Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
  • A61J1/035—Blister-type containers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
  • A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
  • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
  • A61J7/0007—Pill breaking or crushing devices
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
  • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
  • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
  • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
  • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
  • B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D2575/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
  • B65D2575/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by association or interconnecting two or more sheets or blanks
  • B65D2575/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
  • B65D2575/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
  • B65D2575/3209—Details
  • B65D2575/3218—Details with special means for gaining access to the contents

Definitions

• the present invention relates to a divided tablet and a press-through pack, in particular, can be easily and accurately divided without causing chipping, has excellent impact resistance, and does not cause twining or the like between tablets during a film coating process.
• the present invention relates to a press-through pack in which all of the divided tablets can be collected at one time.
• Divided tablets are tablets that are divided by a pharmacist when dispensing according to the dose, or by the patient himself when taking the drug, to optimize dose management for individual patients and improve the convenience of prescribing. Is being developed.
• Such a divided tablet is generally provided with a dividing line (a dividing groove) for dividing the tablet.
• FIG. 13 is a diagram schematically showing a conventional flat split tablet, wherein FIG. 13 (a) is a plan view, FIG. 13 (b) is a bottom view, and FIG. 13 (c) is a side view. , Each shows o
• both the upper surface Sa and the lower surface Sb have a planar shape, and the dividing line Ld is formed on the upper surface Sa along the center line.
• the pharmacist or the patient directly grasps each of the two regions Rl and R2 formed by the dividing line Ld on the upper surface Sa with fingers.
• the divided tablet Te is split along the dividing line Ld by pushing the dividing line Ld.
• the divided tablet Te shown in Fig. 13 is difficult to split into two, and it is difficult for elderly people with reduced fingertip strength and sensation to split the divided tablet Te. is there.
• FIG. 14 is a diagram schematically showing the conventional karate-type split tablet described in Japanese Patent Application Laid-Open No. 61-289027, wherein FIG. 14 (a) is a plan view and FIG. 14 (b) is a bottom view. FIG. 14 (c) shows a side view.
• the lower side Sb of the karate-type tablet T has a planar shape. Also, a dividing line Ld is provided on the upper surface Sa along the center line, and each of the two regions R 1 and R2 formed by the dividing line Ld on the upper surface Sa is a starting point of the dividing line Ld. Each of the lines Ld2 and Ld2 has a plane that is inclined so as to gradually increase the wall thickness in the peripheral direction of the tablet.
• the divided tablet Tf may be divided into two by a pharmacist, a patient, or the like, by directly grasping each of the two regions Rl and R2 with fingers and dividing along the dividing line Ld.
• the divided tablet Tf can be split into two by pressing the upper surface Sa provided with the dividing line Ld of the divided tablet Tf downward and the lower surface Sb upward and pressing it downward from above.
• a tablet may contain, as an active ingredient, a component having an unpleasant odor or taste, or a component having a poor stability to light or the like, and a tablet containing such an active ingredient may be Generally, a film coat is applied to mask the unpleasant odor and taste of the active ingredient and to ensure stability against light and the like.
• each surface of the two regions Rl and R2 formed by the dividing line Ld on the upper surface Sa is formed as a plane, and the lower surface Sb is formed as a plane. Therefore, tablets Tf, ⁇ 'are likely to make surface contact with each other. Therefore, when a film coat is applied to the surface of the tablet Tf, the tablet Tf, in the film coating process, causes a phenomenon that the tablets Tf stick to each other (so-called twinning). There is a problem that it is easy to operate.
• FIG. 15 is a diagram schematically showing an example of a divided tablet described in JP-A-8-53345
• FIG. 15 (a) is a plan view
• FIG. 15 (b) is a bottom view
• FIG. 15 (c) shows a side view, respectively.
• a dividing line Ld is provided on the upper surface Sa along the center line, and each of the two regions R1 and R2 formed by the dividing line Ld on the upper surface Sa is a dividing line. From each of the lines Ld2 and Ld2, which are the starting points of Ld, it has an inclined plane that gradually becomes thicker in the peripheral direction of the tablet, and the lower surface Sb of the tablet Tg has its shape. However, it has a convex shape such that the central portion C rises higher than the edge portion E.
• the tablet Tg since the lower surface Sb of the tablet Tg has a convex shape such that the central portion C rises higher than the edge portion E, the tablet Tg has a surface contact with each other. This is more the case of point contact. For this reason, during the film coating process, thinning or the like hardly occurs.
• the tablet Tg when the tablet Tg is divided into two, a pharmacist or a patient, etc., directly grasps each of the two regions Rl and R2 with a finger and divides the tablet Tg along the dividing line Ld. There is an advantage that the tablet Tg can be split into two by pressing it downward from above.
• FIG. 16 is a diagram schematically showing another example of the split tablet described in Japanese Patent Application Laid-Open No. 8-53345.
• FIG. 16 (a) is a plan view
• FIG. 16 (b) is a bottom view
• FIG. 16 (c) shows a side view, respectively.
• This split tablet (lower punch curved karate tablet) Th has a dividing line Ld on its upper surface Sa along the center line, and two regions R formed by the dividing line Ld on its upper surface Sa. l and R2 are respectively derived from the lines Ld2 and Ld2 which are the starting points of the secant line Ld.
• the tablet Th has a concave shape such that the thickness gradually increases in the direction of the peripheral edge E, and the lower surface Sb force of the tablet Th has a convex shape such that the central portion C rises up from the edge portion E. Have been.
• the divided tablet Th also has a lower surface Sb of the tablet Th having a convex shape such that the central portion C rises up from the edge portion E, so that the tablet Th, It is designed to make point contact easier than surface contact.
• the two regions Rl and R2 formed by the dividing line Ld on the upper surface Sa are each formed into a concave shape, so that a portion having a planar shape from the surface of the tablet Th is formed. ⁇ Winning is less likely to occur during the film coating process compared to the split tablet Tg.
• the pharmacist, the patient, or the like directly grasps each of the two regions Rl and R2 with a finger and divides the tablet Th along the dividing line Ld.
• the tablet Th can be split into two if it is pushed downward from above o
• tablets are generally housed in press-through packs (generally referred to as PTP packaging) to prevent contamination by moisture, dust, mold, bacteria, etc. during storage.
• PTP packaging press-through packs
• FIG. 17 is a sectional view schematically showing an example of such a press-through pack.
• the press-through pack 101 includes a storage body 102 and a sealing sheet 103.
• the storage body 102 is generally made of a synthetic resin such as polyvinyl chloride, polypropylene, or cyclic polyolefin, and is connected by plate-like portions 102a, 102a, and usually, tablets T, ,..., 102b are formed in accordance with the shapes of ⁇ and ⁇ .
