Title of Invention	PROCESS FOR THE PREPARATION OF A COMPOSITION CONTAINING PSYLLIUM HUSK
Abstract	A process for the preparation of a composition containing Psyllium husk in the form of a multi-layered creamy, crunchy, highly palatable biscuits which comprises preparing wheat flour slurry, preparing creamy inner layer containing the Psyllium husk, preparing crispy wheat flour sheets from said wheat flour slurry, and preparing creamy wafers with said crispy wheat flour sheets, with said creamy inner layer containing the Psyllium husk between said sheets, wherein said Psyllium is present at a concentration in the range of 20-80% by weight of the total composition and said wheat flour is present at a concentration in the range of 30-60% by weight of the total composition,.

Title of Invention

PROCESS FOR THE PREPARATION OF A COMPOSITION CONTAINING PSYLLIUM HUSK

Abstract

A process for the preparation of a composition containing Psyllium husk in the form of a multi-layered creamy, crunchy, highly palatable biscuits which comprises preparing wheat flour slurry, preparing creamy inner layer containing the Psyllium husk, preparing crispy wheat flour sheets from said wheat flour slurry, and preparing creamy wafers with said crispy wheat flour sheets, with said creamy inner layer containing the Psyllium husk between said sheets, wherein said Psyllium is present at a concentration in the range of 20-80% by weight of the total composition and said wheat flour is present at a concentration in the range of 30-60% by weight of the total composition,.

