EXPANDABLE, PROTEIN-BASED, LOW-CALORIE COMPOSITIONS

Abstract: There is disclosed compositions comprising non-foamed, non-crosslinked animal and/or vegetable proteins in combination with edible cellulose fibers and/or colloidal cellulose microfibrils in combination with lesser amounts of edible gums as binders. These compositions possess a water-expandable property such as to grow in volume in an aqueous acidic medium and serve as a firm gelatinous binder for the edible components. The above mixture is compressed in dry powder forms into tablets and/or granular compositions capable of swelling at the acid pH of the stomack into a firm gelatinous physical mass or masses that effectively serve to provide a temporary reduction of the appetite by mechanical rather than systemic action.

Description: EXPANDABLE, PROTEIN-BASED, LOW-CALORIE COMPOSITIONS BACKGROUND OF THE INVENTION This invention relates to new weight-control compositions comprising a water-expandable property such as to grow at least to several times their dry volume in an aqueous acidic medium. The above mixture is compressed in dry powder forms into tablets and/or granular compositions capable of swelling at the acid pH of the stomach into a firm gelatinous physical mass or masses that effectively serve to provide a temporary reduction of the appetite by mechanical rather than systemic action. The medical literature provides abundant evidence that the excessive intake of food and overweightness constitute a serious health problem. Calorie intake above an individual's needs as a result of the excessive consumption of foods damage the heart and the circulatory system, particularly in the case of aged persons, pregnant women, and people suffering from diabetes. Recently, the use of appetite-reducing medicaments has become widespread. However, such drugs act as stimulants of the central nervous system and, therefore, the continuous administration thereof leads to serious damages of the central nervous system and also to habituation. The side effect of such systemic drugs to control weight have become so serious in recent time that they have come under FDA control. Amphetamines, for example, can no longer be used for weight control except by prescription under a physician's control; they have been removed for over-the-counter sales. Recently a number of attempts have been made to solve this problem by the administration of compositions containing indigestible substances. The use of these compositions leads to the feeling of fullness without causing weight increase. The following additives have been suggested: casein (British Pat. No. 990,523), mixtures of egg-albumin, casein, cellulose-ether, guar gum, agar pectin, carrageen, and sodium alginate (British pat. No. 993,308), guar gum (British Pat. Nos. 1,041,600 and 1,106,882), a mixture of soluble polyglucose citrate and insoluble polyglucose (British Pat. No. 1,182,961), microcrystalline cellulose (U. S. Pat. No. 3,023,104), a mixture of 50% of glutin flour, 1- 10% of vegetable gums, and 50% of microcrystalline cellulose, peanut-shell, or wood-flour (U. S. Pat. No. 3,023,104), edible cheese DAS No. 1,442,021), and 5-30% of finely dispersed pure cellulose (DAS No. 1,959,196). Special dry cakes for diabetic people have also been described, prepared from 100% soya flour and 30-50% of protein (DAS No. 2,060,797). None of the above products meets in a satisfactory manner the tablet expandability requirements of the present invention for a pleasant and permanent consumption, good taste, and easy absorption from the intestinal tract. Many efforts have been made to use conventional fibrous cellulose as a bulking agent in low calorie food compositions and in pharmaceuticals. Fibrous cellulose has the advantage, in addition to providing desirable dietary fiber, of providing desired bulk without calories. However, a principal defect of this material has been its objectional texture. This characteristic has greatly limited the use of fibrous cellulose, both in the field of food technology and in the field of pharmaceutical preparations. When fibrous cellulose has been mixed according to conventional methods with other food ingredients, the fibrous cellulose is usually very noticeable to the taste, is not smooth, has a fibrous or gritty feel to the tongue and mouth when chewed, and tends to accumulate as an insoluble or residual material in the mouth. As a result, the food compositions themselves have tended to be rendered unpalatable