JPH10175850A - Deformed type division tablet - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a division tablet accurately and readily dividable, hardly being broken by shock during handling, excellent in adaptability to a separately automatic tablet packing machine used in hospitals and pharmacies. SOLUTION: This deformed type division tablet has a major axis L and a minor axis S and is provided with a peripheral side face 1h between the peripheral edges of an upper surface 1f and a lower surface 1g. (a) The ratio of the width D of the major axis to the width D' of the minor axis is 1.2:1 to 3:1, (b) a part of the external shape of the minor axis has a constricted shape shorter than the width of the minor axis, (c) the upper and the lower surfaces are provided with swellings in a projected face state and (d) the upper and the lower surfaces at central line 1c parts obtained by connecting the most constricted parts of the external shape of the minor axis side are vertically opposingly provided with divided channels.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a modified split tablet having split grooves on both upper and lower surfaces.

[0002]

2. Description of the Related Art Japanese Utility Model Laid-Open Publication No. 8-277217 discloses a dividable tablet having constrictions in the vertical and horizontal directions. The dividable tablet described in the publication can be divided without forming a split groove by forming a constricted portion in a vertical direction and / or a horizontal direction, and a film is formed by reducing a contact area from its curved shape. The main purpose is to prevent adhesion in the coating process. Accordingly, the dividable tablet has a shape having two or more divided bodies in which the vertical swelling is considerably raised in its shape. Another difference is that the main purpose is to provide a dividable tablet that can prevent adhesion in the film coating process without using the tablet.

[0003] Japanese Patent Application Publication No. Hei 8-500599 describes a dividable tablet having an oblong outer shape and having swelling on both left and right sides of the upper and lower surfaces, each having a double-sided dividing line. The tablets described in the publication are not only different in shape, but also have an oval left and right bulge in an array-like shape, so that the tablet can be divided when left standing. In this respect, the purpose is different from that of the modified split tablet of the present invention described later.

Japanese Utility Model Application Laid-Open No. 7-19339 describes a circular divided tablet which can be divided into two or a plurality of divided tablets provided with split grooves on both upper and lower surfaces.

Japanese Utility Model Laid-Open No. 14333/1990 discloses a tablet having an elliptical shape adjacent to each other and having a dividing line on both sides of the upper and lower surfaces. It differs from the modified split tablet of the present invention described below in that it is a tablet.

[0006] Further, a double-sided long and short tablet (trade name: Seloken L tablet) having a ratio of a major axis width to a minor axis width of 3: 1 is commercially available. The shape is different in that the modified split tablet of the present invention has a constricted outer shape.

[0007]

Tablets are the most frequently used form of preparation because of the ease of adjusting the dosage. That is, when the dose of the tablet is increased, it can be easily adjusted by increasing the number of tablets, and when the dose is reduced, the tablet can usually be adjusted by dividing the tablet. However, it is not usually easy to divide a tablet accurately, and a tablet intended for division has, for example, a split groove (or a score line) provided in the center on one of the upper and lower surfaces. Something has been devised. However, even in the case of such a tablet, it is known that, in particular, in the case of a round tablet, the patient cannot be accurately divided at the time of division depending on conditions such as the patient to be administered and the direction of the fracture (for example, Fukuda et al., Hospital Pharmacy, Vol.1, No1, 33-35 (197
5)]. Therefore, in order to easily divide the tablet accurately, for example, a circular tablet described in Japanese Utility Model Application Laid-Open No. 7-19339 having split grooves on both sides or the actual Japanese Utility Model Application Laid-Open No. 2-1433.
The production of split tablets with a double-sided split groove and the like in which the elliptical shapes are adjacent to each other described in Japanese Patent Publication No. 3 (JP-A) No. 3 (1999) is attempted. However, it is difficult to say that these tablets are sufficiently satisfactory in view of the easiness of tablet splitting, the accuracy of splitting, and the problems of the strength of the split grooves against accidental impacts such as production, transportation, and dispensing. ,
It has been desired to develop a tablet for division that is easy to crack and that has sufficient strength against accidental impacts such as cracking, manufacturing, transportation, and dispensing.

The inventors of the present invention have conducted intensive studies to solve the above-mentioned problems, in particular, the problem of a double-sided grooved circular tablet.
The deformed splittable tablet shown below is accurately and easily split, and is less likely to be damaged by impact during handling, and has good packaging compatibility with automatic tablet packaging machines used in hospital pharmacies and the like. The inventors have found that the present invention has been completed.

