tablet

Abstract

To provide tablets that suppress the occurrence of appearance defects.SOLUTION: A tablet 10 comprises a cylindrical body 12, a cap portion 14 having a surface protruding in a height direction H, and a printed portion 16 printed on the cap portion 14. The cap portion 14 of a circular shape when viewed from the height direction, has a central portion 18 extending in a plane direction intersecting with the height direction H, and a peripheral portion 20 continuous with an outer edge of the central portion 18. In a cross-sectional view including a central axis of the body 12, a curvature radius R1 of a surface of the central portion 18 and a curvature radius R2 of a surface of the peripheral portion 20 are within a range of ±10% of values calculated by the following formulas (1) and (2), respectively, when a diameter of the cap portion 14 viewed from the height direction H is defined as RC. A non-printed region 24 includes a region of at least 2.6% of a surface area of the cap portion 14, and is a region of 14.5% or less of the surface area of the cap portion 14. The printed portion 16 is provided in a printed region 26 excluding the non-printed region 24. R1=3.226RC-6.983...(1). R2=0.437RC-0.231...(2).SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to tablets, and particularly to tablets printed with identification information indicating characters, symbols, or figures.

Background Art

[0002] Conventionally, tablets mainly composed of magnesium oxide particles are known as antacid or laxative tablets, and their usage is recently increasing. Tablets containing such magnesium oxide particles are manufactured, for example, by blending additives of a binder and a disintegrant with the magnesium oxide particles and tableting them. For example, Patent Document 1 discloses a tablet with a high content of magnesium oxide particles having a short disintegration time of 10 seconds or less, and thus being easy to swallow when taken. The tablet described in Patent Document 1 has an advantage that it is easy to tablet and easy to form into a tablet.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] Generally, there has been a demand for further improvement in suppressing cracks and chipping in the manufacturing process for tablets. Furthermore, for example, tablets may have identification information applied to their surfaces by printing using ink, and there has been a concern that in the manufacturing process of tablets, for example, tablets may come into contact with each other and chipping of the identification information may occur.

[0005] An object of the present invention is to provide a tablet that suppresses the occurrence of defective appearance.

Means for Solving the Problems

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

[0007] [Aspect 1] The tablet comprises a columnar body, a cap, and a printed portion. The cap has a shape that protrudes in the height direction of the body. Furthermore, the cap of the tablet has a printed portion. The printed portion is printed on the cap. The cap is circular when viewed from the height direction. The cap has a central portion and a peripheral portion. The central portion extends in a plane direction intersecting the height direction. The peripheral portion is continuous with the outer edge of the central portion. The surface of the central portion has a non-printed area and a printed area. The non-printed area extends circularly from the center of the cap in the plane direction. The printed area is located outside the non-printed area. When the diameter of the cap as viewed from the height direction is RC, the radius of curvature R1 and the radius of curvature R2 in a cross-sectional view including the central axis of the body are within ±10% of the values ​​calculated by the following formulas (1) and (2), respectively. The radius of curvature R1 indicates the radius of curvature on the surface of the central portion. The radius of curvature R2 indicates the radius of curvature on the surface of the peripheral portion. The non-printed area includes at least 2.6% of the surface area of ​​the cap portion. The non-printed area includes 14.5% or less of the surface area of ​​the cap portion. The printed portion is provided in the printed area excluding the non-printed area. R1 = 3.226RC - 6.983···(1) R² = 0.437RC - 0.231···(2)

[0008] [Aspect 2] The printed portion described above includes a plurality of characters arranged in a straight line in the tablet described in Embodiment 1.

[0009] [Aspect 3] The cap portion described above is provided at at least one end of the body portion in the height direction in the tablet according to Embodiment 1 or Embodiment 2.

[0010] [Aspect 4] The above-mentioned tablet is a tablet in which magnesium oxide is the main component, according to any one of the three embodiments described in Embodiments 1 to 3.

[0011] [Aspect 5] The above-mentioned tablet is printed with an ink containing a dye, a resin, water, and ethanol, as described in any one of embodiments 1 to 4. The amount of ethanol contained in the ink is 5 to 60% by weight relative to the total composition of the ink. [Effects of the Invention]

[0012] The tablets according to the present invention can suppress the occurrence of defects in appearance. [Brief explanation of the drawing]

[0013] [Figure 1] This is a plan view of the tablet according to this embodiment. [Figure 2] This is a cross-sectional view taken along line II-II in Figure 1. [Figure 3] These figures illustrate the examples, with Figure 3(A) showing Design 1 and Figure 3(B) showing Design 2. [Figure 4] This figure is used to illustrate the embodiment and to classify the areas where character loss occurs. [Modes for carrying out the invention]

[0014] [tablet] Hereinafter, the shape of the tablet according to the embodiment of the present invention will be described with reference to the figures. As shown in Figures 1 and 2, the tablet 10 has a height direction H and a surface direction intersecting the height direction H, and comprises a cylindrical body portion 12 having a predetermined length in the height direction H, cap portions 14 provided at both ends of the body portion 12 in the height direction H, and a printed portion 16 provided on the cap portion 14. The tablet 10 is not particularly limited in terms of ease of swallowing as an oral preparation, but 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. Similarly, the upper limit of the length in the height direction H is not particularly limited, but it 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.

[0015] The cap portion 14 of this embodiment has the same shape at both ends of the body portion 12 in the height direction H. Of the two ends of the body portion 12 in the height direction H, only the cap portion 14 provided on the upper side in the height direction H will be described as representative. The cap portion 14 has a surface that protrudes in the height direction H. The height of the cap portion 14 is measured from the upper end 13, which is one end of the body portion 12, to the apex 15 of the cap portion 14. In the case of Figure 2, the height of the cap portion 14 is the height to the center of the cap portion 14 (hereinafter referred to as "cap depth") LH. The height of the cap portion 14 is not particularly limited, but for example, 0.6 mm or more and 1.0 mm or less is preferred, and 0.7 mm or more and 0.9 mm or less is more preferred. The cap portion 14 has a central portion 18 that extends in the planar direction and a peripheral portion 20 that is continuous with the outer edge of the central portion 18. In Figure 1, the dashed line 22 indicates the boundary between the central portion 18 and the peripheral portion 20. The central portion 18 is a disc-shaped part located radially inward from the cap portion 14, as indicated by the dashed line 22.

[0016] The central portion 18 has, on its surface, a non-printing region 24 and a printing region 26. The printing region 26 is an annular region that extends outside the non-printing region 24. The non-printing region 24 is a region that extends circularly in the plane direction from the center of the cap portion 14. The non-printing region 24 includes a region that is at least 2.6% of the surface area of the cap portion 14. And the non-printing region 24 is a region that is 14.5% or less of the surface area of the cap portion 14. Note that the surface area of the cap portion 14 is the area of the cap portion 14 in a plan view. Specifically, the surface area of the cap portion 14 is the area of a shape formed by connecting the intersections of a straight line parallel to the height direction H passing through the outer edge of the cap portion 14 and the plane when the cap portion 14 is viewed from the height direction H with the tablet 10 placed flat on the plane. That is, since the cap portion 14 viewed from the height direction is circular with a diameter RC, the surface area of the cap portion 14 is the area of a circle with a diameter RC. In the case of the tablet 10 shown in FIGS. 1 and 2, the body portion 12 is cylindrical. The diameter of the body portion 12 is the same as the diameter of the cap portion 14.

