JP2022001562A - Escitalopram tablet - Google Patents

Abstract

To provide escitalopram tablets that can be easily divided.SOLUTION: An escitalopram tablet according to the present invention is a tablet containing escitalopram or a pharmaceutically acceptable salt thereof, characterized by having a specific structure with a V-shaped secant.SELECTED DRAWING: None

Description

The present invention relates to escitalopram tablets that can be easily divided.

Serotonin is a type of bioactive amine that acts as a transmitter of the central nervous system and is thought to play an important role in the regulation of brain function. Particularly known to be associated with depression, subjects with a history of depression develop depressed mood when tryptophan deficiency causes a transient decrease in serotonin levels experimentally.

In vivo serotonin is synthesized from the essential amino acid tryptophan, and serotonin released extracellularly by exocytosis activates the receptor of the target cell to exert its effect, and then is taken up into the cell by the serotonin transporter. Thus, agents that inhibit serotonin reuptake maintain or increase the extracellular concentration of serotonin. Escitalopram [(1S) -1- [3- (dimethylamino) propyl] -1- (4-fluorophenyl) -1,3-dihydroisobenzofuran-5-carbonitrile] has a selective serotonin reuptake inhibitory effect. It is considered that the serotonin nervous system is activated by continuously increasing the extracellular serotonin concentration in the brain and exhibits antidepressant action (Non-Patent Document 1).

Especially in the case of antidepressant tablets, they may be molded in a splittable manner in order to adjust the dose. Patent Document 1 does not have a split groove having a V-shaped cross section, and does not have an edge or a corner portion which is a starting point of abrasion or a defect, as a tablet having a characteristic that it can be easily and evenly divided. Dividable tablets are disclosed. In Patent Document 2, a secant line for dividing is provided on at least one surface, the projected shape from the surface side on which the secant line is provided is elliptical, and the surface provided with the secant line faces toward the center of the ellipse. A tablet having a raised shape is disclosed.

Japanese Unexamined Patent Publication No. 2012-36159 Japanese Unexamined Patent Publication No. 2013-127008

Lexapro® lock package insert

As mentioned above, divisible tablets are known. However, for example, the tablet described in Patent Document 1 does not have a V-shaped dividing line, but it cannot be denied that it tends to be difficult to break without the V-shaped dividing line. Further, the tablet specifically disclosed in Patent Document 2 has a raised portion and a V-shaped dividing line on both sides, but when dividing a tablet, a table or a table with the side having the V-shaped dividing line facing down. It is common to apply force from the back side of the palm, etc., and tablets with ridges and V-shaped secant lines on both sides are not easy to break. Further, Patent Document 1 and Patent Document 2 in which the divisible tablet is described do not describe escitalopram as a main agent.
Therefore, an object of the present invention is to provide an escitalopram tablet that can be easily divided.

The present inventors have conducted intensive studies to solve the above problems, and in particular, clarified the relationship between the shape of a tablet and the ease of division, and completed the present invention.
Hereinafter, the present invention will be shown.

[1] A tablet containing escitalopram or a pharmaceutically acceptable salt thereof.
It has a body whose projected shape from the surface side is an oval,
The major axis and the minor axis of the ellipse are the axes of symmetry.
On the surface side of the body portion, a symmetrical ridge portion is provided from the center of the ellipse to both ends of the major axis.
The distance from the short axis at the position of the maximum height of the raised portion is longer than half of the length from the short axis to the end.
From the raised portion to the body portion, the center thereof has a V-shaped secant line on the short axis.
The major axis length is 8 mm or more and 15 mm or less, and the minor axis length is 3 mm or more and 8 mm or less.
The maximum width of the V-shaped dividing line over the two raised portions is 1.1 mm or more and 1.4 mm or less.
The angle of the V-shaped tip of the V-shaped dividing line is 75 ° or more and 110 ° or less.
An escitalopram tablet characterized in that the maximum height of the raised portion from the surface side of the body portion is 1.1 mm or more and 1.4 mm or less.
[2] The escitalopram tablet according to the above [1], which has a flat portion having a width of 0.05 mm or more and 0.4 mm or less on the peripheral edge of the body portion on the surface side.
[3] The escitalopram tablet according to the above [1] or [2], which has a dome portion on the back surface side of the body portion.
[4] The escitalopram tablet according to the above [3], which has a flat portion having a width of 0.05 mm or more and 0.4 mm or less on the peripheral edge on the back surface side of the body portion.
[5] The escitalopram tablet according to the above [3] or [4], wherein the maximum height of the dome portion from the back surface side of the body portion is 0.4 mm or more and 1.0 mm or less.
[6] The escitalopram tablet according to any one of the above [1] to [5], wherein the body thickness is 1.3 mm or more and 2.0 mm or less.

