JP2022177811A - Film-coated tablet having display and method for producing the same - Google Patents

Abstract

To provide a film-coated tablet that achieves reduced abrasion in inkjet printing using a pigment ink or reduced bleeding in inkjet printing using a dye ink, and a method for producing the same.SOLUTION: A tablet according to an embodiment comprises an uncoated tablet and a film that coats at least part of the uncoated tablet. The film comprises a film base and silica. The film comprises, on its surface, a print or a pattern including an edible pigment or dye. The silica may be porous silica.SELECTED DRAWING: Figure 1

Description

An embodiment of the invention relates to a film-coated tablet with an indicia, or an embodiment of the invention relates to a method of manufacturing a film-coated tablet with an indicia.

In order to improve drug compliance and prevent medical malpractice, tablets with information such as the name of the active ingredient and its content directly displayed on the surface are widely used. Methods for displaying information on the surface of tablets include laser printing and ink printing. Ink printing has advantages over laser printing in terms of visibility and tunability of the ink color. In the past, roll-type gravure and offset printing were the mainstream, but there were problems with yield due to problems such as ink bleeding, fading, and poor transfer stains. It is

There are two types of inks used in inkjet printing: dye-based inks and pigment-based inks. Dye-based inks can be layered to create a wide variety of colors, but they have the disadvantage of being prone to bleeding. On the other hand, pigment-based inks are relatively less likely to bleed, but there is a problem that the colors cannot be superimposed and the print is rubbed due to external impact, finger oil, etc. (Patent Document 1 and Non-Patent Document 1).

As an attempt to solve the above problems, for example, Patent Document 1 proposes a method of suppressing print rubbing by including a polymer having a vinyl alcohol unit in the main chain or side chain in the coating layer. there is In addition, in Patent Document 2, in order to improve the printability and wear resistance of printing applied to the surface of a film-coated tablet, it is proposed to treat the surface with an aqueous solution containing polyethylene glycol before printing.

On the other hand, the polyvinyl alcohol-based base described in Patent Document 1 has strong stringiness and adhesiveness, so that the nozzle clogs during coating, and the coated tablet surface does not become smooth, resulting in poor appearance. A known problem is that solid preparations adhere to each other during coating (Patent Document 3).

Japanese Patent Application Laid-Open No. 2020-132600 Japanese Patent No. 4999329 JP 2013-253030 A

Masahiro Kitamura et al., "Evolution of Tablet Printing Technology (Part 1)", PHARMATECH JAPAN, Jiho Co., Ltd., 2013, Vol. 29, No. 9, p. 50-53

An object of the present invention is to solve the above problems, and to provide a film-coated tablet that suppresses rubbing in ink-jet printing using pigment-based inks or improves bleeding in ink-jet printing using dye-based inks. be one of Alternatively, in one embodiment, it is an object to provide a method for producing a film-coated tablet that suppresses rubbing in ink-jet printing using pigment-based ink or improves blurring in ink-jet printing using dye-based ink.

According to one embodiment of the present invention, an uncoated tablet and a film covering at least a part of the uncoated tablet are provided, the film comprises a film base and silica, and the film comprises an edible pigment or dye. A tablet is provided having a print or pattern on its surface comprising:

The silica may be porous silica.

The silica may be fine silica particles having a bulk density of 0.145 g/cm ³ or less.

It may contain more than 0% by weight and up to 10% by weight of silica relative to the film base.

It may contain more than 0 wt% and up to 50 wt% of silica relative to the film base.

According to one embodiment of the present invention, a film coating liquid containing a film base and silica is adhered to at least a portion of the uncoated tablet, solidified to form a film, and an edible pigment is coated on the surface of the film. Alternatively, a method for manufacturing tablets is provided, in which ink containing a dye is ejected to form a print or pattern.

The silica may be porous silica.

The silica may be fine silica particles having a bulk density of 0.145 g/cm ³ or less.

It may contain more than 0% by weight and up to 10% by weight of silica relative to the film base.

It may contain more than 0 wt% and up to 50 wt% of silica relative to the film base.

According to one embodiment of the present invention, there is provided a film-coated tablet with reduced rubbing in inkjet printing using pigment-based inks or improved blurring in inkjet printing with dye-based inks. Alternatively, according to one embodiment, there is provided a method for producing film-coated tablets with reduced rubbing in inkjet printing using pigment-based inks or improved blurring in inkjet printing with dye-based inks.