[0017] In FIG. 1, the two-dot chain line 28 indicates the boundary between the non-printing region 24 and the printing region 26. That is, the two-dot chain line 28 indicates the outer edge of a region that extends circularly in the plane direction from the center of the cap portion 14. The non-printing region 24 is appropriately set within a region that occupies an area of 2.6% or more and 14.5% or less of the surface area of the cap portion 14. The non-printing region 24 is a disk-shaped region inside the cap portion 14 in the radial direction from the two-dot chain line 28. The printing region 26 is an annular region from the outside in the radial direction from the two-dot chain line 28 to the outer edge of the cap portion 14. The outer edge (not shown) of the printing region 26 is appropriately set within a region that occupies an area of 33% or more and 68% or less of the surface area of the cap portion 14.

[0018] The peripheral portion 20 is an annular portion outside the one-dot chain line 22. The peripheral portion 20 includes the outer edge of the cap portion 14. At least a part of the peripheral portion 20 is connected to the body portion 12. The inner edge of the peripheral portion 20 is connected to the central portion 18. The outer edge of the peripheral portion 20 is connected to the upper end 13 of the body portion 12. The outer edge of the printing region 26 may be inside the boundary (one-dot chain line 22) between the central portion 18 and the peripheral portion 20.

[0019] As shown in FIG. 2 which is a cross-sectional view including the central axis of the body portion 12, the radius of curvature R1 of the surface of the central portion 18 and the radius of curvature R2 of the surface of the peripheral portion 20 are values within the range of ±10% of the values calculated by the following formulas (1) and (2), respectively. R1 = 3.226RC - 6.983 ··· (1) R2 = 0.437RC - 0.231 ··· (2)

[0020] Here, RC is the diameter of the cap portion 14 in plan view. In the case of the present embodiment, the diameter RC of the cap portion 14 is the same as the diameter of the body portion 12 of the tablet 10. Values within the range of ±10% of the value calculated by the above formula (1) are hereinafter referred to as the value represented by the above formula (1). Similarly, values within the range of ±10% of the value calculated by the above formula (2) are hereinafter referred to as the value represented by the above formula (2).

[0021] The surface of the peripheral portion 20 preferably has an entry angle α with respect to the height direction H of 30 degrees or more and 35 degrees or less, and more preferably 30 degrees or more and 34 degrees or less. In this specification, the entry angle α refers to the angle between the horizontal direction and the tangent line TL of the surface of the peripheral portion 20. In the case of the present embodiment, the horizontal direction is a direction parallel to the straight line connecting the upper ends 13 of the height direction H of the body portion 12 in the cross-sectional view taken along line II-II. The position of the boundary (dashed line 22) between the central portion 18 and the peripheral portion 20 with reference to the center of the cap portion 14 is represented by the radial length LX and the height direction length LH, and the coordinates represented by LX and LH are called intersection coordinates C. Note that the peripheral portion 20 may have an outer end portion where the radius of curvature of the surface is larger and the surface area is smaller in addition to the portion having the radius of curvature R2.

[0022] The printing section 16 is provided in the printing area 26 of the cap section 14, excluding the non-printing area 24. The printing section 16 is formed by printing ink onto the surface of the cap section 14 in the printing area 26. The printing section 16 is not particularly limited in size, font thickness, or typeface, for example, in the case of printing, as long as it is visible to the naked eye. The printing section 16 may include, for example, the mass of the active ingredient contained in the tablet 10 and the product name of the tablet 10, as shown in Figure 1. Furthermore, the color of the printing section 16 may be changed for each type of tablet 10, for example, according to the mass of the active ingredient contained in the tablet 10.

[0023] The printing section 16 preferably includes, for example, a plurality of characters arranged in a straight line within the printing area 26. The printing section 16 has excellent legibility because the plurality of characters constituting the identification information are arranged in a straight line. The printing section 16 may also include, for example, a plurality of characters arranged in a ring within the printing area 26. The printing section 16 can accommodate a larger number of characters compared to one arranged in a straight line because the plurality of characters constituting the identification information are arranged in a ring.

[0024] The tablet 10 has a radius of curvature R1 of the central part 18 surface that is expressed by formula (1) above. The tablet 10 can be made more robust by having a radius of curvature R2 of the peripheral part 20 surface that is expressed by formula (2) above, thereby suppressing cracking and chipping of the tablet 10.

[0025] The non-printed area 24 is an area that is likely to come into contact with a plane when the tablet 10 is placed on that plane. Therefore, the non-printed area 24 is likely to come into contact with, for example, the transport surface that transports the tablets 10, and with other tablets during the manufacturing process. By providing the printed area 16 in the printed area 26 excluding the non-printed area 24, the occurrence of missing characters in the tablets 10 when, for example, the tablets 10 come into contact with each other during the manufacturing process is suppressed.

[0026] Since the radius of curvature R1 of the central portion 18 of the tablet 10 is the value represented by formula (1) above, cracking and chipping of the tablet 10 can be more reliably suppressed. Similarly, since the radius of curvature R2 of the peripheral portion 20 of the tablet 10 is the value represented by formula (2) above, cracking and chipping of the tablet 10 can be more reliably suppressed. Therefore, the tablet 10 of this embodiment can suppress the occurrence of defects in appearance by suppressing the occurrence of cracking and chipping of the tablet and the loss of printed characters.

[0027] The tablet 10 can have a desired size and mass by having a body portion 12. In this embodiment, the tablet 10 has been described as having a body portion 12, but the present invention is not limited to this. The tablet 10 may not have a body portion 12 and may be formed only of a cap portion 14. Furthermore, in this embodiment, the tablet 10 has been described as having cap portions 14 at both ends of the body portion 12 in the height direction H, but the present invention is not limited to this, and the cap portion 14 may be at only one end of the body portion 12 in the height direction H.

[0028] In this embodiment, the case where the body portion 12 is cylindrical has been described, but the present invention is not limited to this. For example, the body portion 12 is preferably rounded in shape, and may be a triangular prism, elliptical prism, square prism, or polygonal prism. Furthermore, "prism-shaped" is not necessarily limited to an elongated shape, but includes shapes in which the length in the face direction is greater than the length in the height direction. If the shape of the body portion 12 and the cap portion 14 are different, a part of the body portion 12 may protrude outward in the face direction from the outer edge of the cap portion 14. Also, if the shape of the body portion 12 and the cap portion 14 are different, a part of the cap portion 14 may protrude outward in the face direction from the body portion 12.

[0029] The present invention has described a case in which the tablet 10 has printed sections 16 on each of the cap sections 14 provided at both ends of the body section 12 in the height direction H. However, the present invention is not limited to this case, and the printed section 16 may be provided on only one of the cap sections 14.

[0030] Tablet 10 may contain magnesium oxide as its main component. This makes it possible to obtain a magnesium oxide-based tablet in which the occurrence of cracking, chipping, and loss of printed characters is suppressed. Furthermore, tablet 10 has the characteristics described later, which further suppresses the occurrence of cracking and chipping. The case in which tablet 10 contains magnesium oxide as its main component will be described in detail below.

