White coating composition for solid preparation, white-coated solid preparation, and method for producing white-coated solid preparation

Abstract

To provide a white-coated solid preparation suitable for food use, having adequate whiteness and reduced adhesiveness, and being free of titanium dioxide, to provide a white coating composition usable for forming a coating layer of the white-coated solid preparation, and to provide a method for producing the white-coated solid preparation.SOLUTION: The present invention relates to a white coating composition for solid preparations, the composition containing hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, cornstarch, and water.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a composition for white coating a solid preparation, a white-coated solid preparation, a method for producing a white-coated solid preparation, and the like. [Background technology]

[0002] Tablets coated with a coating agent (coated tablets) are widely used in the fields of food, medicine, cosmetics, and the like. The white appearance of tablets is not limited to coated tablets, but is applied to various types of tablets, as it provides a sense of cleanliness to users. Coated tablets are produced by coating a core tablet (plain tablet) with a tablet coating composition (coating liquid). In the production of coated tablets with a white appearance (white-coated tablets), a white coating layer (coating layer) is formed on the surface of the plain tablet by treating the plain tablet with a tablet coating composition containing titanium dioxide (TiO2) or the like, thereby achieving a white coated tablet even if the plain tablet is non-white. However, in recent years, the use of titanium dioxide in food has been restricted in the EU, and therefore titanium dioxide-free white-coated tablets are desired. Furthermore, Test Example 2 of Patent Document 1 describes a film-coated tablet containing calcium lactate in addition to a film-coated tablet containing titanium oxide. In the production of these film-coated tablets containing calcium lactate, a coating liquid containing hydroxypropyl cellulose, calcium lactate, polyethylene glycol, and purified water is used as the tablet coating composition. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 3759949 Summary of the Invention [Problem to be solved by the invention]

[0004] The present inventors produced coated tablets using a titanium dioxide-free white coating composition containing calcium carbonate and checked the whiteness. The yellow color inherent in the plain tablets was not sufficiently suppressed, and the tablets were yellowish and had a weak white color (Comparative Example 3). Furthermore, when these coated tablets were left to stand at a humidity of 60% and a temperature of 25°C for 7 days, they were found to be highly adhesive, making them unsuitable for use as solid preparations.

[0005] On the other hand, when plain tablets were coated with a coating liquid consisting of hydroxypropyl cellulose (HPMC), calcium lactate, polyethylene glycol (PEG), and purified water, similar to the coating liquid described in Test Example 2 of Patent Document 1, coated tablets that were visually white were obtained. Furthermore, when these coated tablets were allowed to stand at a humidity of 60% and a temperature of 25°C for 7 days, no adhesion was observed (Comparative Example 2). However, because the use of this coating liquid and the PEG contained in the coated tablets in food applications is restricted, these coated tablets cannot be used in food applications.

[0006] An object of the present invention is to provide a white-coated solid preparation that can be used in food, has sufficient whiteness, is suppressed in adhesion, and is free of titanium dioxide.An object of the present invention is to provide a white coating composition that can be used to form a coating layer of the white-coated solid preparation.An object of the present invention is to provide a method for producing the white-coated solid preparation. [Means for solving the problem]

[0007] The present inventors have found that the above-mentioned problems can be solved by coating a solid preparation (preferably a tablet) with a white coating composition for a solid preparation, which contains hydroxypropylmethylcellulose, calcium lactate, hydroxypropylcellulose, and cornstarch, and have completed the present invention.

[0008] The present invention includes, for example, the following aspects. Section 1. A white coating composition for solid dosage forms comprising hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, corn starch, and water. Section 2. Item 1. The white coating composition according to Item 1, wherein the solid formulation is a tablet. Section 3. A white coated solid preparation comprising a solid preparation and a coating layer on the surface of the solid preparation, the coating layer containing hydroxypropylmethylcellulose, calcium lactate, hydroxypropylcellulose, and cornstarch. Section 4. Item 4. The white coated solid formulation according to Item 3, wherein the solid formulation is a tablet. Section 5. A method for producing a white-coated solid preparation, comprising spraying a white coating composition for a solid preparation, the composition containing hydroxypropylmethylcellulose, calcium lactate, hydroxypropylcellulose, cornstarch, and water, onto the surface of the solid preparation, and then drying the composition. Section 6. Item 6. The method for producing a white-coated solid preparation according to Item 5, wherein the drying temperature is 50 to 80°C. Section 7. Item 7. The method for producing a white-coated solid preparation according to Item 5 or 6, wherein the solid preparation is a tablet. [Effects of the Invention]