Full Text	FORM 2 The PATENT ACT, 1970 (39 of 1970) Complete Specification NOVEL DELIVERY SYSTEM FOR ISAPGHULA HUSK AND A PROCESS FOR THE PREPRATION THERE OF A COMPOSITION CONTAINIG CADILA HEALTH CARE LTD, Zydus Tower, Satellite Cross Road, Ahmedabad-380015, Gujarat, India. The following specification describes and ascertains the nature of the invention, .and the manner in FIELD OF INVENTION The present invention relates to a process for the preparation of crunchy, highly palatable, bulk increasing, dietary fiber supplement compositions. More particularly, this invention relates to a process for preparing creamy wafers containing psyllium husks, a food-grade vegetable fat, which is solid at room temperature, a sweetening agent and a flavoring agent useful as dietary supplement. The whole psyllium husks range in size from about 12 to 100 mesh and, when incorporated into a sweetened, flavored, food-grade vegetable fat at a certain level, provide a crunchiness which makes a high-fiber product appealing as well as efficacious. In a further embodiment, dietary fibers other than those derived from whole psyllium husks may be additionally included in the bulk-increasing dietary supplement composition of this invention. Such products as of the present invention are useful in the mitigation of various disorders which vary a lot. These bakery products may be administered to humans and animals susceptible to or afflicted with hypercholesterolemia to lower serum cholesterol or to individuals in need of dietary regulation. The invention also relates to the production of such products, in which raw psyllium is incorporated into the said product. BACKGROUND TO THE INVENTION Psyllium fibers in powdered or in seed form have been admixed with other fibers to provide bulk laxatives or products which are said to stimulate the natural digestive processes. Also it is well known that psyllium decreases plasma triglycerides and LDL cholesterol, particularly in humans. The specific use of a psyllium hydrophilic mucilloid to lower cholesterol in serum was documented by Anderson et al. Notwithstanding the undesirable flavor and texture imparted to an ingestible composition by psyllium or psyllium husks, various psyllium-containing foodstuffs have been proposed which purport to take advantage of the natural digestion regulation properties of psyllium, or the satiating or "fullness-feeling" effect of psyllium. See, for example, U.S. Pat Nos. 3,574,634 and 4,348,379. The products containing Psyllium incorporated into foodstuffs such as snacks, cereals, muffins, confectioneries, bakery products such as biscuits are commercially available. Examples of the patent literature involving psyllium are U.S. Pat. Nos. 5,223,298, 5,227,248, 4,766,004, 5,024,996, 5,015,486, 5,024,996, and 5,026,689. Other foodstuffs, which include psyllium, are taught in U.S. Pat. Nos.5,095,008 and 5,950,140 both of which teach cookies with incorporated psyllium. U.S. Pat. No. 5,164,216 discloses bread suitable for microwaving which contain required levels of shortening and fiber. The use of fiber supplements as bulk laxatives or for bowel normalization is also known in the art. Products that provide approximately 5 grams of corn or wheat fiber per supplement are sold commercially. In additional, natural fiber laxative products containing psyllium, a bulk producing dietary fiber, are also known in the art and available commercially. For example, a thin wafer which contains psyllium as well as other fibers such as wheat bran and oat bran is commercially available. Another well-known commercially available bulk laxative product provides granules of psyllium, which are admixed with water prior to ingestion. European patent application No. 0068229, to Kleinert, discloses the addition of the seed coats (episperm) of cocoa beans in finely powdered form, to dough, bread, snacks, and chocolate to increase bulk and stimulate the intestinal tract. Japanese patent application No. 53081662, Japanese patent application No. 53081663 to Fuji, Pat. No. 4,421,771 to Stock et al., German Federal Republic Patent Application No. 2,746,479 to Charlet et al., U.S. Pat. No. 4,565,702 to Morley, et al., describes dietary compositions containing psyllum wherein an admixture is formed into a bar or any desired shape U.S. Pat. No. 4,568,557, to Becker et al., discloses a snack food product prepared by premixing a dietary fiber with a food grade oil; premixing a compound coating containing a fractionated fat, sweetener, milk solids, yogurt, and a flavoring agent; blending the two pre-mixtures and adding a cereal product to obtain texture and a dried fruit or nut for flavor; and extruding the resulting mixture into a desired shape. The above products disclose various methods attempted to significantly improve the organoleptic characteristics of the item made using Psyllium. Usually the taste of products containing high amount of fiber materials is not appealing. In addition, psyllium has property to acquire a slimy or adhesive texture and mouthfeel upon hydration. The listed prior art solves the problem partly. However, due to its mucilaginous nature, psyllium acquires a slimy or adhesive texture and mouthfeel upon hydration. Psyllium normally forms a gelatinous mass when contacted with water and exhibits poor dispensability and mixability in water. Psyllium also develops a distinctive, undesirable flavor in the presence of heat and moisture, which further limits its use in food products. This slimy mouthfeel is unpalatable and, accordingly, various additives have been incorporated in psyllium-containing ingestible compositions in order to mask the undesirable texture and mouthfeel of the psyllium. However, it is also noted that along with soluble dietary fiber, addition of insoluble fiber has effect that is more beneficial. High amount of either sugar and/or fat-containing ingredients such as chocolate, or food-grade oils or vegetable fat are used in order to improve its palatability, texture and mouthful feeling. Such substances are useful in enhancing the organoleptic properties, but are not considered healthy when it is also concurrently or independently used for decreasing plasma triglycerides and LDL cholesterol. OBJECTS OF THE INVENTION The object of the invention is to provide a dietary composition containing Psyllium husk in a highly palatable form. Another object of the invention is to provide a bakery composition containing psyllium husks, food grade vegetable fat that is solid in room temperature, a sweetening agent and a flavouring agent as a dietary supplement. Another object of the present invention is to provide a composition containing optionally an added dietary fiber other than psyllium. A further object of the present invention is to provide the said dietary composition in the form of crunchy, highly satiable, creamy wafers. A still further object of the present invention is to provide a method of preparation of such dietary composition. A further object of the invention is to prepare such dietary composition as described above through a cold process wherein no undesirable odour develops. In one aspect, the present invention provides a composition useful as bulk laxatives or products, which stimulate the natural digestive processes. In another aspect, the present invention provides a composition useful in the treatment of hypercholesterolemia, triglyceride level and serum cholesterol level. In another aspect, the present invention provides a method for reducing the blood serum cholesterol in mammals comprising the oral administration in mammals of effective amounts of the composition of the present invention. Another object of the invention is to provide a composition which upon ingestion, the psyllium should readily becomes mucilaginous when it comes in contact with saliva. A further objective of the invention is to provide a dietary composition as described above in the form of a product having low-calorie value. A still further objective is to formulate a crunchy product of the above composition in the form of creamy wafers. SUMMARY OF THE INVENTION The present invention relates to a bakery formulation containing Psyllium husk through a cold process. Particularly it relates to preparation of a low calorific the product useful as bulk laxative as well as in lowering triglycerides and cholesterol. DETAILED DESCRD7TION OF THE INVENTION Psyllium seed gum is well known and has a long history of use by humans and is a staple item of commerce. The sourcing and use of psyllium is well described in various literature sources including Industrial Gums: Polysaccharides and Their Uses, second edition, edited by Whistler et al., Academic Press, NY 1973, more briefly in the United States Pharmacopoeia, 12th edition: The National Formulary, 15th edition, The United States Pharmacopeia Convention Inc., Jul. 1, 1980, page 915, page 929, Plants for Man, second edition, by R. W. Schery, Prentice Hall Inc., 1973, page 319. See also, U.S. Pat. Nos. 4,321,263 (issued Mar. 23, 1982 to Powell), 4,459,280 (issued Jul. 10, 1984 to Colliopoulos et al.), and 4,766,004 (issued Aug. 3,1988 to Moskowitz), each of which is incorporated herein by reference. As used in the present invention, the noun "psyllium" is meant to refer to psyllium husks and not to psyllium seed or to psyllium seed gum. The products of the present invention may be administered to humans and animals susceptible to or afflicted with hypercholesterolemia to lower serum cholesterol or to individuals in need of dietary regulation. Psyllium husks are described in the United States Pharmacopeia, Volume 21, as the cleaned, dried seed coat which is separated by winnowing and thrashing from the seeds of Plantago ovata Forskal, known in commerce as Blond Psyllium, Indian Psyllium or Ispaghula; or from Plantago psyllium Linne or from Plantago indica Linne (Plantago arenaria Waldstein and Kitaibel), known in commerce as Spanish or French Psyllium. Both the psyllium seed and psyllium husks are classified as bulk forming laxatives, that is, as agents which increase the bulk volume and water content of the stool, thereby promoting bowel movement. Psyllium husks are commercially available in whole or in powdered form. The whole psyllium husks, when separated from psyllium seeds by commonly used processes, range in size from about 40 mesh to about 100 mesh. The mesh size in this instance is the United States Standard Sieve Series wherein the sieve or mesh number refers to the number of sieve openings to a linear inch of the sieve through which the particles being described will pass. Particles designated 8 to 20 mesh are generally considered very coarse to coarse. The present invention has two components inner core referred to as 'creamy portion' and other is 'outer cover of crunchy palatable wafers' having a crunchy and highly palatable taste. The bakery product of the present invention comprises of about 2% to about 30% by weight of whole psyllium husks having a particle size of from about 40 to about 100 mesh, wherein at least about 25% to about 95%, preferably about 40% to about 90% by weight are in the about 40 to about 80 mesh size range; about 22.9% to about 40% by weight of a food-grade vegetable fat which is solid at room temperature; about 25% to about 45% by weight of a sweetening agent; and about 0.1% to about 5% by weight of at least one flavoring agent, all percentages being by weight, based on the weight of the total composition. In a further embodiment of the invention, there is additionally present in the dietary fiber supplement composition from about 2% to about 28% by weight, based on the weight of the total composition, of a dietary fiber, other than whole psyllium husks, which additional fiber may include fruit fiber, grain fiber, vegetable fiber, cellulose fiber, water-soluble gums and mixtures thereof. The crunchy, highly palatable, bulk-increasing, bakery product of this invention is prepared by mixing a food-grade vegetable fat, milk solids, powered psyllium husks having a particle size ranging from about 40 to about 100 mesh, along with additives such as sweetening agent and at least one flavoring agent until a homogenous mixture is obtained. This creamy substance is later enclosed in an outer covering composition a discussed below. The bakery products of the present invention can include additional or supplemental sources of soluble fiber in addition to psyllium. Other useful sources of soluble fiber include oat bran, guar gum, carboxymethyl cellulose and mixtures thereof. If present, each of these supplemental soluble fiber sources can comprise from about 1% to about 10 % of the compositions. If desired, the present bakery product can additionally comprise about 0.1 % to about 30 % by weight sugar(s) or, synonymously herein, nutritive carbohydrate sweetening agents. Suclrmaterials are also well known in the prior art. Useful herein as the sugar component is sucrose. However, the sugar(s) component can additionally comprise conventional fructose, maltose, dextrose, honey, fruit juice solids, brown sugar, and the like. In addition to providing desirable sweetness, the sugaf comppnent additionally beneficially affects the cereal color and texture. Better results are obtained when the sugar(s) component comprises from about 5 % to about 15 % by weight of the composition. Sucrose can be added to the cereal composition, as a sugar coating, or both. The outer covering can be fabricated into any of a variety of common forms including, biscuits, waffles, wafers and so on of any common form, shape or size. Both conventional sugar coatings and coatings employing high potency sweeteners, especially aspartame and potassium acesulfame, are known and can be used to provide the desired sweetening. The cream portion present bakery product are further essentially defined in part by lower fat levels, compared to known counter parts. However, the total fat content of the bakery product should be less than about 15 %. The next critical ingredient used in this invention is a food-grade vegetable fat which is semi-solid at room temperature (24 °C). Although