Tablet manufacturing method

Abstract

To provide a manufacturing method of a tablet in which lack of identification information printed on a surface thereof is further suppressed.SOLUTION: A manufacturing method of a tablet 20 includes: a conveyance step of dropping the tablet 20 from a preprocessing step on a conveyance surface 24 in which the tablet 20 is conveyed and conveying the tablet 20; and a printing step of performing printing on a surface of the tablet 20 after the conveyance step. The conveyance step includes a first suction step of sucking powder separated from the surface of the tablet 20 dropped in the conveyance step.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a method for producing printed tablets. [Background technology]

[0002] Tablets are formed by compressing powder using a tablet press to have a predetermined size and shape. Tablets formed in this manner may have powder adhering to their surfaces. For example, Patent Document 1 discloses a powder removal device as a means for removing powder adhering to the tablet surface. The device has a cover attached to a transport case that transports tablets discharged from a tablet press downstream, a spray device installed inside the cover, and sprays high-pressure air onto the tablets in the transport case to remove the powder from the tablet surface. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Publication No. 11-290806 Summary of the Invention [Problem to be solved by the invention]

[0004] There was a concern that the powder removal device described in Patent Document 1 may not be able to sufficiently remove powder from the surface of tablets. The present inventors discovered that when printing is performed using ink on the surface of a tablet with powder adhering to its surface, the printed characters, symbols, or figures are particularly likely to be missing from the identification information.

[0005] An object of the present invention is to provide a method for producing tablets in which the identification information printed on the surface has fewer defects. [Means for solving the problem]

[0006] The present disclosure provides, for example, the following aspects.

[0007] [Aspect 1] The tablet manufacturing method includes a conveying step and a printing step. The conveying step involves dropping the tablet from a pre-treatment step onto a conveying surface for conveying the tablet. The conveying step involves conveying the tablet. The conveying step includes a first suction step. The first suction step involves sucking powder that has separated from the surface of the dropped tablet. The printing step involves printing on the surface of the tablet after the conveying step.

[0008] [Aspect 2] In the tablet manufacturing method according to the first aspect, the conveying step further includes a second suction step of sucking gas above the conveying surface from below the conveying surface.

[0009] [Aspect 3] In the tablet manufacturing method according to aspect 1 or 2, the printing step includes a third suction step in which the tablet is dropped from the conveying surface onto a printing conveying surface that conveys the tablet. In the third suction step, powder separated from the surface of the tablet is sucked in before printing is performed on the surface of the tablet.

[0010] [Aspect 4] In the tablet manufacturing method according to any one of Aspects 1 to 3, the printing step includes a powder removal step in which, before printing on the surface of the tablet, gas is blown onto a printing conveying surface that conveys the tablet in a direction opposite to the conveying direction, and powder that has separated from the surface of the tablet is sucked in.

[0011] [Aspect 5] In the tablet manufacturing method according to any one of Aspects 1 to 4, the pre-treatment step includes a mixing step, a granulation step, and a tableting step. The mixing step involves mixing magnesium oxide particles with an internal additive to obtain a mixture. The internal additive includes cellulose and / or a cellulose derivative. The granulation step involves granulating the mixture to form granules. The tableting step involves tableting the granules.

[0012] [Aspect 6] In the tablet production method according to aspect 5, in the tableting step, an external additive is added in addition to the granules. The external additive includes cellulose and / or a cellulose derivative. The cellulose and / or the cellulose derivative includes crystalline cellulose having an average particle size of 50 μm or less.

[0013] [Aspect 7] The tablet manufacturing apparatus comprises a first conveying lane and a second conveying lane. The first conveying lane has a conveying surface for conveying the tablets located below the discharge outlet of a hopper containing a plurality of tablets. The first conveying lane has a suction port connected to the conveying surface onto which the tablets drop from the hopper and for sucking in gas. The second conveying lane conveys the tablets supplied from the first conveying lane in a conveying direction. The second conveying lane has a printing unit for printing on the surfaces of the tablets.

[0014] [Aspect 8] In the tablet manufacturing apparatus according to aspect 7, the first conveying lane has an air vent formed therethrough in the thickness direction. The first conveying lane further has a second suction port. The second suction port is disposed on the opposite side of the conveying surface. The second suction port is connected to the air vent and sucks gas from above the conveying surface.

[0015] [Aspect 9] In the tablet manufacturing apparatus according to aspect 7 or 8, the second conveyor lane has a printing conveying surface that conveys the tablets, and is disposed below the conveying surface of the first conveyor lane. The second conveyor lane has a third suction port. The third suction port is connected to the printing conveying surface onto which the tablets fall from the conveying surface of the first conveyor lane, and sucks in gas.

[0016] [Aspect 10] In the tablet manufacturing apparatus according to any one of aspects 7 to 9, the second conveying lane has a powder removal section upstream of the printing conveying surface from the printing section. The powder removal section has a cover, a fourth suction port, and an outlet. The cover is provided facing the printing conveying surface. The fourth suction port and the outlet are provided on the cover. The fourth suction port and the outlet are arranged in order from upstream to downstream in the conveying direction. The fourth suction port sucks in gas. The outlet blows out gas. The outlet is open to the printing conveying surface in the opposite direction to the conveying direction. [Effects of the Invention]

[0017] According to the present invention, tablets can be obtained that have fewer defects in the identification information printed on the surface. [Brief explanation of the drawings]

[0018] [Figure 1] FIG. 1 is a front view schematically showing a manufacturing apparatus according to a first embodiment. [Figure 2] 2A and 2B are diagrams showing a powder removal unit of a manufacturing apparatus according to a first embodiment, in which FIG. 2A is a plan view and FIG. 2B is a schematic front cross-sectional view. [Figure 3] FIG. 2 is a schematic external view showing a tablet collection container of the manufacturing apparatus according to the first embodiment. [Figure 4] FIG. 10 is a schematic explanatory view showing a bucket lifter and a tablet buffering chute of a manufacturing apparatus according to a second embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0019] (First embodiment) [Tablet manufacturing equipment] A tablet manufacturing apparatus according to a first embodiment of the present invention will be described below with reference to the drawings. Fig. 1 is a front view schematically showing the manufacturing apparatus according to the first embodiment, and Fig. 2 is a view schematically showing the powder removal section of the manufacturing apparatus according to the first embodiment, with Fig. 2(A) being a plan view and Fig. 2(B) being a front cross-sectional view.

[0020] As shown in FIG. 1, the manufacturing apparatus 10 includes, in this order from upstream to downstream in the conveying direction F, a hopper 12, a first conveying lane 14, a second conveying lane 16, and a recovery unit 18. The hopper 12 stores a plurality of tablets 20 compressed in the pre-processing step. The hopper 12 has a discharge outlet 22 located vertically downward. The hopper 12 may have a feeder at the discharge outlet 22, although not shown.

[0021] The shape of the tablet 20 is not particularly limited. Examples of the tablet 20 include a disc, a lenticular shape, and a rod shape. When the tablet 20 has a discoid or lenticular shape, for example, the upper limit of the diameter can be 14 mm or less, or 10 mm or less, and the lower limit can be 5 mm or more, or 6 mm or more. The upper limit of the thickness of the tablet 20 is also not particularly limited. For example, the upper limit of the thickness of the tablet 20 can be 8 mm or less, or 7 mm or less, and the lower limit can be 3 mm or more, or 4 mm or more. Furthermore, the tablet 20 may have a shape including, for example, a cylindrical body and curved convex cap portions at the axial ends of the body. Furthermore, the shape of the tablet 20 in a plan view is not limited to a circular shape, and may be an elliptical shape or a polygonal shape.

[0022] The first conveying lane 14 has a conveying surface 24 that conveys the tablets 20. The conveying surface 24 is disposed vertically below the discharge port 22. The first conveying lane 14 includes a connecting pipe 26, a first suction port 28 provided in the connecting pipe 26, a conveying body 30 having the conveying surface 24, and a second suction port 32 provided in the conveying body 30.

[0023] The connecting pipe 26 connects the discharge outlet 22 of the hopper 12 to the conveying surface 24. The connecting pipe 26 is arranged so that the tablets 20 stored in the hopper 12 can fall from the discharge outlet 22 through the connecting pipe 26 onto the conveying surface 24 by their own weight. One axial end of the connecting pipe 26 is connected to the discharge outlet 22 of the hopper 12. The other axial end of the connecting pipe 26 opens toward the conveying surface 24.

[0024] The first suction port 28 sucks gas between the connecting pipe 26 and the conveying surface 24. The first suction port 28 is a cylindrical member, and one axial end of the first suction port 28 is connected to the conveying surface 24 via the connecting pipe 26. The other axial end of the first suction port 28 is connected to the suction pump 34 via piping. In this specification, the phrase "connected to the conveying surface" means that the suction port is open toward the conveying surface 24 so that gas above the conveying surface 24 can circulate. The phrase "connected to the conveying surface" means that the suction port may be in contact with or separated from the conveying surface 24. The first suction port 28 sucks gas from one end through the other end by the suction pump 34. In the case of FIG. 1, the first suction port 28 is provided to penetrate the connecting pipe 26, and one end is disposed within the connecting pipe 26.

