MXPA01001208A - Novel chitosan-containing liquid compositions and methods for their preparation and use - Google Patents

Abstract

The invention is novel liquid chitosan-containing compositions, their methods of preparation, and their methods of use. In particular, the invention is a novel chitosan-containing liquid suspension composition which remains stable and is usable as an additive, for instance, in water or aqueous solution (i.e., water-based liquids).

Description

NEW LIQUID COMPOSITIONS CONTAINING QUITOSAN AND METHODS FOR PREPARATION AND USE TECHNICAL FIELD OF THE INVENTION The present invention pertains to new liquid compositions containing chitosan, its methods of preparation, and its methods of use. In particular, the invention pertains to a liquid suspension composition containing chitosan which remains stable and is useful as an additive, for example, in water or water-based liquids.

BACKGROUND OF THE INVENTION We live in a society obsessed with the overall personal appearance and weight loss. Despite this obsession, medical reports confirm that 68% of all Americans are overweight, and 33% of those over the age of 20 are clinically obese. This equals 64 million overweight adults in the United States alone. Beyond obvious cosmetic considerations, obesity is one of the leading causes of heart disease, hypertension, stroke and diabetes, and is a contributing cause of cancer. The size of the market for weight control products is estimated at over $ 100 billion per year worldwide and is always growing. There is clearly a need for a product to control effective, safe and tasty weight to stop this growing problem. The medical profession has long proclaimed the benefits of a diet high in fiber and low in fat. Chitosan has received considerable attention in this context since it can be applied to bind fat in food, creating an indigestible mass that allows fat to pass without absorbing through the digestive system of an individual outside the body. Chitosan (ie, (1? 4) 2-amino-2-deoxy-β-D-glucosamine also known as polyglucosamine) is a water-immiscible biopolymer compound that partially or completely comprises a deacetylated chitin. a cellulose-like polymer that is present in fungal walls and arthropod exoskeletons that include insects, crabs, shrimps and lobsters.Chitosan can bind up to 4 to 6 times its weight in oils, fats, and toxic substances (Nauss et al. al., Lipids, 18 (10), 714-719 (1983).) This ability of chitosan because of its possession of positively charged amino groups that bind to negatively charged fatty acids (the building blocks of fat) and bile acids (used to make cholesterol) The unique abilities of chitosan are responsible for its use as an additive or primary component in numerous applications in the fields of food, health, cosmetics, agriculture, tion of waste water, as well as in other industries. In the food and health industry, chitosan is commonly available in tablet form under various trade names. Also, tablets containing chitosan combined with ascorbic acid are currently marketed. Ascorbic acid acts in synergy with chitosan to provide fat absorption properties which are greatly increased over those of chitosan alone. However, chitosan tablets are bulky, need to be taken in large quantities, have an unpleasant taste, and may have other noticeable side effects. Thus, there is a current need for a product that provides weight control and is easy to use, particularly compared to capsules containing chitosan. U.S. Patent 5,736,532 pertains to a cholesterol absorption and fat absorption formulation comprising chitosan and nicotinic acid, and describes the use of this formulation to reduce cholesterol. The patent discloses that the formulation must contain chitosan and nicotinic acid, and may additionally contain one or more other water-soluble acid vitamins, such as ascorbic acid, folic acid, etc. The patent describes the formulation of the mixture as a powder which is then formed into tablets or packed into gelatin capsules. Of course, these tablets and capsules are as inconvenient to take as are chitosan tablets. Also, it is well known that oral nicotinic acid taken by itself in high doses is effective in reducing serum cholesterol and triglyceride levels. However, in therapeutic doses, niocin can have various side effects, including stroke, skin rash, liver problems, activation of peptic ulcers, gout, worsening of diabetes control, as well as others (see, "Niacin for Cholesterolterol Lowering at http://www.heartinfo.com/niacin.html 6/7/99).) Certain patents describe, among other things, chitosan that may be in a liquid formulation, related US Patents 5,453,282, and 5,654,001 describe each a liquid chitosan formulation containing ascorbic acid (see, for example, Table 8 which describes a formulation containing fruit juice (210 g / l), sugar (100 g / l), ascorbic acid (1 g / l), essence (1 g / l), and chitosan (20 g / l)) that can be used to treat obesity, however, the liquid chitosan formulation of these patents has a questionable shelf life because the liquid contains high amounts of sugar without preservatives . Further, the patents do not provide teaching of the ways of solubilizing chitosan in the liquid (i.e., the weight ratio of chitosan to ascorbic acid employed in Table 8 is 20: 1, and no instructions are given in the patent regarding the special mixture to dissolve the chitosan in the liquid), meaning that the chitosan in the described liquid composition probably remains in the form of flake or powder.

Similarly, U.S. Patent 4,223,023 claims a "method for reducing lipid absorption in mammals which comprises orally administering to the mammal an amount of chitosan effective to substantially reduce lipid absorption" (claim 1). Example 6 of this patent pertains to a mixture of chitosan powder for oral administration which contains chitosan (80 g), lactose (10 g), sucrose (9.9 g), and flavoring. The powder mixture should be administered as a suspension in water, or other liquid. However, the patent does not provide instruction as to how much liquid should be added to the powder, much less provide any instruction regarding the solubilization of the chitosan in the liquid. All the remaining examples of this patent pertain to formulations in which the chitosan is combined to the mixture with fat or fatty acid. Such a combination will cause precipitation of the chitosan in the composition within a short period of time. In comparison, US Patents 4,202,881, 4,363,801, 4,474,769, and 4,512,968, and PCT International Application WO 98/32335 describe: (a) treatment of chitosan with acid, (b) rendering the water soluble chitosan by treatment with acid, and / or (c) liquid chitosan formulations. Especially, U.S. Patent 4,202,881 claims a process for shampoo and hair conditioner comprising adding to the hair an aqueous solution, emulsion, or gel containing TO a "water soluble salt of chitosan, the chitosan salt having been prepared by reacting chitosan ... with a sufficient amount of acid to neutralize the free amino groups present in the chitosan and to form a water soluble salt thereof" (claim 1). Column 2, lines 23-43 describes that the amino groups in chitosan can be neutralized with acids (especially with acetic acid, formic acid, and lactic acid) to obtain salts which are soluble in water, the patent, however, fails in describing the process by which a solution containing chitosan, emulsion, or gel can be obtained without adding the water-soluble salt of a chitosan to a hair conditioner and / or hair shampoo. U.S. Patent 4,512,968 claims a composition containing chitosan (which includes a liquid mouthwash) to reduce tooth decay (claim 1). Example 4 describes an aqueous mouthwash formulation and Example 6 describes a liquid oral refresher. Column 2, lines 37-47 describes that chitosan is first dissolved in weak inorganic acids to make it soluble in water, the patent, however, fails to describe the process by which a composition containing chitosan can be obtained without including in the formulation other ingredients that impact the character of the composition (for example, ethyl alcohol, sodium lauryl sulfonate, sodium α-olefin sulphonate, lauroyl sarcosinate sodium and / or glycerin or other agents).

In comparison, U.S. Patent 4,474,769 claims a formulation of chitosan as a contraceptive. Column 2, lines 44-53 describes that chitosan dissolves first into weak acids (especially acetic acid, formic acid, and lactic acid). The amount of chitosan can vary from 10 ppm to 5%, and the amount of acidic material used to dissolve the chitosan can vary from 5 ppm to 10%. U.S. Patent No. 4,363,801 claims a "method for treating hyperbilirubinemia which comprises orally administering to the affected patient an amount of soluble chitosan effective to substantially reduce the amount of bilirubin in the blood" (claim 1). column 3, lines 11-18 describes that chitosan is first dissolved in weak acids (especially acetic acid, formic acid, and citric acid) to produce a chitosan salt. The chitosan salt is preferably formed by dissolving chitosan in the weak acid, stirring the solution (for example in a mixer), lyophilizing the solution, and pulverizing the chitosan salts produced by lyophilization to obtain a finely ground powder. The ground powder is then mixed when it is ready to be used with a solution of water or another beverage. Similarly, the PCT International Application WO 98/32335 claims a chitosan solution for treating cotyledon plants. The paragraph, bridge pages 15 and 16 describes the preparation of a solution of aqueous chitosan acetate which presents sufficient longevity to be packed in a laboratory and transported for use in the field. This solution is obtained by stirring vigorously flakes of chitosan in water at a temperature of 60 ° C, adding acetic acid with continued high agitation at temperature to dissolve the chitosan, filter the solution, dilute with water, and pack the solution. Thus, these references describe at the most, a liquid composition produced by the treatment of chitosan with acid. It is not clear if all these preparations contain chitosan in solubilized form and / or have some stability. More importantly, since certain of these preparations contain other specific ingredients for particular uses, it is not clear whether these preparations are suitable for human consumption in a weight-management regimen, much less if they are palatable for human consumption. Finally, the PCT International Application WO 98/34625 belongs to the so-called "microcrystalline chitosan" that can be used to reduce the absorption of lipids. The microcrystalline chitosan optionally is in the form of a gel or powder-like dispersion. The microcrystalline chitosan appears to be prepared by a process that involves adding the glucosamine macromolecules from a solution of chitosan into an acid by introducing an alkaline solution (i.e., as described in International Application PCT 91/00298). However, it is not clear from the description exactly what < » characteristics of the gel should be (eg, stiffness, etc.), and what other components may be optionally present in, or needed for, the dispersion. More recently, a highly refined 5 'liquid form of polyglucosamine has been made available for sale, for example, FTF Liquid Chitosan (sold by a variety of Internet vendors including Discover Nutrition at http: //www.discovernutrition. com (February 1999), also described under the name Maderia Liquid Poly Glucosamine, 0 marketed by Maderia, Inc. at http://maderia.com (February 1999)). This liquid form comprises purified liquid polyglucosamine (ie, solubilized polyglucosamine) with many of the common components of chitosan removed, which must be measured in precise amounts (eg, an exact number of drops) within another liquid to form an entire solution. liquid dosage of chitosan. The product itself is a clear solution, the miscibility of the liquid chitosan in another liquid means that there is no clear change in the form of the solution containing chitosan when compared to the solution that does not contain chitosan. This causes uncertainty in the consumer regarding whether the beverage that is consumed is truly a solution containing chitosan, and that could conceivably lead to overdose (for example, when chitosan is added to the solution more than once.) Furthermore, the lack of shape change of the solution denies the consumer some Clear sense of satisfaction that a weight treatment solution containing chitosan is being absorbed. Of course, many times, in a weight treatment regimen, the perception that an action is being taken and that an effect is observed as a consequence of that action, is key to obtain a beneficial result. Along with similar lines, Collaborative Laboratories markets a polioelectrolyte composed of ascorbic acid and polyglucosamine (ie Ascorbil Glucosamine ™, marketed as http://www.collabo.com (February 1999)). This polypelectrolyte is not described as being effective for the prevention of fat absorption (although a substantial number of its properties are described). However, if the poly electrolyte can be used as such (by the weight treatment regimen), it suffers from the same problems as described for the solubilized chitosan. Mainly, polyglucosamine is a liquid that is soluble in water. Accordingly, the present invention provides novel liquid compositions containing chitosan, as well as methods for their preparation and use. The chitosan-containing compositions of the invention are tasty and can be used, inter alia, in a weight treatment program. In particular, the invention desirably provides a liquid suspension composition containing chitosan, which remains stable and is useful as an additive, for example in water. or water based liquids. These and other objects and advantages of the present invention, as well as additional inventive features, will be apparent from the description of the invention provided herein.

