Container-packaged tablet composition, and method for reducing the abrasion of the tablet composition.

Abstract

The present invention provides a containerized tablet composition comprising a container and a tablet composition sealed in the container, wherein the degree of abrasion of the tablet composition can be reduced. [Solution] A containerized tablet composition comprising a container and a tablet composition sealed in the container, wherein the volume of the container is 30 cm³. 3 A tablet composition in a container, wherein the tablet composition contains one or more selected from the group consisting of ascorbic acid derivatives, yeast, and zinc gluconate, and the moisture content of the tablet composition is 5% by mass or less.

Description

Technical Field

[0001] The present invention relates to a tablet composition contained in a container and a method for reducing the friability of a tablet composition.

Background Art

[0002] Tablet compositions used in pharmaceuticals, supplements and the like are often transported while being sealed in containers formed of glass, resin or the like. For this reason, the tablet composition may be abraded inside the container, or components of the tablet composition may adhere to the container. Patent Document 1 discusses a method for suppressing the adhesion of components contained in a tablet composition to a container or the like.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] Patent Document 1 discusses suppression of the adhesion of components contained in a tablet composition to a container or the like, but it is also important to suppress the abrasion of the tablet composition inside the container.

[0005] An object of the present invention is to provide a container-equipped tablet composition that includes a container and a tablet composition sealed in the container, and that is capable of reducing the friability of the tablet composition.

Means for Solving the Problems

[0006] In general, it is said that the lower the water content of a tablet composition, the more easily the tablet composition is abraded. However, as a result of intensive studies, the present inventors have found that by incorporating a predetermined component into the tablet composition, adjusting the water content of the tablet composition, and further enclosing the tablet composition in a container of a predetermined size, the friability of the tablet composition, particularly the friability of the tablet composition accompanying shaking of the container, can be reduced, and the present invention has been completed.

[0007] The present invention includes, for example, the following respective inventions. [1] A container-packed tablet composition comprising a container and a tablet composition enclosed in the container, wherein the volume of the container is 30 cm 3 or less, the tablet composition contains one or more selected from the group consisting of ascorbic acids, yeast and zinc gluconate, and the water content of the tablet composition is 5% by mass or less. [2] A container-packed tablet composition comprising a container and a tablet composition enclosed in the container, wherein the void ratio of the container is 98% by volume or less, the tablet composition contains one or more selected from the group consisting of ascorbic acids, yeast and zinc gluconate, and the water content of the tablet composition is 5% by mass or less. [3] A container-packed tablet composition comprising a container and a tablet composition enclosed in the container, wherein the void volume of the container is 29 cm 3 or less, the tablet composition contains one or more selected from the group consisting of ascorbic acids, yeast and zinc gluconate, and the water content of the tablet composition is 5% by mass or less. [4] The container-packed tablet composition according to [1], wherein the void ratio of the container is 98% by volume or less. [5] The void volume of the container is 29 cm 3 or less, The container-packed tablet composition according to [1] or [4]. [6] The container-packed tablet composition according to any one of [1] to [5], wherein at least a part of the container is formed of a resin. [7] The container-packed tablet composition according to any one of [1] to [6], wherein the content of ascorbic acids is 10% by mass or more based on the total amount of the tablet composition. [8] A containerized tablet composition according to any one of [1] to [7], wherein the yeast contains zinc. [9] A tablet composition in a container according to any one of [1] to [8], wherein the tablet composition has a circular shape.

[10] A tablet composition in a container according to any one of [1] to [9], wherein only one tablet of the tablet composition is enclosed.

[11] A method for reducing the abrasion of a tablet composition, comprising sealing a tablet composition containing one or more selected from the group consisting of ascorbic acids, yeast and zinc gluconate in a container, wherein the volume of the container is 30 cm³. 3 The method is as follows, wherein the moisture content of the tablet composition is 5% by mass or less.

[12] A method for reducing the abrasion of a tablet composition, comprising sealing a tablet composition containing one or more selected from the group consisting of ascorbic acids, yeast and zinc gluconate in a container, wherein the moisture content of the tablet composition is 5% by mass or less, and the porosity of the container in which the tablet composition is sealed is 98% by volume or less.

[13] A method for reducing the abrasion of a tablet composition, comprising sealing a tablet composition containing one or more selected from the group consisting of ascorbic acids, yeast and zinc gluconate in a container, wherein the moisture content of the tablet composition is 5% by mass or less, and the void volume of the container in which the tablet composition is sealed is 29 cm³. 3 The method is as follows: [Effects of the Invention]

[0008] According to the present invention, it is possible to provide a containerized tablet composition that can reduce the degree of abrasion of the tablet composition. [Brief explanation of the drawing]

[0009] [Figure 1] This is a schematic diagram showing a tablet composition according to one embodiment. [Figure 2]Figure 2(a) shows the results of an abrasion test after sealing a tablet composition containing ascorbic acid in a small container and shaking it for 10 minutes, and Figure 2(b) shows the results of an abrasion test after sealing a tablet composition containing ascorbic acid in a large container and shaking it for 10 minutes. In each case, the relative values ​​of abrasion are shown with the abrasion of the tablet composition according to Production Example 5 set to 1. [Figure 3] This is the result of an abrasion test conducted after sealing a tablet composition containing ascorbic acid in a small container and shaking it for 70 minutes. The abrasion values ​​shown are relative values ​​when the abrasion of the tablet composition according to Production Example 5 is set to 1. [Figure 4] Figure 4(a) shows the results of calculating the abrasion improvement rate after sealing a tablet composition containing yeast or zinc gluconate in a small container and shaking it for 10 minutes, and Figure 4(b) shows the results of calculating the abrasion improvement rate after sealing a tablet composition containing yeast or zinc gluconate in a large container and shaking it for 10 minutes. In each case, the relative values ​​of the abrasion improvement rate are shown with the abrasion improvement rate of the tablet composition according to Production Example 5 set to 1. [Modes for carrying out the invention]

[0010] The embodiments for carrying out the present invention will be described in detail below. However, the present invention is not limited to the following embodiments.

