Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Matrices
Reexamination Certificate
2000-03-22
2002-12-10
Webman, Edward J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Matrices
C424S439000, C424S484000, C424S487000, C424S457000, C424S468000, C424S400000, C512S014000, C512S014000
Reexamination Certificate
active
06491952
ABSTRACT:
TECHNICAL FIELD
The present application describes a composition containing a cholesterol lowering component, as &bgr;-sitosterol and/or &bgr;-sitostanol, food containing such a composition, and a method to prepare the composition.
BACKGROUND OF THE INVENTION
A daily intake of some compounds similar to cholesterol has been shown to have a cholesterol lowering effect. Specifically this is true for &bgr;-sitosterol and the hydrogenated form &bgr;-sitostanol (1-5).
Under &bgr;-sitosterol is also understood mixtures containing &bgr;-sitosterol, &bgr;-sitostanol and campesterol isolated from for instance soy or tall oil. Under &bgr;-sitostanol is also understood fully or partly hydrogenated &bgr;-sitosterol as above.
It is known that sterols and stanols are compounds with a very low solubility. They also crystallize easily. Several researchers have pointed at the importance that &bgr;-sitosterol and &bgr;-sitostanol must be administered in a formulation giving the optimal cholesterol lowering effect in the body. In a crystalline form even after efficient micronisation and/or in suspension the effect is lower than for solutions or emulsions (6-15). Hitherto described solutions and emulsions, however, have the disadvantage being too dilute to allow a simple intake in doses necessary of about 1.5 g/day (16-18).
The solubility in fat of sterols and stanols, both being alcohols, can be increased considerably by esterification with fatty acids. These esters are hydrolyzed in the stomach and sterols and stanols are liberated as the initial alcohols in a concentration low enough not to allow re-crystallization. The cholesterol lowering effect in the gut is thus improved (16-20).
We have now shown that it is not necessary to esterify sterols and stanols to be able to distribute them in a sufficiently high concentration in a monomolecular, low associated or “cluster form” to reach necessary daily doses.
DESCRIPTION OF THE INVENTION
In the present invention we show how sterols and stanols by simple methods can be stabilised in monomolecular, low associated or “cluster” form by distributing and immobilising a solution of high concentration or a melt of sterols and/or stanols in a matrix.
Sterols and/or stanols are initially dissolved in an organic phase, for instance in mono, di- or triglycerides, fatty acids, lecithin and others preferentially at an elevated temperature. The solution is then mixed with a stabilising phase matrix, containing a high molecular material e.g., gelatin, casein, starch syrup, pectin, ethylhydroxyethylcellulose or other at an elevated temperature. The mixture is then allowed to set to a solid, rubberlike or highly viscous mass. The stabilising phase can also be based on solvents being solid at room temperature.
An alternative way to make the composition is to foam a solution of the sterols and/or stanols containing a solvent solid at room temperature possibly in the presence of a foam building component under rapid cooling. The surface of sterols and/or stanols accessible to the stomach thus becomes extremely large. Foaming can be done in different known ways. Some percent of ethanol can be added to the sterols and/or stanols, the mixture is melted at elevated temperatures, the alcohol evaporated in vacuo under formation of foam.
The solutions described above can also be mixed into different food e.g. chocolate, dough/bread, jelly, mashed potatoes, butter/margarine, yougurt and others or be encapsulated or mixed into tablets.
The special characteristics of the present innovation are also shown by the enclosed claims.
The present innovation is described below by not limiting examples. If not otherwise stated the given values are in weight or weight %.
REFERENCES:
patent: 3881005 (1975-04-01), Thakkar et al.
patent: 5244887 (1993-09-01), Straub
patent: 4038385 (1992-06-01), None
patent: 0357967 (1990-03-01), None
patent: 1365661 (1974-09-01), None
Nisshin Oil Mills Ltd., “Instant powder compsns with improved dispersibility—contg. lecithin and sterol (deriv.)”, File WPI, Derwent accession No. 87-196297.
Nguyen Helen
Triple Crown AB
Webman Edward J.
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