• a synthetic resin such as polyvinyl chloride, polypropylene, or cyclic polyolefin
• the sealing sheet 103 includes a base material 105 made of aluminum foil or the like,
• the press-through pack 101 stores the tablets ⁇ , ⁇ , ⁇ in each of the storage recesses 102b, ⁇ , 102b and the adhesive layer 104 of the sealing sheet 103.
• Each of the plate portions 102a, 102a, 102a of the main body 102 The storage body 102 is hermetically sealed by a sealing sheet 103.
• Such a press-through pack 101 includes a storage recess 102b of the storage body 102,
• the divided tablets Te and Tf are stored in such a press-through pack 101, generally, the divided tablets Te and Tf are broken by the divided tablets Te and Tf stored in the storage recesses 102b, 102b. Then, the divided tablets Te and Tf are taken out one by one from the press-through park 101, and then, if necessary, the divided tablets Te and Tf are divided into two by a pharmacist or a patient by hand.
• the divided tablets Tg and Th can be divided into two when the divided tablets Tg and Th are divided into two. Eliminates the need to grab with your fingers. As a result, when the divided tablets Tg and Th are divided into two, the situation where the fingers contaminate the tablets Tg and Th does not occur.
• the divided tablet Tg has a problem that cabbing is likely to occur at the pointed edge Pe in the tableting process.
• each of the two regions Rl and R2 formed by the dividing line Ld on the upper surface Sa of the tablet Tg is a plane
• the region R1 of a certain tablet Tg and the region R1 of a certain tablet Tg come into contact with each other.
• a region R1 of a certain tablet Tg and a region R2 of a certain tablet Tg come into contact with each other, or a region R2 of a certain tablet Tg and a region R2 of a certain tablet Tg come into contact with each other.
• the tablet Tg, '′ comes into surface contact with each other. It is not resolved.
• edge Pe of the upper surface Sa of the tablet Tg is sharp, the tablets Tg, '' collide with each other in the coating process, thereby causing the core erosion (uncoated tablet). Loss phenomena) and edge Chibbing (phenomena of chipped edge).
• the tablets Tg may collide with each other during the pneumatic transport, or the tablets Tg may be transported by pipes.
• the edge Pe of the Sa chip may be chipped off due to collision with the tablet Tg.
• the press-through pack 101 is used to transport the tablet, the upper surface of the tablet Tg may be vibrated. There is a problem that the edge Pe of the Sa collides with the storage body 102 and the sealing sheet 103 to cause chipping, and that the sealing sheet 103 is broken by the edge Pe.
• the tablet Tg is stored in the press-through pack 101, the tablet Tg is stored in the storage recess 102b of the storage body 102 of the press-through pack 101, and the tablet Tg is scored toward the sealing sheet 103.
• the convex portion serving as the storage recess 102b of the storage body 102 of the press-through pack 101 is provided.
• the tablet Tg can be easily divided into two by pressing the convex central part of the lower surface Sb of the tablet Tg with the finger (right side in Fig.
• the tablet Tg is stored in the storage recess 102b of the storage body 102 of the press-through pack 101, while the tablet Tg is stored in the storage recess 102b of the press-through pack 101.
• the upper surface Sa on the side where the dividing line Ld of the tablet Tg is provided is facing (see the tablet Tg stored in the storage recess 102b on the left side in FIG. 19 (a)).
• the convex portion 102c which is the storage recess 102b of the storage body 102 of the press-through pack 101, is generally V-shaped when viewed from the side.
• the shape of the storage recess 102b and the shape of the finger that are crushed into a shape is aligned with the shape formed by the two regions R1 and R2 formed by the secant line Ld of the upper surface Sa of the tablet Tg.
• the tablet Tg cannot be split into two without applying considerable force to the finger.
• the tablet Tg before taking out the tablet Tg from the storage recess 102b of the storage body 102 of the breath-through pack 101, the tablet Tg must be easily divided into two before removing the tablet Tg, as shown in FIG.
• the tablets Tg to be stored in each of the storage recesses 102b,... Of the storage body 102 of the press-through pack 101 are all replaced with the tablets T toward the sealing sheet 103.
• the direction must be regulated so that the upper surface Sa on the side where the dividing line Ld of g is provided is oriented, in this way, all the directions of the tablets Tg, There is a problem that it is extremely difficult to accommodate each of the storage recesses 102b,.
• all of the tablets Tg can be stored in each of the storage recesses 102b of the storage body 102 of the press-through pack 101.
• Each of the tablets Tg is placed in each of the storage recesses 102b, with the upper surface Sa on the side provided with the dividing line Ld of the tablet Tg facing the sealing sheet 103.
• the pointed edge Pe faces the direction of the sealing sheet 103, so that the pointed edge Pe causes the sealing sheet 103 to move with the finger or the like. Easy to break without pressing.
• edge P e of the upper surface Sa of the tablet Th is pointed, the tablet Th,. It is easy to cause abrasion of the tablet) and edge chipping (a phenomenon of chipping of the edge).
• the tablets Th, ... when the tablets Th, ... are transported by air from one place to another, during transportation, the tablets Th, ..., collide with each other or the tablets Th, ..., collide with the transport pipe. If the edge Pe of the upper surface Sa of the tablet Th is chipped, or if it is transported in the press-through pack 101, the edge Pe of the upper surface Sa of the tablet Th is deformed due to vibrations generated during transport. However, there is a problem that the storage body 102 collides with the sealing sheet 103 to cause chipping, and the sealing sheet 103 is broken by the edge Pe. The tablets Th, ... 'collide with each other, or the tablets Th, ...' collide with the bottle due to vibrations, etc., resulting in the lack of the edge Pe force. .
• the tablet Th when the tablet Th is stored in the press-through pack 101, the tablet Th force is inserted into the storage recess 102b of the storage body 102 of the press-through pack 101, and the tablet Tg is inserted into the sealing sheet 103.
• the upper surface Sa on the side where the score line Ld is provided is facing (see the tablet Th stored in the right storage recess 102b in FIG. 21 (a))
• the breath-through pack When the finger presses the convex portion 102c serving as the storage recess 102b of the storage body 102 of the tablet 101, the tablet Th is easily pressed by pressing the central portion of the convex shape of the lower surface Sb of the tablet Th with the finger.
• the storage body 102 of the press-through pack 101 can be divided into two.
• Storage recess 102b In the case where the upper surface Sa on the side where the dividing line L d of the tablet Th is provided faces the storage body 102 of the tablet T g force (the storage recess on the left side in FIG.
• the tablets are mutually connected as in the divided tablet Tg.