[0031] [Abrasion level] In this specification, "abrasion degree" is an index of the abrasion resistance and brittleness of tablet 10 to impact, and can be measured by the method described in "The Seventeenth Edition of the Japanese Pharmacopoeia, Reference Information - Test Method for Tablet Abrasion Degree." Specifically, for a number of tablets in an amount close to 6.5 g, a tablet abrasion meter (TFT-1200, manufactured by Toyama Sangyo Co., Ltd.) is used to subject the test tablets to abrasion at 100 rotations (24-26 rotations / min), the initial mass of the tablets before abrasion and the mass of the tablets after abrasion are measured, and the abrasion degree can be calculated according to the following formula 3.

[0032]

number

[0033] When using the above measurement method, the abrasion degree of the tablet 10 in this embodiment should be less than 0.40% as the upper limit, but preferably less than 0.35%, and even more preferably less than 0.30%. On the other hand, since a lower abrasion degree is desirable, no lower limit is set.

[0034] [Capping] In this specification, "capping" refers to the peeling of the upper or lower surface of tablet 10 into 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 rate can be determined by a cassette rotor test. More specifically, the capping rate is determined by discharging tablets from a cassette rotor set at a height of 2m and counting the number of capped tablets from the dropped tablets. To determine the capping rate, a sufficient number, for example, 100 test tablets, are tested. The capping rate is calculated by counting the number of tablets that capped out of the 100 test tablets and calculating the percentage. For example, a cassette rotor manufactured by TOSHO, for Magmit 500mg tablets, can be used. When calculating the capping rate, the floor material specifications used can be concrete trowel + epoxy floor coating + paste method (thickness 2mm) (ABC Corporation) Chemicrete E or equivalent specifications.

[0035]

number

[0036] The capping rate of the tablet 10 in this embodiment is preferably less than 12%, more preferably less than 11%, and even more preferably less than 10%, when using the above measurement method. On the other hand, since a lower capping rate is desirable, no lower limit is set.

[0037] [hardness] In this specification, "hardness" is an index of the hardness of a tablet, which can be measured with a tablet hardness tester. For example, the DC-50 from Okada Seikou Co., Ltd. can be used as a tablet hardness tester. Hardness can be determined, for example, by measuring the hardness of the tablet in the diametrical direction using a tablet hardness tester. If the hardness of the tablet is too low, the degree of abrasion will increase, so a lower limit of 30N or higher is preferable, more preferably 40N or higher, and even more preferably 50N or higher. On the other hand, since it is desirable for the tablet to be harder, no upper limit is set.

[0038] [Collapse Time] In this specification, "disintegration time" is an indicator of how easily a tablet disintegrates in a solution. Disintegration time can be measured according to the general test methods and disintegration test methods of the 17th edition of the Japanese Pharmacopoeia. It can be determined by measuring the disintegration time using a disintegration tester. More specifically, "disintegration time" is measured using a disintegration tester with a test solution containing an appropriate number, for example, 6 test tablets. For example, the NT-20HS disintegration tester manufactured by Toyama Sangyo Co., Ltd. can be used. Tablets with an appropriate disintegration time are preferable because they disintegrate quickly in the mouth after ingestion, making them easy to swallow. The upper limit of an appropriate disintegration time is preferably 20 seconds or less, more preferably 15 seconds or less, and even more preferably 11 seconds or less. There is no particular lower limit to an appropriate disintegration time, but 0.5 seconds or more, or 1 second or more, is preferred.

[0039] [Cellulose and / or cellulose derivatives] In this specification, "cellulose" refers to a linear polymer of β-glucose molecules via glycosidic bonds (C6H 10 O5) nThis refers to linear polymers represented by , such as crystalline cellulose, microcrystalline cellulose, and powdered cellulose. "Cellulose derivatives" refer to molecules in which different substituents have been introduced to the hydroxyl group via ether or ester bonds, such as methylcellulose, ethylcellulose, carboxymethylcellulose, calcium carboxymethylcellulose, sodium carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, and low-substituted hydroxypropylcellulose. In this specification, "cellulose and / or cellulose derivatives" refers to at least one selected from the above-mentioned "cellulose" and "cellulose derivatives." Low-substituted hydroxypropylcellulose refers to cellulose in which a very small amount of hydroxypropoxy groups have been introduced to the glucose ring, that is, cellulose with a low level of O-(2-hydroxypropyl)ation and a molar substitution degree of 0.2 to 0.4. Such cellulose derivatives can take the form of powder, particulate, or fine particles.

[0040] For example, various grades of Ceolus® from Asahi Kasei Corporation can be used as cellulose and / or cellulose derivatives. Specifically, crystalline cellulose such as Ceolus® PH-101, UF-711, PH-102, PH-200, PH-301, PH-302, PH-20JP, UF-702, KG-802, and KG-1000 can be used as cellulose and / or cellulose derivatives.

[0041] [Magnesium oxide particles]

[0042] The magnesium oxide particles used in this embodiment are magnesium oxide (MgO) particles. These magnesium oxide particles can be obtained by calcining magnesium hydroxide particles. For example, they can be obtained by calcining magnesium hydroxide with an average particle size of 1 to 10 μm, determined by laser diffraction scattering, at 600 to 1000°C. Magnesium oxide particles can be obtained from, for example, the heavy grade from Kyowa Chemical Industry Co., Ltd., the powder grade from Kamishima Chemical Industry Co., Ltd., or the light grade and heavy grade from Tomita Pharmaceutical Co., Ltd., all of which are Japanese Pharmacopoeia magnesium oxide.

[0043] The magnesium oxide particles used in this embodiment may be in powder or granular form, but the granular form offers superior wear prevention for the tablet press and allows for the production of high-content tablets 10 with better shape retention stability.

[0044] The magnesium oxide particles used in this embodiment are not limited, but it is preferable that they have a predetermined particle size. The upper limit of the average particle size of magnesium oxide particles measured by laser diffraction scattering can be, for example, 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 below the above upper limit, the size of suspended particles when the tablet disintegrates becomes smaller, which may result in a tablet with less grittiness in the oral cavity. On the other hand, the lower limit of the average particle size is not limited, but from the perspective of manufacturing limitations and cost-effectiveness, it can be, for example, 0.25 μm or more, 0.5 μm or more, or 1 μm or more.

[0045] The average particle size and average particle diameter of the magnesium oxide particles and magnesium hydroxide particles used as raw materials in this embodiment can be measured using a laser diffraction scattering method measuring device. Measurement using the laser diffraction scattering method can be achieved, for example, by using the Microtrac Bell MT3300EX2 particle size distribution analyzer.

[0046] In this embodiment, the bulk density of magnesium oxide particles can be set to an upper limit of 0.8 g / mL or less, or 0.7 g / mL or less, because if it is too high, it may cause a decrease in hardness. On the other hand, if the bulk density is too low, it may cause capping and lamination, so the lower limit can 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 (measured mass value (g) / 100 (mL)).

