Manufacturing method of tablet
The method addresses the issue of powder adherence on tablets by using a multi-step suction and gas blowing process in the tablet manufacturing apparatus, ensuring minimal powder adherence and reducing printing defects.
Patent Information
- Application Number
- JP2023102025
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-06-21
- Publication Date
- 2025-01-09
- Estimated Expiration
- 2043-06-21
AI Technical Summary
Existing methods for removing powder from tablet surfaces are inadequate, leading to chipping of identification information during printing, especially in printed characters, symbols, or figures.
A method involving a conveying process with multiple suction steps to remove powder from tablet surfaces, followed by a printing process that includes additional suction and gas blowing to ensure minimal powder adherence, using a tablet manufacturing apparatus with dedicated transport lanes and suction ports to enhance powder removal.
The method effectively reduces powder adherence on tablets, minimizing printing defects such as missing characters or symbols, thereby improving the quality of printed identification information.
Smart Images

Figure 2025002097000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to a method for producing printed tablets. [Background technology]
[0002] Tablets are formed by compressing powder with a tablet press to have a predetermined size and shape. Tablets formed in this way may have powder attached to their surfaces. For example, Patent Document 1 discloses a powder removal device that removes powder from the tablet surface by attaching a cover to surround a transport case that transports tablets discharged from a tablet press downstream, installing a spray device inside the cover, and spraying high-pressure air onto the tablets in the transport case. [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 is a concern that the powder removing device described in the above Patent Document 1 may not be able to sufficiently remove powder from the surface of the tablet. The present inventors have found that when printing is performed with ink on the surface of a tablet with powder adhering to the surface, the identification information, particularly the printed letters, symbols, or figures, is likely to be chipped.
[0005] An object of the present invention is to provide a method for producing tablets which have fewer defects in the identification information printed on the surface. [Means for solving the problem]
[0006] The present disclosure provides, for example, the following aspects.
[0007] [Aspect 1] The method for manufacturing a tablet includes a conveying step and a printing step. The conveying step involves dropping the tablet from a pretreatment 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 the first or second aspect, the printing step includes a third suction step. In the third suction step, 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 removing step in which, before printing is performed 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 separated from the surface of the tablet is sucked up.
[0011] [Aspect 5] In the method for producing a tablet according to any one of aspects 1 to 4, the pretreatment 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 manufacturing method according to the fifth aspect, in addition to the granules, an external additive is added in the tableting step. 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 includes a first conveying lane and a second conveying lane. The first conveying lane has a conveying surface for conveying the tablets, which is disposed 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 fall 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 the seventh aspect, the first conveying lane has an air hole penetrating 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 hole and sucks gas on the conveying surface.
[0015] [Aspect 9] In the tablet manufacturing apparatus according to aspect 7 or 8, the second transport lane has a printing transport surface that transports the tablets, which is disposed below the transport surface of the first transport lane. The second transport lane has a third suction port. The third suction port is connected to the printing transport surface onto which the tablets fall from the transport surface of the first transport 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. Effect 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 description of the drawings]
[0018] [Figure 1] FIG. 1 is a front view showing a schematic diagram of a manufacturing apparatus according to a first embodiment. [Diagram 2] 2A and 2B are diagrams illustrating a powder removing 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 sectional view. [Diagram 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. 11 is a schematic explanatory view showing a bucket lifter and a tablet buffer chute of a manufacturing apparatus according to a second embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0019] (First embodiment) [Tablet manufacturing equipment] Hereinafter, the tablet manufacturing apparatus according to the first embodiment of the present invention will be described with reference to the drawings. Fig. 1 is a front view showing the manufacturing apparatus according to the first embodiment, and Fig. 2 is a view showing the powder removing section of the manufacturing apparatus according to the first embodiment, in which Fig. 2(A) is a plan view and Fig. 2(B) is a front cross-sectional view.
[0020] As shown in Fig. 1, the manufacturing apparatus 10 includes, in this order from upstream to downstream in a conveying direction F, a hopper 12, a first conveying lane 14, a second conveying lane 16, and a recovery section 18. The hopper 12 stores a plurality of tablets 20 compressed in a pretreatment step. The hopper 12 has a discharge port 22 located vertically downward. The hopper 12 may have a feeder at the discharge port 22, although not shown.
[0021] The shape of the tablet 20 is not particularly limited. Examples of the tablet 20 include a disk shape, a lens shape, and a rod shape. When the tablet 20 has a disk shape or a lens 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. The thickness of the tablet 20 can be, for example, an upper limit of 8 mm or less, or 7 mm or less, and a lower limit of 3 mm or more, or 4 mm or more. In addition, the tablet 20 may have a shape including, for example, a cylindrical body and a curved convex cap portion at each axial end 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 conveyor lane 14 has a conveying surface 24 for conveying the tablets 20. The conveying surface 24 is disposed vertically below the discharge port 22. The first conveyor lane 14 includes a connecting pipe 26, a first suction port 28 provided in the connecting pipe 26, a conveyor 30 having the conveying surface 24, and a second suction port 32 provided in the conveyor 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 disposed so that the tablets 20 contained 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 through the connecting pipe 26. The other axial end of the first suction port 28 is connected to the suction pump 34 through a pipe. In this specification, the suction port is "connected to the conveying surface" as long as the suction port is open toward the conveying surface 24 so that gas above the conveying surface 24 can flow. The suction port may be in contact with the conveying surface 24 or may be 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 so as to penetrate the connecting pipe 26, and one end is disposed inside 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 vibration feeder. The conveying body 30 shown in FIG. 1 is a vibration feeder that conveys the conveyed object 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 fallen 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, which penetrate in the thickness direction. The conveying section 38 can be, for example, a mesh, a punching metal, or a resin belt having a through hole. The conveying section 38 may be inclined downward toward the downstream. In the conveying body 30, powder caused by the tablets 20 may be generated from the surface of the tablets 20 due to the impact of being discharged from the hopper 12. The conveying body 30 conveys the powder separated from the surface of the tablets 20 on the conveying surface 24 together with the tablets 20.