• the coating process although thinning is less likely to occur in the coating process than in the divided tablet T g, two regions R 1, formed by the dividing line L d of the upper surface Sa of the tablet Th, If each of R 2 is concave and the division is not made at the dividing line L d, the tablet Th is broken into two in the vicinity of either dividing line L d of the two regions R l and R 2. (See crease R 11 in Fig. 20 (b)).
• the conventional press-through pack sheet is manufactured on the premise that tablets are taken out one by one.
• the two divided tablets must be taken out of each of the storage recesses 102 b,..., Respectively, and the work of taking out the two divided tablets from the press-through pack is also troublesome. is there.
• the present invention has been made in order to solve the above-described problems, and it is possible to easily and accurately divide the tablet into two without regulating the direction of the upper surface or the lower surface of the tablet, and to pneumatically transport the tablet during production. It is an object of the present invention to provide a divided tablet in which the tablet is not easily chipped at the time of and / or during transport, and does not cause problems such as thinning even when film-coated.
• the present invention allows a pharmacist, a patient, or the like to easily divide a divided tablet at a time without manually touching the divided tablet, and to easily and easily collect a tablet divided into two. It is intended to provide a press-through pack. Disclosure of the invention
• the divided tablet according to claim 1 has a dividing line formed along the center line on the upper surface of the tablet, and two regions formed by the dividing line on the upper surface of the tablet.
• a ridge is provided so as to be located inside the edge, and a shape is provided on the lower surface of the tablet, which gradually rises from the edge of the tablet toward the center, and each of the two ridges is a region around the ridge.
• a region around each ridge line of the two ridge lines is formed by a convex curved surface, and Since the sharp edges are eliminated from the upper surface, when a force is applied from above to below the tablet, the tablet can be divided neatly along the score line without chipping. In addition, tablets are less likely to be chipped during the tableting process, during pneumatic transportation, or when transporting in a press-through pack or bottle.
• the divided tablet according to claim 2 is the divided tablet according to claim 1, wherein each of the two regions formed by the dividing line on the upper surface of the tablet has two ridge lines from each of the lines that are the starting points of the dividing line.
• the shape of the surface up to each is constituted by a convex curved surface.
• the “convex surface” of the shape of the surface from each of the lines that are the starting points of the secant line to each of the two ridge lines in each of the two regions is a gently raised surface. More specifically, the surface of each of the two regions has a curvature continuously from a surface having a small curvature to a surface having a large curvature in a ridge direction from a line which is the start of the secant line. As a result, the overall shape is a gentle raised surface.
• the lower surface of the tablet is provided with a shape that gradually rises from the edge of the tablet toward the center thereof.
• the tablet When the upper surface of the side where the score line of the tablet is provided faces the sealing sheet, when the finger presses the convex part which becomes the storage recess of the storage body of the breath-through pack, the lower surface of the tablet is pressed. By pressing the convex central part of the tablet with a finger, the tablet can be easily divided into two.
• a tablet score line is provided in the storage recess of the press-through pack. Even if the storage side of the breath-through pack is pressed with a finger, even if the storage side is stored so that the storage side faces the storage body, when viewed from the side, the storage In the shape of the finger, each of the two areas formed by the score lines on the upper surface of the tablet has opposing curved surfaces, so that the force acts on the tablet in the direction that opens the score line without applying any force to the finger. As a result, the tablet can be easily divided into two even when the press-through pack is stored so that the side where the score line is provided faces the storage main body in the storage recess of the press-through pack.
• the split tablet has two convex surfaces on the upper surface and a convex surface on the lower surface, the tablets do not make surface contact with each other, but make point contact. As a result, twinning hardly occurs in the coating process.
• the divided tablet according to claim 3 is characterized in that the scored line of the divided tablet according to claim 1 or 2 is formed by a groove deeper than the upper surface of the edge of the tablet.
• deep groove used in the present invention means a groove whose deepest part is located below the upper edge of the tablet.
• the vertical distance from the top of the tablet bottom to the deepest part of the secant is shorter than the vertical distance from the top of the tablet bottom to the top of the tablet edge. It means there is.
• the tablet dividing line is formed deeper than the normal dividing tablet dividing line, so that it can be neatly divided along the dividing line.
• the divided tablet according to claim 4 is the divided tablet according to any one of claims 1 to 3,
• the score line is a V-groove or a U-groove.
• V-groove used in this specification means a V-groove and a case where the groove is substantially a V-groove.
• the “generally V-groove” is, for example, a shape in which the vicinity of the apex angle of the V-groove is formed as a round curve, a shape such as a vertex of a parabola (quadratic curve), or a V-groove. This includes the case where the round curve near the apex angle is polygonal with a bent portion.
• U-groove used in this specification means a U-groove and a case where the groove is substantially a U-groove.
• the “generally U-shaped groove” includes, for example, a case where a round curved portion of the U-shaped groove is formed in a polygonal shape having a bent portion.
• the surface forming the score line is a flat surface or a concave surface, and has a shape different from the convex shape of each of the two regions from the line serving as the start line of the score line to each of the ridge lines.
• the thickness of the tablet from the deepest part of the score to each of the lines starting from the score is generally gradually increased in the case of the V-groove.
• the thickness gradually increases from the deepest part of the secant line to each of the starting lines of the dividing line, and rapidly increases in the vicinity of each of the starting lines of the dividing line.
• the surface from each of the two lines from the starting line of the secant line to each of the ridge lines has a convex shape, the starting point of the ridge line in each direction from the starting line of the dividing line to the ridge line At each position near the edge line, the tablet thickness increases rapidly.
• the change in the thickness of the tablet within the scored area and the respective positions near the starting line in each direction from the line starting from the dividing line to the ridge line The thickness of the tablet at each position near the starting line in each direction of the ridge line from the starting line of the dividing line, while significantly changing the change in the tablet thickness at
• the force acting from the outside of the tablet per unit volume is large within the area of the score line, and in the direction of the ridge line from the line from the start line of the score line to the vicinity of the line of the start line.
• the force acting from the outside of the tablet per unit volume in the scored area is made smaller, so if this tablet is divided into two, it can be divided neatly along the scored line.
• the divided tablet according to claim 5 is the divided tablet according to any one of claims 1 to 4, Each of the line portions serving as the start ends of the score lines is provided above the upper surface of the edge of the tablet.
• the line that is the starting point of the secant means the two lines that are the starting points of the dividing line.
• the position above the upper surface of the edge of the tablet means, more specifically, the position on the surface of each of the two surfaces from each of the lines that are the start of the score line to each of the two ridge lines. means.