[0025] The conveying body 30 conveys the tablets 20 discharged from the hopper 12 through the connecting pipe 26. The conveying body 30 can be configured using, for example, a belt conveyor or a vibrating feeder. The conveying body 30 shown in FIG. 1 is a vibrating feeder that conveys the objects in a linear direction by vibration. The conveying body 30 includes a receiving section 36 and a conveying section 38. The receiving section 36 is provided directly below the discharge port 22 of the hopper 12 in the vertical direction. The receiving section 36 receives the tablets 20 that have dropped from the discharge port 22 of the hopper 12. The conveying section 38 is disposed downstream of the receiving section 36 in the conveying direction F. The conveying section 38 has a plurality of vent holes 40 formed in the conveying surface 24 that penetrate in the thickness direction. The conveying section 38 can be made of, for example, a mesh, a punched metal, or a resin belt with through holes. The conveying section 38 may be inclined downward toward the downstream side. The conveying body 30 may generate powder from the surface of the tablet 20 due to the impact of the tablet 20 being discharged from the hopper 12. The conveying body 30 conveys the powder separated from the surface of the tablet 20 along with the tablet 20 on the conveying surface 24.

[0026] The second suction port 32 sucks powder on the conveying surface 24 away from the surface of the tablet 20. The second suction port 32 is arranged on the opposite side of the conveying surface 24 of the conveying body 30. The second suction port 32 is composed of a tubular member. One axial end of the second suction port 32 is connected to the air vent 40. The other axial end of the second suction port 32 is connected to the suction pump 34 via piping. The second suction port 32 sucks gas from one end through the other axial end by the suction pump 34. The second suction port 32 sucks gas on the conveying surface 24 downward. In this embodiment, the second suction port 32 is connected to the air intake port 33. The air intake port 33 covers the opposite side of the conveying surface 24.

[0027] The second conveyor lane 16 conveys the tablets 20 supplied from the first conveyor lane 14 while removing powder from the surface of the tablets 20. The second conveyor lane 16 prints on the surfaces of the tablets 20. The second conveyor lane 16 is arranged downstream of the first conveyor lane 14 in the conveying direction F. The second conveyor lane 16 includes a second conveyor 44. The second conveyor 44 has a printing conveying surface 42. The second conveyor 44 can be configured using, for example, a belt conveyor. The second conveyor 44 conveys the tablets 20 from upstream to downstream in the conveying direction F, passing through the second receiver 46, the powder removal unit 48, and the printing unit 50, respectively. The second conveyor 44 conveys the printed tablets 20 to the recovery unit 18. The recovery unit 18 recovers the conveyed tablets 20.

[0028] The print conveying surface 42 is disposed vertically below the conveying surface 24 of the first conveying lane 14. In other words, the print conveying surface 42 of the second receiving unit 46 is disposed below the conveying surface 24 on the downstream side of the first conveying lane 14.

[0029] The second receiving unit 46 removes powder that has detached from the surface of the tablet 20 due to the impact of dropping the tablet 20. The second receiving unit 46 has a third suction port 52 that sucks in gas on the print transport surface 42. The third suction port 52 is composed of a cylindrical member. The third suction port 52 has an opening at one axial end. One end of the third suction port 52 is disposed on the print transport surface 42, and the other axial end is connected to the suction pump 34. The third suction port 52 sucks in gas from one end through the other end by the suction pump 34. The second receiving unit 46 may have a receiving unit cover 54 that covers the print transport surface 42. In this embodiment, one end of the third suction port 52 is disposed perpendicular to the print transport surface 42. The third suction port 52 sucks in gas on the print transport surface 42 vertically upward.

[0030] Powder removal unit 48 removes powder remaining on print conveying surface 42. Powder removal unit 48 has a cover 58 provided facing print conveying surface 42, a fourth suction port 60, and an outlet 62. Powder removal unit 48 has fourth suction port 60 and outlet 62 provided in cover 58. Fourth suction port 60 and outlet 62 are arranged in this order from upstream to downstream in conveying direction F.

[0031] The cover 58 covers a predetermined area of ​​the printing conveying surface 42 so as to retain gas in that area. As shown in Figures 2(A) and 2(B), the cover 58 has a covering portion 64 and a guide portion 66. The covering portion 64 is a plate-shaped member provided opposite the printing conveying surface 42. In a plan view, the covering portion 64 has a tapered shape that protrudes toward the upstream side. In a front view, the covering portion 64 may have an inclined surface 68 that slopes downward from downstream to upstream. The guide portion 66 is plate-shaped and is provided integrally with the outer edge of the covering portion 64, protruding toward the printing conveying surface 42. As shown in Figure 2(B), a heightwise gap 70 that is shorter than the heightwise length of the tablet 20 is formed between the lower end of the guide portion 66 and the printing conveying surface 42. The guide portions 66 are provided on the outer edge of the covering portion 64 excluding at least the downstream end, i.e., on a pair of inclined upstream outer edges 72 on the upstream side and a pair of width-side outer edges 74 along the conveying direction F. As shown in FIG. 2(A), a widthwise gap 76 is formed between the cover 58 and the second conveying body 44 in the width direction. The maximum length of one tablet 20 in plan view is the diameter of the tablet 20 when the tablet 20 has a circular shape in plan view.

[0032] The fourth suction port 60 sucks gas trapped inside the cover 58 in the powder removal unit 48. The fourth suction port 60 is made of a cylindrical member. The fourth suction port 60 is located upstream of the cover 58. One axial end of the fourth suction port 60 is connected to the inside of the cover 58, and the other axial end is connected to the suction pump 34. The fourth suction port 60 sucks gas from one end through the other end by the suction pump 34. The number of fourth suction ports 60 is not limited to one as shown in FIG. 2(B). Two or more fourth suction ports 60 may be provided.

[0033] The blowout port 62 blows out gas to stir up powder remaining on the print transport surface 42. The blowout port 62 is located downstream of the fourth suction port. In the cases of FIGS. 2(A) and 2(B), the blowout port 62 is located at the downstream end of the cover 58. The blowout port 62 is composed of a cylindrical member. One axial end of the blowout port 62 opens in the opposite direction to the transport direction F relative to the print transport surface 42. The other axial end of the blowout port 62 is connected to an air compressor (not shown) through a pipe (not shown). The blowout port 62 blows out gas from one end that is supplied to the other end from the air compressor. The blowout port 62 blows out gas toward the print transport surface 42. The number of blowout ports 62 is not limited to two as shown in FIG. 2(A). The number of blowout ports 62 may be one, or three or more.

[0034] The printing unit 50 has, in order from upstream to downstream in the conveying direction F, an inspection camera 78 and a print head 80. The inspection camera 78 takes an image of the surface of the tablet 20. The inspection camera 78 is not particularly limited, but may be, for example, a CCD (Charge Coupled Device) camera or a CMOS (Complementary Metal Oxide Semiconductor) camera. The print head 80 may be, for example, an inkjet type.

[0035] The following description will be given taking ink used in inkjet printing as an example. For example, ink for inkjet printers contains a dye, water, ethanol, and a resin. The ink for inkjet printers may also contain other ingredients, such as a water-soluble high-boiling organic solvent, an emulsifier, a pH adjuster, a flavoring agent, and a preservative, as needed. It is preferable that all of the ink compositions are edible.

[0036] (dye) The coloring agent can be one or more selected from synthetic food coloring agents and natural food coloring agents. Examples of synthetic food coloring agents include tar-based coloring agents, natural coloring derivatives, natural synthetic coloring agents, and titanium dioxide. Examples of tar-based coloring agents include Food Red No. 2, Food Red No. 3, Food Red No. 40, Food Red No. 102, Food Red No. 104, Food Red No. 105, Food Red No. 106, Food Yellow No. 4, Food Yellow No. 5, Food Green No. 3, Food Blue No. 1, Food Blue No. 2, Food Blue No. 1 Aluminum Lake, 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 No. 5 Aluminum Lake, and Food Blue No. 2 Aluminum Lake. Examples of natural coloring agent derivatives include copper chlorophyll, copper chlorophyllin sodium, and norbixin potassium. Examples of natural synthetic pigments include β-carotene and riboflavin.

[0037] Examples of natural food dyes include plant charcoal pigments, anthocyanin pigments, carotenoid pigments, quinone pigments, flavonoid pigments, betaine pigments, monascus pigments, and other pigments derived from natural sources. Examples of anthocyanin pigments include red radish pigment, red cabbage pigment, red rice pigment, elderberry pigment, cowberry pigment, gooseberry pigment, cranberry pigment, salmonberry pigment, perilla pigment, sweet blueberry pigment, strawberry pigment, dark sweet cherry pigment, cherry pigment, hibiscus pigment, huckleberry pigment, grape juice pigment, grape skin pigment, blackcurrant pigment, blackberry pigment, blueberry pigment, plum pigment, watermelon pigment, boysenberry pigment, mulberry pigment, purple sweet potato pigment, purple corn pigment, purple yam pigment, raspberry pigment, redcurrant pigment, loganberry pigment, and other anthocyanin pigments. Carotenoid pigments include annatto pigment, gardenia yellow, and other carotenoid pigments.Quinone pigments include cochineal pigment, lithospermum root pigment, lac pigment, and other quinone pigments.Flavonoid pigments include safflower yellow, sorghum pigment, onion pigment, and other flavonoid pigments.Betaine pigments include beet red pigment.Monascus pigments include monascus pigment and monascus yellow pigment.Other pigments derived from natural products include turmeric pigment, gardenia blue pigment, gardenia red pigment, and spirulina blue pigment.

