JP2007326835A - Dividable tablet - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To obtain a tablet that is dividable irrespective of the obverse and reverse of a tablet, accurately divided equally, has a sufficient tablet weight and does not crack during pressing for division. <P>SOLUTION: The dividable tablet has a division line 2 for dividing the tablet into at least two tablet pieces on the surface of at least one side of both upper and lower surfaces of the tablet 1. Each table piece has inclined surfaces 4a, 4b, 5a and 5b extended at fixed angles from a division surface 3 side passing the division line 2 of the tablet 1 to side edge parts 9a and 9b sides on both the upper and lower surfaces. Two adjoining tablet pieces 1a and 1b with the division surface 3 in between make a pair and form an inverted V shape in a cross section or a V shape in a cross section. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a divided tablet, and more particularly to a divided tablet that can be divided into at least two by pressing from above the package in a packaged state regardless of the front and back of the tablet in the package.

  Tablets are widely used in the pharmaceutical industry for administration in unit dosage forms because they are particularly well tolerated by patients. In recent years, in order to optimize dose management for individual patients and increase flexibility during prescribing, the tablet can be divided equally into at least two parts by providing one or more notches (secant) on the tablet surface. Divided tablets to be taken have been developed.

  This type of tablet is of a type in which the tablet is picked up with fingers and divided by applying force with both fingers (for example, Patent Documents 1 to 3), and the tablet is placed on a hard flat surface and pressed from above with a finger or the like. It is roughly classified into a type that is divided by the above (for example, Patent Documents 4 to 9), and PTP (vinyl chloride / vinylidene chloride composite sheet) packaging is adopted as the packaging form of these tablets.

  In the former case, the user is required to take a series of steps of taking out the tablet from the PTP package, picking the tablet with fingers of both hands, and then applying force to split the tablet, so it is difficult to pick up the tablet. It is difficult to handle for elderly patients. In addition, there is a problem that a relatively strong force is required to divide, and there is a problem that the tablet may roll and lose when attempting to divide. In addition, from the viewpoint of ease of swallowing, tablets have been becoming smaller in recent years, and film coating has been applied for the purpose of making it difficult to divide small and thick divided tablets, masking of drug stability and bitterness, etc. When applied, a greater force is required, and there is a problem that the tablet is more difficult to be divided. Further, when the tablet is divided, it is necessary to store the portion that is not taken after directly touching the tablet by hand, which is not preferable from the viewpoint of hygiene.

  Since the latter divided tablet can be divided while the tablet is PTP-wrapped, it is easy for the user to handle, but those of Patent Documents 4 to 6 are not easily divided unless the dividing line is downward. Therefore, it is necessary to change the orientation of the PTP packaging so that the surface with the secant line is on the hard flat side depending on the front and back orientation of the PTP-packed tablets. In addition to the possibility of sometimes damaging the aluminum foil used in PTP packaging, there is a problem that, depending on the shape of the edge of the tablet, there is a risk of chipping by pressing.

  On the other hand, since the divided tablet described in Patent Document 7 has a dividing line on both the upper and lower surfaces, it is possible to avoid the problem of division related to the PTP packaging. However, since it is a divided tablet having a side band portion having a constant width over the entire circumference, it is difficult to manufacture a tablet having a structural thickness. This makes it necessary to increase the tablet diameter in order to achieve the desired tablet weight, which is inconvenient for both packaging and the user. In addition, there is a concern that the hardness is inferior, and there is a possibility that the tablet may be arbitrarily divided when it is taken out from the PTP packaging, and a new problem arises that it is not suitable for film coating operation.

  Further, the split tablet described in Patent Document 8 is a tablet having large grooves on both upper and lower surfaces, and is apparently formed on each bottom portion of the groove, and a central portion on each of the upper and lower surfaces of the tablet. , There are at least one pair of parallel secant lines that divide the tablet into two equal parts, and the left and right sides are symmetrical with respect to a cross section including the pair of secant lines. Therefore, a thick tablet can be manufactured. However, if the groove is enlarged, that is, if the depth of the dividing line is increased in order to facilitate division, the strength of the groove portion becomes extremely weak, and the tablet is arbitrarily divided into two even though it is not intended to be divided. There is a problem that it becomes easy, and this is considered unsuitable for film coating operations.