[0026] The second suction port 32 sucks the powder on the conveying surface 24 away from the surface of the tablet 20. The second suction port 32 is disposed on the opposite side of the conveying surface 24 of the conveying body 30. The second suction port 32 is composed of a cylindrical member. One axial end of the second suction port 32 is connected to the air hole 40. The other axial end of the second suction port 32 is connected to the suction pump 34 through a pipe. 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 conveying lane 16 conveys the tablet 20 while removing powder from the surface of the tablet 20 supplied from the first conveying lane 14. The second conveying lane 16 applies printing to the surface of the tablet 20. The second conveying lane 16 is disposed downstream of the first conveying lane 14 in the conveying direction F. The second conveying lane 16 includes a second conveying body 44. The second conveying body 44 has a printing conveying surface 42. The second conveying body 44 can be configured using, for example, a belt conveyor. The second conveying body 44 conveys the tablet 20 so that it passes through the second receiving section 46, the powder removing section 48, and the printing section 50 in this order from upstream to downstream in the conveying direction F. The second conveying body 44 conveys the printed tablet 20 to the collecting section 18. The collecting section 18 collects the conveyed tablet 20.
[0028] The print transport surface 42 is disposed vertically below the transport surface 24 of the first transport lane 14. In other words, the print transport surface 42 of the second receiver 46 is disposed below the downstream transport surface 24 of the first transport lane 14.
[0029] The second receiving section 46 removes powder that has been separated from the surface of the tablet 20 due to the impact of dropping the tablet 20. The second receiving section 46 has a third suction port 52 that sucks in gas on the print transport surface 42. The third suction port 52 is made of a cylindrical member. The third suction port 52 has an opening at one end in the axial direction. One end of the third suction port 52 is disposed on the print transport surface 42, and the other end in the axial direction 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 section 46 may have a receiving section 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 upward in the vertical direction.
[0030] Powder removal unit 48 removes powder remaining on print transport surface 42. Powder removal unit 48 has a cover 58 provided facing print transport 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 order from upstream to downstream in transport direction F.
[0031] The cover 58 covers the printing conveying surface 42 in a predetermined area so as to retain the gas in the predetermined area on the printing conveying surface 42. The cover 58 has a covering portion 64 and a guide portion 66, as shown in FIG. 2(A) and FIG. 2(B). The covering portion 64 is a plate-shaped member provided opposite the printing conveying surface 42. The covering portion 64 has a tapered shape protruding toward the upstream side in a plan view. The covering portion 64 may have an inclined surface 68 that inclines downward from downstream to upstream in a front view. The guide portion 66 is plate-shaped, is integrally provided on the outer edge of the covering portion 64, and protrudes toward the printing conveying surface 42. Between the lower end of the guide portion 66 and the printing conveying surface 42, a height direction gap 70 shorter than the height direction length of the tablet 20 is formed, as shown in FIG. 2(B). 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 that is equal to or greater than the maximum length of one tablet 20 in a planar view is formed between the cover 58 and the second conveying body 44 in the width direction. The maximum length of one tablet 20 in a planar view is the diameter of the tablet 20 when the shape of the tablet 20 in a planar view is circular.
[0032] The fourth suction port 60 sucks gas remaining in the cover 58 in the powder removal section 48. The fourth suction port 60 is configured of a cylindrical member. The fourth suction port 60 is disposed on the upstream side 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 the 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 blowing port 62 blows out gas to make the powder remaining on the print transport surface 42 fly up. The blowing port 62 is provided downstream of the fourth suction port. In the case of Figs. 2(A) and 2(B), the blowing port 62 is provided at the downstream end of the cover 58. The blowing port 62 is made of a cylindrical member. One axial end of the blowing port 62 opens in the opposite direction to the transport direction F with respect to the print transport surface 42. The other axial end of the blowing port 62 is connected to an air compressor (not shown) through a pipe (not shown). The blowing port 62 blows out gas supplied from the air compressor to the other end from one end. The blowing port 62 blows out gas toward the print transport surface 42. The number of blowing ports 62 is not limited to two as shown in Fig. 2(A). The number of blowing 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, and 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, an ink for an inkjet printer contains a colorant, water, ethanol, and a resin. The ink for an inkjet printer may further contain, as necessary, a water-soluble high-boiling organic solvent, an emulsifier, a pH adjuster, a flavoring agent, and a preservative. All of the ink compositions are preferably edible.