COMPENDIUM OF THE INVENTION The present invention provides, inter alia, new liquid compositions containing chitosan, its methods of preparation, and its methods of use. In particular, the invention provides a liquid suspension composition containing chitosan which remains stable and is useful as an additive, for example, in water or water-based liquids.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES The present invention pertains to new liquid compositions containing chitosan, its methods of preparation, and its methods of use. In particular, the invention desirably provides stable compositions containing chitosan (especially a stable liquid suspension composition), the invention desirably further provides a process for producing stable compositions containing chitosan (especially a liquid suspension composition). The invention further provides methods for using the stable compositions containing chitosan (especially a stable liquid suspension composition), for example, in a weight treatment program. the present invention accordingly pertains to products (especially so-called "weight treatment products" defined below) which are described herein by various names, for example "chitosan-containing compositions of the invention", liquid compositions containing chitosan "," chitosan suspensions "," liquid chitosan suspension compositions ", etc., and more particularly, described by patent names, "Kitabsorbe ™" and "X-Fat ™". A particularly preferred formulation of the invention is that described in Example 5, which can be further modified in terms of the acid used, flavoring used, etc. Thus, the invention makes chitosan available in a liquid form desirably exhibiting improved flavor, effectiveness, and ease of use (eg, when compared to tablet formulations, and liquid formulations). There are certain improvements achieved by the products of the invention that make them preferable over other available chitosan products. For example, the liquid compositions containing chitosan of the invention are preferable because: (1) the products control the absorption of fat, resulting optimally in the treatment of weight; (2) the products are easy to use (for example, approximately one-half ounce of the liquid product is simply pour into the drink (or be consumed "as it is") and be taken before, during or after a meal, and the process of absorbing fat begins); (3) the products are derived primarily from natural ingredients and optionally contain no stimulants (e.g., caffeine or other agents present in certain other weight-loss promoter formulations); (4) the products are sufficiently tasty to encourage their use by the subject; and (5) optionally, the products exhibit long-term stability (ie shelf life). Furthermore, the chitosan-containing compositions of the invention are favorable because they desirably do not contain the odious fishy taste and smell of fish and shellfish that is inherent in chitosan.

Liquid Compositions Containing Chitosan The new liquid compositions containing chitosan are preferably stable compositions, and are optimally stable liquid suspension compositions, and desirably stable under commercial and industrial applications, as well as in consumer use. In particular, the present invention provides a stable liquid suspension composition which desirably comprises (eg, consists essentially of) chitosan, a non-fatty acid or a salt thereof, water or aqueous solution, wherein each is present in the composition in a stabilizing amount enough to effect the formation of a stable liquid suspension. The term "stable liquid suspension" as used herein refers to, unless otherwise indicated, a liquid suspension containing chitosan which, after preferably at least about 12 months, desirably after at least about 5 years, and optimally after at least about 20 years of storage, optimally at about 25 ° C, remains flowable, and has little or no solids segment. The liquid suspensions containing chitosan according to the invention are also desirably stable (ie, they remain flowable and have little or no solid segment) after being maintained at a temperature of from about 0 ° C to about 100 ° C, especially after maintained at a temperature of about 10 ° C to about 50 ° C, for a period of time ranging from preferably at least about 12 months, desirably at least about 5 years, and optimally, at least about 20 years. It is preferable that the stable liquid suspension according to the invention be stable indefinitely, or almost indefinitely. It is further desired according to the invention that compositions containing chitosan that are not suspensions present stability as described for liquid suspension compositions. A "suspension as described herein is a two-phase system in which a phase (the dispersed phase, also called the discontinuous or internal phase") is distributed as particles or droplets in a second phase (also called the external phase, continuous phase, or dispersing medium.) The suspensions may be made of particles that are gaseous, liquid or solid, comprising suspensions that are solid / gas (for example aerosol), solid / solid, solid / liquid, liquid / liquid (e.g. , emulsions), and gas / liquid (e.g., foams) Desirably according to the invention, the suspension is any system containing chitosan in which the small solid or liquid particles are more or less equally dispersed in a liquid medium. Optimally the suspension is a liquid / liquid suspension.An especially preferred suspension of the invention has a uniform dispersion of the particles through liquid. The dispersed particles are desirably so large that they do not quickly feed into the container. Optimally, the surface area of the particles is so much larger than their volume that the particles do not tend to settle by gravity (ie they do not tend to sink or float). In the event that any small (ie non-significant) amount of sedimentation occurs in a suspension of the invention, the sediment it preferably does not form a hard cake, but desirably is capable of redispersing with minimal effort. A suspension according to the invention is preferably a colloidal suspension having a particle size range of about 1-10 nanometers (10-100 Angstroms) up to the size at which the particles become visible under an optical microscope (i.e. light) (approximately 0.5 to 5 micrometers) (Aldridge, "Some Notes on Colloid to Suspensions", Available at http://www5.onramp.net/~jaldr/colloids.html (March 1999)). Due to its small size, the colloidal dispersions undergo little or no sedimentation or cream-movement Brownian keeps the dispersed particles in suspension (Schott, "Colloidal Dispersions" Remington: The Science and Practice of Pharmacy, 19th Ed., Mack Publishing Co .: Easton, Pannsylvania (1995)). A suspension of the invention is also desirably a coarse dispersion in which the particle size exceeds 0.5 micrometers, and preferably ranges from about 0.1 to about 150 micrometers, optionally from about 50 to about 100 micrometers. Accordingly, the particle size of a suspension according to the invention optionally varies from about 1 nanometer to about 150 microns, but, more desirably, the particle size is that expected of a colloid.

The Tyndall effect can be used to differentiate a colloidal suspension from a true solution in cases where a beam of light can be passed through the material (Aldridge, "Some Notes on Colloidal Suspensions", available at http: // www5.onramp .net / ~ jaldr / colloids.html (March 1999)). In a true solution, the light passes through the material relatively unimpeded and will not be visible from the side view. In a colloidal suspension, the colloidal particles are large enough to significantly disperse the light and make the beam visible from the side view. True solutions are different from colloids because the agents dispersed in the true solutions (ie the solutes) are typically atoms, ions, or quite small molecules. As previously mentioned, a composition containing chitosan according to the invention can be a suspension (i.e. it includes a colloidal suspension) or a solution (i.e., a true solution). Desirably, however, a chitosan-containing composition of the invention exhibits a Tyndall effect such that particles present in the composition scatter light. Accordingly, the present invention desirably provides a stable liquid suspension composition (or a composition containing chitosan that is not a suspension) which may comprise, consist essentially of, or consist of chitosan, a non-fatty acid or salt thereof, and water or aqueous solution, wherein each is present in the composition in a sufficient stabilizing amount to effect the formation of a stable liquid suspension. Desirably the chitosan is present in this composition in an amount of about 2.5% to about 4.0% (mass / volume) of the composition, and the non-fatty acid or salt thereof is present in an amount of about 2.5% to about 4.0% (mass / volume) of the composition. Such a suspension prepared as described herein (and which may contain other ingredients) is described by the patent name "Kytabsorbe ™". Preferably this composition is tasty. Optimally this composition has a pH of about 3.6 to about 4.2, preferably a pH of about 3.8. Also, desirably this composition has a viscosity of about 120 to about 390 centipoise, especially a viscosity of about 200 to 300 centipoise, and particularly a viscosity of about 240 centipoise (rotational viscosity). As described in the examples that follow, (particularly example 13), preferably a composition according to the invention (ie, a composition consisting essentially of chitosan, water or aqueous solution, and a non-fatty acid) binds at least about 3 grams of fat per gram of chitosan, desirably from about 3 to about 12 grams of fat per gram of chitosan, and optionally from about 6 to about 7 grams of fat per gram of chitosan. However, these ranges are merely an example of the fat binding capacity of the chitosan formulations observed with the use of particular fats and particular conditions. It is likely that even higher capacities (ie fat binding capacity, free fatty acids, cholesterol, other than cholesterol, and bile acids) will be obtained with the optimization of conditions, and with the use of particular agents (for example , particular fats, free fatty acids, etc.). Preferably according to the invention, the chitosan-containing composition may contain other optional components, for example, dietary fiber. Thus, the present invention also provides a stable liquid suspension composition comprising (ie, or consisting essentially of, or consisting of): (a) chitosan, a non-fatty acid or salt thereof, and water or aqueous solution, in where each is present in the composition in a sufficient stabilizing amount to effect the formation of a stable liquid suspension; and (b) diet fiber. Optionally the dietary fiber is inulin. Desirably, chitosan is present in this composition in an amount of about 2.5% to about 4.0% (mass / volume) of the composition, the non-fatty acid or salt of the composition.

The same is present in an amount of about 2.5% to about 4.0% (mass / volume) of the composition, and the diet fiber is present in an amount of about 2.0% to about 10.0% (volume / volume) of the composition. Preferably this composition is tasty. Optimally this composition has a pH of about 3.6 to about 4.2, preferably a pH of about 3.8. Also, desirably this composition has a viscosity of about 120 to about 390 centipoise, especially a viscosity of about 200 to 300 centipoise, and particularly a viscosity of about 240 centipoise (rotational viscosity). In addition, the composition may provide a further optional component, in particular, to provide a stable liquid suspension composition which preferably consists essentially of: (a) chitosan, a non-fatty acid or salt thereof, and water or aqueous solution, in where each is present in the composition in a sufficient stabilizing amount to effect the formation of a stable liquid suspension; and (b) diet fiber, preservative and flavoring. Thus, the present invention optimally provides a stable liquid suspension composition which desirably consists essentially of: (a) chitosan, a non-fatty acid or salt thereof, and water or aqueous solution, wherein each is present in the composition in a sufficient stabilizing amount to effect the formation of a stable liquid suspension; and (b) diet fiber, preservative and flavoring. wherein the chitosan is present in an amount from about 2.5% to about 4.0% (mass / volume), the non-fatty acid or salt thereof is present in an amount of about 2.5% to about 4.0% (mass / volume), the dietary fiber is present in an amount of about 2.0% up to about 10.0% (volume / volume), the preservative is present in an amount of about 2.5% up to about 4.0% (mass / volume), and the flavor is present in an amount of about 2.0% to about 4.0% (mass / volume) of the composition. Preferably this composition is tasty.

Optimally this composition has a pH of about 3. 6 to about 4.2, preferably a pH of about 3.8. Also, desirably this composition has a viscosity of about 120 up to about 390 centipoise, especially a viscosity of about 200 to 300 centipoise, and particularly a viscosity of about 240 centipoise (rotational viscosity). As described in the examples that follow particularly Example 13), preferably a composition according to the invention (ie, a composition consisting essentially of chitosan, water or aqueous solution, a non-fatty acid or salt thereof, fiber of diet, preservative, and flavoring) binds at least about 2 grams of fat per gram of chitosan, desirably from about 2 to about 10 grams of fat per gram of chitosan, and optionally from about 2 to about 5 grams of fat per gram of chitosan . However, these ranges are merely exemplary of the fat binding capacity of the chitosan formulations observed with the use of particular fats, and particular conditions. It is likely that even higher binding capacities (ie fat binding capacity, free fatty acids, cholesterol, non-cholesterol sterols, and bile acids) are obtained with the optimization of conditions, and with the use of particular agents ( for example, particular fats, free fatty acids, etc.). When the composition of the invention has the particular formulation set forth in Example 5, it is known under the patent name "X-Fat ™".

Other characteristics of a chitosan-containing composition of the invention include that the composition is clear (ie, means non-opaque). Chitosan remains in suspension.

