Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2000-04-05
2003-05-13
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S400000, C424S439000, C424S440000, C424S441000, C424S465000, C424S489000, C424S500000, C424S502000, C514S929000, C514S937000, C514S938000, C514S939000, C514S943000, C514S948000, C514S951000, C514S960000
Reexamination Certificate
active
06562372
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a tocotrienol-containing powder which is excellent in storage stability and flowability, to a process for preparing a tocotrienol-containing powder efficiently without accompanying adhesion of it to the wall of a spray-drier in the case where its preparation is accomplished by a spray-drying method, and to a tablet comprising said powder compressed into a tablet form.
BACKGROUND TECHNOLOGY
Tocotrienol which is present in vegetable oils such as coconut oil, palm oil, rice bran oil, soybean oil and the like have been extracted and concentrated by various methods. Tocotrienol resulted from the extract of these natural materials is a mixture of plural tocotrienols.
Recently, usefulness of tocotrienol in a wide variety of fields has been studied and many examples have been reported of utilization having made in the fields of drugs, foods, cosmetics and resin composition. That is, specific utilization examples in these fields have been reported as shown below.
In the field of drugs; antisterility drug for animal, therapeutic drug for oxygen disorder (Japanese Patent Application Laid-Open No. Sho 58-96021), antitumor drug (Japanese Patent Application Laid-Open No. Sho 61-210030, therapeutic drug for hypercholesterolemia, lipemia and thrombosis (Japanese Patent Application Laid-Open No. Hei 3-246222), therapeutic drug for immunity accommodation disease, inflammation, pyrexia, edema, diabetes mellitus, pain etc. (Japanese International Patent Application Laid-Open No. Hei 7-504887), a vital aging inhibitory agent and antioxidant for composition for skin use (Japanese Patent Application Laid-Open No. Hei 8-176005), eye drops and delayed and therapeutic drug for cataract (Japanese Patent Application Laid-Open No. Hei 9-157165), poultice having blood-flow promotion action (Japanese Patent Application Laid-Open No. Hei 9-208460).
In the field of foods; nutrition food (Japanese Patent Application Laid-Open No. Sho 58-99475), antioxidant for food, use for preventing quality deterioration of food or feed by oxidation (Japanese Patent Application Laid-Open No. Hei 9-9939).
In the field of cosmetics; additive for cosmetics (Japanese Patent Application Laid-Open No. Sho 58-99475), a hair tonic (Japanese Patent Application Laid-Open Nos. Hei 8-12532 and Hei 9-157136), a deodorant and dental composition (Japanese Patent Application Laid-Open No. Hei 8-92050), skin whitening agent for external use (Japanese Patent Application Laid-Open No. Hei 8-92062), a repressing and removing agent for bad breath (Japanese Patent Application Laid-Open No. Hei 10-182388).
In the field of resin composition; an antioxidant for a polysaturated compound (Japanese Patent Application Laid-Open No. Hei 6-57247), a heat and oxidation-stabilized olefinic polymer composition wherein ascorbic acid and tocotrienols are incorporated (Japanese Patent Application Laid-Open No. Hei 8-41252)
As tocotrienols have 3 double bonds in the intramolecular side chain and are colorless to yellow, clear and oily materials, they have disadvantages that they are more sensitive to air and light than vitamin E (tocopherol) and further that blending and metering procedures with other solid substances and handling are inconvenient. Therefore, there has been a need for the development of solid or powdery tocotrienol having good storage stability.