[0011] In the numerical ranges described stepwise in this specification, the upper or lower limit of one step in the numerical range may be arbitrarily combined with the upper or lower limit of another step in the numerical range. In the numerical ranges described in this specification, the upper or lower limit of that numerical range may be replaced with the values ​​shown in the examples. Unless otherwise specified, the components or materials exemplified in this specification may be used individually or in combination of two or more.

[0012] The containerized tablet composition according to this embodiment comprises a container and a tablet composition sealed in the container.

[0013] In the containerized tablet composition according to this embodiment, the tablet composition enclosed in the container contains one or more selected from the group consisting of ascorbic acid derivatives, yeast, and zinc gluconate.

[0014] In this specification, "ascorbic acids" means at least one selected from the group consisting of ascorbic acid, ascorbic acid derivatives, and salts thereof. Examples of ascorbic acid derivatives among the ascorbic acids include L-ascorbic acid monoesters such as ethyl ascorbic acid, ascorbic acid 2-glucoside, ascorbic acid-2-phosphate ester, ascorbic acid-3-phosphate ester, ascorbic acid-6-phosphate ester, ascorbic acid-2-polyphosphate ester, and ascorbic acid-2-sulfate ester. Examples of ascorbic acid salts include sodium salt, potassium salt, magnesium salt, calcium salt, barium salt, ammonium salt, monoethanolamine salt, diethanolamine salt, triethanolamine salt, monoisopropanolamine salt, and triisopropanolamine salt. Examples of ascorbic acid derivative salts include sodium salt, potassium salt, magnesium salt, calcium salt, barium salt, ammonium salt, monoethanolamine salt, diethanolamine salt, triethanolamine salt, monoisopropanolamine salt, and triisopropanolamine salt. Preferred ascorbic acid derivatives are ascorbic acid, ethyl ascorbic acid, ascorbic acid 2-glucoside, ascorbic acid palmitate, and magnesium ascorbyl phosphate, with magnesium ascorbyl phosphate being more preferred. Furthermore, L-ascorbic acid and its derivatives are preferred as the ascorbic acid itself.

[0015] If the tablet composition according to this embodiment contains ascorbic acid, the ascorbic acid content is preferably 0.001% by mass or more, 0.01% by mass or more, 0.1% by mass or more, 1% by mass or more, 5% by mass or more, 8% by mass or more, 10% by mass or more, 13% by mass or more, or 15% by mass or more, based on the total amount of the tablet composition, from the viewpoint of further enhancing the effects of the present invention, and may also be 40% by mass or less, 35% by mass or less, 30% by mass or less, 25% by mass or less, 23% by mass or less, or 20% by mass or less. The ascorbic acid content is 20% by mass or more, 30% by mass or more, 40% by mass or more, 50% by mass or more, 60% by mass or more, 70% by mass or more, or 80% by mass or more, based on the total amount of the tablet composition, and may also be 100% by mass or less, 90% by mass or less, 80% by mass or less, 70% by mass or less, 60% by mass or less, or 50% by mass or less.

[0016] If the tablet composition according to this embodiment contains yeast, the yeast is not particularly limited as long as it is a yeast that can be used in pharmaceuticals, quasi-drugs, or food compositions. The yeast may be a dried yeast powder or an extract obtained from yeast. Examples of yeast include yeasts belonging to the genera Saccharomyces, Mycotorula, Candida, Schizosaccharomyces, Zygosaccharomyces, Pichia, Torlopsis, Jarrowia, Hansenula, Kruywelomyces, Devariomyces, or Geotrichum. Preferably, the yeast is a yeast belonging to the genera Saccharomyces or Candida. Examples of yeasts belonging to the genus Saccharomyces include Saccharomyces cerevisiae, Saccharomyces boulardii, and Saccharomyces pastorianus. Among the yeasts belonging to the genus Saccharomyces, Saccharomyces cerevisiae is preferred. Furthermore, among the yeasts belonging to the genus Candida, Candida stellata and Candida utilis (also known as Torula yeast) are examples, with Candida utilis being preferred.

[0017] From the viewpoint of further enhancing the effects of the present invention, the yeast is preferably a mineral-containing yeast (also referred to as "mineral-containing yeast"). Examples of minerals include zinc, iron, copper, chromium, selenium, calcium, sodium, magnesium, potassium, iodine, and molybdenum, but the mineral is preferably zinc. In other words, the yeast according to this embodiment is preferably a zinc-containing yeast (also referred to as "zinc-containing yeast").

[0018] The mineral content in mineral-containing yeast may be 0.01% by mass or more, 0.1% by mass or more, 1% by mass or more, 3% by mass or more, 5% by mass or more, 7% by mass or more, or 10% by mass or more, based on the total amount of yeast, and may also be 50% by mass or less, 30% by mass or less, 20% by mass or less, 15% by mass or less, 10% by mass or less, 7% by mass or less, 5% by mass or less, 1% by mass or less, 0.5% by mass or less, 0.1% by mass or less, or 0.01% by mass or less.

[0019] Zinc-containing yeast can be obtained, for example, by adding zinc to the culture medium when culturing yeast, allowing the yeast to take up zinc while growing. Commercially available yeasts such as "OMEY-ZN-10" (manufactured by Omnica Co., Ltd.) can also be used for this purpose.

[0020] The zinc content in zinc-containing yeast may be 0.01% by mass or more, 0.1% by mass or more, 1% by mass or more, 3% by mass or more, 5% by mass or more, 7% by mass or more, or 10% by mass or more, based on the total amount of yeast, and may also be 50% by mass or less, 30% by mass or less, 20% by mass or less, 15% by mass or less, 10% by mass or less, 7% by mass or less, 5% by mass or less, or 1% by mass or less.

[0021] If the tablet composition according to this embodiment contains yeast, the yeast content is preferably 0.001% by mass or more, 0.01% by mass or more, 0.1% by mass or more, 0.5% by mass or more, 1% by mass or more, 1.5% by mass or more, or 2% by mass or more, based on the total amount of the tablet composition, from the viewpoint of further enhancing the effects of the present invention, and may also be 90% by mass or less, 80% by mass or less, 70% by mass or less, 60% by mass or less, 50% by mass or less, 40% by mass or less, 30% by mass or less, 20% by mass or less, 10% by mass or less, or 5% by mass or less, based on the total amount of the tablet composition.