[0009]

According to the present invention, there is provided a deformable tablet having a major axis and a minor axis, and having a peripheral side surface between peripheral edges of an upper surface and a lower surface, comprising: The ratio of width to short axis width is 1.
2: 1 to 3: 1, (b) a part of the outer shape on the short axis side has a constricted shape shorter than the short axis width, and (c) gently convex bulges are provided on the upper and lower surfaces. (D) A modified split tablet characterized in that split grooves are provided so as to be vertically opposed to each other on upper and lower surfaces of a center line portion connecting the most constricted portions of the outer shape on the short axis side.

[0010]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, some terms used in the present invention and the characteristics of the modified divided tablet of the present invention will be described with reference to the drawings showing the tablets of the examples.

The "long axis side" means an end side of a long axis (for example, see L in FIG. 1A) which connects the longer one when divided into two directions perpendicular to each other in a tablet other than a circle. , “Minor axis side” means the end side of the minor axis perpendicular to the major axis (for example, see S in FIG. 1A), and “major axis width” means the longest length of the major axis. (For example, see D in FIG. 1), and the “short axis width” means the width of the longest one of the short axes (for example, see D ′ in FIG. 1A).

The "peripheral side surface" means a continuous surface formed substantially vertically on the upper and lower surfaces on the peripheral edge of the tablet (for example, see 1h in FIGS. 1B and 1C).

The "center line" is defined as the most constricted portion of the constriction formed in the outer shape on the short axis side [for example, 1d and 1d in FIG.
e [see FIG. 1A).
See]. “Center line portion” means a nearby portion including the center line. In the modified split tablet of the present invention, since the split groove is provided in the center line portion, the "center line portion"
In the following description may be referred to as a "slit groove portion".

The term "slit groove" means a groove cut into the upper and lower surfaces of the tablet at a certain width toward the center of the tablet to a certain depth. The split groove is usually a line because the tablet is usually small. Since it looks like this, it may be called a dividing line, and in the present specification, the dividing groove and the dividing line are used as having the same meaning (for example, see 1p and 1q in FIG. 1B).

"Chamfering" means applying a surface having a certain length and a certain inclination from the periphery of the tablet to the upper surface and / or the lower surface of the tablet, and the formed surface is referred to as "a chamfer". It is referred to as an “inclined edge surface” (for example, see 1i and 1j in FIG. 1B).

The tablet of the present invention is a modified form of a long and short tablet, and the ratio of the long axis width to the short axis width is usually in the range of 1.2: 1 to 3: 1, but 1.5: 1. To 2.5: 1, particularly about 2: 1.

The shape of the peripheral edge on the long axis side is such that the tablet is less damaged when it hits a machine or the like during dispensing.
1A and 1b in FIG. 1 (A), a straight line in which the corners of both ends on the long axis side are rounded (for example, see FIG. 5), or a rounded end. A triangular shape (for example, see FIG. 7) is preferred, but an arc shape is preferable, and a shape in which the short axis width (for example, see D ′ in FIG. 1A) is the diameter of the arc is particularly preferable.

The tablet of the present invention is preferably provided with an inclined edge by chamfering the peripheral edge where the upper and lower surfaces and the peripheral side are in contact with each other.
(See (B)) is usually about 10 degrees to about 50 degrees, but preferably about 30 degrees.

As the shape of the constriction near both ends of the center line of the tablet of the present invention, a symmetrical arc shape [for example, FIG.
1d and 1e), a gentle V-shape with both ends of the center line at the bottom (for example, see FIG. 8).
An arc shape is preferred from the viewpoint of tablet strength during film coating and handling.

An arc forming a constriction (see, for example, a curve connecting the dotted line and the constricted portion 1d or 1e in FIG. 2).
For example, on an extension line on both sides of the center line, each dimension is about 1 to about a short axis width (D ′) (for example, see FIG. 2) from the center point of the center line (for example, 1x in FIG. 2). 3 times, preferably about 1.5 times (for example, 1y or 1z in FIG. 2)
), The length (D ″) between the maximum constrictions (see, for example, FIG. 2) is about 70 to about 9 of the short axis width D ′.
The arc is set so as to be 0%.

