Dietary emulsion formulations and methods for using the same

Patent metadata

Field	Value
Publication number	US-10328045-B2
Application number	US-201515509766-A
Country	US
Kind code	B2
Filing date	Sep 10, 2015
Priority date	Sep 12, 2014
Publication date	Jun 25, 2019
Grant date	Jun 25, 2019

Abstract

Disclosed herein is a formulation that can take the form of an emulsion which contains total enteral or parenteral nutrition for a recipient subject. The formulation includes as the sole fat components: (i) medium chain triglycerides; and (ii) very long chain fatty acids selected from (a) very long chain omega-3 polyunsaturated fatty acids; and (b) docosahexaenoic acid and arachidonic acid in a ratio of about 10:1 (v/v or w/w) to about 2000:1 (v/v or w/w). The sole fat components provide about 10% to about 90% total calories of the formulation, and the medium chain triglycerides provide about 25%-95% total fat calories of the formulation. Methods and kits for utilizing the formulation and for treating various disorders and diseases that involve an inflammatory response are also disclosed.

First claim

The invention claimed is:

1. An emulsion formulation for total enteral or parenteral nutrition of a human subject comprising as the sole fat components:
(i) medium chain triglycerides; and
(ii) very long chain fatty acids selected from the group consisting of (a) very long chain omega-3 polyunsaturated fatty acids (VLC omega-3 PUFAs) and (b) docosahexaenoic acid (DHA) and arachidonic acid (AA) in a ratio of about 10:1 (v/v or w/w) to about 2000:1 (v/v or w/w);
wherein the weight ratio of the medium chain triglycerides and VLC omega-3 PUFAs is greater than 1:1;
wherein the sole fat components provide about 10% to about 90% total calories of the formulation, and
wherein the medium chain triglycerides provide about 25%-95% total fat calories.

2. The emulsion formulation of claim 1 , wherein the sole fat components are present in an amount of about 10 g to about 50 g per 100 mL of the formulation.

3. The emulsion formulation of claim 2 , wherein the sole fat components are present in an amount of about 20 g to about 30 g per 100 mL of the formulation.

4. The emulsion formulation of claim 2 , wherein the total calories of the formulation is from about 1000 kcal/kg of the formulation to about 4000 kcal/kg of the formulation.

5. The emulsion formulation of claim 1 , wherein the weight ratio of the medium chain triglycerides to the very long chain fatty acids is about 70:30.

6. The emulsion formulation of claim 1 , wherein the medium chain triglycerides have a carbon length of 6, 8, and/or 10.

7. The emulsion formulation of claim 1 , wherein the very long chain fatty acids provide about 2-10% total calories of the formulation.

8. The emulsion formulation of claim 1 , wherein the very long chain fatty acids provide about 3% total calories of the formulation.

9. The emulsion formulation of claim 1 , wherein the VLC omega-3 PUFAs are selected from the group consisting of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and 5-docosapentaenoic acid (DPA), and combinations thereof.

10. The emulsion formulation of claim 1 , wherein the very long chain fatty acids are docosahexaenoic acid (DHA) and arachidonic acid (AA) in a ratio of about 20:1 (v/v or w/w).

11. The emulsion formulation of claim 1 , wherein:
a) the sole fat components are present in an amount of about 40 g/100 ml;
b) the medium chain triglycerides have a carbon length of 6, 8, and/or 10, and provided at a weight ratio of 70:30 to the weight of the very long chain fatty acids;
c) wherein the very long chain fatty acids are docosahexaenoic acid (DHA) and arachidonic acid (AA) present in a ratio of about 20:1 (v/v or w/w) wherein these very long chain fatty acids provide about 3% total calories of the formulation;
d) wherein the total calories of the formulation is from about 1000 kcal/kg to about 4000 kcal/kg;
e) wherein the above total fat components provide from about 10% to about 90% total calories of the formulation; and
f) wherein the medium chain triglycerides provide from about 25%-95% total fat calories.

12. The emulsion formulation of claim 1 , wherein the very long chain fatty acids provide about 0.05-70% total calories of the formulation.

Assignees

• Childrens Medical Center
• Beth Israel Deaconess Medical Ct Inc
• Childrens Medical Center Corp Inc

Inventors

• Puder Mark
• Bistrian Bruce R

Classifications

• A61K8/97

  from algae, fungi, lichens or plants; from derivatives thereof · CPC title

• A61K8/64

  Proteins; Peptides; Derivatives or degradation products thereof · CPC title

• A61K2800/884

  Sequential application · CPC title

• A61K2800/20

  Chemical, physico-chemical or functional or structural properties of the composition as a whole · CPC title

• A23L33/30

  Dietetic or nutritional methods, e.g. for losing weight (A23L33/10 takes precedence) · CPC title