Furthermore, the divided tablet described in Patent Document 9 has a convex surface formed of a curved surface, a dividing line formed on the opposite surface along the center line, a peripheral portion of the surface, and two regions formed by the dividing line. Each has a convex curved surface. Therefore, the tablet can be divided by pressing from the top of the packaging, regardless of the direction of the tablet in the PTP packaging, that is, without restricting the direction when the tablet is packaged, but the surface facing the pressed surface is , Point contact or line contact with the hard flat surface on which the tablet is placed, which is very unstable upon division. Further, due to such instability, the tablet may not be equally divided into two depending on the direction of the pressing force.
JP-A-8-277218 Japanese Utility Model Publication No. 5-37924 Japanese Utility Model Publication No. 7-19339 Japanese Utility Model Publication No. 40-3680 JP-A 61-289027 JP-A-8-53345 JP 7-179333 A Japanese Patent Laid-Open No. 11-1425 WO99 / 51207

  Therefore, even if the tablet in the PTP packaging is pressed with a finger or the like from outside the packaging, the present invention makes the tablet in the PTP packaging into two or more equivalent tablet pieces regardless of the front and back and without causing chipping. An object of the present invention is to provide a tablet which can be divided and does not damage the PTP package at the time of division, and which is a dosage form suitable for operations usually used for tablet production such as film coating.

  In order to solve the above-mentioned problems, the inventors of the present invention provide a tablet having a dividing line that divides the tablet into at least two tablet pieces on at least one surface of both upper and lower surfaces of the tablet, and each tablet piece is a part of the tablet. Both upper and lower surfaces have inclined surfaces extending at a predetermined angle from the divided surface side passing through the dividing line of the tablet toward the side edge side, and two adjacent tablet pieces sandwiching the divided surface form a pair. In addition, a shape having an inverted V-shaped cross section or a V-shaped cross section is formed.

  In a preferred embodiment, the tablet of the present invention comprises a split groove having a V-shaped cross section or an inverted V-shaped cross section with the dividing line as a bottom or a ridge at the center of the one side surface of the pair of tablet pieces, and There is a horizontal plane extending in a direction orthogonal to the dividing surface from the dividing groove toward the side edge of each tablet piece and continuing to the inclined surface, and the opposite surface formed by the pair of tablet pieces is the tablet piece. Each tablet piece has a horizontal plane extending from the side edge portion toward the central portion in a direction orthogonal to the dividing surface and continuing to the inclined surface.

  In a more preferred embodiment, in the tablet of the present invention, the inclined surface on one surface of each tablet piece and the inclined surface on the opposite surface of the tablet piece are parallel.

  In a more preferred embodiment, the tablet of the present invention has an angle formed by the inclined surface of each tablet piece and the horizontal surface of 10 degrees or more.

  In a more preferred embodiment, in the tablet of the present invention, the length of the horizontal plane including the split groove on one side surface composed of the pair of tablet pieces is between both edges of the inclined surfaces on the opposite side surface of the pair of tablet pieces. Shorter than the length of.

  In a preferred embodiment, the tablet of the present invention is such that the opposite surface composed of the pair of tablet pieces is parallel to the split groove of the one side surface of the pair of tablet pieces at the intersection of the inclined surfaces of the tablet pieces. A split groove having an inverted V-shaped cross section or a V-shaped cross section is included.

  In a more preferred embodiment, the tablet of the present invention has the pair of tablet pieces having a dividing groove having a ridge line on each side of the dividing line between the upper and lower surfaces of the pair of tablet pieces.

  In a preferred embodiment, in the tablet of the present invention, one side surface constituted by the pair of tablet pieces has a bulging portion at a central portion including the split groove.

  Moreover, the tablet of this invention WHEREIN: The opposite side surface comprised with the said tablet piece of a pair has a bulging part in the both sides.

  In a particularly preferred embodiment, the tablet of the present invention is a tablet in which the tablet can be divided into two tablet pieces, and one side surface formed by the pair of tablet pieces has a V-shaped cross section in which the tablet is divided into two at the center. A horizontal plane that extends in the direction perpendicular to the dividing plane that divides the tablet from each edge of the tablet and from the respective edges of the tablet, and the horizontal plane An inclined surface extending at a predetermined angle from both edges toward each side edge and toward the opposite surface formed by each tablet piece, and the opposite surface extends from the center to each side edge. An inclined surface extending at a predetermined angle in a direction away from the one side surface, and a horizontal plane extending from an edge of each inclined surface toward each side edge and in a direction orthogonal to the dividing surface. Comprising.