Although escitaloplum or a salt thereof, which is the main ingredient of the tablet according to the present invention, has an antidepressant effect, it has been reported that administration of an antidepressant increases the risk of suicidal ideation and suicide attempt in depressed patients. It is necessary to finely adjust the dose of such tablets by dividing them, etc., while carefully observing the patient's symptoms. The tablet according to the present invention is easy to be divided into two, is less likely to give stress to a patient or the like at the time of division, has a small mass difference between the divided tablets, and has a small amount of loss due to the division. Therefore, the escitalopram tablet according to the present invention is useful as an antidepressant that is easy to divide.

FIG. 1 is a schematic view from the upper surface of one aspect of the escitalopram tablet according to the present invention. FIG. 2 is a schematic view from an aspect of one aspect of the escitalopram tablet according to the present invention. FIG. 3 is a schematic view from an aspect of one aspect of the escitalopram tablet according to the present invention.

The escitalopram tablet according to the present invention contains escitalopram or a pharmaceutically acceptable salt thereof.

The chemical name of escitalopram is (1S) -1- [3- (dimethylamino) propyl] -1- (4-fluorophenyl) -1,3-dihydroisobenzofuran-5-carbonitrile, and escitalopram has the following chemistry. It has a structure, exhibits an inhibitory effect on serotonin (5-HT) reuptake, and activates the 5-HT nervous system by continuously increasing the extracellular 5-HT concentration in the brain to exhibit antidepressant effect.

Escitalopram may be incorporated into the pharmaceutical composition in the form of a pharmaceutically acceptable salt. The acid forming the salt with escitaloplum is not particularly limited as long as it is pharmaceutically acceptable, but it is an inorganic substance such as hydrochloric acid, hydrobromic acid, hydroiodic acid, sulfuric acid, nitric acid, perchloric acid, and phosphoric acid. Acids; oxalic acid, malonic acid, maleic acid, fumaric acid, lactic acid, malic acid, citric acid, tartaric acid, benzoic acid, trifluoroacetic acid, acetic acid, methanesulfonic acid, p-toluenesulfonic acid, trifluoromethanesulfonic acid, glutamate and Examples include organic acids such as acidic amino acids such as aspartic acid. In addition, escitalopram and a salt thereof may be incorporated into a pharmaceutical composition in the form of a hydrate.

The size of the raw material escitalopram and its salt may be adjusted as appropriate. For example, the average particle size can be 5 μm or more and 200 μm or less, preferably 10 μm or more and 100 μm or less. Therefore, it is preferable to grind escitalopram and its salt in advance. In the present disclosure, the average particle size shall be measured on a volume basis by a laser diffraction type particle size distribution measuring device.

The amount and ratio of escitalopram and a salt thereof in the tablet according to the present invention may be appropriately adjusted within a range in which escitalopram can exert its action and effect. For example, the amount of escitalopram per tablet can be 1 mg or more and 100 mg or less, preferably 5 mg or more and 50 mg or less, and more preferably 10 mg or 50 mg. The proportion of escitalopram or a salt thereof in the pharmaceutical composition can be 1% by mass or more and 50% by mass or less, preferably 2% by mass or more and 20% by mass or less, and 5% by mass or more and 10% by mass or less. Is more preferable.

In the escitalopram tablet according to the present invention, in addition to the main agent escitalopram or a salt thereof, general ingredients to be blended in the tablet may be blended. Examples of such tablet components include excipients, disintegrants, binders and lubricants.