• Divided tablets can be easily split into two if the score is made larger (the depth of the score is deeper). However, when the score is made larger (the depth of the score is deeper), the tablet is drawn vertically from the top of the tablet. If the score is formed deeper in the direction, the mechanical strength of the tablet becomes weaker in the area where the score is provided, and the tablet is divided into two without permission, even though the tablet is not intended to be divided. There is a problem that it is easy to end up.
• the line that is the starting line of the score is not formed on the upper surface of the tablet, but is provided above the upper surface of the edge of the tablet.
• the score line can be made large (the depth of the score line can be increased) without forming the score line.
• the shape of the divided tablet according to any one of claims 1 to 5 from each of the two ridge lines on the upper surface of the tablet to the edge of the tablet is a steep slope. It is characterized by that.
• the shape from each of the two ridges on the upper surface of the tablet to the edge of the tablet is made a steep slope, and the shape from the line starting from the dividing line on the upper surface of the tablet to the ridge is changed to two Since the shape of the ridge is gentler than the shape from each edge to the edge of the tablet, when a force is applied to the tablet from top to bottom, the force is easily applied in the direction of opening the score line. This makes it possible to cleanly divide along the score line with a small force.
• the divided tablet according to claim 7 is characterized in that the steep slope of the divided tablet according to claim 6 is a straight or convex curved line when viewed from a cross section.
• the vicinity of the two ridges formed on the upper surface of the tablet is not a sharp edge, but is composed of a convex curved surface, and when a force is applied to the tablet from top to bottom,
• the shape from the line from the starting line of the score line to the ridge line on the upper surface of the tablet should be as gentle as possible.
• the shape of the slope having a steep shape up to the edge may be a straight line or a convex curve if it is not concave when viewed in cross section.
• the shape of the steep slope from the ridgeline on the upper surface of the tablet to the edge of the tablet is made a straight or convex curve may be determined from the design surface of the tablet. Therefore, based on the medicinal effect, efficacy, effect, and the like of the divided tablet, the shape of the tablet can be produced so that the doctor, pharmacist, patient, and the like can impress the shape of the tablet.
• the split tablet according to claim 8 is the split tablet according to any one of claims 1 to 7, wherein the dividing line is formed such that each of the regions near the intersection with the edge of the tablet sandwiches the dividing line. It is characterized in that it is chamfered into two convex shapes.
• each of the regions in the vicinity of the intersection point intersecting with the edge of the tablet is chamfered into two convex shapes formed so as to sandwich the dividing line, so that the tablet is less likely to be chipped.
• the divided tablet according to any one of claims 1 to 8 may be an uncoated tablet (naked tablet) or a tablet coated with a suitable coating such as a film coat or sugar coating on the surface. Good. Further, the divided tablet according to any one of claims 1 to 8 may contain, in addition to the active ingredient, an excipient, a binder, a disintegrant, and in some cases, a lubricant. Further, if necessary, the preparation may be prepared by adding a sweetening agent, a coloring agent, a flavoring agent, an antioxidant and the like.
• Such a divided tablet can be produced, for example, by a compression molding method.
• the mixed powder may be directly compressed into tablets, and the powder may be dried or wet granulated into granules having a predetermined particle size and particle size distribution, and the drying step and the sizing step may be performed. After that, granules and fine granules are mixed with a small amount of lubricant, and then compressed and formed into tablets May be.
• the lubricant may be added in advance to the active ingredient, excipient, etc., and the kneaded product of the active ingredient, excipient, etc., and the lubricant may be compressed into tablets.
• a tablet manufacturing method is referred to as an internal lubrication method.
• a lubricant is sprayed on the surface of Kizuki without adding it to the active ingredients, excipients, etc.
• the kneaded product of active ingredients, excipients, etc. may be tableted using a tablet with a lubricant layer (the method of manufacturing such a tablet is referred to as the external lubrication method). Is done).
• various coating methods can be used as long as it is a conventional coating method.
• a pan (or drum) coating method and a fluid coating method can be used.
• the pressure of such a coating is not particularly limited, but is preferably in the range of 10 m to 50 m.
• excipients can be used and are not particularly limited.
• lactose, mannitol, sucrose, glucose, and other sugars such as starch, or inorganic salts such as precipitated calcium carbonate, calcium phosphate, and sodium chloride, and crystalline cellulose can be used.
• the excipient is generally contained in a range of 10 to 95 parts by weight per tablet.
• binders can be used, and are not particularly limited.
• the binder include partially saponified polyvinyl alcohol, hydroxyprocellulose, hydroxypropylmethylcellulose, polyvinylbilidone, pullulan, and methyl. Any known materials such as cellulose, gum arabic and starches can be used.
• the binder is contained in an amount of 0.5 to 5 parts by weight per tablet.
• disintegrants can be used and are not particularly limited. Examples thereof include crospovidone, low-substituted hydroxypropyl cellulose, croscarmellose sodium, carboxymethyl cellulose, and carboxymethyl cellulose calcium. Any known compounds such as sodium carboxymethyl starch, partially pregelatinized starch hydroxypropyl starch, and the like can be used, but crospovidone, low-substituted hydroxypropyl cellulose, croscarmellose sodium are preferred. It is.
• the disintegrant is contained in a range of 1 part by weight to 15 parts by weight in one tablet.
• Lubricating tablets used for tableting include magnesium stearate, calcium stearate, zinc stearate, stearic acid, talc, hydrogenated vegetable oil, talc, etc., and preferably magnesium stearate and calcium stearate. is there.
• the lubricant is generally contained in an amount of 0.01 to 5 parts by weight per tablet.
• the press-through pack according to claim 9, further comprising: a storage body having a plurality of storage recesses connected by a plate-shaped portion; a base; and an adhesive layer provided on one surface of the base.
• An adhesive layer of the sealing sheet and the storage body in a state where the divided tablet according to any one of claims 1 to 8 is stored in each of the plurality of storage recesses of the storage body.
• the storage body is sealed by a sealing sheet, and the sealing sheet is outside the storage recess storing the divided tablet according to any one of claims 1 to 8.
• the phrase “adhered to the plate-shaped portion of the storage body so that it can be easily peeled off from the storage body.” is described in more detail.
• the sealing sheet of the press-through pack is turned up, the sealing is performed. Easy to store the sheet without breaking It means that it is adhered so that it can be separated from the plate-shaped part of the body.
• the divided tablets stored in any of the storage recesses of the storage body may be stored in the storage recess so that the surface provided with the dividing line of the split tablet faces the storage body side.
• the tablets may be stored so that the surface facing the surface where the score lines are provided faces the storage body side, and further, the surface where the split lines of the split tablets are provided faces the storage body side.
• both the tablet and the one that is stored so that the surface opposite to the surface on which the score line of the divided tablet faces the storage body face the storage body. It may be stored.
