JPH111425A - Dividable tablet - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a dividable tablet for medical use, divided by pressing downward using the finger cushion, free of problems related to PTP packing in the pressing direction, more uniformly divided than is the conventional dividable tablet, and having some thickness and relatively small tablet diameter. SOLUTION: This tablet has large grooves, 4 to 10 mm wide, both on the upper and lower sides, with at least a pair of visible dividing lines parallel to each other, one on the upper side and the other on the lower side at the bottom of each groove to divide the tablet into two along the center of each side, wherein the tablet is symmetrical with respect to the section containing the dividing line, the dividing lines on the upper and lower sides are 2 to 8 mm apart from each other, and tablet thickness is 4 to 10 mm.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates to a medical divided tablet. More specifically, the present invention relates to a divided medical tablet that can be divided into at least two parts by placing a tablet on a hard surface and pressing the tablet from above. Here, the “divided tablet” refers to a tablet that is assumed to be divided into at least two equal parts and taken.

[0002]

2. Description of the Related Art Divided tablets have been developed to adjust the dosage according to the individual patient and to broaden the range of formulations.

[0003] The divided tablet is usually of a type in which a finger is picked with a finger and divided by applying force to the inside with both fingers (for example, see Japanese Patent Application Laid-open No. Hei 8-2772).
No. 18, No. 5-37924, No. 7-19339) and a type in which the tablet is placed on a hard surface and divided by pressing from above using the belly of a finger (mainly a thumb) ( For example, Japanese Utility Model Publication No. 40-3680, Japanese Unexamined Patent Publication No.
8-1012 JP), JP-A-7-179333, JP-A-8-5334
No. 5).

[0004] The former type is inconvenient for patients who have difficulty in picking up tablets because the tablets must be taken out of the PTP package and divided when the tablets are packaged in PTP, which is a normal packaging form. . Also, a relatively strong force is required to divide. On the other hand, the latter type can be divided even in the PTP-packaged state, so that the above-mentioned patient can be dealt with. However, the method of applying the force becomes uneven, and the uniform division cannot be sufficiently performed. There is a risk. Also, when dividing in the state of PTP packaging, if the surface with the dividing line faces upward, it will be pressed from the back of the PTP packaging, but in such a case, the cover sheet of the PTP packaging becomes an obstacle, A stronger pressing force is required for dividing. In the case of a film-coated tablet, a stronger pressing force is required.

[0005] The divided tablet described in JP-A-7-179333 can have a score line on both upper and lower surfaces.
The problem of division related to the PTP packaging can be avoided. However, since it is a divided tablet having a side band part of a constant width over the entire circumference, it is extremely difficult to produce a tablet having a large thickness in production, and it is inevitably a thin tablet having a large tablet diameter. Be restricted. When the tablet diameter is large, it is inconvenient for both the user who takes the package and who takes the tablet. It is also feared that the hardness is inferior.

[0006]

SUMMARY OF THE INVENTION An object of the present invention is to provide a PT
There is no such problem relating to the P packaging, and a more uniform division can be performed.
Another object of the present invention is to provide a thick divided medical tablet having a relatively small tablet diameter.

[0007]

Means for Solving the Problems As a result of intensive studies, the present inventors have achieved the above object by forming relatively large grooves having an appropriate width with a score line on both upper and lower surfaces of the tablet. Having found what can be achieved, the present invention has been completed.

The present invention relates to a tablet having large grooves on both upper and lower surfaces, wherein the width of each groove is 4 mm.
1010 mm, and at the bottom of each of the grooves there is at least one pair of parallel secant lines that are apparently formed and bisect the tablet along the center of each of the upper and lower surfaces of the tablet. The left and right sides are symmetrical with respect to the cross section including the pair of secant lines, and the distance between the secant lines on the upper and lower surfaces is 2 mm to 8 mm.
mm, and the tablet thickness (the longest distance between the upper and lower surfaces) is in the range of 4 mm to 10 mm (hereinafter referred to as “the divided tablet of the present invention”).