Excipients are additives that are added to dilute the main agent or increase the amount of the pharmaceutical product in order to improve the moldability and ease of administration of the pharmaceutical product. Examples of the excipient include crystalline cellulose, lactose, starch, hydroxypropyl cellulose, mannitol, dextrin, sucrose and the like.

The amount of the excipient in the tablet may be appropriately adjusted, but for example, it can be 50% by mass or more, 90% by mass or less, preferably 60% by mass or more, and 70% by mass or more with respect to the entire uncoated tablet. More preferred.

Crystalline cellulose has a relatively high hardness, and it is possible to increase the tablet strength by blending it in a tablet. For example, if crystalline cellulose treated with silicic acid (“PROSOLV ^(R) SMCC” or the like) is blended, a tablet having a low tablet pressure and a high hardness can be obtained. However, since the hardness of crystalline cellulose treated with silicic acid alone may become too high, when crystalline cellulose is blended as an excipient in tablets, crystalline cellulose treated with silicic acid or crystalline cellulose having a relatively large average particle size is used. It is preferable to use treated crystalline cellulose or crystalline cellulose having a relatively small average particle size in combination. The mixing ratio thereof may be appropriately adjusted. For example, silicate-treated crystalline cellulose or crystalline cellulose having a relatively large average particle size is multiplied by 1 by mass with respect to untreated crystalline cellulose or crystalline cellulose having a relatively small average particle size. As mentioned above, it can be used in an amount of 4 times or less. The mixing ratio is preferably 1.5 times by mass or more, preferably 3 times by mass or less, and more preferably 2.5 times by mass or less. If there is a catalog value, the average particle size may be referred to, but for example, the volume average particle size may be actually measured.

The disintegrant is an ingredient that is added to take in water, promote the disintegration of the tablet, and facilitate the release of the active ingredient. The disintegrant is not particularly limited, and examples thereof include croscarmellose sodium, sodium starch glycolate, low-degree-of-substitution hydroxypropyl cellulose, cros polyvinylpyrrolidone, carboxymethyl cellulose, and carboxymethyl cellulose calcium.

The amount and ratio of the disintegrant in the tablet of the present invention may be appropriately adjusted within a range in which the tablet disintegrates well after administration. For example, it can be 0.5% by mass or more and 10% by mass or less with respect to the entire uncoated tablet, preferably 1% by mass or more, more preferably 2% by mass or more, and preferably 5% by mass or less.

A binder is a component added to bind each component and increase the strength of the tablet. The binder is not particularly limited, and for example, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone, polyvinyl alcohol, ethyl cellulose and the like can be used. Although hydroxypropyl cellulose is exemplified above as an excipient, it also exhibits an action as a binder.
The amount and ratio of the binder in the tablet of the present invention may be appropriately adjusted according to the desired tablet strength and the like. For example, it can be 1% by mass or more and 10% by mass or less with respect to the entire uncoated tablet. As the ratio, 2% by mass or more is preferable, 3% by mass or more is more preferable, 6% by mass or less is preferable, and 5% by mass or less is more preferable. It is not necessary to add a binder.

The lubricant is a component added to adhere to the surface of each component to increase its fluidity or to suppress the adhesion of each component to a device. The lubricant is not particularly limited, but for example, magnesium stearate, talc, hydrogenated vegetable oil, polyglycerin fatty acid ester, sucrose fatty acid ester and the like can be used, and the stability of the main agent escitaloplum or a salt thereof can be used. From the viewpoint, magnesium stearate is preferable.

The amount and ratio of the lubricant may be appropriately adjusted within a range in which tableting can be performed well. For example, it can be 0.1% by mass or more and 5% by mass or less with respect to the entire uncoated tablet. The ratio is preferably 0.2% by mass or more, more preferably 0.5% by mass or more, preferably 2% by mass or less, and more preferably 1.5% by mass or less.

The escitalopram tablet according to the present invention may be a film-coated tablet having a film-coated layer on the surface of the uncoated tablet.
The film coating layer of a tablet generally contains hydroxypropylmethylcellulose, talc, e-strap, shellac, zein and the like as a film-forming agent. The ratio of the film forming agent in 100% by mass of the film coating layer can be, for example, 30% by mass or more and 80% by mass or less.