[0022] If the yeast is a mineral-containing yeast, the mineral content in the tablet composition may be 0.0001% by mass or more, 0.001% by mass or more, 0.01% by mass or more, 0.05% by mass or more, 0.1% by mass or more, 0.5% by mass or more, 1% by mass or more, or 2% by mass or more, based on the total amount of the tablet composition, and may also be 10% by mass or less, 8% by mass or less, 5% by mass or less, 3% by mass or less, 1% by mass or less, 0.5% by mass or less, 0.1% by mass or less, or 0.01% by mass or less.

[0023] If the yeast is a zinc-containing yeast, the zinc content in the tablet composition may be 0.0001% by mass or more, 0.001% by mass or more, 0.01% by mass or more, 0.05% by mass or more, 0.1% by mass or more, 0.5% by mass or more, or 1% by mass or more, based on the total amount of the tablet composition, and may also be 10% by mass or less, 8% by mass or less, 5% by mass or less, 3% by mass or less, 1% by mass or less, 0.5% by mass or less, 0.1% by mass or less, or 0.01% by mass or less.

[0024] The yeast according to this embodiment may contain physiologically active components other than minerals. Examples of physiologically active components include collagen, ubiquinone (coenzyme Q10), ceramide, hyaluronic acid, elastin, royal jelly, placenta, glutathione, nicotinamide mononucleotide (NMN), vitamin C, vitamin B6, vitamin B12, vitamin D, vitamin A, vitamin E, niacin, calcium pantothenate, taurine, carnosine, anserine, balenine, citrulline, gamma-aminobutyric acid, valine, leucine, isoleucine, glycine, glutamic acid, and glutamic acid. Examples include creatine, carnitine, luteolin, quercetin, genistin, cyanidin, resveratrol, diosgenin, isoflavone aglycone, lipoic acid, astaxanthin, zeaxanthin, beta-carotene, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidonic acid, placenta extract, pycnogenol, isoerucitrin, hyperoside, docosahexaenoic acid, eicosapentaenoic acid, arctigenin, pyrroloquinoline quinone, etc.

[0025] If the yeast contains physiologically active components other than minerals, the amount of physiologically active components contained in the yeast may be 0.01% by mass or more, 0.1% by mass or more, 0.5% by mass or more, 1% by mass or more, 5% by mass or more, 10% by mass or more, or 20% by mass or more, based on the total amount of yeast, and may also be 50% by mass or less, 30% by mass or less, 20% by mass or less, 15% by mass or less, 10% by mass or less, 5% by mass or less, or 1% by mass or less.

[0026] If the yeast is a yeast that contains physiologically active components other than minerals, the amount of physiologically active components contained in the tablet composition may be 0.001% by mass or more, 0.01% by mass or more, 0.05% by mass or more, 0.1% by mass or more, 0.5% by mass or more, 1% by mass or more, 5% by mass or more, 10% by mass or more, or 20% by mass or more, based on the total amount of the tablet composition, and may also be 50% by mass or less, 30% by mass or less, 20% by mass or less, 10% by mass or less, 5% by mass or less, 3% by mass or less, 1% by mass or less, or 0.5% by mass or less.

[0027] If the tablet composition according to this embodiment contains zinc gluconate, commercially available products such as "Helxus Zn" (manufactured by Fuso Chemical Industry Co., Ltd.) can be used as zinc gluconate. If the tablet composition according to this embodiment contains zinc gluconate, the zinc gluconate content is preferably 0.01% by mass or more, 0.05% by mass or more, 0.1% by mass or more, 0.5% by mass or more, 1% by mass or more, 3% by mass or more, 5% by mass or more, or 7% by mass or more, based on the total amount of the tablet composition, and also preferably 10% by mass or less, 8% by mass or less, 5% by mass or less, 3% by mass or less, or 1% by mass or less.

[0028] The tablet composition according to this embodiment may further contain various additives, as long as they do not impair the effects of the present invention. Specific examples of such additives include, for example, excipients, binders, disintegrants, lubricants, coating agents, colorants, flavoring agents, odor masking agents, oils and fats, emulsifiers, thickeners, fragrances, and preservatives.

[0029] Excipients are not limited to sugars, but include sugars, sugar alcohols, polysaccharides, and silicic acids. Examples of sugars include lactose, sucrose, glucose, sucrose (sugar), isomerized sugar, glucose, fructose, palatinose, trehalose, lactose, xylose, and oligosaccharides (fructooligosaccharides, lactulose, etc.). Examples of sugar alcohols include sorbitol, xylitol, erythritol, lactitol, maltitol, palatinose, reduced starch syrup, reduced maltose syrup, glycerin, propylene glycol, and mannitol. Examples of polysaccharides include starch, crystalline cellulose, and dextrins such as dextrin, maltodextrin, and indigestible dextrin. Examples of silicic acids include light anhydrous silicic acid and silicon dioxide.

[0030] If the tablet composition contains an excipient, the amount of the excipient may be 10% or more by mass, 20% or more by mass, 30% or more by mass, 40% or more by mass, 45% or more by mass, 50% or more by mass, 55% or more by mass, 60% or more by mass, 65% or more by mass, 70% or more by mass, 75% or more by mass, 80% or more by mass, or 90% or more by mass, based on the total amount of the tablet composition, and may be 95% or less by mass, 85% or less by mass, 80% or less by mass, 75% or less by mass, 70% or less by mass, 60% or less by mass, 40% or less by mass, or 30% or less by mass.

[0031] Examples of binders include water, ethanol, propanol, simple syrup, glucose solution, starch solution, gelatin solution, cellulose, carboxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxypropyl starch, methylcellulose, ethylcellulose, carboxymethylcellulose calcium, and polyvinylpyrrolidone. Examples of disintegrants include dried starch, agar powder, and stearate monoglyceride.

[0032] Examples of lubricants, though not limited to them, include talc, stearates (calcium stearate, magnesium stearate, etc.), borax, and polyethylene glycol. Stearates are preferred as lubricants.