The width of the groove according to the present invention is suitably in the range of 4 mm to 10 mm both above and below, but is preferably in the range of 5 mm to 8 mm from the dividing method described later. Further, the shape of the vertical orthogonal cross section of the groove may be the same shape in the upper and lower sides or may be the different shape in the upper and lower sides, so that the width of the groove may be different between the upper and lower sides. However, an upper and lower same type is appropriate. The depth of the groove is appropriately in the range of 1.5 mm to 8 mm, and preferably in the range of 2 mm to 5 mm, without considering a slight dent that can be formed in the score line portion as described later.

As the shape of the cross section of the groove at right angles to the vertical, various shapes can be considered for both the upper and lower surfaces, as exemplified in the front views (2) of FIGS. FIGS. 1 to 4 show the same V-shape, and FIGS. 5 and 6 show the same two-stage V-shape.
FIG. 7 shows a vertically arcuate convex arc type, and FIG. 8 shows a vertically irregular V-shape. Among them, a V-shape or a two-stage V-shape having the same upper and lower shapes is preferable. In the case of a groove that is not formed by a single slope such as a two-stage V-shaped or arc-shaped V-shaped, it can have a flat portion in the middle. Further, in a two-stage V-shape or the like, by making the bottom portion an acute V-shape, it is possible to make the recognition of the deepest part of the dividing line better.

The score line according to the present invention can have at least one pair on each of the upper and lower surfaces, but one pair is suitable on each of the upper and lower surfaces. The dividable tablet of the present invention having the pair of split lines can divide the tablet into two equal parts, and can be said to be a dividable tablet of the present invention. Two of two perpendicular to each other on both the upper and lower surfaces
In the case of the dividable tablet of the present invention having a pair of score lines, the dividable tablet of the present invention can be equally divided into four equal parts, and can be referred to as the dividable tablet of the present invention. It is appropriate that the dividing line can be recognized as a straight line so that the central part can be accurately recognized, but if the central part can be recognized and there is substantially no problem in dividing equally,
It may be a flat or curved surface having a small width (for example, 0.1 mm to 0.5 mm). Such planes and curved surfaces corresponding to the secant may be slightly concave. In the present invention, the distance between the secant lines on the upper and lower surfaces is suitably in the range of 2 mm to 8 mm, but is preferably in the range of 3 mm to 5 mm.
The thickness of the tablet (the longest distance between the upper and lower surfaces) is suitably in the range of 3 mm to 10 mm, but is preferably in the range of 4 mm to 6 mm. As described above, the tablet of the present invention can be a relatively thick tablet.

Although the longest diameter of the divided tablet of the present invention is not particularly limited, it is suitably in the range of 6 mm to 12 mm, and 7 mm to 12 mm.
It is preferably within the range of 10 mm. The shortest diameter of the divided tablet of the present invention is
Although not particularly limited, a range of 4 mm to 12 mm is appropriate, and a range of 6 mm to 10 mm is preferable.

The split tablet of the present invention can have a flat portion on the upper and lower surfaces or on one of the cut surfaces and the edge of the groove toward the score line. It is preferable to have a flat portion at any position between the notch and the edge of the groove on both the upper and lower surfaces. By having such a flat portion, collapse of the fulcrum due to pressing can be reduced.
The maximum width of the flat portion varies depending on the planar shape of the tablet, the width of the groove, and the like, and is not particularly limited.
mm to 1.5 mm is sufficient. In addition, it is preferable that each cut-out of the groove is rounded. By providing such roundness, it is possible to reduce collapse of each cutout due to pressing.