many fats fall into this category, it has been found that fats commercially available for use in food products which are suitable for inclusion in the dietary supplement composition of this invention generally include food-grade vegetable fats such as cocoa butter, palm kernel oil, and palm oil; and a number of other hard butters or vegetable oils which have been fractionated, hydrogenated or partially hydrogenated to make such oils solid at room temperature. Typically, such hardened vegetable oils which are suitable for use in the practice of this invention include hardened coconut oil, cottonseed oil, soybean oil, and the like. Mixtures of aforementioned naturally hard butters and hardened vegetable oils are also suitable for use in the practice of this invention. The preferred food-grade vegetable fats include cocoa butter and other vegetable fats and oils which, after treatment, have the following general characteristics: a distinct brittle fracture below about 20 °C, a fairly sharp, complete melting at about 35 °C, with an incipient fusion or softening at about 30 °C. to about 32 °C. The amount of food grade fat utilized is from about 22.9 % to 40 % by weight, preferably from about 26 % to 34 %, most preferably from about 28 % to 32 % by weight, based on the weight of the total composition. As will be seen in the examples set forth below, additional vegetable fat may be added, if necessary, to commercially available compound coatings during the preparation of the crunchy dietary supplement composition of this invention. It should be noted that, in commercially available compound coatings and confectionery coatings containing a mixture of vegetable fats or butters, the individual oils, and/or their concentrations, in such mixture may vary depending on the availability and price of vegetable oils at the time the compound coating is being manufactured. In those instances where the sweetening agent chosen does not provide bulk, such as where artificial sweeteners are used, the term sweetening agent, for purposes of this invention, is meant to include artificial sweeteners and bulking agents. Typical bulking agents such as maltodextrin, polydextrose, and the like, are utilized in amounts of about 25% to about 72.5% by weight, together with one or more of the artificial sweeteners described above, which artificial sweeteners are utilized in amounts of about 0.005%) to about 5.0%), most preferably about 0.05%> to about 2.5%> by weight, based on the weight of the total dietary fiber supplement compositions. The amounts of sweetening agents described above are ordinarily necessary to achieve a desired level of sweetness independent of the flavor level achieved from the inclusion of flavoring agents. Flavoring agents well-known in the food and confectionery art are utilized in the dietary supplement composition of this invention. Typically, such flavors include cocoa powder; carob powder; peanut powder, vanilla, mango banana, chocolate; natural or synthetic fruit flavors such as dried fruit or dehydrated fruit juices, citrus oils and fruit essences; flavor oils such as cinnamon oil or mint oils; and milk products such as whole milk powders, yogurt powder and the non-fat variations thereof. At least one of aforementioned flavoring agents is included in the dietary supplement composition of the invention in amounts of about 0.1% to about 25%, most preferably about 0.5% to about 20%), by weight, based on the weight of the total supplement composition, and depending to a large extent on the type of flavor being used. In one embodiment of this invention, the inclusion of an additional dietary fiber other than whole psyllium husks is contemplated. The aforementioned dietary fiber may be a fruit fiber, a grain fiber, a vegetable fiber, a cellulose fiber, water-soluble gums or mixtures thereof, and it may be used in the dietary supplement composition of this invention in amounts ranging from about 2%> to about 28%, preferably about 6% to about 11%, most preferably about 8% to about 9% by weight, based on the weight of the total dietary fiber supplement composition. The preferred additional dietary fibers are those which have a high dietary fiber content and which are known to be beneficial to health such as corn bran, wheat bran, soy fiber, guar gum and mixtures thereof. If desired, the cream portion of the bakery product can additionally include a variety of materials designed to improve the aesthetic, organoleptic or nutritional qualities of the cereal. These adjuvant materials can include vitamin and/or mineral fortification, antioxidants, preservatives, colors, flavors, high potency sweetener(s), and mixtures thereof. The precise ingredient concentration in the present cereal composition will vary in known manner. Generally, however, such materials can each comprise about 0.01% to about 2% by weight of the cream composition. One especially useful material is common salt. Desirably, the salt comprises about 0.1% to 2%, preferably about 0.5% to 1.0% of the cereal composition. Other food additives, well known to those skilled in the art, may be incorporated into the dietary supplement composition of this invention to achieve certain effects, including emulsifiers, preservatives, coloring agents, FDC approved food coloring agents and the like. It is important that the present compositions have an insoluble fiber component as well as a soluble fiber component. High concentrations of soluble fibers in the product can however, result in undesirable organoleptic attributes including upon consumption a slimy or gummy texture. The outer covering provides insoluble dietary fiber and thus achieve our another objective. The cereal flours used while preparing outer covering will provide the product of this invention with some insoluble fiber concentration, particularly when whole grain, e.g., whole wheat, flours are employed. Suitable materials for use herein as insoluble fiber sources are well known and the skilled artisan will have no difficulty in selecting materials suitable for use herein. Especially useful herein as sources of insoluble fiber are cereal brans including wheat bran, corn bran, rice bran, oat bran, rye bran, barley and mixtures thereof. It will be appreciated that such sources may also contribute minor amounts of soluble fiber as well. Also useful herein are non-cereal fiber sources including cellulose flour, cellulose fiber, sugar beet fiber, etc. Sugar beet fiber can comprise up to 80% total dietary fiber with about 20% soluble fiber and 60% insoluble fiber. Sufficient amounts of these materials are used so as to achieve the weight ratio of soluble to insoluble fibers herein. Another optional component of the present bakery product is a starchy cereal(s). This component can comprise any conventionally employed starchy cereal or, synonymously, farinaceous material, such as cereal flours from wheat, rice, corn, oats, barley, rye, or other cereal grains and mixtures thereof. The flours can be whole flours or flour fractions such as with the germ fraction or husk fraction removed. Of course, this art is well developed and the skilled artisan will have no difficulty selecting suitable farinaceous materials for use herein. The starchy component of the outer covering can comprise from about 20% to 80%o of the composition for outer covering. Better-results in terms of organoleptic attributes and reductions in frangibility are obtained when the starchy fraction comprises about 30% to 70% of the composition. For best results the starchy fraction comprises about 40% to 50%) of the present cereal compositions. The measurement of total dietary fiber, soluble fiber, and insoluble fiber is subject to disparate analytical methods and values determined thereby. For purposes of the present invention, "soluble" and "insoluble" fiber values are to be determined by an accepted test procedure for fiber developed by Prosky et al. and described in "Determination of Insoluble, Soluble and Total Dietary Fiber in Foods and Food Products," Journal of the Association of Official Analytical Chemists, Vol. 71, No. 5 (1988) which is incorporated herein by reference. The procedure there described involves an enzymatic-gravametric procedure adopted by final action of the AOAC. Fiber, especially insoluble fiber, is believed to affect adversely selected mineral and vitamin absorption. Accordingly, in highly preferred embodiments, in particular, the present bakery product can be fortified with bioavailable sources of calcium, iron, riboflavin and the like. These mineral fortifiers can be incorporated into the bakery compositions directly. It is also" desirable to "vitamin fortify the present bakery product, especially selected B vitamins, e.g., riboflavin. Conventional methods and techniques of vitamin fortification can be used herein. Due in part to/their heat sensitivity, the process of this invention has advantage over the others in the prior art. Typically the composition of the present invention can be prepared following the general procedure as described below: A. Preparation of wheat flour slurry for sheets 1. All the ingredients required to prepare wheat flour slurry were weighed & checked. 2. Required quantity of purified water in a S.S. vessel equipped with stirrer was taken. 3. Salt, sodium bicarbonate and ammonium bicarbonate were added to the vessel and dissolved with stirring. 4. Wheat flour and starch solution was dispersed in the above solution and stirred for 10 minutes to obtain uniform dispersion. 5. To it was added required quantity of emulsifier with stirring. B. Preparation of cream 1. Vegetable ghee or other suitable vegetable fat was melted, if required, at 50 °C in a suitable container and mixed with palm oil. 2. The mass so obtained was loaded in a mass mixture. 3. To it was added suitable sweetening agents and the mass was kneaded for 15-30 minutes to obtain a uniform mixture. 4. Suitable emulsifying agent was added to the mixture to obtain a homogenised mass of required consistency. 5. Suitable preservatives and antioxidants were added to it while mixing. 6. To the mixture was added Psyllium husk obtained from suitable sources and mixed for about 20 minutes to 30 minutes to obtain a uniform distribution of ingredients. 7. To it were added suitable flavouring and colouring agents with mixing to obtain homogeneity. 8. The mass was kneaded for 10-30 minutes to obtain a homogenous cream. C. Preparation of crispy wheat flour sheets 1. The plate was heated to required temperature. 2. The wheat flour was spread as a uniform thickness layer on the hot plate. 3. The thickness of the sheet in the hot plate was suitably adjusted. And sheet of wheat flour was allowed to be formed which were subsequently collected. D. Preparation of cream wafers 1. The cream bulk prepared in step B above was transferred to a cream spreading machine. The machine was adjusted to spread the cream evenly. 2. The cream loaded sheet was cut into required size wafer with the help of a cutter. 3. The cream wafers were packed in pouches. The process of the present invention avoids high shear mixing of the components, thereby preserving the efficacy of the soluble fiber. Nor is psyllium subjected to high temperature or pressure nor is any special equipment required for its formulation. There is no need for special care like controlling the total moisture, which can cause processing and handling problems, but also, and more importantly, in adversely affecting the mouthfeel and texture of the preparation. The overall process of the product of this invention offers simple preparation, without affecting the efficacy of the product. Without further elaboration, it is believed that one skilled in the art can, using the preceding description, utilize the present invention to its fullest extent. The following preferred specific embodiments are, therefore, to be construed as merely illustrative and not limitative of the remainder of the disclosure. It will be appreciated that other modifications of the present invention, within the skill of those in the similar art, can be undertaken without departing from the spirit and scope of the invention. Example: 1 A) Preparation of Wheat flour slurry (for a batch size of 2000 wafers): 1. Wheat flour 8.5 kg 2. Starch 70 g 3. Skimmed Milk Powder 140 g 4. Ammonium Chloride 70 g 5. Sodium Bicarbonate 25g 6. Sodium Methyl Paraben 25g 7. Colour : Sunset Yellow 0.5g 8. Purified water q.s. The above quantities are inclusive of 40% excess to compensate the process loss. Procedure: 1) Prepare a dispersion of wheat flour and starch and colour in purified water in a suitable s.s. vessel, and continue to stir until the slurry is formed. 2) Take about 500 ml of purified water, add skimmed milk powder to it and make creamy suspension and add the same to the wheat flour dispersion of step No. 1. 3) Take about 500ml of purified water, add Sodium Bicarbonate, Ammonium Chloride, and salt to it, make a clear solution and add the same to the dispersion of step No. 1. Stir the mixture of step No. 1 for about 15 minutes and the slurry is now ready for use. B) Preparation of Cream: 1. Pulverized Sugar 15 kg 2. Ispaghula fine powder 10 kg 3. Vegetable oil 23 kg 4. Vegetable ghee 5 kg 5. Soy Lecithin 1 kg 6. Ascorbyl Palmitate 28 g 7. Methyl paraben 28 g 8. Colour: Sunset Yellow 1.4 g 9. Flavour: Vanilla Liq. Essence 100 ml. 10. Flavour: Mango Flavour SPL q.s. The above quantities are inclusive of 30% excess to compensate the process Wastage. Procedure: 1) Take Vegetable ghee in suitable s.s. vessel and heat up to 50 -60° C, add vegetable oil, Methyl paraben, Ascorbyl Palmitate to it. 2) Load pulverized Sugar, Ispaghula fine powder to a suitable mixer and mix properly. 