Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1999-03-31
2001-02-20
Lovering, Richard D. (Department: 1712)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S094100, C424S489000, C426S650000, C426S655000, C514S938000, C514S964000, C514S974000, C516S021000, C516S022000, C516S029000, C516S031000
Reexamination Certificate
active
06190680
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field of the Invention
The present invention relates to an oily composition and a process for producing the composition. More particularly, the present invention pertains to an oily composition excellent in storage stability and a process for producing the composition. The oily composition of the present invention may be used in the fields of foods, feeds, cosmetics, medicines, agricultural chemicals, machines and other various industrial fields, because of its excellent storage stability.
2. Prior Art
A water-soluble effective substance and/or a water-dispersible effective substance (hereinafter referred to as “aqueous effective substance”) may be dispersed in an oil by directly adding the aqueous effective substance to the oil containing an emulsifying agent dissolved therein and mixing them. However, this process does not permit easy preparation of any uniform and stable dispersion of such an aqueous effective substance in an oil phase and does not ensure any effect of masking the taste of the aqueous effective substance. This is because the dispersion prepared by the method entrains coagulation and/or precipitation of the effective substance. In general, there has widely been adopted a method comprising the step of mixing and emulsifying a solution of an aqueous effective substance in an aqueous phase with an oil phase to thus give a water-in-oil type emulsified composition. As such water-in-oil (or W/O) type emulsified compositions whose aqueous phase contains certain substances, there have been proposed, for instance, a W/O type emulsion containing an antioxidant hardly soluble in oils and fats or a synergist [Japanese Patent Publication for Opposition Purpose (hereinafter referred to as “J. P. KOKOKU”) No. Hei 4-64638], a W/O type lipophilic antioxidant containing a water-soluble antioxidant substance emulsified therein [Japanese Patent Un-Examined Published Application (hereinafter referred to as “J. P. KOKAI”) No. Sho 63-135483], and a W/O type emulsified composition containing an acidic substance and/or a salt thereof (J. P. KOKAI No. Hei 6-343400).
However, any W/O type emulsified composition has not yet been developed, which can sufficiently, satisfactorily be applied to various applications in the foregoing industrial fields because the foregoing W/O type emulsified composition does not undergo any separation immediately after the preparation, but the composition causes the separation of the aqueous phase or the oiling off phenomenon during storage thereof due to the action of salts and acidic substances coexisting in the aqueous phase. In addition, a large quantity of water is present in the aqueous phase and this becomes a cause of hygienic problems such as decomposition and/or putrefaction of the aqueous effective substances and the growth of mold. Moreover, the W/O type emulsion never ensures a sufficient effect of masking the taste of the aqueous effective substances.
PROBLEMS THAT THE INVENTION IS TO SOLVE
Accordingly, it is an object of the present invention to provide an oily composition which does not entrain any precipitation of aqueous effective substances, has excellent storage stability shows an effect of masking the taste of the aqueous effective substances, and is excellent in hygienic properties even when it is stored for a long time period, which can show a variety of functions such as an anti-oxidant action superior to that observed when the aqueous effective substance per se is used as an anti-oxidizing agent, and which can be used in combination with an oily antioxidant, as well as a method for preparing the composition.
MEANS FOR SOLVING THE PROBLEMS
The inventors of this invention have conducted various studies and have found that the foregoing objects of the invention can be accomplished by providing an oily composition wherein an aqueous effective substance, in a specific fine particulate state, is dispersed in an oil phase and the overall content of water in the composition is limited to a specific range.
The present invention has been completed on the basis of the foregoing finding and relates to an oily composition which comprises a solid phase containing a water-soluble effective substance and/or a water-dispersible effective substance and an oil phase containing an oily component and an emulsifying agent whose HLB value is not more than 10, wherein the foregoing solid phase is dispersed in the oil phase in a fine particulate state whose average particle size is not more than 5 &mgr;m and wherein the content of water or alcoholic aqueous solution present in the solid phase is not more than 30% by weight.
According to another aspect of the present invention, there is provided an oily composition which comprises a solid phase containing a water-soluble effective substance and/or a water-dispersible effective substance and a water-soluble film-forming agent in an amount ranging from 1 to 2000 parts by weight per 100 parts by weight of the sum of the water-soluble effective substance and/or the water-dispersible effective substance; and an oil phase containing an oily component and an emulsifying agent whose HLB value is not more than 10, wherein the foregoing solid phase is dispersed in the oil phase in a fine particulate state whose average particle size is not more than 5 &mgr;m and wherein the content of water present in the solid phase is not more than 30% by weight.
According to a still another aspect of the present invention, there is provided a process for preparing an oily composition which comprises the steps of emulsifying an aqueous phase containing a water-soluble effective substance and/or a water-dispersible effective substance, a water-soluble film-forming agent and water or an aqueous alcohol solution with an oil phase containing an oily component and an emulsifying agent to give a W/O type emulsion and then drying the resulting emulsion.
MODE FOR CARRYING OUT THE INVENTION
The oily composition of the present invention will first be described in detail below.
The oily composition of the present invention comprises a solid phase containing an aqueous effective substance and an oil phase containing an oil component and an emulsifying agent having an HLB value of not more than 10.
The aqueous effective substance used in the present invention is not restricted to any specific one and may be any substance soluble in water and dispersible in water, with those soluble in water or an aqueous alcohol solution being preferred. The term “aqueous alcohol solution” used above means a mixed solution of water and an alcohol, for instance, a solution obtained by dissolving 1 to 300 parts by weight of a primary alcohol such as ethanol or methanol in 100 parts by weight of water.
The method for preparing the foregoing aqueous effective substance is not also restricted to any specific one and those prepared by a variety of methods may be used in the invention without any restriction.
The aqueous effective substance may be, for instance, drugs, vaccines and extracts of animals and plants such as coloring agent, enzymes, bacteria, antioxidants, physiologically active substances, preservatives, bitter agents, acidulants, flavoring agents, anti-oxidizing agents, seasonings, inorganic salts, starch, starch hydrolyzates, peptides, polypeptides possessing physiological activity, amino acids, dietary fibers, celluloses, nutrient enrichment agents, crude drug extracts, drugs for treating diabetes, antipyretics, anti-inflammatory agents, analgesics, sedatives, antiallergic agents, antibiotics, antiulcerous agents, antitumour agents, anticoagulants, antihemorrhagics, cardiacs, muscle relaxants, anesthetics, antiarrhythmic agents and vasodilators. Specific examples thereof includes citric acid and salts thereof, phosphoric acid and salts thereof, metaphosphoric acid and salts thereof, gardenian blue color, caramel, cacao pigment, grape skin color, strawberry color, shisonin color, phospholipase, amylase, dehydrogenase, Takadiastase N1, lactic acid bacteria, butyric acid bacteria, bifidus bacte
Sakurada Satoshi
Yoshino Hisako
Burns Doane , Swecker, Mathis LLP
Lovering Richard D.
The Nisshin Oil Mills Ltd.
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