  In another preferred embodiment, the tablet of the present invention is a tablet in which the tablet can be divided into three or more tablet pieces, and the tablet is divided into three or more tablet pieces on the upper and lower surfaces of the tablet. It has a dividing line to be divided, and two tablet pieces adjacent to each other across a dividing surface passing through the dividing line are paired to form a reverse V-shaped section or a V-shaped section.

  The shape of the tablet may be any as long as it is usually used for tablets. For example, a disk shape, an elliptical disk shape, a rectangular shape, a rectangular parallelepiped shape, a polygonal disk shape, or the like may be employed, but the present invention is not limited to this. A disk shape, an elliptical disk shape or a rectangular parallelepiped shape is preferable.

  The active ingredient of the divided tablet of the present invention is not particularly limited, and any active ingredient can be adopted as long as it is preferably administered in the form of a tablet, particularly a divided tablet for oral administration.

  The additive that can be added to the divided tablet of the present invention is not particularly limited, and any additive or a combination thereof can be adopted as long as it is an additive that is commonly used by those skilled in the art. it can. Examples of such additives include: a) excipients such as lactose, dextrin, sucrose, mannitol, sorbitol, crystalline cellulose, starch and / or glycine; b) silicon dioxide, talc, stearic acid, its magnesium or calcium Lubricants such as salts; c) binders such as magnesium aluminum silicate, starch paste, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose and or povidone; d) croscarmellose sodium, crospovidone, agar, alginic acid or Disintegrants such as its sodium salt or partially pregelatinized starch; and / or e) absorbents, colorants, flavoring and sweetening agents and the like.

  The divided tablet of the present invention can be produced by an arbitrary method, but usually, a composition prepared by blending an active ingredient, an excipient and, if necessary, an additive is granulated into granules, and the granules are formed. A method of locking to obtain an uncoated tablet is employed. The granulation method includes a dry method and a wet method, and any method may be adopted.

  The uncoated tablet can be used as it is, but it may be coated to reduce the influence of light, humidity, etc. or to make it easy to take. The coating includes sugar coating, film coating and the like, and film coating is particularly preferable. The coating material is not particularly limited as long as it is used in pharmaceutical preparations. For example, hydroxypropylmethylcellulose, hydroxypropylcellulose, ethyl acrylate / methyl methacrylate copolymer, aminoalkyl methacrylate copolymer, carboxyvinyl polymer, pullulan, Povidone, stearyl alcohol, cetanol, shellac, triacetin, macrogol, polysorbate 80 and the like can be mentioned. When the uncoated tablet is coated, it can be made into a preparation that is stable to the environment such as light and humidity, has little or no change in quality, discoloration, etc. it can. In general, obstacles such as twinning (tablet sticking) may occur when a film coating is applied. However, in the divided tablet of the present invention, the occurrence of twining can be reduced due to its unique shape.

  According to the present invention, for example, a tablet that can be easily divided by pressing with a finger or the like from above regardless of the size or the upper and lower sides of the front and back is obtained. In the tablet of the present invention, since a part of one side surface always comes into surface contact with the hard flat surface regardless of which side is in the PTP package, the position and direction for dividing the tablet when pressed are stable. The division is performed very accurately, and no chipping occurs when pressed, and the PTP packaging is not damaged. Each of the divided tablet pieces can be separately taken out from the PTP package by pressing with a finger or the like. For example, when the user intends to take only one tablet piece and the other tablet piece at a later time, after removing the one tablet piece from the PTP package by the above method, By simply folding the PTP packaging sheet inside the tablet storage body while leaving the tablet pieces in the PTP packaging, the tablets can be stored easily.

  In addition, since the tablet of the present invention is not obtained by reducing the thickness of the tablet and obtaining the ease of cracking, the tablet of the present invention is compared with a tablet having a secant on both surfaces in order to obtain the same ease of division as the tablet of the present invention. Thus, the weight of the tablet can be increased. This can reduce the number of drugs that the user should take at one time, which is convenient for the user.