(a) is a perspective view showing a tablet 10 according to an embodiment of the present invention, (b) is a top view of the tablet 10, and (c) is a cross section of the tablet 10 taken along line segment AA' of (b). It is an end view. (a) is a perspective view showing a tablet 20 according to an embodiment of the present invention, (b) is a top view of the tablet 20, and (c) is a cross section of the tablet 20 taken along line segment AA' of (b). It is an end view. (a) is the tablet of Comparative Example 1 immediately after printing, (b) is the tablet of Comparative Example 1 after storage, (c) is the tablet of Example 1 immediately after printing, and (d) is storage Tablets of Example 1 below. (a) is the tablet of Comparative Example 2 immediately after printing, (b) is the tablet of Comparative Example 2 rubbed five times with a finger, (c) is the tablet of Example 2 immediately after printing, and (d ) is the tablet of Example 2 rubbed five times with the finger. (a) is the tablet of Example 3 immediately after printing, (b) is the tablet of Example 3 after five finger rubs, (c) is the tablet of Example 4 immediately after printing, (d) is the tablet of Example 4 after 5 finger rubs, (e) is the tablet of Example 5 immediately after printing, and (f) is the tablet of Example 5 after 5 finger rubs. is a tablet of (a) is the tablet of Example 6 immediately after printing, (b) is the tablet of Example 6 after five finger rubs, (c) is the tablet of Example 7 immediately after printing, (d) is the tablet of Example 7 after five finger rubs. (a) is the tablet of Comparative Example 3 immediately after printing, (b) is the tablet of Comparative Example 3 after being rubbed five times with a finger, (c) is the tablet of Comparative Example 4 immediately after printing, (d) is the tablet of Comparative Example 4 after five finger rubs, (e) is the tablet of Comparative Example 5 immediately after printing, and (f) is the tablet of Comparative Example 5 after five finger rubs. is a tablet of (a) is the tablet of Comparative Example 6 immediately after printing, (b) is the tablet of Comparative Example 6 after being rubbed five times with a finger, (c) is the tablet of Comparative Example 7 immediately after printing, (d) is the tablet of Comparative Example 7 after five finger rubs, (e) is the tablet of Comparative Example 8 immediately after printing, and (f) is the tablet of Comparative Example 8 after five finger rubs. is a tablet of (a) is the tablet of Comparative Example 9 immediately after printing and (b) is the tablet of Comparative Example 9 after five finger rubs. (a) is the tablet of Example 8 immediately after printing, (b) is the tablet of Example 8 after five finger rubs, (c) is the tablet of Example 9 immediately after printing, (d) is the tablet of Example 9 after five finger rubs.

As a result of studies by the present inventors, by placing silica, particularly porous silica, on the surface (printing surface) of the tablet, it is possible to suppress the rubbing of printing in inkjet printing using pigment-based ink, and dye-based ink It was found that ink bleeding in ink jet printing using can be improved. Suppression of print rubbing or improvement of print bleeding by containing silica in the film is proposed for the first time by the present invention, and is a novel approach that has never existed before.

Hereinafter, a tablet having a print according to the present invention and a method for producing the same will be described in detail. However, the printed tablet and the manufacturing method thereof according to the present invention should not be construed as being limited to the description of the embodiments and examples below.

FIG. 1(a) is a perspective view showing a tablet 10 according to one embodiment of the present invention. FIG. 1(b) is a top view of the tablet 10. FIG. FIG. 1(c) is a cross-sectional end view of tablet 10 taken along line AA' in FIG. 1(b). Tablet 10 with indicia has tablet 11 and indicia 15 disposed on surface 13 of tablet 11 . Tablet 11 includes uncoated tablet 1 and film 3 covering at least a portion of uncoated tablet 1 . The film 3 preferably covers the entire uncoated tablet 1 . A print 15a or a pattern 15b is arranged on the surface of the film 3 .

[Uncoated tablet]
In this embodiment, the uncoated tablet 1 may be a known disk-shaped, oval or rectangular tablet, and is not particularly limited. Moreover, the size of the uncoated tablet 1 is not particularly limited as long as the film 3 can be arranged on the uncoated tablet 1 . The active ingredient and additives contained in the uncoated tablet 1 may also be known active ingredients and pharmaceutically acceptable additives, and are not particularly limited. In addition, as the uncoated tablet 1, an immediate release tablet, an enteric coated tablet, an orally disintegrating tablet, a chewable tablet, an effervescent tablet, a dispersible tablet, a dissolving tablet, a troche tablet, a sublingual tablet, or a buccal tablet can be used. The uncoated tablet 1 may be a two-layer tablet, a multilayer tablet having three or more layers, or a dry-coated tablet.

Furthermore, the uncoated tablet 1 is not limited to pharmaceuticals, and may be nutritional supplements containing vitamins or the like, or tablet-like confectionery such as soda pop. Alternatively, the uncoated tablet 1 may be a tablet bath agent.

The manufacturing method of the uncoated tablet 1 is not particularly limited, and a known tablet manufacturing method can be used. As a method for producing the uncoated tablet 1, any of a wet granulation method, a dry granulation method and a direct compression method may be used.

[the film]
The film 3 according to this embodiment contains a film base and silica. Also, the film 3 may further comprise one or more additives selected from plasticizers, disintegrants, lubricants, flavoring agents, colorants and the like. Moreover, the coating liquid used to form the film 3 can contain a solvent for dissolving or dispersing these additives.