[0047] In this embodiment, the angle of repose of the magnesium oxide particles used can be set to an upper limit of 50° or 48° or less, as a larger angle of repose may lead to poor fluidity and variations in tablet mass during tableting. On the other hand, a lower angle of repose is desirable, so no lower limit is set. The angle of repose can be measured, for example, using a multi-tester MT-1 manufactured by Seishin Corporation.

[0048] [Porosity] In this embodiment, the magnesium oxide particles used are preferably adjusted to have a porosity within a predetermined range from the viewpoint of the ink's lightfastness. The porosity of the magnesium oxide particles is preferably 30.0% to 55.0%, and more preferably 40.0% to 50.0%. By setting the porosity within the above range, ink penetrates into the voids, making it difficult for light to reach the penetrated ink, which can improve the ink's stability, lightfastness, and ultimately, its resistance to fading. Furthermore, the magnesium oxide particles can be further made to suppress bleeding and fading by adjusting the blending of ethanol, resin, etc., in the ink.

[0049] [Ingredients of the tablets] Tablet 10 may contain magnesium oxide as an active ingredient. Preferably, tablet 10 contains granules containing magnesium oxide particles and an internal additive, and an external additive. In this case, it is preferable that tablet 10 contains at least cellulose and / or a cellulose derivative as the internal additive and / or external additive. When tablet 10 contains cellulose and / or a cellulose derivative as the internal additive and / or external additive, the mass ratio of [cellulose and / or cellulose derivative contained as internal additive]:[cellulose and / or cellulose derivative contained as external additive] may be within a certain range.

[0050] Magnesium oxide particles are preferably included in the granules along with internal additives. If the magnesium oxide particle content is too high, the moldability may be insufficient. Therefore, the magnesium oxide particle content can be, for example, 90% by mass or less, or 88% by mass or less, relative to the total tablet 10. If the magnesium oxide particle content is too low, additives with high compressibility and plastic deformability can be incorporated. If additives with high compressibility and plastic deformability can be incorporated, a tablet 10 with high moldability can be obtained, but the cost per tablet will be higher. Therefore, it is preferable that the magnesium oxide particle content be, for example, 80% by mass or more, or 85% by mass or more, relative to the total tablet 10.

[0051] In this embodiment, the tablet 10 has a certain mass ratio of [cellulose and / or cellulose derivatives contained as internal additives]:[cellulose and / or cellulose derivatives contained as external additives]. By increasing the proportion of external additives contained in the tablet 10, it is expected that the hardness will increase and the degree of abrasion will decrease. If the proportion of external additives contained in the tablet 10 is increased too much, it will lead to, for example, an increase in the rate of capping and a decrease in tube passability. Therefore, when the mass ratio of cellulose and / or cellulose derivatives contained in the entire tablet 10 is taken as 100, it is preferable that the upper limit of the mass ratio of external additives contained in the tablet 10 is 90 or less, for example, 88 or less, 85 or less, 80 or less, or 75 or less. When the mass of cellulose and / or cellulose derivatives contained in the entire tablet 10 is taken as 100, it is preferable that the lower limit of the mass ratio of external additives contained in the tablet 10 is greater 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 proportion of internal additives in tablet 10 is too small, densification will be insufficient, resulting in the generation of many fine particles, which are prone to trapping air. During subsequent tableting, the air may not be completely removed, potentially causing capped tablets. Therefore, tablet 10 requires a certain amount of internal additives. Conversely, if the proportion of internal additives is too high, granules that are densified by granulation will be obtained, making them less susceptible to damage during further densification in tableting. When the granules of tablet 10 become less susceptible to damage during further densification in tableting, it leads to a decrease in moldability, i.e., an increase in abrasion. Therefore, it is preferable that the mass ratio of the internal additives be less than 80 when the total mass of cellulose and / or cellulose derivatives contained in tablet 10 is set to 100. The mass ratio of the internal additives is more preferably set to an upper limit of 79 or less, 78 or less, 77 or less, 76 or less, or 75 or less, when the total mass of cellulose and / or cellulose derivatives contained in the entire tablet 10 is set to 100. The lower limit of the internal additives is more preferably set to 10 or more, for example, 12 or more, 15 or more, 20 or more, or 25 or more, when the total mass of cellulose and / or cellulose derivatives contained in the entire tablet 10 is set to 100.

[0052] Furthermore, the content of cellulose and / or cellulose derivatives relative to the entire tablet 10 can be set to 20% by mass or less, 15% by mass or less, or 12% by mass or less, relative to the entire tablet 10, because if it is too high, the cost per tablet will increase. The content of cellulose and / or cellulose derivatives relative to the entire tablet 10 can be set to 5% by mass or more, 7% by mass or more, or 9% by mass or more, relative to the entire tablet 10, because if it is too low, the effects of this embodiment may not be achieved.

[0053] In the tablet 10 of this embodiment, the cellulose and / or cellulose derivative defined above is preferably used as an excipient or binder in both the internal and external additives. Furthermore, the cellulose and / or cellulose derivative contained in the internal and external additives may be the same or different.

[0054] In this embodiment, the term "internal additive" refers to an additive containing one or more substances that are added to and mixed with the active ingredient before the granulation process in the manufacture of the tablet 10. Other additives besides the cellulose and / or cellulose derivatives defined above may be added as internal additives. In particular, to adjust to the preferred disintegration time as described above, it is preferable to add disintegrants such as croscarmellose sodium, corn starch, carmellose calcium, crospovidone, and carboxystarch sodium as internal additives, in addition to the cellulose and / or cellulose derivatives contained in the internal and external additives in the specific ratios defined above. For example, Kikkolate® ND-2HS manufactured by Nichirin Chemical Industries, Ltd. can be used as a disintegrant. If the amount of disintegrant is too large relative to the total tablet 10, it may become difficult to form the tablet 10. The upper limit of the disintegrant can be, for example, 5% by mass or less, or 3.5% by mass or less, relative to the total tablet 10. If the amount of disintegrant is too small relative to the total tablet 10, it may become difficult to disintegrate. The disintegrant can be, as a lower limit, 1% by mass or 2% by mass or more relative to the total weight of the tablet 10.

[0055] In this embodiment, the external additive refers to an additive that is added to the granules produced after the granulation process in the manufacture of tablet 10 and compressed together with the granules. The additive comprises one or more substances. The external additive may include other additives in addition to cellulose and / or cellulose derivatives contained in the internal additive and external additive in the specific ratio defined above. For example, it is preferable to add a lubricant as the external additive. The external additive may not contain cellulose and / or cellulose derivatives, but may contain a lubricant. Examples of lubricants include stearic acid and its salts (Mg,Ca salts), preferably stearates, with magnesium stearate and calcium stearate being preferred. Too much lubricant may lead to delayed disintegration. The upper limit of the lubricant can be, for example, 2% by mass or less, 1.5% by mass or less, or 1.0% by mass or less, relative to the total weight of tablet 10. Too little lubricant may cause it to adhere to the pestle and mortar. The amount of lubricant added to the total tablet 10 can be 0.2% by mass or more, or 0.5% by mass or more, or 0.9% by mass or more, as the lower limit of the amount of lubricant added to the total tablet 10.

[0056] The mass of the tablet 10 in this embodiment, as a tablet containing magnesium oxide as the active ingredient, can be, for example, with an upper limit of 1000 mg or less, or 800 mg or less, or 600 mg or less per tablet, and a lower limit of 10 mg or more, or 50 mg or more, or 100 mg or more.