The length (D '') between the maximum constrictions on the arc or V is usually set to be about 70 to about 90% of the short axis width, but is preferably set to about 75 to about 85%. It is preferable to set. The reason for this is that if the dimension exceeds 90%,
The effect of the constriction is poor and the splitting ability is reduced.
If it is less than 0%, the strength of the connecting portion between the upper and lower split grooves is reduced, and there is a possibility that cracks may be generated during the transportation, during dispensing, or even during storage, even if only an impact is applied.

The gently convex bulges provided on the upper and lower surfaces of the tablet of the present invention include, for example, an arc shape (see, for example, FIG. 4B) (however, except for a groove portion). Preferably, an inclined edge surface is formed, and the shape of an arc [for example, rising from the inner ends of the inclined edge surface (for example, see 1k and 1l in FIG. 1B) toward the center of the tablet [for example, FIG. 1 (B)] (however, excluding the split groove portion).

The inclined edge surface is usually an inclined continuous flat surface, but may be a continuous gentle curved surface. In addition, near the contact point between the peripheral side surface and the sloped edge surface or the bulge on the upper and lower surfaces, a partially horizontal plane, that is, a hook portion may be formed instead of the sloped surface or the bulge.

The width of the inclined edge surface is usually about 10% of the major axis width.
The following is preferred, but about 5 to about 8% is preferred.

As the degree of the bulge, when there is no inclined edge surface (see, for example, FIG. 4B), the vertical dimension (t) between the upper end (or lower end) of the peripheral side surface and the top of the bulge.
[See, for example, FIG. 4B] is usually set to about 5 to about 25% of the maximum thickness (T) of the tablet (for example, see FIG. 4B), but to about 10 to about 18%. It is preferably set, and more preferably about 15%. The reason for this is that if the above dimensional ratio is less than 5%, the upper and lower surfaces are almost planar, so that the effect of providing swelling is poor, and the strength of the connecting portion between the upper and lower split grooves is reduced. %, The resolvability decreases.

When an inclined edge surface is provided (for example, see FIG. 1B), the inner end of the inclined edge surface [1 in FIG.
k, 1 l (1 l), 1 r or 1 s] and the top and bottom of the bulge (t ′) (for example, see FIG. 1B)
Is preferably set to about 20 to about 60% of the vertical dimension (t) between the end of the peripheral side surface and the top of the bulge (for example, see FIG. 1B), and to about 25 to about 40%. Is more preferred. The reason for this is that if the dimensional ratio is less than 20%, the upper and lower surfaces are almost planar, so that the effect of providing the swelling is poor, and the strength of the connecting portion between the upper and lower split grooves is reduced. %, The resolvability decreases.

The maximum thickness (T) of the tablet is usually about 20 to about 40% of the major axis width, preferably about 25 to about 30%.

The width (T-2t) between the upper and lower ends of the peripheral side surface (for example, see FIG. 1B) is usually about 40 to about 80% of the maximum thickness (T) of the tablet, but is about 60 to 80%. About 70% is preferred.

The split grooves on the upper and lower surfaces may have a V-shaped, concave or arcuate cross section, but the V-shape is most preferable.
In addition, the vicinity of the V-shaped tip may be rounded or flat, or may be trapezoidal with the upper and lower surface sides widened.

In the case of the V-shape, the outward opening angle (β) (for example, see FIG. 1B) is about 40 to about 120.
Degrees, preferably about 60 to about 120 degrees, and more preferably about 90 degrees.

The depth (H) (for example, see FIG. 1B) of each split groove cut from the upper and lower surfaces is about the maximum thickness (T) of the tablet (for example, see FIG. 1B). 5 to about 30
%, Preferably in the range of about 6 to about 20%, with a particularly preferred range being about 8 to about 18%.

The modified split tablet of the present invention thus described specifically includes the symmetrical tablets shown in FIGS. 1, 4 and 5 to 8, and the left and right portions of these tablets or Tablets of the present invention also include tablets in which the upper and lower portions are separated and combined.