3) Add the melted vegetable ghee and vegetable oil mix containing preservatives and antioxidants, continue mixing to get a uniform mass. 4) Add Flavour and Colour, knead the mass for 15 minutes to get the homogeneous creamy mass. C) Preparation of Crispy wheat flour sheets: Adjust the temperature and speed of the roller to get crispy sheets without any visible defects. D) Preparation of Cream Wafer: Spread the weighed quantity of cream on each wafer sheet, the cream quantity to be adjusted to get 3.5 gm of Ispaghula per wafer. The cream should be sandwiched between two wheat slurry sheets. E. In - Process Tests: The following tests are to be conducted at regular frequency during manufacturing: 1. Description: Cream colored rectangular wafer with characteristic odour enclosing cream between two crispy layers. 2. Length: 65 mm - 85mm 3. Width: 30mm - 40mm 4. Thickness: 10-15mm 5. Weight: 14 -22 g Example: 2 A) Preparation of Wheat flour shirry(for a batch size of 2000 wafers): 1. Wheat flour 8.5 kg 2. Starch 70 g 3. Skimmed Milk Powder 140 g 4. Ammonium Chloride 70 g 5. Sodium Bicarbonate 25g 6. Sodium Benzoate 45 g 7. Colour: Sunset Yellow 0.5g 8. Purified water q.s. The above quantities are inclusive of 40% excess to compensate the process loss. Procedure: 1) Prepare a dispersion of wheat flour and starch and color in purified water in a suitable s.s. vessel, continue to stir until the slurry is formed. 2) Take about 500 ml of purified water, add skimmed milk powder to it and make creamy suspension and add it to the dispersion from step No. 1. 3) Take about 500ml of purified water, add Sodium Bicarbonate, Ammonium Chloride, and salt to it make a clear solution and add it to the dispersion from step No. 1. Stir the mixture of step No. 1 for about 15 minutes and the slurry is now ready for use. B) Preparation of Cream: 1. Pulverized Sugar 15 kg 2. Ispaghula fine powder 10 kg 3. Vanillin crystals 25 g 4. Vegetable oil 23 kg 5. Vegetable ghee 5 kg 6. Soy Lecithin 1 kg 7. Ascorbyl Palmitate 28 g 8. Sodium Benzoate 45 g 9. Methyl paraben 28 g 10. Flavour: Vanilla Liq. Essence 100 ml. The above quantities are inclusive of 30% excess to compensate the process wastage. Procedure: 1. Take Vegetable ghee in suitable s.s. vessel and heat up to 50 -60° C, add vegetable oil, Methyl paraben, Ascorbyl Palmitate to it. 2. Load pulverized Sugar, Ispaghula fine powder to a suitable mixer and mix properly. 3. Add the melted vegetable ghee and vegetable oil mix containing preservatives and antioxidants, continue mixing to get a uniform mass. 4. Add flavour and colour, knead the mass for 15 minutes to get the homogeneous creamy mass. C) Preparation of Crispy wheat flour sheets: Adjust the temperature and speed of the roller to get crispy sheets without any visible defects. D) Preparation of Cream Wafer: Spread the weighed quantity of cream on each wafer sheet, the cream quantity to be adjusted to get 3.5gm of Ispaghula per wafer. The cream should be sandwiched between two wheat slurry sheets. E) In - Process Tests: The following test to be conducted at regular frequency during manufacturing: 1. Description: Cream colored rectangular wafer with characteristic odor enclosing cream between two crispy layers. 2. Length: 65 mm - 85mm 3. Width: 30mm - 40mm 4. Thickness: 10-15mm 5. Weight: 14 -22 g Example: 3 A) Preparation of Wheat flour slurry (For a batch size of 2000 wafer): 1. Wheat flour 8kg 2. Starch 570 g 3. Skimmed Milk Powder 140 g 4. Ammonium Chloride 70 g 5. Sodium Bicarbonate 25g 6. Sodium Benzoate 45 g 7. Colour. Sunset Yellow 0.5 g 8. Purified water q.s. The above quantities are inclusive of 40% excess to compensate the process loss. Procedure: 1) Prepare a dispersion of wheat flour and starch and color in purified water in a suitable s.s. vessel, continue to stir until the slurry is formed. 2) Take about 500 ml of purified water, add skimmed milk powder and Sodium Benzoate to it and make creamy suspension and add it to the dispersion from step No. 1. , 3) Take about 500ml of purified water add Sodium Bicarbonate, Ammonium Chloride, and salt to it make a clear solution and add it to dispersion from step No. 1. Stir the mixture of step No.l for about 15 minutes and the slurry is now ready for use. B) Preparation of Cream: 1. Pulverized Sugar 15 kg 2. Ispaghula fine powder 10 kg 3. Vanillin crystals 5g 4. Vegetable oil 23 kg 5. Vegetable ghee 5 kg 6. Soy Lecithin 1kg 7. Ascorbyl Palmitate 28 g 8. Methyl paraben 28 g 9. Propyl Paraben 5.6 g 10. Colour: Sunset Yellow 2g 11. Flavour: Mixed Fruit q.s. The above quantities are inclusive of 30% excess to compensate the process wastage. Procedure: 1. Take Vegetable ghee in suitable s.s. vessel and heat up to 50 -60° C add vegetable oil, Methyl paraben, Propyl Paraben, Ascorbyl Palmitate to it. 2. Load pulverized Sugar, Ispaghula fine powder to a suitable mixer and mix properly. 3. Add the melted vegetable ghee and vegetable oil mix containing preservatives and antioxidants, continue mixing to get a uniform mass. 4. Add Flavour and Colour, knead the mass for 15 minutes to get the homogeneous creamy mass. C) Preparation of Crispy wheat flour sheets: Adjust the temperature and speed of the roller to get crispy sheets without any visible defects. D) Preparation of Cream Wafer: Spread the weighed quantity of cream on each wafer sheet, the cream quantity to be adjusted to get 3.5 gm of Ispaghula per wafer. The cream should be sandwiched between two wheat slurry sheets. E) In - Process Tests: The following test to be conducted at regular frequency during manufacturing: 1. Description: Cream colored rectangular wafer with characteristic odour enclosing cream between two crispy layers. 2. Length: 65 mm - 85mm 3. Width: 30mm-40mm 4. Thickness: 10-15mm 5. Weight: 14-22g Example: 4 A) Preparation of Wheat flour slurry (For a batch size of 2000 wafer): 1. Wheat flour 8 kg 2. Starch 570 g 3. Skimmed Milk Powder 140 g 4. Ammonium Chloride 70 g 5. Sodium Bicarbonate 25g 6. Sodium Benzoate 45 g 7. Colour: Sunset Yellow 0.5 g 8. Purified water q.s. The above quantities are inclusive of 40% excess to compensate the process loss. Procedure: 1) Prepare a dispersion of wheat flour and starch and color in purified water in a suitable s.s. vessel, continue to stir until the slurry is formed. 2) Take about 500 ml of purified water, add skimmed milk powder and Sodium Benzoate to it and make creamy suspension and add to dispersion from step No.l. 3) Take about 500ml of purified water add Sodium Bicarbonate, Ammonium Chloride, and salt to it make a clear solution and add to dispersion from step No.l. Stir the mixture of step No. 1 for about 15 minutes and the slurry is now ready for use. B) Preparation of Cream: 1. Pulverized Sugar 15 kg 2. Ispaghula fine powder 10 kg 3. Vanillin crystals 5g 4. Vegetable oil 23 kg 5. Vegetable ghee 5 kg 6. Soy Lecithin 1 kg 7. Ascorbyl Palmitate 28 g 8. Methyl paraben 28 g 9. Propylparaben 5.6 g 10. Colour: Sunset Yellow 2g 11. Flavour: Orange q.s. The above quantities are inclusive of 30% excess to compensate the process wastage. Procedure: 1. Take Vegetable ghee in suitable s.s. vessel and heat up to 50- 60° C add vegetable oil, Methyl paraben, Propyl Paraben, Ascorbyl Palmitate to it. 2. Load pulverized Sugar, Ispaghula fine powder to a suitable mixer and mix properly. 3. Add the melted vegetable ghee and vegetable oil mix containing preservatives and antioxidants, continue mixing to get a uniform mass. 4. Add Flavour and Colour, knead the mass for 15 minutes to get the homogeneous creamy mass. C) Preparation of Crispy wheat flour sheets: Adjust the temperature and speed of the roller to get crispy sheets without any visible defects. D) Preparation of Cream Wafer: Spread the weighed quantity of cream on each wafer sheet, the cream quantity to be adjusted to get 3.5 gm of Ispaghula per wafer. The cream should be sandwiched between two wheat slurry sheets. E) In - Process Tests: The following test to be conducted at regular frequency during manufacturing: 1. Description: Cream colored rectangular wafer with characteristic odour enclosing cream between two crispy layers. 2. Length: 65 mm - 85mm 3. Width: 30mm-40mm 4. Thickness: 10-15mm 5. Weight: 14 -22 g The present invention can be consumed in a conventional manner to obtain the nutritional and physiological benefits of a high soluble fiber cereal food. In particular, it has been surprisingly discovered that the present cereal compositions when consumed regularly in prescribed dosage amounts can be used, and thus provide the additional benefit, of antihypercholesterolemia. That is, for persons having elevated levels of blood serum cholesterol, consumption of the present bakery product effectively lowers their blood serum cholesterol. The present methods essentially comprise the oral administration of the bakery product to hypercholesterolemic individuals for extended time periods. Optionally, the dosage can be administered in multiple doses, e.g., thrice daily, which collectively add up to the dosage levels specified. In individuals exhibiting hyper blood serum cholesterolemia, e.g., >220 mg/dl, an antihypercholesterolemic effect on the order of a 10% reduction can be expected after six weeks as part of a low fat, low cholesterol diet. Fiber has been mentioned as having possible value in a variety of preventative medical areas, such as constipation, weight reduction, diverticulitis, cardiovascular disease and cancer. However, different fiber components have very different physiological functions and the daily level of a particular dietary fiber recommended to achieve physiological effects will vary with the type of fiber ingested. For a bulk laxative effect, a dietary dosage of psyllium fiber, whether it be derived from psyllium seeds or psyllium husks, in an amount of from about 5 to 30 grams is recommended. In accordance with the practice of this invention, dietary supplement compositions may be prepared in units of about 1 to about 1.3 ounces, which will contain about 5 grams of psyllium fiber. If minimal bulk laxative effects are desired, it is possible to include the minimum amount of whole psyllium husks necessary to achieve the desired crunchy texture characteristic of the supplement compositions of this invention, and up to about 28% by weight, based on the weight of the total supplement composition, of additional dietary fibers, other than whole psyllium husks which have other beneficial attributes. Thus, the crunchy, highly palatable, dietary fiber supplement compositions of this invention also serve as a vehicle for a variety of dietary fibers that may be recommended for particular medical applications. We Claim: 1. A process for the preparation of a composition containing Psyllium husk in the form of a multi-layered creamy, crunchy, highly palatable biscuits which comprises preparing wheat flour slurry, preparing creamy inner layer containing the Psyllium husk, preparing crispy wheat flour sheets from said wheat flour slurry, and preparing creamy wafers with said crispy wheat flour sheets, with said creamy inner layer containing the Psyllium husk between said sheets, wherein said Psyllium is present at a concentration in the range of 20-80% by weight of the total composition and said wheat flour is present at a concentration in the range of 30-60% by weight of the total composition,. 2. The process as claimed in claim 1 wherein said wheat flour slurry is prepared in the presence of ingestible carrier materials of the kind such as herein described. 3. The process as claimed in claim 2 wherein said carrier materials are selected from the group consisting of conventional vegetable oils and fats, sweetening agents, flavorants, antioxidants, microbial preservatives, emulsifiers, and mixtures thereof. 4. The process as claimed in any preceding claim wherein said Psyllium is present at a concentration of 25-50% of the weight of the total composition. 5. The process as claimed in any preceding claim wherein the particle size of Psyllium husk is between 12-70 ASTM, preferably 30-60 ASTM. 6. The process as claimed in any preceding claim wherein the wheat flour is present at a concentration of 30-50% by weight. 7. The process as claimed in claim 1, wherein the outer layer consists of wheat flour and the inner creamy layer contains the Psyllium husk. 8. The process as claimed in any of the preceding claims, wherein the inner layer contains vegetable fats and oils, Psyllium husk, antioxidants, microbial preservatives and emulsifying agents. 9. The process as claimed in any one of claims 3 to 9 wherein the sweetening agent is selected from the group consisting of sucrose, fructose, dextrose, lactose, sorbitol, mannitol, corn syrup solids, artificial sweetening agents like sodium saccharine, aspartame and mixture thereof. 10. The process as claimed in claim 9, wherein the sweetening agent is sugar. 11. The process as claimed in any one of claims 3 to 10 wherein the flavoring agent is selected from the group consisting of cocoa powder, carob powder, peanut powder, yogurt powder, whole milk powder, vanilla, natural fruit flavors, artificial fruit flavors, natural flavor oils, artificial flavor oils, and mixtures thereof. 12. The process as claimed in claim 11 wherein the flavouring agent is vanilla. 13. The process as claimed in any one of claims 3 to 12, wherein the vegetable fats or oils are selected from hydrogenated or partially hydrogenated vegetable fats or oils. 14. The process as claimed in claim 13, wherein the vegetable fat or oil is palm oil. 15. The process as claimed in any one of claims 3 to 14 wherein the antioxidants are selected from ascorbyl palmitate, tocophenyl ester, butylene, hydroxyanisole, butylated hydroxytoluene or their mixtures thereof. 16. The process for the preparation of the composition of claim 15, wherein the antioxidant is ascorbyl palmitate. 17. A process as claim in any one of claims 3 to 16 wherein the emulsifying agent is soyalectin. 18. A process as claimed in claim 15 or 16, wherein the antioxidants are present at a concentration of 0.1 to 5% by weight of the total composition. 19. A process as claimed in any one of claim 3 to 18, wherein the preservative are present at a concentration of 0.1 to 0.6% by weight of total composition. To The Controller of Patents The Patent Office at Mumbai 20. A process as claimed in any one of claims 3 to 19 wherein the vegetable oils and fats are present at a concentration of 1-10% by weight of the total composition, preferably at a concentration of 1-5%.