[0057] The tablets 10 of this embodiment are administered orally as a pharmaceutical product for humans or animals, for example, as an antacid, laxative, or to prevent the formation of calcium oxalate stones in the urinary tract. The tablets 10 of this embodiment can also be used as a supplement for humans or animals, for example, for magnesium supplementation or to combat hypomagnesemia. The dosage depends on the use, purpose, or medical condition. For example, when used as an antacid, 0.5 to 1.0 g of magnesium oxide per adult per day is administered orally in several divided doses. When used as a laxative, 2 g of magnesium oxide per adult per day is administered orally in three divided doses before or after meals, or as a single dose before bedtime. When used to prevent the formation of calcium oxalate stones in the urinary tract, 0.2 to 0.6 g of magnesium oxide per adult per day is administered orally with a large amount of water. For other uses, the intake should be within the range of the tolerable upper intake level for magnesium. For example, regarding intake from sources other than food, the U.S. Dietary Reference Intakes 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).

[0058] The pharmaceutical product of this embodiment is approved in Japan for use as a desired antacid, laxative, and preventative agent for the formation of urinary tract calcium oxalate stones due to its active ingredient. The internal and / or external additives may contain one or more other optional components, provided that they do not substantially hinder the expected effects in each of its uses, as well as the reduction of abrasion and the reduction of capping incidence. Such other components are not limited to, but include, various pharmaceutically acceptable pharmaceutical additives, such as colorants and flavorings. These components may be used individually or in any combination and ratio of two or more.

[0059] [Method of manufacturing tablets] The tablets 10 according to this embodiment can be manufactured, for example, by granulating powder into granules. Dry granulation is preferred. For example, granules can be produced by granulating using a dry granulator. For example, the dry granulator RC-156 manufactured by Freund Industrial Co., Ltd. can be used.

[0060] Next, the obtained granules are used to form tablets. The tableting pressure, as a punching pressure per tablet, can be set to, for example, an upper limit of 20kN or less, or 18kN or less, or 16kN or less. The tableting pressure, as a punching pressure per tablet, can be set to, for example, a lower limit of 2kN or more, or 3kN or more, or 4kN or more. The shape of the punch can be appropriately selected according to the shape of the tablet 10.

[0061] If tablet 10 is a tablet containing magnesium oxide as an active ingredient, the above manufacturing method may include the steps of mixing magnesium oxide particles with an internal additive containing cellulose and / or a cellulose derivative, granulating the mixture to form granules, and compressing the granules into tablets. Furthermore, if tablet 10 contains an external additive, the above tableting step may include adding the external additive containing cellulose and / or a cellulose derivative to the granules and then compressing them into tablets. When adding the external additive containing cellulose and / or a cellulose derivative to the granules, the mass ratio of [cellulose and / or cellulose derivative contained as an internal additive] to [cellulose and / or cellulose derivative contained as an external additive] may be in the range of 75:25 to 10:90.

[0062] After tableting, a printed area is formed on the cap portion 14 of the tablet by printing. The printing method is not particularly limited, but for example, dye ink or pigment ink may be used to form the printed area using an inkjet printer. The colorants contained in the dye ink or pigment ink are those approved as food additives or those that comply with the Pharmaceutical Affairs Law. Such colorants that can be used include, for example, safflower red pigment, gardenia blue pigment, chlorophyll pigment, turmeric pigment, cocoa pigment, squid ink pigment, titanium dioxide, carbon powder, iron oxide, 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 Blue No. 1, Food Blue No. 2, Food Yellow No. 4, Food Yellow No. 5, and Food Green No. 3.

[0063] The following explanation uses ink used in inkjet printers as an example. For example, inkjet printer inks contain a dye, water, ethanol, and a resin. Other ingredients may be added as needed, such as a water-soluble high-boiling point organic solvent, emulsifier, pH adjuster, flavoring agent, and preservative. Food-grade materials are preferred for all of these ink compositions.

[0064] (dye) The pigments can be selected from one or more types of synthetic food pigments and natural food pigments. Examples of synthetic food pigments include tar-based pigments, natural pigment derivatives, natural synthetic pigments, and titanium dioxide. Examples of tar-based pigments 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 Yellow No. 5 Aluminum Lake, and Food Blue No. 2 Aluminum Lake. Examples of natural pigment derivatives include copper chlorophyll, copper chlorophyllin sodium, and norbixin potassium, while examples of natural synthetic pigments include β-carotene and riboflavin.

[0065] Natural food colorings include, for example, plant charcoal pigments, anthocyanin pigments, carotenoid pigments, quinone pigments, flavonoid pigments, betaine pigments, monascus pigments, and other pigments derived from natural sources. Anthocyanin pigments include red radish pigment, red cabbage pigment, red rice pigment, elderberry pigment, cowberry pigment, gooseberry pigment, cranberry pigment, salmonberry pigment, perilla pigment, 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, whortleberry pigment, boysenberry pigment, mulberry pigment, purple sweet potato pigment, purple corn pigment, purple yam pigment, raspberry pigment, red currant pigment, loganberry pigment, and other anthocyanin pigments. Carotenoid pigments include annatto pigment, gardenia yellow pigment, and other carotenoid pigments. Quinone pigments include cochineal pigment, lithospermum pigment, lac pigment, and other quinone pigments. Flavonoid pigments include safflower yellow pigment, sorghum pigment, onion pigment, and other flavonoid pigments. Betaine pigments include beet red pigment. Monascus pigments include red yeast rice pigment and red yeast rice yellow pigment. Other pigments derived from natural products include, for example, turmeric pigment, gardenia blue pigment, gardenia red pigment, and spirulina blue pigment.

[0066] The pigment content is preferably 0.1 to 10% by weight, and more preferably 0.5 to 8% by weight, relative to the total ink composition. If the pigment content is less than 0.1% by weight, the printed color tends to be lighter and visibility tends to be poor. If the pigment content is more than 10% by weight, the ink viscosity increases, making it difficult for the ink to be ejected properly and tending to result in printing defects.

[0067] (ethanol) For ethanol, naturally brewed ethyl alcohol and sugarcane alcohol are preferred, for example. The ethanol content is preferably 5 to 60% by weight, and more preferably 10 to 40% by weight, relative to the total ink composition. If the ethanol content is less than 5% by weight, the ink tends to dry poorly. If the ink has poor drying properties, for example, taking more than 3 seconds to dry after printing, there is a risk that the ink may peel off during transport after printing, or adhere to other tablets and transport surfaces, causing contamination. Also, if the ethanol content is less than 5% by weight, the surface tension of the ink increases, and the printed ink tends to repel from the surface of the tablets. In other words, the ink does not wet and spread on the surface of the tablets, making it difficult to dry. If the ink does not wet and spread on the surface of the tablets, the contact area with the tablet surface is small, resulting in low adhesion, and there is a risk that it may peel off when rubbed even after 24 hours. Furthermore, if the ethanol content is more than 60% by weight, the ink tends to dry and adhere inside or around the opening of the inkjet nozzle. If the ink dries and clogs the opening, it can lead to problems such as poor ink ejection or misdirection of the ejected ink's flight path, resulting in printing defects.