  Hereinafter, embodiments of divided tablets according to the present invention will be described with reference to the accompanying drawings. For the sake of convenience, the upper surface of the figure will be described as the front surface of the tablet and the lower surface of the figure will be described as the back surface, but these designations are relative and any surface may be the front side. it can.

  1 to 3 show a divided tablet according to an embodiment of the present invention. As shown in FIG. 1, this tablet 1 has an elliptical plate shape having a dividing line 2 for dividing the tablet into two tablet pieces in the center of the front surface, and when necessary, the dividing line 2 is vertically oriented. It is divided into two tablet pieces 1a and 1b on a plane 3 passing through.

  The two tablet pieces 1a and 1b constituting the tablet 1 form a pair, and as shown in FIG. 3, the tablet pieces 1a and 1b are symmetrical with respect to a plane (divided surface) 3 passing through the secant 2 in the vertical direction. 1b has inclined surfaces (4a, 4b, 5a, 5b) extending at predetermined angles from the center side of the tablet to the side edge portions 9a, 9b on both the upper and lower surfaces thereof, and the cross section of the whole tablet is inverted V-shaped. Form. More specifically, the front surface of the tablet 1 is formed with a V-shaped split groove 2 that bisects the tablet at the center thereof, and each tablet piece 1a, 1b from each upper edge of the split groove 2 is formed. Toward the side edge portions 9a, 9b and in the direction orthogonal to the dividing surface 3, and from each edge of the horizontal surfaces 6a, 6b, the side edge portions 9a, 1b of the tablet pieces 1a, 1b, It is composed of inclined surfaces 4a and 4b that extend at a predetermined angle toward the 9b side and toward the back side surface of each tablet piece. On the other hand, the back side surface of the tablet is directed from the center line 8 parallel to the secant 2 2 on the front side surface toward the side edges 9a, 9b of the tablet pieces 1a, 1b and in a direction away from the front side surface of each tablet piece. Inclined surfaces 5a, 5b extending at a predetermined angle (therefore, the center line 8 is a ridge line intersecting the inclined surfaces 5a, 5b) and the side edges of the tablet pieces 1a, 1b from the outer edges of the inclined surfaces 5a, 5b. It is comprised by the division surface 3 and the horizontal surfaces 7a and 7b extended in an orthogonal direction toward 9a and 9b side. Further, the surface of the tablet is covered with a coating layer 10.

The angles θ _{1 and} θ ₂ formed between the inclined surfaces constituting the upper and lower surfaces of each tablet piece and the horizontal plane are ₁₀ to 45 degrees, preferably 12 to 25 degrees, depending on the size of the tablet. However, when the angles θ _{1 and} θ ₂ are less than 10 degrees, it is difficult to divide even when pressed. When the angles θ _{1 and} θ ₂ exceed 45 degrees, the height of the tablet becomes too larger than the major axis and minor axis. This is because division becomes difficult.

Further, the lengths L ₁ and L ₃ from the divided surface or side edge of the tablet to the edge of the horizontal surface on the front surface and the back surface are usually the length from the side edge or divided surface to the end of the inclined surface. More specifically, it is set to 1/2 or less, preferably 1/10 or more and 1/3 or less of the length L ₀ between the divided surface of the tablet and the side edge so as to be shorter than L ₂ and L _4. Is done. This is because when the lengths L ₁ and L _{3 of the} horizontal plane exceed 1/2, when a force is applied to the front surface of the tablet with the back side surface of the tablet facing down or the front side surface of the tablet is down, This is because when force is applied to the back surface, the force applied to the tablet directly acts on the horizontal surface of the tablet contacting the hard surface via the packaging material, making division difficult.

When taking the tablet of the present invention, for example, as shown in FIG. 4, when the tablet is placed on the hard surface 100 with its front surface facing up and pressed, the horizontal surfaces 7 a and 7 b are located on both sides of the back surface. The force F applied to the front surface is divided in two directions parallel to the two inclined surfaces 5a and 5b on the back surface, but the line intersecting the two inclined surfaces. when considering the forces acting on a point on 8, therefore the force is larger than the component of force F ₂ which is a component force F ₁ acting in the horizontal direction acts in the vertical direction, the mechanical pressing force of the front surface of the tablet When it becomes larger than the strength, it cracks along the intersecting line 8 of the two inclined surfaces 5a, 5b and is divided. At this time, due to the presence of the V-shaped dividing groove 2 on the front surface, the strength of the portion along the plane 3 connecting the dividing groove 2 and the intersecting line 8 is weaker than that of the other portions. And is equally divided into two. This is also true when the tablets are contained within the PTP package with the front side facing the visible side of the PTP package.