Full Text

FORM 2

The PATENT ACT, 1970
(39 of 1970)
Complete Specification
NOVEL DELIVERY SYSTEM FOR ISAPGHULA HUSK AND A PROCESS FOR
THE PREPRATION THERE OF A COMPOSITION CONTAINIG
CADILA HEALTH CARE LTD, Zydus Tower, Satellite Cross Road, Ahmedabad-380015, Gujarat, India.
The following specification describes and ascertains the nature of the invention, .and the manner in

FIELD OF INVENTION
The present invention relates to a process for the preparation of crunchy, highly palatable, bulk increasing, dietary fiber supplement compositions. More particularly, this invention relates to a process for preparing creamy wafers containing psyllium husks, a food-grade vegetable fat, which is solid at room temperature, a sweetening agent and a flavoring agent useful as dietary supplement. The whole psyllium husks range in size from about 12 to 100 mesh and, when incorporated into a sweetened, flavored, food-grade vegetable fat at a certain level, provide a crunchiness which makes a high-fiber product appealing as well as efficacious. In a further embodiment, dietary fibers other than those derived from whole psyllium husks may be additionally included in the bulk-increasing dietary supplement composition of this invention.
Such products as of the present invention are useful in the mitigation of various disorders which vary a lot. These bakery products may be administered to humans and animals susceptible to or afflicted with hypercholesterolemia to lower serum cholesterol or to individuals in need of dietary regulation. The invention also relates to the production of such products, in which raw psyllium is incorporated into the said product.
BACKGROUND TO THE INVENTION
Psyllium fibers in powdered or in seed form have been admixed with other fibers to provide bulk laxatives or products which are said to stimulate the natural digestive processes. Also it is well known that psyllium decreases plasma triglycerides and LDL cholesterol, particularly in humans. The specific use of a psyllium hydrophilic mucilloid to lower cholesterol in serum was documented by Anderson et al.
Notwithstanding the undesirable flavor and texture imparted to an ingestible composition by psyllium or psyllium husks, various psyllium-containing foodstuffs have been proposed which purport to take advantage of the natural digestion regulation properties of psyllium, or the satiating or "fullness-feeling" effect of psyllium. See, for example, U.S. Pat Nos. 3,574,634 and 4,348,379. The products containing Psyllium incorporated into foodstuffs such as snacks, cereals, muffins, confectioneries, bakery products such as biscuits are commercially available. Examples of the patent literature involving psyllium are U.S. Pat. Nos. 5,223,298, 5,227,248, 4,766,004, 5,024,996, 5,015,486, 5,024,996, and 5,026,689. Other foodstuffs, which include psyllium, are taught in U.S. Pat. Nos.5,095,008 and 5,950,140 both of which teach cookies with incorporated psyllium. U.S. Pat. No. 5,164,216 discloses bread suitable for microwaving which contain required levels of shortening and fiber.
The use of fiber supplements as bulk laxatives or for bowel normalization is also known in the art. Products that provide approximately 5 grams of corn or wheat fiber per supplement are sold commercially. In additional, natural fiber laxative products containing psyllium, a bulk producing dietary fiber, are also known in the art and available commercially. For example, a thin wafer which

contains psyllium as well as other fibers such as wheat bran and oat bran is commercially available.
Another well-known commercially available bulk laxative product provides granules of psyllium, which are admixed with water prior to ingestion.
European patent application No. 0068229, to Kleinert, discloses the addition of the seed coats (episperm) of cocoa beans in finely powdered form, to dough, bread, snacks, and chocolate to increase bulk and stimulate the intestinal tract.
Japanese patent application No. 53081662, Japanese patent application No. 53081663 to Fuji, Pat. No. 4,421,771 to Stock et al., German Federal Republic Patent Application No. 2,746,479 to Charlet et al., U.S. Pat. No. 4,565,702 to Morley, et al., describes dietary compositions containing psyllum wherein an admixture is formed into a bar or any desired shape
U.S. Pat. No. 4,568,557, to Becker et al., discloses a snack food product prepared by premixing a dietary fiber with a food grade oil; premixing a compound coating containing a fractionated fat, sweetener, milk solids, yogurt, and a flavoring agent; blending the two pre-mixtures and adding a cereal product to obtain texture and a dried fruit or nut for flavor; and extruding the resulting mixture into a desired shape.
The above products disclose various methods attempted to significantly improve the organoleptic characteristics of the item made using Psyllium. Usually the taste of products containing high amount of fiber materials is not appealing. In addition, psyllium has property to acquire a slimy or adhesive texture and mouthfeel upon hydration.
The listed prior art solves the problem partly. However, due to its mucilaginous nature, psyllium acquires a slimy or adhesive texture and mouthfeel upon hydration. Psyllium normally forms a gelatinous mass when contacted with water and exhibits poor dispensability and mixability in water. Psyllium also develops a distinctive, undesirable flavor in the presence of heat and moisture, which further limits its use in food products. This slimy mouthfeel is unpalatable and, accordingly, various additives have been incorporated in psyllium-containing ingestible compositions in order to mask the undesirable texture and mouthfeel of the psyllium.
However, it is also noted that along with soluble dietary fiber, addition of insoluble fiber has effect that is more beneficial. High amount of either sugar and/or fat-containing ingredients such as chocolate, or food-grade oils or vegetable fat are used in order to improve its palatability, texture and mouthful feeling. Such substances are useful in enhancing the organoleptic properties, but are not considered healthy when it is also concurrently or independently used for decreasing plasma triglycerides and LDL cholesterol.
OBJECTS OF THE INVENTION
The object of the invention is to provide a dietary composition containing Psyllium husk in a highly palatable form.

Another object of the invention is to provide a bakery composition containing psyllium husks, food
grade vegetable fat that is solid in room temperature, a sweetening agent and a flavouring agent as a
dietary supplement.
Another object of the present invention is to provide a composition containing optionally an added
dietary fiber other than psyllium.
A further object of the present invention is to provide the said dietary composition in the form of
crunchy, highly satiable, creamy wafers.
A still further object of the present invention is to provide a method of preparation of such dietary
composition.
A further object of the invention is to prepare such dietary composition as described above through a
cold process wherein no undesirable odour develops.
In one aspect, the present invention provides a composition useful as bulk laxatives or products,
which stimulate the natural digestive processes.
In another aspect, the present invention provides a composition useful in the treatment of
hypercholesterolemia, triglyceride level and serum cholesterol level.
In another aspect, the present invention provides a method for reducing the blood serum cholesterol in
mammals comprising the oral administration in mammals of effective amounts of the composition of
the present invention.
Another object of the invention is to provide a composition which upon ingestion, the psyllium should
readily becomes mucilaginous when it comes in contact with saliva.
A further objective of the invention is to provide a dietary composition as described above in the form
of a product having low-calorie value.
A still further objective is to formulate a crunchy product of the above composition in the form of
creamy wafers.
SUMMARY OF THE INVENTION
The present invention relates to a bakery formulation containing Psyllium husk through a cold process. Particularly it relates to preparation of a low calorific the product useful as bulk laxative as well as in lowering triglycerides and cholesterol.
DETAILED DESCRD7TION OF THE INVENTION
Psyllium seed gum is well known and has a long history of use by humans and is a staple item of commerce. The sourcing and use of psyllium is well described in various literature sources including Industrial Gums: Polysaccharides and Their Uses, second edition, edited by Whistler et al., Academic Press, NY 1973, more briefly in the United States Pharmacopoeia, 12th edition: The National Formulary, 15th edition, The United States Pharmacopeia Convention Inc., Jul. 1, 1980, page 915, page 929, Plants for Man, second edition, by R. W. Schery, Prentice Hall Inc., 1973, page 319. See also, U.S. Pat. Nos. 4,321,263 (issued Mar. 23, 1982 to Powell), 4,459,280 (issued Jul. 10, 1984 to

Colliopoulos et al.), and 4,766,004 (issued Aug. 3,1988 to Moskowitz), each of which is incorporated herein by reference. As used in the present invention, the noun "psyllium" is meant to refer to psyllium husks and not to psyllium seed or to psyllium seed gum.
The products of the present invention may be administered to humans and animals susceptible to or afflicted with hypercholesterolemia to lower serum cholesterol or to individuals in need of dietary regulation.
Psyllium husks are described in the United States Pharmacopeia, Volume 21, as the cleaned, dried seed coat which is separated by winnowing and thrashing from the seeds of Plantago ovata Forskal, known in commerce as Blond Psyllium, Indian Psyllium or Ispaghula; or from Plantago psyllium Linne or from Plantago indica Linne (Plantago arenaria Waldstein and Kitaibel), known in commerce as Spanish or French Psyllium. Both the psyllium seed and psyllium husks are classified as bulk forming laxatives, that is, as agents which increase the bulk volume and water content of the stool, thereby promoting bowel movement. Psyllium husks are commercially available in whole or in powdered form. The whole psyllium husks, when separated from psyllium seeds by commonly used processes, range in size from about 40 mesh to about 100 mesh. The mesh size in this instance is the United States Standard Sieve Series wherein the sieve or mesh number refers to the number of sieve openings to a linear inch of the sieve through which the particles being described will pass. Particles designated 8 to 20 mesh are generally considered very coarse to coarse.
The present invention has two components inner core referred to as 'creamy portion' and other is 'outer cover of crunchy palatable wafers' having a crunchy and highly palatable taste. The bakery product of the present invention comprises of about 2% to about 30% by weight of whole psyllium husks having a particle size of from about 40 to about 100 mesh, wherein at least about 25% to about 95%, preferably about 40% to about 90% by weight are in the about 40 to about 80 mesh size range; about 22.9% to about 40% by weight of a food-grade vegetable fat which is solid at room temperature; about 25% to about 45% by weight of a sweetening agent; and about 0.1% to about 5% by weight of at least one flavoring agent, all percentages being by weight, based on the weight of the total composition. In a further embodiment of the invention, there is additionally present in the dietary fiber supplement composition from about 2% to about 28% by weight, based on the weight of the total composition, of a dietary fiber, other than whole psyllium husks, which additional fiber may include fruit fiber, grain fiber, vegetable fiber, cellulose fiber, water-soluble gums and mixtures thereof. The crunchy, highly palatable, bulk-increasing, bakery product of this invention is prepared by mixing a food-grade vegetable fat, milk solids, powered psyllium husks having a particle size ranging from about 40 to about 100 mesh, along with additives such as sweetening agent and at least one flavoring agent until a homogenous mixture is obtained. This creamy substance is later enclosed in an outer covering composition a discussed below.
The bakery products of the present invention can include additional or supplemental sources of soluble fiber in addition to psyllium. Other useful sources of soluble fiber include oat bran, guar gum,