The divided tablet of the present invention may have a chamfered peripheral portion on both upper and lower surfaces or one of the surfaces. It is preferable that both peripheral edges on both upper and lower surfaces are chamfered. By being chamfered in this way, it is possible to prevent chipping of the peripheral portion during transportation or the like. The chamfer angle is suitably in the range of 15 to 60 ° with respect to the peripheral side surface, and preferably in the range of 25 to 45 °. Examples of the planar shape of the upper and lower surfaces of the divided tablet of the present invention include a circle, an ellipse, an incomplete circle, an incomplete ellipse, a rectangle, and a polygon. Examples of the incomplete circular shape and the incomplete elliptical shape include a circular shape and an elliptical shape in which a part of an edge portion is missing so as to be orthogonal or parallel to the dividing line (see FIGS. 2 to 8).

The divided tablets of the present invention may include those coated with a film. The splittable tablet of the present invention coated with a film is also excellent in dividability.

[0016]

BEST MODE FOR CARRYING OUT THE INVENTION The divided tablet of the present invention is prepared, for example, by setting a punch processed into a desired form in a tableting machine, and applying an appropriately formulated tableting granule to the tableting machine. It can be manufactured by feeding and operating a tableting machine in a conventional manner. Tableting punch for producing the split tablet of the present invention,
Since it requires special processing, it can be said that the present invention is special.

The divided tablet of the present invention has a groove having a dividing line on each of the upper and lower surfaces, and the width of the groove is in the range of 4 mm to 10 mm. Therefore, unlike the conventional divided tablet, the claw is formed along the dividing line. Or by applying a pressing force along the dividing line with a suitable tool corresponding to a nail, or pressing the central portion. Further, since the upper and lower surfaces have the dividing lines, the PTP package can be divided as described above from the front surface (the surface where the tablet can be seen) without turning over the PTP packaging surface. As described above, according to the present invention, since the pressing force is concentrated on the dividing line, more excellent and uniform division is possible. If the width of the groove is smaller than 4 mm, it is difficult to divide by raising the nail, and if it is larger than 10 mm, the motivation to divide by raising the nail is weakened. And there is a possibility that a sufficiently uniform division may not be performed.

[0018]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described in further detail below with reference to embodiments shown in the drawings.

The split tablet A-1 of the present invention shown in FIG. 1 has an upper and lower V-shaped groove 1 having a width a of 7 mm and a depth b of 1.5 mm. The tablet is formed along the center of each of the upper and lower surfaces of the tablet.
There is a pair of mutually parallel secant lines 2 that divide
The left and right sides are symmetrical with respect to the XX line cross section including the pair of secant lines 2, the distance c between the upper and lower surfaces is 2 mm, and the tablet thickness d is 5 m.
m, the lock diameter e is 9 mm, the peripheral edges on both upper and lower surfaces are chamfered at an angle of 30 ° (α) with respect to the peripheral side surface, and four grooves 1 on both upper and lower surfaces toward the dividing line 2 are formed. It has a flat portion 4 between the cutout and the chamfered edge 3, and has a circular planar shape.

The splittable tablet A-2 of the present invention shown in FIG. 2 has an upper and lower identical V-shaped groove 1 having a width a of 7 mm and a depth b of 1.5 mm. The tablet is formed along the center of each of the upper and lower surfaces of the tablet.
There is a pair of mutually parallel secant lines 2 that divide
The left and right sides are symmetrical with respect to the XX line cross section including the pair of secant lines 2, the distance c between the upper and lower surfaces is 2 mm, and the tablet thickness d is 5 m.
m, the longest diameter e1 of the tablet is 9 mm, the shortest diameter e2 of the tablet is 8.5 mm, and the peripheral edge on both upper and lower surfaces is chamfered at an angle of 30 ° (α) to the peripheral side surface. The upper groove 1 has a flat portion 4 between the four cutouts toward the dividing line 2 and the chamfered edge 3 so that the plane shape is orthogonal to the dividing line 2 as can be seen from the plan view (1). It is an incomplete circular shape with a part of the edge partly lacking horizontally. The divided tablet A-2 of the present invention is a divided tablet A-1 of the present invention having a circular planar shape.
As compared with, the dividing line is shorter (the distance between the fulcrums is longer), so that the dividing property is more excellent.