On the other hand, as shown in FIG. 5, when the tablet is pressed on the hard surface 100 with its back side surface up, the tablet is in contact with the hard plane at the horizontal surfaces 6 a and 6 b at the center of the front surface, The force F applied to the back surface is divided in two directions perpendicular to the two inclined surfaces 4a and 4b on the front surface by the horizontal surfaces 6a and 6b on the front surface acting as fulcrums, but is on the back surface. When the force acting on the point on the intersecting line 8 of the two inclined surfaces is taken into account, the force is higher than the component force F ₂ acting in the vertical direction because the component force F ₁ acting in the horizontal direction is larger. When the pressing force increases beyond the mechanical strength of the tablet, it cracks along the intersecting line 8 of the two inclined surfaces and is divided (see FIG. 5).

  Regardless of which surface the tablet is pressed from, as described above, since the hard plane and the tablet are always in contact with each other on the horizontal plane, the tablet is not chipped when pressed and the PTP packaging is not damaged. Further, the component force acting in the vertical direction of the pressing force is always applied to the horizontal plane, so that the tablet is stable, and therefore the tablet is divided into two substantially evenly. If the surface of the tablet in contact with the hard plane is a curved surface, even if the pressing force is applied vertically, it is not guaranteed that the force applied to the surface will be applied evenly in the left-right or front-back direction. The direction is not fixed, so the tablets are not evenly divided.

  6 and 7 show a split tablet according to a more preferred embodiment of the present invention. As shown in FIG. 7, this tablet 1 has an elliptical plate shape having secant lines 2 a and 2 b that divide the tablet into two tablet pieces at the center of the front surface and the back surface, and when necessary, It is divided into two tablet pieces 1a and 1b on a plane 3 passing through the secant line 2 in the vertical direction.

  The two tablet pieces 1a, 1b constituting the tablet 1 form a pair, and as shown in FIG. 7, the tablet pieces 1a, 1b are symmetrical with respect to a plane 3 (dividing plane) passing through the secant 2 in the vertical direction, and each tablet piece 1a, 1b has inclined surfaces (4a, 4b, 5a, 5b) extending at predetermined angles from the center side of the tablet to the side edge portions 9a, 9b on both the upper and lower surfaces thereof, and the cross section of the whole tablet is inverted V-shaped. Form. More specifically, the front surface of the tablet 1 is formed with a V-shaped split groove 2a that bisects the tablet at the center thereof, and each tablet piece 1a, 1b from each upper edge of the split groove 2a. Toward the side edge portions 9a, 9b and in the direction orthogonal to the dividing surface 3, and from each edge of the horizontal surfaces 6a, 6b, the side edge portions 9a, 1b of the tablet pieces 1a, 1b, It is composed of inclined surfaces 4a and 4b that extend at a predetermined angle toward the 9b side and toward the back side surface of each tablet piece. On the other hand, the back side surface of the tablet is formed with a split groove 2b having an inverted V-shaped cross section that bisects the tablet along the center line 8 and parallel to the split line 2a formed on the front side surface. Inclined surfaces 5a, 5b extending at a predetermined angle from each lower edge of the groove 2b toward the side edges 9a, 9b of each tablet piece 1a, 1b and away from the front surface of each tablet piece, It is comprised by the horizontal surface 7a, 7b extended in the orthogonal | vertical direction with the division | segmentation surface 3 toward the side edge part 9a, 9b side of each tablet piece 1a, 1b from the outer edge of inclined surface 5a, 5b. Further, the surface of the tablet is covered with a coating layer 10.

  In the tablet having split grooves formed on both the front surface and the back surface, two split grooves are formed along the split surface, so that the tablet thickness at the split surface is thinner than the tablet thickness at other portions. . Accordingly, the mechanical strength of the divided surface is significantly lower than the mechanical strength of the other parts of the tablet. Therefore, when the tablet is divided, a smaller force is required compared to the divided tablet according to the embodiment of the present invention. The tablet can be divided by, and more easily divided.