Porous silica is preferable as the silica contained in the film 3 . As used herein, “porous silica” means fine silica particles having a bulk density of 0.25 g/cm ³ or less. The porous silica contained in the film 3 is preferably silica fine particles of 0.05 g/cm ³ or more and 0.145 g/cm ³ or less, more preferably 0.05 g/cm ³ or more and 0.06 g/cm ³ or less of silica. Fine particles. Examples of porous silica include, but are not limited to, light anhydrous silicic acid, hydrous silicon dioxide, synthetic aluminum silicate, calcium silicate and magnesium aluminometasilicate.

The film base included in the film 3 is not particularly limited as long as it does not prevent the ink from being absorbed by the silica included in the film 3 . Examples of the film base included in the film 3 include lactose hydrate, white sugar, maltose, fructose, glucose, maltose, trehalose and dextrin, sugars such as pullulan, mannitol, maltitol, sorbitol, xylitol, erythritol and lactitol. Starches such as sugar alcohols, starches, pregelatinized starches and partially pregelatinized starches, celluloses such as hydroxypropyl cellulose, hypromellose, ethyl cellulose, carmellose and crystalline cellulose, polyvinyl alcohol, partially saponified polyvinyl acetate, polyvinyl alcohol, polyethylene glycol, At least one selected from graft copolymers and partially saponified copolymers of vinyl acetate, acrylic acid and methacrylic acid esters, and inorganic compounds such as anhydrous calcium hydrogen phosphate, calcium carbonate and calcium sulfate. It can be, but is not limited to.

Examples of plasticizers contained in the film 3 include low-molecular-weight compounds such as triethyl citrate, glycerin fatty acid ester, triacetin, propylene glycol, and glyceryl monostearate, and polyethylene glycol, polypropylene glycol, and copolymerization of ethylene glycol and lactide. At least one selected from polymers such as coalescing can be used.

As the disintegrant contained in the film 3, for example, at least one selected from crospovidone, sodium starch glycolate, croscarmellose sodium, low-substituted hydroxypropylcellulose, and the like can be used.

Lubricants contained in the film 3 include, for example, at least talc, starch, magnesium stearate, calcium stearate, sodium stearyl fumarate, boric acid, paraffin, cocoa butter, polyethylene glycol, leucine and sodium benzoate. One can be used.

At least one selected from erythritol, sodium saccharin, dipotassium glycyrrhizinate, stevia, thaumatin, citric acid, and the like can be used as the flavoring agent contained in the film 3, for example.

As the coloring agent contained in the film 3, for example, at least one selected from iron sesquioxide, yellow iron sesquioxide, aluminum lake, tar pigment, and the like can be used.

The content of the above additives contained in the film 3 is not particularly limited, and can be arbitrarily set within a range capable of forming a coating having desired properties. In addition, the film 3 can contain silica in an amount within a range in which a coating having desired properties can be formed and in which the print 15a or the pattern 15b can be stably arranged. In one embodiment, the film 3 may contain more than 0%, 50% or less, preferably 10% or less silica by weight relative to the film base. If the film base of the film 3 contains 100% by weight or more of silica, the film 3 separates from the uncoated tablet 1 and the display 15 cannot be arranged.

As the solvent contained in the coating liquid used to form the film 3, for example, water, alcohol such as ethanol or ethylene glycol, or a mixed solvent of water and alcohol can be used.

The method for preparing the coating liquid is not particularly limited, and the coating liquid can be prepared by dissolving or dispersing the above additives in a solvent. Alternatively, a film coating liquid containing silica may be adhered to at least a portion of the uncoated tablet 1 and solidified to form the film 3 .

[ink]
The ink used for arranging the print 15a or the pattern 15b is ink for inkjet printing, and is pigment-based ink or dye-based ink that can be used for pharmaceutical applications or food applications. The ink used to place the print 15a or pattern 15b contains edible pigments or dyes. Thus, the print 15a or pattern 15b contains edible pigments or dyes.

Pigment-based inks can contain, for example, edible pigments, water, lower alcohols, dispersants and plasticizers.

Examples of edible pigments include carbon black, food red No. 2 aluminum lake, food red No. 3 aluminum lake, food red No. 40 aluminum lake, food yellow No. 4 aluminum lake, food yellow No. 5 aluminum lake, and food blue No. 1. At least one selected from aluminum lake, food blue No. 2 aluminum lake, ferric oxide, yellow ferric oxide, black ferric oxide and the like can be used.

As the lower alcohol, for example, at least one selected from methanol, ethanol, 1-propanol, 2-propanol, 2-methyl-1-propanol, 2-methyl-2-propanol, 1-butanol and 2-butanol can be used.

Examples of dispersants include polyvinyl alcohol/acrylic acid/methyl methacrylate copolymer, aminoalkyl methacrylate copolymer, hydroxypropylcellulose, polyvinylpyrrolidone, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinyl alcohol polyethylene glycol graft copolymer, and ethyl acrylate. - At least one selected from methyl methacrylate copolymer dispersions and the like can be used.