[0068] (Water-soluble, high-boiling point organic solvent) Water-soluble high-boiling point organic solvents can be used to prevent drying of the nozzles of the inkjet head. For example, one or more water-soluble high-boiling point organic solvents can be selected from propylene glycol and glycerin. The content of the water-soluble high-boiling point organic solvent is preferably 1 to 60% by weight, and more preferably 2 to 55% by weight, relative to the total ink composition. If the content of the water-soluble high-boiling point organic solvent is less than 1% by weight, the ink tends to dry out at the inkjet nozzles, resulting in printing defects. Conversely, if the content of the water-soluble high-boiling point organic solvent is more than 60% by weight, the ink viscosity increases, which may prevent the ink from being ejected properly, potentially leading to printing defects.

[0069] (resin) The ink may also contain edible resins as needed. Examples of edible resins include shellac, gum arabic, starches, cellulose resins, vinyl acetate resins, and polyvinylpyrrolidone. One or more edible resins can be selected.

[0070] (emulsifier) The emulsifier can be selected from, for example, one or more water-soluble types such as 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 ink does not necessarily have to contain an emulsifier. If an emulsifier is included in the ink, the emulsifier content is preferably 0.01 to 5% by weight, and more preferably 0.1 to 2% by weight, relative to the total ink composition. If the emulsifier content is less than 0.01% by weight, the surface tension of the ink may increase, and a proper meniscus state may not be achieved at the nozzle opening. If the ink does not achieve a proper meniscus state at the nozzle opening, printing defects may occur because the ink is not ejected from the nozzle or, even if ejected, does not land in the designated position. Also, if the emulsifier content is more than 5% by weight, for example, the ink may become thicker, and precipitates may form over time, which may clog the nozzle and again result in printing defects.

[0071] (pH adjuster) A pH adjuster can adjust the pH of the ink to a predetermined range. From the viewpoint of water resistance, it is preferable that the pH adjuster is a component that volatilizes after printing. Examples of pH adjusters include ammonium hydroxide, ammonium carbonate, and ammonium chloride. Among these, from the viewpoint of avoiding residue problems, it is preferable to adjust the pH using ammonium hydroxide or ammonium carbonate as the pH adjuster. The porosity of the tablet can be measured, for example, by the mercury intrusion method using a pore size distribution analyzer. For example, the Micrometrics Autopore V9620 can be used as a pore size distribution analyzer.

[0072] For stirring during ink preparation, for example, a magnetic stirrer, a propeller stirrer, or a commonly used stirrer can be used.

[0073] Furthermore, when inks contain pigments such as plant charcoal pigments, titanium dioxide, or aluminum lake, it is necessary to disperse the pigments. Dispersion can be performed using a disperser. Examples of dispersers include ball mills, roll mills, sand mills, and bead mills.

[0074] For example, the ink can be filtered using centrifugal filtration or filter filtration. [Examples]

[0075] The present invention will be described in more detail below with reference to examples, but these examples are merely illustrative examples for explanatory purposes, and the present invention is not limited in any sense to these examples.

[0076] <Example 1> Abrasion degree and capping evaluation [Prescription] In manufacturing the tablets according to this embodiment, the formulation shown in the table below was used.

[0077] [Table 1]

[0078] The details of the raw materials in Table 1 are as follows: Magnesium oxide: Japanese Pharmacopoeia Magnesium Oxide (heavy grade) manufactured by Kyowa Chemical Industry Co., Ltd., Crystalline cellulose: Ceolus KG-1000 manufactured by Asahi Kasei Corporation, Croscarmellose sodium: Kikkolate ND-2HS manufactured by Nichirin Chemical Industry Co., Ltd., Calcium stearate: Calcium stearate (plant-derived) manufactured by Taihei Chemical Industry Co., Ltd. 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 Microtrac Bell Co., Ltd. MT3300 EX2) • Bulk density: 0.249 g / mL (measured using a 100 mL stainless steel cup (actual mass value (g) / 100 (mL))) • Angle of repose: 41.7° (measured using a multi-tester MT-1 manufactured by Seishin Corporation)

[0079] [Manufacturing method] According to the above formulation, each ingredient was weighed using an electronic balance (Mettler Toledo, 5kg capacity, PB5001-S / FACT) on a 15,000-tablet scale. 1.Mixing The weighed magnesium oxide and other raw materials were placed in a polyethylene bag (1100mm x 600mm) and the bag was shaken 30 times from side to side to mix them. 2. Granulation The resulting mixture was granulated using a dry granulator (RC-156, manufactured by Freund Industrial Co., Ltd.) under the following granulation conditions to produce granules.

[0080] [Table 2]

[0081] After granulation, the bulk density and particle size were measured using the following method. • Bulk density: Measured using a 100mL stainless steel cup (actual mass value (g) / 100 (mL)). • Particle size distribution: Measured using a particle size distribution analyzer (LMS-2000e laser diffraction scattering particle size distribution analyzer manufactured by Seishin Corporation). 3.Tablet compression The mixed granules and external additives were compressed into tablets using a tablet press (VIRG, a small, high-speed rotary tablet press manufactured by Kikusui Seisakusho Co., Ltd.) under the following conditions. Tablet compression conditions: φ10.5mm punch, single punch. Rotary disc rotation speed 45 rpm, thickness 5.1 mm (preload thickness 6.0 mm) Tablets were compressed using multiple types of punches, employing both Formula 1 and Formula 2. After compression, the following evaluations were performed. • Mass: (Number of test tablets: 10 tablets) Thickness: (Number of test tablets: 5 tablets), using a thickness gauge manufactured by Ozaki Seisakusho Co., Ltd. • Hardness: (Number of test tablets: 10 tablets), using a DC-50 load cell type bench hardness tester manufactured by Okada Seikou Co., Ltd. • Abrasion resistance test: Conducted using a tablet abrasion resistance tester TFT-1200 manufactured by Toyama Sangyo Co., Ltd., with 100 rotations (number of test tablets: as close as possible to 6.5g). • Tableting status: Visually check the tableting pressure and whether there are any tableting defects. Table 3 shows the composition of the punch and the evaluation results of tablets compressed using the above formulation, while Table 4 shows the measurement results after tableting.

[0082] [Table 3]

[0083] [Table 4]

[0084] In the table above, "R1-R2-Cup" represents R1, R2, and cap depth, respectively. From the above, good results were obtained in both capping and abrasion for tablets formed using punches No. 2 and No. 3. Furthermore, from the results for No. 3, it was found that even better results in abrasion and capping could be obtained by setting the entry angle to 34°. In addition, from the results for No. 5 and No. 6, it was confirmed that good results in abrasion and capping could be obtained in the same way as with No. 3 by forming tablets using a punch similar in shape to No. 3.

[0085] <Example 2> Print Evaluation In accordance with the "Manufacturing Method" described above, magnesium oxide tablets were produced using the No. 3 punch in the first example above. These tablets contained granules containing magnesium oxide particles and an internal additive, as well as an external additive, and included at least cellulose and / or a cellulose derivative as both the internal and external additives, with the mass ratio of [cellulose and / or cellulose derivative contained as internal additive]:[cellulose and / or cellulose derivative contained as external additive] being in the range of 75:25 to 10:90.