  8 and 9 show a split tablet according to another embodiment of the present invention. This tablet is a tablet that can be divided into three tablet pieces 1a, 1b, and 1c. The tablet pieces 1a and 1b and the tablet pieces 1b and 1c are paired with each other. The front surface of the tablet has a secant 2a that divides the tablet into a tablet piece 1a and tablet pieces 1b, 1c, and the back side surface of the tablet is divided into a tablet piece 1c and a tablet piece 1a. , 1b and a dividing line 2b divided into 1b.

  The tablet pieces 1a and 1b and the tablet pieces 1b and 1c constituting the tablet make a pair, and therefore the tablet piece 1b makes a pair with both the tablet pieces 1a and 1c. The tablet pieces 1a, 1b and the tablet pieces 1b, 1c are plane symmetric with respect to the planes (dividing surfaces) 3a, 3b passing through the dividing lines 2a, 2b in the vertical direction, respectively, and each tablet piece 1a, 1b, 1c is The tablet has inclined surfaces extending at a predetermined angle from the divided surface 3a side of the tablet to the side edge portion 9a side and the divided surface 3b side, and from the divided surface 3b side to the side edge portion 9b side. S-shaped form is constituted.

  More specifically, the front surface of the tablet is formed with a V-shaped dividing groove 2a that divides the tablet by 1/3 along a line where the surface and the dividing surface 3a intersect, and the dividing groove 2a From each upper edge toward the side edge 9a side and the dividing surface 3b side of the tablet piece 1a and in a direction orthogonal to the dividing surface 3a, and from the outer edge of each horizontal surface 6a, 6b to the tablet piece A line 8b where the inclined surfaces 4a and 4b extending toward the side edge 9a side and the dividing surface 3b side of 1a and extending at a predetermined angle toward the back surface of each tablet piece, and the front surface and the dividing surface 3b intersect. The inclined surface 4c extending at a predetermined angle toward the side edge portion 9b of the tablet piece 1c and away from the back surface of the tablet piece (the line 8b is a valley line where the inclined surfaces 4b and 4c intersect). Of the tablet piece 1c from the outer edge of the inclined surface 4c. Toward the edge portion 9b side, and is composed of a horizontal plane 6c which extends perpendicularly to the dividing plane 3b. On the other hand, the back side surface of the tablet is formed with an inverted V-shaped dividing groove 2b that divides the tablet by 1/3 along a line where the surface and the dividing surface 3b intersect. Horizontal planes 7c, 7b extending from the edge toward the side edge 9b side and the dividing surface 3a side of the tablet piece 1c and in a direction orthogonal to the dividing surface 3b, and from the outer edge of each horizontal plane 7c, 7b to the side of the tablet piece 1c Inclined surfaces 5c, 5b extending at a predetermined angle toward the edge 9b side and the dividing surface 3a side and toward the front side surfaces of the tablet pieces 1c, 1b, and a line 8a where the surface and the dividing surface 3a intersect. To the side edge 9a side of the tablet piece 1a and the inclined surface 5a extending at a predetermined angle in the direction away from the front surface of the tablet piece (therefore, the line 8a is a ridge line where the inclined surfaces 5a and 5b intersect). And from the outer edge of the inclined surface 5a to the side of the tablet piece 1a Towards the part 9a side, and is composed of a horizontal surface 7a extending in the direction perpendicular to the dividing plane 3a. Further, the surface of the tablet is covered with a coating layer 10.

  When taking a tablet that can be divided into the three tablet pieces of the present invention, for example, by pressing only two tablet pieces that make a pair, according to exactly the same mechanism of action as the tablet that can be divided into two parts, It is divided into one tablet piece and another pair of tablet pieces. It is as above-mentioned that it does not ask the front and back of the tablet pressed at this time. Such forms of tablets are, for example, for patients who have to take a single tablet piece three times in the morning, noon and evening, or for the manufacture of tablets containing active ingredients that are desired to be taken in such a form. Convenient.

  In order to illustrate the tablet of the present invention, examples are described below. However, the examples are described for illustrative purposes, and the present invention is not limited thereto.