• the adhesive strength between the sealing sheet of this press-through pack and the plate part of the storage body is 0.9 N / 15 mm width or more when the T peel test is performed at a peel speed of 200 mm / min. It is preferably 3.1 N / 15 mm width or less, more preferably 1.9 N / 15 mm width or more and 2.7 N / 15 mm or less.
• the width is preferably 4.2 / 15 mm or more and 7.ON / 15 mm or less, and is 4.8 N / 15 mm or more and 6.5 N / More preferably, the width is 15 mm or less.
• the unit “N / 15 mm width” used in this specification is to bond the storage body and the sealing sheet, then cut the bonded part between the storage body and the sealing sheet into a 15 mm width and test this. Means the peel strength when a T-peel test is performed as a test sample.
• T-peel test used in this specification means a test according to JIS K 6845.
• the convex part which is the outer surface of the storage recess for storing the divided tablets of the storage body in the direction of the sealing sheet with your finger, and break the part sealing the storage recess of the sealing sheet.
• the adhesive layer between the adhesive layer of the sealing sheet outside the area of the storage recess (so-called pocket) where the divided tablets of the sealing sheet are taken out and the plate-shaped part of the storage body there is no peeling or floating between the storage body and the sealing sheet, and when the sealing sheet is peeled off and turned up, the sealing sheet is removed from the storage body without breaking the sealing sheet. Can be peeled off.
• the sealing sheet when the sealing sheet is peeled and turned up, the sealing sheet can be peeled off from the storage body without breaking the sealing sheet.
• the convex part which becomes the outer surface of the stored storage recess in the direction of the sealing sheet with a finger, and breaking the sealing sheet to take out the divided tablets the area of the storage recess where the divided tablets of the sealing sheet are taken out At the bonding portion between the adhesive layer of the outer sealing sheet and the plate-shaped portion of the storage body, peeling or floating occurs between the storage body and the sealing sheet, which is not preferable.
• the convex portion serving as the outer surface of the storage recess for storing the divided tablets of the storage main body is pushed out with a finger in the direction of the sealing sheet to break the sealing sheet and take out the divided tablet.
• peeling or floating was observed between the storage body of the sealing sheet and the sealing sheet. Although it does not occur, it is difficult to peel off the sealing sheet, turn it up, and peel off the sealing sheet from the housing body. If this is forcibly peeled off, a part of the sealing sheet is broken, which is not preferable.
• the “adhesive component” means an adhesive used for a normal heat seal or cold seal.
• adhesive strength reducing component means a component having an action of weakening the adhesive strength of the adhesive component, and means an adhesive having a weak adhesive strength, or a material usually used as a release agent, a filler, and the like.
• a resin used as a release agent such as a silicone resin or a fluororesin can be used.
• an acrylic resin can be used as the adhesive force reducing component.
• filler examples include fine powders of silicon oxide, magnesium silicate, titanium dioxide, zinc white, calcium carbonate, alumina, talc and the like.
• an appropriate amount of adhesion-lowering component is blended with the adhesive component, so that the adhesive force of the adhesive can be reduced, and the convex portion on the outer surface of the storage recess storing the divided tablets of the storage body can be sealed with a sealing sheet.
• the adhesive layer of the sealing sheet may be partially coated on one surface of the sealing sheet.
• the storage body of the sealing sheet can be used.
• An adhesive may be applied to the surface on the side facing the surface in any of a stitch shape, a linear shape, or the like, or may be applied by combining at least two of these.
• a part of the sealing sheet is broken by pressing the convex part which is the outer surface of the storage recess storing the divided tablets with your finger by applying the adhesive partially to the adhesive.
• the storage body and the sealing sheet do not peel off or float outside the pocket, and when a part of the sealing sheet is peeled off from the storage body and turned up, Adjustment is made so that the sealing sheet can be peeled off from the storage body without breaking the sheet.
• the divided tablets according to any one of claims 1 to 8 are accommodated in each of the storage recesses of the press-through pack, without restricting the direction of the divided tablets, Even when each of the divided tablets is stored, by pressing the convex part outside the storage recess storing the divided tablets with a finger, the divided tablets can be easily and easily removed before taking out the divided tablets from the storage recess. Can be split into two.
• the divided tablets stored in each of the storage recesses of the press-through pack can be easily and easily split into two before taking out the divided tablets from the storage recess, and then the storage tablet is removed from the storage body. By peeling off the sealing sheet, it is also possible to take out the two tablets stored in this press-through pack at once.
• FIG. 1 is a diagram schematically showing an example of a divided tablet according to the present invention, wherein FIG. 1 (a) is a plan view, FIG. 1 (b) is a bottom view, and FIG. Side views taken along the line II in FIG. 1 (a) are shown.
• FIG. 2 is a side view schematically showing a phenomenon that occurs in the divided tablet when the divided tablet according to the present invention is divided by applying a vertical force from above to below, and FIG. Fig. 2 (b) shows the state immediately before the vertical force is applied to the tablet from above to below, and Fig. 2 (b) shows the state immediately after the vertical force is applied to the divided tablet Ta from above to below. ing.
• Fig. 3 shows the case where the divided tablet according to the present invention stored in the storage recess of the storage body of the press-through pack is divided by applying a vertical force from above to below before being taken out of the storage recess.
• Fig. 3 (a) is a side view schematically showing a phenomenon occurring in the divided tablet
• Fig. 3 (a) is a state immediately before a vertical force is applied to the divided tablet from above to below
• Fig. 3 (b) is The state immediately after the vertical force is applied to the divided tablet from top to bottom is shown.
• FIG. 4 is an explanatory diagram schematically showing an example of a usage example of the press-through pack according to the present invention.
• FIG. 5 is a diagram schematically showing another example of the divided tablet according to the present invention, in which FIG. 5 (a) is a plan view, FIG. 5 (b) is a bottom view, and FIG. Shows side views, respectively.
• FIG. 6 is a diagram schematically showing another example of the divided tablet according to the present invention, in which FIG. 6 (a) is a plan view, FIG. 6 (b) is a bottom view, and FIG. Shows side views, respectively.
• FIG. 7 is a diagram schematically showing another example of the divided tablet according to the present invention, wherein FIG. 7 (a) is a plan view, FIG. 7 (b) is a bottom view, and FIG. Shows side views, respectively.
• FIG. 8 is a schematic diagram schematically showing the shape of the score line provided in the divided tablet according to the present invention, and FIGS. 8 (a) to 8 (e) each illustrate a preferred shape of such a score line. I ing.
• FIG. 9 is a diagram schematically showing the shape of the upper punch used to produce the split tablet according to the present invention, and each of FIGS. 9 (a) to 9 (c) shows the upper punch used in the experiment. A pestle is shown.