A preferred form of the modified split tablet of the present invention is a modified tablet having a peripheral surface, wherein (a) the ratio of the major axis width to the minor axis width is from 1.5: 1 to 2.5. : 1, the outer shape of the peripheral portion on the long axis side is arc-shaped, and (b) the short-axis side outer shape near the center line is a narrow shape shorter than the short-axis width (D '), and its maximum constriction The length between them (D '') is 7
(C) chamfering the peripheral edge where the upper and lower surfaces and the peripheral side surface are in contact with each other to provide an inclined edge surface, and (d) a gently convex bulge on the upper and lower surfaces is the inclined edge surface. The vertical dimension (t ') between the inner end of the inclined edge surface and the top of the bulge is the vertical dimension (t) between the upper end (or lower end) of the peripheral side surface and the top of the bulge. 25-40
(E) A split groove is provided on the upper and lower surfaces of the center line portion so as to be vertically opposed to each other, and the shape of the split groove is V-shaped, and the outward opening angle of the split groove is 60 degrees to 120 degrees. And the depth of each split groove cut from the upper and lower surfaces is about 6% to about 20% with respect to the maximum thickness of the tablet.

The modified split tablet of the present invention is suitable as a medical form for administration of various active substances, and a desired pharmaceutically active ingredient is also used as the active ingredient of the tablet (hereinafter sometimes referred to as the main drug). can do. The active ingredient can be present, for example, at about 0.1 to about 90% by weight of the tablet weight, but preferably about 0.1 to about 70% by weight, and about 0.1 to about 35%.
% By weight is more preferred.

As the tablet formulation for producing the modified split tablet of the present invention, a formulation used for the production of ordinary tablets can be used. Additives used in the formulation include, for example, excipients, binders, disintegrants, lubricants, flow agents, absorption enhancers, and colorants.

The modified split tablet of the present invention can be prepared, for example, by using a conventional tablet formulation and a punch and a die designed into an appropriate mold, for example,
It can be manufactured by tableting into the shape described in Examples below.

Further, the modified split tablet of the present invention can be formed into an appropriate form and then, if necessary, subjected to film coating using a commonly used coating agent.

Specific examples of the split tablet of the present invention include the following K tablets, L tablets, M tablets and N tablets in addition to the tablets described in Examples 1 and 2 below. Is not limited to these tablets.

K tablet: a modified divided tablet shown in FIG. 5, in which the ratio of the major axis width to the minor axis width is about 1.8: 1, and the outer shape of the peripheral portion on the major axis side is that of Example 1 described later. It is a modified split tablet different from that.

L tablet: a modified divided tablet shown in FIG. 6, having a ratio of the major axis width to the minor axis width of about 3: 1.

M tablet: a modified divided tablet shown in FIG. 7, having a ratio of the major axis width to the minor axis width of about 2: 1, and having an outer peripheral portion on the major axis side different from that of Example 1 described later. Different modified split tablets.

N tablet: a modified split tablet shown in FIG. 8, in which the ratio of the major axis width to the minor axis width is about 2: 1 and the shape of the constriction on the minor axis side is different from that of Example 1. It is a divided tablet.

Hereinafter, the present invention will be described in detail with reference to Examples, which show the characteristics of the shape of a modified divided tablet manufactured by a conventional method. Note that the tablet formulation described in the following examples and the tablet formulation described in the comparative example are the same or substantially the same.

[0044]

EXAMPLES Example 1 : Shape characteristics of modified split tablet of the present invention-As shown in FIG. 1 (A), modified split tablet 1 of Example 1
Has a ratio of the major axis width D (11.5 mm) to the minor axis width D '(5.75 mm) of 1: 2, and both ends 1a and 1b of the major axis are arc-shaped with the minor axis width D' as the diameter. The shape near both ends of the center line (that is, the dividing groove) 1c is formed in a symmetrical shape in which the shape near the both ends of the center line (that is, the short axis width D ′) is narrower and shorter than the short axis width D ′, as shown in FIG.
The arc-shaped constrictions 1d and 1e are located on the extension lines on both sides of the center line, starting from a position (1y and 1z) where the respective dimensions are about 1.5 times the short axis width D 'from the center point 1x of the center line. , Each with a radius of 6.5 mm (indicated by dotted line)
And the maximum constriction, that is, the dimension D ″ (4.75 mm) is set to about 83% of the short axis width D ′.

As shown in FIG. 1 (B), the gently convex bulges in the major axis direction provided on the upper surface 1f and the lower surface 1g are chamfered on the peripheral edge where the upper and lower surfaces in the major axis direction are in contact with the peripheral side surface. Is an arc (radius: 81 mm) connecting the ends 1k and 1l (1 el) or 1m and 1n on the inside of the inclined edge surface, and the inside edge (for example, 1k) of the inclined edge surface
Dimension t '(0.15 mm) between the top of the bulge and the top (or lower end) of the peripheral side and t (0.55 mm)
It is set to about 27% of. An upper groove 1p and a lower groove 1q are provided in the upper surface 1f and the lower surface 1g of the center line portion as a V-shaped cross section, and the depth H (0.3 m
m) is 9.4% of the maximum tablet thickness T (3.2 mm),
The opening angle β of the split groove is set to about 90 degrees. In addition, the chamfer angle α of the inclined edge surface is about 30 degrees.

