Administration of leptin

• US 7,354,896 B2
• Filed: 11/04/2002
• Issued: 04/08/2008
• Est. Priority Date: 04/29/1999
• Status: Expired due to Fees

• Current Assignee: Nemours Foundation
• Original Assignee: Nemours Foundation
• Inventors: Kirwin, Susan M., Funanage, Vicky L.
• Primary Examiner(s): DANG, IAN D
• Application Number:
  US10/286,947
• Publication Number:
  US 20030130192A1
• Time in Patent Office: 1,982 Days
• Field of Search: None
• US Class Current: 514/5.2
• CPC Class Codes: A61K 35/20 Milk; Whey; Colostrum
• CPC Class Codes: A61K 38/2264 Obesity-gene products, e.g. leptin
• CPC Class Codes: A61K 9/5015 Organic compounds, e.g. fats, sugars
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00

Abstract

A method and composition for administering leptin to a subject. The invention includes suspending isolated native leptin-containing milk fat globules in a suitable medium for administering to a subject. The suspended milk fat globules may be administered orally as well as by intravenous, intramuscular, intraperitoneal, other enteral routes of administration, and other parenteral routes of administration. The invention includes a method for treating growth or maturational-related disorders in newborns as well as subjects having conditions that can be treated by the administration of leptin.

Claims

1. A method for stimulating growth in an infant, said method comprising the steps of:

administering isolated and substantially purified milk fat globules containing an effective dosage of leptin to the infant, and

stimulating growth in the infant.

2. The method of claim 1, wherein the effective dosage of leptin is in the range of about 0.5 ng to about 1.0 ng of leptin per gram of infant body weight.

3. The method of claim 1, wherein said administering step is performed orally.

4. The method of claim 1, wherein said administering step is performed by an administration route selected from the group consisting of intravenously, subcutaneously, intraperitonally, and intramuscularly.

5. The method of claim 1, wherein the isolated and substantially purified milk fat globules containing the effective dosage of leptin are suspended in a medium appropriate for administration to an infant at a concentration in the range of about 50 ng/ml leptin to about 100 ng/ml leptin.

6. The method of claim 5, wherein the medium is selected from the group consisting of physiologic saline, breast milk, milk, water, and baby formula.

7. The method of claim 6, wherein the medium is baby formula.

8. The method of claim 5, wherein the medium is administered by an administration route selected from the group consisting of intravenously, subcutaneously, intraperitonally, and intramuscularly.

9. The method of claim 1, wherein the infant is a formula-fed infant.

10. The method of claim 1, wherein the infant is a small-for-gestational age infant.

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

12. The method of claim 1, wherein the infant has low leptin levels.