[0009] According to the present invention, it is possible to provide a white-coated solid preparation that can be used in foods, has sufficient whiteness, and is suppressed from being adhesive. According to the present invention, it is possible to provide a white coating composition that can be used to form a coating layer of the white-coated solid preparation. According to the present invention, it is possible to provide a method for producing the white-coated solid preparation. DETAILED DESCRIPTION OF THE INVENTION

[0010] As used herein, the phrase "comprising" is intended to encompass the phrases "consisting essentially of" and "consisting of."

[0011] In the numerical ranges described in stages in this specification, the upper or lower limit of a numerical range in a certain stage can be arbitrarily combined with the upper or lower limit of a numerical range in the same stage or in another stage. In addition, in the numerical ranges described in this specification, the upper or lower limit of the numerical range may be replaced with a value shown in an example or a value that can be unambiguously derived from an example.

[0012] In this specification, numerical values ​​connected with "to" mean a numerical range that includes the numerical values ​​before and after "to" as the lower and upper limits. For example, "1 to 10% by mass" is equivalent to "1% by mass or more and 10% by mass or less." In this specification, with regard to numerical ranges, "to" means equal to or greater than the leftmost numerical value and equal to or less than the rightmost numerical value. For example, "0.5 to 10% by mass" and "0.5% to 10% by mass" both mean "0.5% by mass or greater and 10% by mass or less." Furthermore, with regard to numerical ranges, "equal to or greater than" means "the same as or greater than," and "equal to or less than" means "the same as or less than." As used herein, "HPMC" means hydroxypropyl methylcellulose. As used herein, "HPC" means hydroxypropyl cellulose. As used herein, "Ca lactate" means calcium lactate. As used herein, "PEG" means polyethylene glycol.

[0013] (White coating composition for solid preparations) The present invention may be a white coating composition for solid preparations. The solid preparation may be a tablet, granule, powder, lozenge, capsule, gummy, or the like, with tablets being preferred. The composition of the present invention may be a composition for white coating a solid preparation, preferably containing hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, cornstarch, and water. The inclusion of hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch provides advantageous effects, such as the production of a white-coated solid preparation with high whiteness and reduced adhesion. The white coating composition of the present invention may be a white coating composition for a solid preparation for food use or a white coating composition for a solid preparation for pharmaceutical use, with a white coating composition for a solid preparation for food use being preferred, and a white coating composition for a tablet for food use being more preferred.

[0014] The white coating composition may be in the form of an aqueous liquid (e.g., an aqueous solution or dispersion), preferably an aqueous dispersion. This composition is preferably spray-applied onto a tablet (plain tablet) to be coated, and then dried to produce a white-coated solid formulation by coating the solid formulation.

[0015] In the white coating composition, the water content may be 65 to 98% by mass, preferably 72 to 96% by mass, more preferably 80 to 94% by mass, and even more preferably 87 to 93% by mass, based on the mass of the composition. A water content within this range is advantageous in that a coating with high whiteness can be formed, the composition has a viscosity suitable for spraying, the viscosity of the composition does not become too high, and drying after spraying is efficient, making it easy to suppress adhesion between solid preparations after coating, and drying time does not become too long because drying after spraying is efficient (hereinafter, these points are also collectively referred to as "formation of a coating with high whiteness").

[0016] The white coating composition may contain hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch. In the white coating composition, the total content of hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch may be 2 to 35% by mass, preferably 4 to 28% by mass, more preferably 6 to 20% by mass, and even more preferably 7 to 13% by mass, based on the mass of the composition. Having the total content within this range is advantageous in terms of forming a coating with high whiteness.