As shown in FIG. 1 (C), the gently convex bulges in the short axis direction provided on the upper surface 1f and the lower surface 1g are formed by chamfering the peripheral edge in contact with the upper and lower surfaces in the short axis direction. A circular arc (radius: 14.1 mm) passing through the respective ends 1r and 1s or 1t and 1u and the top 1v of the bulge of the inside of the inclined edge surface.
r) and the dimension t '(0.15 mm) between the top of the bulge and the dimension t' (0.15 mm) is about 27% of the dimension t (0.55 mm) between the end of the peripheral surface and the top of the bulge.
Is set to

When the tablet of Example 1 is divided into two, as shown in FIGS. 3 (A) and 3 (B), hold the mark with a finger and divide the upper groove 1p in the opening direction (A). Even if it divides in the closing direction (B), it can divide correctly along the dividing grooves 1p and 1q.

Example 2 : Shape characteristics of the modified divided tablet (tablet without an inclined edge) of the present invention-As shown in FIG. 4 (A), the modified divided tablet 2 of Example 2
Has a ratio of the major axis width D (11 mm) to the minor axis width D '(5.5 mm) of 1: 2, and both ends 2a and 2b of the major axis are arc-shaped with the minor axis width D' as the diameter. The shape near the both ends of the center line (slit groove) 2c is formed in a symmetrical shape in which the shape near the short axis width D 'is made shorter in an arc shape, and the constriction is formed in the same manner as the method shown in the first embodiment. Let me. The maximum constriction, that is, the dimension (4.2 mm) connecting 2d and 2e, is set to about 76% of the minor axis D '.

As shown in FIG. 4B, the gently convex bulges in the major axis direction provided on the upper surface 2f and the lower surface 2g form ends 2i 'and 2j' of the peripheral surface 2h in the major axis direction. It is a circular arc shape (radius: 30 mm), and the dimension t (0.5 mm) between the upper end (or lower end) of the peripheral side surface and the top of the bulge is set to about 14% of the maximum thickness T (3.6 mm) of the tablet. I have. An upper split groove 2p and a lower split groove 2q are provided on the upper surface 2f and the lower surface 2g of the center line portion as a V-shaped cross section. The depth H (0.4 mm) of these grooves is set to about 11% of the maximum thickness T (3.6 mm) of the tablet.

As shown in FIG. 4 (C), the gently convex bulges in the minor axis direction provided on the upper surface 2f and the lower surface 2g correspond to the ends 2r 'and 2s' of the peripheral side surface 2h in the minor axis direction. It has an arc shape (radius: 7.45 mm) passing through the top 2v of the bulge, and a dimension t (0.5 mm) between the upper end (or lower end) of the peripheral side surface and the bulge top is about 14 times the maximum thickness T (3.6 mm) of the tablet.
% Is set.

Comparative Example Hereinafter, the characteristics of the shape of the tablet used for comparison with the tablets of Examples 1 and 2 (the modified split tablets of FIGS. 1 and 4) in the test described below are described in Comparative Example 1. And FIGS. 9 to 11 show drawings of these tablets.

Comparative Example 1 : Shape characteristics of an oblong double-sided scored tablet--The tablet of Comparative Example 1 shown in FIG. 9 is an oblong flat tablet with no bulges on the upper and lower surfaces. A split groove is provided. The ratio of the major axis width to the minor axis width is 2: 1, and the depth of the V-shaped split groove is approximately 1
3%.

Comparative Example 2 : Shape characteristics of a circular double-sided scored tablet--The tablet of Comparative Example 2 shown in FIG. 10 is a flat tablet having no bulge on the upper and lower surfaces, and is diametrically opposed to the upper and lower surfaces. A split groove is provided. The depth of the V-shaped split groove is about 13% between the upper and lower surfaces.

Comparative Example 3 : Shape characteristics of a deformable double-sided scored tablet (flat tablet)-The tablet of Comparative Example 4 shown in FIG. 11 is a deformable tablet with a double-sided scored line (major axis width: 11.5 mm, minor axis width: 5.75 mm) ) Is different from the tablet of Example 1 in that the upper and lower surfaces are flat without swelling. The depth of the V-shaped split groove is approximately 1 between the upper and lower surfaces.
3%.