by the addition of fibrous cellulose. Reduction of the fibrous cellulose content of such compositions to the point where it is not detectable when chewed has effectively reduced the proportion of fibrous cellulose to the point where it has no longer been effective as a bulking agent or as a source of significant dietary fiber. U.S. Pat. No. 4,042,719 disperses fibrous carbohydrates in a solution of cellulose ethers, subsequently drying the gelled mixture up to temperatures as high as 300° C. to increase palatability by masking the fibrous taste of the fibrous carbohydrate. U.S. Pat. No. 4,401,682 (Battista) specifically uses preformed (wet process) foamed and crosslinked gelatins as the primary component for an expandable low- calorie composition. The economics of this invention are much less favorable than for the present invention whereby excellent expandability properties have been obtained without the prefoaming and noncovalent crosslinking steps required by U.S. Pat. No. 4,401,682. U.S. Pat. No. 4,042,719 (Zimmermann) preswells in an aqueous medium with a 20% cellulose ether solution and, subsequently, dries the preswollen mixture. The coating of "flour" with such a high loading of an aqueous solution of a high viscosity cellulose ether would, as expected, improve palatability by virtue of coating the carbohydrate (flour) particles with a water-soluble coating. However, by the same reasoning, such a dried product would be so densified by drying that tablets made from it would exhibit no swelling, or substantially no swelling, in gastric juice. U.S. Pat. No. 4,670,251 (Blanco) teaches the use of microcrystalline cellulose as a binder (microcrystalline cellulose is the most widely used binder and excipient, worldwide, for making pharmaceutical tablets) and a major ingredient in aqueous dairy whey lactose, subsequently recovering the microcrystalline solid phase and drying it into a chalky white free-flowing powder. Blanco's formulas do not have the unexpected and useful property of growing into a highly swollen mass in gastric juice. U.S. Pat. Nos. 4,042,719, 4,680,189, and 4,710,390 (Schumacker) teaches that all ingredients are mixed in an aqueous mix, drying the resulting aqueous plastic mix and milling the dried product to a powder. The resulting severe hydrogen bonding in the dried granules so produced results in hard granules which, when compressed into tablets, do not demonstrate expandability in gastric juice. SUMMARY OF THE INVENTION According to the present invention, there is provided a process for the preparation of an expandable dry-mix composition that, unlike the closest known prior art, achieves a high level of expandability in gastric juice without requiring the use of highly prefoamed and noncovalent crosslinked gelatin. According to an embodiment of the process of the present invention, the protein component on the one hand and the all other ingredients on the other hand are admixed in a finely divided dry state, optionally in the presence of further minor components such as flavorings and/or coloring, prior to tableting, etc. The main feature of the present invention is that no significant swelling of the compressed ingredients occurs until the compressed components reach the stomach and the swelling of the tablets is maximized when present in the acidic gastric juices. The present invention further discloses that non-foamed, non-crosslinked proteins such as conventional gelatins when used in amounts as high as over 30 percent by weight melt in gastric juice in the stomach (Melting points of commercial, non-crosslinked gelatins is about 32" C. ; whereas, gastric juice in vivo at 37° C. melts the gelatin.) to form a highly-viscous, integral mass in combination with the specific natural gums disclosed. The preferred grade of commercial gelatin (non- foamed and non-crosslinked) used in the present invention has a Bloom Value of about 300, and it is available from the HORMEL CO. in Austin, Minnesota. It is made from porcine skins. Equivalent grades are available from other gelatin suppliers such as KIND & KNOX. One commercially available source of particulate fibrous celluloses satisfactory for use in compressed diet-aid inventions is obtained from the JAMES RIVER CORPORATION of Berlin, New Hampshire, under the trade name SOLKAFLOC. Satisfactory food grades of this particulate fibrous cellulose, also known as powdered cellulose, are grades SW-40 and BW-300. These are mechanically disintegrated and purified