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Last Updated: January 29, 2022

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Claims for Patent: 10,350,186


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Summary for Patent: 10,350,186
Title:Treatment and prevention of liver disease associated with parenteral nutrition (PN)
Abstract: The present invention is based on the discovery that parenteral nutrition (PN) induced liver disease, e.g. fatty liver disease, can be prevented and even reversed by administration of primarily omega-3-fatty acid with PN rather than the administration of the standard intravenous lipid emulsions that contain primarily plant derived omega-6 fatty acid. Thus, the present invention provides a method for treating or preventing liver disease in a human patient obtaining nutritional support through PN. The method comprises intravenous administration of an effective amount of an omega-3-fatty acid emulsion to the patient, wherein the patient is not administered phytosterols or plant derived fatty acids, e.g. omega-6 fatty acids derived from a plant source, and wherein the administration of the omega-3-fatty acid emulsion to the patient is for a period greater than three weeks. Preferably, the administration is for a period of greater than six weeks. More preferably, the administration is for a period greater than three months.
Inventor(s): Puder; Mark (Medfield, MA), Gura; Kathleen M. (Norfolk, MA)
Assignee: CHILDREN'S MEDICAL CENTER CORPORATION (Boston, MA)
Application Number:15/912,851
Patent Claims: 1. A method for preventing parenteral nutrition-associated cholestasis (PNAC) in a human patient obtaining nutritional support through total parenteral nutrition (PN) comprising intravenous administration of an effective amount of a lipid emulsion comprising fish oil derived omega-3-fatty acid as the active ingredient to a human patient obtaining long-term nutritional support through parenteral nutrition, wherein the emulsion does not contain phytosterols or plant derived fatty acids, and wherein the patient is not administered phytosterols or plant derived fatty acids.

2. The method of claim 1, wherein the fish oil is derived from a source selected from the group consisting of menhaden, herring, mackerel, cod, caplin, tilapia, tuna, sardine, pacific saury, salmon, arctic char and krill.

3. The method of claim 1, wherein the emulsion is prepared using an emulsifying agent selected from the group consisting of egg phosphatidylcholine, egg lecithin, L-adipalmitoyl phosphatidylcholine (DPPC), DL-a-dipalmitoyl phosphatidylethanolamine (DPPE), and dioleoyl phosphatidylcholine (DOPC).

4. The method of claim 1, wherein the patient is a newborn.

5. The method of claim 1, wherein the patient is a premature newborn.

6. The method of claim 1, wherein the patient is an infant.

7. The method of claim 6, wherein the infant is less than 2 years old.

8. The method of claim 1, wherein the patient is a child under the age of 18.

9. The method of claim 1, wherein the patient is a child under the age of 12.

10. The method of claim 1, wherein the patient is an adult receiving long term nutritional support through parenteral nutrition.

11. The method of claim 1, wherein the emulsion is administered until said patient is capable of receiving adequate nutrition from enteral food intake.

12. The method of claim 1, wherein the omega-3-fatty acid is administered at a dose of 0.2 g/kg/day to 3.0 g/kg/day.

13. The method of claim 1, wherein the omega-3-fatty acid is administered at a dose of 0.5 g/kg/day to 1.0 g/kg/day.

14. The method of claim 1, wherein the patient has short-bowel syndrome.

15. The method of claim 1, wherein the administration of the lipid emulsion is for a period greater than 3 weeks.

16. The method of claim 1, wherein the administration of the lipid emulsion is for a period greater than 6 weeks.

17. The method of claim 1, wherein the administration of the lipid emulsion is for a period greater than 3 months.

18. A method for preventing parenteral nutrition-associated cholestasis (PNAC) in a human patient less than two years old obtaining nutritional support solely through parenteral nutrition (PN), the method comprising intravenous administration of an effective amount of a lipid emulsion comprising fish oil derived omega-3-fatty acid as the active ingredient to a human patient less than two years old obtaining long-term nutritional support through parenteral nutrition, wherein the emulsion does not contain phytosterols or plant derived fatty acids, wherein the patient is not administered phytosterols or plant derived fatty acids, and wherein the human patient less than two years old has short-bowel syndrome.

19. A method for treating parenteral nutrition-associated cholestasis (PNAC) in a human patient in need thereof comprising intravenous administration of a lipid emulsion to the human patient, wherein the patient is obtaining nutritional requirements solely through total parenteral nutrition, and the lipid emulsion consists essentially of an effective amount of fish oil rich in omega-3-fatty acids and does not contain plant derived omega-6-fatty acids, wherein the patient is administered the lipid emulsion for a period greater than three weeks, wherein the patient is not administered any other form of lipid parenteral emulsion during the period of treatment, and wherein said human patient is a child under the age of 12.

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