[0036] (dye) The coloring matter may be one or more selected from synthetic food coloring matter and natural food coloring matter. Examples of synthetic food coloring matter include tar-based coloring matter, natural coloring derivatives, natural synthetic coloring matter, and titanium dioxide. Examples of tar-based coloring matter 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 matter 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 products. Examples of anthocyanin pigments include red radish pigments, red cabbage pigments, red rice pigments, elderberry pigments, cowberry pigments, gooseberry pigments, cranberry pigments, salmonberry pigments, perilla pigments, sweet blueberry pigments, strawberry pigments, dark sweet cherry pigments, cherry pigments, hibiscus pigments, huckleberry pigments, grape juice pigments, grape skin pigments, blackcurrant pigments, blackberry pigments, blueberry pigments, plum pigments, white wortberry pigments, boysenberry pigments, mulberry pigments, purple sweet potato pigments, purple corn pigments, purple yam pigments, raspberry pigments, redcurrant pigments, loganberry pigments, and other anthocyanin pigments. Carotenoid pigments include annatto pigment, gardenia yellow, and other carotenoid pigments. Quinone pigments include cochineal pigment, lithospermum 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, for example, 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 light and the 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, fermented ethyl alcohol and sugarcane alcohol from natural brewing. The content of ethanol is preferably 5 to 60% by weight, more preferably 10 to 40% by weight, based on the total composition of the ink. If the content of ethanol is less than 5% by weight, the ink tends to dry poorly. For example, if the ink takes 3 seconds or more to dry after printing, the ink may peel off during transportation after printing, or may adhere to other tablets and transportation surfaces, causing stains. In addition, if the surface tension of the ink is high, the printed ink is more likely to be repelled by the surface of the tablet. In other words, the ink does not wet and spread on the surface of the tablet, so it does not dry easily, and the contact area with the tablet surface is small, so the adhesive force tends to be small. If the adhesive force of the ink is small, it may peel off when rubbed even after 24 hours. In addition, if the content of ethanol is more than 60% by weight, 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, it may cause, for example, ejection defects or deviation in the flying direction of the ejected ink. If the ink ejection defects or deviation in the flying direction occurs, it may cause printing defects.
[0040] (Water-soluble high boiling point organic solvent) The water-soluble high boiling point organic solvent can be used for the purpose of preventing the nozzle of the inkjet head from drying. For example, one or more of propylene glycol and glycerin can be selected as the water-soluble high boiling point organic solvent. The content of the water-soluble high boiling point organic solvent is preferably 1 to 60% by weight, more preferably 2 to 55% by weight, based on the total ink composition. If the content of the water-soluble high boiling point organic solvent in the ink is less than 1% by weight, there is a risk of poor printing due to drying of the ink in the inkjet nozzle. If the content of the water-soluble high boiling point organic solvent in the ink is more than 60% by weight, the ink viscosity tends to be too high. If the ink viscosity is too high, the ink cannot be ejected normally, which may result 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 resins, vinyl acetate resins, and polyvinylpyrrolidone.
[0042] (emulsifier) The emulsifier may be selected from one or more water-soluble emulsifiers selected from, for example, lecithin, glycerin fatty acid ester, sucrose fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, and polyoxyethylene sorbitan fatty acid ester. The emulsifier does not necessarily have to be blended into the ink. When blended into the ink, the content of the emulsifier is preferably 0.01 to 5% by weight, more preferably 0.1 to 2% by weight, based on the total ink composition. If the content of the emulsifier is less than 0.01% by weight, the surface tension of the ink tends to be too high. If the surface tension of the ink is too high, it may be difficult for the ink to be in a suitable meniscus state at the nozzle opening. If the ink is not in a meniscus state, the ink may not be ejected from the nozzle, or may not land at a specified position even if it is ejected, which may result in printing defects. In addition, if the content of the emulsifier is more than 5% by weight, the ink may tend to thicken and precipitate over time. Ink may thicken or deposit, causing nozzles to become clogged, resulting in printing defects.
[0043] (pH adjuster) The pH adjuster can be added to adjust the solubility and stability of the resin contained in the ink. Examples of the pH adjuster for adjusting the ink to an acidic state include acetic acid and citric acid. Examples of the pH adjuster for adjusting 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] In addition, in the preparation of ink containing a pigment such as vegetable charcoal pigment, titanium dioxide, or aluminum lake, it is preferable to carry out a pigment dispersion treatment. This dispersion treatment can be carried out using a dispersing machine. Examples of the dispersing machine 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, the 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 the 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 supporting the container 84, and wheels 88 rotatably provided on the frame 86. The container 84 has an inverted pyramid shape and has a discharge port 90 on the bottom surface. The container 84 has a butterfly valve 92 at the discharge port 90. The frame 86 has a support 93 whose upper end is provided at the four corners of the container 84, and a connector 94 that connects the lower ends of the support 93 to each other. The tablet collection container 82 has wheels 88 rotatably provided on the lower ends of the support 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 tablet compression process to the printing process and is disposed above the hopper 12. Next, the tablet collection container 82 opens the butterfly valve 92 and dumps the tablets 20 in the container 84 from the discharge port 90 into the hopper 12. Note that the container 84 is not limited to being in an inverted pyramid shape, and may be in an inverted cone shape.
[0048] [Tablet manufacturing method] Hereinafter, a tablet manufacturing method to which the present invention is applied (hereinafter, may be simply referred to as a manufacturing method) will be described. In the first embodiment, a method for manufacturing a tablet 20 using a manufacturing apparatus 10 of the first embodiment shown in Fig. 1 and Fig. 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 the surface of the tablet 20. That is, the manufacturing method of the tablet 20 of the first embodiment includes the following steps. (1) A conveying process in which the tablets 20 are dropped from a pre-treatment process onto a conveying surface 24 for conveying the tablets 20, and the tablets 20 are conveyed. (2) A printing process for printing on the surface of the tablet 20 after the conveying process. (3) A first suction step of suctioning powder separated from the surface of the dropped tablet 20 in the conveying step. Moreover, 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 in the case where it includes 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, while sucking up powder that has separated from the surface of the tablet 20. 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 by their own weight and randomly fall onto the conveying surface 24 of the receiving section 36. When the tablets 20 are discharged from the hopper 12, they come into contact with other tablets 20. In addition, at least a part 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 risen into the connecting pipe 26. Therefore, the manufacturing method according to the first embodiment can more efficiently remove the powder from the tablet 20, and therefore can manufacture the tablet 20 with less powder adhering to the surface.
