Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
1998-11-16
2001-12-25
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S451000, C264S004100, C426S140000, C426S657000
Reexamination Certificate
active
06333047
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a molded capsule which can be stably obtained with a thin membrane, which is superior in collapsing property but causes substantially no caking nor deformation by the change of pressure, temperature, humidity or the like and which can be useful in foods, drugs and cosmetics and is high in safety.
Molded capsules have been conventionally used in various fields such as foods, drugs and cosmetics. However, the capsule membrane has been prepared mainly by mixing a hydrated and swollen gelatin with a plasticizer and then drying the mixture. Such a capsule can be prepared relatively easily and is high in transparency and excellent in beauty. However, it has many disadvantages as follows. (1) It requires a long period for the preparation and drying of the membrane material in its production. (2) It requires strict temperature control to avoid leakage of packed suspension, formation of so-called avec sphere by mutual adhesion of capsules and deformation. (3) In the storage of capsules, a low humidity causes lowering of strength of the membrane to easily damage it by impact. (4) A high humidity, a high temperature or shortage of releasing agent causes deformation and caking. (5) If the thickness of the membrane is made thin, the strength becomes insufficient. (6) The collapse in digestive organs is slow.
On the other hand, as a method for eliminating these disadvantages of capsule membrane, JP 02-22221 A discloses a method for the preparation of a capsule improved in sliding and collapsing property by using a natural calcium material.
However, this method reduces transparency of the capsule and cannot produce a product of excellent beauty and cannot fully accomplish reduction of manufacturing period, improvement in strength and prevention of avec sphere and deformation, disadvantageously.
An object of the present invention is to eliminate disadvantages of conventional capsules as described above and to provide a molded capsule, i.e., a soft gel capsule, which can be easily and stably prepared and prevents liquid leakage and occurrence of avec sphere and deformation and is rich in membrane strength and has a high stability against changes in pressure, temperature and humidity. Further, an object of the present invention is to make the capsule membrane thin and to make the size of the capsule small and as the result to give a capsule product which can be easily dosed and is high in collapsing property and softness and can be used widely in various fields such as foods, drugs and cosmetics and is superior in safety.
SUMMARY OF THE INVENTION
We solve the above problems by forming a capsule membrane containing “Process Whey Protein” which is obtained by heating milk whey protein under a specific condition.
Thus, the molded capsule of the present invention has a capsule membrane which contains “Process Whey Protein” together with at least one selected from the group consisting of scleroproteins, derived proteins and mucopolysaccharides. The capsule membrane may further contain a plasticizer.
DETAILED DESCRIPTION OF THE INVENTION
“Process Whey Protein” used in the present invention is prepared by a procedure in which low molecular weight compounds other than milk whey protein are substantially removed from milk whey which are a waste material from the manufacture of cheese, butter and casein by using milk as the raw material and then the pH of the product is adjusted to not higher than 4 or not lower than 6 and then heat-treated. For example, by using cheese whey formed in the manufacture of cheese, the low molecular weight compounds in milk whey are removed substantially by a dialysis or a chromatography and the product is heat-treated at a pH not higher than 4 or not lower than 6 to give the Process Whey Protein. For example, the method for the preparation of “Process Whey Protein” is disclosed in U.S. Pat. No. 5,416,196 A and EP 0473270 B which are corresponding to JP 04-228036 A, JP 04-267850 A and JP 06-292514 A, and KINEKAWA, Y. and KITABATAKE, N. “Biosci. Biotech. Biochem.” Vol.51, 834 (1995), KITABATAKE, N., FUJITA, Y. and KINEKAWA, Y. “J. Food Sci.” Vol.61, 500 (1996) and the like. The commercial products include “Genesis (trade name)” manufactured by Daiichi-Kasei Co., Ltd.
Such Process Whey Protein has many functional characteristics which cannot be obtained by other protein materials. For example, it gives a transparent viscous oily liquid showing newtonian behavior, a transparent sol and a transparent gel. Particularly, a transparent gel prepared by adding a salt and heating is not molten even when heated to as high a temperature as in a retort. A high temperature is not especially required for the preparation of sol or gel and it is enough to be 0° C. or higher. A gel can be formed even at room temperature.
Furthermore, Process Whey Protein does not gel by heating when no salt nor mineral is added to form a transparent viscous liquid.
Also, Process Whey Protein is a protein material excellent in emulsification stability and digestive property and high in effective nutritive value.
As the “scleroprotein” constituting the main components of the capsule membrane of the present invention, useful are collagen, collagen hydrolyzate and the like. As the “derived protein”, useful are gelatin, low molecular weight gelatin, gelatin hydrolyzate and the like. As the “mucopolysaccharide”, useful are chondroitin sulfate and hyaluronic acid. They can be used each alone or in combination. Particularly, gelatin is preferred for taste.
The “plasticizer” is not particularly restricted but the useful compounds are glycerol, polyglycerol, polyethylene glycol, propylene glycol and the like. They can be used each alone or in combination.
The amount of “Process Whey Protein” used is not especially restricted but is preferably 0.07 to 2 weight %, more preferably 0.1 to 1 weight %, based on the solid amount of the capsule membrane. Usually, a solution containing 7 to 10 weight % of Process Whey Protein is added in an amount of 1 to 20 weight %, preferably 1 to 10 weight %, based on the total amount of the raw materials for capsule membrane before drying for use.
The amount of scleroproteins, derived proteins and mucopolysaccharides used is also not particularly restricted but usually 40 weight % or more, particularly 60 to 99 weight % in the capsule membrane is preferred. It is preferably 5 to 50 weight % based on the total amount of the raw materials before drying.
The amount of the plasticizer used in the present invention may be 0 to 40 weight %, particularly 5 to 35 weight %, of the capsule membrane and usually it is preferred to use 10 to 30 weight % based on the total amount of the raw materials before drying.
The capsule of the present invention can be prepared by mixing a solution of Process Whey Protein with other materials and heating and drying it. The mixing can be carried out by dissolving or dispersing uniformly for example with stirring according to usual method. A jacketed stirring defoaming vessel can be used for simultaneously carrying out deaeration, stirring and heating.
The heating temperature for the mixture is preferably 50° C. or higher, particularly 70° to 100° C.
The succeeding drying process requires no special means and can be carried out by a usual method, for example by using an air flow type rotary dryer.
The moisture content of the membrane after is preferably 1 to 15 weight %, more preferably 3 to 10 weight %, most preferably 4 to 8 weight %.
The Process Whey Protein used in the present invention is prepared by heat-denaturing whey protein, which is a globular protein, under a specific condition to modify it to “a soluble linear aggregate”.
When no salt is added, the Process Whey Protein aggregates repel each other by static repulsion and therefore it does not gel nor thickens when heated. However, when a salt is added, static repulsion between aggregates is weakened and the aggregates approach each other by intermolecular attraction and hydrophobic interaction and then a fine heat-irreversible gel network is f
Katagihara Hiroshi
Kinekawa Yohichi
Kitabatake Naofumi
Sogawa Satoshi
Ueda Yoshinori
Daiichi Kasei Co., Ltd.
Morgan & Finnegan L.L.P.
Page Thurman K.
Seidleck Brian K.
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