Compositions of human lipids and methods of making and using same

• US 8,377,445 B2
• Filed: 12/10/2007
• Issued: 02/19/2013
• Est. Priority Date: 12/08/2006
• Status: Active Grant

• Current Assignee: Prolacta Bioscience Inc.
• Original Assignee: Prolacta Bioscience Inc.
• Inventors: Medo, Elena M., Eaker, Scott
• Primary Examiner(s): Cutliff, Yate K
• Application Number:
  US12/518,237
• Publication Number:
  US 20100280115A1
• Time in Patent Office: 1,898 Days
• Field of Search: None
• US Class Current: 424/157.1
• CPC Class Codes: A23C 9/206 Colostrum; Human milk
• CPC Class Codes: A23L 33/115 Fatty acids or derivatives thereof; Fats or oils
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/32 having an effect on the health of the digestive tract
• CPC Class Codes: A23V 2250/1868 Docosahexaenoic acid
• CPC Class Codes: A23V 2250/1882 Polyunsaturated fatty acids
• CPC Class Codes: A23V 2300/34 Membrane process
• CPC Class Codes: A61K 35/20 Milk; Whey; Colostrum
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 7/06 Antianaemics

Abstract

The disclosure features methods of making compositions that include a human lipid. The methods can include: obtaining whole human milk; separating the milk into a cream portion and a skim portion; processing the cream portion; and pasteurizing the processed cream portion.

Claims

1. A method of making a composition comprising a human lipid, the method comprising:

(a) obtaining whole human milk;

(b) separating the milk into a cream portion and a skim portion;

(c) filtering the water out of the skim portion after step (b);

(d) suspending the cream portion obtained in step (b) with the water obtained in step (c);

(e) purifying the suspended cream portion obtained in step (d) to obtain a composition comprising a human lipid; and

(f) parenterally administering the composition comprising a human lipid obtained in step (e) to a human subject.

2. The method of claim 1, further comprising

(i) separating the cream portion obtained in step (b) into a second cream portion and a second skim portion;

and

(ii) in step (d) suspending both the cream portion and the second cream portion with the water obtained in step (c).

3. The method of claim 1, further comprising pasteurizing the composition comprising a human lipid after step (e).

4. The method of claim 1, wherein the purifying comprises diafiltration.

5. The method of claim 4, further comprising ultrafiltrating.

6. The method of claim 1, further comprising adding one or more constituents to the composition obtained in step (e) selected from the group consisting of:

an emulsifier, a preservative, a diluent, and an osmolality modifier.

7. The method of claim 6, wherein the preservative is an antioxidant.

8. The method of claim 7, wherein the antioxidant is selected from the group consisting of:

alpha-tocopherol, vitamin C, a carotenoid, and a retinoid.

9. The method of claim 6, wherein the osmolality modifier comprises glycerin.

10. The method of claim 1, further comprising, adding one or more constituents to the composition obtained in step (e) selected from the group consisting of:

a vitamin, a mineral, and a carbohydrate.

11. The method of claim 1, wherein the administration is part of total parenteral nutritional administration.

12. The method of claim 1, wherein the subject is a premature infant.

13. The method of claim 1, wherein the subject has a nutritional disease or disorder.