The film coating layer that coats the tablet generally contains a plasticizer to impart plasticity to the film and increase the strength of the film coating layer. Examples of the plasticizer for the film coating layer include hydroxypropyl cellulose, polyethylene glycol, copolyvidone and the like. The ratio of plasticity in 100% by mass of the film coating layer can be, for example, 1% by mass or more and 20% by mass or less.

The lubricant may also be added to the film coating layer that coats the tablets. As the lubricant for the film coating layer, for example, magnesium stearate, talc, hydrogenated vegetable oil, polyglycerin fatty acid ester, sucrose fatty acid ester and the like can be used. The proportion of the lubricant in 100% by mass of the film coating layer can be, for example, 1% by mass or more and 20% by mass or less.

A dye may be blended in the film coating layer. By coloring the film coating layer with a dye, the design of the tablet may be improved, and the stability of the active ingredient escitalopram or a salt thereof may be further improved. Examples of the dye include metal oxides such as titanium oxide, yellow iron sesquioxide, iron sesquioxide, and zinc oxide; talc; barium sulfate and the like, and metal oxides are preferable, and titanium oxide is more preferable. The proportion of the dye in 100% by mass of the film coating layer can be, for example, 0.1% by mass or more and 10% by mass or less.

The escitalopram tablet according to the present invention (hereinafter abbreviated as "tablet of the present invention") has a V-shaped dividing line for dividing the tablet on one surface, and the projected shape from the surface side having the V-shaped dividing line is long. It has a circular body.

FIG. 1 shows a plan view of the tablet of the present invention seen from the surface side having a V-shaped split line, and FIG. 2 shows a cross section in the thickness direction including the long axis of the tablet of the present invention seen from the arrow A side of FIG. FIG. 3 shows a cross-sectional view of the tablet of the present invention in the thickness direction including the minor axis seen from the arrow B side of FIG. 1, and FIG. 4 shows a book viewed from the back surface side having no split line. The plan view of the invention tablet is shown.

The body portion 3 refers to an elliptical plate portion excluding a raised portion on the front surface side and a dome portion on the back surface side of the tablet of the present invention. The projected shape from the front surface side or the back surface side of the body is an oval. An ellipse is not limited to an ellipse that is a locus of points where the sum of the distances from two points is constant, but is a so-called rounded rectangle in which one or more of the corners, long sides, or short sides have R (R). Circles and rounded squares with the same length on the major axis and the minor axis are also included. However, from the viewpoint of ease of division, it is preferable that the major axis length r1 is longer than the minor axis length r2, and the major axis length r1 (r1 / r2) with respect to the minor axis length r2 is 1. 5 or more and 2.5 or less are preferable, 1.8 or more and 2.2 or less are more preferable, and 2 or more are even more preferable.

The body thickness t can be 1.3 mm or more and 2.0 mm or less, preferably 1.5 mm or more, and more preferably 1.7 mm or more.

In the ellipse, which is the surface shape of the body, the major axis 1 and the minor axis 2 are the axes of symmetry. The axis of symmetry means a straight line when the figure is axisymmetric with one straight line as the axis, that is, the two figures obtained by dividing the ellipse by the major axis 1 or the minor axis 2 are the same. Yes, they are superposed via the major axis 1 or the minor axis 2. As a result of the major axis 1 and the minor axis 2 of the ellipse being the axes of symmetry, when the tablet of the present invention is divided by a score line, the weights of the two divided tablets obtained are the same or substantially the same.

The length r1 of the long axis 1 is 8 mm or more and 15 mm or less, and the length r2 of the short axis 2 is 3 mm or more and 8 mm or less. The length r1 of the long axis 1 is preferably 9 mm or more and 14 mm or less, and the length r2 of the short axis 2 is preferably 4 mm or more and 7 mm or less.