The divided tablet A-3 of the present invention shown in FIG. 3 has a V-shaped groove 1 of the same upper and lower shape having a width a of 7 mm and a depth b of 1.5 mm. The tablet is formed along the center of each of the upper and lower surfaces of the tablet.
There is a pair of mutually parallel secant lines 2 that divide
The left and right sides are symmetrical with respect to the XX line cross section including the pair of secant lines 2, the distance c between the upper and lower surfaces is 2 mm, and the tablet thickness d is 5 m.
m, the longest diameter e1 of the tablet is 9 mm, and the shortest diameter e2 of the tablet is 8
mm, and the peripheral edge on both upper and lower surfaces is chamfered at an angle of 30 ° (α) with respect to the peripheral side surface.
Has a flat portion 4 between the four cutouts toward the score line 2 and the chamfered edge 3, and the four cutouts are rounded off on a so-called R surface, and the plan shape is a plan view (1). )
As can be seen from FIG. 7, the edge is partially incompletely horizontal and is incompletely circular so as to be orthogonal to the dividing line 2. The dividable tablet A-3 of the present invention has a shorter dividing line (longer distance between fulcrums) than the dividable tablet A-1 of the present invention having a circular planar shape, and thus is more excellent in dividability.

The divided tablet A-4 of the present invention shown in FIG. 4 has a vertically-shaped V-shaped groove 1 having a width a of 6 mm and a depth b of 1 mm, and has an apparently formed bottom at each bottom. And a pair of parallel secant lines 2 that divide the tablet into two equal parts along the center of each of the upper and lower surfaces of the tablet. Are symmetrical, the distance c between the secant lines on the upper and lower surfaces is 3 mm, and the tablet thickness d is 5 m
m, the longest diameter e1 of the tablet is 8 mm, and the shortest diameter e2 of the tablet is 9
mm, and the peripheral edge on both upper and lower surfaces is chamfered at an angle of 30 ° (α) with respect to the peripheral side surface.
Has a flat portion 4 between the four cutouts toward the dividing line 2 and the chamfered edge portion 3, and as shown in the plan view (1), the edge portion is parallel to the dividing line 2. It is an incomplete circle that is partially missing horizontally. The divided tablet of the present invention A-
In No. 4, since the longest diameter is parallel to the dividing line, the tablet 4 can be divided along the dividing line even if it is hung on a tablet half-cutting machine that cuts along the direction of the longest diameter.

The divided tablet B-1 of the present invention shown in FIG. 5 has a width a of 7 mm (a1 is 3.0 mm and a2 is 1 mm) and a depth b of 1.5 mm (b1 is 1 mm and b2 is 0.5 mm). A two-stage V-shaped groove 1 of the same upper and lower shape, which is apparently formed at each bottom of the groove 1 and bisects the tablet along the center of each of the upper and lower surfaces of the tablet. Are parallel to each other, and the left and right sides are symmetric with respect to the XX line cross section including the pair of split lines 2, and the distance c between the upper and lower surfaces is c.
Is 2 mm, the tablet thickness d is 5 mm, and the longest diameter e1 of the tablet is 9 m
m, the shortest diameter e2 of the tablet is 8 mm, and the peripheral edge on both upper and lower surfaces is chamfered at an angle of 30 ° (α) with respect to the peripheral side surface, and goes to the dividing line 2 of the groove 1 on both upper and lower surfaces. A flat portion 4 is provided between the four cutouts and the chamfered edge portion 3, and as shown in a plan view (1), the edge portion is partially horizontally chipped so as to be orthogonal to the dividing line 2. It is an incomplete circular shape.

