WO2010002033A2

WO2010002033A2 - Tablet

Info

Publication number: WO2010002033A2
Application number: PCT/JP2009/062400
Authority: WO
Inventors: Takanori Inoue
Original assignee: Otsuka Pharmaceutical Co., Ltd.
Priority date: 2008-07-01
Filing date: 2009-07-01
Publication date: 2010-01-07
Also published as: AR072437A1; TW201014588A; WO2010002033A3; JP2011526582A

Abstract

An object is to provide a tablet that is capable of being finely and easily broken into plural component parts, while making it possible to reduce the possibility of chipping-off of an outer peripheral portion of a tablet, due to the presence of a groove and reduce the friability. A tablet includes a body part 1 having a first surface 2 with a breaking groove 5 formed therein, a first bulging part 10 that bulges from the first surface 2 of the body part 1 to surround the groove 5 and have two apexes B and C, a second bulging part 20 that bulges from a second surface 3 of the body part 1 to increase in height towards a center A thereof, wherein the center A of the second bulging part 20 and the two apexes B and C of the first bulging part 10 define fulcrum points at which force is applied to break the tablet, and wherein the groove 5 decreases in depth towards end portions 5c, 5c of the groove 5 and decreases in width towards the end portions 5c, 5c of the groove 5.

Description

DESCEIPTION

TABLET TECHNICAL FIELD

[0001] The present invention relates to a tablet that has a groove along which the tablet is broken into component parts, enabling fractional dosages of the tablet. BACKGROUND ART [0002]

A tablet of the above type conventionally known includes a body part of, for example, a disk shape having a groove formed as a breaking line (bisect or score) along a center line of a top surface, a first bulging part formed on the top surface of the body part to surround the groove and a second bulging part formed on a bottom surface of the body part (cf. for example, Patent Documents 1 and 2). The groove is formed with a uniform depth to reach the opposite portions of an outer periphery of the body part, and the second bulging part bulges to increase in height towards a center thereof. [0003]

When breaking the tablet into component parts, the tablet is held between flat plates through the top and bottom surfaces of the tablet with the center of the second bulging part of the bottom surface being held in contact with the corresponding flat plate and the two apexes of the first bulging part of the top surface, which are farthermost from the aforesaid center, being held in contact with the corresponding flat plate, thus defining fulcrum points at which force is applied to break the tablet. [PRIOR ART DOCUMENTS] [PATENT DOCUMENTS] [0004] [PATENT DOCUMENT 1]

Japanese Unexamined Patent Application Publication No. 2006-52230

[PATENT DOCUMENT 2]

Japanese Examined Utility Model Application Publication No. Sho-40-3680

DISCLOSURE OF THE INVENTION

PROBLEM TO BE SOLVED BY THE INVENTION

[0005]

The breaking groove of the above conventional tablet has a uniform depth and reaches the outer periphery of the tablet, which causes an edge or sharp angular portion in an outer peripheral portion of the tablet, and thus poses a problem in which the edge or sharp angular portion is chipped off or broken apart when tablets are rubbed each other. A tablet of this type may not be broken into component parts finely along the groove. Also, another problem associated with the conventional tablet especially disclosed in the Patent Document 1 lies in that unintentional breakage of the tablet might take place due to its easily breakable structure, and uncoated tablets before coating during manufacturing tend to have a large friability.

[0006] The present invention was conceived taking into account the above circumstances. It is an object of the present invention to provide a tablet that is capable of being finely and easily broken into plural component parts, while making it possible to reduce the possibility of chipping-off of an outer peripheral portion of the tablet due to the presence of a groove and reduce the abrasion loss ratio.

MEANS FOR SOLVING THE PROBLEM

[0007] According to one aspect of the present invention, there is provided a tablet that defines a groove 5 for breaking the tablet, in which the groove 5 decreases in depth towards end portions 5c, 5c of the groove 5.

