Method for producing dispersible sterol and stanol compounds

Details Method for producing dispersible sterol and stanol compounds Method for producing dispersible sterol and stanol compounds

1998-11-30

2001-06-05

Spear, James M. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S465000, C424S489000, C514S772300, C514S772400, C514S783000, C514S784000, C514S785000, C514S786000, C514S951000

Reexamination Certificate

active

06242001

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a method of producing sterols/stanols, in particular a method for producing &bgr;-sitosterol, with improved wetting and dispersion properties.
BACKGROUND OF THE INVENTION
As disclosed in U.S. Pat. Ser. Nos. 5,244,877, 5,502,045 and 5,578,334, various sterols/stanols, in particular &bgr;-sitosterol, are known to have cholesterol-lowering properties. The consumption of &bgr;-sitosterol is known to reduce cholesterol levels in the blood stream. Presently due to its handling and storage properties, &bgr;-sitosterol is incorporated in foods during its formulation, or while it is being manufactured. While this is effective in producing foods with beneficial effects, the consumer is limited to those foods in which the manufacturers incorporate &bgr;-sitosterol.
It would be highly desirable to provide sterols/stanols in a form that would be readily dispersible in aqueous media, thus increasing the amount available to micelles in the gut.
There have been several attempts to provide such a product with limited success. U.S. Pat. No. 3,881,005 discloses the use of a polyoxyethlene sorbitan monostearate that is added to a sterol suspension prior to spray drying. U.S. Pat. No. 4,195,084 discloses a tall oil suspension suitable for oral administration that is comprised of finely divided particles of &bgr;-sitosterol in water. Other solutions described in the art include, U.S. Pat. Ser. No. 3,004,043 which discloses water-soluble vegetable oil sterol derivatives and U.S. Pat. No. 3,085,939 which discloses oil-in water sterol emulsions. While these disclosures provide edible compositions of sterols, the disclosures fail to provide the sterol in a form that would be more readily available to the body.
FIELD OF THE INVENTION
A primary object of the present invention is to provide orally administered self-dispersing solid compositions and methods of producing these compositions that contain sterols/stanols and hydrocarbons for control of blood serum cholesterol. An orally administered sterols/stanols and highly branched hydrocarbon solid dosage form is also claimed. These compositions are provided without the intentional addition of water to the composition.


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