[0055]

In the following, tests of the tablet of the example and the tablet of the comparative example on the dividability, impact strength and suitability for packaging by an automatic tablet packaging machine are shown, showing the excellent characteristics of the tablet of the present invention.

Test Example 1 : Dividability test--5 panelists (4 males, 1 female) did not explain the purpose of the test to each of the 10 tablets of the Examples and Comparative Examples along the groove. Instructed to split hands. The division method was left to each panelist.

The weight of each of the 20 half-tablets obtained by the division was precisely weighed, the standard deviation of the weight was obtained, and the weight was divided by the average to calculate the coefficient of variation (CV%). Show. In addition, the smaller the coefficient of variation, the higher the accuracy of equality of the divided half tablets. In this experiment, a tablet having a CV% of 4% or less was evaluated as a tablet having good dividability.

[0058]

[Table 1]

As is apparent from Table 1 above, the modified tablet of the present invention has a CV value of 1.2 to 2.9%, the weight variation of the half tablet after division is very small, and the oblong tablet having flat upper and lower surfaces (comparative). Tablet of Example 1) and round tablet (tablet of Comparative Example 2)
The splitting property was clearly superior to that of. Comparative Example 3
Since the tablet of Example 1 had the same shape as that of Example 1 except that the upper and lower surfaces were flat, the dividability was excellent similarly to the tablet of Example 1.

Test Example 2 : Tablet strength measurement test: A glass plate having a thickness of 7 mm was placed on a horizontal floor, and a tablet from the height of 1 m for each of the tablets of the example or the comparative example. The operation of spontaneously falling on the board was repeated 15 times, and the number of times that the board was damaged was measured. The measurement was performed on 10 tablets, and the total number of drops was calculated according to the following equation 1, and the results are shown in Table 2. In addition, in the following Formula 1, when it was not damaged by 15 times, the number of falling points was set to 15.

[0061]

## EQU1 ## Number of drops (points) = (number of drops at which an individual sample was damaged-1) × number of tablets

As is clear from the above formula, the larger the number of falling points, the higher the strength, and in this experiment, tablets having 65 points or more were evaluated as tablets having no problem in strength.

[0063]

[Table 2] ○: no problem in strength; Δ: slight problem in strength ×: problem in strength

As apparent from Table 2 above, the modified divided tablets of the examples were obtained by comparing the drop points (2
7) was clearly superior in strength. The tablet of Comparative Example 3 having the same shape as that of Example 1 except that the upper and lower surfaces are flat was slightly weaker than the tablets of Examples 1 and 2.

Test Example 3 : Compatibility test of packaging machine—Compatibility was tested with an automatic tablet packaging machine usually used in hospital pharmacies, and the results shown in Table 3 were obtained.

[0066]

[Table 3] ○: easy to pack; ×: impossible to pack

As is evident from Table 3, the tablets of Examples 1 and 2 exhibited good packing properties like the circular tablets having no orientation in shape (tablets of Comparative Example 2). On the other hand, the tablets of Comparative Examples 1 and 3, which were flat tablets, lacked fluidity and could not be packaged by an automatic tablet packaging machine.

[0068]

As described above, the modified splittable tablet of the present invention has extremely good splitting accuracy, and has almost no possibility of cracking even when subjected to an impact during transportation, dispensing or storage. When the tablets are packaged by an automatic tablet packager used in pharmacies and the like, direction regulation and the like can be easily performed by rotating the tablets in the horizontal direction, so that the compatibility with the packager is good. Furthermore, since the modified divided tablet of the present invention has a constricted shape, it is easy to hold when divided, and can be easily divided even by elderly people. Also, when taking as it is without dividing,
It can be easily taken without the impression of a large tablet.

[Brief description of the drawings]

FIG. 1 shows a modified divided tablet of Example 1,
(A) is a plan view, (B) is a front view, and (C) is a side view.

FIG. 2 shows a method of forming a constricted portion of the modified divided tablet of Example 1.

FIG. 3 is a schematic view of a method for dividing a tablet with double-sided grooves, (A) showing a case where the tablet is split downward, and (B) showing a case where the tablet is split upward.

FIG. 4 shows a modified divided tablet of Example 2,
(A) is a plan view, (B) is a front view, and (C) is a side view.