[0017] The white coating composition may contain hydroxypropyl methylcellulose. In the white coating composition, the hydroxypropyl methylcellulose has a kinematic viscosity of 1.0 to 10.0 mm. 2 / s, and 4.0 to 7.5 mm 2 The kinematic viscosity of hydroxypropyl methylcellulose can be determined by measuring the kinematic viscosity of a 2% by mass aqueous solution (20°C) by a capillary viscometer method.

[0018] The content of hydroxypropyl methylcellulose in the white coating composition may be 1.0 to 9.4% by mass, preferably 3.0 to 8.5% by mass, more preferably 4.0 to 7.5% by mass, and even more preferably 4.5 to 6.5% by mass, based on the mass of the composition. The content of hydroxypropyl methylcellulose in the white coating composition may be 10 to 93% by mass, preferably 30 to 85% by mass, more preferably 45 to 75% by mass, and even more preferably 45 to 65% by mass, based on the total mass of hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch. A content within the above range is advantageous in terms of forming a coating with high whiteness.

[0019] The white coating composition may contain calcium lactate.

[0020] The content of calcium lactate in the white coating composition may be 0.5 to 9% by mass, preferably 1.0 to 7.0% by mass, more preferably 1.5 to 5.0% by mass, and even more preferably 2.0 to 3.0% by mass, based on the mass of the composition. The content of calcium lactate in the white coating composition may be 5 to 88% by mass, preferably 10 to 70% by mass, more preferably 15 to 50% by mass, and even more preferably 20 to 30% by mass, based on the total mass of hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch. A content within the above range is advantageous in terms of forming a coating with high whiteness.

[0021] The white coating composition may contain hydroxypropyl cellulose. The inclusion of both hydroxypropylmethylcellulose and hydroxypropyl cellulose in the white coating composition provides the white coating composition with plasticity, improving moldability. The white coating composition may contain hydroxypropyl cellulose, and the viscosity of the hydroxypropyl cellulose may be 1.0 to 6.0 mPa·s, preferably 2.0 to 3.0 mPa·s. The viscosity of hydroxypropyl cellulose can be determined by measuring the viscosity of a 2% by mass aqueous solution (20°C) using a rotational viscometer (manufactured by Brookfield).

[0022] The content of hydroxypropyl cellulose in the white coating composition may be 0.1 to 8.5% by mass, preferably 0.3 to 6.0% by mass, more preferably 0.4 to 3.5% by mass, and even more preferably 0.5 to 1.0% by mass, based on the mass of the composition. The content of hydroxypropyl cellulose in the white coating composition may be 1 to 84% by mass, preferably 3 to 60% by mass, more preferably 4 to 35% by mass, and even more preferably 5 to 10% by mass, based on the total mass of hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch. A content within this range imparts plasticity to the white coating composition, which is advantageous in terms of forming a coating with high whiteness.

[0023] The white coating composition may contain cornstarch, which reduces adhesion of the white coating composition.

[0024] The cornstarch content in the white coating composition may be 0.01 to 8.4% by mass, preferably 0.1 to 6.5% by mass, more preferably 0.2 to 4.5% by mass, and even more preferably 0.3 to 2.5% by mass, based on the total mass of the composition. The cornstarch content in the white coating composition may be 0.1 to 84% by mass, preferably 1 to 65% by mass, more preferably 2 to 45% by mass, and even more preferably 3 to 25% by mass, based on the total mass of hydroxypropylmethylcellulose, calcium lactate, hydroxypropylcellulose, and cornstarch. A content within the above range is advantageous in that adhesion is suppressed.

[0025] In addition to hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, cornstarch, and water, the white coating composition may contain other ingredients within the range that does not impair the effects of the present invention. Examples of other ingredients include water-soluble coating substrates, sustained-release coating substrates, enteric coating substrates, calcium-containing substances, starch, plasticizers, and other additives commonly used in coating compositions, and these can be used in appropriate combinations.