[0033] If the tablet composition contains a lubricant, the amount of the lubricant may be 0.01% by mass or more, 0.1% by mass or more, 0.5% by mass or more, 0.8% by mass or more, or 1% by mass or more, based on the total amount of the tablet composition, and may be 5% by mass or less, 4% by mass or less, 3% by mass or less, or 2% by mass or less.

[0034] Coating agents include titanium dioxide, water-soluble polymer compounds, and sugars. Water-soluble polymer compounds include celluloses such as hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxymethylcellulose, methylcellulose, and ethylcellulose; gum arabic, carboxyvinyl polymer, povidone, polyethylene glycol, polyvinyl alcohol, and polyacrylic acid. Sugars include monosaccharides, polysaccharides of disaccharide or higher (sugar (granulated sugar, etc.), lactose, maltose, xylose, isomerized lactose, etc.), sugar alcohols (palatinite, sorbitol, lactitol, erythritol, xylitol, reduced starch syrup, maltitol, mannitol, etc.), corn syrup, isomerized sugars, oligosaccharides, sucrose, trehalose, and reduced starch syrup (reduced starch hydrolysates).

[0035] Examples of flavoring agents include sugars, sugar alcohols / polyhydric alcohols, acidulants, sweeteners, fruit juices, and orange peel.

[0036] Examples of sugars used as flavoring agents include sucrose (sugar), isomerized sugar, glucose, fructose, palatinose, trehalose, lactose, xylose, and oligosaccharides (fructooligosaccharides, lactulose, etc.). Examples of sugar alcohols and polyhydric alcohols used as flavoring agents include sorbitol, xylitol, erythritol, lactitol, maltitol, palatinose, reduced starch syrup, reduced maltose syrup, glycerin, and propylene glycol.

[0037] Examples of acidulants used as flavoring agents include citric acid, lactic acid, malic acid, and tartaric acid. Examples of sweeteners used as flavoring agents include aspartame, stevia, acesulfame potassium, and sucralose. Examples of fruit juices used as flavoring agents include lemon juice, orange juice, berry juice, peach juice, and acerola juice.

[0038] Examples of oils and fats include safflower oil, grape seed oil, sunflower oil, olive oil, corn oil, sesame oil, soybean oil, rapeseed oil, perilla oil, and rice bran oil. Examples of emulsifiers include sucrose fatty acid esters, glycerin fatty acid esters, and lecithin. Examples of thickeners include carrageenan, xanthan gum, guar gum, pectin, and locust bean gum.

[0039] Examples of flavorings include fruit flavors such as grape, apple, peach, acerola, citrus, and berry flavors, as well as vanilla and black tea flavors.

[0040] The content of these additives is not particularly limited; for example, it may be 0.001% by mass or more and 98% by mass or less based on the total amount of the tablet composition.

[0041] The moisture content of the tablet composition according to this embodiment is 5% by mass or less based on the total amount of the tablet composition in order to reduce the degree of abrasion of the tablet composition. Here, the moisture content of the tablet composition can be measured using an infrared moisture meter (for example, "FD-720", manufactured by Kett Scientific Research Institute Co., Ltd.). The moisture content of the tablet composition can also be measured in its state before tableting, for example, by targeting the powder composition before tableting.

[0042] From the viewpoint of further enhancing the effects of the present invention, the moisture content of the tablet composition is preferably 4.8% by mass or less, 4.6% by mass or less, 4.4% by mass or less, 4.2% by mass or less, 4% by mass or less, or 3.8% by mass or less, based on the total amount of the tablet composition. The moisture content of the tablet composition may be 0.5% by mass or more, 1% by mass or more, 1.5% by mass or more, 2% by mass or more, 2.5% by mass or more, or 3% by mass or more, based on the total amount of the tablet composition.

[0043] The shape of the tablet composition is not particularly limited and may be, for example, round (also called round tablets or ball tablets), oval (also called caplet tablets), elliptical (also called oval tablets), triangular, pentagonal, hexagonal, or spherical, or other shapes such as ring-shaped, flower-shaped, star-shaped, or heart-shaped.

[0044] The shape of the tablet composition is preferably circular, oval, or elliptical, and more preferably circular. A circular, oval, or elliptical tablet composition refers to a substantially cylindrical tablet composition whose planar shape is circular, oval, or elliptical.

[0045] Figure 1 is a schematic diagram showing a tablet composition according to one embodiment. The tablet composition 1 in Figure 1 has a circular shape in plan view and has a thickness T in a direction perpendicular to the circular surface. In Figure 1, the thickness direction of the tablet composition 1 is the Z-axis direction, one direction perpendicular to the Z-axis direction is the X-axis direction, and the directions perpendicular to the Z-axis direction and the X-axis direction are the Y-axis direction. The tablet composition 1 in Figure 1 has a shape in which the thickness in the Z-axis direction increases toward the center (there is a bulge), but this bulge is not required, and the tablet may have a shape with a concave shape toward the center.

[0046] If the tablet composition 1 is a caplet tablet or an oval tablet, the planar shape of the tablet composition 1 in Figure 1 will be oval or elliptical.

[0047] If the tablet composition 1 is a round tablet, the diameter D1 in the X-axis direction of the tablet composition 1 is preferably 5 mm or more, 7 mm or more, 8 mm or more, or 9 mm or more, and also preferably 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, 10 mm or less, 9 mm or less, or 8 mm or less.

[0048] When the tablet composition 1 is a caplet tablet or an oval tablet, the diameter D1 in the X-axis direction corresponds to the major axis and is preferably 7 mm or more, 8 mm or more, 10 mm or more, 12 mm or more, or 14 mm or more, and also preferably 20 mm or less, 18 mm or less, 16 mm or less, or 15 mm or less.

[0049] If the tablet composition 1 is a round tablet, the diameter D2 in the Y-axis direction of the tablet composition 1 is preferably 5 mm or more, 7 mm or more, 8 mm or more, or 9 mm or more, and also preferably 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, 10 mm or less, 9 mm or less, or 8 mm or less.

[0050] When the tablet composition 1 is a caplet tablet or an oval tablet, the diameter D2 in the Y-axis direction corresponds to the minor axis and is preferably 3 mm or more, 5 mm or more, 7 mm or more, or 8 mm or more, and also preferably 12 mm or less, 10 mm or less, 8 mm or less, 7 mm or less, or 6 mm or less.