[0052] Furthermore, the tablet 20 is transported from the receiver 36 to the second transport lane 16 through the transport unit 38. Since 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] Then, the tablet 20 is 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 provided 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 part of the remaining powder adhering to the surface of the tablet 20 may be detached from the surface of the tablet 20 and may 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 printing conveying surface 42 of the second receiving unit 46, thereby sucking in the powder that has risen up onto the printing conveying surface 42 of the second receiving unit 46. Therefore, the manufacturing apparatus 10 of the first embodiment can more efficiently remove the powder from the tablet 20. By providing the receiving unit cover 54, the second receiving unit 46 can prevent the risen powder from scattering, and can more reliably suck in the powder from the third suction port 52.
[0056] Next, the tablet 20 is further transported to the powder removing section 48. In the powder removing step (6), the tablet 20 that has reached the powder removing section 48 moves in the width direction of the printing conveying surface 42 by contacting the guide section 66 of the cover 58, because the height direction gap 70 is shorter than the height direction length of the tablet 20, and passes between the cover 58 and the second conveying body 44 in the width direction. In other words, the tablet 20 does not enter the cover 58 from the height direction gap 70, and does not pass between the cover 58 and the printing conveying surface 42.
[0057] The blowing port 62 blows out gas in the opposite direction to the conveying direction F to the printing conveying surface 42. The gas blown out in the opposite direction to the conveying direction F to the printing conveying surface 42 causes the powder on the printing conveying surface 42 to float from the printing conveying surface 42. As a result, the powder rises onto the printing conveying surface 42 together with the blown out gas, and some of the raised powder collides with the surface of the covering portion 64 on the printing conveying surface 42 side, so that the raised powder remains 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 onto the printing conveying surface 42 and remained within the cover 58. Therefore, the manufacturing apparatus 10 separates the tablet 20 from the powder attached to the printing conveying surface 42, and sucks in the powder attached to the printing conveying surface 42, thereby preventing the powder that has left the surface of the tablet 20 from adhering to the surface of the tablet 20 again.
[0058] The powder removing unit 48 moves the tablet 20 to the outside in the width direction of the printing conveying surface 42, forming an area on the inside in the width direction of the printing conveying surface 42 where the tablet 20 does not pass. The gas blown out in the opposite direction to the conveying direction F to the printing conveying surface 42 is blown onto the printing conveying surface 42 where the tablet 20 does not pass, so it does not interfere with the conveyance of the tablet 20. Therefore, the manufacturing apparatus 10 can efficiently remove the powder without reducing the conveyance efficiency. The covering unit 64 has an inclined surface 68 that is inclined downward from downstream to upstream in a front view, so that the powder that collides with the surface of the covering unit 64 on the printing conveying surface 42 side is returned to the downstream side. Therefore, the manufacturing apparatus 10 can more efficiently remove the powder from the printing conveying surface 42.
[0059] Next, the tablet 20 that has passed through the powder removal section 48 is transported to the printing section 50 by the second transport body 44. In the printing process (7), the inspection camera 78 photographs the surface of the tablet 20. The manufacturing apparatus 10 detects, for example, the position and orientation of the tablet 20 based on the photographing result, and prints on the surface of the tablet 20 by 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 section 18. The manufacturing apparatus 10 according to the first embodiment efficiently removes powder from the surface of the tablet 20 before printing, so that it is possible to obtain a tablet 20 that is less likely to suffer from printing defects in the identification information, such as missing characters in the printed letters.
[0060] [Action and Effects] As described above, the manufacturing method of the first embodiment includes a conveying step (1) in which the tablet 20 is dropped from the pre-treatment step onto the conveying surface 24 for conveying the tablet 20, and a printing step (2) in which printing is performed on the surface of the tablet 20 after the conveying step (1), and a configuration including a first suction step (3) in which powder separated from the surface of the dropped tablet 20 is sucked in the conveying step (1). In the conveying step (1), the tablet 20 is dropped from the hopper 12 of the pre-treatment step onto the conveying surface 24, and the powder separated from the surface of the tablet 20 by the impact of the drop is sucked in the first suction step (3), so that the powder can be more efficiently removed from the tablet. Therefore, the present manufacturing method can manufacture the tablet 20 with less powder attached to the surface. Furthermore, according to the present manufacturing method, since printing is performed in the printing step (2) on the surface of the tablet 20 that has been subjected to the above-mentioned conveying step (1), a tablet with less printing defects of the identification information such as missing characters can be obtained.
[0061] The tablet manufacturing apparatus 10 of the first embodiment includes a first conveyor lane 14 in which a conveying surface 24 for conveying the tablets 20 is disposed below the discharge port 22 of the 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 on which the tablets 20 fall from the hopper 12 and for sucking in gas. The second conveyor lane 16 adopts a configuration having a printing unit 50 for applying printing to the surface of the tablets 20. As a result, as described above, the tablets 20 are dropped from the hopper 12 in the pre-treatment process onto the conveying surface 24, and the 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, so that the powder can be more efficiently removed from the tablets 20. Therefore, the present manufacturing apparatus 10 can manufacture tablets 20 with less powder attached to the surface. Furthermore, according to the present manufacturing apparatus 10, the surface of the tablet 20 from which powder has been removed in the first conveying lane 14 is printed in the printing section 50, thereby obtaining tablets 20 which are 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 embodiment, and can be modified as appropriate within the scope of the present invention. For example, the number of the first suction port 28, the second suction port 32, and the third suction port 52 is not particularly limited, and each may be one, or two or more. In addition, the first suction port 28, the second suction port 32, and the third suction port 52 are not limited to cylindrical members, and may be square 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 the first suction port 28 may be provided so that one end of the first suction port 28 is located between the lower end of the connecting pipe 26 and the conveying surface 24.