On the surface side of the body portion 3, there are ridges 4 that are symmetrical from the center of the ellipse to both ends of the major axis. The raised portion 4 makes it easy for the tablet of the present invention to be divided at the score line. The center of an ellipse is the intersection of the major axis and the minor axis of the ellipse. The fact that the ridges are symmetrical from the center of the ellipse to both ends of the ellipse means that, for example, in FIG. 2, which is a cross section in the thickness direction including the major axis of the tablet of the present invention, the thickness passing through the minor axis of the ellipse. It means that the cross-sectional shape of the raised portion is axisymmetric with respect to the line in the vertical direction. As a result, when the tablet of the present invention is divided by a score line, the weights of the two divided tablets obtained are the same or substantially the same. Further, from the viewpoint of ease of administration, it is preferable that the shape of the raised portion 4 from the center of the ellipse to both ends of the minor axis is also symmetrical.

The distance l2 from the short axis 2 at the position 6 of the maximum height of the raised portion 4 is on the end side of the half of the length l1 from the short axis 2 to the end. That is, the maximum height positions of the raised portions in the cross section in the thickness direction parallel to the major axis of the elliptical circle are unevenly distributed at both ends. As a result, the tablet of the present invention is easily divided by a score line.

The maximum height h1 of the raised portion 4 from the surface side of the body portion 3 is 1.1 mm or more and 1.4 mm or less. When the maximum height h1 is 1.1 mm or more, the tablet of the present invention can be easily divided by a score line. If the maximum height h1 is too high, the overall thickness of the tablet may become too high with respect to the size of the planar shape of the tablet, and it may be difficult to divide the tablet. Therefore, the maximum height h1 is 1.4 mm. The following is preferable.

The raised portion 4 preferably has no corners from the viewpoint of ease of taking the tablet. That is, it is preferable that the raised portion has two or more Rs in the cross section in the major axis direction as shown in FIG. 2 and in the cross section in the minor axis direction as shown in FIG.

The tablet of the present invention has a V-shaped dividing line 7 whose center is on the short axis 2 from the raised portion 4 to the body portion 3. The V-shaped dividing line 7 extends from the raised portion 4 to the body portion 3, and naturally extends over the two raised portions 4 centered on the short axis 2, and the maximum width w1 thereof is 1.1 mm or more and 1.4 mm or less. And the angle θ of the V-shaped tip is 75 ° or more and 110 ° or less. When the maximum width w1 of the V-shaped dividing line 7 is 1.1 mm or more and 1.4 mm or less and the angle θ of the V-shaped tip portion is 75 ° or more and 110 ° or less, the tablet of the present invention can be easily divided by the dividing line. The width of the V-shaped dividing line 7 is the distance between two intersections of a straight line parallel to the long axis 1 and the boundary between the end of the V-shaped dividing line 7 opposite to the V-shaped tip and the surface of the raised portion 4. The distance of. Further, the maximum width of the V-shaped dividing line 7 is defined by the shape of the V-shaped dividing line 7, that is, the V-shaped dividing line 7 as shown in FIG. 1 when the raised portion 4 has R (R) in the minor axis direction. This is because the shape of the boundary between the ridge portion 4 and the raised portion 4 is leaf-shaped, and the width of the V-shaped dividing line 7 is not constant.

The V-shaped tip portion of the V-shaped dividing line 7 may also have an R (R). Even if the V-shaped tip of the V-shaped dividing line 7 has an R (R), the angle θ of the V-shaped tip is as long as the cross section of the side surface of the raised portion 4 constituting the V-shaped dividing line 7 is straight. Can be measured or identified.

A flat portion having a width w2 of 0.05 mm or more and 0.4 mm or less may be provided on the peripheral edge of the body portion 3 on the surface side. It can be said that the flat portion is a portion on the surface side peripheral edge of the body portion 3 that does not have the raised portion 4 over a width w2 of 0.05 mm or more and 0.4 mm or less. The width w2 is preferably 0.3 mm or less, more preferably 0.2 mm or less.

The dome portion 5 may be provided on the opposite side of the front surface side having the V-shaped dividing line, that is, the back surface side having no V-shaped dividing line. A dome generally refers to a locally raised structure having a circular or near-circular horizontal cross section. The dome portion 5 also preferably has no corners from the viewpoint of ease of taking tablets. That is, it is preferable that the dome portion 5 has two or more Rs in the cross section in the major axis direction as shown in FIG. 2 and in the cross section in the minor axis direction as shown in FIG.