[0051] The ratio of diameter D1 to diameter D2 in tablet composition 1 (diameter D1 / diameter D2) is preferably 0.8 or higher, more preferably 0.9 or higher, even more preferably 0.95 or higher, and also preferably 1.2 or lower, more preferably 1.1 or lower, and even more preferably 1.05 or lower, when tablet composition 1 is a round tablet. This ratio may also be 1 when tablet composition 1 is a round tablet.

[0052] The ratio of diameter D1 to diameter D2 (diameter D1 / diameter D2) in the tablet composition 1 is preferably greater than 1, more preferably 1.3 or more, 1.5 or more, or 1.7 or more when the tablet composition 1 is a caplet tablet or an oval tablet, and is also preferably 2.3 or less, 2 or less, 1.9 or less, 1.7 or less, 1.5 or less, or 1.4 or less.

[0053] The thickness T of the tablet composition 1 is preferably 3 mm or more, 4 mm or more, or 5 mm or more from the viewpoint of further enhancing the effect of the present invention, and is also preferably 12 mm or less, 10 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, or 4 mm or less. The thickness T in the present specification is a value measured at the thickest part of the tablet composition 1.

[0054] The volume of the tablet composition 1 is preferably 0.1 cm 3 or more, 0.2 cm 3 or more, 0.3 cm 3 or more, or 0.35 cm 3 or more, and is also preferably 2.5 cm 3 or less, 2 cm 3 or less, 1.5 cm 3 or less, 1 cm 3 or less, 0.8 cm 3 or less, 0.6 cm 3 or less, or 0.5 cm 3 or less. The volume of the tablet composition means the sum of the volumes of the respective tablet compositions when the container-containing tablet composition in the present embodiment contains two or more tablet compositions, and means the volume of a single tablet composition when only one tablet composition is contained.

[0055] From the viewpoint of further enhancing the effects of the present invention, the mass of tablet composition 1 is preferably 100 mg or more, 200 mg or more, 300 mg or more, 350 mg or more, 400 mg or more, 450 mg or more, or 500 mg or more. Alternatively, the mass of tablet composition 1 is preferably 1500 mg or less, 1200 mg or less, 1000 mg or less, 900 mg or less, 800 mg or less, 750 mg or less, 700 mg or less, 650 mg or less, 600 mg or less, 550 mg or less, 500 mg or less, 450 mg or less, or 400 mg or less. In this embodiment, the mass of tablet composition 1 refers to the sum of the masses of each tablet composition if the containerized tablet composition contains two or more tablets of the tablet composition, and refers to the mass of one tablet of the tablet composition if it contains only one tablet of the tablet composition.

[0056] The dosage form of tablet composition 1 may be a plain tablet, effervescent tablet, matrix tablet, orally disintegrating tablet, chewable tablet, lozenge, etc. These tablet compositions may be coated with sugar, film, or other coatings.

[0057] The tablet composition according to this embodiment can be formed by known methods, for example, by molding methods such as direct powder compression (direct compression method) or granule compression (indirect tableting method). The molding method for the tablet composition is preferably direct powder compression.

[0058] The containerized tablet composition according to this embodiment has a volume of 30 cm³ in order to reduce the degree of abrasion of the tablet composition. 3 The product is sealed in the following container. From the viewpoint of further enhancing the effects of the present invention, the volume of the container is preferably 28 cm³. 3 Below, 25cm 3 Below, 20cm 3 Below, 18cm 3 Below, 15cm 3 Below, 13cm 3 Below, 10cm 3 Below, 9cm 3 Below, 8cm 3 Below, 7cm 3 Below, 6cm 3 Below, 5cm 3 Below, or 4cm 3The following applies: The volume of the container is 1 cm³. 3 Over 1.5cm 3 Above 2cm 3 Over 2.5cm 3 or more, or 3cm 3 The above may be sufficient. In this specification, the volume of a container means its internal volume.

[0059] The shape of the container according to this embodiment may be a special shape such as a cylindrical, prismatic, spherical, hemispherical, or concrete shape. The shape of the container is preferably cylindrical or prismatic, and more preferably cylindrical. Containers of these shapes are preferably composed of a container body having an opening and a lid covering the opening.

[0060] The material of the container according to this embodiment is not particularly limited and may be made of resin, glass, etc., but from the viewpoint of further enhancing the effects of the present invention, preferably at least a part of the container is made of resin. In this case, for example, at least one of the bottom surface and the side surface of the container may be made of resin, preferably the bottom surface and the side surface are made of resin. If the container is a container consisting of a container body having an opening and a lid that covers the opening, the container body may be made of resin and the lid may be made of a material other than resin (metal, paper, etc.). Alternatively, the entire container, including the top surface, bottom surface and side surface, may be made of resin.

[0061] Examples of resins used to form the container include polypropylene, polyethylene terephthalate, polyethylene, polystyrene, polycarbonate, and polycyclohexylene dimethylene terephthalate. Polypropylene is preferred as the resin used to form the container. The container may be formed using only one or more of these resins.

[0062] In the containerized tablet composition according to this embodiment, the container may contain one or more tablets of the above-described tablet composition, but preferably only one tablet is contained within it.

[0063] In the containerized tablet composition according to this embodiment, the void volume of the container after the tablet composition has been sealed in the container is preferably 29 cm³. 3 Below, 25cm 3 Below, 23cm 3 Below, 20cm 3 Below, 18cm 3 Below, 15cm 3 Below, 13cm 3 Below, 10cm 3 Below, 9cm 3 Below, 8cm 3 Below, 7cm 3 Below, 6cm 3 Below, 5cm 3 Below, or 4cm 3 The following applies. Furthermore, the void volume of the container is 0.5 cm³. 3 More than 1cm 3 Above 2cm 3 or more, or 2.5 cm 3 The above is sufficient. The void volume of the container in this specification is the value calculated by the following formula (1). Void volume (cm 3 ) = Volume of container - Volume of tablet composition...(1)