[0026] Examples of water-soluble coating substrates include cellulose-based polymers other than hydroxypropyl cellulose and hydroxypropylmethylcellulose, such as methyl cellulose, ethyl cellulose, and methylhydroxyethyl cellulose; synthetic polymers such as polyvinyl acetal diethylaminoacetate, aminoalkyl methacrylate copolymer E (Eudragit E (trade name), Rohm Pharma), and polyvinylpyrrolidone; polysaccharides such as pullulan, carrageenan (a polymeric polysaccharide extracted from seaweed (red algae, Gigartinales) for thickening and gelling), hemilose (a polysaccharide found in plants), alginic acid, and mannitol; disaccharides such as sucrose; monosaccharides such as glucose; sugar alcohols such as sorbitol; and gelatin. These can be used in appropriate combinations.

[0027] Examples of sustained-release coating substrates include cellulose-based polymers other than hydroxypropyl cellulose and hydroxypropylmethyl cellulose, such as methyl cellulose, ethyl cellulose, and methylhydroxyethyl cellulose; and acrylic acid-based polymers such as ethyl acrylate-methyl methacrylate copolymer suspension (Eudragit NE (trade name), Rohm Pharma). These may be used in appropriate combinations.

[0028] Examples of enteric coating substrates include cellulose-based polymers such as hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, and carboxymethyl ethyl cellulose; and acrylic acid-based polymers such as methacrylic acid copolymer L (Eudragit L (trade name), Rohm Pharma) and methacrylic acid copolymer LD (Eudragit L-30D55 ​​(trade name), Rohm Pharma). These can be used in appropriate combinations. Cellulose-based polymers are preferred. When the white coating composition contains other components, the content of the other components may be 0.01 to 18% by mass, preferably 0.1 to 15% by mass, and more preferably 0.2 to 11% by mass, based on the total mass of the hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch. When the white coating composition contains other components, the content of the other components may be 0.1 to 94% by mass, preferably 1 to 85% by mass, and more preferably 2 to 75% by mass, based on the total mass of the hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch.

[0029] Examples of calcium-containing substances include inorganic calcium salts, organic calcium salts, calcium-containing compounds derived from minerals, calcium-containing compounds derived from natural products, and calcined products of calcium-containing compounds derived from natural products, and these can be used in appropriate combinations.

[0030] Inorganic calcium salts include calcium hydroxide, calcium oxide, calcium complexes, dolomite (CaMg(CO3)2), hydroxyapatite (Ca 10 (PO4)6(OH)2), calcium fluoride, calcium chloride, calcium bromide, calcium carbonate, calcium hydrogen carbonate, calcium phosphate, calcium hydrogen phosphate, calcium monohydrogen phosphate, calcium dihydrogen phosphate, calcium silicate, calcium sulfate, calcium hydrogen sulfate, and calcium nitrate, and these can be used in appropriate combinations.

[0031] Examples of organic calcium salts include calcium acetate, calcium citrate, calcium tartrate, calcium pantothenate, calcium gluconate, calcium succinate, calcium glycerophosphate, calcium saccharate, calcium stearate, and calcium ascorbate, and these can be used in appropriate combinations.

[0032] Mineral-derived calcium-containing substances include dolomite (CaMg(CO3)2), hydroxyapatite (Ca 10 (PO4)6(OH)2), sclerotium, gypsum, etc., which can be used in appropriate combinations.

[0033] Examples of calcium-containing substances derived from natural products include borey (derived from oysters), coral calcium (derived from coral), beef bone powder, fish bone powder, shell powder, eggshell, etc., and these can be used in appropriate combinations.

[0034] Examples of starch include wheat starch, potato starch, sweet potato starch, tapioca starch, sago starch, bracken starch, lotus root starch, and mung bean starch, and these can be used in appropriate combinations.

[0035] Examples of the plasticizer include propylene glycol, glycerins, triacetin, medium-chain fatty acid triglycerides, acetylglycerin fatty acid esters, triethyl citrate, and sorbitol, and these can be used in appropriate combinations.