The maximum height of the dome portion 5 from the back surface side of the body portion 3 is preferably 0.4 mm or more and 1.0 mm or less. Further, a flat portion having a width w3 of 0.05 mm or more and 0.4 mm or less may be provided on the peripheral edge of the body portion 3 on the back surface side. The width w3 is preferably 0.3 mm or less, more preferably 0.2 mm or less.

The tablet of the present invention can be produced by a conventional method. Specifically, the main agent escitalopram or a salt thereof is mixed well with an excipient, a disintegrant, a binder, etc., and a lubricant is further mixed, or a lubricant is attached to the pestle only of the tableting machine. After that, you can lock it. In the case of further coating, the coating component may be dissolved or dispersed in a solvent such as purified water, the obtained solution or dispersion may be sprayed on the uncoated tablet, dried, and then cooled.
The dose of the tablet of the present invention may be appropriately adjusted according to the patient's symptoms, severity, age, gender, etc., and for example, 5 mg or more and 20 mg or less per day in terms of the dose of escitalopram. It may be administered once.

Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited by the following examples as well as the present invention, and appropriate modifications are made to the extent that it can meet the purposes of the preceding and the following. Of course, it is possible to carry out, and all of them are included in the technical scope of the present invention.

Example 1: Production of escitalopram tablets With the composition shown in Table 1, escitalopram oxalate, silicic acid-treated crystalline cellulose, crystalline cellulose, and croscarmellose sodium are mixed, and then magnesium stearate is added and mixed to produce. By locking, an uncoated tablet containing 10 mg of escitalopram and having a mass of 110 mg was obtained. A film-coated solution in which hypromellose, hydroxypropyl cellulose, titanium oxide, and talc were dissolved or dispersed was sprayed on the uncoated tablets to obtain a film-coated tablet having the shape shown in FIG. 1 and having a mass of 115 mg.

The sizes of the obtained tablets are as follows.
Body long axis (r1): 10.0 mm
Torso short axis (r2): 4.6 mm
Body thickness (t): 1.4 mm
Maximum height of the ridge (h1): 1.2 mm
V-shaped secant angle (θ): 90 °
Maximum width of V-shaped secant line (w1): 1.2 mm
Surface side peripheral flat portion width (w2): 0.2 mm
Maximum height of dome on the back side (h2): 0.67 mm
Back side peripheral flat portion width (w3): 0.2 mm
Length from the short axis to the end (l1): 5.0 mm
Distance from the short axis of the position of the maximum height of the raised portion (l2): 3.73 mm

Comparative Example 1: Production of Escitalopram Tablets Escitalopram tablets were produced in the same manner as in Example 1 except that the maximum height (h1) of the raised portion was lowered to 0.974 mm.

Comparative Example 2: Production of Escitalopram Tablets Escitalopram tablets were produced in the same manner as in Comparative Example 1 except that the maximum width (w1) of the V-shaped dividing line was narrowed to 1.0 mm.

Comparative Example 3: Production of Escitalopram Tablets Escitalopram tablets were produced in the same manner as in Comparative Example 1 except that the V-shaped secant angle (θ) was widened to 124 °.

Test Example 1: Evaluation of splitability On a 3-point bending jig in which two metal plates are opposed to each other at an interval of 2 mm, the major axis direction is orthogonal to the plate surface direction, and the surface side having a score line is on the bottom. The uncoated tablets manufactured in Examples 1 and Comparative Examples 1 to 3 were placed, and the indenter of the jig was installed so as to be in parallel with the score line of the uncoated tablet. ) Was used to lower the indenter at a speed of 1 mm / sec, and the load when the uncoated tablet broke was measured as the breaking strength.
In addition, after the division, each divided piece was accurately weighed, and the mass difference between the two was determined.
The measurement was performed in 10 cases for each uncoated tablet, and the average value and standard deviation were obtained. The results are shown in Table 2.