carboxymethyl cellulose and mixtures thereof. If present, each of these supplemental soluble fiber sources can comprise from about 1% to about 10 % of the compositions.
If desired, the present bakery product can additionally comprise about 0.1 % to about 30 % by weight sugar(s) or, synonymously herein, nutritive carbohydrate sweetening agents. Suclrmaterials are also well known in the prior art. Useful herein as the sugar component is sucrose. However, the sugar(s) component can additionally comprise conventional fructose, maltose, dextrose, honey, fruit juice solids, brown sugar, and the like. In addition to providing desirable sweetness, the sugaf comppnent additionally beneficially affects the cereal color and texture. Better results are obtained when the sugar(s) component comprises from about 5 % to about 15 % by weight of the composition. Sucrose can be added to the cereal composition, as a sugar coating, or both. The outer covering can be fabricated into any of a variety of common forms including, biscuits, waffles, wafers and so on of any common form, shape or size.
Both conventional sugar coatings and coatings employing high potency sweeteners, especially aspartame and potassium acesulfame, are known and can be used to provide the desired sweetening. The cream portion present bakery product are further essentially defined in part by lower fat levels, compared to known counter parts. However, the total fat content of the bakery product should be less than about 15 %.
The next critical ingredient used in this invention is a food-grade vegetable fat which is semi-solid at room temperature (24 °C). Although many fats fall into this category, it has been found that fats commercially available for use in food products which are suitable for inclusion in the dietary supplement composition of this invention generally include food-grade vegetable fats such as cocoa butter, palm kernel oil, and palm oil; and a number of other hard butters or vegetable oils which have been fractionated, hydrogenated or partially hydrogenated to make such oils solid at room temperature. Typically, such hardened vegetable oils which are suitable for use in the practice of this invention include hardened coconut oil, cottonseed oil, soybean oil, and the like. Mixtures of aforementioned naturally hard butters and hardened vegetable oils are also suitable for use in the practice of this invention. The preferred food-grade vegetable fats include cocoa butter and other vegetable fats and oils which, after treatment, have the following general characteristics: a distinct brittle fracture below about 20 °C, a fairly sharp, complete melting at about 35 °C, with an incipient fusion or softening at about 30 °C. to about 32 °C.
The amount of food grade fat utilized is from about 22.9 % to 40 % by weight, preferably from about 26 % to 34 %, most preferably from about 28 % to 32 % by weight, based on the weight of the total composition.
As will be seen in the examples set forth below, additional vegetable fat may be added, if necessary, to commercially available compound coatings during the preparation of the crunchy dietary supplement composition of this invention. It should be noted that, in commercially available compound coatings and confectionery coatings containing a mixture of vegetable fats or butters, the

individual oils, and/or their concentrations, in such mixture may vary depending on the availability and price of vegetable oils at the time the compound coating is being manufactured. In those instances where the sweetening agent chosen does not provide bulk, such as where artificial sweeteners are used, the term sweetening agent, for purposes of this invention, is meant to include artificial sweeteners and bulking agents. Typical bulking agents such as maltodextrin, polydextrose, and the like, are utilized in amounts of about 25% to about 72.5% by weight, together with one or more of the artificial sweeteners described above, which artificial sweeteners are utilized in amounts of about 0.005%) to about 5.0%), most preferably about 0.05%> to about 2.5%> by weight, based on the weight of the total dietary fiber supplement compositions. The amounts of sweetening agents described above are ordinarily necessary to achieve a desired level of sweetness independent of the flavor level achieved from the inclusion of flavoring agents.
Flavoring agents well-known in the food and confectionery art are utilized in the dietary supplement composition of this invention. Typically, such flavors include cocoa powder; carob powder; peanut powder, vanilla, mango banana, chocolate; natural or synthetic fruit flavors such as dried fruit or dehydrated fruit juices, citrus oils and fruit essences; flavor oils such as cinnamon oil or mint oils; and milk products such as whole milk powders, yogurt powder and the non-fat variations thereof. At least one of aforementioned flavoring agents is included in the dietary supplement composition of the invention in amounts of about 0.1% to about 25%, most preferably about 0.5% to about 20%), by weight, based on the weight of the total supplement composition, and depending to a large extent on the type of flavor being used.
In one embodiment of this invention, the inclusion of an additional dietary fiber other than whole psyllium husks is contemplated. The aforementioned dietary fiber may be a fruit fiber, a grain fiber, a vegetable fiber, a cellulose fiber, water-soluble gums or mixtures thereof, and it may be used in the dietary supplement composition of this invention in amounts ranging from about 2%> to about 28%, preferably about 6% to about 11%, most preferably about 8% to about 9% by weight, based on the weight of the total dietary fiber supplement composition. The preferred additional dietary fibers are those which have a high dietary fiber content and which are known to be beneficial to health such as corn bran, wheat bran, soy fiber, guar gum and mixtures thereof.
If desired, the cream portion of the bakery product can additionally include a variety of materials designed to improve the aesthetic, organoleptic or nutritional qualities of the cereal. These adjuvant materials can include vitamin and/or mineral fortification, antioxidants, preservatives, colors, flavors, high potency sweetener(s), and mixtures thereof. The precise ingredient concentration in the present cereal composition will vary in known manner. Generally, however, such materials can each comprise about 0.01% to about 2% by weight of the cream composition.
One especially useful material is common salt. Desirably, the salt comprises about 0.1% to 2%, preferably about 0.5% to 1.0% of the cereal composition.

Other food additives, well known to those skilled in the art, may be incorporated into the dietary supplement composition of this invention to achieve certain effects, including emulsifiers, preservatives, coloring agents, FDC approved food coloring agents and the like. It is important that the present compositions have an insoluble fiber component as well as a soluble fiber component. High concentrations of soluble fibers in the product can however, result in undesirable organoleptic attributes including upon consumption a slimy or gummy texture. The outer covering provides insoluble dietary fiber and thus achieve our another objective. The cereal flours used while preparing outer covering will provide the product of this invention with some insoluble fiber concentration, particularly when whole grain, e.g., whole wheat, flours are employed. Suitable materials for use herein as insoluble fiber sources are well known and the skilled artisan will have no difficulty in selecting materials suitable for use herein. Especially useful herein as sources of insoluble fiber are cereal brans including wheat bran, corn bran, rice bran, oat bran, rye bran, barley and mixtures thereof. It will be appreciated that such sources may also contribute minor amounts of soluble fiber as well. Also useful herein are non-cereal fiber sources including cellulose flour, cellulose fiber, sugar beet fiber, etc. Sugar beet fiber can comprise up to 80% total dietary fiber with about 20% soluble fiber and 60% insoluble fiber. Sufficient amounts of these materials are used so as to achieve the weight ratio of soluble to insoluble fibers herein.
Another optional component of the present bakery product is a starchy cereal(s). This component can comprise any conventionally employed starchy cereal or, synonymously, farinaceous material, such as cereal flours from wheat, rice, corn, oats, barley, rye, or other cereal grains and mixtures thereof. The flours can be whole flours or flour fractions such as with the germ fraction or husk fraction removed. Of course, this art is well developed and the skilled artisan will have no difficulty selecting suitable farinaceous materials for use herein. The starchy component of the outer covering can comprise from about 20% to 80%o of the composition for outer covering. Better-results in terms of organoleptic attributes and reductions in frangibility are obtained when the starchy fraction comprises about 30% to 70% of the composition. For best results the starchy fraction comprises about 40% to 50%) of the present cereal compositions.
The measurement of total dietary fiber, soluble fiber, and insoluble fiber is subject to disparate analytical methods and values determined thereby. For purposes of the present invention, "soluble" and "insoluble" fiber values are to be determined by an accepted test procedure for fiber developed by Prosky et al. and described in "Determination of Insoluble, Soluble and Total Dietary Fiber in Foods and Food Products," Journal of the Association of Official Analytical Chemists, Vol. 71, No. 5 (1988) which is incorporated herein by reference. The procedure there described involves an enzymatic-gravametric procedure adopted by final action of the AOAC.
Fiber, especially insoluble fiber, is believed to affect adversely selected mineral and vitamin absorption. Accordingly, in highly preferred embodiments, in particular, the present bakery product can be fortified with bioavailable sources of calcium, iron, riboflavin and the like. These mineral

fortifiers can be incorporated into the bakery compositions directly. It is also" desirable to "vitamin fortify the present bakery product, especially selected B vitamins, e.g., riboflavin. Conventional methods and techniques of vitamin fortification can be used herein. Due in part to/their heat sensitivity, the process of this invention has advantage over the others in the prior art.
Typically the composition of the present invention can be prepared following the general procedure as described below:
A. Preparation of wheat flour slurry for sheets
1. All the ingredients required to prepare wheat flour slurry were weighed & checked.
2. Required quantity of purified water in a S.S. vessel equipped with stirrer was taken.
3. Salt, sodium bicarbonate and ammonium bicarbonate were added to the vessel and dissolved with stirring.
4. Wheat flour and starch solution was dispersed in the above solution and stirred for 10 minutes to obtain uniform dispersion.
5. To it was added required quantity of emulsifier with stirring.
B. Preparation of cream
1. Vegetable ghee or other suitable vegetable fat was melted, if required, at 50 °C in a suitable container and mixed with palm oil.
2. The mass so obtained was loaded in a mass mixture.
3. To it was added suitable sweetening agents and the mass was kneaded for 15-30 minutes to obtain a uniform mixture.
4. Suitable emulsifying agent was added to the mixture to obtain a homogenised mass of required consistency.
5. Suitable preservatives and antioxidants were added to it while mixing.
6. To the mixture was added Psyllium husk obtained from suitable sources and mixed for about 20 minutes to 30 minutes to obtain a uniform distribution of ingredients.
7. To it were added suitable flavouring and colouring agents with mixing to obtain homogeneity.
8. The mass was kneaded for 10-30 minutes to obtain a homogenous cream.
C. Preparation of crispy wheat flour sheets
1. The plate was heated to required temperature.
2. The wheat flour was spread as a uniform thickness layer on the hot plate.
3. The thickness of the sheet in the hot plate was suitably adjusted. And sheet of wheat flour was allowed to be formed which were subsequently collected.