If the hitherto proposed process for preparing powdery fat-soluble vitamins is illustrated with an example of the representative vitamin E preparation, it has been conducted by a process wherein vitamin E (or vitamin E-containing oil) is emulsified with a wide variety of emusifying agents, proteins etc., followed by the addition of an excipient, and the resultant emulsion composition is subjected to spray-drying. It has also been prepared by a process wherein vitamin E and an emulsifying agent are added to an excipient and the resultant emulsion is sprayed while granulation and drying are simultaneously accomplished. It has further been conducted by mixing vitamin E (or vitamin E-containing oil) with a carrier. More specifically, {circle around (1)} Japanese Patent Publication No. Hei 1-52367 discloses a process for preparing vitamin E-containing powdery saccharide wherein vitamin E and a forming agent are added to a concentrated solution of a saccharide heated to 125-165° C., which is foamed by stirring, and then the solution is cooled so that the saccharide is precipitated and water in the solution is evaporated simultaneously. {circle around (2)} Japanese Patent Application Laid-Open No. Sho 48-22613 discloses a process for preparing powdery vitamin E containing about 40-60% by weight of a vitamin E active compound and about 60-40% by weight of a gelatin hydrolyzate having a molecular weight of about 9,000- about 11,000 wherein an aqueous emulsion containing the vitamin E active compound, 0 Bloom and the gelatin hydrolyzate is subjected to spray-drying. {circle around (3)} Japanese Patent Application Laid-Open No. Sho 60-64919 discloses a process for preparing powdery or granular vitamin E preparation wherein vitamin E is emulsified or solubilized in an aqueous phase in the presence of a saponin, an excipient is added thereto and dissolved in the resultant solution or solubilized product, which is subjected to spray-drying. {circle around (4)} Japanese Patent Application Laid-Open No. Hei 8-143456 discloses a process for preparing powdery oil soluble vitamins wherein a lipid containing fat-soluble vitamins is homogeneously dispersed in a solution of an excipient containing a defatted soybean as an effective ingredient, the dispersion is mechanically emulsified, and then the resultant emulsion is subjected to a spray- or freeze-drying. Also, {circle around (5)} Japanese Patent No.2626975 discloses a process for preparing a granule containing a vitamin E-related substance wherein the vitamin E-related substance is blended with more than 30% by weight of calcium silicate as an absorbent.
However, the above mentioned {circle around (1)} process involves the complicated procedure that the saccharide is precipitated, evaporating water simultaneously and causes a problem of coloration in the product. In the case where the process is conducted on a continuous and large scale, it is difficult to obtain a powder wherein vitamin E is homogeneously dispersed. The processes {circle around (2)} and {circle around (3)} as stated above, cannot yield any powders having a good formability and sufficient flowability. In the {circle around (4)} process wherein a defatted soybean is used as the excipient, the size of the powder obtained is uneven and coarse and hence its usefulness is inevitably limited. Also, the {circle around (5)} process wherein powdery calcium silicate and vitamin E are merely blended has a problem that it takes a certain time until the mixture becomes homogeneous.
DISCLOSURE OF THE INVENTION
It is an object of the present invention to provide a tocotrienol-containing powder which has an excellent storage stability and a good flowability.
It is another object of the present invention to provide a process for preparing efficiently a tocotrienol-containing powder having a free flowability causing no adhesion of the powder to the wall of a spray-drier during its preparation step based on spray drying.
It is still another object of the present invention to provide a tablet comprising said tocotrienol-containing powder compressed into a tablet form.
In order to achieve the above objectives, the present inventors attempted previously to make tocotrienol-containing oil consisting of a mixture of plural tocotrienols resulted from the extract of the natural materials (hereinafter, referred to as tocotrienol-containing oil) powdery by application of the hitherto known process for preparing a powdery vitamin E. However, the desired powdery product could not be obtained. Even in the case where powdery product was obtained, in most cases it was difficult to recover the powdery product in a good yield from the spray chamber due to its adhesion to the wall of the sp
Horita Yoshiharu
Hosokawa Terumasa
Ikushima Heiji
Shishido Takeshi
Tanaka Nobukazu
Burns Doane , Swecker, Mathis LLP
Evans Charesse
Fuji Chemical Industry Co., Ltd.
Page Thurman K.
LandOfFree
Tocotrienol-containing powder, a process for preparing it... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Tocotrienol-containing powder, a process for preparing it..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Tocotrienol-containing powder, a process for preparing it... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3080886