A mixed tablet powder consisting of 67 parts by weight of crystalline cellulose, 30 parts by weight of lactose, 2 parts by weight of carmellose calcium and 1 part by weight of magnesium stearate is set to 150 mg, and a rotary tableting machine (PICCOLA (registered trademark)). ) D8 Tablets (manufactured by Nara Machinery Co., Ltd.), and the elliptical uncoated tablets shown in FIG. 1 (major axis 9 mm, minor axis 5.5 mm, thickness 3 mm, upper and lower horizontal plane lengths L ₁ and L ₂ : 1 .5mm (1/3 of major axis radius _{L 0),} the upper and lower inclined surfaces of the surface angle theta ₁ and theta _2: 15 to give °, the opening width 0.4mm of the V-shaped split groove depth 0.23 mm) and It was. The tableting pressure was adjusted so that the hardness of the uncoated tablet was 10.0 to 11.0 kg / cm ² when measured with a Monsanto hardness meter with the dividing line of the uncoated tablet being vertical. Next, 7 parts by weight of hydroxypropylmethylcellulose 2910 (TC-5R (trade name) manufactured by Shin-Etsu Chemical Co., Ltd.), 2 parts by weight of Macrogol (6000) and 3 parts by weight of titanium oxide were added to the obtained uncoated tablets. Using a film coating solution dissolved in 88 parts by weight of a mixed solution of ethanol and absolute ethanol, 5 mg of film was coated per tablet to obtain tablets.

Comparative example

  Using mixed powders of the same raw materials and compositions as in the examples, tableting was performed in the same manner as in the examples, the upper and lower surfaces were flat, the planar shape was an ellipse having a major axis of 9 mm and a minor axis of 5.5 mm. An uncoated tablet with a weight of 150 mg having a V-shaped split groove (opening width 0.4 mm, depth 0.23 mm) only on the surface was obtained, and a film coating of 5 mg per tablet was applied to this as in the Example, and the tablets Got.

数値はそれぞれ錠剤５個の平均値である。 About each tablet of an Example and a comparative example, while using a Monsanto hardness meter and making a dividing line perpendicular | vertical, tablet hardness is measured, From the front and back of a tablet using Rheometer CR-200D by Sun Scientific Co., Ltd. The pressure at the time when the tablet was divided by applying a force perpendicular to the tablet surface was measured. Separately from this, each tablet obtained in the examples and comparative examples was subjected to PTP packaging using vinyl chloride having a thickness of 0.2 mm and aluminum foil having a thickness of 0.02 mm, with the front surface facing up. A sample with the back side surface up was obtained, and the pressure at the time when the tablet was divided by the above method was measured from above the PTP package. The results are shown in Table 1.

Each numerical value is an average value of 5 tablets.

  As is apparent from the results shown in Table 1, there is a significant difference in the ease of division between the tablets according to the examples of the present invention and those of the comparative examples, even if the tablets have substantially the same hardness. It is done. The tablet of the comparative example requires a pressure exceeding the range that can be measured by a rheometer, but it can be seen that the tablet of the present invention can be easily divided by pressing with a finger or the like regardless of the front and back.

The perspective view of the tablet which concerns on one Example of this invention Top view of the tablet shown in FIG. Sectional drawing in the AA line of the tablet shown in FIG. The figure which shows the direction where force is added when the tablet of this invention shown in FIG. 1 is pressed with the front side surface up. The figure which shows the direction where force is added when the tablet of this invention shown in FIG. 1 is pressed with the back side surface up. The perspective view of the tablet which concerns on more preferable embodiment of this invention Cross section of the tablet shown in FIG. The perspective view of the tablet which concerns on the other Example of this invention. Cross section of the tablet shown in FIG.

Explanation of symbols

1: Tablet 1a, 1b, 1c: Tablet piece 2, 2a, 2b: Split groove 3, 3a, 3b: Dividing surface 4a, 4b, 4c: Inclined surface on the front surface 5a, 5b, 5c: Inclined surface on the back surface 6a 6b, 6c: Horizontal surface of the front surface 7a, 7b, 7c: Horizontal surface of the back surface 8, 8a, 8b: Valleys or ridges formed by pairs of inclined surfaces 4 or 5 9a, 9b: Side edges 10 : Coating layer 100: Hard plane θ ₁ : Angle formed by the horizontal surface and the inclined surface on the front surface θ ₂ : Angle formed by the horizontal surface and the inclined surface on the back surface L ₀ : Length between the divided surface and the side edge L ₁ : Length from the dividing surface on the front surface to the edge of the horizontal plane L ₂ : Length from the side edge on the front surface to the edge of the inclined surface L ₃ : Length from the side edge on the back surface to the edge of the horizontal plane L _4: inclined from the dividing plane in the backside surface Length up to the end