[0036] (White coated solid preparation) The present invention may be a white-coated solid preparation coated with a white coating layer. The solid preparation may be a tablet, granule, powder, lozenge, capsule, gummy bear, etc., with tablets being preferred. Therefore, the white-coated solid preparation may be a white-coated tablet, white-coated granule, white-coated powder, white-coated lozenge, white-coated capsule, white-coated gummy bear, etc., with white-coated tablets being preferred. The white-coated tablet of the present invention may have a solid formulation and a coating layer containing hydroxypropylmethylcellulose, calcium lactate, hydroxypropylcellulose, and cornstarch on the surface of the solid formulation. This coating layer can typically be produced by spraying the white coating composition of the present invention onto the solid formulation and then drying it. The above description of the white coating composition can also be applied to the white-coated solid formulation. The white-coated solid formulation of the present invention may be a white-coated food solid formulation or a white-coated pharmaceutical solid formulation, with white-coated food solid formulations being preferred. The white-coated solid formulation of the present invention may exhibit advantageous effects such as high whiteness and reduced adhesion.

[0037] In the white-coated solid preparation, any solid preparation that can be used for coated solid preparations can be used without any particular limitation, and since the covering power of the coating layer is high, it may be a non-white (preferably yellow) solid preparation. The shape and size of the solid preparation depend on the dosage form, but may be the shape and size of a general solid preparation.

[0038] The individual contents of hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch in the coating layer can be determined by the individual contents of each component relative to the total mass of hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch in the above-mentioned white coating composition of the present invention.

[0039] The coating layer may contain other components in addition to hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, cornstarch, and water. When the coating layer contains other components, the content of the other components relative to the total mass of hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch in the white coating composition of the present invention can be applied.

[0040] (Manufacturing method of white coated solid preparations) The present invention may be a method for producing a white-coated solid preparation, which comprises spraying a white coating composition (preferably the white coating composition of the present invention) containing hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch onto the surface of a solid preparation, followed by drying. This production method produces a white-coated solid preparation having a solid preparation and a coating layer containing hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, and cornstarch on the surface of the solid preparation. The above descriptions regarding the white coating composition and white-coated solid preparations can also be applied to the method for producing a white-coated solid preparation.

[0041] In the step of spraying a white coating composition (preferably the white coating composition of the present invention) containing hydroxypropylmethylcellulose, calcium lactate, hydroxypropylcellulose, and cornstarch onto the surface of a solid preparation (preferably a tablet), a spray coating method using a sprayer that is generally used in methods for producing coated solid preparations can be applied.

[0042] The solid preparation having the surface sprayed with the tablet coating composition is subjected to a drying step. The drying temperature may be 0 to 100° C., preferably 50 to 80° C., and more preferably 58 to 70° C. A drying temperature within the above range is advantageous in that the white coated solid preparation produced has a high degree of whiteness.

[0043] The spray rate (spray liquid rate) of the white coating composition in the spray application step can be 0.1 to 10 g / min, preferably 0.5 to 7 g / min, and more preferably 1 to 4 g / min.

[0044] The production method of the present invention may be similar to the method of producing a coated tablet solid dosage form by general spray drying, except that the tablet coating composition of the present invention is used. The production method of the present invention can exhibit advantageous effects such as high whiteness of the produced white coated solid dosage form and suppressed adhesion. [Example]

[0045] The present invention will be described in more detail below with reference to examples, but is not limited to these. In the examples, the notation "%" simply means "% by mass." The materials, devices, etc. used in the following examples are as follows.

[0046] Hydroxypropyl methylcellulose: Metrolose® SE-06; Shin-Etsu Chemical Co., Ltd. Hydroxypropyl cellulose: CELNY-SSL; Nippon Soda Co., Ltd. Calcium lactate: Food additive calcium lactate; Showa Kako Co., Ltd. Glycerin: Food grade glycerin-S; New Japan Chemical Co., Ltd. Polyethylene glycol: Polyethylene Glycol 6000; Tokyo Chemical Industry Co., Ltd. Cornstarch: White Cornstarch; Oji Cornstarch Co., Ltd. Rotary tablet press: VERGO; Kikusui Seisakusho Tablet coating machine: DRC-200; Powrex Corporation Thermostatic bath: NST-800; Nagano Science Co., Ltd.