celluloses generally obtained from primarily alpha cellulose derived from wood pulp. Ninety-nine and five-tenths percent of this material will pass through a 33-micron screen and 99.0 percent will pass through a 23-micron screen. The average fiber length is 21 microns and the average fiber width is 17 microns. Such relatively fine powdered celluloses, or an equivalent finely powdered cellulose, provide cellulose fibers which may be used as one bulking ingredient in producing our low-calorie, edible, carbohydrate/protein diet-aid tablets or capsules. The second fibrous carbohydrate ingredient of this invention comprises microcrystalline cellulose, commercially known as AVICEL and produced by the acid hydrolysis of alpha cellulose. These ultrapure forms of colloidal powdered celluloses are available from FMC CORPORATION of Philadelphia, Pennsylvania, as grades PH101, PH105, and RC581. The advantages of the instant invention can be further appreciated by reference to the following examples. These examples are intended to illustrate preferred embodiments and are by no means intended to limit the effective scope of the claims. EXAMPLE 1 The following dry * materials, in the amounts listed as Parts by Weight, were dry blended in a blender (such as a Waring Blender) until a fluffy, precursor, homogeneous, dry mix was obtained: Ingredients Parts By Wt Commercial 300 Bloom Porcine Gelatin 15 (Non-foamed and Non-Crosslinked) in Fine Powder Form SW-40 Fibrous Alpha Cellulose 30 Microcrystalline Cellulose, Grade RC581 35 Carageenan UE Grade (Food Grade) 10 Food Grade Guar Gum 10 The blended dry mix was pre-slugged to convert the fluffy powder into a compressed, higher-density, precursor, granulated form to facilitate high-speed tableting. The pre-slugged precursor product was compressed into 0.675 gm oblong tablets, using a compression weight of 6 kilograms. When tablets so made were added to simulated gastric juice at 37° C. , the tablet expanded slowly into a gelatinous mass that was about 8 times the original volume of the tablet. EXAMPLE 2 The following dry materials, in the amounts listed as Parts by Weight, were dry blended in a blender (such as a Waring Blender) until a fluffy, precursor, homogeneous, dry mix was obtained: Ingredients Parts By Wt Commercial 300 Bloom Porcine Gelatin 15 in Fine Powder Form SW-40 Fibrous Alpha Cellulose 35 Microcrystalline Cellulose, Grade RC581 30 Carageenan UE Grade (Food Grade) 10 Food Grade Guar Gum 10 The blended dry mix was pre-slugged to convert the fluffy powder into a compressed, higher-density, precursor, granulated form to facilitate high-speed tableting. The pre-slugged precursor product was compressed into 0.675 gm oblong tablets, using a compression weight of 12 kilograms. When tablets so made were added to simulated gastric juice at 37° C. , they expanded slowly, at first, and then more rapidly, in a matter of 2 - 3, minutes into a gelatinous mass that was at least about 8 times the original volume of the tablet. EXAMPLE 3 The following dry materials, in the amounts listed as Parts by Weight, were dry blended in a blender (such as a Waring Blender) until a fluffy, precursor, homogeneous, dry mix was obtained. However, in this Example, the dry commercial gelatin and the dry fibrous alpha cellulose (Grade SW-40) were first dry blended together before the remaining dry ingredients were added and blended into a uniform, tableting, precursor product. Ingredients Parts By Wt Commercial 300 Bloom Porcine Gelatin 20 in Fine Powder Form SW-40 Fibrous Alpha Cellulose 30 Microcrystalline Cellulose, Grade RC581 30 Carageenan UE Grade (Food Grade) 15 Food Grade Guar Gum 5 The blended, dry mix was pre-slugged to convert the fluffy powder into a compressed, higher-density, precursor, granulated form to facilitate high-speed tableting. The pre-slugged precursor product was compressed into 0.675 gm oblong tablets, using a compression weight of 10 kilograms. When tablets so made were added to simulated gastric juice at 37" C. , the tablet expanded slowly into a gelatinous mass that was at least about 8 times the original volume of the tablet. EXAMPLE 4 The following dry materials, in the amounts listed as Parts by Weight, were dry blended in a blender (such as a Waring Blender) until a fluffy, precursor, homogeneous, dry mix was obtained: Ingredients Commercial 300 Bloom Porcine Gelatin in Fine Powder Form SW-40 Fibrous Alpha Cellulose Microcrystalline Cellulose, Grade RC581 Microcrystalline Cellulose, Grade