[0064] In the containerized tablet composition according to this embodiment, the porosity of the container after the tablet composition has been sealed in the container is preferably 99% by volume or less, 98% by volume or less, 97% by volume or less, 96% by volume or less, 95% by volume or less, 94% by volume or less, 93% by volume or less, 92% by volume or less, 91% by volume or less, or 90% by volume or less, and also preferably 60% by volume or more, 70% by volume or more, 75% by volume or more, 80% by volume or more, 85% by volume or more, 90% by volume or more, 91% by volume or more, 92% by volume or more, 93% by volume or more, or 94% by volume or more. The porosity of the container in this specification is a value calculated by the following formula (2). Porosity (volume %) = void volume / internal volume of container × 100 ... (2)

[0065] The containerized tablet composition according to this embodiment can be used as a pharmaceutical, quasi-drug, or food composition. Furthermore, the containerized tablet composition according to the above embodiment can also be used, for example, as a pharmaceutical preparation, a quasi-drug preparation, a food for specified health uses, a nutritional functional food, a food for the elderly, a food for special dietary uses, a food with functional claims, a health supplement, or a food preparation (e.g., confectionery tablets). In addition, the containerized tablet composition according to the above embodiment can also be used, for example, as a veterinary drug or a feed additive.

[0066] In the containerized tablet composition according to this embodiment, the dosage of the tablet composition is not particularly limited and can be appropriately set according to the type, condition, and age of the recipient. As an example of the dosage when the tablet composition contains ascorbic acid, the daily dose of ascorbic acid may be in the range of 1 mg or more, 10 mg or more, 50 mg or more, or 100 mg or more, or in the range of 3000 mg or less, 2000 mg or less, 1000 mg or less, 500 mg or less, 400 mg or less, 300 mg or less, or 200 mg or less.

[0067] An example of the dosage when the tablet composition contains zinc-containing yeast or zinc gluconate is that the daily dose of zinc may be in the range of 0.1 mg or more, 0.5 mg or more, 1 mg or more, 5 mg or more, 8 mg or more, 10 mg or more, or 13 mg or more, or it may be in the range of 50 mg or less, 40 mg or less, 30 mg or less, 20 mg or less, 10 mg or less, 5 mg or less, or 3 mg or less.

[0068] In another embodiment of the present invention, a method for reducing the abrasion of a tablet composition is provided, which includes sealing the tablet composition containing one or more selected from the group consisting of ascorbic acid, yeast, and zinc gluconate in a container, wherein the volume of the container is 30 cm³. 3 The following method is provided, wherein the moisture content of the tablet composition is 5% by mass or less.

[0069] Furthermore, in another embodiment of the present invention, a method for reducing the abrasion of a tablet composition is provided, comprising sealing a tablet composition containing one or more selected from the group consisting of ascorbic acid, yeast, and zinc gluconate in a container, wherein the moisture content of the tablet composition is 5% by mass or less, and the porosity of the container in which the tablet composition is sealed is 98% by volume or less.

[0070] Furthermore, in another embodiment of the present invention, a method for reducing the abrasion of a tablet composition is provided, which includes sealing a tablet composition containing one or more selected from the group consisting of ascorbic acid, yeast, and zinc gluconate in a container, wherein the moisture content of the tablet composition is 5% by mass or less, and the void volume of the container in which the tablet composition is sealed is 29 cm³. 3 The following method is provided.

[0071] These methods provide a way to reduce the degree of abrasion of a tablet composition in a container, particularly the degree of abrasion of the tablet composition due to shaking of the container.

[0072] In the methods according to each of the above embodiments, the specific aspects of the container and tablet composition, their physical properties, etc., can be the same as those described above for the containerized tablet composition. [Examples]

[0073] The present invention will be described in more detail below using examples, but the present invention is not limited to the following examples.

[0074] <Abrasion resistance test of tablet compositions containing ascorbic acid> [Preparation of tablet composition] (Manufacturing Examples 1-3) 120 mg (21.8% by mass) of ascorbic acid ("Japanese Pharmacopoeia Ascorbic Acid," manufactured by Fuso Chemical Industries, Ltd.), 55 mg (10% by mass) of lactose ("Pharmatose® 100M," manufactured by DFE Pharma), and 6.6 mg (1.2% by mass) of calcium stearate ("Japanese Pharmacopoeia Calcium Stearate," manufactured by NOF Corporation) as a lubricant were measured out, and the remaining amount was used as an excipient indigestible dextrin ("Reduced Indigestible Dextrin Fibersol 2H," manufactured by Matsutani Chemical Industry Co., Ltd.), resulting in a total of 550 mg of powdered composition. The moisture content of this powdered composition was adjusted by humidification, water addition, or drying. Three types of powdered compositions with different moisture content were prepared using this method, and were designated as powdered composition a, powdered composition b, and powdered composition c, respectively. The moisture content of each composition after moisture content adjustment was measured using an infrared moisture meter FD-720 (manufactured by Kett Scientific Research Institute Co., Ltd.). The moisture content of powder composition a was 7.24% by mass, powder composition b was 4.36% by mass, and powder composition c was 3.62% by mass.

[0075] Powder composition a, powder composition b, and powder composition c were each compressed using a tabletop tablet molding machine (HANDTAB-200, manufactured by Ichihashi Seiki Co., Ltd.) under a compression pressure of 10kN to produce the resulting tablet compositions (round tablets, 1cm in diameter, 0.5cm thick, 0.4cm in volume). 3 A tablet composition was obtained using powder composition a, the tablet composition obtained using powder composition b was designated as the tablet composition of Production Example 1, the tablet composition obtained using powder composition b was designated as the tablet composition of Production Example 2, and the tablet composition obtained using powder composition c was designated as the tablet composition of Production Example 3.

[0076] (Manufacturing examples 4 and 5) A tablet composition without ascorbic acid was prepared using a similar method. The amounts of lactose and calcium stearate added were the same as in production examples 1 to 3 above, and the remainder was used as indigestible dextrin to prepare a powder composition. Subsequently, the moisture content was adjusted using the same method as above to obtain powder composition d and powder composition e. When the moisture content of each composition was measured, the moisture content of powder composition d was 5.89% by mass, and the moisture content of powder composition e was 3.97% by mass.