[0086] Furthermore, a printed area was formed on the tablet using dye ink or pigment ink, with the following equipment and an inkjet printer. ·Printing device • Tablet printing machine: Manufactured by Ikegami Tsushinki Co., Ltd. (TIE-4500P) • Tablet printing inspection: Manufactured by Daiichi Jitsugyo Biswill Co., Ltd. (System TIPS-EX4-CD) The printed design consisted of two types: tablet 100, shown in Figure 3(A), and tablet 110, shown in Figure 3(B). Tablet 100 has design 1, in which text is formed as identification information across the entire cap portion 14. Tablet 110 has design 2, in which text is formed as identification information across the portion of the cap portion 14 excluding the non-printed area. The dye ink used contained food blue No. 1, water, ethanol, propylene glycol, and shellac.

[0087] [Vibration Test] The obtained tablets were evaluated by vibration testing using the method described below. • Vibration testing equipment: Manufactured by IMV Corporation • Test method: 1000 printed tablets were filled into bottles, and the final packaged product (20 bottles) was tested according to JIS Z0200 Packaging goods - General rules for performance testing and JIS Z0232 Packaging goods - Vibration testing. • Vibration test conditions: The test was conducted under vibration test level 2, simulating long-distance domestic or international transport in a temperate climate with appropriate transport conditions, and involved random vibration in the z-axis for 90 minutes. • Evaluation method: After testing, the tablets were removed from the bottle, and the number of tablets with transfer or missing characters was counted visually to determine the frequency of occurrence.

[0088] [Packaging Test] The obtained tablets were evaluated by a dispensing test using the method described below. • Automatic tablet packaging machine: Manufactured by Tosho Co., Ltd. (Xana-120) • Test method: 1000 printed tablets were filled into a cassette for the dispensing machine, the cassette was placed on the upper level of the dispensing machine, and 200 packets of 5 tablets each were dispensed. • Evaluation method: After packaging, the tablets were removed from the packaging paper, and the number of tablets with transfer or missing characters was counted by visual inspection to determine the frequency of occurrence.

[0089] [Evaluation Results] The combination of the printed design and ink, as well as the results of the vibration test and packaging test, are shown in the table below.

[0090] [Table 5]

[0091] It was confirmed that Design 2 reduced the occurrence of transfer and character loss compared to Design 1 (comparison of Example 2-1 with Comparative Example 2-1, and Examples 2-2 and 2-3 with Comparative Examples 2-2 and 2-3, respectively).

[0092] The following table shows the results of classifying the locations of missing letters in tablets where missing letters occurred, according to the regions shown in Figure 4. In tablet 100 shown in Figure 4, the four circles represented by dashed lines are regions that extend circularly in the direction of the surface from the center of the cap portion 14, with circle A representing a region of 2.6% of the surface area of ​​the cap portion 14, circle B representing a region of 14.5% of the surface area of ​​the cap portion 14, circle C representing a region of 33.3% of the surface area of ​​the cap portion 14, and circle D representing a region of 68.2% of the surface area of ​​the cap portion 14.

[0093] [Table 6]

[0094] In Table 6, region A represents the circular surface enclosed by circle A, region B represents the annular surface obtained by subtracting the surface enclosed by circle A from the surface enclosed by circle B, region C represents the annular surface obtained by subtracting the surface enclosed by circle B from the surface enclosed by circle C, and region D represents the annular surface obtained by subtracting the surface enclosed by circle C from the surface enclosed by circle D. From the above results, it was found that the rate of character loss in region A, where the area ratio of the cap portion 14 is 2.6%, and in region B, where the area ratio is 14.5% or less, is higher than the rate of character loss in regions C and D, which are outside these ranges. Therefore, it was confirmed that the occurrence of character loss can be suppressed by providing the printed area outside the non-printed area, excluding the non-printed area which includes 2.6% of the surface area of ​​the cap portion 14 and is within the range of 14.5% or less.

[0095] <Third Example> [Prescription] The tablets were manufactured using the formulations shown in the table below.

[0096] [Table 7]

[0097] [Table 8]

[0098] The details of the raw materials used in each of the above examples and comparative examples are as follows. Magnesium Oxide: Manufactured by Kyowa Chemical Industry Co., Ltd. Japanese Pharmacopoeia Magnesium Oxide (Heavy Grade) Crystalline cellulose: Ceolus PH-101 (Examples 3-1 to 3-3, Comparative Examples 3-1 to 3-3), Ceolus UF-711 (Examples 3-4 to 3-6, Comparative Examples 3-4 to 3-6), manufactured by Asahi Kasei Corporation. Croscarmellose sodium: Manufactured by Nichirin Chemical Industries Co., Ltd., Kikkolate ND-2HS Calcium stearate: Manufactured by Taihei Chemical Industry Co., Ltd. Calcium stearate (plant-derived) 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 Microtrac Bell Co., Ltd. MT3300 EX2) • Bulk density: 0.249 g / mL (measured using a 100 mL stainless steel cup (actual mass value (g) / 100 (mL))) • Angle of repose: 41.7° (measured using a multi-tester MT-1 manufactured by Seishin Corporation)

[0099] [Manufacturing method] According to the above formulation, each ingredient was weighed using an electronic balance (Mettler Toledo, 5kg capacity, PB5001-S / FACT) on a 15,000-tablet scale. 1.Mixing The weighed magnesium oxide and the raw materials for the internal additive were placed in a polyethylene bag (1100 mm x 600 mm), and the bag was shaken 30 times from side to side to mix. After the mixing process, the bulk density was measured using a 100 mL stainless steel cup (measured mass value (g) / 100 (mL)). 2. Granulation The resulting mixture was granulated using a dry granulator (RC-156, manufactured by Freund Industrial Co., Ltd.) under the following granulation conditions to produce granules.

[0100] [Table 9]

[0101] After granulation, the following evaluation items were performed. • Flake ratio: The mass of the 1-minute processed product (A) and the 1-minute processed product (A) sieved through a 1000 μm sieve (B) are measured and calculated using the following formula 5.

[0102]

number

[0103] • Bulk density: Measured using a 100mL stainless steel cup (actual mass value (g) / 100 (mL)). • Particle size distribution: Measured using a particle size distribution analyzer (LMS-2000e laser diffraction scattering particle size distribution analyzer manufactured by Seishin Corporation).

[0104] 3. Addition of external additives The granules and the weighed raw materials for the external additive were placed in a polyethylene bag (1100mm x 600mm) and the bag was shaken 30 times from side to side to mix them. After mixing, the following evaluation items were performed. • Bulk density: Measured using a 100mL stainless steel cup (actual mass value (g) / 100 (mL)). • Angle of repose: Measured using the MT-1 multi-tester manufactured by Seishin Corporation. 4.Tablet compression The mixed granules and external additives were compressed into tablets using a tablet press (VIRG, a small, high-speed rotary tablet press manufactured by Kikusui Seisakusho Co., Ltd.) under the following conditions.