[0008] The tablet having the above structure may have any of a rectangular parallelepiped shape, a disk shape and an angular plate shape. While it is essential to have a groove decreasing in depth towards the end portions 5c, 5c of the groove 5, it is preferable to minimize the depth of the end portions 5c, 5c of the groove 5 as much as possible to prevent occurrence of an edge or sharp angular portion in the outer peripheral portion of the tablet. With this, it is possible to prevent occurrence of chipping- off of the tablet due to the presence of such an edge or sharp angular portion. In other words, it is possible to prevent increase in the friability. When a tablet has a rectangular parallelepiped shape, a groove may be formed along a lateral side surface of the tablet, which enables the tablet to be simply broken into component parts, while not being necessarily broken into equal component parts. When a tablet has a disk shape, plural grooves may be formed to extend radially from the center of the tablet or a single groove may be formed along a center line. When a tablet has an angular plate shape, a groove may be formed along a diagonal line or a center line. When a tablet has a disk shape or angular plate shape, grooves may be respectively formed in a pair of surfaces extending parallel to each other. [0009]

According to another aspect of the present invention, there is provided a tablet that includes a body part 1 having a first surface 2 with a groove 5 for breaking the tablet formed therein, a first bulging part 10 that bulges from the first surface 2 of the body part 1 to surround the groove 5 and have two apexes B and C, a second bulging part 20 that bulges from a second surface 3 of the body part 1 to increase in height towards a center A thereof, wherein the center A of the second bulging part 20 and the two apexes B and C of the first bulging part 10 define fulcrum points at which force is applied to break the tablet, and wherein the groove 5 decreases in depth towards end portions 5c, 5c of the groove 5. [0010]

According to the tablet having the above structure, the center. A of the second bulging part 20, and the two apexes B and C of the first bulging part 10 define the fulcrum points at which force is applied. In addition thereto, the distance between the deepest point of the groove 5 and the center A of the second bulging part 20 is decreased while the distance between the deepest point of the groove 5 and the two apexes B and C is increased, so that force applied to the groove 5 is enhanced and hence the tablet can be easily broken with the deepest point of the groove 5 acting as a starting point for breaking. [0011] According to the tablet of each of the first and second aspects of the present invention, the groove 5 may decrease in width towards the end portions 5c, 5c of the groove 5. [0012] In the above case, in addition to the depth of the groove 5, the width of the same is greatly changed in size between a center portion 5b and the end portions 5c, 5c, of the groove 5, so that it is possible to further reduce the possibility of chipping-off of the outer peripheral portion of the tablet, while it is possible to easily break the tablet into component parts. By changing the width of the groove in size between the center portion 5b and the end portions 5c, 5c of the groove 5 is meant herein to have the width being large at the center portion 5b of the groove 5 and decreasing towards the end portions 5c, 5c. By the groove decreasing in width towards the end portions 5c, 5c of the groove 5 is meant herein a groove having an oval shape, a lozenge shape or the like as a whole in plan view, or. a groove having a stepped shape gradually or stepwisely decreasing in width towards a corresponding end portion.

[0013] According to a third aspect of the present invention, there is provided a tablet that defines a groove 5 for breaking the tablet, in which the groove 5 decreases in width towards end portions 5c, 5c of the groove 5. [0014]

According to a fourth aspect of the present invention, there is provided a tablet that includes a body part 1 having a first surface 2 with a groove 5 for breaking the tablet formed therein, a first bulging part 10 that bulges from the first surface 2 of the body part 1 to surround the groove 5 and have two apexes B and C, a second bulging part 20 that bulges from a second surface 3 of the body part 1 to increase in height towards a center A thereof, wherein the center A of the second bulging part 20 and the two apexes B and C of the first bulging part 10 define fulcrum points at which force is applied to break the tablet, and wherein the groove 5 decreases in width towards end portions 5c, 5c of the groove 5. [0015]

According to the tablet having the above structure, forces which act in directions opposite to each other are applied to at least one of the opening edge portion 5a of the groove 5, a side wall portion of the groove 5 and a bottom portion of the groove 5, which enables the tablet to be easily broken into component parts. On the other hand, the width of each of the end portions 5c, 5c of the groove 5 is small, so that an edge or sharp angular portion is unlikely to be formed in the outer peripheral portion of the tablet, and thus the possibility of chipping-off of the outer peripheral portion can be minimized. [0016] According to the third and fourth aspects of the present invention, the groove 5 may be formed to decrease in depth towards the end portions 5c, 5c of the groove 5.