The divided tablet B-2 of the present invention shown in FIG. 6 has a width a of 7 mm (a1 is 1 mm, a2 is 2 mm, and a3 is 1 m).
m), depth b is 1 mm (b1 is 0.5 mm, b2 is 0.1 mm).
5 mm) has a two-stage V-shaped groove 1 of the same shape as the upper and lower sides having a flat portion 5 at the bottom of each groove 1, and is formed apparently at the bottom of the groove along the center of each of the upper and lower surfaces of the tablet. There is a pair of parallel secant lines 2 that divide the tablet into two equal parts, and the left and right sides are symmetrical with respect to the XX line cross section including the pair of secant lines 2, and the distance c between the upper and lower surfaces is 2 .5m
m, the tablet thickness d is 4.5 mm, the longest diameter e1 of the tablet is 9 mm,
The shortest diameter e2 of the tablet is 8 mm, the peripheral edge on both upper and lower surfaces is chamfered at an angle of 30 ° (α) to the peripheral side surface, and four grooves 1 on both upper and lower surfaces toward the dividing line 2 are formed. A flat portion 4 is provided between the cutout and the chamfered edge portion 3, and the edge portion is partially horizontal so as to be orthogonal to the dividing line 2 as can be seen from the plan view (1). It is a perfect circle.

The split tablet C-1 of the present invention shown in FIG. 7 has a convex arc-shaped groove 1 having a width a of 7 mm and a depth b of 1.5 mm and having the same shape as the upper and lower sides.
At the bottom of the groove 1, there is a pair of parallel secant lines 2 which are apparently formed and bisect the tablet along the center of each of the upper and lower surfaces of the tablet. The left and right sides are symmetric with respect to the XX line cross section including the pair of secant lines 2, the distance c between the secant lines on the upper and lower surfaces is 2 mm, and the tablet thickness d is 5
mm, the longest diameter e1 of the tablet is 9 mm, the shortest diameter e2 of the tablet is 8 mm, and the peripheral edge on both upper and lower surfaces is chamfered at an angle of 30 ° (α) with respect to the peripheral side surface. Four notches and chamfered edges 3 of groove 1 towards score line 2
And a plane shape is an incomplete circular shape whose edge part is partially horizontally cut off so as to be orthogonal to the dividing line 2 as can be seen from the plan view (1).

The divided tablet D-1 of the present invention shown in FIG.
Is a groove 1 having an upper surface of 7 mm and a depth b1 of 1.5 mm.
And V-shaped grooves 1 and 1 ′ of upper and lower irregular shapes composed of a groove 1 ′ having a width a2 of 7 mm and a depth b2 of 1.5 mm on the lower surface, and at the bottom of each of the grooves 1 and 1 ′ Apparently formed,
There is a pair of parallel secant lines 2 and 2 ′ for bisecting the tablet along the center of each of the upper and lower surfaces of the tablet, and the XX line cross section including the pair of secant lines 2 and 2 ′ Is symmetrical to the left and right, and the distance c
Is 2 mm, the tablet thickness d is 5 mm, and the longest diameter e1 of the tablet is 9 m
m, the shortest diameter e2 of the tablet is 8 mm, the peripheral edges on both upper and lower surfaces are chamfered at an angle of 30 ° (α) with respect to the peripheral side surface, and the dividing lines of the grooves 1 and 1 ′ on both upper and lower surfaces 2 has a flat portion 4 between the four notches and the chamfered edge portion 3, and the edge portion is perpendicular to the dividing lines 2 and 2 ′ as seen in a plan view (1). It is an incomplete circle that is partially missing horizontally.

Test Example 1 Properties of Divided Tablets Tablets produced by a conventional method were weighed at 280 mg and tableting pressure at 700 kg using an application tester, Autograph AG-5000A (Shimadzu Corporation, same hereafter), using an applied test device. Under the conditions described above, four types of samples (all plain tablets) shown in the column of the shape of Table 1 were produced. In addition, the obtained four types of naked tablets were coated mainly with hydroxypropylmethylcellulose using a coating apparatus Doria Coater Model 500 (manufactured by Powrex) to obtain coated tablets. The sample No. The groove angles of all of tablets 1 to 3 are about 150 degrees. 4 has a groove angle of about 90 degrees and a depth of about 0.5 mm.

