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.