[0017] With the above structure, in addition to the shape of the width of the groove 5, the depth of the groove 5 is different from the depth of the end portions 5c, 5c, so that it is possible to further reduce the possibility of chipping-off of the outer peripheral portion of the tablet, while it is possible to easily break the tablet into component parts. [0018]

According to the first to fourth aspects of the present invention, it is possible to employ an arrangement in which the first bulging part 10 is located more inside of the body part 1 than the outer periphery of the body part 1, and the groove 5 has the end portions 5c, 5c located at an outer periphery of the first bulging part 10. [0019]

With the above structure, the end portions 5c, 5c of the groove 5 are formed not to reach the outer periphery of the tablet so that it is possible to prevent occurrence of chipping-off of the outer peripheral portion of the tablet. Because of this, it is possible to manufacture tablets with a high yield by a tablet press for use in manufacturing, and also it is possible to package tablets even by an existing tablet packaging machine when producing blister pack and preparing a medicine at hospital or the like without causing any troubles since there are no great changes in thickness between the tablets of the present invention and conventional tablets. [0020] According to the first to fourth aspects of the present invention, the end portions 5c, 5c of the groove 5 each may be formed with a curved surface having a curvature larger than the curvature of a curved surface of the center portion 5b.

[0021]

With the above structure, the center portion 5b of the groove 5 is a deepest portion having a small curvature and therefore a force to the center portion 5b is easy to be transferred. As a result, the center portion 5b of the groove 5 acts as a break starting point when in breaking a tablet, and thus a crack easily progresses from the center portion 5b towards the outer peripheral portion. That is, the tablet can be easily broken into component parts. ADVANTAGE OF THE INVENTION

[0022]

Since the tablet of the present invention includes a breaking groove which is formed to decrease in depth towards the end portions of the groove, the tablet can be easily broken into component parts, and at the same time ensure reduction of occurrence of an edge or sharp angular portion in an outer peripheral portion of the tablet and thus prevention of chipping-off of the outer peripheral portion of the tablet.

The tablet friability of the present invention satisfies the standard of the friability test of the Japanese Pharmacopoeia, the United States Pharmacopoeia and the European Pharmacopoeia. Although the tablet of the present invention has a deep breaking line (bisect or score), it satisfies the standard of the friability test of the Japanese Pharmacopoeia, the United States Pharmacopoeia and the European Pharmacopoeia.

[0023] Since the groove is formed to decrease in width towards the end portions of the groove, occurrence of an edge or sharp angular portion in the outer periphery of the tablet is further reduced, and thus chipping-off of the outer peripheral portion of the tablet can be effectively prevented. Furthermore, forces which act in directions opposite to each other are applied to the opening edge portion of the groove, and accordingly, a tablet can be more easily broken into component parts. [0024]

In addition, the variation in the divided weight for each tablet, that is, the variation in the weight of each divided component part of a tablet is smaller than acceptance value of the weight variation as described in the Japanese Pharmacopoeia, the United States Pharmacopoeia and the European Pharmacopoeia.

BRIEF DESCRIPTION OF THE DRAWINGS

[0025]

FIG. IA is a plan view of a tablet according to one embodiment of the present invention. FIG. IB is a side view as viewed in a direction represented by arrows A-A in FIG. IA.

FIG. 1C is a side view as viewed in a direction represented by arrows B-B.

FIG. 2A is a cross sectional view taken along a line of A-A in FIG. IA.

FIG. 2B is a cross sectional view taken along a line of B-B in FIG. IA. FIG. 3 is a bottom view of the tablet.

FIG. 4A is an explanatory view for explaining a case in which a tablet is broken into component parts when it is placed with the groove facing upwards.

FIG. 4B is an explanatory view for explaining a case in which a tablet is broken into component parts, when it is placed with the groove facing downwards. FIG. 5A is a view of a tablet with an opening edge portion of the groove formed into a lozenge shape.