D. Preparation of cream wafers
1. The cream bulk prepared in step B above was transferred to a cream spreading machine. The machine was adjusted to spread the cream evenly.
2. The cream loaded sheet was cut into required size wafer with the help of a cutter.
3. The cream wafers were packed in pouches.
The process of the present invention avoids high shear mixing of the components, thereby preserving the efficacy of the soluble fiber. Nor is psyllium subjected to high temperature or pressure nor is any special equipment required for its formulation. There is no need for special care like controlling the total moisture, which can cause processing and handling problems, but also, and more importantly, in adversely affecting the mouthfeel and texture of the preparation.
The overall process of the product of this invention offers simple preparation, without affecting the efficacy of the product.
Without further elaboration, it is believed that one skilled in the art can, using the preceding description, utilize the present invention to its fullest extent. The following preferred specific embodiments are, therefore, to be construed as merely illustrative and not limitative of the remainder of the disclosure. It will be appreciated that other modifications of the present invention, within the skill of those in the similar art, can be undertaken without departing from the spirit and scope of the invention.
Example: 1 A) Preparation of Wheat flour slurry (for a batch size of 2000 wafers):
1. Wheat flour 8.5 kg
2. Starch 70 g
3. Skimmed Milk Powder 140 g
4. Ammonium Chloride 70 g
5. Sodium Bicarbonate 25g
6. Sodium Methyl Paraben 25g
7. Colour : Sunset Yellow 0.5g
8. Purified water q.s.
The above quantities are inclusive of 40% excess to compensate the process loss. Procedure:
1) Prepare a dispersion of wheat flour and starch and colour in purified water in a suitable s.s. vessel, and continue to stir until the slurry is formed.
2) Take about 500 ml of purified water, add skimmed milk powder to it and make creamy suspension and add the same to the wheat flour dispersion of step No. 1.
3) Take about 500ml of purified water, add Sodium Bicarbonate, Ammonium Chloride, and salt to it, make a clear solution and add the same to the dispersion of step No. 1.

Stir the mixture of step No. 1 for about 15 minutes and the slurry is now ready for use.
B) Preparation of Cream:
1. Pulverized Sugar 15 kg
2. Ispaghula fine powder 10 kg
3. Vegetable oil 23 kg
4. Vegetable ghee 5 kg
5. Soy Lecithin 1 kg
6. Ascorbyl Palmitate 28 g
7. Methyl paraben 28 g
8. Colour: Sunset Yellow 1.4 g
9. Flavour: Vanilla Liq. Essence 100 ml.
10. Flavour: Mango Flavour SPL q.s.
The above quantities are inclusive of 30% excess to compensate the process Wastage. Procedure:
1) Take Vegetable ghee in suitable s.s. vessel and heat up to 50 -60° C, add vegetable oil, Methyl paraben, Ascorbyl Palmitate to it.
2) Load pulverized Sugar, Ispaghula fine powder to a suitable mixer and mix properly.
3) Add the melted vegetable ghee and vegetable oil mix containing preservatives and antioxidants, continue mixing to get a uniform mass.
4) Add Flavour and Colour, knead the mass for 15 minutes to get the homogeneous creamy mass.
C) Preparation of Crispy wheat flour sheets:
Adjust the temperature and speed of the roller to get crispy sheets without any visible defects.
D) Preparation of Cream Wafer:
Spread the weighed quantity of cream on each wafer sheet, the cream quantity to be adjusted to get
3.5 gm of Ispaghula per wafer.
The cream should be sandwiched between two wheat slurry sheets.
E. In - Process Tests:
The following tests are to be conducted at regular frequency during manufacturing:
1. Description: Cream colored rectangular wafer with characteristic odour enclosing cream between two crispy layers.
2. Length: 65 mm - 85mm
3. Width: 30mm - 40mm
4. Thickness: 10-15mm
5. Weight: 14 -22 g

Example: 2
A) Preparation of Wheat flour shirry(for a batch size of 2000 wafers):
1. Wheat flour 8.5 kg
2. Starch 70 g
3. Skimmed Milk Powder 140 g
4. Ammonium Chloride 70 g
5. Sodium Bicarbonate 25g
6. Sodium Benzoate 45 g
7. Colour: Sunset Yellow 0.5g
8. Purified water q.s.
The above quantities are inclusive of 40% excess to compensate the process loss. Procedure:
1) Prepare a dispersion of wheat flour and starch and color in purified water in a suitable s.s. vessel, continue to stir until the slurry is formed.
2) Take about 500 ml of purified water, add skimmed milk powder to it and make creamy suspension and add it to the dispersion from step No. 1.
3) Take about 500ml of purified water, add Sodium Bicarbonate, Ammonium Chloride, and salt to it make a clear solution and add it to the dispersion from step No. 1.
Stir the mixture of step No. 1 for about 15 minutes and the slurry is now ready for use.
B) Preparation of Cream:
1. Pulverized Sugar 15 kg
2. Ispaghula fine powder 10 kg
3. Vanillin crystals 25 g
4. Vegetable oil 23 kg
5. Vegetable ghee 5 kg
6. Soy Lecithin 1 kg
7. Ascorbyl Palmitate 28 g
8. Sodium Benzoate 45 g
9. Methyl paraben 28 g
10. Flavour: Vanilla Liq. Essence 100 ml.
The above quantities are inclusive of 30% excess to compensate the process wastage. Procedure:
1. Take Vegetable ghee in suitable s.s. vessel and heat up to 50 -60° C, add vegetable oil, Methyl paraben, Ascorbyl Palmitate to it.
2. Load pulverized Sugar, Ispaghula fine powder to a suitable mixer and mix properly.

3. Add the melted vegetable ghee and vegetable oil mix containing preservatives and antioxidants, continue mixing to get a uniform mass.
4. Add flavour and colour, knead the mass for 15 minutes to get the homogeneous creamy mass.
C) Preparation of Crispy wheat flour sheets:
Adjust the temperature and speed of the roller to get crispy sheets without any visible defects.
D) Preparation of Cream Wafer:
Spread the weighed quantity of cream on each wafer sheet, the cream quantity to be adjusted to get
3.5gm of Ispaghula per wafer.
The cream should be sandwiched between two wheat slurry sheets.
E) In - Process Tests:
The following test to be conducted at regular frequency during manufacturing:
1. Description: Cream colored rectangular wafer with characteristic odor enclosing cream between two crispy layers.
2. Length: 65 mm - 85mm
3. Width: 30mm - 40mm
4. Thickness: 10-15mm
5. Weight: 14 -22 g
Example: 3 A) Preparation of Wheat flour slurry (For a batch size of 2000 wafer):
1. Wheat flour 8kg
2. Starch 570 g
3. Skimmed Milk Powder 140 g
4. Ammonium Chloride 70 g
5. Sodium Bicarbonate 25g
6. Sodium Benzoate 45 g
7. Colour. Sunset Yellow 0.5 g
8. Purified water q.s.
The above quantities are inclusive of 40% excess to compensate the process loss. Procedure:
1) Prepare a dispersion of wheat flour and starch and color in purified water in a suitable s.s. vessel, continue to stir until the slurry is formed.
2) Take about 500 ml of purified water, add skimmed milk powder and Sodium Benzoate to it and make creamy suspension and add it to the dispersion from step No. 1.

, 3) Take about 500ml of purified water add Sodium Bicarbonate, Ammonium Chloride, and salt to it make a clear solution and add it to dispersion from step No. 1. Stir the mixture of step No.l for about 15 minutes and the slurry is now ready for use.

B) Preparation of Cream:
1. Pulverized Sugar 15 kg
2. Ispaghula fine powder 10 kg
3. Vanillin crystals 5g
4. Vegetable oil 23 kg
5. Vegetable ghee 5 kg
6. Soy Lecithin 1kg
7. Ascorbyl Palmitate 28 g
8. Methyl paraben 28 g
9. Propyl Paraben 5.6 g
10. Colour: Sunset Yellow 2g
11. Flavour: Mixed Fruit q.s.
The above quantities are inclusive of 30% excess to compensate the process wastage. Procedure:
1. Take Vegetable ghee in suitable s.s. vessel and heat up to 50 -60° C add vegetable oil, Methyl paraben, Propyl Paraben, Ascorbyl Palmitate to it.
2. Load pulverized Sugar, Ispaghula fine powder to a suitable mixer and mix properly.
3. Add the melted vegetable ghee and vegetable oil mix containing preservatives and antioxidants, continue mixing to get a uniform mass.
4. Add Flavour and Colour, knead the mass for 15 minutes to get the homogeneous creamy mass.
C) Preparation of Crispy wheat flour sheets:
Adjust the temperature and speed of the roller to get crispy sheets without any visible defects.
D) Preparation of Cream Wafer:
Spread the weighed quantity of cream on each wafer sheet, the cream quantity to be adjusted to get
3.5 gm of Ispaghula per wafer.
The cream should be sandwiched between two wheat slurry sheets.
E) In - Process Tests:
The following test to be conducted at regular frequency during manufacturing:
1. Description: Cream colored rectangular wafer with characteristic odour enclosing cream between two crispy layers.
2. Length: 65 mm - 85mm