Examples of plasticizers include sesame oil, castor oil, cottonseed oil, soybean oil, olive oil, rapeseed oil, oleic acid, dimethylpolysiloxane/silicon dioxide mixture, medium-chain fatty acid triglycerides, triethyl citrate, triacetin, diethyl phthalate, and phthalate. At least one selected from dibutyl acid, butyl phthalyl butyl glycolate, and the like can be used.

The content of the edible pigment and the additive contained in the pigment-based ink can be arbitrarily adjusted as long as ink-jet printing is possible.

Dye-based inks include, for example, edible dyes, water, surface tension modifiers, wetting agents, water-soluble resins, organic amines, surfactants, pH modifiers, chelating agents, preservatives, viscosity modifiers, and antifoaming agents. etc.

Edible dyes include, for example, edible synthetic dyes such as azo dyes, triphenylmethane dyes, xanthene dyes and indigoid dyes, and edible natural dyes such as cochineal dyes, sodium copper chlorophyllin, cacao dyes and caramel dyes. etc. can be used.

Examples of surface tension modifiers include decaglyceryl caprylate, hexaglyceryl laurate, hexaglycerol oleate, condensed tetraglyceryl linolenate, fatty acid ester coconut palm, and decaglyceryl laurate having an HLB of 15 or less and At least one selected from decaglyceryl oleate having an HLB of less than 13 can be used.

At least one selected from propylene glycol, glycerin, and the like can be used as the humectant, for example.

The contents of the edible dye and the above-described additive contained in the dye-based ink can be arbitrarily adjusted within a range that enables inkjet printing.

In this embodiment, an inkjet printing method can be used as a method of placing the print 15a or the pattern 15b on the surface of the film 3 . Ink containing an edible pigment or dye can be ejected onto the surface of the film 3 to form a print 15a or a pattern 15b. In the present invention, by including silica, particularly porous silica, in the film 3 covering the tablet 1, the fixability of printing in inkjet printing using edible pigment-based ink is improved, and external impact and finger pressure are improved. It is possible to suppress rubbing of the print due to the oil content etc. In addition, by preventing the diffusion of the edible dye in the film 3 by adsorbing the edible dye to the silica, it is possible to improve the blurring of printing in inkjet printing using an edible dye-based ink. can be done.

For the purpose of improving the fixability of ink, there is known a technique of arranging a coat layer containing porous particles on the surface of paper for inkjet printing. However, it is necessary to use edible ink when printing on medical products and foods, but there are not many studies on the fixability and bleeding of the print in inkjet printing using edible ink. Most of the investigations are only about the ink, such as blending the binder with the ink. In tablets used as pharmaceuticals and foods, there are almost no examples of adding silica to the film from the viewpoint of film properties. It is usually used for prevention, and the combination of edible ink and silica contained in a film that coats tablets in order to solve problems that occur in inkjet printing was found for the first time in the present invention. It is.

[Modification of tablet]
In the above-described embodiment, an example in which silica is included in the film covering the uncoated tablet has been described, but by including silica in the uncoated tablet, it is possible to improve the fixability of printing and improve the bleeding of printing. .

FIG. 2(a) is a perspective view showing a tablet 20 according to one modification of the present invention. FIG. 2(b) is a top view of the tablet 20. FIG. FIG. 2(c) is a cross-sectional end view of tablet 20 taken along line AA' in FIG. 2(b). Tablet 20 with indicia has tablet 21 and indicia 25 disposed on surface 23 of tablet 21 . Print 25a or pattern 25b is arranged on the surface of tablet 21 .

In one embodiment, tablet 21 comprises silica, preferably porous silica. The definition of "porous silica" is as described above. In one embodiment, tablet 21 may contain greater than 0% and less than 5% silica by weight per tablet. Silica may be arranged throughout the tablet 21 or may have a concentration distribution such that a large amount of silica is arranged on the surface of the tablet 21 . Tablet 21 can also increase the hardness of the tablet by containing silica. In addition, a tablet 21 obtained by forming solid drug dispersion particles using porous silica as a carrier and compressing the particles can also be used.

[Uncoated tablet]
The uncoated tablets used in the following examples were produced by a known method.

[Example 1]
As Example 1, hypromellose (TC-5 (registered trademark) E, Shin-Etsu Chemical Co., Ltd.) 41.5 g, macrogol 6000 (NOF Corporation) 5.5 g, titanium oxide (NA61, Toho Titanium Co., Ltd.) 4 g , Talc (Crown Talc, Matsumura Sangyo Co., Ltd.) 4 g, light anhydrous silicic acid (Adsolider (registered trademark) 101, Freund Sangyo Co., Ltd., bulk density: 0.056 g / cm ³ ) 4 g, iron sesquioxide and yellow iron sesquioxide were dispersed in water to prepare the coating liquid of Example 1. Using a coating machine (HC-LABO20, Freund Corporation), 270 mg of uncoated tablets were coated with a coating liquid to obtain 281.8 mg of film-coated tablets of Example 1 containing 0.8 mg of silica per tablet. Obtained. In addition, in Example 1, 10% by weight of silica is contained with respect to the film base.