[0047] Examples 1 to 3 Model tablets (plain tablets) were coated with a white coating composition containing hydroxypropylmethylcellulose, calcium lactate, hydroxypropylcellulose, cornstarch, and water, and the appearance (including whiteness) and adhesion of the resulting white-coated tablets were evaluated (after leaving them at 60% humidity, 25°C, and standing for 7 days). Details are given below.

[0048] <Preparation of coating solution (tablet coating composition) and model tablets> The food ingredients in the amounts (mass percent concentration) shown in Table 1 were simply mixed to uniformly dissolve them, thereby preparing 250 g of an aqueous solution for coating. Model tablets (plain tablets) to be coated were produced by tableting a simple powder mixture consisting of maltitol, crystalline cellulose, tricalcium phosphate, sucrose fatty acid ester, and riboflavin using a rotary tablet press. Specifically, 0.8 kg of tricalcium phosphate, 4 kg of sucrose fatty acid ester, and 0.04 kg of riboflavin were mixed with an equal amount of maltitol and sieved through a No. 20 sieve. This sieved material, maltitol sieved through a No. 20 sieve (total amount of maltitol used: 47.16 kg), and crystalline cellulose were placed in a powder mixer (Bohle Container Mixer, Hiroshima Metal & Machinery Co., Ltd.) and mixed for 5 minutes at a mixing speed of 10 rpm and a chopper speed of 1200 rpm to produce a tableting raw material powder. The resulting tableting raw material powder was tableted using a rotary tablet press. The resulting tablets were yellow in color, had a hardness of 15 kgf, and weighed 285 mg per tablet.

[0049] <Manufacturing of coated tablets> Using a tablet coating machine, 200 g of tablets were spray-coated (spray application) with a target coating rate of 8%. Here, the coating rate refers to the percentage increase in the uncoated tablet mass after coating relative to the uncoated tablet mass before coating. The coating conditions were as follows: inlet air temperature: 60-64°C, exhaust air temperature: 40-47°C, drum rotation speed: 20 rpm, spray pressure: 0.1 MPa, and spray liquid rate: 1-4 g / min. The mass was checked periodically, and the coating endpoint was reached when the target coating rate was reached. From that point, the liquid spray was stopped, and the inlet air temperature was increased to 80°C for 20 minutes for finishing drying, bringing the tablet temperature to 60-65°C. After this, heating was stopped, and the tablet temperature was lowered by ventilation until it reached 40°C or below.

[0050] <Evaluation of whiteness> Regarding whiteness, three researchers (excluding the inventor) visually observed each coated tablet and judged it as either white or non-white (e.g., yellowish). Tablets judged as white by two or more people were rated as passing and marked with "◯" in Table 1, while other tablets were rated as failing and marked with "×" in Table 1. The uncoated tablets were yellow. The results are shown in Table 1.

[0051] <Adhesion test> Thirty tablets of each type of coated tablet were placed in a glass screw vial, and the open screw vial (Maruem screw vial No. 5, capacity 20 mL, diameter 27 mm) was placed in a thermostatic chamber and exposed to a temperature of 25°C and humidity of 60%. After one week, the screw vial was turned upside down and the number of coated tablets that fell out (number of uncoated tablets) was counted. A number of 30 coated tablets that fell out was evaluated as passing, and is recorded as "Good" in Table 1. A number of 0 to 29 coated tablets that fell out was evaluated as failing, and is recorded as "Poor" in Table 1. The results are shown in Table 1.

[0052] <Food compatibility> In Table 1, coated tablets that can be used for food applications are marked with "O" and those that cannot be used are marked with "X". Polyethylene glycol (PEG) cannot be used in food. Furthermore, although titanium dioxide is permitted for use in food in Japan, its addition to food is prohibited in the EU. For this reason, coated tablets containing titanium dioxide (Reference Example 1) are marked with "-" in Table 1.