[0038] The content of the dye is preferably 0.1 to 10% by weight, more preferably 0.5 to 8% by weight, based on the total weight of the ink composition. If the content of the dye is less than 0.1% by weight, the printed color tends to be pale and visibility tends to be poor. If the content of the dye is more than 10% by weight, the ink viscosity increases, making it difficult to eject the ink normally, which tends to result in poor printing.

[0039] (ethanol) Ethanol is preferably, for example, naturally brewed fermented ethyl alcohol or sugarcane alcohol. The ethanol content is preferably 5 to 60 wt % and more preferably 10 to 40 wt % based on the total ink composition. If the ethanol content of the ink is less than 5 wt %, the ink tends to dry poorly. For example, if the ink takes more than 3 seconds to dry after printing, the ink may peel off or adhere to other tablets or conveyance surfaces during transport after printing, causing staining. Furthermore, if the surface tension of the ink is high, the printed ink is more likely to be repelled by the tablet surface. In other words, the ink does not wet and spread on the tablet surface, so it takes longer to dry, and the contact area with the tablet surface is small, so the adhesive strength tends to be weak. If the adhesive strength of the ink is weak, it may peel off when rubbed, even after 24 hours, for example. Furthermore, if the ethanol content of the ink is more than 60 wt %, there is a risk that the ink may dry and adhere to the inside or around the opening of the inkjet nozzle. If the ink dries and blocks the openings, there is a risk that ejection defects or deviations in the flight direction of the ejected ink may occur. If ejection defects or deviations in the flight direction of the ink occur, printing defects may occur.

[0040] (Water-soluble high-boiling organic solvent) The water-soluble high-boiling organic solvent can be used to prevent the nozzles of the inkjet head from drying out. Examples of the water-soluble high-boiling organic solvent include one or more selected from propylene glycol and glycerin. The content of the water-soluble high-boiling organic solvent is preferably 1 to 60 wt % and more preferably 2 to 55 wt % of the total ink composition. If the content of the water-soluble high-boiling organic solvent in the ink is less than 1 wt %, the ink may dry out in the inkjet nozzles, resulting in poor printing. If the content of the water-soluble high-boiling organic solvent in the ink is more than 60 wt %, the ink viscosity tends to be too high. If the ink viscosity is too high, the ink may not be ejected properly, resulting in poor printing.

[0041] (resin) If necessary, an edible resin can be added to the ink, such as one or more selected from the group consisting of shellac, gum arabic, starches, cellulose resin, vinyl acetate resin, and polyvinylpyrrolidone.

[0042] (emulsifier) The emulsifier may be one or more water-soluble emulsifiers selected from the group consisting of lecithin, glycerin fatty acid esters, sucrose fatty acid esters, sorbitan fatty acid esters, propylene glycol fatty acid esters, and polyoxyethylene sorbitan fatty acid esters. The emulsifier does not necessarily need to be incorporated into the ink. When incorporated into the ink, the emulsifier content is preferably 0.01 to 5 wt %, more preferably 0.1 to 2 wt %, based on the total ink composition. If the emulsifier content is less than 0.01 wt %, the ink surface tension tends to be too high. If the ink surface tension is too high, it may be difficult to form an appropriate meniscus at the nozzle opening. If the ink does not form a meniscus, the ink may not be ejected from the nozzle or may not land at the desired position, resulting in printing defects. Furthermore, if the emulsifier content is greater than 5 wt %, the ink may tend to thicken and precipitate over time. Ink may thicken or deposit, clogging the nozzles and causing printing defects.

[0043] (pH adjuster) A pH adjuster can be added to adjust the solubility and stability of the resin contained in the ink. Examples of pH adjusters that can be added to adjust the ink to an acidic state include acetic acid and citric acid. Examples of pH adjusters that can be added to adjust the ink to an alkaline state include ammonium carbonate.

[0044] For stirring in preparing the ink, for example, a magnetic stirrer, a propeller stirrer, or a commonly used stirrer can be used.

[0045] Furthermore, when preparing an ink containing a pigment such as a plant charcoal pigment, titanium dioxide, or aluminum lake, it is preferable to disperse the pigment. This dispersion treatment can be carried out using a dispersing machine. Examples of dispersing machines include a ball mill, a roll mill, a sand mill, and a bead mill.

[0046] The ink can be filtered by, for example, centrifugal filtration or filter filtration.

[0047] In the tablet manufacturing method of this embodiment, tablets compressed in the pretreatment step can be fed into the hopper 12 shown in FIG. 1 using a tablet collection container 82 shown in FIG. 3. In other words, the tablet collection container 82 is configured to store tablets 20 compressed by a tablet press (not shown) and to feed the tablets 20 into the hopper 12. The tablet collection container 82 has a container 84, a frame 86 that supports the container 84, and wheels 88 rotatably mounted on the frame 86. The container 84 has an inverted pyramid shape and has a discharge outlet 90 on its bottom. The container 84 has a butterfly valve 92 at the discharge outlet 90. The frame 86 has support posts 93 whose upper ends are mounted at the four corners of the container 84, and a connector 94 that connects the lower ends of the support posts 93 together. The tablet collection container 82 has wheels 88 rotatably mounted on the lower ends of the support posts 93. The tablet collection container 82 stores the tablets 20 compressed by the tablet press in a container 84. Thereafter, the tablet collection container 82 moves from the tableting process to the printing process and is placed above the hopper 12. Next, the tablet collection container 82 opens the butterfly valve 92 and dumps the tablets 20 in the container 84 into the hopper 12 through the discharge port 90. Note that the container 84 is not limited to being in an inverted pyramid shape, but may also be in an inverted cone shape.

[0048] [Tablet manufacturing method] A tablet manufacturing method to which the present invention is applied (hereinafter, sometimes simply referred to as a manufacturing method) will be described below. In the first embodiment, a method for manufacturing a tablet 20 using the manufacturing apparatus 10 of the first embodiment shown in Figures 1 and 2 will be described. In the following description, descriptions of configurations that overlap with the description of the manufacturing apparatus 10 will be omitted.

[0049] The manufacturing method of the first embodiment is a method of obtaining a printed tablet 20 by removing powder adhering to the surface of the tablet 20 from the compressed tablet 20 and then printing on the surface of the tablet 20. That is, the manufacturing method of the tablet 20 of the first embodiment comprises the following steps. (1) A conveying step in which the tablets 20 are dropped from the pre-treatment step onto a conveying surface 24 for conveying the tablets 20 and then conveyed. (2) A printing step of printing on the surface of the tablet 20 after the conveying step. (3) A first suction step of suctioning powder separated from the surface of the dropped tablet 20 in the conveying step. Furthermore, the transport step (1) will be described as including a second suction step (4) of suctioning gas above the transport surface 24 from below the transport surface 24. Furthermore, the printing step (2) will be described as including the following steps. (5) A third suction step in which the tablet 20 is dropped from the conveying surface 24 onto the printing conveying surface 42 that conveys the tablet 20, and powder separated from the surface of the tablet 20 is sucked in before printing is performed on the surface of the tablet 20. (6) A powder removal step in which, before printing on the surface of the tablet 20, gas is blown onto the print conveying surface 42 in the direction opposite to the conveying direction F, and powder separated from the surface of the tablet 20 is sucked in. The manufacturing method of the first embodiment includes a printing process step (7) of printing on the surface of the tablet 20 after the above steps (3) to (6).

[0050] The following will explain in order. In the pre-processing step, a plurality of tablets 20 formed by tableting powder are stored in the hopper 12. First, in the conveying step (1), a plurality of tablets 20 are discharged from the discharge port 22 of the hopper 12. The discharged tablets 20 pass through the connecting pipe 26 due to their own weight and fall randomly onto the conveying surface 24 of the receiving unit 36. When the tablets 20 are discharged from the hopper 12, they come into contact with other tablets 20. In addition, at least a portion of the powder adhering to the surface of the tablets 20 is separated from the surface of the tablets 20 due to the impact they receive from the conveying surface 24 after falling. The powder separated from the surface of the tablets 20 may fly up into the connecting pipe 26.

[0051] In the first suction step (3), the first suction port 28 sucks the gas in the connecting pipe 26 from one end, thereby sucking in the powder that has been stirred up into the connecting pipe 26. Therefore, the manufacturing method according to the first embodiment can more efficiently remove powder from the tablet 20, and can manufacture tablets 20 with less powder adhering to the surface.

[0052] Furthermore, the tablet 20 is transported from the receiving unit 36 ​​to the second transport lane 16 through the transport unit 38. Because the transport unit 38 is a vibrating feeder, the tablet 20 vibrates together with the transport unit 38. As a result, the tablet 20 is transported in the transport direction F, and at least a portion of the remaining powder adhering to the surface is detached from the surface of the tablet 20. The powder detached from the surface of the tablet 20 is transported in the transport direction F on the transport surface 24 together with the tablet 20.

