii) free of a bitterness masking agent, or iii) free of a rapid onset sweetener.

15. The dry blended preparation of claim 1 , wherein the excipient formulation is less than about 30% of the composition by weight.

16. The dry blended preparation of claim 1 , which comprises at least four amino acid entities.

17. The dry blended preparation of claim 1 , wherein the pH of the composition when dissolved in water is less than or equal to 6.

18. The dry blended preparation of claim 1 , wherein the excipient formulation has fewer than ten (10), nine (9), eight (8), seven (7), six (6), or five (5) ingredients.

19. The dry blended preparation of claim 1 , wherein the taste of the composition is less bitter than the taste of the at least one amino acid entity having a bitter taste.

20. The dry blended preparation of claim 1 , wherein the dry blended preparation comprises less than or equal to 1% water by weight (w/w).

21. The dry blended preparation of claim 1 , wherein the excipient formulation comprises acesulfame, and acesulfame is present in the composition at a level less than 1% (w/w).

22. The dry blended preparation of claim 1 , wherein the excipient formulation comprises sucralose, and sucralose is present in the composition at a level less than 3.9% (w/w).

23. The dry blended preparation of claim 1 , wherein:

the excipient formulation comprises acesulfame, and acesulfame is present in the composition at a level less than 1% (w/w); and

the excipient formulation comprises sucralose, and sucralose is present in the composition at a level less than 3.9% (w/w).

24. The dry blended preparation of claim 23 , wherein the excipient formulation is less than about 20% of the dry blended composition by weight.

25. The dry blended preparation of claim 1 , wherein the dry blended preparation is formulated into a unit dosage of between about 4 g and about 80 g total amino acids.

26. The dry blended preparation of claim 17 , wherein the pH of the dry blended preparation when dissolved in water is from 3 to 4.6.

27. The dry blended preparation of claim 17 , wherein the pH of the dry blended preparation when dissolved in water is from 3.5 to 6.

28. The dry blended preparation of claim 17 , wherein the pH of the dry blended preparation when dissolved in water is from 3 to 5.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2023
From: AXCELLA HEALTH INC.
To: AXCELLA (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC
Reel/Frame 066043/0001 →
RELEASE OF SECURITY INTEREST Recorded Dec 15, 2022
From: SLR INVESTMENT CORP.
To: AXCELLA HEALTH INC.
Reel/Frame 062137/0569 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Sep 2, 2021
From: AXCELLA HEALTH INC.
To: SLR INVESTMENT CORP., AS AGENT
Reel/Frame 057435/0136 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 29, 2020
From: HANLON, THOMAS; WOOD, ANDREW M.
To: AXCELLA HEALTH INC.
Reel/Frame 054766/0240 →
Continuity (2)
Provisional Application 62687715 · Jun 20, 2018
Related Publication 20190388375A1 · Dec 26, 2019