Constituent Components of the Liquid Compositions Containing Chitosan In the compositions of the invention, the chitosan may optionally be obtained from any possible source, for example, fungal walls and arthropod exoskeletons including but not limited to insects, crabs, shrimps and lobsters and by alkaline N-deacetylation of chitin. Chitosan can also preferably be purchased directly from commercial suppliers, for example, Chitosan SC 143 and Chitosan SC 243 obtained from Natural Biopolymer Inc., Raymond, WA (product code 27130123, generic name "chitosan"), or other commercial vendor; Chitosan can desirably be applied in the form of chitosan, or any other suitable form, for example, chitin, chitosan salt (such as the lactate salt of chitosan). Thus, according to this invention a "chitosan" encompasses chitosan per se (ie the product obtained by the N-deacetylation of chitin), as well as chitin, but desirably is in the form of chitosan per se. A preferred source of chitosan according to the invention is shrimp. Preferably the chitosan used in the invention is administered at least about 75% deacetylated, yet more preferably it is at least about 90% deacetylated, and optimally, it is at least about 95% deacetylated. Generally, the pharmaceutical grade chitosan is deacetylated between about 90 and 95%, and can absorb approximately 10 to 12 times its weight in fat, while the nutritional grade chitosan is deacetylated between about 75 and 80%, and can absorb about 4 to 6. times its weight in fat. Typically, as the viscosity or deacetylation of a chitosan preparation increases, its effect on the digestibility of fats increases (Deuchi et al., Biosci, Biotechnol. Biochem., 59 (5), 781-5 (1995)). ), so for greater fat absorption, an increased amount of deacetylation is preferred. Preferably the chitosan used to make the compositions of the invention has a viscosity of about 40 mPas to about 100 mPas, even more desirably, of about 50 to about 80 mPas. Typically, the chitosan used to make the compositions of the invention has an average molecular weight of from about 30,000 to about 300,000 daltons, and a preferred average molecular weight of from about 100,000 to about 200,000 daltons. Desirably, the average particle size of the chitosan can be assessed, for example, using sieve analysis. Using such a proposal, the particles typically pass a sieve 40-50 industrial mesh and are retained by a 60-100 industrial mesh screen having an average size of approximately 80 mesh, ie corresponding to approximately 7/1000 of an inch. Of course, however, there is a particle size distribution. Generally, however, it is preferred that the "ground" of chitosan be thinner than that typically used for example, for full capsules. The chitosan present in the chitosan-containing compositions of the invention optimally comprises from about 2.5% to about 4.0% (mass / volume) of the liquid composition containing chitosan of the invention, even more desirably from about 3.0% to about 3.5% ( mass / volume), and especially approximately 3.25% (mass / volume). Chitosan can be added to the preparation in the form of chitosan flake (for example, ground either "coarse", "flake" or "fine"), chitosan powder, or solubilized chitosan. While the chitosan flake and the chitosan powder are commercially available, desirably solubilized chitosan can be obtained from chitosan flake and chitosan powder at the solubility of the chitosan first with a suitable non-fatty acid or acid salt as a solubilizing agent. According to the invention, the appropriate non-fatty acids or acid salts include, but are not limited to, acids non-organic fatty acids or acid salts having from 1 to 10 carbon atoms, preferably from 2 to 7 carbon atoms, such as acetic acid, adipic acid, citric acid, formic acid lactic acid, malic acid and other appropriate non-fatty acids or acid salts, which are suitable for dispersing the chitosan without detrimentally impacting the properties of the liquid composition containing chitosan. Generally, such an acid salt or non-fatty acid is present in the chitosan-containing composition in an amount ranging from about 2.5% to about 4.0% (mass / volume) of the liquid composition containing chitosan of the invention, even more desirably from about 3.0% to about 3.5% (mass / volume), and especially about 3.25% (mass / volume). Preferably, the non-fatty acid or acid salt is present in the liquid composition containing chitosan to comprise a ratio of 1:10 mass: mass with chitosan at a ratio 10: 1 mass: mass with chitosan, and optimally comprises a ratio of 1: : 2 to 5: 1 dough: dough with chitosan. An especially preferred non-fatty acid or acid salt for use in the liquid chitosan-containing compositions of the invention is an acid vitamin, such as ascorbic acid, folic acid, pantothenic acid, biotin, etc. Particularly preferred for use in the invention are ascorbic acid, ascorbate or an ascorbic acid salt. The acid Ascorbic acid (ie, Vitamin C) can be obtained from Natural Biopolymer (Hebei, China), Laboratories (La Jolla, CA), or other commercial vendors. The ascorbic acid present in the formulation optimally comprises from about 2.5% to about 4.0% (mass / volume) of the liquid composition containing chitosan of the invention, even more desirably from about 3.0% to about 3.5% (mass / volume) and especially about 3.25% (mass / volume.) Desirably, ascorbic acid is present in the liquid composition containing chitosan to comprise about a ratio 1:10 mass: mass with chitosan, of about 10: 1 ratio mass: mass with chitosan and optimally comprises approximately a 1: 1 mass: mass ratio with chitosan.Ascorbic acid is especially preferred for use in the invention since ascorbic acid or ascorbate formulations have been shown to increase the effectiveness of chitosan (see, for example, Kanauchi et al., Bioschi, Biotechnol. Biochem., 59 (5), 786-90 (1995), Bugamelli et al., Arch. Pharm. (Weincheim), 33 1 (4), 133-8 (1988), Deuchi et al., Biosci. Biotechnol. Biochem., 59 (7), 1211-6 (1995)). Chitosan that is properly dispersed with a non-fatty acid and / or acid salt is preferably formulated appropriately at a desired concentration by mixing with water (eg, aerated, oxygenated, distilled, deionized, Spring, or other) or a predominantly based solution in water (ie, an "aqueous solution" or a water solution that optionally contains other components). Desirably the water is Spring water, particularly Spring water purchased from an appropriate commercial vendor. Any appropriate source of water can be used, as long as the water has a desired level of sterility, that is, levels that are safe for human consumption, particularly levels that are not detectable. The amount of water or aqueous solution employed in accordance with the invention is dependent on the concentration of chitosan and other desired components, but typically ranges from about 10 to 50 times, more preferably from about 20 to 40 times, still more desirably about 30. times the amount (weight / weight or volume / volume) of chitosan present in the liquid composition containing chitosan. Optimally according to the invention, this mixture results in a composition or fluid in which the chitosan flakes, liquid powder are suspended ultra-submicroscopically to create a suspension composition, as defined above. Desirably, such a suspension composition exhibits stability. Especially, desirably, chitosan remains in suspension without precipitation for at least a year, probably up to 5 years, and quite possibly, up to 30 years, optimally at temperatures ranging from below 30 ° F to 210 ° F at the level of sea. According to the invention, chitosan is in suspension (ie, opposite to being precipitated) when it comprises a clear liquid is transmissible to light. The liquid compositions containing chitosan of the invention also desirably possess a source of dietary fiber. The generic term "dietary fiber" according to the invention is meant fiber other than chitosan to a product derived from chitin, and which is suitable for human consumption (ie, is not harmful to the human body) and not digested by endogenous intestinal enzymes. A preferred dietary fiber according to the invention is inulin, which is a preferred food for lactobacilli in the intestine and can improve the balance of friendly bacteria in the intestine (Wang et al., J. Appl. Bacteriol., 75 (4), 373-380 (1993), and additionally has cancer-preventing properties (Spiller, Dietary Fiber in Health and Nutrition, Boca Raton, FL; CRC Press (1994); Reddy et al., Carcinogenesis, 18 (7). ), 1371-1374 (1997).) The addition of dietary fiber in the compositions of the invention is also desirable because such dietary fiber tends to fill, in this sense, it would have a positive effect on a weight control regimen. Optimally, the dietary fiber applied in the composition of the invention is added in a soluble (ie, liquid) form, preferably in the form of a liquid extract, In such an extract, optionally other components are also present. present, but preferably, the total amount of the fiber present in the extract comprises from about 40 to about 99%, desirably, from about 60% to about 75% of the total extract. Desirably, this dietary fiber (ie, an extract of dietary fiber or soluble solution) is then present in a chitosan-containing composition of the invention in an amount ranging from about 2.0% to about 10.0% (volume / volume) of the liquid composition containing chitosan of the invention, even more desirably from about 4.0% to about 8.0% (volume / volume) and especially of approximately 6.2% a (volume / volume). Accordingly, with the use of such an extract or soluble solution, the total diet fiber present in a chitosan composition of the invention may vary from about 0.8% to about 9.9% of the liquid composition containing chitosan of the invention. GAEDIET ™ -SP produced by Colibree Company, Inc. (Aspen, Colorado) can be used in this capacity as a source of fructooligosaccharide (FOS), or inulin, from the blue agave plant. The GAVEDIET ™ "SP de Colibree is a soluble dietary fiber / inulin obtained by the physical process of extracting and purifying blue agave plant juice.The product is a crystalline syrup, neutral in taste, slightly sweet.The inulin / FOS has utility, for example as a low ingredient in fat and / or low cholesterol food, as a substitute for fat (for example, in oil, fat, and butter substitutes, and to improve mouthfeel), as a calorie reducer in food manufacturing, such as a thickening and texturizing agent, etc. The inulin or FOS is preferably present in a chitosan-containing composition of the invention in an amount ranging from about 2.0% to about 10.0% (volume / volume) of the liquid composition containing chitosan of the invention, even more desirably from about 4.0% to approximately 8.0% (volume / volume), and especially approximately 6.2% (volume / volume). However, desirably, other sources of FOS and / or inulin may also be applied in the present invention, particularly oligosaccharides having an average chain length and improved fat mimicking properties. For example, desirable chicory can be obtained from Orafti (Belgium) or Sulker Unie (Breda.The Netherlands), or Jerusalem Artichoke can be obtained from IFP (International Flavors and Fragrances, Dayton, NJ). Also, preferably Neoazúcar (ie, a synthetic FOS) can be obtained from Meij Seika Kaisha (Japan), or Dahlia can be obtained from California Natural Products (Santa Barbara, CA). Optionally, also medical inulin derived from Jerusalem Artichoke, Chicory and Dahlia Dahlia can be obtained from Sigma, Aldrich (St. Louis, MO).

The flavor employed of the invention can be any flavor, for example, cranberry, grape, orange, raspberry, banana, lime, lemon, cherry, grapefruit, apple, peach, tea, cola, as well as any other flavor, but desirably, it is a tasty flavor that has a long shelf life and which does not crystallize or precipitate from the composition with prolonged storage. In some cases, it is preferable that the flavor be a meat, poultry, or fish flavor. In particular, the sour cranberry flavor desirably (eg, "Natural SN038222" obtained from International Flavors and Fragrances, Dayton, NJ) can be employed in a liquid composition containing chitosan according to the invention. The amount of added flavor may vary with the flavor employed. Desirably, however, the flavor comprises from about 2.0% to about 4.0% (volume / volume) of the liquid composition containing chitosan of the invention, even more desirably from about 3.0% to about 3.5% (volume / volume) and especially approximately 3.25% (volume / volume). Preferably, preservatives are added to the liquid compositions containing chitosan according to the invention. Any suitable preservative can be employed, so long as the preservative does not deny other desirable properties of the compositions containing chitosan. Preferred preservatives include, but are not limited to, benzoate of sodium and potassium sorbate which can be obtained from any commercial supplier. Desirably, these preservatives are of a high degree of purity. Preferably, these preservatives are obtained from Spectrum Quality Products, Inc. (Gardena, CA, Catalog Numbers S1146 P1408, respectively), from Sigma-Aldrich (St. Louis MO, Catalog Numbers B3420 and S7420, respectively). Other suitable preservatives are alcohol (from about 15 to about 20%), benzoic acid (about 0.1%) methylparaben (from about 0.025% to about 0.2%), propylparaben (from about 0.025% to about 0.2%), and acid sorbic (approximately 0.1%). Sodium benzoate and potassium sorbate (or other suitable preservatives) should be employed in a liquid composition containing chitosan of the invention in amounts ranging from about 0.01% to about 1.0% by weight (mass / volume, such as g / l) of the liquid composition containing chitosan of the invention, even more desirably from about 0.05% to about 0.5% by weight (mass / volume) and especially about 0.1% by weight (mass / volume). Optionally, sweeteners may also be added to the liquid compositions containing chitosan of the invention, for example, sweeteners such as sugars natural (for example, glucose, sucrose, fructose) and synthetic sugars (for example, Aspartame, etc.). A preferred flavor source according to the invention is GAVESWEET ™ -SP produced by Colibree Company, Inc. (Aspen, Colorado), which can be used as a source of pure agave nectar, or high fructose agave syrup. The GIBESWEET ™ -SP from Colibree is an all-natural fructose syrup. The physical process of extraction and purification of inulin that occurs naturally in the blue agave plant is obtained, followed by an enzymatic hydrolysis process. The product is a crystalline syrup, with a very sweet neutral flavor. Desirably, however, other sweeteners may also be applied in the present invention, particularly other natural fructose sweeteners (especially those that do not have such a high content of a refined fructose, whose high fructose content has been suggested to exacerbate copper deficiency and is associated with heart disease characterized by high triglyceride levels), and especially sweeteners that have a long shelf life and that do not crystallize or precipitate from the composition with prolonged storage. Other preferred natural sweeteners that may be employed in the invention, include but are not limited to: Bee Honey (Dutch Gold Honey, Lancaster, PA), Organic Bee Honey (various vendors); arley Malt syrups (Briess Industries New York, NY); deionized fruit juice (Daystar-Robinson, Lake Success, New York); liquid Fruitrim (Adept Solutions); Fruitrim powder (Adept Solutions Capitola, CA), Brown rice syrup (California Natural Produts Santa Barbara, CA); organic coffee rice syrup (california Natural Products); oat syrup (T &Gourmet); Raw or Turbinado sugar (C &H sugar La Palma, CA); Sucanat (Wholesome Foods Palm Bay, FL); Organic Sucanat (Wholesome Foods Palm Bay, FL); Organic Sugar (Wholsome Foods Palm Bay, FL); and evaporated cane juice (Florida Crystals Palm Beach, FL); Ki-Sweet (kiwi fruit sweetener, marketed on the Internet). The chitosan-containing preparations of the invention may desirably contain other natural and man-made compounds, such as would be suitable for a particular application, eg, other carriers, stabilizers, preservatives, active agents, flavors, fragrances, etc. as long as these other compounds do not negate the desirable properties of the liquid compositions containing chitosan. Especially preferred for addition according to the invention are vitamins, particularly fat-soluble vitamins, and especially vitamins A, B, D, E and K.