[Comparative Example 1]
A coating liquid of Comparative Example 1 was prepared in the same manner as in Example 1, except that light anhydrous silicic acid was not added. A 270 mg uncoated tablet was coated with the coating liquid in the same manner as in Example 1 to obtain a 281.0 mg film-coated tablet of Comparative Example 1.

Inkjet printing was performed on the film-coated tablets of Example 1 and Comparative Example 1 using a dye-based ink (Black No. 1, Qualicaps Co., Ltd.). The tablet of Comparative Example 1 immediately after printing is shown in FIG. 3(a), and the tablet of Example 1 is shown in FIG. 3(c). The tablets of Example 1 and Comparative Example 1 were stored at 25°C and 75% RH for 2 weeks. The tablet of Comparative Example 1 after storage is shown in FIG. 3(b), and the tablet of Example 1 is shown in FIG. 3(d).

In the tablet of Comparative Example 1, printing bleeding was observed due to storage under high humidity conditions. On the other hand, in the tablet of Example 1 containing silica in the film, no significant bleeding of printing was observed even after storage, demonstrating that silica exhibits an effect of suppressing bleeding.

[Example 2]
As Example 2, hypromellose (TC-5 (registered trademark) E, Shin-Etsu Chemical Co., Ltd.) 52.5 g, macrogol 6000 (NOF Corporation) 5 g, titanium oxide (NA61, Toho Titanium Co., Ltd.) 5 g, talc (Crown talc, Matsumura Sangyo Co., Ltd.) 5 g, light anhydrous silicic acid (Adsolider (registered trademark) 101, Freund Sangyo Co., Ltd., bulk density: 0.056 g / cm ³ ) 2.5 g are dispersed in water, 2 coating solutions were prepared. Using a coating machine (HC-LABO20, Freund Corporation), 366 mg of uncoated tablets were coated with a coating liquid to obtain 380.0 mg of film-coated tablets of Example 2 containing 0.5 mg of silica per tablet. Obtained. In addition, in Example 2, 5% by weight of silica is contained with respect to the film base.

[Comparative Example 2]
A coating liquid of Comparative Example 2 was prepared in the same manner as in Example 2, except that hypromellose was changed to 55 g without adding light anhydrous silicic acid. A 366 mg uncoated tablet was coated with the coating liquid in the same manner as in Example 2 to obtain a 380.0 mg film-coated tablet of Comparative Example 2.

Inkjet printing was performed on the film-coated tablets of Example 2 and Comparative Example 2 using a pigment-based ink (No. 101, black, Qualicaps Co., Ltd.). The tablet of Comparative Example 2 immediately after printing is shown in FIG. 4(a), and the tablet of Example 2 is shown in FIG. 4(c). The tablets of Example 2 and Comparative Example 2 were rubbed five times with the fingers. The tablet of Comparative Example 2 rubbed with a finger is shown in FIG. 4(b) and the tablet of Example 2 is shown in FIG. 4(d).

On the tablet of Comparative Example 2, it was found that most of the print was erased by rubbing with a finger. On the other hand, in the tablet of Example 2 containing silica in the film, it was found that the print remained legible even when rubbed with a finger, demonstrating that silica improves the fixability of the print.

[Example 3]
As Example 3, the silica was changed to colloidal silica. Hypromellose (TC-5 (registered trademark) E, Shin-Etsu Chemical Co., Ltd.) 54.5 g, Macrogol 6000 (NOF Corporation) 5 g, titanium oxide (NA61, Toho Titanium Co., Ltd.) 5 g, talc (Crown Talc, Matsumura Sangyo Co., Ltd.) and 0.5 g of colloidal silica (Silysia (registered trademark) 320, Fuji Silysia Chemical Co., Ltd., bulk density: 0.056 g/cm ³ ) were dispersed in water, and the coating liquid of Example 2 was prepared. prepared. Using a coating machine (HC-LABO20, Freund Corporation), 366 mg of uncoated tablets were coated with a coating liquid, and 380.0 mg of film-coated tablets of Example 3 containing 0.1 mg of silica per tablet were obtained. Obtained. In addition, in Example 3, 1% by weight of silica is contained with respect to the film base.

[Example 4]
A coating solution of Example 4 was prepared in the same manner as in Example 3, except that hypromellose was changed to 52.5 g and colloidal silica was changed to 2.5 g. In the same manner as in Example 3, 366 mg of uncoated tablets were coated with the coating liquid to obtain 380.0 mg of film-coated tablets of Example 4 containing 0.5 mg of silica per tablet. In addition, in Example 4, 5% by weight of silica is contained with respect to the film base.

[Example 5]
A coating liquid of Example 5 was prepared in the same manner as in Example 3, except that hypromellose was changed to 50 g and colloidal silica was changed to 5 g. In the same manner as in Example 3, 366 mg of uncoated tablets were coated with the coating liquid to obtain 380.0 mg of film-coated tablets of Example 5 containing 1.0 mg of silica per tablet. In addition, in Example 5, 10% by weight of silica is contained with respect to the film base.