[0064] In the first embodiment, a case has been described in which 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, 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 in gas on the conveying surface 24 from some of the ventilation holes 40 that are aligned in the width direction of the conveying body 30 among the ventilation holes 40 formed in the conveying surface 24.
[0065] In the first embodiment, one end of the third suction port 52 is disposed on the print transport surface 42 in a direction 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 disposed on the print transport surface 42, tilted at a predetermined angle within a range of less than ±90 degrees in the width direction and within a range of less than ±90 degrees in the transport direction with respect to the perpendicular direction of 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 disposed outside in a direction perpendicular to the transport direction F and 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 has the guide portion 66, but the present invention is not limited to this, and the cover 58 does not need to have the guide portion 66. If the cover 58 does not have the guide portion 66, the tablet 20 on the printing conveying surface 42 passes between the powder removal unit 48 and the printing conveying surface 42, and is conveyed while moving against the gas blown out from the blowing port 62. By being exposed to the gas blown out from the blowing port 62, the powder adhering to the surface of the tablet 20 is more reliably separated 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 powder removal sections 48 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 blowing port 62 blows out gas in the direction opposite to the conveying direction F, but the present invention is not limited to this. For example, in addition to the blowing port 62 that blows out gas in the direction opposite to the conveying direction F, the manufacturing apparatus 10 may have at least one of a blowing port that blows out gas in the forward direction relative to the conveying direction F and a blowing port that blows out gas in a direction intersecting the conveying direction F.
[0069] Second embodiment Next, the manufacturing apparatus 10A according to the 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 pressed by the tablet press 110 to putting 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 convenience of explanation, the tablet buffer chute 98 and the hopper 12 are shown in FIG. 4 as a schematic partial cross section. 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 in the vertical direction. 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 is stretched from the lower end portion 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 portion 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 can be formed of, for example, an actuator powered by air pressure. The lifting mechanism 104 may also be formed of, for example, 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 blowing 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 spiral curved surface and extends from the upper end to the lower end of the cylindrical portion 118.
[0074] The second blowing port 120 is provided below the center in the vertical direction of the cylindrical portion 118. In the manufacturing apparatus 10A according to the second embodiment, two second blowing ports 120 are provided. The number of the second blowing ports 120 may be one, three or more. The second blowing port 120 is a cylindrical member, one end in the axial direction of which opens into the inside of the cylindrical portion 118, and the other end in the axial direction of which is connected to an air compressor through a pipe not shown. The fifth suction port 122 is provided vertically above the second blowing port 120, preferably above the center in the vertical direction of the cylindrical portion 118. A plurality of fifth suction ports 122 may be provided. The fifth suction port 122 is a cylindrical member, one end in the axial direction of which opens into the inside of the cylindrical portion 118, and the other end in the axial direction of which is connected to the suction pump 34 through a pipe.
[0075] The 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 the tablets 20 are 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 the 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 blowing port 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 making it possible to prevent the powder that has separated 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 the case where 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 buffering 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 buffering 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 the tablet manufactured by the above 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, which will be described later. 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. In addition, 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 a reduction in tablet abrasion degree and a reduction in the incidence of capping. The manufacturing apparatus and manufacturing method according to the third embodiment are suitable for the above-mentioned tablet. In other words, by applying the manufacturing apparatus and manufacturing method according to the third embodiment to the above tablet, a tablet with less powder adhering to the surface can be obtained.
[0080] The tablet may contain crystalline cellulose having an average particle size of 50 μm or less as an external additive. 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 with the case where an external additive having a large particle size is added. According to the present manufacturing method, the powder can be efficiently removed, so that a tablet having less powder adhering to the tablet surface can be obtained.
[0081] [Wearability] In the third embodiment, the "friability" is, for example, an index of the friability and brittleness of a tablet against impact, and can be measured by the method described in "Japanese Pharmacopoeia, 17th Edition, Reference Information, Tablet Friability Test Method." Specifically, for a number of tablets close to 6.5 g, a tablet friability meter (Toyama Sangyo Co., Ltd., tablet friability tester TFT-1200) is used to subject test tablets to abrasion at 100 revolutions (24 to 26 revolutions / min), and 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] The range of the friability of the tablet of the third embodiment, when the above-mentioned measurement method is used, may be less than 0.40% as an upper limit, and is preferably less than 0.35%, and 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 upper or lower surface of a tablet peeling off as a cross-section piece. "Capping" occurs, for example, due to impact during tableting, transportation, and packaging during the tablet manufacturing process. The capping incidence rate can be determined by a cassette rotor test. The capping incidence rate can be determined by calculating 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 tablets that have fallen. The capping incidence rate is determined by testing, for example, 100 test tablets as a sufficient number. The capping incidence rate is determined by counting the number of tablets that have capping among the 100 test tablets tested, and calculating the ratio. For example, a cassette rotor manufactured by TOSHO, for Magmit tablets 500 mg, can be used. In addition, when calculating the capping occurrence rate, the flooring specifications used may be concrete trowel + epoxy floor coating material + paste method (thickness 2 mm) (ABC Shokai) Chemicrete E or its equivalent.
[0085]
number
[0086] The range of the capping incidence rate of the tablet of the third embodiment, when the above-mentioned measurement method is used, is preferably less than 12%, more preferably less than 11%, and even more preferably less than 10%. On the other hand, since the capping incidence rate is preferably as low as possible, no lower limit is particularly set.