[0105] [Table 10]

[0106] After tableting, the following evaluation items were performed. • Mass: (Number of test tablets: 10 tablets) • Thickness: (Number of test tablets: 5), using a Peacock thickness gauge. • Hardness: (Number of test tablets: 10 tablets), using a DC-50 load cell type bench hardness tester manufactured by Okada Seikou Co., Ltd. • Abrasion resistance test: Conducted using a tablet abrasion resistance tester TFT-1200 manufactured by Toyama Sangyo Co., Ltd., with 100 rotations (number of test tablets: as close as possible to 6.5g). • Disintegration time: (Number of test tablets: 6 tablets), in accordance with the 17th edition of the Japanese Pharmacopoeia, general test methods, 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 the tableting pressure and whether there are any tableting defects. • Suspended particle size D50 (μm): (Number of test tablets: 1 tablet), the suspended particle size was measured when the test tablet was suspended in water using the LMS-2000e laser diffraction scattering particle size analyzer manufactured by Seishin Corporation. • Tube purging ability (5Fr): The plunger of a catheter syringe (Nipro Corporation, Enteral Nutrition Infusion Set Syringe DS 20mL Catheter Yellow) was removed, one tablet was placed inside the outer barrel, the plunger was returned, 20mL of 55°C warm water was drawn in, the end of the barrel was capped, and it was left standing for 5 minutes. After 5 minutes, the catheter syringe was manually rotated 90 degrees 15 times, then an enteral nutrition tube (Atom Medical, Atom Nutrition Catheter T; diameter 5Fr, length 120cm) was connected, and 20mL of the internal suspension and ion-exchanged water for washing was injected to check whether the tube was blocked. This test was performed three times, and it was evaluated as "suitable" if the tube was not blocked and "unsuitable" if it was blocked. • Calculation of compression ratio in the tableting process: Let the filling depth be (a) and the final compression thickness be (b), and calculate using the following formula 6.

[0107]

number

[0108] [result] The table below shows the measurement results of the bulk density of the resulting product (mixture) after mixing.

[0109] [Table 11]

[0110] [Table 12]

[0111] The bulk density of the mixed product was within the range of 0.20 to 0.25 (g / mL) for both the examples and comparative examples, and no significant differences were observed. The measurement results for each item of the granulated product after granulation are shown in the table below.

[0112] [Table 13]

[0113] [Table 14]

[0114] Regarding granulation properties, the higher the amount of crystalline cellulose contained as an internal additive, the better the processing capacity, 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. The measurement results after the addition of the external additive are shown in the table below.

[0115] [Table 15]

[0116] [Table 16]

[0117] When comparing the particle size after the addition of the external additive in Comparative Examples 3-1 and 3-4, which did not contain crystalline cellulose as an external additive, with that of Comparative Examples 3-3 and 3-6, which contained 100% crystalline cellulose as an external additive, an increase of 150 μm Pass was observed in Comparative Examples 3-3 and 3-6. However, since the angle of repose was within the range of 40° to 44° in all cases, there was not much difference, and therefore it is considered that there was no difference in fluidity.

[0118] The measurement results for each item after tableting are shown in the table below.

[0119] [Table 17]

[0120] [Table 18]

[0121] As the mass ratio of crystalline cellulose contained as an external additive to the crystalline cellulose contained as an internal additive increased (Comparative Example 3-1 → Comparative Example 3-3, Comparative Example 3-4 → Comparative Example 3-6), hardness increased and abrasion decreased, but an increase in the rate of capping and aggregation of suspended particles were observed. It is thought that 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 could contribute to tablet formation increased, and the compression ratio during tableting increased, leading to increased hardness and decreased abrasion. On the other hand, it is thought that the insufficient compaction during granulation made it easier for fine particles that did not become flakes to trap air, and the overall bulk density of the granules to be tableted also decreased due to the influence of the uncompressed crystalline cellulose added later, resulting in insufficient degassing during compression and trapping air, which is the cause of the increased rate of capping. In addition, in Comparative Example 3-3, where the entire amount of crystalline cellulose was contained as an external additive, clogging was also observed in the tube passability test. Therefore, in order to reduce the degree of abrasion, the mass ratio of crystalline cellulose contained as an external additive is preferably approximately 25 or more, and appropriately approximately 90 or less, when the total mass of cellulose and / or cellulose derivatives contained in the tablet is taken as 100.

[0122] The tablet thickness after compression was within the range of 5.3 to 5.5 mm in all cases, with no significant differences observed. The disintegration time was within an appropriate range for both the example and the comparative example.

[0123] From the above results, it was found that by adjusting the mass ratio of [cellulose and / or cellulose derivatives contained as internal additives]:[cellulose and / or cellulose derivatives contained as external additives] to a range of 75:25 to 10:90, for example, within the range of 75:25 to 20:80, and especially within the range of 75:25 to 25:75, magnesium oxide tablets that can simultaneously reduce abrasion and capping can be efficiently manufactured. Furthermore, with such a ratio, it is possible to achieve both a reduction in abrasion and a reduction in capping while ensuring the physical properties required during tablet manufacturing, such as moldability, granulation, tabletability, flowability, and tube passage, as well as the physical properties required for magnesium oxide tablets, such as disintegration. [Industrial applicability]

[0124] This invention has extremely high applicability in industrial fields where tablets with fewer appearance defects are required, particularly in the fields of pharmaceutical manufacturing and distribution. [Explanation of symbols]

[0125] 10 tablets 12 Torso 13 Upper end of the torso 14. Cap section 15. The top of the cap 16 Printing Department 18 Central part 20 Peripheral area 22 dash-dotted line 24 Non-print area 26 Print area 28. Dotted line 100 tablets 110 tablets H (height direction)

Claims

1. A columnar body, The cap portion protruding in the height direction of the body, The cap portion comprises a printing section on which identification information is printed, The aforementioned cap portion is The shape is circular when viewed from the height direction, The central portion extends in a plane direction that intersects the aforementioned height direction, It has a peripheral portion that is continuous with the outer edge of the central portion, The surface of the central part is A non-printed area that extends circularly from the center of the cap portion in the direction of the surface, The non-printing area has a printing area outside of it, When the diameter of the cap portion as viewed from the height direction is RC (mm), in a cross-sectional view including the central axis of the body portion, the radius of curvature R1 (mm) of the surface of the central portion and the radius of curvature R2 (mm) of the surface of the peripheral portion are within ±10% of the values ​​calculated by the following formulas (1), (2), and (3), respectively. The non-printed area includes an area of ​​at least 2.6% of the surface area of ​​the cap portion and an area of ​​14.5% or less of the surface area of ​​the cap portion. The printed portion is provided in the printed area excluding the non-printed area, and the tablet is otherwise provided. R1=3.226RC-6.983...(1) R2=0.437RC-0.231...(2) 8.0 ≤ RC ≤ 10.5 ... (3)

2. The tablet according to claim 1, wherein the printed portion includes a plurality of characters arranged in a straight line.

3. The tablet according to claim 1, wherein the cap portion is provided at least one end of the body portion in the height direction.

4. The tablet according to claim 1, wherein the tablet is a tablet whose main component is magnesium oxide.

5. The aforementioned tablets are printed with an ink containing a dye, a resin, water, and ethanol. The tablet according to claim 1, wherein the ethanol content in the ink is 5 to 60% by weight relative to the entire composition of the ink.

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