FIG. 5B is a view of a table with an opening edge portion of the groove formed to gradually decrease in width towards opposite end portions of the groove. PREFEERED EMBODIMENTS FOR CARRYING OUT THE INVENTION

[0026]

Now, the description will be made for a tablet according to an embodiment of the present invention with reference to the attached drawings.

[0027]

As shown in FIGS. 1-3, a tablet according to the present invention includes a body part 1 having a groove 5 as a breaking line (bisect or score) formed along a theoretical center line on a top surface 2, a first bulging part 10 that bulges to surround the groove on the top surface 2 of the body part 1, and a second bulging part 20 formed on a bottom surface 3 of the body part 1.

[0028]

The body part 1 has a disk shape and a diameter of, for example, 5-15 mm.

[0029] As shown in FIGS. IA and 1C, the end portions 5c, 5c of the groove 5 do not reach the outer periphery of the body part 1, and are located at an outer periphery of an outwardly downwardly curved surface 13 of the first bulging part 10. That is, the end portions 5c, 5c do not reach the outer periphery of the body part 1 and are located inwardly than the outer periphery of the body part. An opening end edge portion 5a of the groove 5 defines a substantially oval shape in plan view, has a width being large at the center portion 5b and decreasing towards the end portions 5c, 5c. Furthermore, as shown in FIGS. 2A and 2B, the depth of the groove 5 is large at the center portion 5b and decreases towards the end portions 5c, 5c. The deepest portion of the groove 5 is formed with a depth of, for example, about 0.6 mm and the groove 5 has a V-shape in cross section with lateral side walls thereof crossing at right angle. The curved surface of each end portion 5c of the groove 5 has a curvature of, for example, R18-R10, and the curved surface of the center portion 5b of the groove 5 has a curvature of, for example, R2-R15 so that the curved surface of the center portion 5b is larger in curvature than the end portions 5c, 5c. In other words, the groove has a V-shape while bulges laterally outwardly and vertically outwardly simulating a ship bottom, which shape enables a tablet to be finely broken into component parts by an appropriate pressure. The angle defined by the opening end edge portion 5a of the groove 5 and each of the lateral side walls of the groove 5 is greater than 90 degrees, thereby causing no sharp edge portion.

[0030] As shown in FIGS. IA and IB, the tablet is separated into two sections Ll and L2 with the groove 5, which sections having a diameter slightly smaller than the diameter of the body part 1, and the first bulging part 10 is formed on these sections Ll and L2, while bulging from those sections respectively having apexes, and a pair of arc-shaped ridges connecting between the opposite end portions 5c, 5c of the groove 5 are formed to surround the groove 5, and to be located inwardly than the peripheral end of the body part 1. An area surrounded by these ridges 11, 11 has a substantially oval shape in plan view. [0031]

Therefore, since the first bulging part 10 is formed on the sections Ll, L2 having a diameter slightly smaller than the diameter of the body part 1 and the end portions 5c, 5c of the groove 5 are located at an outer periphery of the first bulging part 10, the body part 1 has an annular projection (land) 4 having a width of, for example, 0.1 mm around the outer periphery thereof. That is, this annular projection 4 protects the outer peripheral portion of the tablet and thus prevents chipping-off of the outer peripheral portion of the tablet. [0032] The first bulging part 10 has inwardly inclined surfaces 12, each having a substantially semilunar shape extending downwardly from the ridges 11, 11 towards the opening edge portion 5a of the groove 5, and outwardly downwardly curved surfaces 13 extending downwardly towards an inner peripheral portion of the top surface of the body part 1 while bulging outwardly. That is, since the inwardly inclined surface 12 and the outwardly downwardly curved surface 13 are continuously formed with each other around each ridge 11 and each outwardly downwardly curved surface 13 extends downward while bulging outwardly, an edge or sharp angular portion is not formed around each ridge. With this structure, for example, even when a force is applied to these ridges 11, 11 by having fingers of the user contacting thereto or by lightly hitting them with a flat surface of a hammer or mallet for breaking a tablet into component parts, they are unlikely to be chipped off.