Comparative Example 3 is an example in which the V-shaped secant angle (θ) is changed from 90 ° to 124 °, but the breaking strength is high and it is difficult to crack, and the mass difference of the divided pieces after division is large. Was shown.
Comparative Example 1 is an example in which the maximum height (h1) of the raised portion is lowered, and Comparative Example 2 is an example in which the maximum width (w1) of the V-shaped dividing line is narrowed. The mass difference between the latter two pieces was relatively large, and there was still a problem.
On the other hand, the uncoated tablet of Example 1 according to the present invention has a small breaking strength at the time of division and is easy to divide, and also has a small mass difference of the divided pieces after division.

Test Example 2: Dividability evaluation Example 1 and Comparative Examples 1 to 5 males in their 20s to 50s and 1 female in their 20s placed on a table with the front side having a score line facing down. By pressing the tablets of No. 3 with their thumbs from above, the tablets were divided into 6 pieces, and the tablets were evaluated on a 5-point scale from 1 which is easy to break to 5 which is hard to break.
In addition, after the division, each divided piece was accurately weighed, and the mass difference between the two was determined.
Further, after the division, the loss rate after the division was calculated by the following formula. The results are shown in Table 3.
Loss rate after division (%) = 100-[(sum of mass of tablets after division) / (mass of tablets before division)] × 100

As shown in the results shown in Table 3, the tablet of Example 1 having a score line and a relatively high height of the raised portion on the surface side seemed to be perceived as "easy to crack".
The mass difference after division was large between the tablet of Comparative Example 2 having a relatively narrow V-shaped dividing line width and the tablet of Comparative Example 3 having a relatively wide V-shaped dividing line angle. The mass difference after division was the smallest in the tablet of Comparative Example 1 in which the height of the raised portion on the surface side having the score line was relatively low, but the tablet of Example 1 was next.
Regarding the loss rate after division, the tablet of Example 1 had the lowest. It can be said that this result indicates that the tablet was divided into two without any disturbance at the score line portion in relation to the above-mentioned ease of splitting.

1: Long axis of oval 2: Short axis of oval 3: Body 4: Raised part 5: Dome part 6: Maximum height position of raised part 7: V-shaped split line part r1: Long axis length r2: Short axis length l1: Length from the short axis to the end in the long axis direction l2: Distance from the short axis at the position of the maximum height of the raised part t: Body thickness θ: V-shaped split line angle w1: V-shaped Maximum width of the dividing line w2: Flat portion width of the peripheral edge on the front surface side of the fuselage w3: Flat portion width of the peripheral edge on the back surface side of the fuselage h1: Maximum height of the raised portion on the front surface side of the fuselage h2: Back surface of the fuselage portion Maximum height of the dome on the side

Claims (6)

A tablet containing escitalopram or a pharmaceutically acceptable salt thereof.
It has a body whose projected shape from the surface side is an oval,
The major axis and the minor axis of the ellipse are the axes of symmetry.
On the surface side of the body portion, a symmetrical ridge portion is provided from the center of the ellipse to both ends of the major axis.
The distance from the short axis at the position of the maximum height of the raised portion is longer than half of the length from the short axis to the end.
From the raised portion to the body portion, the center thereof has a V-shaped secant line on the short axis.
The major axis length is 8 mm or more and 15 mm or less, and the minor axis length is 3 mm or more and 8 mm or less.
The maximum width of the V-shaped dividing line over the two raised portions is 1.1 mm or more and 1.4 mm or less.
The angle of the V-shaped tip of the V-shaped dividing line is 75 ° or more and 110 ° or less.
An escitalopram tablet characterized in that the maximum height of the raised portion from the surface side of the body portion is 1.1 mm or more and 1.4 mm or less. The escitalopram tablet according to claim 1, which has a flat portion having a width of 0.05 mm or more and 0.4 mm or less on the peripheral edge on the surface side of the body portion. The escitalopram tablet according to claim 1 or 2, which has a dome portion on the back surface side of the body portion. The escitalopram tablet according to claim 3, which has a flat portion having a width of 0.05 mm or more and 0.4 mm or less on the peripheral edge on the back surface side of the body portion. The escitalopram tablet according to claim 3 or 4, wherein the maximum height of the dome portion from the back surface side of the body portion is 0.4 mm or more and 1.0 mm or less. The escitalopram tablet according to any one of claims 1 to 5, wherein the body thickness is 1.3 mm or more and 2.0 mm or less.

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