PH101 Carageenan UE Grade (Food Grade) Food Grade Guar Gum The blended dry mix was pre-slugged to convert the fluffy powder into a compressed, higher-density, precursor, granulated form to facilitate high-speed tableting. The pre-slugged precursor product was compressed into 0.675 gm oblong tablets, using a compression weight of 6 kilograms. When tablets so made were added to simulated gastric juice at 37" C. , the tablet expanded slowly into a gelatinous mass that was about 12 times the original volume of the tablet. EXAMPLE 5 The following dry materials, in the amounts listed as Parts by Weight, were dry blended in a blender (such as a Waring Blender) until a fluffy, precursor, homogeneous, dry mix was obtained: Ingredients Parts Bv Wt Commercial 175 Bloom Porcine Gelatin 40 in Fine Powder Form SW-40 Fibrous Alpha Cellulose 30 The above ingredients were dry blended together first and then dry blended with the remaining ingredients: Microcrystalline Cellulose, Grade RC581 10 Carageenan UE Grade (Food Grade) 10 Food Grade Guar Gum 10 The blended dry mix was pre-slugged to convert the fluffy powder into a compressed, higher-density, precursor, granulated form to facilitate high-speed tableting. The pre-slugged precursor product was compressed into 0.675 gm oblong tablets, using a compression weight of 15 kilograms. When tablets so made were added to simulated gastric juice at 37° C, the tablet expanded slowly into a gelatinous mass that was about 14 times the original volume of the tablet. EXAMPLE 6 The following dry materials, in the amounts listed as Parts by Weight, were dry blended in a blender (such as a Waring Blender) until a fluffy, precursor, homogeneous, dry mix was obtained: Ingredients Parts Bv Wt Commercial 300 Bloom Porcine Gelatin 40 in Fine Powder Form SW-40 Fibrous Alpha Cellulose 30 Microcrystalline Cellulose, Grade RC581 10 Microcrystalline Cellulose, Grade PH101 5 Carageenan UE Grade (Food Grade) 10 Food Grade Guar Gum 5 The blended dry mix was pre-slugged to convert the fluffy powder into a compressed, higher-density, precursor, granulated form to facilitate high-speed tableting. The pre-slugged precursor product was compressed into 0.675 gm oblong tablets, using a compression weight of 5 kilograms. When tablets so made were added to simulated gastric juice at 37° C, the tablet expanded rapidly into a gelatinous mass that was about 10 times the original volume of the tablet. EXAMPLE 7 The following dry materials, in the amounts listed as Parts by Weight, were dry blended in a blender (such as a Waring Blender) until a fluffy, precursor, homogeneous, dry mix was obtained: Ingredients Parts By Wt Commercial 300 Bloom Porcine Gelatin 25 in Fine Powder Form SW-40 Fibrous Alpha Cellulose 25 Microcrystalline Cellulose, Grade RC581 20 Microcrystalline Cellulose, Grade PH101 10 Carageenan UE Grade (Food Grade) 10 Food Grade Guar Gum 10 The blended dry mix was pre-slugged to convert the fluffy powder into a compressed, higher-density, precursor, granulated form to facilitate high-speed tableting. * The pre-slugged precursor product was compressed into 0.675 gm oblong tablets, using a compression weight of 14 kilograms. When tablets so made were added to plastic vials containing 50 ml of simulated gastric juice at 37° C. , the tablet expanded rapidly into a gelatinous mass that was about 12 times the original volume of the tablet. EXAMPLE 8 Using the dry mix pretableting formula in Example 1, tablets were prepared using molds of varying shapes - all 0.675 gm in weight and at compressions of 6 kilograms. The results, listed below, show that the design of the mold at a fixed compression does have an effect on the volume expansivity of the dry-compressed tablets in our standard simulated gastric juice test. Mold Shape Tablet Weight Kilograms of Volume Gms Compression Expansivity Circular 0.675 6 16 Elliptical 0.675 6 10 with Tapered Ends Elliptical 0.675 15 with Tapered Ends Compressed, 0.675 10 Short, Thick Oblong EXAMPLE 9 Using the dry mix pretableting formula of Example 4, tablets were prepared using a circular mold at varying kilograms of compression. The results, shown below, demonstrate the role of tablet compression on the rate of volume expansivity with time. Expansivity Volume 5 Mins 30 Mins 60 Mins Various changes and modifications may be made in practicing this invention without departing from the spirit and scope thereof and, therefore, the invention is not to be limited except as defined in the appended claims.