[0033]

As illustrated in FIGS. IB and 1C and FIG. 3, the second bulging part 20 has an inwardly located bulging curved surface 21 that has a center portion bulging along the axial direction, and an outwardly located bulging curved surface 22 having an annular shape that downwardly extends from the outer peripheral portion of the inwardly located bulging curved surface 21 while bulging outwardly towards the inner peripheral portion of the bottom surface of the body part 1. The inwardly located bulging curved surface 21 has a curvature of, for example, R10-R18, and the outwardly located bulging curved surface 22 has the same curvature as that of the outwardly downwardly curved surface 13 of the first bulging part 10. Whereby, it is possible to manufacture tablets without variation in thickness and size or dimension compared with those conventional tablets. Thus, there is no need to modify an existing manufacturing line.

[0034]

Now, the description will be made for the manner of breaking a tablet into component parts. As shown in FIGS. 4A and 4B, the tablet has a center A of the inwardly located bulging curved surface 21 of the second bulging part 20, and two apexes B and C on the ridges 11, 11 of the first bulging part 20, which are farthermost from the aforesaid center A, and the center A and the apexes B and C define fulcrum points. In addition to this, another structural feature of the present invention lies in that a distance Hl between the deepest portion of the groove 5 and the center A of the second bulging part 20 is smaller, and a distance H2 between the deepest portion of the groove 5 and the two apexes B and C on the ridges 11, 11 is larger, as compared with a conventional tablet having a groove of a uniform depth. With this, a force applied to the groove 5 is enhanced and forces which act in directions opposite to each other are caused respectively to one lateral side wall and the corresponding opening edge portion 5a, of the groove 5, and another lateral side wall and the corresponding opening edge portion 5a, of the groove 5, thereby causing a crack at the center portion 5b of the groove 5 which progresses towards the end portions 5c, 5c. Thus, the tablet is broken into component parts. For example, as shown in FIG. 4A, a tablet is placed on a flat surface 30 so as to have the groove 5 facing upwards and the center of the second bulging part 20 abutting against the flat surface 30, then a force is applied from above onto the tablet by pressing the ridges 11, 11 of the first bulging part 10 with a finger of the user or the like, or lightly hitting them with a flat surface of a hammer or mallet (not shown), so that the tablet is broken along the groove 5 while these three points A, B and C act as fulcrum points. Also, as shown in FIG. 4B, a tablet is placed on a flat surface 30 so as to have the groove 5 facing downwards and the first bulging part 10 abutting against the flat surface 30, and a force is applied from above onto the center of the second bulging part 20 in the same manner as above, that is, by pressing the center of the second bulging part 20 with a finger of the user or the like or lightly hitting it with a flat surface of a hammer or mallet. This also enables the tablet to be broken.

[0035]

As shown in FIG. lA, the first bulging part 10 is constituted by plural sections Ll, L2 separated by the groove 5. The center A of the second bulging part 20, and the two apexes B and C on the ridges 11, 11, which apexes are farthermost from the aforesaid center A, respectively define fulcrum points, at which a force is applied to break the tablet.

[0036]

The present invention is not necessarily limited to the above embodiment, and may be subjected to modification or change without extending beyond the intended scope of the present invention according to the needs and circumstances.

[0037]

For example, the opening edge portion 5a of the groove 5 has a substantially oval shape in the aforesaid embodiment, while it is possible to have the opening edge portion 5a formed into a lozenge shape, as shown in FIG. 5A, or have a stepped opening edge portion 500a stepwisely decreasing in width towards respective end portions 500c, 500c, as shown in FIG. 5B.

[0038]

The groove 5 is formed along a theoretical center line on the top surface of the body part 1 in the aforesaid embodiment, while it is possible to have plural grooves radially extending from the geometrical center of the tablet at small intervals or three or four grooves at an equal interval.