[0053] In the second suction step (4), the second suction port 32 of the conveying section 38 sucks the gas on the conveying surface 24 from below the conveying surface 24 through the ventilation holes 40 formed in the conveying surface 24, thereby sucking in the powder on the conveying surface 24, particularly the powder present between the conveying surface 24 and the tablet 20. Therefore, the manufacturing method can prevent the powder that has once detached from the surface of the tablet 20 from adhering to the surface of the tablet 20 again.

[0054] The tablet 20 is then transported from the first transport lane 14 to the second transport lane 16. In the printing step (2), the printing transport surface 42 of the second transport lane 16 is located below the transport surface 24 of the first transport lane 14, so the tablet 20 falls from the transport surface 24 to the printing transport surface 42 of the second receiver 46 due to its own weight. Due to the impact that the tablet 20 receives from the printing transport surface 42 after falling, at least a portion of the remaining powder adhering to the surface of the tablet 20 may detach from the surface of the tablet 20 and fly up onto the printing transport surface 42 of the second receiver 46.

[0055] In the third suction step (5), the third suction port 52 sucks in the gas above the print conveying surface 42 of the second receiving unit 46, thereby sucking in the powder that has been blown up onto the print conveying surface 42 of the second receiving unit 46. Therefore, the manufacturing apparatus 10 of the first embodiment can more efficiently remove powder from the tablets 20. By providing the second receiving unit 46 with the receiving unit cover 54, the blown up powder can be prevented from scattering, and the powder can be more reliably sucked in from the third suction port 52.

[0056] Next, tablet 20 is further transported to powder removal section 48. In powder removal step (6), tablet 20 that has reached powder removal section 48 comes into contact with guide section 66 of cover 58, because height gap 70 is shorter than the height length of tablet 20, and moves in the width direction of print conveying surface 42, passing between cover 58 and second conveying body 44 in the width direction. In other words, tablet 20 does not enter cover 58 through height gap 70, and does not pass between cover 58 and print conveying surface 42.

[0057] The blowing port 62 blows gas toward the printing conveying surface 42 in the opposite direction to the conveying direction F. The gas blown toward the printing conveying surface 42 in the opposite direction to the conveying direction F causes the powder on the printing conveying surface 42 to float up from the printing conveying surface 42. As a result, the powder rises above the printing conveying surface 42 along with the blown gas, and some of the raised powder collides with the surface of the covering portion 64 on the printing conveying surface 42 side, causing the raised powder to accumulate within the cover 58. The fourth suction port 60 sucks in the gas within the cover 58, i.e., between the covering portion 64 and the printing conveying surface 42, thereby sucking in the powder that has risen above the printing conveying surface 42 and accumulated within the cover 58. Therefore, the manufacturing apparatus 10 separates the tablet 20 from the powder adhering to the printing conveying surface 42 and sucks in the powder adhering to the printing conveying surface 42, thereby preventing the powder that has separated from the surface of the tablet 20 from re-adhering to the surface of the tablet 20.

[0058] The powder removal unit 48 moves the tablets 20 outward in the width direction of the printing conveying surface 42, forming an area on the inside of the printing conveying surface 42 where the tablets 20 do not pass. The gas blown out in the direction opposite to the conveying direction F onto the printing conveying surface 42 is blown onto the printing conveying surface 42 where the tablets 20 do not pass, and therefore does not interfere with the conveyance of the tablets 20. Therefore, the manufacturing apparatus 10 can efficiently remove powder without reducing conveyance efficiency. The covering unit 64 has an inclined surface 68 that slopes downward from downstream to upstream in a front view, thereby returning powder that collides with the surface of the covering unit 64 on the printing conveying surface 42 side to the downstream side. Therefore, the manufacturing apparatus 10 can more efficiently remove powder from the printing conveying surface 42.

[0059] Next, the tablet 20 that has passed through the powder removal unit 48 is transported to the printing unit 50 by the second transport body 44. In the printing processing step (7), the inspection camera 78 photographs the surface of the tablet 20. Based on the photographed result, the manufacturing apparatus 10 detects, for example, the position and orientation of the tablet 20, and prints on the surface of the tablet 20 using the print head 80 according to the position of the tablet 20. The printed tablet 20 is transported further downstream by the second transport body 44 and collected in the collection unit 18. The manufacturing apparatus 10 according to the first embodiment efficiently removes powder from the surface of the tablet 20 before printing, thereby making it possible to obtain tablets 20 that are less likely to have printing defects in the identification information, such as missing characters.

[0060] [Action and effect] As described above, the manufacturing method of the first embodiment includes a conveying step (1) in which tablets 20 are dropped from a pre-processing step onto a conveying surface 24 for conveying the tablets 20, and a printing step (2) in which printing is performed on the surfaces of the tablets 20 after the conveying step (1). The method also includes a first suction step (3) in which powder that has separated from the surface of the dropped tablets 20 is sucked in the conveying step (1). In the conveying step (1), tablets 20 are dropped from the hopper 12 of the pre-processing step onto the conveying surface 24, and powder that has separated from the surface of the tablets 20 due to the impact of the drop is sucked in the first suction step (3), thereby more efficiently removing powder from the tablets. Therefore, this manufacturing method can manufacture tablets 20 with less powder adhering to the surface. Furthermore, according to this manufacturing method, since printing is performed in the printing step (2) on the surfaces of the tablets 20 that have undergone the conveying step (1), tablets with fewer printing defects of identification information, such as missing characters, can be obtained.

[0061] The tablet manufacturing apparatus 10 of the first embodiment also includes a first conveyor lane 14, which has a conveying surface 24 for conveying the tablets 20, located below the discharge port 22 of a hopper 12 containing a plurality of tablets 20, and a second conveyor lane 16 for conveying the tablets 20 supplied from the first conveyor lane 14 in the conveying direction F. The first conveyor lane 14 has a first suction port 28 connected to the conveying surface 24 onto which the tablets 20 fall from the hopper 12 and for sucking in gas. The second conveyor lane 16 is configured to have a printing unit 50 for printing on the surface of the tablets 20. As described above, the tablets 20 are dropped from the hopper 12 in the pre-treatment process onto the conveying surface 24, and powder that has separated from the surface of the tablets 20 due to the impact of the drop is sucked through the first suction port 28, thereby more efficiently removing powder from the tablets 20. Therefore, the present manufacturing apparatus 10 can manufacture tablets 20 with less powder adhering to their surfaces. Furthermore, according to the present manufacturing apparatus 10, the surface of the tablet 20 from which the powder has been removed in the first conveying lane 14 is printed in the printing section 50, thereby obtaining a tablet 20 that is less likely to have printing defects in the identification information, such as missing characters.

[0062] [Variations] The present invention is not limited to the above-described embodiment and can be modified as appropriate within the scope of the present invention. For example, the number of first suction port 28, second suction port 32, and third suction port 52 is not particularly limited and may be one, two, or more. Furthermore, first suction port 28, second suction port 32, and third suction port 52 are not limited to cylindrical members, and may also be rectangular cylindrical members.

[0063] In the first embodiment, the first suction port 28 is described as being provided in the connecting pipe 26, but the present invention is not limited to this, and one end of the first suction port 28 may be disposed between the lower end of the connecting pipe 26 and the conveying surface 24.

[0064] In the first embodiment, the case where one end of the second suction port 32 is connected to an air intake port covering the opposite side of the conveying surface 24 having the ventilation holes 40 has been described, but the present invention is not limited to this. For example, one end of the second suction port 32 may have a linear opening extending along the width direction of the conveying body 30, and may be configured to suck gas on the conveying surface 24 through some of the ventilation holes 40 formed in the conveying surface 24 that are aligned in the width direction of the conveying body 30.

[0065] In the first embodiment, one end of the third suction port 52 is located on the print transport surface 42 and is arranged perpendicular to the print transport surface 42, but the present invention is not limited to this. For example, one end of the third suction port 52 may be located on the print transport surface 42 and tilted at a predetermined angle within a range of less than ±90 degrees in the width direction and less than ±90 degrees in the transport direction with respect to the perpendicular direction to the print transport surface 42. Furthermore, as long as one end of the third suction port 52 is connected to the print transport surface 42, it may be located outside the direction perpendicular to the transport direction F and the vertical direction of the transport body 30 (hereinafter also referred to as the "width direction").

[0066] In the first embodiment, the cover 58 of the powder removal unit 48 is described as having the guide portion 66, but the present invention is not limited to this, and the cover 58 does not have to have the guide portion 66. If the cover 58 does not have the guide portion 66, the tablet 20 on the print conveying surface 42 passes between the powder removal unit 48 and the print conveying surface 42, and is conveyed while moving against the gas blown out from the outlet 62. By being exposed to the gas blown out from the outlet 62, powder adhering to the surface of the tablet 20 is more reliably removed from the surface of the tablet 20 and is sucked in by the fourth suction port 60.

[0067] In the first embodiment, a single powder removal section 48 is provided on the printing conveying surface 42, but the present invention is not limited to this. For example, multiple powder removal sections 48 may be provided in the width direction perpendicular to the conveying direction F, or multiple sections may be provided along the conveying direction F, or they may be provided randomly, such as in a staggered pattern.

[0068] In the first embodiment, the case where the outlet 62 blows out gas in the direction opposite to the conveying direction F has been described, but the present invention is not limited to this. For example, in addition to the outlet 62 that blows out gas in the direction opposite to the conveying direction F, the manufacturing apparatus 10 may have at least one of an outlet that blows out gas in the forward direction relative to the conveying direction F and an outlet that blows out gas in a direction intersecting the conveying direction F.