3. Width: 30mm-40mm
4. Thickness: 10-15mm
5. Weight: 14-22g
Example: 4
A) Preparation of Wheat flour slurry (For a batch size of 2000 wafer):
1. Wheat flour 8 kg
2. Starch 570 g
3. Skimmed Milk Powder 140 g
4. Ammonium Chloride 70 g
5. Sodium Bicarbonate 25g
6. Sodium Benzoate 45 g
7. Colour: Sunset Yellow 0.5 g
8. Purified water q.s.
The above quantities are inclusive of 40% excess to compensate the process loss. Procedure:
1) Prepare a dispersion of wheat flour and starch and color in purified water in a suitable s.s. vessel, continue to stir until the slurry is formed.
2) Take about 500 ml of purified water, add skimmed milk powder and Sodium Benzoate to it and make creamy suspension and add to dispersion from step No.l.
3) Take about 500ml of purified water add Sodium Bicarbonate, Ammonium Chloride, and salt to it make a clear solution and add to dispersion from step No.l.
Stir the mixture of step No. 1 for about 15 minutes and the slurry is now ready for use.
B) Preparation of Cream:
1. Pulverized Sugar 15 kg
2. Ispaghula fine powder 10 kg
3. Vanillin crystals 5g
4. Vegetable oil 23 kg
5. Vegetable ghee 5 kg
6. Soy Lecithin 1 kg
7. Ascorbyl Palmitate 28 g
8. Methyl paraben 28 g
9. Propylparaben 5.6 g
10. Colour: Sunset Yellow 2g
11. Flavour: Orange q.s.
The above quantities are inclusive of 30% excess to compensate the process wastage. Procedure:

1. Take Vegetable ghee in suitable s.s. vessel and heat up to 50- 60° C add vegetable oil, Methyl paraben, Propyl Paraben, Ascorbyl Palmitate to it.
2. Load pulverized Sugar, Ispaghula fine powder to a suitable mixer and mix properly.
3. Add the melted vegetable ghee and vegetable oil mix containing preservatives and antioxidants, continue mixing to get a uniform mass.
4. Add Flavour and Colour, knead the mass for 15 minutes to get the homogeneous creamy mass.
C) Preparation of Crispy wheat flour sheets:
Adjust the temperature and speed of the roller to get crispy sheets without any visible defects.
D) Preparation of Cream Wafer:
Spread the weighed quantity of cream on each wafer sheet, the cream quantity to be adjusted to get
3.5 gm of Ispaghula per wafer.
The cream should be sandwiched between two wheat slurry sheets.
E) In - Process Tests:
The following test to be conducted at regular frequency during manufacturing:
1. Description: Cream colored rectangular wafer with characteristic odour enclosing cream between two crispy layers.
2. Length: 65 mm - 85mm
3. Width: 30mm-40mm
4. Thickness: 10-15mm
5. Weight: 14 -22 g
The present invention can be consumed in a conventional manner to obtain the nutritional and physiological benefits of a high soluble fiber cereal food. In particular, it has been surprisingly discovered that the present cereal compositions when consumed regularly in prescribed dosage amounts can be used, and thus provide the additional benefit, of antihypercholesterolemia. That is, for persons having elevated levels of blood serum cholesterol, consumption of the present bakery product effectively lowers their blood serum cholesterol. The present methods essentially comprise the oral administration of the bakery product to hypercholesterolemic individuals for extended time periods. Optionally, the dosage can be administered in multiple doses, e.g., thrice daily, which collectively add up to the dosage levels specified. In individuals exhibiting hyper blood serum cholesterolemia, e.g., >220 mg/dl, an antihypercholesterolemic effect on the order of a 10% reduction can be expected after six weeks as part of a low fat, low cholesterol diet. Fiber has been mentioned as having possible value in a variety of preventative medical areas, such as constipation, weight reduction, diverticulitis, cardiovascular disease and cancer. However, different fiber components have very different physiological functions and the daily level of a particular dietary fiber recommended to achieve

physiological effects will vary with the type of fiber ingested. For a bulk laxative effect, a dietary dosage of psyllium fiber, whether it be derived from psyllium seeds or psyllium husks, in an amount of from about 5 to 30 grams is recommended. In accordance with the practice of this invention, dietary supplement compositions may be prepared in units of about 1 to about 1.3 ounces, which will contain about 5 grams of psyllium fiber. If minimal bulk laxative effects are desired, it is possible to include the minimum amount of whole psyllium husks necessary to achieve the desired crunchy texture characteristic of the supplement compositions of this invention, and up to about 28% by weight, based on the weight of the total supplement composition, of additional dietary fibers, other than whole psyllium husks which have other beneficial attributes. Thus, the crunchy, highly palatable, dietary fiber supplement compositions of this invention also serve as a vehicle for a variety of dietary fibers that may be recommended for particular medical applications.

We Claim:
1. A process for the preparation of a composition containing Psyllium husk in the form of a multi-layered creamy, crunchy, highly palatable biscuits which comprises preparing wheat flour slurry, preparing creamy inner layer containing the Psyllium husk, preparing crispy wheat flour sheets from said wheat flour slurry, and preparing creamy wafers with said crispy wheat flour sheets, with said creamy inner layer containing the Psyllium husk between said sheets, wherein said Psyllium is present at a concentration in the range of 20-80% by weight of the total composition and said wheat flour is present at a concentration in the range of 30-60% by weight of the total composition,.
2. The process as claimed in claim 1 wherein said wheat flour slurry is prepared in the presence of ingestible carrier materials of the kind such as herein described.
3. The process as claimed in claim 2 wherein said carrier materials are selected from the group consisting of conventional vegetable oils and fats, sweetening agents, flavorants, antioxidants, microbial preservatives, emulsifiers, and mixtures thereof.
4. The process as claimed in any preceding claim wherein said Psyllium is present at a concentration of 25-50% of the weight of the total composition.
5. The process as claimed in any preceding claim wherein the particle size of Psyllium husk is between 12-70 ASTM, preferably 30-60 ASTM.
6. The process as claimed in any preceding claim wherein the wheat flour is present at a concentration of 30-50% by weight.
7. The process as claimed in claim 1, wherein the outer layer consists of wheat flour and the inner creamy layer contains the Psyllium husk.

8. The process as claimed in any of the preceding claims, wherein the inner layer contains vegetable fats and oils, Psyllium husk, antioxidants, microbial preservatives and emulsifying agents.
9. The process as claimed in any one of claims 3 to 9 wherein the sweetening agent is selected from the group consisting of sucrose, fructose, dextrose, lactose, sorbitol, mannitol, corn syrup solids, artificial sweetening agents like sodium saccharine, aspartame and mixture thereof.
10. The process as claimed in claim 9, wherein the sweetening agent is sugar.
11. The process as claimed in any one of claims 3 to 10 wherein the flavoring agent is selected from the group consisting of cocoa powder, carob powder, peanut powder, yogurt powder, whole milk powder, vanilla, natural fruit flavors, artificial fruit flavors, natural flavor oils, artificial flavor oils, and mixtures thereof.
12. The process as claimed in claim 11 wherein the flavouring agent is vanilla.
13. The process as claimed in any one of claims 3 to 12, wherein the vegetable fats or oils are selected from hydrogenated or partially hydrogenated vegetable fats or oils.
14. The process as claimed in claim 13, wherein the vegetable fat or oil is palm oil.
15. The process as claimed in any one of claims 3 to 14 wherein the antioxidants are selected from ascorbyl palmitate, tocophenyl ester, butylene, hydroxyanisole, butylated hydroxytoluene or their mixtures thereof.
16. The process for the preparation of the composition of claim 15, wherein the antioxidant is ascorbyl palmitate.

17. A process as claim in any one of claims 3 to 16 wherein the emulsifying agent is soyalectin.
18. A process as claimed in claim 15 or 16, wherein the antioxidants are present at a concentration of 0.1 to 5% by weight of the total composition.
19. A process as claimed in any one of claim 3 to 18, wherein the preservative are present at a concentration of 0.1 to 0.6% by weight of total composition.

To
The Controller of Patents
The Patent Office
at Mumbai
20. A process as claimed in any one of claims 3 to 19 wherein the vegetable oils and fats are present at a concentration of 1-10% by weight of the total composition, preferably at a concentration of 1-5%.

Documents:

1217-mum-2001-cancelled pages(10-12-2004).pdf

1217-mum-2001-claims(granted)- (10-12-2004).doc

1217-mum-2001-claims(granted)-(10-12-2004).pdf

1217-mum-2001-correspondence 1(23-02-2007).pdf

1217-mum-2001-correspondence 2(23-12-2004).pdf

1217-mum-2001-correspondence(ipo)-(29-09-2004).pdf

1217-mum-2001-form 1(05-02-2002).pdf

1217-mum-2001-form 19(30-10-2003).pdf

1217-mum-2001-form 2(granted)- (10-12-2004).doc

1217-mum-2001-form 2(granted)-(10-12-2004).pdf

1217-mum-2001-form 3(27-12-2001).pdf

1217-mum-2001-form 4(04-02-2003).pdf

1217-mum-2001-form 5(04-02-2003).pdf

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Patent Number

205016

Indian Patent Application Number

1217/MUM/2001

PG Journal Number

25/2007

Publication Date

22-Jun-2007

Grant Date

13-Mar-2007

Date of Filing

27-Dec-2001

Name of Patentee

CADILA HEALTHCARE LTD.

Applicant Address

ZYDUS TOWER, SATELLITE CROSS ROADS, AHMEDABAD 380 015,

Inventors:

#	Inventor's Name	Inventor's Address
1	TADURI VEERABABU, GEMBALI SEETARAJU	M/S CADILA HEALTHCARE LTD., ZYDUS TOWER, SATELLITE-CROSSROADS, AHMEDABAD - 380 015,

PCT International Classification Number

A 23 L 1/308

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA