Scored tablet

Abstract

To provide a tablet having a scored shape having excellent splitting property.SOLUTION: A scored tablet 10 has: an upper face part 110 having a curved portion for at least a part of an outer peripheral edge 110a and a lower face part; and a side face part provided by being connected to the upper face part and the lower face part, where each of the upper face part and the lower face part is provided in a curved surface shape so as to rise from the outer peripheral edge toward a center 110c, each of the upper face part and the lower face part has a scored part 140 which passes through the center, is provided along a first axis and has a groove shape, an upper end part 140ue of the scored part is provided linearly in a plane view, and a bottom part 140b of the scored part is parallel with a horizontal plane.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a scored tablet, specifically a scored tablet having a scoring shape that is excellent in divisibility when divided with a dispensing pliers.

Background Art

[0002] Tablets prescribed to patients may be divided into two, for example, using a dispensing pliers at a dispensing site such as a hospital or a pharmacy in order to adjust the dosage. Therefore, among tablets, there are those provided with a score line for dividing, as disclosed in, for example, Patent Document 1. Since the tablet is divided to adjust the dosage, it is desirable that the mass of each fragment of the divided tablet be nearly uniform.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, even if it has a score line, depending on the shape of the score line of the tablet, it may not be possible to divide it uniformly with a dispensing pliers.

[0005] One object of an embodiment of the present invention is to provide a tablet having a score line shape that is excellent in divisibility when divided with a dispensing pliers.

Means for Solving the Problems

[0006] According to an embodiment of the present invention, there is provided a secant tablet having an upper surface portion and a lower surface portion each having a curved portion at at least a part of the outer peripheral edge, and side surface portions connected to the upper surface portion and the lower surface portion, wherein each of the upper surface portion and the lower surface portion is provided in a curved shape so as to bulge from the outer peripheral edge toward the center, and each of the upper surface portion and the lower surface portion has a secant portion provided along a first axis passing through the center and having a groove shape, an upper end portion of the secant portion is provided linearly in a plan view, and a bottom portion of the secant portion is parallel to a horizontal plane.

[0007] In the above secant tablet, the secant portion has a first secant side surface portion and a second secant side surface portion facing the first secant side surface portion, and an angle formed by a surface corresponding to the first secant side surface portion and a surface corresponding to the second secant side surface portion may be 50 degrees or more.

[0008] In the above secant tablet, the outer peripheral edges of the upper surface portion and the lower surface portion may have a circular shape.

[0009] In the above secant tablet, the outer peripheral edges of the upper surface portion and the lower surface portion may have an elliptical shape, and the first axis may be a minor axis.

[0010] In the above secant tablet, when a plurality of the secant tablets are prepared and divided through the secant portion, a determination value obtained by dividing a standard deviation of masses of respective fragments in the plurality of divided secant tablets by an average value of the masses of the respective fragments may be 10% or less.

Advantages of the Invention

[0011] According to an embodiment of the present invention, it is possible to provide a tablet having a secant shape excellent in divisibility when divided with a dispensing cutter.

Brief Description of the Drawings

[0012]

Figure 1

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[0013] Hereinafter, each embodiment of the invention disclosed in this application will be described with reference to the drawings. However, the present invention can be implemented in various forms without departing from the gist thereof, and is not to be construed as being limited to the description of the embodiments exemplified below.

[0014] In the drawings referred to in this embodiment, the same parts or parts having the same function are denoted by the same reference numerals or similar reference numerals (reference numerals with A, B, etc. appended after the numbers), and the repeated description thereof may be omitted. In addition, the dimensional ratios in the drawings may be different from the actual ratios for convenience of explanation, or a part of the configuration may be omitted from the drawings.

[0015] The inventors have found that when a tablet with a curved upper and bottom surface is divided with a dispensing tweezer, the divisibility is impaired, and as a result of intensive studies to provide a tablet with excellent divisibility, it has been found that the divisibility is improved by making the bottom of the score line straight.

[0016] <First Embodiment> In this embodiment, the scored tablet will be described in detail below.

[0017] (1. Configuration of Scored Tablet) FIG. 1 is a schematic plan view of the scored tablet 10. FIG. 2 is a schematic side view when viewed from the D1 direction. FIG. 3 is a schematic cross-sectional view between A1 - A2 of the scored tablet 10. As shown in FIGS. 1 to 3, the scored tablet 10 has an upper surface portion 110, a lower surface portion 120, and a side surface portion 130.

[0018] In one embodiment of the present invention, the upper surface portion 110 and the lower surface portion 120 have the same shape in an upside-down form. Therefore, for the sake of explanation, the upper surface portion 110 will be mainly described.

[0019] In one embodiment of the present invention, the outer peripheral edge 110a of the upper surface portion 110 has a circular shape. As shown in FIGS. 2 and 3, the upper surface portion 110 is provided in a curved shape so as to bulge from the outer peripheral edge 110a toward the center 110c.

[0020] The upper surface portion 110 has a scored portion 140. The scored portion 140 is composed of a first upper end portion 140ue1, a first scored side surface portion 140s1, a bottom portion 140b, a second scored side surface portion 140s2, and a second upper end portion 140ue2. The scored portion 140 passes through the center 110c of the upper surface portion 110 and is provided along the first axis (in this example, the first direction D1) and has a groove shape.

[0021] As shown in FIG. 1, the upper end portions 140ue (the first upper end portion 140ue1 and the second upper end portion 140ue2) and the bottom portion 140b are provided linearly when the scored tablet 10 is viewed from a direction perpendicular to the upper surface portion 110 (in a plan view). Therefore, the scored portion 140 can also be referred to as a straight score line. Also, as shown in FIG. 3, when the cross-section of the scored tablet 10 is viewed, the bottom portion 140b is provided parallel to the horizontal plane. The depth T3 of the scored portion 140 may be 0.1 mm or more and 10 mm. Also, the deeper the depth of the scored portion, the more the dividing blade of the dispensing pliers is fixed when the dividing blade is applied to the score line. Therefore, the depth T3 of the scored portion 140 is desirably 0.58 mm or more and 10 mm.

[0022] In one embodiment of the present invention, the angle θ (also referred to as the groove angle) formed by the surface corresponding to the first score line side surface 140s1 (the surface formed by expanding the first score line side surface 140s1) and the surface corresponding to the second score line side surface 140s2 (the surface formed by expanding the second score line side surface 140s2) is preferably 50 degrees or more, more preferably 70 degrees or more and 110 degrees or less.

[0023] The side surface portion 130 is provided connected to the upper surface portion 110 and the lower surface portion 120. As shown in FIG. 2, the side surface portion 130 is provided in a strip shape when viewed from the side. The width T1 of the side surface portion 130 is not particularly limited, but is preferably 0.1 mm or more and 20 mm or less, more preferably 0.1 mm or more and 2.3 mm or less. Further, the side surface portion 130 may be provided in a string shape.

[0024] The diameter R1 of the scored tablet 10 (upper surface portion 110) is not particularly limited, but is preferably 4 mm or more and 20 mm or less.

[0025] The thickness T2 of the scored tablet 10 is not particularly limited, but is preferably 1 mm or more and 20 mm or less.

[0026] The material used for the scored tablet 10 in one embodiment of the present invention is not particularly limited. For the scored tablet 10, excipients, binders, coloring agents, disintegrants, etc. may be used in addition to the active ingredient.

[0027] The excipients are not particularly limited, and examples thereof include sugars or sugar alcohols such as lactose, fructose, glucose, sucrose, mannitol, and sorbitol; starches such as corn starch and potato starch; celluloses such as crystalline cellulose; and inorganic salts such as anhydrous calcium phosphate, precipitated calcium carbonate, calcium silicate, and sodium chloride.

[0028] The binder is not particularly limited, and examples thereof include partially saponified polyvinyl alcohol, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, pullulan, methylcellulose, gum arabic, starches, etc.

[0029] The colorant is not particularly limited, and examples thereof include colorants that exhibit yellow (e.g., yellow ferric oxide, yellow iron oxide, aluminum lake of food yellow No. 4, red iron oxide, etc.), colorants that exhibit red (e.g., ferric oxide, food red No. 2, food red No. 3, food red No. 102, etc.), colorants that exhibit black (e.g., black iron oxide, carbon black, medicinal charcoal, etc.), colorants that exhibit white (e.g., titanium oxide, etc.), caramel, etc. Preferably, yellow ferric oxide and ferric oxide are used.

[0030] The disintegrant is not particularly limited, and examples thereof include crospovidone, croscarmellose sodium, carboxymethyl cellulose, partially α - modified starch, hydroxypropyl starch, corn starch, potato starch, sodium starch glycolate, etc.

[0031] The lubricant is not particularly limited, and examples thereof include glyceryl monostearate, glyceryl palmitostearate, sodium stearyl fumarate, sucrose fatty acid ester, carnauba wax, L - leucine, macrogol, magnesium stearate, talc, sucrose fatty acid ester or polyethylene glycol, etc.

[0032] (2. Method for manufacturing the scored tablet 10) Next, a method for manufacturing the scored tablet 10 in one embodiment of the present invention will be described. The scored tablet 10 in one embodiment of the present invention can be manufactured by a known method (e.g., mixing, tableting). At this time, in one embodiment of the present invention, a scored tablet can be manufactured by tableting using a tableting punch having a shape corresponding to the scored portion.

[0033] (3. Action and effect of the scored tablet) In one embodiment of the present invention, since the scored tablet 10 has the above-described configuration, specifically, the upper end portion of the scored portion is linear and the bottom portion is parallel to the horizontal plane, the contact area between the tablet and the dividing blade of the dividing tool becomes large when dividing with the dividing tool. As a result, the pressure during division is dispersed (equalized), and local pressurization is suppressed. As a result, it is possible to suppress partial loss of the tablet. That is, by using one embodiment of the present invention, the loss rate when dividing the tablet can be reduced. Further, by designing the angle of the groove and the depth of the scored portion so that the dividing blade of the dividing tool hits the bottom of the score line, the tablet can be divided uniformly.

[0034] In the scored tablet according to one embodiment of the present invention, the determination value when the scored tablet is divided into two fragments (also referred to as the first part and the second part) satisfies a predetermined condition. The determination value can be calculated using Equation 1. In this example, the predetermined condition is desirably 10% or less, more preferably 6% or less.

Number

[0035] (Modification example) Those skilled in the art can conceive of various modification examples and correction examples within the scope of the idea of the present invention, and it is understood that those modification examples and correction examples also belong to the scope of the present invention. For example, with respect to each of the above-described embodiments, those obtained by appropriately adding or deleting components, combining or designing changes of each embodiment by those skilled in the art, or adding, omitting, or changing conditions of processing also fall within the scope of the present invention as long as they have the gist of the present invention.

[0036] Note that the outer peripheral shape of the upper surface 110 may be an elliptical shape. In this case, the scored portion 140 may be provided along the minor axis direction. Thereby, the loss rate at the time of division can be further reduced.

Example

[0037] Hereinafter, the present invention will be described in more detail by way of examples, but the scope of the present invention is not limited by the following examples.

[0038] In this example, the evaluation of tablet splitting was performed based on the difference in the shape of the bottom of the score part.

[0039] [Preparation of Scored Tablets in Examples] Drugs A and B with different formulations were mixed in a plastic bag with additives, and the mixed powder was tableted using a rotary tablet press (Kikusui Seisakusho, VELA5) to prepare the scored tablets of the examples. The diameter of the tablets of drug A was 7 mm, the thickness of the tablets was 3.5 mm, the width of the side surface part was 2.3 mm, the diameter of the tablets of drug B was 7 mm, the thickness of the tablets was 3.3 mm, the width of the side surface part was 2.1 mm, the depth of the score part was 0.59 mm respectively, and the angle of the groove of the score part was 70 degrees respectively. In this evaluation, scored tablets using drug A and scored tablets using drug B were prepared.

[0040] [Preparation of Scored Tablets in Comparative Examples] Scored tablets of the comparative examples were prepared. FIGS. 4 to 6 are schematic diagrams of the comparative examples. FIG. 4 is a schematic plan view of the scored tablet 50. FIG. 5 is a schematic side view when viewed from the D1 direction of the scored tablet 50. FIG. 6 is a schematic cross-sectional view of the scored tablet 50 between A1 - A2. In the scored tablet 50 of the comparative example, the upper end part 540ue in the score part 540 is provided linearly, but the bottom part 540b has the same shape as the curved surface shape of the upper surface part 510. The diameter of the tablets of drug A was 7 mm, the thickness of the tablets was 3.4 mm, the width of the side surface part was 2.2 mm, the diameter of the tablets of drug B was 7 mm, the thickness of the tablets was 3.3 mm, the width of the side surface part was 2.1 mm, the depth of the score part was 0.28 mm respectively, and the angle of the groove of the score part was 90 degrees respectively.

[0041] [Conditions for Evaluation of Splitting of Scored Tablets] As a dividing device for evaluating the division of secant tablets, a scissors-shaped dividing device (tablet cutter AIT-CH manufactured by Aiteks Co., Ltd.) was used. As the division evaluation, the determination value of the divided secant tablets was calculated. The method for calculating the determination value is as described above. Also, in this evaluation, seven tablets of each condition were prepared.

[0042] Figure 7 shows the division evaluation results of secant tablets using drug A. Figure 8 shows the division evaluation results of secant tablets using drug B. As shown in Figure 7, in the secant tablets of drug A, the determination value of the secant tablets of the comparative example was 10.9% (standard deviation 5.1), whereas the determination value of the secant tablets of the example was 3.2% (standard deviation 0.8), indicating a good determination value in the secant tablets of the example. As shown in Figure 8, also in the secant tablets using drug B, the determination value of the secant tablets of the comparative example was 10.4% (standard deviation 4.4), whereas the determination value of the secant tablets of the example was 5.1% (standard deviation 1.3), showing the same result. That is, according to one embodiment of the present invention, it is possible to provide a tablet having a secant shape with excellent divisibility when divided with a dispensing scissors.

Explanation of Reference Numerals

[0043] 10 ··· secant tablet, 50 ··· secant tablet, 110 ··· upper surface part, 110a ··· outer peripheral edge, 110c ··· center, 120 ··· lower surface part, 130 ··· side surface part, 140 ··· secant part, 140b ··· bottom, 140s1 ··· first secant side surface part, 140s2 ··· second secant side surface part, 140ue ··· upper end part, 140ue1 ··· first upper end part, 140ue2 ··· second upper end part, 540 ··· secant part, 540b ··· bottom, 540ue ··· upper end part

Claims

1. The device has an upper surface portion and a lower surface portion having a curved portion on at least a part of an outer periphery, and a side surface portion provided and connected to the upper surface portion and the lower surface portion, each of the upper surface portion and the lower surface portion is curved so as to rise from the outer circumferential edge toward the center; Each of the upper surface portion and the lower surface portion has a dividing line portion that passes through the center and is provided along a first axis and has a groove shape, The upper end of the dividing line portion is provided in a straight line shape in a plan view, The bottom of the dividing line is parallel to the horizontal plane. Scored tablets.

2. The dividing line portion has a first dividing line side portion and a second dividing line side portion opposed to the first dividing line side portion, The angle between the surface corresponding to the first dividing line side portion and the surface corresponding to the second dividing line side portion is 50 degrees or more. The scored tablet according to claim 1.

3. The outer periphery of the upper surface portion and the lower surface portion has a circular shape. The scored tablet according to claim 1.

4. The outer periphery of the upper surface portion and the lower surface portion has an elliptical shape, The first axis is a minor axis. The scored tablet according to claim 1.

5. A plurality of the scored tablets are prepared, When a plurality of scored tablets are divided along the score lines, a judgment value obtained by dividing the standard deviation of the mass of each piece of the divided plurality of scored tablets by the average value of the mass of each piece is 10% or less. The scored tablet according to any one of claims 1 to 4.

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