[0039]

The bottom portion of the groove 5 is formed with a curved surface in the aforesaid embodiment, while it is possible to have the bottom portion of the groove 5 composed of a pair of inclined surfaces downwardly inclined towards the center portion 5b, or stepwisely increased in depth towards the center portion 5b. [0040]

The groove 5 has a V-shape in cross section with lateral side walls thereof crossing at right angle in the aforesaid embodiment, while it is possible to have the groove of a U-shape. However, a groove of a V-shape is preferable, when considering ease of breaking.

[0041]

The body part 1 has a disk shape in the aforesaid embodiment, while it is possible to have a body part of an angular plate shape, a circular column shape, an angular column shape or an oblong shape in plan view. The body part 1 preferably has such a shape as to enable a tablet to be equally broken with a groove or grooves.

[0042]

The value of the depth (d) (cf. FIG. l) is set to be in a range of preferably from 0.1 to 0.8 mm, more preferably from 0.3 to 0.7 mm, and much more preferably from 0.4 to 0.6 mm. These values are preferable for ease of breaking.

[0043]

Pharmacologically active substances for use in a table with a breaking line (bisect or score) of the present invention are not limited to specific ones, while various substances can be used. Examples of the pharmacologically active substances, which can be used, include procaterol, carteolol, cilostazol, rebamipide, tolvaptan, tetomilast, mozavaptan, and aripiprazole. They may be used solely or in combination of two or more. DESCRIPTION OF THE REFERENCE NUMERALS

[0044] 1^: body part, 2- top surface, 3: bottom surface, 4: annular projection

(land), 5: groove, 5a, 50a, 500a: opening edge portions, 5b, 50b, 500b: center portions, 5c, 50c, 500c: end portions, 10: first bulging part, H: ridge, 12: inwardly inclined surface, 13: outwardly downwardly curved surface, 20: second bulging part, 21: inwardly located bulging curved surface, 22: outwardly located bulging curved surface, 30: flat surface, Ll, L2: sections, A, B, C: fulcrum points, D, d: depths, Hl, H2: distances

Claims

1. A tablet that defines a groove (5) for breaking the tablet, in which the groove (5) decreases in depth towards end portions (5c, 5c) of the groove (5).

2. A tablet comprising a body part (l) having a first surface (2) with a groove (5) for breaking the tablet formed therein, a first bulging part (10) that bulges from the first surface (2) of the body part (l) to surround the groove (5) and have two apexes (B, C), a second bulging part (20) that bulges from a second surface (3) of the body part (l) to increase in height towards a center (A) thereof, wherein the center (A) of the second bulging part (20) and the two apexes (B, C) of the first bulging part (lθ) define fulcrum points at which force is applied to break the tablet, and wherein the groove (5) decreases in depth towards end portions (5c, 5c) of the groove (5).

3. The tablet according to any one of claims 1 and 2, wherein the groove (5) decreases in width towards the end portions (5c, 5c) of the groove (5).

4. A tablet that defines a groove (5) for breaking the tablet, wherein the groove (5) decreases in width towards end portions (5c, 5c) of the groove (δ).

5. A tablet comprising a body part (l) having a first surface (2) with a groove (5) for breaking the tablet formed therein, a first bulging part (lθ) that bulges from the first surface (2) of the body part (l) to surround the groove (5) and have two apexes (B, C), a second bulging part (20) that bulges from a second surface (3) of the body part (l) to increase in height towards a center (A) thereof, wherein the center (A) of the second bulging part (20) and the two apexes (B, C) of the first bulging part (lθ) define fulcrum points at which force is applied to break the tablet, and wherein the groove (5) decreases in width towards end portions (5c, 5c) of the groove (5).

6. The tablet according to any one of claims 4 and 5, wherein the groove

(5) decreases in depth towards the end portions (5c, 5c) of the groove (5).

7. The tablet according to any one of claims 2 and 5, wherein the first bulging part (lθ) is located more inside of the body part (l) than the outer periphery of the body part (l), and the groove (5) has the end portions (5c, 5c) located at an outer periphery of the first bulging part (lθ).

8. The tablet according to any one of claims 1 to 7, wherein the end portions (5c, 5c) of the groove (5) each are formed with a curved surface having a curvature larger than the curvature of a curved surface of the center portion (5b).