• FIG. 10 is a diagram schematically showing the shape of the lower punch used for producing the split tablet according to the present invention, and FIGS. 10 (a) and 10 (b) each show the shape of the lower punch used in the experiment. The pestle is shown.
• FIG. 11 is a diagram schematically showing the shapes of an upper punch and a lower punch used for producing a conventionally known lower punch curved karate tablet, and FIG. 11 (a) shows the upper punch used in the experiment. FIG. 11 (b) shows the lower punches used in the experiment.
• Fig. 12 is an explanatory view for explaining the observation place of the chipped portion in the drop test.
• Fig. 12 (a) shows the location of the top surface Sa of the divided tablet
• Fig. 12 (b) Indicates the observation location of the lower surface Sb of the divided tablet, respectively.
• FIG. 13 is a diagram schematically showing a conventional flat split tablet, in which FIG. 13 (a) is a plan view, FIG. 13 (b) is a bottom view, and FIG. 13 (c) is FIG. (a) shows side views according to the line I-I shown in FIG.
• FIG. 14 is a diagram schematically showing a conventional karate-type split tablet described in Japanese Patent Application Laid-Open No. 61-289027, wherein FIG. 14 (a) is a plan view, FIG. 14 (b) is a bottom view, FIG. 14 (c) is a side view taken along the line II shown in FIG. 14 (a).
• FIG. 15 is a diagram schematically showing an example of a divided tablet described in JP-A-8-53345
• FIG. 15 (a) is a plan view
• FIG. 15 (b) is a bottom view
• FIG. 15 (c) shows a side view according to the line I-I shown in FIG. 15 (a), respectively.
• FIG. 16 is a diagram schematically showing another example of the divided tablet described in JP-A-8-53345, wherein FIG. 16 (a) is a plan view, FIG. 16 (b) is a bottom view, Further, FIG. 16 (c) shows a side view according to the line II shown in FIG. 16 (a), respectively.
• FIG. 17 is a cross-sectional view schematically showing one example of a conventional press-through pack.
• FIG. 17 is a cross-sectional view schematically showing one example of a conventional press-through pack.
• FIG. 18 is a side view schematically showing a phenomenon that occurs in a divided tablet when a conventional divided tablet is divided by applying a vertical force from above to below
• FIG. 18 (a) is a side view of the divided tablet.
• Fig. 18 (b) shows the state immediately before the vertical force is applied from top to bottom
• Fig. 18 (b) shows the state immediately after the vertical force is applied from top to bottom. ing.
• Fig. 19 is a diagram schematically illustrating a problem that occurs when the conventional divided tablet is stored in the storage recess of the press-through pack and divided into two while being stored in the storage recess. a) shows the state immediately before the vertical force is applied to the split tablet from above to below, and Fig. 18 (b) shows the state immediately after the vertical force is applied to the split tablet from above to below. Each is shown.
• FIG. 20 is a side view schematically showing a phenomenon that occurs in a divided tablet when a conventional divided tablet is divided by applying a vertical force from above to below
• FIG. 20 (a) is a side view of the divided tablet.
• FIG. 20 (b) shows a state immediately before a vertical force is applied from above to below
• FIG. 20 (b) shows a state immediately after a vertical force is applied from above to below.
• FIG. 21 is a diagram schematically illustrating a problem that occurs when the conventional divided tablet is stored in the storage recess of the press-through pack and divided into two while being stored in the storage recess. a) shows the state immediately before applying a vertical force to the split tablet from above to below, and Fig. 21 (b) shows the state immediately after applying a vertical force to the split tablet from above to below. Each is shown. BEST MODE FOR CARRYING OUT THE INVENTION
• FIG. 1 is a diagram schematically showing an example of a divided tablet according to the present invention, wherein FIG. 1 (a) is a plan view, FIG. 1 (b) is a bottom view, and FIG. 1 (c) is a side view. Each figure is shown.
• the divided tablet Ta has a circular shape in plan view, and has a dividing line Ld provided along the center line on the upper surface Sa thereof.
• the shape of the two regions R 1 and R 2 formed by the dividing line Ld on the upper surface Sa of the tablet Ta has a shape that is in a mirror image relationship with the dividing line Ld interposed therebetween.
• the score line Ld extends from one edge e1 of the tablet Ta to the other edge e2 opposite to the one edge e1, and forms a deep groove.
• the dividing line Ld has a V-groove shape.
• the apex angle 0 of the V groove constituting the dividing line Ld is preferably in a range of 40 degrees or more and 90 degrees or less, more preferably 45 degrees or more. It is preferably in the range of 90 ° or less, and more preferably in the range of 5 ° to 60 °.
• the position H2 in the vertical direction (the Y-axis direction shown in FIG. 1 (c)) of the line Ld2 which is the starting end of the dividing line Ld is the deepest part of the dividing line Ld (the line formed at the deepest part of the dividing line) Ld
• the position l in the vertical direction (the Y-axis direction shown in Fig. 1 (c)) may be any position as long as it is higher than the position H1.
• the tablet Ta be located at a position higher than the vertical position H3 of the edge E of the upper surface Sa.
• the vertical position H 1 of the deepest part Ld 1 of the dividing line Ld may be located higher than the position H 3 of the edge E of the upper surface Sa of the tablet Ta, In consideration of easiness, etc., the vertical position H 1 of the deepest part Ld 1 of the dividing line Ld is set to be lower than the position H 3 of the edge E of the upper surface Sa of the tablet Ta. Is preferred. More specifically, the vertical distance Y 3 from the vertex of the bottom surface of the tablet Ta (vertex A 5 shown in FIG. 1 (c)) to the deepest portion Ld 1 of the dividing line Ld is defined as the bottom surface of the tablet Ta. It is preferable that the relationship be shorter than the vertical distance Y1 from the vertex A5 of the tablet A to the upper surface Sa of the edge E of the tablet Ta.
• the divided tablet Ta can be easily divided into two if the dividing line Ld is increased (the deepest part Ld1 of the dividing line Ld is deepened), but the deepest part Ld1 of the dividing line Ld is Forming deeper from the position H3 in the vertical direction (Y-axis direction shown in Fig. 1 (c)) in the lower surface Sb direction of the tablet Ta reduces the mechanical strength of the tablet Ta, and there is no need to split the tablet Ta. In addition, it is easy to be divided into two.
• the position of the deepest part Ld 1 of the dividing line Ld should not be provided at a position much deeper than the position H 3 of the upper surface Sa of the tablet Ta, and the starting point of the dividing line Ld It is preferable to increase the secant line Ld by providing the positions A 2 and A 2 of the line Ld 2 higher than the position H 3 of the upper surface Sa of the tablet Ta.
