Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active... – Ion exchange resin
Patent
1994-05-25
1997-12-09
Kulkosky, Peter F.
Drug, bio-affecting and body treating compositions
Solid synthetic organic polymer as designated organic active...
Ion exchange resin
424439, 424440, A61K 4700, A61K 31785
Patent
active
056957491
DESCRIPTION:
BRIEF SUMMARY
The invention relates to a method of producing oil-free compositions containing cholestyramine and starch, esp. in the form of bars for the immediate consumption by hypercholesterolemia patients.
Cholestyramine is the international free name (INN of WHO) for the chloride of a styrene-divinyl benzene-copolymerisate containing quaternary ammonium groups. Cholestyramine is effective as ion exchanger for binding of gallic acids and at hypercholesterolemia as lipid-lowering agent. In the last mentioned use quite large dosages have to be used, which might be as high as between 4 and 16 g for each separate delivery and up to 32 g daily. This is a problem because cholestyramine is present in the form of very fine, water-insoluble ion-exchange particles. When eating this in suspended or solid form a fishy smell and taste occurs and moreover an unpleasant sandy taste remains in the mouth thereafter, which sometimes is also called "drifting sand effect". Therefor it is difficult to get patients to take in cholestyramine preparations on a regular basis over a prolonged time in the required high doses.
The most varying attempts have already been made to transfer cholestyramine into a more patient-friendly form, which should be easy to use, i.e. could be eaten directly, and tasty. Among others, suspensions (e.g. in the form of fruit juices), powder, bakery products and bars (for example in the form of sweet nougat or chocolate bars) have been developed.
The cholestyramine compositions according to DE-A-38 08 191 are present in the form of an aquous suspension with fixed viscosity.
The EP-A-347 014 describes cholestyramine containing bakery products, which are manufactured by baking for 20 minutes at about 150.degree.-180.degree. C. from a dough, which, besides water contains a cooking oil, a mono- or polysaccharide, flavorings as well as cholestyramine.
From the EP-A-492 235 are previously known non-baked cholestyramine products with a moisture content of <11%. These products contain cholestyramine, cereals such as flour or bran, sugar, flavorings, binding agents based on starch as well as optionally cooking oil. The working is performed in such a way that the mixture is not baked at temperatures of 150.degree. C. or above, but instead is dried at about 70.degree. C. under reduced pressure over a long time of about 16 to 48 hours, until the desired low moisture content has been achieved.
None of the suggestions known sofar has led to a cholestyramine product in solid form, which fulfill the above mentioned claims regarding smell and taste, having a simple composition and being apt to be manufactured only with the aid of technologies at disposal. The object of the invention is to solve these problems.
Surprisingly it has been found that in view of nutritional physiology and also in view of taste and smell in all aspects satisfactory cholestyramine products are obtained in solid form, when the recipe as well as the manufacturing conditions are selected in a certain way and are adjusted to each other.
Thus, the object of the invention is a method for manufacturing cholestyramine and starch containing compositions free of oil, preferably in the form of bars, especially for the immediate intake by hypercholesterolemia patients, which is characterized in that cholestyramine and grain starch in a weight ratio of 1:1.8 to 2.9, preferably 1:2.2 to 2.7, with the addition of grain bran as filling agent and optionally a flavoring with 10-35% by weight of water (relative to the starting materials) are mixed into a homogeneous moist mass, which mass is processed by extrusion into a string, whereby the temperature (measured in the mass in the extrusion head) is 105.degree.-180.degree. C. and the pressure (measured in the extrusion head) is 30-70 bar, and in that subsequently a drying is performed at a temperature above 100.degree. C. to a remaining moisture content of .ltoreq.3,5% by weight, whereby the extruded material preferably before or after the drying step is divided into bars or is ground into a powder.
By "bars" within the
REFERENCES:
patent: 5026555 (1991-06-01), Schulz
patent: 5167965 (1992-12-01), Killeen
Friess Stefan
Heckenmuller Harald
Astra Aktiebolag
Kulkosky Peter F.
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