[0087] [hardness] In the third embodiment, "hardness" is an index of tablet hardness, and can be measured by a tablet hardness tester. DC-50 manufactured by Okada Seiko Co., Ltd. can be used as the tablet hardness tester. For example, the hardness can be determined by measuring the tablet hardness in the diameter direction using a tablet hardness tester. If the tablet hardness is too low, the degree of wear increases, so the lower limit is preferably 30N or more, more preferably 40N or more, and even more preferably 50N or more. On the other hand, from the viewpoint of powder generation, the higher the hardness of the tablet, the more desirable it is, so no upper limit is set.
[0088] [Collapse time] In the third embodiment, the "disintegration time" is an index of the ease of disintegration of a tablet in a solution. The disintegration time can be measured by the 17th revised Japanese Pharmacopoeia, General Test Methods, Disintegration Test Method. The disintegration time can be measured using a disintegration tester. More specifically, the "disintegration time" is measured by measuring the disintegration time in water using a disintegration tester for a suitable number of test tablets, for example, 6 test tablets as a test solution. For example, the disintegration tester NT-20HS manufactured by Toyama Sangyo Co., Ltd. can be used as the disintegration tester. For tablets, a suitable disintegration time is preferable because it provides tablets that disintegrate in the oral cavity in a short time when taken and are easy to swallow. The upper limit of the suitable disintegration time is 20 seconds or less, preferably 15 seconds or less, and 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 by glycosidic bonds, and examples of such cellulose derivatives include crystalline cellulose, microcrystalline cellulose, and powdered cellulose. "Cellulose derivatives" refers to cellulose molecules in which different substituents are introduced into hydroxy groups in the molecules by ether bonds or ester bonds, and examples of such cellulose derivatives include methyl cellulose, ethyl cellulose, carboxymethyl cellulose, calcium carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl 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 amount of hydroxypropoxy groups are introduced into the glucose ring, that is, cellulose with a molar substitution of 0.2 to 0.4 that is O-(2-hydroxypropyl)-converted at a low level. The shape of such cellulose derivatives includes, for example, powder, particles, and fine particles.
[0090] The cellulose and / or cellulose derivative may be synthesized or commercially available. Commercially available products include crystalline cellulose such as various grades of CEOLUS (registered trademark) from Asahi Kasei Corporation, for example, 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, magnesium hydroxide having an average particle diameter of 1 to 10 μm as measured by a laser diffraction scattering method can be obtained by calcining at 600 to 1000° C. The magnesium oxide particles may be synthesized or may be commercially available. For example, the magnesium oxide particles may be 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 specified by the Japanese Pharmacopoeia.
[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 can also produce 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 it is not limited thereto. For example, the upper limit of the average particle size of the magnesium oxide particles measured by the laser diffraction scattering method may be, for example, usually 40 μm or less, or 20 μm or less, or 10 μm or less. By making the average particle size of the magnesium oxide particles equal to or less than the above upper limit, the suspended particle size at the time of tablet disintegration may become small, and the effect of obtaining a tablet with less roughness in the oral cavity may be obtained. On the other hand, the lower limit of the average particle size is not limited, but may be, for example, usually 0.25 μm or more, 0.5 μm or more, or 1 μm or more, for example, from the viewpoint of manufacturing limitations and cost-effectiveness.
[0094] The average particle size and the average particle size of the magnesium oxide particles of the third embodiment and the magnesium hydroxide particles, which are the raw material thereof, can be measured by a measuring device using a laser diffraction scattering method. The measuring device using the laser diffraction scattering method can be, for example, 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 cause a decrease in hardness if it is too high, so the upper limit may be 0.8 g / mL or less, or 0.7 g / mL or less. On the other hand, if the bulk density is too low, capping and lamination may occur, so the lower limit may be 0.1 g / mL or more, or 0.2 g / mL or more. The bulk density may be measured, for example, using a 100 mL stainless steel cup (actual measured mass value (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 a decrease in fluidity and a 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 the lower the angle of repose, the more desirable it is, no lower limit is set. The angle of repose can be measured, for example, using a multi-tester MT-1 manufactured by Seishin Enterprise Co., Ltd.
[0097] [tablet] An 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 include 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 high plastic deformability can be blended, resulting in a tablet with high moldability, but the cost per tablet will be high. Therefore, it is preferable that the content of the magnesium oxide particles is, for example, 80% by mass or more, or 85% by mass or more, based on the entire tablet.
[0099] The tablet of the third embodiment has a mass ratio of [cellulose and / or cellulose derivatives contained as internal additives]:[cellulose and / or cellulose derivatives contained as external additives] within a certain range. By increasing the ratio of the external additives contained in the tablet, an increase in hardness and a decrease in friability can be expected. If the ratio of the external additives contained in the tablet is increased too much, for example, the capping occurrence rate and the tube passability will be increased. Therefore, when the mass of the cellulose and / or cellulose derivatives contained in the entire tablet is taken as 100, the mass ratio contained as the external additive is preferably 90 or less, for example, 88 or less, 85 or less, 80 or less, or 75 or less, and the lower limit is preferably more than 20, for example, 21 or more, 22 or more, 23 or more, 24 or more, or 25 or more. On the other hand, if the ratio of the internal additives contained in the tablet is too small, compaction will be insufficient, resulting in the generation of many fine particles, which will make it easier to hold air, and the air will not be completely removed during subsequent tableting, which may cause capping tablets. Therefore, a tablet needs to be formulated with a certain amount of internal additives, but conversely, if the ratio of internal additives contained is too high, granules are obtained that are compacted by granulation, and the granules are less likely to be destroyed by further compaction during tableting. When the granules of a tablet are less likely to be destroyed by further compaction during tableting, the moldability is reduced, that is, the friability is increased. Therefore, the mass ratio contained as an internal additive is preferably set to an upper limit of less than 80 when the mass of the cellulose and / or cellulose derivative contained in the entire tablet is taken as 100. The mass ratio contained as an internal additive is more preferably set to, for example, an upper limit of 79 or less, 78 or less, 77 or less, 76 or less, or 75 or less when the mass of the cellulose and / or cellulose derivative contained in the entire tablet is taken as 100. The mass ratio contained as an internal additive is more preferably set to, for example, an upper limit of 10 or more, for example, 12 or more, 15 or more, 20 or more, or 25 or more when the mass of the cellulose and / or cellulose derivative contained in the entire tablet is taken as 100.