• Each of the two regions R 1 and R 2 formed by the dividing line Ld on the upper surface Sa of the tablet Ta is located so as to surround the dividing line Ld and inside the edge E of the tablet Ta.
• ridge lines Ll and L2 are provided.
• Each of the ridge line peripheral regions RL 1 and RL 2 of the ridge lines L l and L 2 is formed of a convex curved surface so as not to have a sharp edge portion.
• the ridge line L 1 formed in the region R 1 is a gentle uplift curve (convex-shaped curve) formed from the line Ld 2 which is the starting point of the secant line L d
• the ridge line L1 and the ridge line peripheral region RL1 are formed of a convex curved surface.
• a gentle uplift curve (curve having a convex shape) formed from the line Ld2 which is the starting point of the secant line Ld of the region R1 will be described in more detail.
• the curvature gradually changes from a surface with a small curvature to a surface with a large curvature gradually, and as a whole, a gently raised curved surface It has become.
• the steep slope R3 and the raised surface of the region R1 or the region R2 are joined at or near the top of the ridgeline L1, but the steep slope R3 and the raised surface of the region R1 or the region R2 are It may be performed through a plurality of curved surfaces.
• the ridge line L 2 formed in the region R 2 is also a gentle uplift curve (convex curve) formed from the line Ld 2 which is the starting end of the dividing line Ld.
• a convex curved surface formed by a steep slope R4 formed on the upper surface Sa of the tablet Ta along the edge E of the tablet Ta is assembled.
• the ridge line peripheral region RL 2 of the ridge line L 2 is also formed of a convex curved surface.
• the gentle uplift curve (convex curve) formed from the line Ld2 which is the starting point of the secant line Ld in the region R2 will be described more specifically.
• chamfering may be performed near the intersection between the dividing line Ld and the ridge line L1, or near the intersection between the dividing line Ld and the ridge line L2.
• positions R5 and R6 near the part e1 where the dividing line Ld intersects the edge E of the tablet, and the positions R7 and R8 near the other edge e2 where the dividing line Ld intersects the edge E of the tablet. Have a convex shape and a chamfered shape, respectively.
• the shape of the chamfer may be flat.
• the ridge line L1 is an intersection point A1 between a line Ld2 which is the starting point of the dividing line Ld and a region R5 which has a chamfered shape, a line Ld2 which is the starting point of the dividing line Ld, and a chamfer. It continues up to the intersection A2 with the region R7 where the shape has been cut, and gradually rises in the vertical direction (Y-axis direction) of the tablet Ta from each of the intersections A1 and A2, At the intersection A3 between the center point C of the tablet Ta and the line L3 orthogonal to the secant line Ld, the position is the highest position H4 in the vertical direction (Y-axis direction).
• the ridge line L2 is also the intersection A1 between the line Ld2 which is the starting point of the dividing line Ld and the region R6 which is a chamfered shape, and the starting point of the dividing line Ld.
• the line Ld2 continues to the intersection A2 of the chamfered area R8, and the vertical direction (Y-axis direction) of the tablet Ta gradually from each of the intersections A1 and A2.
• the tablet Ta has a shape gradually rising from the edge E of the tablet Ta toward the center C on the lower surface Sb, that is, a convex shape (see FIG. 1 (c)).
• a convex shape see FIG. 1 (c)
• the horizontal direction the X-axis direction shown in Fig. 1 (c)
• the horizontal direction the horizontal direction from the center point C of the tablet Ta to the intersection A4 of the edge E with the line L3 passing through the center point C and orthogonal to the dividing line Ld (shown in Fig.
• the ratio ((X1 / X2) X100) of the distance X1 to the distance X2 is preferably in the range of 60% or more and 80% or less, more preferably , 70% or less
• the upper range is 80% or less, and particularly preferably 75%.
• the ratio of the distance Y1 to the distance Y2 ((Y1 / Y2) X 100) is preferably in the range of 20% or more and 50% or less, more preferably in the range of 20% or more and 30% or less, and particularly preferably in the range of 23% or more and 25% or less.
• the shape of the lower surface Sb of the tablet Ta, which gradually rises from the edge E of the tablet Ta toward the center C, that is, the curvature of the convex-shaped curve is represented by the radius of the curve (Fig. 1 (c)
• the ratio (Ds / D) of the curve radius Ds) shown in Fig. 1 to the diameter of tablet Ta (diameter D of tablet Ta shown in Fig. 1 (b)) is in the range of 1.25 to 2.5. Is preferred.
• the diameter D of the tablet Ta is preferably 5 mm or more and 14 mm or less in consideration of the compliance when taking the tablet without division and the ease of division. It is preferably not less than 10 mm and not more than 10 mm.
• the divided tablet Ta When the divided tablet Ta is divided into two, a pharmacist, a patient, or the like can directly grasp each of the two regions Rl and R2 with a finger and can divide it along the dividing line Ld. Furthermore, there is an advantage that the tablet Ta can be split into two by pressing it downward from above.
• FIG. 2 is a side view schematically showing a phenomenon that occurs in the divided tablet Ta when the divided tablet Ta is divided by applying a vertical force from above to below, and FIG. FIG. 2 (b) shows a state immediately before a vertical force is applied to the divided tablet Ta from above to below, and FIG. 2 (b) shows a state immediately after a vertical force is applied to the divided tablet Ta from above to below. Each is shown.
• each of the ridge lines L 1 and RL 2 around the ridge line L 1 and L 2 of the upper surface S a of the tablet Ta is constituted by a convex curved surface (see FIG. 2 (a)), and the tablet Tg and Since the sharp edges P e of the upper surface Sa of the tablets Tg and Th as seen in the tablet Th are eliminated, each of the ridge line peripheral regions RL 1 and RL 2 does not crush or chip. .
• the tablet Ta By pressing the tablet Ta downward from above, the tablet Ta Can be nicely split into two.
• the divided tablet Ta is made such that the pointed edge Pe as seen in the tablet Tg and the tablet Th is eliminated from the upper surface Sa of the tablet Ta. It is difficult for cabbing to occur (see Fig. 2 (b)).
• the divided tablet Ta has two convex surfaces R 1 and R 2 on the upper surface and a convex surface R 6 on the lower surface, the tablets do not come into surface contact with each other, but come into point contact. . As a result, twinning hardly occurs in the coating process.
• the score line Ld is formed in a V-groove shape.
• each of the two inclined surfaces SLd and SLd forming the V-groove, which connects the deepest part Ld1 and each of the starting lines Ld2 and Ld2, is a plane.
• the shape of each of the two regions R 1 and R 2 from each of the lines Ld 2 and Ld 2 which are the start of the scored line Ld to each of the ridge lines L l and L 2 is a convex shape.