Methods for Preparing Liquid Compositions Containing Chitosan X-Fat ™ and other products of the invention which relate to chitosan-containing compositions are optionally produced using a proprietary process as described herein, which optimally provides a long-term stable composition such as a solution, and particularly of preferred form produces a stable suspension. The liquid compositions containing chitosan of the invention, i.e., the stable chitosan suspension compositions desirably are obtained by preparing the chitosan in such a way that a suspension is obtained. This differs from merely adding chitosan into a mixture. The order in which the addition is made, and the means by which the addition is carried out, is important. Desirably, the process is carried out at room temperature, although other temperatures may also be optionally employed. In particular, preferably according to the invention, the chitosan "moistens" first in a small amount of aqueous solution (e.g., water). Preferably, from about 0.25 to about 1.0 ml of water is used per gram of chitosan. Chitosan is added in a precise manner, preferably by slowly mixing the chitosan into a vortex that has been created by high-speed liquid agitation. If it is not added within a vortex, then desirably, the liquid is stirred in some way to prevent that the chitosan merely forms an insoluble mass at the bottom of the liquid. The forces in the liquid are most desirable to mix the chitosan when a vortex is used (as opposed to other means of agitation). After the initial addition of the chitosan, the vortex is allowed to calm, but before it has completely finished, in a desirable manner, the slow stirring of the mixture has begun. Preferably, this slow agitation is in a reverse direction to that of the vortex. Optimally, this agitation is done with an implement (especially a plastic implement) having a large surface area to compact the mixture, for example, optionally mixing with a plastic shovel in a commercial tub mixer. Inverse agitation is carried out in a gentle manner until the chitosan has dispersed uniformly, optimally from about 10 minutes to 2 hours, desirably from about 10 minutes to about 45 minutes. Desirably, acid (i.e., as described herein) is then added to the chitosan composition. The acid is added slowly and the agitation of the composition preferably remains smooth through this addition, and until the acid is dispersed. Optimally, the gentle agitation of the mixture was continued, optimally from about 10 minutes to 2 hours, desirably from about 10 minutes to about 1 hour. Preferably this Agitation is done with an implementor (especially a plastic implement) that has a large surface area, for example, a shovel. The mixture is thick. With smooth continuous agitation, the thick liquid takes on a golden color. Desirably, the mixture in this step has an acidic pH (for example, preferably between about 2 and about 4, optimally about 3.9). The chitosan acid composition optionally is a suspension containing stable chitosan according to the invention. The chitosan acid composition can preferably be used "as is". Alternatively, the chitosan acid composition can be used with the addition of other preferred components, (eg, diet fiber, preservatives, and / or flavoring, as described above) to still comprise other preferred stable chitosan-containing suspension compositions in accordance with the invention Thus, the present invention provides a method for preparing a chitosan-containing composition of the invention, wherein the method preferably comprises: (a) obtaining solid chitosan; (b) moisten the chitosan with water or aqueous solution; and (c) mixing a non-fatty acid or acid salt to the chitosan and the water or aqueous solution to obtain the composition.

Where the composition of chitosan comprises (e.g., consists essentially of) chitosan, water or aqueous solution, a non-fatty acid, and dietary fiber, the present invention provides a method for preparing this composition wherein the method desirably comprises: a) obtain solid chitosan; (b) moisten the chitosan with water or aqueous solution; (c) mixing a non-fatty acid or acid salt to the chitosan and the water or aqueous solution to obtain a chitosan acid mixture, (d) in a separate vessel add water or aqueous solution; (e) mixing diet fiber in the separate container; and (f) mixing the chitosan acid mixture with that contained in the separate vessel to obtain the composition. In a preferred embodiment according to the invention, the chitosan-containing composition is formulated with chitosan, water or aqueous solution, non-fatty acid, diet fiber, preservatives, and flavoring in the method described herein to produce a formulation containing patent chitosan (ie, Kytabsorbe ™). When the formulation has the particular ingredients set forth in Example 5, this is known under the patent name X-Fat. However, it is anticipated that this formulation is easily modified in accordance with the teachings herein to produce other stable suspension compositions containing chitosan. With the addition of certain flavorings, it is anticipated that particles may be introduced into the formulations, for example due to fruit pulps and the like. Such particles should not be considered sediment from suspensions containing chitosan (and can be distinguished from sediment), but are more appropriately considered flavorings per se. Such flavor particles desirably do not detrimentally impact the long-term stability of the chitosan-containing suspension composition. Accordingly, in order to add other components to the chitosan acid suspension composition, it is desirable that such components be mixed in water (or aqueous solution) in a separate container, and then added to the chitosan acid suspension. In cases where only preservatives are added, these preservatives are desirably mixed well in the separate tub and then preferably added to the acid suspension mixture containing chitosan with complete mixing. Optimally the amount of water or aqueous solution employed in the second tank is less than, or approximately equal to the amount of water or aqueous solution initially used in the chitosan acid suspension composition.

It is also preferred that the flavor and / or dietary fiber be added to the chitosan acid suspension composition, either in the presence or absence of preservative addition, as described above. In the case where the preservative is present, the preservative is desirably mixed first in a separate ink, as previously described. Optionally, when the diet or flavor fiber is added, preferably the flavor fiber diet is then added to the second tank containing the preservative (with complete mixing) and the contents of the second ink are added with complete mixing to the contents of the first tub. In cases where the dietary fiber or flavoring is added in the absence of preservatives, then desirably the diet or flavor fiber is first mixed with water (or aqueous solution) in a separate tub (i.e., an amount of water or solution). aqueous less than, or equal to, the amount added to the first tub), and after thorough mixing, the contents of the second tub are mixed gently and completely with the contents of the first tub. In cases where dietary and flavoring fiber is added (i.e. in the presence or absence of preservative) the flavor is optimally added to the mixture in the last second tub. Desirably the flavor is filtered before addition to reduce any particles present.

Alternatively, when preservatives are not used, the diet and / or flavor fiber may desirably be added simply to the tub containing the chitosan acid suspension. Similarly, when preservatives are employed, desirably the preservatives (once dissolved) can be added from the second tub into the tub containing the chitosan acid suspension, and then desirably, the dietary fiber and / or flavoring can be added thereto. tub. Thus, the present invention further provides a method for preparing a composition according to the invention (ie, a composition containing chitosan, water or aqueous solution, non-fatty acid, diet fiber, flavoring, and preservatives, wherein the method Desirably comprises: (a) obtaining solid chitosan, (b) moistening the chitosan with water or aqueous solution, (c) mixing a non-fatty acid or acid salt with the chitosan and the water or aqueous solution to obtain an acid chitosan mixture, ( d) add water or aqueous solution in a separate container, (e) mix diet fiber in the separate container, (f) mix the diet fiber in the separate container; (g) mixing the flavor in the separate container; and (h) mixing the contents of the separate vessel with the chitosan acid mixture to obtain the composition. Alternatively, this method preferably comprises: (a) obtaining solid chitosan; (b) moisten the chitosan with water or aqueous solution; (c) mixing a non-fatty acid or acid salt to the chitosan and the water or aqueous solution to obtain a chitosan acid mixture, (d) in a separate vessel add water or aqueous solution; (e) mixing diet fiber in the separate container; (f) mixing the contents of the separate vessel with the chitosan acid mixture to obtain a mixture of preservative-acid-chitosan; (g) mixing the diet fiber with the preservative-acid-chitosan mixture; and (h) mixing the tastant with the consorbator-acid-chitosan mixture to obtain the composition.

Optimally, the pH of the products unaltered by the above processes is typically acidic (e.g., between about 2 and about 4, preferably about 3.9). Optionally, the obtained mixture may in this step be pumped through a funnel in separate packages, or otherwise packaged. It is preferable to this method of the invention that the flavoring be added to the suspension composition after the preservatives (eg, sodium benzoate, potassium sorbate) have been added and dissolved. If the flavoring is added before the preservatives and dietary fiber, it is possible that the preservatives do not completely dissolve.

Characterization of Liquid Compositions Containing Chitosan The liquid compositions containing chitosan of the invention can be characterized and confirmed in terms of their constituents, for example, total fat / saturated fat or ability to bind total fat / saturated fat (eg, by extraction ), saturated fat cholesterol or ability to bind cholesterol (eg, by gas chromatography) total carbohydrates (eg, by calculations), dietary fiber, soluble fibers, sugars (eg, FOS, D-fructose, D-glucose) ), protein (for example, by Lowry test), vitamin C (for example, by titration), sodium (for example, by sources external of a company that measures the level of sodium), chitosan (for example, by determination of Kjeldahl nitrogen), and inulin. The composition containing chitosan can be further evaluated by total solids (eg H2O), pH, conductivity, taste, color, dispersibility in water, total aerobic plate count, yeast count and molds (Bacillus cereus beads, coliform count) total in 1 gram, account for Staphylococcus aureus in 1 gram and Salmonella count in 25 grams, as well as for other factors.The lipid binding capacity of liquid compositions containing chitosan can also be assessed using a standard solution of polysaccharide lipid and adding by titration a product of the invention (for example, "X-fat" product) The loss of lipid polysaccharide can be measured instrumentally, for example, by using a syn thetic chromogenic lipid analyzer Other characterization means are set in the examples continue, and those skilled in the art are known.

Use of the Liquid Compositions Containing Chitosan of the Invention in a Weight Treatment Regimen. The products of the invention contain all chitosan, which can be used in weight reduction and / or weight control on the basis that they prevent fat from breaking in the stomach and digestive tract, before it passes into the circulatory system. In other words, chitosan binds with fat making it digestible and prevents fat from entering the bloodstream. The fat is expelled naturally from the body. This ejection of fat opposite fat absorption essentially produces a "fat-free" or "reduced fat" diet when the products of the invention are used as described herein. A fat-free diet and a reduced-fat diet can (1) substantially reduce (if not stop completely), gain weight, (2) contribute substantially to weight loss, and / or (3) substantially facilitate weight maintenance . Thus, preferably, the chitosan-containing compositions, (especially the stable suspension) of the invention, are employed in a weight treatment regimen. A "weight treatment regimen" as used herein means any program employed to promote weight loss, promote weight maintenance and / or prevent weight gain. Similarly, a "weight treatment composition" encompasses a chitosan-containing composition according to the invention that is used for weight loss (i.e., helping to decrease the weight in an individual over time), weight maintenance ( that is, help maintain an individual's weight over time), and / or prevent weight gain (ie, help prevent the sporadic consumption of a high-fat / high-calorie meal that results in weight gain). A weight treatment composition comprising an "effective binding amount of chitosan", ie an amount of chitosan as described herein, which is effective for binding fat, free fatty acids, cholesterol, sterols, other than cholesterol , and / or bile acids, and which results in the weight treatment when applied in a weight treatment program according to the invention. A "program" means a course of action (ie consumption of a weight treatment composition according to the invention) that is repeated over a period of time, for example desirably in minimal form over a period of about one week to preferably, at most approximately the lifetime of the individual. Repetition within a program varies optimally depending on whether the weight treatment composition is used to promote weight loss, promote weight maintenance, and / or prevent weight gain. For example, when used to promote weight loss, it is preferable that the weight treatment composition is consumed on at least one daily basis (as further described below) for a period of time that varies optimally from about week until preferably, at most approximately one year.