[Example 6]
As Example 6, silica was changed to wet silica. Hypromellose (TC-5 (registered trademark) E, Shin-Etsu Chemical Co., Ltd.) 52.5 g, Macrogol 6000 (NOF Corporation) 5 g, titanium oxide (NA61, Toho Titanium Co., Ltd.) 5 g, talc (Crown Talc, Matsumura Sangyo Co., Ltd.) and 2.5 g of wet silica (Carplex (registered trademark) #80, Evonik Japan Co., Ltd., bulk density: 0.145 g/cm ³ ) were dispersed in water, and the coating liquid of Example 6 was prepared. prepared. Using a coating machine (HC-LABO20, Freund Corporation), 366 mg of uncoated tablets were coated with a coating liquid to obtain 380.0 mg of film-coated tablets of Example 6 containing 0.5 mg of silica per tablet. Obtained. In addition, in Example 6, 5% by weight of silica is contained with respect to the film base.

[Example 7]
As Example 7, silica was changed to hydrophilic fumed silica. Hypromellose (TC-5 (registered trademark) E, Shin-Etsu Chemical Co., Ltd.) 52.5 g, Macrogol 6000 (NOF Corporation) 5 g, titanium oxide (NA61, Toho Titanium Co., Ltd.) 5 g, talc (Crown Talc, Matsumura Sangyo Co., Ltd.) and 2.5 g of hydrophilic fumed silica (Aerosil (registered trademark) 200, Nippon Aerosil Co., Ltd., bulk density: 0.05 g/cm ³ ) were dispersed in water to prepare the coating liquid of Example 7. was prepared. Using a coating machine (HC-LABO20, Freund Corporation), 366 mg of uncoated tablets were coated with a coating liquid to obtain 380.0 mg of film-coated tablets of Example 7 containing 0.5 mg of silica per tablet. Obtained. In addition, in Example 7, 5% by weight of silica is contained with respect to the film base.

In the same manner as in Example 2, the film-coated tablets of Examples 3 to 7 were subjected to inkjet printing using a pigment-based ink (No. 101, Qualicaps Co., Ltd.). Figure 5(a) shows the tablet of Example 3 immediately after printing and Figure 5(b) shows the tablet of Example 3 after five finger rubs. Figure 5(c) shows the tablet of Example 4 immediately after printing and Figure 5(d) shows the tablet of Example 4 after five finger rubs. Figure 5(e) shows the tablet of Example 5 immediately after printing and Figure 5(f) shows the tablet of Example 5 after five finger rubs. Figure 6(a) shows the tablet of Example 6 immediately after printing and Figure 6(b) shows the tablet of Example 6 after five finger rubs. Figure 6(c) shows the tablet of Example 7 immediately after printing and Figure 6(d) shows the tablet of Example 7 after five finger rubs. In any of the examples, it was found that the print remained legible even when rubbed with a finger, and it was clarified that all silicas improve the fixability of the print.

[Example 8]
As Example 8, silica was changed to hydrous silicon dioxide. Hypromellose (TC-5 (registered trademark) E, Shin-Etsu Chemical Co., Ltd.) 14.7 g, Macrogol 6000 (NOF Corporation) 1.4 g, titanium oxide (NA61, Toho Titanium Co., Ltd.) 1.4 g, talc ( 1.4 g of crown talc, Matsumura Sangyo Co., Ltd.) and 0.7 g of hydrous silicon dioxide (Adsolider (registered trademark) 102, Freund Sangyo Co., Ltd., bulk density: 0.25 g/cm ³ ) were dispersed in water. 8 coating solutions were prepared. Using a coating machine (HC-LABO20, Freund Corporation), 366 mg of uncoated tablets were coated with a coating liquid, and 380.0 mg of film-coated tablets of Example 8 containing 0.5 mg of silica per tablet were obtained. Obtained. In addition, in Example 8, 5% by weight of silica is contained with respect to the film base.

[Example 9]
As Example 9, the content of colloidal silica in Example 3 was changed to 50% by weight based on the film base. Hypromellose (TC-5 (registered trademark) E, Shin-Etsu Chemical Co., Ltd.) 10.22 g, Macrogol 6000 (NOF Corporation) 1.4 g, titanium oxide (NA61, Toho Titanium Co., Ltd.) 1.4 g, talc ( Crown talc, Matsumura Sangyo Co., Ltd.) 1.4 g and colloidal silica (Sylysia (registered trademark) 320, Fuji Silysia Chemical Co., Ltd., bulk density: 0.056 g/cm ³ ) 5.18 g were dispersed in water and carried out. A coating solution of Example 9 was prepared. Using a coating machine (HC-LABO20, Freund Corporation), 366 mg of uncoated tablets were coated with a coating liquid, and 380.0 mg of film-coated tablets of Example 9 containing 3.7 mg of silica per tablet were obtained. Obtained.