Claims: I claim: 1. A method for the preparation of a very low- calorie edible produce capable of expanding into a highly-swollen water-holding mass that expands to at least about 5 times its original volume when in contact with the gastric juices of the stomach, comprising dry blending only dry, solid, particulate ingredients at least from about 10 percent to as high as about 50 percent which consists of animal or vegetable proteins, at least about 5 percent alpha cellulose, and at least about 10 to about 50 percent microcrystalline cellulose, in combination with dry, fine, edible gums in dry powder form, constituting from about 10 to about 25 percent by weight of the blend and compressing such dry compositions into a shaped for. 2. The method as defined in Claim 1 wherein the total non-foamed non-crosslinked protein constitutes from about 10 to about 50 percent of the blend. 3. The method as defined in Claim 1 wherein the total non-foamed non-crosslinked protein constitutes about 30 percent of the blend. 4. The method as defined in Claim 1 wherein the blend is compressed into a shaped form at the pressure of about 2 to about 20 kilograms or more. 5. The method as defined in Claim 1 wherein the dry, particulate, non-foamed, non-crosslinked protein constitutes at least about 20 percent by weight of the blend, at least about 5 percent of finely-divided, particulate, alpha cellulose, about 20 to about 40 percent microcrystalline cellulose, and about 10 to about 20 percent of edible gums. 6. The method as defined in Claim 1 wherein the blend is compressed into shaped forms having designs such as circular, elliptical, oblong, and round-edged, thick, rectangular-shaped products, using pressures from about 4 to about 16 kilograms or more. 7. As an article of manufacture wherein the compressed shaped forms consisting essentially from about 10 to about 50 percent by weight of finely-divided, non- foamed, non-crosslinked, edible gelatin and about 10 to about 20 percent by weight of edible water-soluble gums in dry, finely-divided, particulate forms and which shaped forms being further characterized in that when ingested and upon coming into contact with aqueous liquids including gastric juices of the stomach expand into a gelatinous mass of about 5 times ore more of their original dry volume. 8. An article of manufacture as defined in Claim 7 wherein the dry, edible, water-soluble gums comprising dry, particulate, carrageenans and guar gum, respectively, and less than about 50 percent of non- foamed, non-crosslinked animal or vegetable proteins. 9. An article of manufacture as defined in Claim 7 wherein the dry, edible, non-foamed, non- crosslinked particulate protein at a total concentration of about 30 percent is dry blended with the alpha cellulose prior to dry blending these two dry ingredients with all the other dry particulate ingredients prior to converting the final dry mix into shaped forms. 10. An article of manufacture as defined in Claim 7 wherein the shaped form comprises about 10 percent of carrageenan, about 10 percent of guar gum, about 20 percent of alpha cellulose, and the balance consisting of non-foamed, non-crosslinked, protein, microcrystalline cellulose RC581 and microcrystalline cellulose PH101 or their respective commercial equivalents or analogs. 11. An article of manufacture as defined in Claim 7 wherein the non-foamed, non-crosslinked protein is an animal protein. 12. An article of manufacture as defined in Claim 7 wherein the non-foamed non-crosslinked protein is gelatin. 13. An article of manufacture as defined in Claim 7 wherein the non-foamed non-crosslinked protein is soybean protein.

Inventors: BATTISTA ORLANDO A, BATTISTA, ORLANDO, A.
Applicants: BATTISTA ORLANDO A, BATTISTA, ORLANDO, A.
Application year: 1989
Main classification: A23L1
IPC codes: A23L1, A61K9, A61K38, A61P3