When used to promote weight maintenance, it is preferable that the weight treatment composition is consumed at most on a twice daily basis (as further described below) for a period of time that varies optimally from about a week to preferably, at most, about a year. When used to prevent weight gain, it is preferable that the weight treatment composition is consumed on an "as needed" basis (as further described below) for a period of time that varies optimally from about one week preferably, at most the life time of the individual. The chitosan-containing compositions of the invention (or variations thereof) can be applied to any ingestible beverage, for example, water, ice tea, fruit drinks, soft drinks, colas, diet beverages and potions, "healthy" beverages, systems of gastrointestinal cleansing, and the like. When used in this form, the compositions containing chitosan (for example, present as part of another beverage) can be further changed into consistency, for example, by freezing to create a Popsicle or partially melted snow, mixing in a mixer with bits of ice to create a soft, cold drink that has a consistency similar to the milkshake and the like. Similarly, the chitosan-containing compositions of the invention (or variations thereof) may be applied "as is", for example, by merely drinking the compositions or adding as a component another liquid or semiliquid formulation not for drinking, but, for example, to be applied to the surface of another food, such as a seasoning, icing, dressing, or other. This is preferably used wherein the other food is a non-fatty food, eg, fruit, seed, walnut and other vegetable which must be eaten as part of a meal as a fat, and / or food containing cholesterol. For example, the compositions containing chitosan may be mixed with other non-fatty flavoring ingredients (eg, vinegar, vinegar sauce), and poured or sprayed onto the surface of the solid food for consumption. Alternatively, the fruit, seed, nut and / or vegetable, the compositions containing chitosan and the other liquid or semi-liquid formulations can be mixed together, for example, to produce a soup, chili, sauce, glaze, or other similar thing. With the careful selection of other ingredients, and with the selection of a non-greasy food, fish or poultry, it may be possible to apply the compositions containing chitosan as a sauce, glaze, seasoning, etc., for meat, fish and / or poultry. to be eaten as part of a meal with a food that contains fat and / or cholesterol. Additionally, the preferred compositions can be pre-formulated as, or merely added before being consumed, to any semisolid non-greasy formulation, by example, non-fatty pudding, Jell-O, gelatin or tofu. However, the rigidity of these formulations can be altered with the addition of the products of the invention. Chitosan is already approved for sale in the form of tablets and sold in various stores for weight control / weight loss. Thus, there is a large source of data already available that suggests its safety and efficiency for its use. The side effects of chitosan that have been reported appear minor (for example, flatulence, reduction in the intake of vitamins, etc.). Similarly, acetic acid, lactic acid and ascorbic acid have been used safely for human consumption. However, individuals who have allergies to shellfish, pregnant or lactating women, persons under eighteen years of age and individuals on medication that is soluble in fat or whose intake would otherwise be diminished by consumption of products containing chitosan from the invention should not consume X-Fat ™, or any other product containing chitosan according to the invention. For prolonged users of the current chitosan products of the invention, vitamin supplements high in fat-soluble vitamins (particularly vitamins A, B, D, E and K) should preferably be taken with breakfast at another appropriate occasion on a daily basis . Optimally, fat intake will be observed to ensure that the appropriate recommended grams of fat are consumed (ie, and currently assimilated by the body) on a daily basis. Medical supervision is recommended so that anyone with concerns about a weight loss or chitosan weight maintenance regimen. Thus, generally, the use of the chitosan-containing products of the invention is preferred for those individuals who do not have a pre-existing health condition that would impact the use of the chitosan-containing compositions of the invention. While X-Fat ™ (and other liquid compositions containing chitosan of the invention) have the ability to modify the absorption of fats, they do not otherwise control calorie intake. Thus, while the liquid chitosan-containing compositions of the invention (including X-Fat ™) when used alone, should facilitate weight loss, facilitate the prevention of weight gain, and / or facilitate weight maintenance. , faster and / or more optimally desirable results will be obtained when the chitosan-containing compositions of the invention are used in conjunction with a diet of ^ Controlled calories, preferably combined with exercise. Additionally, in desired form the product must be taken before, concurrently with, or after a meal, i.e., especially a meal containing an object selected from the group consisting of fat, free fatty acids, cholesterol, sterols other than cholesterol, and bile acids. According to the invention, a "meal" can be any food consumed by an individual that includes, but is not limited to, those consumer courses known as "breakfast," "lunch," "dinner," and "snack." By "before" is meant an amount of time that varies from about 10 seconds to desirably, no more than about 30 minutes before the consumption of the food. By "concurrent with" is meant approximately, or approximately the same time of consumption of the food. By "after" is meant an amount of time that varies from about 10 seconds to desirably, no more than about 30 minutes after the consumption of the food. Optimally, according to the invention, the product is not taken before, concurrent with, or after the meal which is a fat-free meal, or reduced fat unless the meal contains substantial amounts of cholesterol and / or bile acids . By "substantial amounts" is meant an amount of cholesterol and / or bile acid that would typically be unacceptable in a medically approved diet for an individual who has a need to control the intake of cholesterol and / or bile acids. It is further desirable according to the invention for people to discontinue the use of the product for a minimum of a two week period of time after a weight loss of ten percent of the initial weight, if such weight loss occurs within a month. Additionally, it is Preferably, a person who routinely consumes the chitosan-containing compositions of the invention also ingests approximately 8 glasses of water per day. The preferred dosage as described herein (see, for example, Example 5) is from an ingestion of the liquid compositions containing chitosan (each containing approximately 0.5 g of chitosan), which desirably should not be taken more than twice. in one day. Accordingly, the present invention provides a method for using a chitosan composition according to the invention in a subject's weight treatment program, the method desirably comprises the subject's consumption of the composition either prior to, concurrent with, or after a meal Optimally, the food contains an object selected from the group consisting of fat, free fatty acids, cholesterol, sterols other than cholesterol, and bile acids. The present invention additionally provides an improved method of weight treatment, the improvement desirably comprises a consumption of the subject of the composition of the invention, either before, concurrent with, or after a meal.

Other Illustrative Uses of Liquid Compositions Containing Chitosan Also, as further described herein, the liquid chitosan-containing compositions of the invention can be used in a wide variety of applications other than weight loss / weight maintenance due to the unique properties of chitosan. This example describes only a few means by which the preparations according to the invention, or variations of these compositions, can be applied. Of course, other means are available, and those familiar with the properties of chitosan should be apparent. Apart from a positive effect in weight reduction, prevention of weight gain, and weight control, there is evidence of other positive effects observed by people who have used products containing chitosan on a regular basis, for example, control of the blood pressure, improved cholesterol levels (ie, increased HDL cholesterol levels, reduced LDL cholesterol levels), promotion of wound healing, antibacterial effects, anti-retroviral effects, antiviral effects, antacid activity, inhibition of plaque formation / reduction in tooth decay, faster bone repair, improved calcium absorption, and reduced levels of uric acid (Hennen, Chitosan, Pleasant Grove, UT, Woodland Publishing, Inc., (1996)). The compositions containing chitosan of the invention, while secondarily they can treat, cure or prevent any particular disease, are tried mainly as described herein to contribute to weight loss, prevention of weight gain, and / or maintenance of a weight particular. The compositions containing chitosan do this by helping to control the absorption of fats, thereby assisting in the loss of weight and preventing or reducing weight gain. However, the compositions of the invention can also be used as described below. The compositions containing chitosan can be used in a cholesterol treatment program of the subject, such as cholesterol treatment compositions in a manner analogous to the use of the composition in a weight treatment program, wherein the subject consumes the composition either before of, concurrent with, or after a meal. As used herein, a "cholesterol treatment program" means any program used to promote cholesterol reduction, promote cholesterol maintenance and / or prevent increases in cholesterol. A cholesterol treatment composition comprises an "effective chitosan binding amount", i.e., an amount of chitosan as described herein, which is effective for binding cholesterol, non-cholesterol sterols, and / or bile acids, and which results in the treatment of cholesterol when applied in a program of cholesterol treatment according to the invention. A "schedule" is as previously defined, and desirably carried out as described for the weight management program. In particular, the cholesterol treatment program may be applied where a subject consumes a meal containing an object selected from the group consisting of cholesterol, sterols other than cholesterol, and bile acids. The chitosan-containing compositions of the invention (or variations thereof) may desirably be applied as an oral oral wash, for example, in the form of a fine mist spray, or the more traditional "rinse and spit" formulation. The use of the compositions in this form can help in the prevention of plaque formation and halitosis by facilitating the removal of certain compounds before they contribute to plaque and bad breath. The compositions may also aid in the healing of mouth lesions, eg, cancer pains and cold pains, by eliminating the compounds from, and out of these pains. The cleaning properties of the chitosan which additionally provide the chitosan-containing compositions (or variations thereof) can preferably be applied for bath treatments for wounds and / or burns and / or any other type of injury (preferably an external injury), as well as additives for local treatments for the same, as long as the chitosan does not deny any other beneficial / therapeutic compounds present in the formulation. Along with the same line, optionally the chitosan-containing compositions of the invention (or variations thereof) can be applied for a number of veterinary applications where their cleansing properties would prove to be therapeutic, for example, as veterinary pet gutters, or in the cleaning of any type of infestation, plague, burn or injury. Desirably, the flavor used in the composition is one that is palatable to the animal, for example, meat or fish flavor. Also, the chitosan-containing compositions of the invention (or variations thereof) can preferably be applied in a variety of personal cleansing regimens, for example, formulations for removing cosmetics or cleansing the skin, shampoos, or hair clarifiers, or so-called products to "leave on" hair, skin, or nails to prevent the accumulation of waste on the hair follicle, skin, or nails, which can contribute to an oily or oily appearance. When employed in this capacity, it may be desirable (but optional) to replace the flavoring ingredient with, for example, a fragrance, as is known, and commercially available. Similarly, the chitosan-containing compositions of the invention (or variations thereof) desirably can be applied in a variety of products. of general cleaning, for example, detergents, soaps, or shampoos for laundry, carpets, dish soap, dishwashers, car washes, upholstery, leather / vinyl, and the like, as well as in any general household cleaning product, for example, glass cleaner, floor cleaner and / or wax, general detergents, cleaners for kitchen and bathroom and many others. When employed in this capacity, it may be desired that any sweetener and / or flavoring agent be omitted from the chitosan-containing compositions of the invention. Thus, it is particularly preferred that the chitosan-containing compositions according to the invention additionally comprise a potion, a drink, a fog mist for mouthwash, bathing treatment for sores and / or burns, liquid cosmetics cleansers, veterinary solutions and others.

EXAMPLES The following examples further illustrate the present invention, but certainly should not be construed as limiting its scope in any way.

Example 1 This Example describes the preparation of a composition containing chitosan that can be used, for example, as a lipid binder. Optimally this The composition is used as a detoxifying system (ie, a composition that binds fat and other components undesirably ingested).

Table 1: Composition containing chitosan Quantity Components 5.0 grams flake or powder or chitosan salt 2.5 grams citric acid - and / or other acid or powder salt 5.0 fluid ounces (eg water or aqueous solution) 50 grams Aspartame 25 cc extract mint 25 cc lemon extract 25 cc orange extract 50 cc color and preservative In Table 1, the amounts and types of flavor extract (eg mint, lemon, orange) and the sweetener can be varied or omitted, depending on taste and desired odor of the resulting composition. Similarly, the amount and inclusion of color and preservative is optional. The composition is obtained by placing the flake, powder or chitosan salt mixed with the acid powder (s) or salt in a measuring cup, adding 5 fluid ounces, shaking briefly for 10 to 20 seconds, letting the mixture settle until about 10 minutes or until all the chitosan has dissolved. In this method, the chitosan and the citric acid salt are dissolved in ultramicroscopic particles suspended in the composition. In these stages, other components that impact the taste, appearance, smell or other properties of the mixture containing chitosan can be added. For example, as set forth in Table 1, a sweetener such as Aspartame can be added to, or pre-mixed with the composition containing chitosan, together with various flavoring extracts. The mixture is then shaken or stirred until the mixture is likewise suspended. Refrigeration of the composition containing chitosan is optional, and can be stored for future use. The chitosan-containing composition can be used to empty one ounce of the mixture from Table 1 in one liter or quarter-size containers together with other liquids or compositions intended for human (or mammal) consumption, and mix well. Preferably, the liquids or compositions do not contain a fatty bile acid or compound. Thus, the composition of Table 1 provides five 1-ounce applications each are ready to be used.

Example 2 This Example describes the preparation of a liquid composition containing chitosan that can be used, example, as a lipid binder and / or detoxifying system. Optimally, the composition has favorable effects on virility, or the person's perception of virility after consumption of the composition.

Table 2: Composition containing chitosan Amount Components 5.0 grams Flakes or powder or chitosan salt 2.5 grams Lactic acid - and / or other ingestible salts / powder 5.0 fluid ounces (eg water or aqueous solution) 2.0 grams Rhodiola Rosea salt 50 grams Aspartame 25 cc Vanilla extract 25 cc Mint extract 25 cc Lemon extract 25 cc Orange extract Optional color and preservative In Table 2, the amounts and types of flavoring extract (for example mint, lemon, orange) can be varied, or omitted depending on the desired flavor and odor of the resulting composition. Similarly, the amount and inclusion of color and preservative is optional.

The composition is obtained by placing the flake or chitosan powder mixed with the acid powder (s) or salt in a measuring cup, adding 5 fluid ounces, shaking briefly for 10 to 20 seconds, letting the mixture settle for approximately 10 minutes or until all the chitosan has dissolved. In this method, the chitosan and the acid salt are dissolved in ultramicroscopic particles suspended in the composition. In this stage, other components that impact the taste, appearance, smell or other properties of the mixture containing chitosan can be added. For example, as set forth in Table 2, the Rhodiola Rosea salt can be added to, or pre-mixed with the composition containing chitosan, together with various flavor extracts. The mixture is then shaken or stirred until the mixture is likewise suspended. Refrigeration of the composition containing chitosan is preferable (but not necessary), and can be stored for future use. The chitosan-containing composition can be used to empty one ounce of the mixture from Table 2 in one liter or one quarter size containers together with other liquids or compositions intended for human (or mammal) consumption, and mix well. Preferably, the liquids or compositions do not contain a fatty bile acid or compound. Thus, the composition of Table 2 provides five 1-ounce applications each that are ready to be used.

The beverage mixtures in this example and the above may optionally be modified to include additional agents, including but not limited to, other unnatural or man-made compounds, elements or acids such as dehydroepiandrosterone (DHEA), or oligomeric proanthocyanidin ( OPC), etc.

Example 3 This Example describes the preparation of a liquid composition containing chitosan that can be used, for example, in local applications of burns / sores. Table 3: Composition containing chitosan Quantity Component 30 grams Chitosan 45 grams Salt of lactic acid (or other salt acid salt such as acetic acid salt) 5 oz Distilled or filtered water 50 cc Extract of soft soluble gel Optional Color and preservative In the Table 3, the amounts and types of color and preservative can be varied or omitted. The composition obtained by placing the chitosan flake mixed with the acid salt (s) in a measuring cup, adding 5 fluid ounces, shaking briefly for 30 minutes. seconds, leaving the mixture to settle until all the chitosan has dissolved. In this method, the chitosan and the acid salt are dissolved in ultramicroscopic particles suspended in the composition. At this stage, other components that impact the appearance or other properties of the mixture containing chitosan can be added. For example, as set forth in Table 3, a mild soluble gel may be added to, or pre-mixed with, the composition containing chitosan (ie, to facilitate application). Optionally, other therapeutic agents may also be present in the gel. Then, the mixture is stirred until it is likewise mixed. The composition containing chitosan can be stored for future use.

EXAMPLE 4 This Example describes the preparation of a liquid composition containing chitosan that can be used, for example, in weight reduction, as well as in other applications, for example, in veterinary applications, such as animal dewatering.

Table 4: Composition containing chitosan Quantity Component 20 grams Chitosan 12 grams Formic acid salt / powder citric acid / 5 oz. salt Distilled or filtered water 50 cc Extract of meat or flavoring (that does not contain fat) 50 cc Extract of chicken or flavoring (that does not contain fat) 50 cc Color Optional Conservative In Table 4, the quantities and types Color and preservative can be varied or omitted. Similarly, the amount and types of flavor agent extracts can be varied. The composition is obtained by placing the mixture of chitosan with the acid powder (s) / salt in a measuring cup, adding 5 ounces of fluid, stirring briefly for 30 seconds, allowing the mixture to settle until all the chitosan dissolves. In this method, the chitosan and the acid salt are dissolved in ultramicroscopic particles suspended in the composition. At this stage, other components that impact the flavor, odor, or other properties of the mixture containing chitosan can be added. For example, as set forth in Table 4, extracts or flavoring agents may be added to, or pre-mixed with, the composition containing chitosan (i.e., to increase flavor). Afterwards, the mixture is stirred until it mixes equally. The composition containing chitosan can be stored for future use.

Example 5: Preparation of a Liquid Composition Containing Chitosan Approximately 30 ounces of suspension composition containing chitosan ("X-fat") can be prepared, and for example, packaged in 60 x 0.5 ounce packs or other convenient sized packages using the following formulation: Table 5: Formulation of chitosan composition (approximately 30 fluid ounces).

This can be scaled, for example, to a commercial tub size of approximately 80 liters, as follows: Table 6: Formulation of chitosan composition (approximately 80 liters) All the mixture of the components to obtain the composition containing chitosan is made at room temperature. The formulation is obtained by slowly mixing in the chitosan in a vortex created by the high-speed agitation of Spring water (eg, 16 ounces for a 30-ounce formulation) present in a tub ("Tub A"). The mixture is shaken in reverse gently with a plastic shovel until the chitosan is evenly dispersed. This usually takes less than an hour. The ascorbic acid is then added slowly and gently stirred until it disperses. This forms a viscous material that is best agitated with a shovel. The thick liquid takes on a golden color with continuous gentle agitation (ie, generally less than one hour). Typically, the mixture in this stage has an acidic pH (by example, between about 2 and about 4, typically about 3.9). Spring water (for example, 11 ounces for a 30-ounce formulation) is added to a separate strip ("Tina B"). The preservatives are added to the tub B and mixed well. Then, the contents of the tub B are added to the tub A, and the liquid is mixed with slow stirring. Then, the inulin is added, and the reaction is mixed gently and completely. The cranberry flavor is added through a filter (or filtered first and then added) and mixed thoroughly. The pH of the unaltered product obtained by this process is typically acidic (between about 2 and about 4, typically about 3.9). Optionally, the mixture in this step can be pumped through a funnel in separate packages. It is important for this process that the sour cranberry flavor is added after the preservatives (sodium benzoate, potassium sorbate) have gone into solution. If the sour cranberry flavor is added before the preservatives and the inulin, the preservatives added later will not be solubilized. This process can similarly be carried out with the use of acids other than ascorbic acid, and with another dietary fiber, or by omitting the dietary fiber. Similarly, the flavor can be varied.

Example 6: Evaluation of Samples Components containing Chitosan. These studies were carried out to assess various characteristics of chitosan suspension samples prepared according to Example 5. For these experiments, all analyzes were carried out by Gibraltar Laboratories, Inc., Fairfield, NJ, a biological research service and regulatory test that conducts the testing of biological samples using established research practices. The results of such tests for three separate samples of chitosan beverage synthesized according to the invention are set forth in Table 7 below.

Table 7: Summary of the Chemical Analysis of Three Samples Containing Chitosan The protein could not be determined by standard Kjeldahl nitrogen analysis due to chitosan interference. The Bradford protein termination method was used instead. Similarly, interference was obtained with the use of the Lowry test attempted by two methods. Similar results as presented in Table 7 were obtained from other sample analyzes.

Example 7: Evaluation of Microbial Concentration in Chitosan Compositions. These studies were carried out to determine the aerobic plate count of two liquid samples of separate chitosan prepared according to Example 5 as well as the presence / absence of specific USP Indicator Organisms. For these studies, the Microbial Limits Test USP was carried out by adding 10 ml of sample to 90 ml of GBL STAT Broth (Trypticase Soy Broth containing 4% Tween 20, 0.5% lecithin, and 1% lactose). The jar shook to give a 1:10 suspension (enrichment). Suitable aliquots were seeded with GBL STAT Agar (Trypticase Soy Agar, containing 4% Tween 20 and 0.5% lecithin) for bacterial counts (30 to 35 ° C / 48 to 72 hours). The enrichment of 10 ml above was then incubated at 30 to 35 ° C for 48 to 72 hours and subcultured on selective and differential media (30 to 35 ° C / 24 to 48 hours) as cited in USP. The results of these tests confirm that the samples of chitosan suspension house each, a bacterial count of less than about 10 cfu / ml, and a mold / yeast count of less than about 10 cfu / ml. Escherichia coli and Salmonella sp. In the enrichment of 10 ml. When tested by Pseudomonas aerugunosa and Staphylococcus aereus it was not detected similarly. Similar results were obtained from other sample analyzes. Similar results were obtained in experiments conducted according to a USP 23 methodology. The medium for this method is as follows: Modified Lactose Broth North American Patent (MLB) A32; Soya Broth Trypticase Modified North American Patent (MTSB) A1; Broth GBL STAT A2 TSB A5; Cysteine Selenite Broth (SCB) A57 *; Tetrathionate Broth (TB A74; GBL STAT A32 Agar; Sabouraud Dextrose Agar (SDA) L67; Mannitol Salt Agar (MSA) K140; MacConkey Agar "(MAC) A9; Cetrimide (CET) K68; Agar Xylose Lysine Sesoxieholate (XLD) A29; and BGA A64. The abbreviations of the media are: MLB (ie lactose broth containing 4% Tween 20 and 0.5% lecithin); MTSB (ie Trypticase Soy Broth (TSB) containing 4% Tween 20 and 0.5% Lecithin); GBL Stat broth (ie, TSB containing 4% Tween 20 and 0.5% lecithin); TSB (ie, Casein Digested Broth Soya); SDA (ie, Agar Dextrose Sabouraud); and STAT Agar (ie, TSA containing 4% Tween 20 + 0.5% Lecithin). The USP 23 methodology was carried out as follows: 1. A 1:10 dilution of the test material was prepared in MTSB (25 ml of the test material + 225 ml of MTSB). The dilution of broth-test material was aseptically subdivided into four 15 ml portions in sterile test tubes. 2. A 1:10 dilution of the test material was also prepared in MLB (25 ml of the test material + 225 ml of MLB). The dilution of the broth-test material was aseptically subdivided into two 15 ml portions in sterile test tubes. 3. Indicator cultures of organisms were grown at 30 to 35 ° C for 24 +/- 8 hours in TSB e where they were diluted 1: 10,000 (104) in sterile physiological saline. { Candida albicans and Aspergillus niger, were diluted 1: 100, 102). One ml of each organism was inoculated separately into the ml portions of the test material from steps 1 and 2 and mixed. The MTSB tubes (stage 1) were inoculated separately with Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and A. Niger. The MLB tubes (stage 2) were inoculated separately with Salmonella choleroaesuis and Escherichia coli. To validate that the tracing medium test could promote the growth of the indicator organisms grown in stage 3 above, one ml of each organism diluted as in step 3 was inoculated separately into the 15 ml of MTSB and MLB (controls). The MTSB control tubes were inoculated separately with Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and A. Niger. The MLB control tubes were inoculated separately with Salmonella choleroaesuis and Escherichia coli. The number of organisms inoculated within the test material and within the controls was determined by ten-fold serial dilutions (101 to 10"3) within GBL Stat Broth (TB containing 4% Tween 20 and 0.5% Lecithin Four plates of each dilution were made with TSA (bacteria) and SDA (mushrooms). The plates were incubated for 48 to 72 hours at 30 to 35 ° C (bacteria) or 20 to 25 ° C for 5 to 7 days (fungi) and the colony forming units were counted on a dark field Quebec colony counter. 6. 15 ml portions of the inoculated MTSB test material from step 3 (except Candida albicans and A. niger) and 15 ml portions of the inoculated MTSB broth controls from step 4 were then incubated for 48 to 72 hours at 30 a 35 ° C (bacteria) or 20 to 25 ° C for 5 to 7 days (fungus). 7. 15 ml portions of the inoculated MLB test material from step 3 and the 15 ml portions of the inoculated MLB broth controls from step 4 were then incubated for 24 +/- 8 hours at 30 to 35 ° C. After 24 +/- 8 oras at 30 a ° C incubation, one ml of the enrichment (MTSB and MLB, Salmonella choleroaesuis only) was transferred into 10 ml of SCB and one ml of the enrichment was transferred into 10 ml of TB. The MLB, SCB and TB were then incubated at 30 to 35 ° C for 12 to 24 hours. 8. The enrichments of steps 6 and 7 were then observed by dense turbidity and a broth of the broth was then placed in selective medium to confirm the growth of the indicated organisms. When studied by a USP 23 methodology, inhibition was noted. Inhibition was observed when small numbers of the aforementioned organisms were deliberately inoculated into the chitosan preparation. The interpretation of this result was that the preparation itself or the constituents of the microbial limit test USP 23 were toxic in the presence of low amounts of microorganisms. It is known that the components of subculture USP Caldo Tetrathionate Fluid and Cystine Broth Selenite are toxic to low amounts of organisms and, as a result of this, the inhibition noted was not surprising. If any microorganisms are possibly present in any composition prepared according to the invention, the level is so low that it is insubstantial. The results obtained with the USP Microbial Limits test demonstrate the absence of the above microorganisms. In conclusion, the data confirm the absence of pathogens and the low amounts, if any, of the microorganisms present in the chitosan compositions prepared according to the invention. These results confirm that the chitosan-containing compositions of the invention are substantially sterile.