FIG. 5 shows a modified split tablet (K included in the present invention).
FIG.

FIG. 6 shows a modified split tablet (L) contained in the present invention.
FIG.

FIG. 7 shows a modified split tablet (M) contained in the present invention.
FIG.

FIG. 8 shows a modified split tablet (N) included in the present invention.
FIG.

FIG. 9 shows the tablet of Comparative Example 1, wherein (A) is a plan view and (B) is a front view.

FIG. 10 shows a tablet of Comparative Example 2, wherein (A) is a plan view and (B) is a front view.

11 shows a modified tablet (upper and lower plane type) of Comparative Example 3, (A) is a plan view and (B) is a front view. FIG.

[Explanation of Signs] D: Long axis width D ': Short axis width D'': Maximum constriction length L: Long axis S: Short axis H: Depth of split groove (top of bulge and minimum of split groove) T: Maximum thickness of the tablet t: Vertical dimension between the upper end (or lower end) of the peripheral side surface and the top of the bulge t ': 1 k, 1 l (1 el), 1 m, 1 n, 1 r, 1
Vertical dimension between s, 1t or 1u and the top of the bulge α: chamfering angle β: opening angle of split groove 1, 2: tablet 1a, 1b, 2a, 2b: outer shape of peripheral portion on long axis side 1c, 2c: center Lines 1d, 1e, 2d, 2e: constricted portion of short axis side outer shape 1f, 2f: upper surface 1g, 2g: lower surface 1h, 2h: peripheral side surface 1i: upper inclined edge surface 1j: lower inclined edge surface 1k, 1l ( 1l), 1r, 1s: boundaries between the sloping edge surface on the upper surface and gentle convex bulges 1m, 1n, 1t, 1u: boundaries between the sloping edge surface on the lower surface and gentle convex bulges 1p, 2p: Upper split groove (part) 1q, 2q: Lower split groove (part) 2i ', 2j', 2r ', 2s': Upper end of peripheral side surface 1v, 2v: Top of bulge in short axis direction 1x: Center line Center point 1y, 1z: center of arc

[Procedure amendment]

[Submission date] April 24, 1997

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] 0002

[Correction method] Change

[Correction contents]

[0002]

BACKGROUND OF THE INVENTION JP-A-8-277217 and JP-dividable tablets having a vertical and horizontal direction constricted portion is described. The dividable tablet described in the publication, by forming a constriction in the vertical and / or horizontal direction,
The main object of the present invention is to prevent the adhesion in the film coating process by dividing the curved shape without forming the groove and reducing the contact area due to the curved shape. Accordingly, the dividable tablet has a shape having two or more divided bodies in which the vertical swelling is considerably raised in its shape. Another difference is that the main purpose is to provide a dividable tablet that can prevent adhesion in the film coating process without using the tablet.

Claims (7)

[Claims] 1. A deformable tablet having a major axis and a minor axis, and having a peripheral side surface between peripheral edges of an upper surface and a lower surface, wherein (a) the ratio of the major axis width to the minor axis width is 1 (B) a part of the outer shape on the short axis side has a constricted shape shorter than the short axis width, and (c) a gentle convex bulge is provided on the upper and lower surfaces. (D) A modified split tablet characterized in that split grooves are provided on the upper and lower surfaces of a center line portion connecting the most constricted portions of the outer shape on the short axis side so as to be vertically opposed to each other. 2. The modified split tablet according to claim 1, wherein the cross section of the split groove is V-shaped, concave or arc-shaped. 3. The modified split tablet according to claim 2, wherein the cross section of the split groove is V-shaped, and the outward opening angle is 60 to 120 degrees. 4. The modified divided tablet according to claim 3, wherein the peripheral edges where the upper and lower surfaces and the peripheral side surface are in contact with each other are chamfered to provide an inclined edge surface. 5. The method according to claim 1, wherein the ratio of the major axis width to the minor axis width is 1.5: 1 to 2.5: 1, and the outer shape of the peripheral portion on the major axis side is arcuate on both sides. The modified divided tablet according to any one of the above. 6. The modified divided tablet according to claim 5, wherein the outer shape of the peripheral portion on the long axis side is arc-shaped on both sides with the short axis width as the diameter. 7. The modified divided tablet according to claim 6, wherein the depth of each split groove cut from the upper and lower surfaces is 6% to 20% with respect to the maximum thickness of the tablet.