[0053] Comparative Examples 1-2 Test Example 1 of Patent Document 1 describes that a white coating film can be obtained when calcium lactate is blended with hydroxypropyl methylcellulose at a ratio of 1.25% to 75%. Furthermore, Test Example 2 describes that a coating solution containing hydroxypropyl methylcellulose and calcium lactate in a mass ratio of 4:1 (i.e., 25% calcium lactate to hydroxypropyl methylcellulose) and polyethylene glycol 6000 equivalent to 10% of the combined mass is prepared, and that white film tablets can be obtained by coating this solution. However, although polyethylene glycol 6000 is a pharmaceutical additive, it is not approved for use in food applications. Therefore, hydroxypropyl cellulose, which is suitable for food applications, was used as a plasticizer instead of polyethylene glycol 6000 (Comparative Example 1). Specifically, coated tablets of Comparative Example 1 were prepared in the same manner as in Example 1 using the formulation shown in Table 1. Furthermore, coated tablets (Comparative Example 2) were prepared in the same manner as in Example 1 using the formulation shown as Comparative Example 2 in Table 1 as a model for the coating solution used in Test Example 1 of Patent Document 1. The resulting coated tablets were evaluated in the same manner as in Example 1. The results are shown in Table 1.

[0054] Comparative Example 3 Coated tablets were produced using a general coating agent that did not contain titanium dioxide. This coating agent contained hydroxypropyl methylcellulose, calcium carbonate, and glycerin in the amounts shown in Table 1. This coating agent was mixed with water to prepare a 10% by mass aqueous solution (coating composition). Using this aqueous solution, coated tablets were produced in the same manner as in Example 1, and the resulting coated tablets were evaluated. The results are shown in Table 1.

[0055] Reference example 1 Coated tablets were produced using a common coating agent containing titanium dioxide. This coating agent contained hydroxypropyl methylcellulose, titanium dioxide, and glycerin in the amounts shown in Table 1. This coating agent was mixed with water to prepare a 10% by mass aqueous solution (coating composition). Using this aqueous solution, coated tablets were produced in the same manner as in Example 1, and the resulting coated tablets were evaluated. The results are shown in Table 1.

[0056] [Table 1]

[0057] In all Examples, it was possible to produce white-coated tablets. Furthermore, in all Examples, defects such as peeling of the coating layer due to adhesion or color unevenness were not observed in the appearance of the white-coated tablets. On the other hand, the coated tablets of Comparative Example 3 were yellowish and had a weak white color, as the yellow color derived from the plain tablets was not sufficiently suppressed. In the adhesion test, no adhesion was observed in the formulation containing polyethylene glycol 6000 (Comparative Example 2) and the formulation containing cornstarch (Examples 1 to 3). On the other hand, adhesion of the coated tablets occurred in the formulation containing hydroxypropyl cellulose but not cornstarch (Comparative Example 1). Therefore, it was confirmed that adhesion can be suppressed by adding cornstarch. It was confirmed that the white coating compositions of Examples 1 to 3 do not contain titanium dioxide, can be used on food, and have the same adhesion as titanium dioxide-containing coating compositions and the same whiteness as evaluated by the above-mentioned whiteness test.

Claims

1. A white coating composition for solid dosage forms comprising hydroxypropyl methylcellulose, calcium lactate, hydroxypropyl cellulose, corn starch, and water.

2. The white coating composition according to claim 1, wherein the solid formulation is a tablet.

3. A white coated solid preparation comprising a solid preparation and a coating layer on the surface of the solid preparation, the coating layer containing hydroxypropylmethylcellulose, calcium lactate, hydroxypropylcellulose, and cornstarch.

4. 4. The white-coated solid dosage form according to claim 3, wherein the solid dosage form is a tablet.

5. A method for producing a white-coated solid preparation, comprising spraying a white coating composition for a solid preparation, the composition containing hydroxypropylmethylcellulose, calcium lactate, hydroxypropylcellulose, cornstarch, and water, onto the surface of the solid preparation, and then drying the composition.

6. The method for producing a white-coated solid preparation according to claim 5, wherein the drying temperature is 50 to 80°C.

7. The method for producing a white-coated solid preparation according to claim 5 or 6, wherein the solid preparation is a tablet.

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