[0077] Tablet compositions were prepared using powder composition d and powder composition e under the same conditions as described above. The tablet composition obtained using powder composition d was designated as the tablet composition according to Production Example 4, and the tablet composition obtained using powder composition e was designated as the tablet composition according to Production Example 5.

[0078] Before the shaking test, the mass of the tablet compositions according to manufacturing examples 1 to 5 was measured.

[0079] [Shaking test of tablet composition] The tablet compositions according to manufacturing examples 1 to 5 are placed in a small resin container with a lid (container body: polypropylene, lid: high-density polyethylene, shape: cylindrical, diameter: 2.1 cm, height: 2 cm, container volume: 6.93 cm³). 3 One tablet was placed in each container. In addition, the tablet compositions according to Manufacturing Examples 2-3 and Manufacturing Example 5 were placed in a large glass container with a lid (No. 5 bottle, shape: roughly cylindrical, base diameter: 3.5 cm, height: 6.5 cm, container volume: 50 cm³). 3 One tablet was placed in each container. The void volume and void ratio when each tablet composition was placed in a small or large container are shown in Table 1.

[0080] [Table 1]

[0081] Small containers containing the tablet composition were placed in a shaker (KM Shaker V-DX, manufactured by Iwaki Sangyo Co., Ltd.) and shaken for 10 minutes or 70 minutes at a speed of 100. Similarly, large containers containing the tablet composition were shaken for 10 minutes under the same conditions.

[0082] [Calculates degree of wear] The tablet composition was removed from the container after shaking, and its mass was measured. The degree of abrasion of the tablet composition was then calculated according to the following formula (3). Abrasion degree (%) = (Mass of tablet composition before shaking - Mass of tablet composition after shaking) / Mass of tablet composition before shaking × 100 ... (3)

[0083] [evaluation] The relative abrasion values ​​of the tablet compositions for each manufacturing example were calculated, with the abrasion value of the tablet composition for Manufacturing Example 5 (without ascorbic acid, moisture content 3.97% by mass) set to 1. The results are shown in Figure 2. Figure 2(a) shows the results after the tablet composition was sealed in a small container and shaken for 10 minutes, and Figure 2(b) shows the results after the tablet composition was sealed in a large container and shaken for 10 minutes.

[0084] As shown in Figure 2(a), when comparing the abrasion of the tablet compositions according to Production Example 4 and Production Example 5, which do not contain ascorbic acid, there was almost no change in abrasion even when the moisture content of the tablet composition was reduced to 5% by mass or less. However, when comparing Production Examples 1 to 3, which are tablet compositions with added ascorbic acid, it was found that the abrasion decreased when the moisture content was reduced to 5% by mass or less. Furthermore, when comparing Production Example 5 (without ascorbic acid) and Production Example 3 (with ascorbic acid), which have similar moisture content, it can be seen that the tablet composition of Production Example 3, which contains ascorbic acid, exhibits lower abrasion.

[0085] Furthermore, as shown in Figures 2(a) and 2(b), regarding the degree of abrasion of the tablet composition according to Production Example 2 containing ascorbic acid, it can be seen that the relative value to the degree of abrasion of Production Example 5 is smaller when the tablet composition is sealed in a small container (Figure 2(a)) compared with when it is sealed in a large container (Figure 2(b)). This trend was similar for the tablet composition according to Production Example 3, which had a different moisture content. In other words, it was found that for tablet compositions containing ascorbic acid with a moisture content of 5% by mass or less, sealing them in a small container results in a lower degree of abrasion after shaking than sealing them in a large container.

[0086] On the other hand, regarding the abrasion of the tablet composition according to Production Example 1, which contains ascorbic acid but has a moisture content of more than 5% by mass, the relative value to the abrasion of Production Example 5 was larger when the tablet composition was sealed in a small container (Figure 2(a)) compared with when it was sealed in a large container (Figure 2(b)). From this, it was found that when a tablet composition containing ascorbic acid is sealed in a small container, the abrasion actually increases when the moisture content of the tablet composition exceeds 5% by mass. However, this problem can be solved by keeping the moisture content of the tablet composition at 5% by mass or less, and the abrasion when sealed in a small container can be reduced.

[0087] Figure 3 shows the results of sealing the tablet compositions in small containers and shaking them for 70 minutes. It shows the relative abrasion values ​​of Production Examples 2 and 3 (with ascorbic acid) when the abrasion of the tablet composition of Production Example 5 (without ascorbic acid) is set to 1. As shown in Figure 3, even when shaken in small containers for 70 minutes, the abrasion of the tablet compositions of Production Examples 2 and 3, which contain ascorbic acid and have a moisture content of 5% by mass or less, is smaller than that of the tablet composition of Production Example 5, which does not contain ascorbic acid.

[0088] As shown above, the results in Figures 2 and 3 indicate that by sealing a tablet composition containing ascorbic acid with a moisture content of 5% by mass or less in a small container, the degree of abrasion caused by shaking of the container can be reduced.

[0089] <Abrasion resistance test of tablet compositions containing yeast or zinc gluconate> The above tests showed that when a tablet composition with a moisture content of 5% by mass or less was sealed in a small container, the degree of abrasion of the tablet composition could be reduced. Therefore, we replaced ascorbic acid with another component and conducted similar tests to confirm how much the degree of abrasion of the tablet composition could be improved.

[0090] [Preparation of tablet composition] (Manufacturing examples 6, 7) 14.5 mg (2.64% by mass) of zinc-containing yeast ("OMEY-ZN-10," manufactured by Omnica Co., Ltd.), 55 mg of lactose (10% by mass), and 6.6 mg of calcium stearate (1.2% by mass) as a lubricant were measured out, and the remaining amount was used as indigestible dextrin as an excipient, to obtain a total of 550 mg of powdered composition. The moisture content was adjusted in the same manner as above to prepare powdered composition f and powdered composition g with different moisture content. When the moisture content of each composition was measured, the moisture content of powdered composition f was 5.7% by mass, and the moisture content of powdered composition g was 4.57% by mass.

[0091] Tablet compositions were prepared using powder composition f and powder composition g under the same conditions as described above. The tablet composition obtained using powder composition f was designated as the tablet composition of Production Example 6, and the tablet composition obtained using powder composition g was designated as the tablet composition of Production Example 7.