For the film-coated tablets of Examples 8 and 9, ink-jet printing was performed in the same manner as in Example 2 using a pigment-based ink (No. 101, Qualicaps Co., Ltd.). Figure 10(a) shows the tablet of Example 8 immediately after printing and Figure 10(b) shows the tablet of Example 8 after five finger rubs. Figure 10(c) shows the tablet of Example 9 immediately after printing and Figure 10(d) shows the tablet of Example 9 after five finger rubs. In any of the examples, it was found that the print remained legible even when rubbed with a finger, and it was clarified that all silicas improve the fixability of the print. On the other hand, it was confirmed that the film-coated tablets of Example 8 had weaker print fixability than the film-coated tablets of other Examples. In addition, the film-coated tablet of Example 9 was found to have lower film properties than the film-coated tablets of other Examples.

[Comparative Example 3]
As Comparative Example 3, 30 g of hypromellose (TC-5 (registered trademark) E, Shin-Etsu Chemical Co., Ltd.), 2 g of macrogol 6000 (NOF Corporation), and 8 g of titanium oxide (NA61, Toho Titanium Co., Ltd.) were dispersed in water. Then, a coating liquid of Comparative Example 3 was prepared. Using a coating machine (HC-LABO20, Freund Corporation), 236 mg of uncoated tablets were coated with the coating liquid to obtain 244 mg of film-coated tablets. Furthermore, 0.2 g of Macrogol 6000 (NOF Corporation) was dissolved in 50 g of water to prepare an overcoating liquid of Comparative Example 3, and a coating machine (HC-LABO20, Freund Corporation) was used to coat 244 mg. The coated tablets were overcoated to obtain 244 mg of film-coated tablets of Comparative Example 3 containing a trace amount of Macrogol 6000 per tablet.

[Comparative Example 4]
As Comparative Example 4, 244 mg film-coated tablets of Comparative Example 4 containing a trace amount of propylene glycol per tablet were obtained in the same manner as in Comparative Example 3, except that Macrogol 6000 in the overcoating liquid was changed to propylene glycol. rice field.

[Comparative Example 5]
As Comparative Example 5, 1 244 mg of film-coated tablets of Comparative Example 5 containing traces of propylene glycol per tablet were obtained.

[Comparative Example 6]
As Comparative Example 6, a small amount of propylene glycol was added per tablet in the same manner as in Comparative Example 3, except that Macrogol 6000 in the overcoating liquid was changed to D-mannitol (Mannitol P, Mitsubishi Life Sciences Co., Ltd.). 244 mg of film-coated tablets of Comparative Example 6 were obtained.

[Comparative Example 7]
As Comparative Example 7, 244 mg per tablet containing a trace amount of propylene glycol was prepared in the same manner as in Comparative Example 3 except that Macrogol 6000 in the overcoating liquid was changed to lactose hydrate (Pharmatose (200M), DMV). A film-coated tablet of Comparative Example 7 was obtained.

[Comparative Example 8]
As Comparative Example 8, 244 mg containing a trace amount of propylene glycol per tablet was prepared in the same manner as in Example 3 except that Macrogol 6000 in the overcoating liquid was changed to hydroxypropyl cellulose (HPC-SSL, Nippon Soda). A film-coated tablet of Comparative Example 8 was obtained.

[Comparative Example 9]
As Comparative Example 9, 30 g of hypromellose (TC-5 (registered trademark) E, Shin-Etsu Chemical Co., Ltd.), 2 g of macrogol 6000 (NOF Corporation), and 8 g of titanium oxide (NA61, Toho Titanium Co., Ltd.) were dispersed in water. Then, a coating liquid of Comparative Example 8 was prepared. Using a coating machine (HC-LABO20, Freund Corporation), a 236 mg uncoated tablet was coated with a coating liquid, and a 244 mg film was obtained in the same manner as in Comparative Examples 3 to 8 except that no overcoating was performed. Got coated tablets.

The overcoating performed in Comparative Examples 3 to 8 is an operation performed when using a conventional roll type tablet printing machine as described in Patent Document 2, and also has the effect of improving the fixability of the ink. In Comparative Examples 3 to 9, a small amount of various additives were sprayed onto the film-coated tablets as an undercoating before printing, printing was performed with pigment ink (No. 101, Qualicaps Co., Ltd.) of an inkjet printer, and the fixability was evaluated. did. FIG. 7(a) shows the tablet of Comparative Example 3 immediately after printing, and FIG. 7(b) shows the tablet of Comparative Example 3 after five finger rubs. FIG. 7(c) shows the tablet of Comparative Example 4 immediately after printing, and FIG. 7(d) shows the tablet of Comparative Example 4 after five finger rubs. FIG. 7(e) shows the tablet of Comparative Example 5 immediately after printing, and FIG. 7(f) shows the tablet of Comparative Example 5 after being rubbed five times with a finger. FIG. 8(a) shows the tablet of Comparative Example 6 immediately after printing, and FIG. 8(b) shows the tablet of Comparative Example 6 after five finger rubs. FIG. 8(c) shows the tablet of Comparative Example 7 immediately after printing, and FIG. 8(d) shows the tablet of Comparative Example 7 after five finger rubs. FIG. 8(e) shows the tablet of Comparative Example 8 immediately after printing, and FIG. 8(f) shows the tablet of Comparative Example 8 after five finger rubs. Figure 9(a) shows the tablet of Comparative Example 9 immediately after printing and Figure 9(b) shows the tablet of Comparative Example 9 after being rubbed five times with a finger. In any of the comparative examples, when rubbed with a finger five times, the print was blurred and the characters became unrecognizable. In other words, it has become clear that the overcoating cannot suppress the rubbing of the pigment ink in the inkjet printer.