Claims (13)

  A tablet having a dividing line for dividing the tablet into at least two tablet pieces on at least one surface of both upper and lower surfaces of the tablet, wherein each tablet piece has a side edge from the dividing surface side passing through the dividing line of the tablet on both upper and lower surfaces thereof Each of which has an inclined surface extending at a predetermined angle toward the part side, and two tablet pieces adjacent to each other across the dividing surface form a pair to form an inverted V-shaped section or a V-shaped section. A divided tablet characterized by comprising:   One side surface of the pair of tablet pieces includes a split groove having a V-shaped cross section or a reverse V-shaped cross section with the dividing line as a bottom or a ridge at the center thereof, and the side of each tablet piece from the split groove It has a horizontal plane extending in the direction orthogonal to the dividing surface toward the edge side and continuing to the inclined surface, and the opposite surface formed by the pair of tablet pieces is a side edge of each tablet piece of the pair of tablet pieces. 2. The divided tablet according to claim 1, wherein the divided tablet has a horizontal plane extending in a direction orthogonal to the divided surface toward the center portion and continuing to the inclined surface.   The divided tablet according to claim 1 or 2, wherein an inclined surface of one side surface of each tablet piece and an inclined surface of the opposite surface of the tablet piece are parallel.   The divided tablet according to claim 2 or 3, wherein an angle formed between the inclined surface of each tablet piece and the horizontal surface is 10 degrees or more.   5. The length of a horizontal plane including the split groove on one surface of the pair of tablet pieces is shorter than the length between both edges of each inclined surface on the opposite surface of the pair of tablet pieces. A divided tablet according to any one of the above.   The opposite surface composed of the pair of tablet pieces has an inverted V-shaped cross section or a V-shaped cross section parallel to the split groove of the one side surface of the pair of tablet pieces at the intersection of the inclined surfaces of the tablet pieces. The divided tablet according to any one of claims 1 to 5, comprising a split groove.   6. The split tablet according to claim 5, wherein the pair of tablet pieces has a split groove having a ridge line on each side of the dividing line between the upper and lower surfaces of the pair of tablet pieces.   The split tablet according to any one of claims 1 to 7, wherein the one-side surface composed of the pair of tablet pieces has a bulging portion at a central portion including the split groove.   The divided tablet according to any one of claims 1 to 8, wherein the opposite surface composed of the pair of tablet pieces has a bulging portion on both sides thereof.   The tablet is a tablet that can be divided into two tablet pieces, and one side surface formed by the pair of tablet pieces has a V-shaped or inverted V-shaped dividing groove in which the tablet is divided into two at the center. A horizontal plane extending from each edge of the dividing groove to each side edge of the tablet and in a direction orthogonal to a dividing surface for dividing the tablet, and from both edges of the horizontal plane to each side edge. And an inclined surface extending at a predetermined angle toward the opposite surface of each tablet piece, wherein the opposite surface extends from the center toward each side edge and from the one surface. An inclined surface extending at a predetermined angle in a direction away from each other, and a horizontal plane extending from an edge of each inclined surface toward each side edge and in a direction orthogonal to the dividing surface. The divided tablet as described in any one of 1-9.   The tablet is a tablet that can be divided into three tablet pieces, each of which has a dividing line that divides the tablet into three tablet pieces on the upper and lower surfaces of the tablet, and is adjacent to each other across a dividing surface that passes through the dividing line. The divided tablet according to any one of claims 1 to 9, wherein two tablet pieces each form a pair and form an inverted V-shaped section or a V-shaped section.   The divided tablet according to any one of claims 1 to 11, wherein the tablet is a round tablet, an elliptical tablet, an incomplete circular tablet, an incomplete elliptical tablet, a rectangular tablet or a polygonal tablet.   The divided tablet according to any one of claims 1 to 12, wherein the tablet has a film coating on the surface thereof.

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