[0069] (Second embodiment) Next, a manufacturing apparatus 10A according to a second embodiment will be described with reference to FIG. 4. The manufacturing apparatus 10A according to the second embodiment differs from the manufacturing apparatus 10 according to the first embodiment in the mechanism from collecting the tablets 20 compressed by the tablet press 110 to feeding them into the hopper 12. The manufacturing apparatus 10A according to the second embodiment includes a bucket lifter 96 and a tablet buffer chute 98. For ease of explanation, the tablet buffer chute 98 and the hopper 12 are shown in partial cross section in FIG. 4. In the manufacturing apparatus 10A according to the second embodiment, the bucket lifter 96 and the tablet buffer chute 98 are arranged between the tablet press 110 and the hopper 12.

[0070] The bucket lifter 96 has a tower 100, a bucket 102, and a lifting mechanism 104. The tower 100 extends vertically. The tower 100 has a receiving port portion 106 and a supply port portion 108. The receiving port portion 106 receives tablets 20 from a tablet press 110. The receiving port portion 106 is a tubular member that spans from the lower end of the tower 100 to the tablet press 110. The supply port portion 108 supplies the tablets 20 to the tablet buffer chute 98. The supply port portion 108 is a tubular member that extends from the upper end of the tower 100 toward the tablet buffer chute 98.

[0071] The bucket 102 is disposed within the tower 100. The bucket 102 has an internal space 112 for storing the tablets 20, and a receiving port 114 and a supply port 116 that communicate with the internal space 112. The bucket 102 can be moved vertically within the tower 100 by the lifting mechanism 104. When the bucket 102 is located at the lower end within the tower 100, the receiving port 114 is connected to the receiving port portion 106. When the bucket 102 is located at the upper end within the tower 100, the supply port 116 is connected to the supply port portion 108.

[0072] The lifting mechanism 104 moves the bucket 102 vertically upward and downward within the tower 100. The lifting mechanism 104 may be configured, for example, by an actuator powered by air pressure. Alternatively, the lifting mechanism 104 may be configured, for example, by a chain mechanism powered by a motor.

[0073] The tablet buffering chute 98 is disposed between the supply port portion 108 and the hopper 12. In the manufacturing apparatus 10A according to the second embodiment, the tablet buffering chute 98 is disposed in the center of the hopper 12. The tablet buffering chute 98 has a cylindrical portion 118, a second outlet port 120, and a fifth suction port 122. The cylindrical portion 118 is a cylindrical member having an opening along the vertical direction. The cylindrical portion 118 has a sliding portion 124 on its inner surface as a buffer material. The sliding portion 124 has a spirally curved surface and extends from the upper end to the lower end of the cylindrical portion 118.

[0074] The second blow-out port 120 is provided below the vertical center of the cylindrical portion 118. In the manufacturing apparatus 10A according to the second embodiment, two second blow-out ports 120 are provided. The number of second blow-out ports 120 may be one, three, or more. The second blow-out port 120 is a cylindrical member, one axial end of which opens into the interior of the cylindrical portion 118, and the other axial end of which is connected to an air compressor via a pipe (not shown). The fifth suction port 122 is provided vertically above the second blow-out port 120, preferably above the vertical center of the cylindrical portion 118. Multiple fifth suction ports 122 may be provided. The fifth suction port 122 is a cylindrical member, one axial end of which opens into the interior of the cylindrical portion 118, and the other axial end of which is connected to the suction pump 34 via a pipe.

[0075] Tablets 20 compressed by the tablet press 110 are supplied into the tower 100 through the receiving port 106. The tablets 20 pass through the receiving port 106 and are stored in the internal space 112 of the bucket 102 through the receiving port 114. When a certain amount or more of tablets 20 has been stored in the internal space 112, the bucket 102 is moved to the upper end of the tower 100 by the lifting mechanism 104. The bucket 102 that has reached the upper end of the tower 100 supplies tablets 20 from the supply port 116 to the supply port 108. The tablets 20 supplied to the supply port 108 move downward from the opening at the upper end of the tablet buffer chute 98 while sliding on the sliding portion 124. The tablets 20 that have reached the lower end of the tablet buffer chute 98 fall into the hopper 12.

[0076] The second air outlet 120 blows gas toward the inside of the cylindrical portion 118. The gas blown toward the inside of the cylindrical portion 118 causes the powder on the sliding portion 124 to float from the surface of the sliding portion 124. As a result, the powder floats upward inside the cylindrical portion 118 together with the blown gas. The fifth suction port 122 sucks in the gas inside the cylindrical portion 118, thereby preventing the powder that has detached from the surface of the tablet 20 from adhering to the surface of the tablet 20 again.

[0077] The manufacturing apparatus 10A according to the second embodiment can continuously feed the tablets 20 into the hopper 12 by using a bucket lifter 96. The manufacturing apparatus 10A can reduce vibrations applied to the tablets 20 compared to when the tablet collection container 82 is moved as in the first embodiment. Therefore, the manufacturing apparatus 10A according to the second embodiment can further suppress the generation of powder from the tablets 20.

[0078] The tablets 20 supplied to the tablet buffer chute 98 slide along the sliding portion 124 and move downward while spirally circling the inner surface of the cylindrical portion 118. In other words, the tablet buffer chute 98 can reduce the impact on the tablets 20 when they are fed into the hopper 12. As a result, the manufacturing apparatus 10A according to the second embodiment can temporarily store the tablets 20 in the hopper 12 and can further suppress the generation of powder in the hopper 12.

[0079] (Third embodiment) Next, an embodiment of a tablet manufactured by the above-mentioned manufacturing apparatus will be described. The tablet according to the third embodiment can be manufactured by the manufacturing method and manufacturing apparatus according to the first and second embodiments. The tablet according to the third embodiment is a tablet containing magnesium oxide as an active ingredient, as described below. It has been found that such tablets tend to have a particularly large amount of powder adhering to the surface of the tablet immediately after tableting. More specifically, the tablet according to the third embodiment contains granules containing magnesium oxide particles and an internal additive. The tablet preferably further contains granules and an external additive. Furthermore, the tablet more preferably contains, for example, cellulose and / or a cellulose derivative as an internal additive and / or an external additive. It is more preferable that the tablet has a mass ratio of [cellulose and / or cellulose derivative contained as an internal additive]:[cellulose and / or cellulose derivative contained as an external additive] within a certain range. The above-mentioned tablet can achieve both reduced tablet friability and a reduced incidence of capping. The manufacturing apparatus and manufacturing method according to the third embodiment are suitable for the above-mentioned tablet. That is, by applying the manufacturing apparatus and manufacturing method according to the third embodiment to the above tablets, tablets with less powder adhering to the surface can be obtained.

[0080] The tablet may contain, as an external additive, crystalline cellulose having an average particle size of 50 μm or less. When crystalline cellulose having an average particle size of 50 μm or less is added as an external additive, the amount of powder adhering to the tablet surface tends to increase, compared to when an external additive with a large particle size is added. According to this manufacturing method, the powder can be efficiently removed, so that tablets with less powder adhering to the tablet surface can be obtained.

[0081] [Wearability] In the third embodiment, "friability" refers to, for example, an index of the abrasion and brittleness of a tablet against impact, and can be measured by the method described in "Reference Information - Tablet Friability Test Method, 17th Edition of the Japanese Pharmacopoeia." Specifically, for a number of tablets weighing approximately 6.5 g, a tablet friability tester (Toyama Sangyo Co., Ltd., Tablet Friability Tester TFT-1200) is used to abrade test tablets at 100 revolutions (24 to 26 revolutions per minute), the initial tablet mass before abrasion and the tablet mass after abrasion are measured, and the friability can be calculated according to the following formula 1.

[0082]

number

[0083] When the above-mentioned measurement method is used, the upper limit of the friability range of the tablet of the third embodiment is less than 0.40%, and more preferably less than 0.35%, and even more preferably less than 0.30%. On the other hand, since the lower the friability, the more desirable it is, no lower limit is particularly set.

[0084] [Capping] In the third embodiment, "capping" refers to the peeling off of the upper or lower surface of a tablet as a cross-sectional piece. "Capping" occurs, for example, due to impact during tableting in the tablet manufacturing process, during transportation, or during packaging. The capping incidence rate can be determined by a cassette rotor test. The capping incidence rate can be calculated according to the following formula 2. More specifically, the capping incidence rate is determined by discharging tablets from a cassette rotor set at a height of 2 m and counting the number of capped tablets from the dropped tablets. The capping incidence rate is determined by testing a sufficient number of test tablets, for example, 100 tablets. The capping incidence rate is calculated by counting the number of tablets that have capped out of the 100 test tablets tested, and calculating the percentage. For example, a cassette rotor for Magmit 500 mg tablets manufactured by TOSHO can be used. When calculating the capping occurrence rate, the flooring specifications used can be concrete trowel + epoxy floor coating + paste method (thickness 2 mm) (ABC Shokai) Chemicrete E or equivalent specifications.

[0085]

number

[0086] When the above-mentioned measurement method is used, the range of the capping incidence rate of the tablet of the third embodiment is preferably less than 12%, more preferably less than 11%, and even more preferably less than 10%. On the other hand, since the lower the capping incidence rate, the more desirable it is, no lower limit is particularly set.

