Administration of leptin

• US 6,475,984 B2
• Filed: 04/29/1999
• Issued: 11/05/2002
• Est. Priority Date: 04/29/1999
• Status: Active Grant

• Current Assignee: Nemours Foundation
• Original Assignee: Nemours Foundation
• Inventors: Kirwin, Susan M., Funanage, Vicky L.
• Primary Examiner(s): Crouch, Deborah
• Assistant Examiner(s): WOITACH, JOSEPH T
• Application Number:
  US09/302,117
• Publication Number:
  US 20020015709A1
• Time in Patent Office: 1,286 Days
• Field of Search: 530/350, 514/21, 514/2, 424/198.1
• US Class Current: 514/4.8
• 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 preparing isolated milk fat globules containing leptin comprising the steps of:

centrifuging milk from a mammal to produce a supernatant having a cream portion;

isolating the cream from the supernatant;

centrifuging the cream at 4°

C.-6°

C. and at 100 g to collect milk fat globules in the form of a congealed cream; and

washing the congealed cream to produce isolated milk fat globules containing leptin.

2. A method for increasing the growth of a small-for-gestational age infant comprising the step of administering isolated milk fat globules containing leptin to the small for gestational age infant in an amount ranging from about 0.5 ng to about 1.0 ng of leptin per gram of infant body weight per feeding.

3. The method of claim 2 wherein the step of administration is performed orally.

4. The method of claim 2 wherein the step of administration is performed enterally.

5. The method of claim 2 wherein the step of administering comprises milk fat globules containing leptin prepared by;

centrifuging milk from a mammal to produce a cream;

isolating the cream;

centrifuging the cream at 4°

C.-6°

C. and at 100 g to form a congealed cream; and

washing the congealed cream to produce isolated milk fat globules containing leptin.

6. The method of claim 2 wherein the milk fat globules contain leptin are suspended in a medium at a concentration between about 50 ng/ml leptin to about 100 ng/ml leptin.

7. A method for increasing the growth of a premature infant comprising the step of administering isolated milk fat globules containing leptin to the premature infant in an amount ranging from about 0.5 ng to about 1.0 ng of leptin per gram of infant body weight per feeding.

8. The method of claim 7 wherein the step of administration is performed orally.

9. The method of claim 7 wherein the step of administration is performed enterally.

10. The method of claim 7, wherein the step of administering comprises

milk fat globules containing leptin prepared by:

centrifuging milk from a mammal to produce a cream;

isolating the cream;

centrifuging the cream at 4°

C.-6°

C. and at 100 g to form a congealed cream; and

washing the congealed cream to produce isolated milk fat globules containing leptin.

11. The method of claim 7 wherein the milk fat globules containing leptin are suspended in a medium at a concentration between about 50 ng/ml leptin to about 100 ng/ml leptin.