[0100] In addition, the content of cellulose and / or cellulose derivatives in the entire tablet can be 20% by mass or less, 15% by mass or less, or 12% by mass or less, since too much cellulose and / or cellulose derivatives increases the cost per tablet, whereas too little cellulose and / or cellulose derivatives can be 5% by mass or more, 7% by mass or more, or 9% by mass or more, since too little cellulose and / or cellulose derivatives may not achieve the effects of the present invention.
[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. Also, 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 that are added to and mixed with the active ingredient before the granulation step in the production of tablets. As the internal additive, other additives may be added in addition to the cellulose and / or cellulose derivatives defined above. In particular, in order to adjust the disintegration time to the preferred value as described above, it is preferable to add a disintegrant such as croscarmellose sodium, corn starch, carmellose calcium, crospovidone, and carboxystarch sodium as the internal additive in addition to the cellulose and / or cellulose derivatives contained in the internal additive and the external additive at the specific ratio defined above. The disintegrant may be synthesized or may be commercially available. As a commercially available product, for example, Kiccolate (registered trademark) ND-2HS manufactured by Nichirin Chemical Industry Co., Ltd. can be used. Since it may be difficult to mold the tablet, the upper limit may be, for example, 5% by mass or less, or 3.5% by mass or less, based on the entire tablet. On the other hand, since it may be difficult to disintegrate if the amount is too small, the lower limit may be, for example, 1% by mass or more, or 2% by mass or more, based on the entire tablet.
[0103] In the third embodiment, the external additive refers to an additive containing one or more substances that are added to the granules produced after the granulation step in the production of tablets and compressed together with the granules. Other additives may be added as the external additive in addition to the cellulose and / or cellulose derivatives contained in the internal additive and the external additive at the specific ratio defined above. In particular, it is preferable to add a lubricant from the viewpoint of the success of the present invention. Examples of the lubricant include stearic acid and its salts (Mg, Ca salts). The lubricant is preferably a stearate salt, and among them, magnesium stearate and calcium stearate are more preferable. Since too much lubricant may lead to delayed disintegration, the upper limit can be, for example, 2% by mass or less, 1.5% by mass or less, or 1.0% by mass or less with respect to the entire tablet. On the other hand, if the amount of lubricant is too small, it may adhere to the punch and die, so the lower limit of the amount of lubricant added to the entire tablet can be, 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. 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 antacidity, laxatives, and prevention of calcium oxalate urinary calculi. It can also be used as a supplement for humans or animals for magnesium supplementation and antihypomagnesemia. The dosage depends on the application, purpose, or condition. For example, when used as an antacid, 0.5 to 1.0 g per adult per day is orally administered in several divided doses in terms of magnesium oxide. When used as a laxative, 2 g per adult per day is orally administered in three divided doses before or after meals, or once before bedtime. When used as a prevention of calcium oxalate urinary calculi, 0.2 to 0.6 g per adult per day is orally administered with a large amount of water in terms of magnesium oxide. For other applications, it is usually taken within the range of the tolerable upper limit of magnesium. For example, the U.S. Dietary Reference Intakes for magnesium from sources other than regular foods are set at 350 mg 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 occurrence of urinary calcium oxalate stones, as desired, by the active ingredient. The internal additive and / or external additive may further contain one or more other optional ingredients, so long as they do not substantially impede the effects expected 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 pharma- ceutically acceptable pharmaceutical additives, such as colorants and flavoring agents. Any one of these ingredients may be used alone, or any 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 process: A method for producing a tablet 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, the magnesium oxide particles, the internal additives including cellulose and / or cellulose derivatives, and optionally one or more other ingredients are mixed together. The resulting mixture is then granulated to produce granules. In view of the ingredients of the tablet of the third embodiment, it is preferable to granulate by dry granulation. Granulation by dry granulation can be performed, for example, using a dry granulator RC-156 manufactured by Freund Corporation to produce granules.
[0109] The granules thus produced are added with external additives including cellulose and / or a cellulose derivative and optionally one or more other components, and then compressed into tablets. Any method can be used for adding the external additives as long as the method allows the external additives to be added around the granules. The tableting pressure, as the 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, in addition to the standard R, any of, for example, a two-stage R, a sugar-coated R, a corner R, a corner flat surface, and a rounded corner flat surface.
[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, it is possible to extract other optional aspects of the present invention from the above detailed description and the description of the embodiments described below. EXAMPLES
[0111] The present invention will be described in more detail below with reference to examples. However, these examples are merely illustrative and are not intended to limit the present invention in any way.
[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 were as follows: Average particle size: 7.691 μm (measured by laser diffraction scattering method using Microtrackbell Co., Ltd. MT3300 EX2) Bulk density: 0.249g / mL (measured using a 100mL stainless steel cup (actual mass (g) / 100 (mL))) Angle of repose: 41.7° (measured using a multi-tester MT-1 manufactured by Seishin Enterprise Co., Ltd.)