A force was applied to the obtained four types of uncoated tablets and coated tablets in the radial direction with an Autograph AG-5000A, and the maximum pressing force until the tablets were broken is shown in Table 1 as hardness. The measured values were obtained by vertically dividing the tablet score line (5
(Tablets) and those with the score line positioned horizontally (5 tablets).

[0029]

[Table 1]

Sample No. In one of the divided tablets of the present invention, both the uncoated tablet and the film-coated tablet had hardness equal to or better than other conventional divided tablets.

Test Example 2 Pressing force required for division and uniformity of division When a force was applied to the four types of naked tablets and coated tablets according to Test Example 1 in the thickness direction using an Autograph AG-5000A, and the tablets were divided. The maximum pressing force was measured. The CV value (%) was determined from the weight of the divided tablet pieces. Where CV
The value is a value obtained by dividing the weight deviation value between the divided tablet pieces by the average weight and expressing the result in%, which is an index indicating the uniformity of the division. The smaller the CV value, the more evenly the CV value is divided. For the measurement of the maximum pressing force at the time of division, the sample tablet was placed on two bar-shaped members B with an interval of 6 mm on the sample table A so that the score line was downward and parallel to the bar-shaped member B. The cutting was performed by positioning the tip of a blade-shaped pressing jig C whose angle was cut off to about 60 degrees so as to be parallel to the dividing line of each tablet, and moving this downward to press the tablets.

FIG. 10 shows a schematic diagram of the dividing method at this time, FIG. 11 shows the measurement results of the pressing force, and FIG.
2 respectively. As a result of the measurement of the pressing force, No. 1 corresponding to the divided tablet of the present invention was obtained. One tablet was divided with the smallest pressing force despite the hardness being high for both the uncoated tablet and the coated tablet. Regarding the uniformity of division, Nos. 1 to 3 tablets were excellent. 1
Tablets were the best.

Test Example 3 Pressing force required for dividing in packaging material (PTP) (upper surface) Four types of bare tablets and coated tablets according to Test Example 1 were packaged in PTP so that the score line was on the lower surface, and the thickness was increased with fingers. Apply a force in the direction to determine the maximum pressing force when the tablet is split.
Measured at -5000A. PTP packaging is vinyl chloride D
Was formed in a pocket shape, and each sample tablet was put into the pocket shape. Here, No. Regarding one tablet, the form may be determined regardless of its direction. 2,
For three tablets, the score line was located on the aluminum foil side. The maximum pressing force at the time of division was measured by placing each of the tablets packaged in the PTP on the sample table A and applying the method of easiest division, that is, pressing with the thumb in the vertical direction from the vinyl chloride side. Note that the pressing method is the easiest to split, ie, N
o. In the case of one tablet, a method 1 in which the nail is applied to the score line and pressed vertically is used. In the case of a few tablets, Method 2 was used in which the top of the tablet was pressed vertically by the belly of the thumb.

FIG. 13 shows a schematic diagram of the dividing method at this time, and FIG. 14 shows the measurement results of the pressing force. As a result of the measurement of the pressing force, No. 1 corresponding to the divided tablet of the present invention was obtained. One tablet is
Both the uncoated tablet and the coated tablet were split with the smallest pressing force despite the high hardness. Regarding the uniformity of division, the same result as in Test Example 2 was obtained.