[0092] (Manufacturing examples 8, 9) 10.1 mg of zinc gluconate ("Helsius Zn," manufactured by Fuso Chemical Industries, Ltd.) (1.84% by mass), 55 mg of lactose (10% by mass), and 6.6 mg of calcium stearate (1.2% by mass) as a lubricant were measured out, and the remaining amount was used as indigestible dextrin as an excipient, to obtain a total of 550 mg of powdered composition. The moisture content was adjusted in the same manner as above to prepare powdered composition h and powdered composition i with different moisture content. When the moisture content of each composition was measured, the moisture content of powdered composition h was 5.6% by mass, and the moisture content of powdered composition i was 4.62% by mass.

[0093] Tablet compositions were prepared using powder composition h and powder composition i under the same conditions as described above. The tablet composition obtained using powder composition h was designated as the tablet composition according to Production Example 8, and the tablet composition obtained using powder composition i was designated as the tablet composition according to Production Example 9.

[0094] [Shaking test of tablet composition] The tablet compositions according to Production Examples 6-9 and Production Examples 4-5 described above were placed one tablet per container in the aforementioned small and large resin containers with lids. The void volume and void ratio when the tablet composition was placed in the small or large container were the same as those in Table 1 described above. The small and large containers containing the tablet composition were then shaken for 10 minutes under the same conditions as in the above-described test.

[0095] [Measurement and evaluation of wear and tear] The tablet compositions were removed from the small or large containers after shaking, and the degree of abrasion was determined for each according to the same method as described above. Then, the ratio of the degree of abrasion of the manufacturing example with a moisture content of 5% by mass or less to the degree of abrasion of the manufacturing example with a moisture content of 5% by mass was calculated according to the following formulas (4) to (6), and this was defined as the degree of abrasion improvement rate (%). The wear improvement rate (%) for manufacturing example 7 = Wear degree of manufacturing example 7 / Wear degree of manufacturing example 6 × 100 ... (4) The percentage improvement in wear rate for manufacturing example 9 (%) = Wear rate of manufacturing example 9 / Wear rate of manufacturing example 8 × 100 ... (5) The rate of improvement in wear degree for manufacturing example 5 (%) = Wear degree of manufacturing example 5 / Wear degree of manufacturing example 4 × 100 ... (6)

[0096] Figure 4 shows the ratio of the wear improvement rates of Production Example 7 and Production Example 9, with the wear improvement rate of Production Example 5 set to 1. Figure 4(a) shows the results of sealing the tablet composition in a small container and shaking it for 10 minutes, and Figure 4(b) shows the results of sealing the tablet composition in a large container and shaking it for 10 minutes.

[0097] As shown in Figure 4(a), in the tablet compositions containing yeast or zinc gluconate (Production Examples 7 and 9), the improvement rate of abrasion when the moisture content of the tablet composition was changed from more than 5% by mass to 5% by mass or less was greater than the improvement rate of abrasion when the moisture content of the tablet composition was changed from more than 5% by mass to 5% by mass or less in the tablet composition without additives (Production Example 5). In other words, it was found that by including yeast or zinc gluconate in the tablet composition, the improvement rate of abrasion when the moisture content of the tablet composition was changed from more than 5% by mass to 5% by mass or less can be increased.

[0098] Furthermore, comparing Figure 4(a) and Figure 4(b), the relative improvement rate of abrasion in Production Example 7, which had yeast added, was greater when the test was conducted using small containers than when the test was conducted using large containers. Similarly, the relative improvement rate of abrasion in Production Example 9, which had zinc gluconate added, was also greater when the test was conducted using small containers than when the test was conducted using large containers. In other words, it was found that packaging tablet compositions containing yeast or zinc gluconate in small containers, rather than in large containers, further improved the abrasion rate achieved by reducing the moisture content to 5% by mass or less.

[0099] Tables 2 to 5 below describe examples of formulations of the containerized tablet composition of the present invention. In these formulation examples as well, the moisture content of the tablet composition is adjusted to 5% by mass or less, and the volume is 30 cm³. 3 By sealing the tablet composition in the following small containers, the degree of abrasion is reduced.

[0100] [Table 2]

[0101] [Table 3]

[0102] [Table 4]

[0103] [Table 5] [Explanation of symbols]

[0104] 1…Tablet composition.

Claims

1. A containerized tablet composition comprising a container and a tablet composition sealed in the container, The volume of the container is 30 cm³. ３ The following: The tablet composition contains one or more selected from the group consisting of ascorbic acid, yeast, and zinc gluconate. A tablet composition in a container, wherein the moisture content of the tablet composition is 5% by mass or less.

2. A containerized tablet composition comprising a container and a tablet composition sealed in the container, The void ratio of the container is 98% by volume or less. The tablet composition contains one or more selected from the group consisting of ascorbic acid, yeast, and zinc gluconate. A tablet composition in a container, wherein the moisture content of the tablet composition is 5% by mass or less.

3. A containerized tablet composition comprising a container and a tablet composition sealed in the container, The void volume of the aforementioned container is 29 cm³. ３ The following: The tablet composition contains one or more selected from the group consisting of ascorbic acid, yeast, and zinc gluconate. A tablet composition in a container, wherein the moisture content of the tablet composition is 5% by mass or less.

4. The container-packaged tablet composition according to any one of claims 1 to 3, wherein at least a portion of the container is made of resin.

5. The containerized tablet composition according to any one of claims 1 to 3, wherein the content of the ascorbic acid derivatives is 10% by mass or more based on the total amount of the tablet composition.

6. The container-packaged tablet composition according to any one of claims 1 to 3, wherein the yeast contains zinc.

7. The container-packaged tablet composition according to any one of claims 1 to 3, wherein the shape of the tablet composition is circular.

8. The container-packaged tablet composition according to any one of claims 1 to 3, wherein only one tablet of the tablet composition is enclosed.

9. A method for reducing the abrasion of a tablet composition, The method involves enclosing the tablet composition containing one or more selected from the group consisting of ascorbic acid, yeast, and zinc gluconate in a container. The volume of the container is 30 cm³. ３ The following: A method wherein the moisture content of the tablet composition is 5% by mass or less.

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