Example 8: Evaluation of the Effect of Storage on Liquid Compositions Containing Chitosan This example exposes the effect of storage on samples containing chitosan prepared according to Example 5, ie if the samples can be maintained for a long period of time without showing growth microbial.

For these studies, samples (1) kept in non-refrigeration for at least one year ("Sample A"), (2) kept refrigerated for at least one year ("Sample B") or (3) recently manufactured ("Sample C") were used. ). 25 ml of the sample was added to 225 ml of GBL STAT broth (Trypticase Soy Broth containing 4% Tween 20, 0.5% lecithin, and 1% lactose). The jar was shaken to give a dilution of 1: 1) (enrichment). Suitable aliquots were seeded with GBL STAT Agar (Trypticase Soy Agar containing 4% Tween 20 and 0.5% lecithin) for bacterial counts (30 to 351C for 48 to 72 hours) and with Sabouraud Dextrose Agar (SDA) for accounts of mold / yeast (20 to 25 ° C for 7 days). The above enrichment was then incubated at 30 to 35 ° C for 48 to 72 hours and subcultured on selective and differential medium (30 to 35 ° C / 24 to 48 hours) as cited in USP. 25 ml of the samples were filtered through a sterile 0.2 micron membrane filter and washed three times with 100 ml of 0.1% Peptone Water. The filtrate was seeded in m-Endo agar. Plates were incubated at 30 to 35 ° C for 24 to 32 hours and observed by typical coliform morphology (ie colonies with metallic luster).

Table 8: Results of the USP Microbial Limit Preparation Test These results confirm that the products of the invention are stable in long-term storage even in the absence of refrigeration.

Example 9: Evaluation of the Viscosity and pH of the Liquid Compositions Containing Chitosan.

This example establishes an assessment of the viscosity and pH of the liquid compositions containing chitosan of the invention. Representative samples of chitosan prepared according to Example 5 were evaluated by viscosity (ie, rotational viscosity using a Brookfield viscometer) and pH (ie potentiometer). The average viscosity was determined to be 241.50 centipoise (3 samples) with an upper and lower standard limit, respectively, of 390 and 120 centipoise. The average pH was determined to be 3.8.

Example 10: Assessment of the In Vitro Fat Bonding Ability of Liquid Compositions Containing Chitosan. This example establishes an assessment of the fat binding ability of the liquid chitosan-containing compositions of the invention prepared as in Example 5. For these studies, 15 ml of melted ice cream was placed in beakers. In some of the beakers, 30 ml of water was added. In the others, 7.5 ml of a sample of chitosan and 22.5 ml of water were added. The resulting mixtures were centrifuged. The material treated with the composition containing chitosan gave a clear solution with centrifugation with the fat remaining on top of the solution. The untreated material gave a cloudy solution. Aliquots of 20 ml of the supernatants (ie, the clarified solution obtained for the sample treated with chitosan and the turbid solution obtained for the untreated sample) were then extracted using the conditions as outlined in the Associate Official Analytical Chemists Manual for the determination of fat in ice cream. The resulting extracts were evaporated and the amount of fat recovered was determined.

Table 9: Results of the Fat Reduction Test NA = Not applicable Calculation% of Loss = (average fat weight in the untreated extract - Fat Weight in each treated extract x 100 average fat weight in untreated extract These results confirm that the method can be used to show the level of fat absorption by the chitosan-containing composition of the invention.

Example 11: Use of Liquid Compositions containing Chitosan in a Weight Reduction and / or Weight Maintenance Regime. This example establishes the manner in which liquid compositions containing chitosan can be employed on a routine basis to prevent increases in weight gain, bring about weight reduction and / or help maintain a preferred weight. The use of the liquid compositions containing chitosan (e.g., as described in Example 5) is generally as follows. Before one of the individual's two largest meals of the day (eg, typically lunch or dinner), approximately 0.5 ounces of liquid product (ie, approximately 14 drops) is mixed in at least about 2 ounces of water. It is preferred that the Composition is mixed in water, since the product containing chitosan will almost immediately begin to bind with any fat, (or perhaps other large complex molecules) present in the liquid, which could have a negative impact on the appearance of the drink. However, the compositions can be mixed with another beverage, so long as drinks with milk, cream or fat are avoided, and preferably as long as the beverage is fat-free. After mixing, the drink is consumed. The consumption of chitosan as a liquid (that is, opposed to a tablet), followed by the consumption of additional liquid, has the added advantage of tending to fill the stomach, which could help reduce intake. Typically, a "chalky" residual flavor is experienced, this probably indicates that the liquid product containing chitosan has begun to gather the fat (eg, residues on the tongue and inside the mouth). It is recommended, for example, to facilitate digestion as well as the sensation, that the consumption of the product is followed by the consumption of another glass of water. After ingestion of the product containing chitosan, an individual can participate in a meal in a typical way. The use of the product containing chitosan can then be repeated before the other biggest meal of the day.

Example 12: Use of Liquid Compositions Containing Chitosan-Double Blind Clinical Study This example describes clinical studies to confirm the effect of a chitosan-containing composition of the invention (eg, prepared as described in Example 5) on absorption of fat. This study is double-blind, randomized, and includes a pass over to evaluate the effect of chitosan-containing compositions on post-meal changes in lipids and lipoproteins, and serum triglyceride levels after a standardized fatty meal, consisting of of a half cup of Haagen Daz vanilla ice cream or chocolate) in normal subjects. Preferably the study involves twenty patients, male or female, between 21 and 60 years of age. Subjects are selected who do not have a documented history of hypertriglyceridemia and who have not been on a low fat diet (<30% fat, <300 mg cholesterol) for at least the last four weeks. It is additionally necessary for inclusion in the clinical study that the subject: have normal fasting plasma triglycerides < 250 mg / dl and total cholesterol in fasting plasma > 220 mg / dl; have not taken lipid-lowering drugs within four weeks before the determination of lipid rating levels; have not taken any of the prohibited treatments of hormone therapy (dose of estrogen> 0.03 mg), immunosuppressive agents, and chronic administration of corticosteroids (except local or inhaled) within 2 weeks before the study; have no active liver disease (ie, elevations in AST or ALT are less than, or equal to 1.5 of the normal range); have serum creatinine less than or equal to 1.2 mg / dl; have a CPK that is less than or equal to twice the normal range. Any of the following are criteria that exclude a subject from participation in the clinical study: an acute myocardial infarction or cerebrovascular accident within 3 months; coronary artery bypass surgery or PTCA within the past 3 months; an unstable cardiovascular condition (unstable angina, congestive heart failure, NYHA grade III or IV); a history of clinically significant gastrointestinal disease within the past 3 months; a history of liver disease or a history of biliary tract disease without a cholecystectomy; known diabetes Type I or Type II or fasting glucose > 140 mg / dl; a malignancy, except for cutaneous squamous or basal cell cancers; a body mass index > 37 kg / m2, the subject is taking oral anticoagulant therapy or has an abnormal prothrombin time; active psychosis; and untreated hypothyroid condition (> the upper normal limit for TSH); a history of chronic or acute drug abuse or alcohol during the past 6 months; an allergy to shellfish or iodine; abnormal cholesterol (> 220 mg / dl) or triglyceride levels (> 250 mg / d); take fat-soluble medication; a possibility of pregnancy in the following 6 months. The post-ingestion test proceeds in the following stages. The blood is drawn for the first lipid test (0 hours after the meal) and for laboratory safety tests. The subject consumes the standard fat meal within 30 minutes of the 0 hour blood draw. Immediately after the meal, the subject consumes the chitosan-containing composition of the invention mixed in 2 ounces of water, followed by an additional 6 ounces of water. The blood is removed for lipid testing 4 to 4 1/2 hours after the meal. Blood samples are analyzed for a variety of tests, for example, chemistry (such as sodium, potassium, calcium, glucose, BUN, creatinine, total protein, alkaline phosphate, gamma GT, SGOT (AST), SGPT (ALT), albumin, total bilirubin, uric acid and CPK), urinary chemistry (such as appearance of urine, pH of urine, specific gravity, urinary protein, urine glucose, urinary ketones, urinary bilirubin, urinary red blood cells, urinary white blood cells and molding), hematology (such as white blood cells, red blood cells, hemoglobin, hematocrit, platelet counts , monocytes, eosinophils, basophils, neutrophils, and lymphocytes), and other tests (such as insulin, TSH selection, serum β-hCG). Double-blind, randomized, patients are treated one week with the composition containing chitosan and the other week with placebo. Based on the confirmed properties of chitosan, these studies should validate the effectiveness of the chitosan compositions of the invention in preventing the absorption of fat. Example 13: Evaluation of the Fat Bond and Particle Analysis This example establishes a fat bond titration and particle analysis for chitosan suspensions prepared according to the invention. A chitosan / acid / water suspension was prepared essentially as described in Example 5 for the preparation of "Tub A", with the addition of additional water to fill the volume. Primarily, chitosan / acid / water contains approximately 3% mass / volume of chitosan and about 3% mass / volume of acid, and (apart from water) without additional components. The acid used to make the chitosan / acid / water suspension was ascorbic acid or citric acid. An acid containing "complete" suspension was prepared essentially as described in Example 5 for the preparation of the complete formulation (i.e. including other agents besides chitosan and acid). The acid used to make the "complete" suspension containing acid was ascorbic acid and citric acid. A "complete" suspension containing less chitosan acid was prepared essentially as described in Example 5 for preparation of the complete formulation (ie, including other agents in addition to the chitosan and acid), except that the chitosan was omitted from the formulation and the difference (if any) in volume was adjusted with water. The acid used to make. the "complete" suspension containing less chitosan acid was ascorbic acid or citric acid. An aged sample was prepared essentially as described for the preparation of the chitosan / acid / water suspension using citric acid. The sample had been kept at room temperature for approximately about 5 months, and then stored at about 4 ° C for about 5 months. Additionally, a control containing inulin only in the same percentage as that described in Example 5 was studied. The Fat link was evaluated as follows. 15 ml of the tested sample were added to 5 g of extra virgin olive oil and 10 ml of 0.01 N hydrochloric acid. Shaken on a Burrell wrist action shaker for 2 hours at approximately 22 ° C. The mixture was brought to pH 7.4 with NaOH, and then resuscitated for 30 minutes as described above. Then, the tubes were centrifuged at 10,000 r.p.m. for 20 minutes in a Sorvall RC2B centrifuge at 20 ° C. The supernatant oil was aspirated and weighed. The particle analysis was carried out as follows. The study was done on a Hyac Royco Model 3000A Particle Size Analyzer. The samples were diluted in sterile water for irrigation 1: 100 and 1: 1000. 5 ml samples were tested in the instrument and the amount of particles greater than 25, and greater than 10 microns, were measured by laser light dimming. The results of these studies are reported in the Table 10 Table 10: Fat Link and Particle Analysis As can be seen in this Table, all chitosan / acid / water suspensions contained particles that are larger than 10 microns. In comparison, a "water" control does not. The amount of particles obtained with a chitosan / acid / water suspension, made with ascorbic acid appeared scarcely equivalent to those obtained with a suspension made with citric acid. The chitosan / acid / water suspension containing ascorbic acid and containing citric acid showed a similar ability to bind fat - approximately 6.8-6.9 grams of fat bonded per gram of chitosan present in the suspension. The "complete" suspension containing acid made with ascorbic acid or citric acid has a higher particle count and similar range of binding capacity in accordance with comparable suspensions of chitosan / acid / water. However, when the "complete" formula is made without the chitosan, the particle count falls to the level that the chitosan gave in the comparable chitosan / acid / water suspensions. This means that the formation of chitosan particles (particle suspension) is even higher when used in the "complete" formula under the conditions of the present experiment and suggests that the particles measured are those of the additional ingredients not tested in the experiment. .