Test Example 4 Pressing force required for division in the packaging material (PTP) (lower surface) Four types of bare tablets and coated tablets according to Test Example 1 were PTP-packed so that the score line was on the upper surface, and the thickness was increased with fingers. Apply a force in the direction to determine the maximum pressing force when the tablet is split.
Measured at -5000A. PTP packaging is vinyl chloride D
Was formed in a pocket shape, and each sample tablet was put into the pocket shape. Here, No. Regarding one tablet, the form may be determined regardless of its direction. 2,
For three tablets, the score line was located on the vinyl chloride side. Measurement of the maximum pressing force at the time of division is performed by placing each tablet packaged in PTP on the sample table A and using the method that is most easily divided, that is, N
o. No. 1 tablet from the vinyl chloride side. For a few tablets, thumb pressure was applied vertically from the aluminum foil side with the thumb. The pressing method is the easiest method to split, that is, No. In the case of one tablet, a method 1 in which the nail is applied to the score line and pressed vertically is used. In the case of a few tablets, Method 3 was used in which the top of the tablet was pressed vertically with the belly of the thumb.

FIG. 15 shows a schematic diagram of the dividing method at this time, and FIG. 16 shows the measurement results of the pressing force. As a result of the measurement of the pressing force, No. 1 corresponding to the divided tablet of the present invention was obtained. One tablet is
Both the uncoated tablet and the coated tablet were split with the smallest pressing force despite the high hardness. No. It is considered that the reason why a few tablets required a large pressing force for the division was that the vinyl chloride sheet as the packaging material hindered the force of opening the score line of the tablet by the pressing force. Regarding the uniformity of division, the same result as in Test Example 2 was obtained. Note that N
o. 2 tablets and no. Contrary to the above, when three tablets were pressed in the vertical direction from the vinyl chloride side (upper surface) with the belly of the thumb, even if the pressing force exceeded 20 kg, the tablets were not divided, and division was practically impossible. .

[0037]

The effects of the present invention include, for example, the following effects in addition to the effects listed above. The splittable tablet of the present invention having a dividing line in the minor axis, the upper and lower surfaces of which are elliptical in plane shape, and a part of the edge part is missing so as to be orthogonal to the dividing line, and the upper and lower surfaces are incompletely circular in plan shape. Since the split tablet of the present invention can shorten the score line or lengthen the distance between the fulcrums, it can improve the dividability (equal division, reduction of pressing force, etc.). Conversely, having a dividing line in the major axis, the two-sided tablet of the present invention in which the upper and lower surfaces have an elliptical planar shape,
The divided tablet of the present invention, in which the upper and lower surfaces are incompletely circular in plan shape, in which a part of the edge is chipped so as to be parallel to the dividing line, is usually hung by a so-called tablet half-cut device used in hospitals and the like. Can also be divided along the secant line.

When a divided tablet having both upper and lower surfaces in a circular plane is manufactured by a general tableting machine, both the lower punch and the die are cylindrical, so that the lower punch freely rotates in the die. As a result, it is difficult to position the upper and lower secant lines in parallel. However, in the case of the divided tablet of the present invention in which the upper and lower surfaces are not circular, since the structure of the lower punch and the die is such that the lower punch cannot freely rotate in the die, the upper and lower split lines are easily placed in parallel. Can be done. In the divided tablet of the present invention, since the pressing point at the time of division is located below the peripheral portion of the tablet, unnecessary division due to external pressure during transportation or the like can be reduced. The divided tablet of the present invention has a thick structure at the periphery of the tablet, so that it is easy to hold even in the dividing method in which the tablet is held with both hands, and is excellent in dividability.

[Brief description of the drawings]

FIG. 1 shows one embodiment of the divided tablet of the present invention in three views, (1)
Is a plan view, (2) is a front view, and (3) is a side view.

FIG. 2 shows one embodiment of the divided tablet of the present invention in four views, (1)
Is a plan view, (2) is a front view, (3) is a side view, and (4) is a rear view.

FIG. 3 shows one embodiment of the divided tablet of the present invention in three views, (1)
Is a plan view, (2) is a front view, and (3) is a side view.

FIG. 4 shows one embodiment of the divided tablet of the present invention in three views, (1)
Is a plan view, (2) is a front view, and (3) is a side view.

FIG. 5 shows one embodiment of the divided tablet of the present invention in three views, (1)
Is a plan view, (2) is a front view, and (3) is a side view.