[0087] [hardness] In the third embodiment, "hardness" refers to an index of tablet hardness, and can be measured with a tablet hardness tester. The tablet hardness tester that can be used is the DC-50 manufactured by Okada Seiko Co., Ltd. The hardness can be determined, for example, by measuring the tablet hardness in the diameter direction using a tablet hardness tester. If the tablet hardness is too low, the friability increases, so the lower limit is preferably 30 N or more, more preferably 40 N or more, and even more preferably 50 N or more. On the other hand, from the viewpoint of powder generation, the higher the tablet hardness, the more desirable it is, and therefore no upper limit is set.

[0088] [Collapse time] In the third embodiment, "disintegration time" is an index of the ease with which a tablet disintegrates in a solution. Disintegration time can be measured according to the General Test Method / Disintegration Test Method in the Seventeenth Edition of the Japanese Pharmacopoeia. Disintegration time can be measured using a disintegration tester. More specifically, the "disintegration time" is measured by measuring the disintegration time in water using an appropriate number of test tablets, for example, six tablets, as a test solution. The disintegration tester can be, for example, the NT-20HS disintegration tester manufactured by Toyama Sangyo Co., Ltd. Tablets with an appropriate disintegration time are preferred because they disintegrate in the oral cavity in a short time and are easy to swallow. The upper limit of the appropriate disintegration time is 20 seconds or less, preferably 15 seconds or less, and even more preferably 11 seconds or less. The lower limit is not particularly limited, but is usually 0.5 seconds or more, or 1 second or more.

[0089] [Cellulose and / or cellulose derivatives] In the third embodiment, "cellulose" refers to a linear polymer represented by (C6H10O5)n in which β-glucose molecules are linearly polymerized via glycosidic bonds. Examples include crystalline cellulose, microcrystalline cellulose, and powdered cellulose. "Cellulose derivatives" refer to cellulose molecules in which different substituents have been introduced into hydroxy groups via ether or ester bonds. Examples include methyl cellulose, ethyl cellulose, carboxymethyl cellulose, calcium carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, and low-substituted hydroxypropyl cellulose. "Cellulose and / or cellulose derivatives" as defined in the third embodiment refers to at least one selected from the above-mentioned "cellulose" and "cellulose derivatives." Low-substituted hydroxypropyl cellulose refers to cellulose in which an extremely small number of hydroxypropoxy groups have been introduced into the glucose ring, i.e., cellulose with a low level of O-(2-hydroxypropyl) molar substitution of 0.2 to 0.4. Such cellulose derivatives may be in the form of, for example, powder, particles, or fine particles.

[0090] The cellulose and / or cellulose derivative may be synthesized or commercially available. Commercially available crystalline celluloses include those available from Asahi Kasei Corporation under the trademark Ceolus (registered trademark) in various grades, such as Ceolus (registered trademark) PH-101, UF-711, PH-102, PH-200, PH-301, PH-302, PH-20JP, UF-702, KG-802, and KG-1000.

[0091] [Magnesium oxide particles] The magnesium oxide particles used in the third embodiment are particles of magnesium oxide (MgO). The magnesium oxide particles used in the third embodiment can be obtained by calcining magnesium hydroxide particles. For example, they can be obtained by calcining magnesium hydroxide having an average particle diameter of 1 to 10 μm as measured by a laser diffraction scattering method at 600 to 1000°C. The magnesium oxide particles may be synthesized or commercially available. For example, heavy grade magnesium oxide manufactured by Kyowa Chemical Industry Co., Ltd., powder grade magnesium oxide manufactured by Konoshima Chemical Co., Ltd., or light grade and heavy grade magnesium oxide manufactured by Tomita Pharmaceutical Co., Ltd., as listed in the Japanese Pharmacopoeia, can be used.

[0092] The magnesium oxide particles used in the third embodiment may be in either powder or granular form, but granular form is more effective in preventing wear on the tablet press and also allows for the production of high-content tablets with better shape retention stability.

[0093] The magnesium oxide particles used in the third embodiment may preferably have a predetermined particle size, although this is not limited thereto. For example, the upper limit of the average particle size of the magnesium oxide particles measured by a laser diffraction scattering method can be, for example, typically 40 μm or less, 20 μm or less, or 10 μm or less. By setting the average particle size of the magnesium oxide particles to the above-mentioned upper limit or less, the suspended particle size upon tablet disintegration may be reduced, resulting in a tablet with less roughness in the oral cavity. On the other hand, the lower limit of the average particle size is not limited, but can be, for example, typically 0.25 μm or more, 0.5 μm or more, or 1 μm or more, depending on production limitations and cost-effectiveness.

[0094] The average particle size and average particle diameter of the magnesium oxide particles of the third embodiment and the magnesium hydroxide particles that are the raw material thereof can be measured using a measuring device that employs a laser diffraction scattering method, such as a particle size distribution measuring device MT3300EX2 manufactured by Microtrackbell Corporation.

[0095] The bulk density of the magnesium oxide particles used in the third embodiment may be set to 0.8 g / mL or less, or 0.7 g / mL or less, because a too high bulk density may cause a decrease in hardness. On the other hand, a too low bulk density may cause capping and lamination, so the lower limit may be set to 0.1 g / mL or more, or 0.2 g / mL or more. The bulk density can be measured, for example, using a 100 mL stainless steel cup (actual measured mass (g) / 100 (mL)).

[0096] If the angle of repose of the magnesium oxide particles used in the third embodiment is too large, it may lead to poor flowability and variation in tablet mass during tableting, so the upper limit can be set to 50° or less, or 48° or less. On the other hand, since a lower angle of repose is more desirable, no lower limit is set. The angle of repose can be measured, for example, using a Multitester MT-1 manufactured by Seishin Enterprise Co., Ltd.

[0097] [tablet] One aspect of the third embodiment is a tablet containing magnesium oxide as an active ingredient. The tablet of the third embodiment includes granules containing magnesium oxide particles and an internal additive. The tablet of the third embodiment may include an external additive added to the granules. The tablet of the third embodiment may contain at least cellulose and / or a cellulose derivative as the internal additive and / or the external additive. The tablet of the third embodiment has a mass ratio of [cellulose and / or cellulose derivative contained as an internal additive]:[cellulose and / or cellulose derivative contained as an external additive] within a certain range.

[0098] The magnesium oxide particles are preferably contained in the granules together with the internal additive. If the content of the magnesium oxide particles is too high, the moldability may be insufficient, so it can be, for example, 90% by mass or less, or 88% by mass or less, based on the entire tablet. On the other hand, if the content of the magnesium oxide particles is too low, an additive with high compressibility and plastic deformability can be blended therein, resulting in a tablet with high moldability, but the cost per tablet will increase. Therefore, it is preferable that the content of the magnesium oxide particles be, for example, 80% by mass or more, or 85% by mass or more, based on the entire tablet.

[0099] In the tablet of the third embodiment, the mass ratio of [cellulose and / or cellulose derivatives contained as internal additives] to [cellulose and / or cellulose derivatives contained as external additives] is within a certain range. By increasing the proportion of external additives, tablets can be expected to have increased hardness and reduced friability. Increasing the proportion of external additives in tablets too much can result in, for example, an increased incidence of capping and decreased tube passability. Therefore, the mass ratio of cellulose and / or cellulose derivatives contained as external additives, assuming the mass of the cellulose and / or cellulose derivatives contained in the entire tablet as 100, is preferably set to an upper limit of 90 or less, e.g., 88 or less, 85 or less, 80 or less, or 75 or less, and preferably set to a lower limit of more than 20, e.g., 21 or more, 22 or more, 23 or more, 24 or more, or 25 or more. On the other hand, if the proportion of internal additives in a tablet is too low, compaction will be insufficient, resulting in the generation of many fine particles and the tendency for air to be trapped. This air may not be completely removed during subsequent tableting, resulting in capped tablets. Therefore, tablets require the incorporation of a certain amount of internal additives. However, if the proportion of internal additives is too high, compacted granules are obtained by granulation, and the granules are less likely to break down due to further compaction during tableting. When the granules become less likely to break down due to further compaction during tableting, the tablet's moldability decreases, i.e., the friability increases. Therefore, the mass ratio of the internal additive contained in the tablet is preferably less than 80, where the mass of the cellulose and / or cellulose derivatives contained in the entire tablet is taken as 100. The mass ratio of the internal additive contained in the tablet is more preferably 79 or less, 78 or less, 77 or less, 76 or less, or 75 or less, where the mass of the cellulose and / or cellulose derivatives contained in the entire tablet is taken as 100. The mass ratio of the internal additive contained in the tablet is more preferably 10 or more, for example, 12 or more, 15 or more, 20 or more, or 25 or more, where the mass of the cellulose and / or cellulose derivatives contained in the entire tablet is taken as 100.

[0100] Furthermore, since too much cellulose and / or cellulose derivative content in the entire tablet increases the cost per tablet, it can be set to 20% by mass or less, 15% by mass or less, or 12% by mass or less of the entire tablet. On the other hand, too little cellulose and / or cellulose derivative content may not achieve the effects of the present invention, so it can be set to 5% by mass or more, 7% by mass or more, or 9% by mass or more of the entire tablet.