While the same protocol was done for all samples, it was not optimized to show maximum link efficiency. It has been shown that the type of dietary fat influences the effect exerted by chitosan on lipid absorption, as described, for example, in Ikeda et al.,: Nutr., 119 (110), 1383-7 (1989). ). Accordingly, the results of Table 10 are merely exemplary of the fat binding capacity of the chitosan formulations of the invention, and do not illustrthe full potential of the formulations. It is entirely possible that even higher binding capacities are obtained with the use of particular fats, free fatty acids, cholesterol, sterols other than cholesterols, bile acids and the like. The "aged" formula gave comparable particle results according to the chitosan / acid / w suspensions. This shows that the present method for obtaining a chitosan suspension is reproducible. Example 14: Evaluation of Suspended Particles of Stored Sample This example describes the colloidal characteristics of a sample of stored chitosan suspension. The chitosan suspension sample was the "aged" sample described in Example 13. The visual examination of liquid showed a deep Tyndall example. The liquid showed Brownian particle movement without any sedimentation of the particles. This confirms the stability of the suspension over time. All references cited herein are hereby incorpor by reference in their entirety. While this invention has been described with an emphasis on a preferred embodiment, it will be obvious to those of ordinary skill in the art that variations in the preferred compositions and method may be used and that the invention is intended to be practiced otherwise as specifically described herein. Accordingly, this invention includes all modifications encompassed within the spirit and scope of the invention as defined by the following claims.

Claims (41)

1. CLAIMS 1. A stable liquid suspension composition, consisting essentially of chitosan, a non-fatty acid or salt thereof, and water or aqueous solution, characterized in that each is present in the composition in a sufficient amount of stabilizer to effect the formation of a stable liquid suspension. The composition according to claim 1, characterized in that the composition is stable for at least about 12 months to be maintained at a temperature of from about 0 ° C to about 100 ° C. 3. The composition according to claim 1, characterized in that the suspension has a particle size of about 1 nm to about 150 microns. The composition according to claim 1, characterized in that the composition has the viscosity from about 120 centipoise to about 390 centipoise. 5. The composition in accordance with the claim 1, characterized in that the composition has a pH of from about 3.6 to about 4.2. 6. The composition according to claim 1, characterized in that it binds at least about 3 grams of fat per gram of chitosan. The composition according to claim 1, characterized in that the chitosan is present in an amount of about 2.5% to about 4.0% (mass / volume) of the composition. The composition according to claim 1, characterized in that the non-fatty acid or salt thereof is present in an amount of about 2.5% to about 4.0% (mass / volume) of the composition. 9. The composition according to claim 1, characterized in that the non-fatty acid or salt thereof is ascorbic acid. The composition according to claim 1, characterized in that the non-fatty acid or salt thereof is selected from the group consisting of acetic acid, adipic acid, citric acid, formic acid, lactic acid, malic acid, folic acid, acid pantothenic and biotin. 11. A stable liquid suspension composition characterized in that it consists essentially of: (a) chitosan, a non-fatty acid, or salt thereof, and water or aqueous solution, wherein each is present in the composition in a sufficient stabilizing amount to effect the formation of a stable liquid suspension; and (b) diet fiber. 12. The composition according to claim 11, characterized in that the dietary fiber is inulin. The composition according to claim 11, characterized in that the diet fiber is present in an amount of about 2.0% to about 10.0% (volume / volume) of the composition. 14. A stable liquid suspension composition characterized in that it consists essentially of: (a) chitosan, a non-fatty acid, or salt thereof, and water or aqueous solution, wherein each is present in the composition in a sufficient stabilizing amount to effect the formation of a stable liquid suspension; and (b) diet fiber, preservative and flavoring. 15. The composition according to claim 14, characterized in that the preservative is present in an amount of about 2.5% to about 4.0% (mass / volume) of the composition. 16. The composition according to claim 14, characterized in that the preservative is Select from the group consisting of sodium benzoate, potassium sorbate, benzoic acid, methylparaben, alcohol and sorbic acid. The composition according to claim 14, characterized in that the flavor is present in an amount of about 2.0% to about 4.0% (mass / volume) of the composition. 18. The composition according to claim 14, characterized in that it binds at least about 2 grams of fat per gram of chitosan. 19. A stable liquid suspension composition characterized in that it consists essentially of: (a) chitosan, a non-fatty acid, or salt thereof, and water or aqueous solution, wherein each is present in the composition in a sufficient stabilizing amount for effect the formation of a stable liquid suspension; and (b) diet, preservative and flavoring fiber, wherein the chitosan is present in an amount of about 2.5% to about 4.0% (mass / volume), the non-fatty acid or salt thereof is present in an amount of about 2.5% up to about 4.0% (mass / volume), the dietary fiber is present in an amount of about 2.0% up to about 10.0% (volume / volume), the preservative is present in an amount of about 2.5% up to about 4.0% (mass / volume), and the flavor is present in an amount of about 2.0% to about 4.0% (mass / volume) of the composition. 20. The method for preparing the composition according to claim 1, the method is characterized in that it comprises: (a) obtaining solid chitosan; (b) moisten the chitosan with water or aqueous solution; (c) mixing an acid or acid salt with the chitosan and water or aqueous solution to obtain the composition. 21. The method for preparing the composition according to claim 11, the method is characterized in that it comprises: (a) obtaining solid chitosan; (b) moisten the chitosan with water or aqueous solution; (c) mixing the non-fatty acid or acid salt with the chitosan and the water or aqueous solution to obtain a mixture of acid-chitosan; (d) in a separate container, add water or aqueous solution; (e) mixing diet fiber with the water or aqueous solution in the separate container; and (f) mixing the acid-chitosan mixture with the contents of the separate container to obtain the composition. 22. The method for preparing the composition according to claim 14, the method is characterized in that it comprises: (a) obtaining solid chitosan; (b) moisten the chitosan with water or aqueous solution; 15 (c) mixing the non-fatty acid or acid salt with the chitosan and the water or aqueous solution to obtain a mixture of acid-chitosan; (d) in a separate container, add water or aqueous solution; 20 (e) mix the preservative in the separate container; (f) mixing the diet fiber in the separate container; (g) mixing the flavor in the separate container; Y (h) mixing the contents of the separate vessel with the acid-chitosan mixture to obtain the composition. 23. The method for preparing the composition according to claim 14, the method is characterized in that it comprises: (a) obtaining solid chitosan; (b) moisten the chitosan with water or aqueous solution; (c) mixing the non-fatty acid or acid salt with the chitosan and the water or aqueous solution to obtain a mixture of acid-chitosan; (d) in a separate container, add water or aqueous solution; (e) mixing the preservative in a separate container; (f) mixing the contents of the separate vessel with the acid-chitosan mixture to obtain a mixture of preservative-acid-chitosan; (g) mixing the diet fiber with the preservative-acid-chitosan mixture; and (h) mixing the flavor with the preservative-acid-chitosan mixture to obtain the composition. 24. The method for using the composition according to claim 1, in a subject weight treatment program, the method is characterized in that it comprises the consumption of the subject of the composition comprising an amount of effective binding of chitosan, either before, concurrent with, or after a meal to result in weight treatment. 25. The method according to claim 24, characterized in that the food contains an object selected from the group consisting of fat, free fatty acids, cholesterol, sterols other than cholesterols, and bile acids. 26. In a method of weight treatment, the improvement is characterized in that it comprises a consumption of the subject of the composition according to claim 1, comprising an amount of effective binding of chitosan either before, concurrent with, or after a meal to result in weight treatment. 27. The method for using the composition according to claim 1, in a cholesterol treatment program of the subject, the method is characterized in that it comprises the consumption of the subject of the composition comprising an effective binding amount of chitosan, either before, concurrent with, or after a meal to result in the treatment of cholesterol. 28. The method according to claim 27, characterized in that the food contains a selected object of the group consisting of cholesterol, sterols other than cholesterol, and bile acids. 29. In a cholesterol treatment method, the improvement is characterized in that it comprises the consumption of a The subject of the composition according to claim 1, comprising an effective amount of chitosan binding either before, concurrent with, or after a meal to result in the treatment of cholesterol. 30. The method for using the composition according to claim 11, in a subject weight treatment program, the method is characterized in that it comprises the consumption of the subject of the composition comprising an effective binding amount of chitosan either before, concurrent with, or after a meal to result in the 15 peso treatment. 31. The method according to claim 30, characterized in that the food contains an object selected from the group consisting of fat, free fatty acids, cholesterol, sterols other than cholesterols, and bile acids. 32. In a weight treatment method, the improvement is characterized in that it comprises a consumption of the subject of the composition according to claim 11, comprising an effective binding amount of chitosan either before, concurrent with, or after a meal to result in weight management. 33. The method for using the composition according to claim 11, in a cholesterol treatment program of the subject, the method is characterized in that it comprises the consumption of the subject of the composition comprising an effective binding amount of chitosan, either before, concurrent with, or after a meal to result in the treatment of cholesterol. 34. The method according to claim 33, characterized in that the food contains an object selected from the group consisting of cholesterol, sterols other than cholesterol, and bile acids. 35. In a cholesterol treatment method, the improvement is characterized in that it comprises the consumption of a subject of the composition of claim 11, comprising an effective amount of chitosan binding either before, concurrent with, or after a Food to result in the treatment of cholesterol. 36. The method for using the composition according to claim 14, in the weight treatment program of the subject, the method is characterized in that it comprises the consumption of the subject of the composition comprising a • Effective amount of chitosan binding either before, concurrent with, or after a meal to result in weight management. 37. The method according to claim 36, characterized in that the food contains an object selected from the group consisting of fat, free fatty acids, cholesterol, sterols other than cholesterols, and bile acids. 38. In a weight treatment method, the improvement is characterized in that it comprises a consumption of the subject of the The composition according to claim 14, comprising an effective binding amount of chitosan either before, concurrent with, or after a meal to result in weight treatment. 39. A method for using the composition according to claim 14, in a cholesterol treatment program of the subject, the method is characterized in that it comprises the consumption of the subject of the composition comprising an effective binding amount of chitosan, and be before, concurrent with, or after a meal to turn out 20 in the treatment of cholesterol. 40. The method according to claim 39, characterized in that the food contains a selected object * f v of the group consisting of cholesterol, sterols other than cholesterols, and bile acids. 41. In a cholesterol treatment method, the improvement is characterized in that it comprises the consumption of a subject of the composition according to claim 14, comprising an effective amount of chitosan binding either before, concurrent with, or after of a meal to result in the treatment of cholesterol.