FIG. 6 shows one embodiment of the divided tablet of the present invention in three views, and (1)
Is a plan view, (2) is a front view, and (3) is a side view.

FIG. 7 shows one embodiment of the divided tablet of the present invention in three views, and (1)
Is a plan view, (2) is a front view, and (3) is a side view.

FIG. 8 shows one embodiment of the divided tablet of the present invention in four views, and (1)
Is a plan view, (2) is a front view, (3) is a side view, and (4) is a bottom view.

FIG. 9 shows a perspective view of the divided tablet A-1 of the present invention.

FIG. 10 shows a schematic diagram of a division method in Test Example 2.
The thick arrow indicates the direction of the force.

FIG. 11 shows the maximum pressing force required for division. The horizontal axis represents the sample tablet number, and the vertical axis represents the maximum pressing force (kg). The left blank column shows the data of each bare tablet, the right black column shows the data of each film-coated tablet,
Respectively.

FIG. 12 shows the weight deviation of each tablet piece after division. The horizontal axis represents the sample tablet number, and the vertical axis represents the CV value (%). The white columns on the left represent data for each uncoated tablet, and the black columns on the right represent data for each film-coated tablet.

FIG. 13 shows a schematic diagram of a dividing method in Test Example 3.
The thick arrow indicates the direction of the force.

FIG. 14 shows the maximum pressing force required for division from the upper surface of the packaging material. The horizontal axis is the sample tablet number, and the vertical axis is the maximum pressing force (k
g) respectively. The white columns on the left represent data for each uncoated tablet, and the black columns on the right represent data for each film-coated tablet.

FIG. 15 shows a schematic diagram of a division method in Test Example 4.
The thick arrow indicates the direction of the force.

FIG. 16 shows the maximum pressing force required for division from the lower surface of the packaging material. The horizontal axis is the sample tablet number, and the vertical axis is the maximum pressing force (k
g) respectively. The white columns on the left represent data for each uncoated tablet, and the black columns on the right represent data for each film-coated tablet.

[Explanation of symbols]

 1, 1 '... groove 2, 2' ... dividing line 3 ... chamfered edge 4 ... flat portion 5 ... flat portion in groove 6 ... peripheral side surface

Claims (8)

[Claims] 1. A tablet having a large groove on each of the upper and lower surfaces, wherein the width of each groove is within a range of 4 mm to 10 mm, and each tablet is apparently formed at each bottom of the groove.
There is at least one pair of parallel secant lines bisecting the tablet along the center of each of the upper and lower surfaces of the tablet, and the left and right sides are symmetrical with respect to the cross section including the pair of secant lines. The distance between the surface secant lines is in the range of 2 mm to 8 mm, and the tablet thickness (the longest distance between the upper and lower surfaces) is 4 m
A divided tablet for medical use, which is within a range of m to 10 mm. 2. The divided tablet for medical use according to claim 1, wherein the longest diameter of the tablet is 6 mm to 12 mm, and the shortest diameter is 4 mm to 12 mm. 3. On both upper and lower surfaces or on one of the upper and lower surfaces,
3. The divided tablet for medical use according to claim 1, having a flat portion between the cutout of the groove toward the score line and the edge. 4. On the upper and lower surfaces or on one of the surfaces,
The divided medical tablet according to any one of claims 1 to 3, wherein a peripheral portion is chamfered. 5. The medical division according to claim 1, wherein the vertical cross section of the groove present on both upper and lower surfaces has the same upper and lower shape, a V-shape, or a two-stage V-shape. Tablets. 6. The planar shape of both upper and lower surfaces is circular, elliptical,
The medical divided tablet according to any one of claims 1 to 5, wherein the tablet is in an incomplete circle, an incomplete ellipse, a rectangle, or a polygon. 7. The method according to claim 1, wherein the film is coated.
7. The divided tablet for medical use according to any one of claims 6 to 6. 8. A tableting punch for producing the divided medical tablet according to any one of claims 1 to 6.