[0101] In the tablet of the third embodiment, the cellulose and / or cellulose derivatives defined above are preferably used as excipients or binders in both the internal additive and the external additive. The cellulose and / or cellulose derivatives contained in the internal additive and the external additive may be the same or different.

[0102] In the third embodiment, the internal additive refers to an additive containing one or more substances added to and mixed with the active ingredient before the granulation step in tablet production. Other additives may be added as the internal additive in addition to the cellulose and / or cellulose derivatives defined above. In particular, to adjust the preferred disintegration time as described above, it is preferable to add a disintegrant such as croscarmellose sodium, corn starch, carmellose calcium, crospovidone, or carboxystarch sodium as the internal additive in addition to the cellulose and / or cellulose derivatives contained in the internal additive and external additive at the specific ratio defined above. The disintegrant may be synthesized or commercially available. For example, Kiccolate (registered trademark) ND-2HS manufactured by Nichirin Chemical Industry Co., Ltd. can be used. Because tablet molding may be difficult, the upper limit may be set to, for example, 5% by mass or less or 3.5% by mass or less based on the total tablet. On the other hand, because a too small amount may make disintegration difficult, the lower limit may be set to, for example, 1% by mass or more or 2% by mass or more based on the total tablet.

[0103] In the third embodiment, the external additive refers to an additive containing one or more substances added to the granules produced after the granulation step in tablet production and compressed together with the granules. In addition to the cellulose and / or cellulose derivatives contained in the internal additive and the external additive at the specific ratio defined above, other additives may also be added as external additives. From the perspective of achieving the desired results, adding a lubricant is particularly preferred. Examples of lubricants include stearic acid and its salts (Mg and Ca salts). Lubricants are preferably stearates, with magnesium stearate and calcium stearate being more preferred. Since too much lubricant can delay disintegration, the upper limit can be set to, for example, 2% by mass or less, 1.5% by mass or less, or 1.0% by mass or less relative to the total tablet. On the other hand, since too little lubricant can cause adhesion to punches and dies, the lower limit of the amount of lubricant added relative to the total tablet can be set to, for example, 0.2% by mass or more, 0.5% by mass or more, or 0.9% by mass or more.

[0104] The mass of the tablet of the third embodiment, which contains magnesium oxide as an active ingredient, can be, for example, up to 1000 mg, up to 800 mg, or up to 600 mg per tablet, and the lower limit of the mass of the tablet of the third embodiment can be 10 mg or more, 50 mg or more, or 100 mg or more.

[0105] The tablet of the third embodiment is orally administered as a pharmaceutical for humans or animals, for example, for antacid, laxative, or prevention of urinary calcium oxalate stones. It can also be used as a supplement for humans or animals for magnesium supplementation or antihypomagnesemia. The dosage varies depending on the application, purpose, or condition. For example, when used as an antacid, an adult typically orally administers 0.5 to 1.0 g per day in divided doses in terms of magnesium oxide. When used as a laxative, an adult typically orally administers 2 g per day in terms of magnesium oxide, divided into three doses before or after meals, or once before bedtime. When used to prevent urinary calcium oxalate stones, an adult typically orally administers 0.2 to 0.6 g per day in terms of magnesium oxide with a large amount of water. For other uses, the dose is usually taken within the tolerable upper limit of magnesium intake. For example, the US Dietary Reference Intakes for sources other than regular food are set at 350 mg of magnesium per day for healthy adults and 5 mg per kg of body weight per day for healthy children (Institute of Medicine (IOM). Food and Nutrition Board. "Dietary Reference Intakes: Calcium, Phosphorus, Magnesium, Vitamin D and Fluoride". Washington, DC: National Academy Press, 1997).

[0106] The pharmaceutical product of the third embodiment has been approved in Japan for use as an antacid, laxative, or to prevent the formation of urinary calcium oxalate stones, based on the active ingredient. The internal additive and / or external additive may further contain one or more other optional ingredients, as long as they do not substantially interfere with the desired effects in each application, as well as the reduction in friability and the reduction in the incidence of capping. Examples of such other ingredients include, but are not limited to, various pharmaceutically acceptable pharmaceutical additives, such as colorants and flavoring agents. These ingredients may be used alone, or two or more may be used in any combination and ratio.

[0107] The above-mentioned tablets can be produced, for example, by the following pretreatment method: a method for producing tablets containing magnesium oxide as an active ingredient, comprising mixing magnesium oxide particles with an internal additive containing cellulose and / or a cellulose derivative; granulating said mixture into granules; adding an external additive containing cellulose and / or a cellulose derivative to the granules and tableting the granules; The present invention relates to a production method in which the mass ratio of [cellulose and / or cellulose derivative contained as an internal additive]:[cellulose and / or cellulose derivative contained as an external additive] is within the range of 75:25 to 10:90.

[0108] First, magnesium oxide particles, cellulose and / or a cellulose derivative, and optionally an internal additive containing one or more other ingredients are mixed together. The resulting mixture is then granulated to form granules. In view of the ingredients of the tablet of the third embodiment, dry granulation is preferred. Granulation by dry granulation can be carried out using, for example, a dry granulator RC-156 manufactured by Freund Corporation.

[0109] The granules thus produced are then tableted after adding external additives containing cellulose and / or a cellulose derivative and, optionally, one or more other ingredients. Any method can be used to add the external additives to the periphery of the granules. The tableting pressure, in terms of punch pressure per tablet, can be, for example, an upper limit of 20 kN or less, or 18 kN or less, or 16 kN or less, and a lower limit of 2 kN or more, or 3 kN or more, or 4 kN or more. The shape of the punch may be a standard R, or may be, for example, a double R, a sugar-coated R, a corner R, a corner flat, or a rounded flat.

[0110] Although various aspects of the present invention have been described above, the present invention is not limited to these aspects. As will be apparent to those skilled in the art, any other aspect of the present invention may be extracted from the above detailed description and the following description of the examples. [Example]

[0111] The present invention will be described in more detail below with reference to examples. However, these examples are merely examples shown for the convenience of explanation, and the present invention is not limited to these examples in any sense.

[0112] [Prescription] Tablets were manufactured according to the formulation shown in the table below.

[0113] [Table 1]

[0114] [Table 2]

[0115] Details of the raw materials used in the above examples and comparative examples are as follows. Magnesium oxide: Kyowa Chemical Industry Co., Ltd., Japanese Pharmacopoeia Magnesium Oxide (heavy grade) Crystalline cellulose: Ceolus PH-101 (Examples 1-4, Comparative Examples 1-3), Ceolus UF-711 (Examples 5-8, Comparative Examples 4-6), manufactured by Asahi Kasei Corporation Croscarmellose sodium: Kiccolate ND-2HS manufactured by Nichirin Chemical Industry Co., Ltd. Calcium stearate: Taihei Chemical Industry Co., Ltd. Calcium stearate (vegetable)

[0116] The physical properties of the magnesium oxide used in this example were measured and found to be as follows: Average particle size: 7.691 μm (measured by laser diffraction scattering method using Microtrackbell MT3300 EX2) Bulk density: 0.249 g / mL (measured using a 100 mL stainless steel cup (actual mass (g) / 100 (mL))) Angle of repose: 41.7° (measured using the Multitester MT-1 manufactured by Seishin Enterprise Co., Ltd.)

[0117] [Manufacturing method] According to the above recipe, each raw material was weighed on a 15,000 tablet scale using an electronic balance (Mettler Toledo, 5 kg capacity PB5001-S / FACT). 1.Mixing The weighed magnesium oxide and internal additive raw materials were placed in a polyethylene bag (1100 mm x 600 mm) and mixed by shaking the bag 30 times. After the mixing process, the bulk density was measured using a 100 mL stainless steel cup (actual measured mass (g) / 100 (mL)). 2. Granulation The resulting mixture was granulated using a dry granulator (Dry Granulator RC-156 manufactured by Freund Corporation) under the following granulation conditions to produce granules.

[0118] [Table 3]

[0119] After granulation, the following evaluation items were evaluated. Flake rate: The masses of the 1-minute processed product (A) obtained by carrying out the granulation process for 1 minute and the product (B) obtained by sieving the 1-minute processed product (A) through a 1000 μm sieve were measured and calculated using the following formula 3.

[0120]

number

[0121] Bulk density: Measured using a 100 mL stainless steel cup (actual mass (g) / 100 (mL)) Particle size distribution: Measured using a particle size distribution analyzer (Seishin Enterprise Co., Ltd. Laser diffraction scattering particle size distribution analyzer LMS-2000e) 3.Addition of external additives The granules and the weighed raw materials of the external additives were placed in a polyethylene bag (1100 mm x 600 mm), and the bag was shaken left and right 30 times to mix. After mixing, the following evaluation items were evaluated. Bulk density: Measured using a 100 mL stainless steel cup (actual mass (g) / 100 (mL)) Angle of repose: Measured using the Multitester MT-1 manufactured by Seishin Enterprise Co., Ltd. 4.Tablet compression The mixed granules and external additives were compressed into tablets using a tablet press (KIKUSUI SEISAKUSHO VIRG, a small high-speed rotary tablet press) under the following conditions.