[Comparative Example 10]
As Comparative Example 10, the content of colloidal silica in Example 3 was changed to 100% by weight based on the film base. Hypromellose (TC-5 (registered trademark) E, Shin-Etsu Chemical Co., Ltd.) 7.7 g, Macrogol 6000 (NOF Corporation) 1.4 g, titanium oxide (NA61, Toho Titanium Co., Ltd.) 1.4 g, talc ( Crown talc, Matsumura Sangyo Co., Ltd.) 1.4 g and colloidal silica (Silysia (registered trademark) 320, Fuji Silysia Chemical Co., Ltd., bulk density: 0.056 g/cm ³ ) 7.7 g were dispersed in water and compared. A coating solution of Example 10 was prepared. Using a coating machine (HC-LABO20, Freund Corporation), 366 mg of uncoated tablets were coated with a coating liquid, and 380.0 mg of film-coated tablets of Comparative Example 10 containing 5.5 mg of silica per tablet were obtained. Obtained.

Regarding the film-coated tablets of Comparative Example 10, inkjet printing was attempted with a pigment-based ink (No. 101, Qualicaps Co., Ltd.) in the same manner as in Example 2. I couldn't.

[Sensory test]
For the film-coated tablets of Example 1 and the film-coated tablets of Comparative Example 1 described above, the presence or absence of ink bleeding was evaluated by visual sensory test by three testers. Specifically, 1 point was given to the film-coated tablet judged by the examiner to have no bleeding of the ink, and a total of 3 points by 3 people was evaluated as a full score. Table 1 shows the evaluation results.

From the results of Table 1 and the results of the sensory test, the tablets of Comparative Example 1 showed bleeding of printing, whereas the tablets of Example 1 containing silica in the film showed no bleeding of printing. However, it was found that silica exhibits an effect of suppressing bleeding.

Further, the film-coated tablets of Examples 2 to 8 and the film-coated tablets of Comparative Examples 2 to 9 described above were subjected to visual sensory tests by three testers to evaluate the identification rate of printed characters. Specifically, the average number of characters that could not be identified by three testers was obtained, and the identification rate of characters that could be identified was calculated from the number of printed characters. Table 2 shows the evaluation results.

From the results of Table 2, it was clarified from the results of the sensory test that any silica improves the print fixability in the film-coated tablets of Examples 2 to 9 containing silica in the film. On the other hand, the results of the sensory test also revealed that the film-coated tablets of Comparative Example 2 and the overcoatings of Comparative Examples 3 to 9 could not suppress the rubbing of the pigment ink in the inkjet printer.

1 uncoated tablet 3 film 10 tablet 11 tablet 13 surface 15 display 15a printing 15b pattern 20 tablet 21 tablet 23 surface 25 display 25a printing 25b pattern

Claims (10)

An uncoated tablet and a film covering at least part of the uncoated tablet,
the film comprises a film base and silica;
A tablet, wherein the film has a print or pattern containing an edible pigment or dye on its surface. 2. The tablet of claim 1, wherein said silica is porous silica. The tablet according to claim 1, wherein the silica is fine silica particles having a bulk density of 0.145 g/ ^cm3 or less. 4. The tablet according to any one of claims 1 to 3, comprising more than 0% and up to 10% by weight of silica relative to the film base. 4. The tablet according to any one of claims 1 to 3, comprising more than 0% and up to 50% by weight of silica relative to the film base. A film coating liquid containing a film base and silica is attached to at least a portion of the uncoated tablet and solidified to form a film,
A method for producing a tablet, comprising ejecting an ink containing an edible pigment or dye onto the surface of the film to form a print or pattern. 7. The method for producing a tablet according to claim 6, wherein said silica is porous silica. The method for producing a tablet according to claim 6, wherein the silica is fine silica particles having a bulk density of 0.145 g/ ^cm3 or less. 9. The method for producing a tablet according to any one of claims 6 to 8, comprising more than 0% by weight and 10% by weight or less of silica relative to the film base. 9. The method for producing a tablet according to any one of claims 6 to 8, comprising more than 0% by weight and 50% by weight or less of silica relative to the film base.

Images