Inclusion complexes and methods for making the same

Patent metadata

Field	Value
Publication number	US-2016263245-A1
Application number	US-201615069371-A
Country	US
Kind code	A1
Filing date	Mar 14, 2016
Priority date	Mar 12, 2015
Publication date	Sep 15, 2016
Grant date	—

Abstract

The invention provides novel formulations comprising a stable inclusion complex of tributyrin and a cyclodextrin. In one particular embodiment, the formulation comprises an oven dried inclusion complex of tributyrin and γ-cyclodextrin that is effective in minimizing or preventing the unpleasant taste and odor of tributyrin, thus making it suitable for oral administration and delivery to the digestive tract and intestines. The invention provides compositions of these inclusion complexes and methods of using them that are advantageous as food, medicinal and other products, where the negative sensory properties of tributyrin can be a liability.

First claim

What is claimed is:

1 . A stable inclusion complex comprising tributyrin and a cyclodextrin.

2 . The inclusion complex of claim 1 where the cyclodextrin is γ-cyclodextrin.

3 . The inclusion complex of claim 2 where the molar ratio of tributyrin to γ-cyclodextrin is greater than or equal to about 1:1.

4 . The inclusion complex of claim 3 where the molar ratio of tributyrin to γ-cyclodextrin is from about 1:1 to about 1:3

5 . The inclusion complex of claim 1 which has less than about 20% of water.

6 . The inclusion complex of claim 1 which has been oven dried.

7 . An oral powder or capsule comprising the inclusion complex of claim 1 .

8 . A pharmaceutical composition comprising the inclusion complex of claim 1 and a pharmaceutically acceptable excipient.

9 . A food additive comprising the inclusion complex of claim 1 and a dietary acceptable supplement.

10 . The food additive of claim 9 further comprising one or more of the following ingredients: calcium, at least one natural flavor, at least one sweetener, at least one disintegrant, at least one protein, at least one carbohydrate, at least one mineral, at least one vitamin and/or at least one organic acid.

11 . The food additive of claim 9 where the supplement comprises an omega-3 fatty acid, Vitamin A, Vitamin D3, Vitamin E, or a combination thereof.

12 . An oral infant formula comprising the inclusion complex of claim 1 and one or more of the following ingredients: sugar, milk, water, a protein, a carbohydrate, a mineral, a vitamin and/or an edible fat.

13 . A method for preparing a stable inclusion complex of a cyclodextrin and tributyrin comprising:
a. mixing the cyclodextrin with water to form a first mixture; b. adding tributyrin to the first mixture to form a second mixture; c. mixing the second mixture to form a first inclusion complex; d. centrifuging the first inclusion complex; e. decanting the first inclusion complex to provide a centrifugate; f. drying the centrifugate; and g. crushing the centrifugate to form the stable inclusion complex.

14 . A method for preparing a powdered stable inclusion complex of a cyclodextrin and tributyrin comprising:
a. shear mixing a cyclodextrin with water to form a first mixture; b. adding tributyrin to the first mixture to form a second mixture; c. shear mixing the second mixture to form a first inclusion complex; d. allowing the first inclusion complex to sit for a period of time; e. shear mixing the first inclusion complex to form a second inclusion complex; f. allowing the second inclusion complex to sit for a period of time; g. removing excess tributyrin and water from the second inclusion complex to form a third inclusion complex; h. centrifuging the third inclusion complex; i. decanting excess tributyrin and water from the third inclusion complex to form a fourth inclusion complex; j. heating the fourth inclusion complex to form a solid inclusion complex; and k. grinding the solid inclusion complex to form the powdered stable inclusion complex.

15 . A method of treating or prophylactically protecting against the onset of an inflammatory bowel disease or disorder comprising administering a therapeutically effective amount of the inclusion complex of claim 1 to a mammal in need of such treatment.

16 . The method of claim 15 which is in an oral dosage form.

17 . The method of claim 15 where the inflammatory bowel disease or disorder comprises ulcerative colitis, Crohn's disease, irritable bowel syndrome, shortened bowel syndrome, or a combination thereof.

18 . A method of treating or prophylactically protecting against the onset of colon cancer comprising administering a therapeutically effective amount of the inclusion complex of claim 1 to a mammal in need of such treatment.

19 . The method of claim 18 which is in an oral dosage form.

20 . A method of treating or prophylactically protecting against the onset of food deficiency comprising administering a therapeutically effective amount of the inclusion complex of claim 1 to a mammal in need of such treatment.

Assignees

• Univ Illinois
• Univ Illinois

Inventors

• Donovan Joseph D
• Lee Soo-Yeun
• Lee Youngsoo

Classifications

• A61K31/225

  Polycarboxylic acids · CPC title

• A23V2002/00

  Food compositions, function of food ingredients or processes for food or foodstuffs · CPC title

• A23L1/303

  Human Necessities · mapped topic

• A23L1/305

  Human Necessities · mapped topic

• A23L1/30

  Human Necessities · mapped topic