[0122] [Table 4]

[0123] After tableting, the following evaluation items were evaluated. Mass: (Number of tablets tested: 10 tablets) Thickness: (Number of tablets tested: 5 tablets) Using a Peacock thickness gauge Hardness: (Number of tablets tested: 10 tablets) Using a load cell type benchtop hardness tester DC-50 manufactured by Okada Seiko Co., Ltd. Friability test: Toyama Sangyo Co., Ltd. tablet friability tester TFT-1200 was used, and the test was performed at 100 rotations (number of test tablets: as close as possible to 6.5g). Disintegration time: (Number of test tablets: 6 tablets) Compliant with the 17th revised Japanese Pharmacopoeia, General Test Method, Disintegration Test Method. The disintegration time of the test tablets in water was measured using a disintegration tester (Toyama Sangyo Co., Ltd., Disintegration Tester NT-20HS). Tableting status: Visually check tableting pressure / tableting problems Suspended particle diameter D50 (μm): (Number of test tablets: 1 tablet) The suspended particle diameter was measured when the test tablet was suspended in water using a laser diffraction scattering particle size distribution analyzer LMS-2000e manufactured by Seishin Enterprise Co., Ltd. Tube passability 5 Fr: The plunger of a catheter syringe (Nipro Corporation, Enteral Nutrition Infusion Set Syringe DS 20 mL Catheter Yellow) was removed, one tablet was placed in the outer barrel, the plunger was replaced, 20 mL of 55°C warm water was drawn in, the tip of the syringe was capped, and the syringe was left to stand for 5 minutes. After 5 minutes, the catheter syringe was manually rotated 90 degrees back and forth 15 times, after which an enteral feeding tube (Atom Medical, Atom Nutrition Catheter T; 5 Fr diameter, 120 cm length) was connected, and an additional 20 mL of the suspension and ion-exchanged water for rinsing was injected to check for tube occlusion. This test was performed three times; if the tube was not occluded, it was evaluated as "pass"; if it was occluded, it was evaluated as "fail." Calculation of compression rate in tableting process: Filling depth (a) and main compression thickness (b) are calculated using the following formula 4

[0124]

number

[0125] [result] The results of measuring the bulk density of the resulting mixture (mixture) after mixing are shown in the table below.

[0126] [Table 5]

[0127] [Table 6]

[0128] The bulk density of the mixtures was within the range of 0.20 to 0.25 (g / mL) in both the Examples and Comparative Examples, and no particularly large difference was observed. The measurement results for each item of the granules (granulated product) after granulation are shown in the table below.

[0129] [Table 7]

[0130] [Table 8]

[0131] Regarding granulation properties, the more crystalline cellulose contained as an internal additive, the better the processing ability and flake rate, and the higher the bulk density of the granulated product. Therefore, it is preferable to include a certain amount of crystalline cellulose as an internal additive.

[0132] The measurement results after adding the external additives are shown in the table below.

[0133] [Table 9]

[0134] [Table 10]

[0135] When comparing the particle diameters after addition of external additives between Comparative Examples 1 and 4, which do not contain crystalline cellulose as an external additive, and Comparative Examples 3 and 6, which contain 100% crystalline cellulose as an external additive, an increase of 150 μm Pass was observed in Comparative Examples 3 and 6, but the angle of repose was in the range of 40° to 44°, with little difference observed, so it is thought that there is no difference in fluidity.

[0136] The measurement results for each item after tableting are shown in the table below.

[0137] [Table 11]

[0138] [Table 12]

[0139] As the mass ratio of crystalline cellulose contained as an external additive to the crystalline cellulose contained as an internal additive increased (Comparative Example 1 → Comparative Example 3, Comparative Example 4 → Comparative Example 6), the hardness increased and the friability decreased, but the incidence of capping increased and aggregation of suspended particles was observed. As the mass ratio of crystalline cellulose contained as an external additive to the crystalline cellulose contained as an internal additive increased, the proportion of uncompressed crystalline cellulose that can contribute to tablet formation increased, and the compression rate during tableting increased, which is thought to have led to an increase in hardness and a decrease in friability. On the other hand, due to insufficient compaction during granulation, fine particles that did not become flakes tend to entrap air, and the bulk density of the entire granules to be tableted also decreased due to the influence of the uncompressed crystalline cellulose added later, resulting in insufficient degassing during compression, resulting in an air-trapped state, which is thought to be the cause of the increase in the incidence of capping. In addition, in Comparative Example 3, in which the entire amount of crystalline cellulose was contained as an external additive, clogging was also observed in the tube passability test. Therefore, the mass ratio of crystalline cellulose contained as an external additive to reduce friability is preferably approximately 25 or more, and approximately 90 or less, when the mass of cellulose and / or cellulose derivatives contained in the entire tablet is taken as 100, and is considered appropriate.

[0140] The tablet thickness after compression was in the range of 5.3 to 5.5 mm, with no significant difference observed. The disintegration time was within an appropriate range for both the Examples and Comparative Examples.

[0141] From the above results, it was found that magnesium oxide tablets that can achieve both reduced friability and reduced capping incidence can be efficiently produced by adjusting the mass ratio of [cellulose and / or cellulose derivatives contained as internal additives]:[cellulose and / or cellulose derivatives contained as external additives] within the range of 75:25 to 10:90, for example, within the range of 75:25 to 20:80, and particularly within the range of 75:25 to 25:75. Furthermore, by adjusting such a ratio, it becomes possible to achieve both reduced friability and reduced capping incidence while ensuring the physical properties required for tablet production, such as moldability, granulation ability, tableting ability, flowability, and tube passability, as well as the physical properties required for magnesium oxide tablets, such as disintegration ability. [Industrial Applicability]

[0142] INDUSTRIAL APPLICABILITY The present invention has extremely high applicability in industrial fields where tablets with fewer defects in the identification information printed on the surface are required, particularly in the fields of pharmaceutical manufacturing and distribution. [Explanation of symbols]

[0143] 10, 10A manufacturing equipment 12 Hopper 14 First Transport Lane 16 Second Transport Lane 18 Collection Department 20 tablets 22 Outlet 24 conveying surface 26 Connecting pipe 28 1st suction port 30 Transporter 32 2nd suction port 33 Air intake 34 Suction pump 36 Receptor 38 Conveyor 40 ventilation holes 42 Printing transport surface 44 Second Carrier 46 Second Receptor 48 Powder removal section 50 Printing Department 52 3rd suction port 54 Receptacle cover 58 Cover 60 4th suction port 62 Air Outlet 64 Covering part 66 Guide part 68 Slope 70-way gap 72 upstream outer edge 74 outer edge of width side 76 Width gap 78 Inspection Camera 80 print heads 82 Tablet collection container 84 Container 86 frames 88 wheels 90 Outlet 92 Butterfly valve 93 Post 94 Concatenation 96 Bucket Lifter 98 Tablet buffer chute 100 Tower 102 Bucket 104 Lifting mechanism 106 Receptor port 108 Supply port 110 Tablet press 112 Interior Space 114 Receptor 116 Supply port 118 Cylindrical part 120 Second air outlet 122 5th suction port 124 Sliding part

Claims

1. a conveying step of dropping the tablets manufactured in the pre-treatment step from a connecting pipe connected to a hopper into a receiving section below in a vertical direction on a conveying surface for conveying the tablets, and conveying the tablets from the receiving section downstream in the conveying direction; A printing process is provided for printing on the surface of the tablet after the conveying process, The conveying step includes a first suction step of suctioning powder separated from the surface of the dropped tablet by suctioning gas between the connecting pipe and the conveying surface, The conveying step is inclined downward in the vertical direction toward the downstream of the conveying direction, and further includes a second suction step of sucking powder separated from the surface of the tablet by sucking gas above the conveying surface from below the conveying surface downstream of the receiving section in the conveying direction, The second suction step uses a mesh or punched metal that sucks powder away from the surface of the tablet, The printing step includes a powder removal step of blowing gas onto a printing conveying surface that conveys the tablet in a direction opposite to the conveying direction and sucking up powder that has separated from the surface of the tablet before printing on the surface of the tablet, The powder removal step includes a cover having a height gap shorter than the height length of the tablet, preventing the tablet from entering through the height gap and preventing the tablet from passing between the printing conveying surfaces that convey the tablet, and the gas blown out in the opposite direction to the conveying direction toward the printing conveying surface that conveys the tablet is sucked in the cover. Tablet manufacturing method.

2. The tablet manufacturing method according to claim 1 , wherein the conveying step is performed using a vibrating feeder.

3. The method for manufacturing a tablet as described in claim 1, further comprising a third suction step in which the tablet is dropped from the conveying surface of the conveying step onto a printing conveying surface that conveys the tablet in the printing step, and powder that has separated from the surface of the tablet is sucked in before printing is applied to the surface of the tablet.

4. The pretreatment step includes: a mixing step of mixing magnesium oxide particles with an internal additive containing cellulose and / or a cellulose derivative to obtain a mixture; a granulation step of granulating the mixture into granules; a tableting step of tableting the granules; The method for producing a tablet according to claim 1, comprising:

5. In the tableting step, an external additive containing cellulose and / or a cellulose derivative is added in addition to the granules, The method for producing a tablet according to claim 4, wherein the cellulose and / or the cellulose derivative comprises crystalline cellulose having an average particle size of 50 μm or less.

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