[0117] [Manufacturing method] According to the above recipe, each raw material was weighed out 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 the raw materials of the internal additives were placed in a polyethylene bag (1100 mm x 600 mm) and mixed by shaking the bag left and right 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 mixture obtained 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 product (A) that has been subjected to a granulation process for 1 minute and the product (B) that has been sieved through a 1000 μm sieve from the product (A) that has been processed for 1 minute are measured and calculated using the following formula 3.
[0120]
number
[0121] Bulk density: Measured using a 100mL 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 100mL stainless steel cup (actual mass (g) / 100 (mL)) Angle of repose: Measured using the Multi-Tester 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 MFG. CO., LTD., small high-speed rotary tablet press, VIRG) 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 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: Using a tablet friability tester TFT-1200 manufactured by Toyama Sangyo Co., Ltd., the test was performed at 100 revolutions (number of test tablets: number of tablets as close as possible to 6.5g). Disintegration time: (Number of test tablets: 6 tablets), based on 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 5Fr: Remove the plunger of a catheter syringe (Nipro Corporation, Enteral Nutrition Infusion Set Syringe DS 20mL Catheter Yellow), place one tablet into the outer cylinder, return the plunger, suck up 20mL of 55℃ hot water, cap the tip of the cylinder and leave it for 5 minutes. After 5 minutes, rotate the catheter syringe 90 degrees 15 times by hand, then connect an enteral nutrition tube (Atom Medical, Atom Nutrition Catheter T; diameter 5Fr, length 120cm) and inject an additional 20mL of the suspension inside and ion-exchanged water for washing to check for tube blockage. This test was performed 3 times, and if the tube was not blocked, it was evaluated as "successful", and if it was blocked, it was evaluated as "unsuccessful". Calculation of compression ratio 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 mixture was within the range of 0.20 to 0.25 (g / mL) in both the Examples and Comparative Examples, and no significant 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 in the 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 size after addition of the external additive in Comparative Examples 1 and 4, which do not contain crystalline cellulose as an external additive, with 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 since there was not much difference in the angle of repose, both of which were within the range of 40° to 44°, it is considered that there is no difference in fluidity.
[0136] The measurement results of 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 crystalline cellulose contained as an internal additive increases (Comparative Example 1 → Comparative Example 3, Comparative Example 4 → Comparative Example 6), the hardness increases and the friability decreases, but the capping incidence rate increases and the aggregation of suspended particles is observed. As the mass ratio of crystalline cellulose contained as an external additive to crystalline cellulose contained as an internal additive increases, the proportion of uncompressed crystalline cellulose that can contribute to tablet formation increases, and the compression rate during tableting increases, which is thought to have led to an increase in hardness and a decrease in friability. On the other hand, since the compaction during granulation is insufficient, the fine particles that could not be made into flakes tend to entrap air, and the bulk density of the entire granules to be tableted also decreases due to the influence of the uncompressed crystalline cellulose added later, which is thought to be the cause of the increase in the capping incidence rate. In addition, in Comparative Example 3, in which the entire amount of crystalline cellulose is 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 appropriately approximately 90 or less, when the mass of cellulose and / or cellulose derivatives contained in the entire tablet is taken as 100.
[0140] The tablet thickness after compression was within the range of 5.3 to 5.5 mm, with no significant difference being observed. The disintegration time was within an appropriate range in both the Examples and Comparative Examples.
[0141] From the above results, it was found that, in particular, 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, particularly within the range of 75:25 to 25:75, magnesium oxide tablets that can simultaneously achieve reduced friability and reduced capping incidence can be efficiently produced. Furthermore, such a ratio makes it possible to simultaneously achieve reduced friability and reduced capping incidence while ensuring physical properties required for tablet production, such as moldability, granulation ability, tableting ability, flowability, and tube passability, as well as physical properties required for magnesium oxide tablets, such as disintegrability. [Industrial Applicability]
[0142] INDUSTRIAL APPLICABILITY The present invention has extremely high applicability in industrial fields in which tablets with fewer defects in the identification information printed on the surface are required, particularly in the fields of pharmaceutical production 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 Carrier 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 Directional Gap 72 Outer edge of upstream 74 Width side outer edge 76 Width direction gap 78 Inspection Camera 80 Print Head 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 Receptacle 108 Supply port 110 Tablet press 112 Interior Space 114 Receptor 116 Supply Inlet 118 Cylindrical part 120 Second Air Outlet 122 5th suction port 124 Sliding part
Claims
1. a conveying step of dropping the tablets from a pretreatment step onto a conveying surface for conveying the tablets, and conveying the tablets; A printing process for printing on the surface of the tablet after the conveying process. A method for manufacturing a tablet, comprising a first suction step of suctioning powder that has separated from the surface of the dropped tablet in the conveying step.
2. The method for producing tablets according to claim 1 , wherein the conveying step further includes a second suction step of suctioning gas above the conveying surface from below the conveying surface.
3. The method for producing a tablet as described in claim 1, further comprising a third suction step of dropping the tablet from a printing conveying surface onto a printing conveying surface that conveys the tablet in the printing step, and suctioning powder that has separated from the surface of the tablet before printing is applied to the surface of the tablet.
4. The method for manufacturing a tablet as described in claim 1, wherein the printing process includes a powder removal process in which, before printing is performed on the surface of the tablet, gas is blown onto a printing transport surface that transports the tablet in a direction opposite to the transport direction, and powder that has separated from the surface of the tablet is sucked up.
5. 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 the tablet according to claim 1, comprising:
6. In the tableting step, in addition to the granules, an external additive containing cellulose and / or a cellulose derivative is added, The method for producing a tablet according to claim 5 , wherein the cellulose and / or the cellulose derivative comprises crystalline cellulose having an average particle size of 50 μm or less.
Citation Information
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