• the two slopes SLd, which form the V-groove, are different in shape from those of SLd.
• the dividing line Ld is a V-groove
• the lines Ld2 and Ld2 which are the starting points of the dividing line Ld from the deepest portion Ld1 of the dividing line Ld in the horizontal direction (the X-axis direction shown in FIG. 1 (c)).
• the rate of increase in the thickness of the tablet Ta (the thickness in the vertical direction (the Y-axis direction shown in Fig. 1 (c))) up to each of the above is uniform and becomes gradually thicker.
• the change in the thickness of the tablet Ta in the vertical direction with respect to the horizontal direction within the area of the dividing line Ld and the lines Ld 2 and Ld 2 which are the starting points of the dividing line Ld And the change in the thickness of the tablet Ta in the vertical direction with respect to the horizontal direction at the position near each of the starting lines Ld2 and Ld2 in each direction of the ridge lines Ll and L2
• the tablet T in the vicinity of each of the leading lines Ld2 and Ld2 in the direction of each of the ridgelines L1 and L2 from each of the leading lines Ld2 and Ld2 of the dividing line Ld.
• the thickness of a in the vertical direction with respect to the horizontal direction is rapidly increased, and the force acting from the outside of the tablet Ta per unit volume is large in the area of the dividing line Ld, and the starting point of the dividing line Ld In the direction from each of the lines Ld 2 and Ld 2 to each of the ridge lines L 1 and L 2, at the position near each of the starting lines Ld 2 and Ld 2, the dividing line Since the force acting from the outside of the tablet Ta per unit ⁇ $ ⁇ in the region of Ld is made smaller, the tablet Ta can be divided finely according to the dividing line Ld when divided into two.
• the deepest part Ld1 of the dividing line Ld is set so that the position H1 of the deepest part Ld1 is located below the upper position H3 of the edge E of the tablet Ta.
• the dividing line Ld is formed deeper than the dividing line of an ordinary divided tablet, so that it can be divided neatly along the dividing line d.
• FIG. 3 shows the divided tablets Ta stored in the storage recess 2b of the storage body 2 of the press-through pack 1 before being taken out of the storage recess 2b by applying a vertical force from the top to the bottom to separate the tablets.
• FIG. 3 (a) is a side view schematically showing a phenomenon occurring in the divided tablet Ta
• FIG. 3 (a) shows a state immediately before a vertical force is applied to the divided tablet Ta from above to below.
• Figure 3 (b) shows the state immediately after a vertical force was applied to the divided tablet Ta from top to bottom. State is shown respectively.
• the lower surface Sb of the tablet Ta has a shape that gradually rises from the edge E to the center C of the tablet Ta, so that the storage body 2 of the press-through pack 1 is stored.
• the upper surface Sa on the side where the score line L d is provided faces the sealing sheet 3 in the recess 2 b (the housing sheet 2 is stored in the storage recess 2 b on the left side in FIG. 3 (a)).
• the tablet Ta By pressing the central part A5 of the shape with a finger, the tablet Ta can be easily divided into two (the tablets stored in the storage recess 2b on the left side in Fig. 3 (b)). Ta)).
• the shape of the surface from each of the lines L d 2, L d 2, which are the starting ends of the secant line L d, to each of the two ridge lines L 1, L 2 is composed of a convex curved surface, so press-through
• the side where the dividing line L d of the tablet Ta is provided is stored in the storage recess 2 b of the pack 1 so as to face the storage body 2 (the right storage recess in FIG. 3 (a)).
• the press-through pack 1 shown in FIG. 3 includes a storage body 2 and a sealing sheet 5, and the adhesive layer 4 of the sealing sheet 3 has a plate-like portion 2 a of the storage body 2. It has a structure that is adhered to.
• the storage main body 2 is usually formed by heating and forming a plurality of storage recesses 2 b, 2 b, 2 b according to the shape of the divided tablets T a,.
• the shape is connected by the parts 2a, ⁇ ⁇ ⁇ , 2a.
• polyvinyl chloride, polyp which is generally used, is used.
• a thermoplastic synthetic resin such as lovirene, polystyrene, or cyclic polyolefin can be used. If such a storage body material is used, a plurality of storage recesses 2b, 2b, and 2b are divided tablets to be stored. It can be easily formed by heat molding according to the shape of Ta, ⁇ , Ta.
• the sealing sheet 3 has a base material 5 and an adhesive layer 4 provided on one surface of the base material 5.
• the divided tablets T a,..., T a stored in each of the storage recesses 2 b,.
• each of the convex portions 2 c,..., 2 c which are the outer surfaces of the storage recesses 2 b,.
• Place 2b, ..., Divided tablets contained in each of 2b Ta, ..., and materials that can be easily broken by each of Ta Preferred examples of such materials include aluminum foil, glassine paper, synthetic resin sheets containing a filler for facilitating breakage, and paper. Can be.
• the thickness is preferably 5 111 or more and 30 // 111 or less, more preferably 15 / m 2 or more.
• the base weight is 30.5 g / m 2 .
• the thickness is preferably 9 / zm or more and 100 / zm or less, More preferably, those having a thickness of 12 to 80 m are used.
• thermoplastic synthetic resin such as polyvinyl chloride, polypropylene, polystyrene, or linear polypropylene is preferably used.
• the filler to be contained in the synthetic resin for example, various materials such as silicon oxide, magnesium silicate, titanium dioxide, zinc white, calcium carbonate, alumina, and talc can be used, and the average particle size is 1 / zm 5 to 15% by weight, preferably 5 to 70% by weight, in the synthetic resin I do.
• the physical properties and composition of the base material 5 of the sealing sheet 3 as described above mainly depend on the convexity 2 c of the storage body 2, which is the outer surface of the storage recess 2 b storing the divided tablet T, and the sealing material.
• the convexity 2 c of the storage body 2 which is the outer surface of the storage recess 2 b storing the divided tablet T
• the sealing material When the finger is pressed in the direction of the arrow 5, when the finger is pressed, the recesses 2 b,... Of the sealing sheet 5 that seals the recess 2 b are sealed in parts r 1,. Rl is broken so that the divided tablet T can be taken out.
• the above configuration is the same as that of the conventional press-through pack 101, but in this press-through pack 1, the adhesive layer 4 of the sealing sheet 3 and the plate-like portion 2a, 2
• the adhesive strength with a is as follows:
• the convex portions 2c which are the outer surfaces of the storage recesses 2b, 2b, 2b, which store each of the divided tablets Ta, When each finger is pushed in the direction of the sealing sheet 3 in the direction of the sealing sheet 3, the sealing sheet 3 breaks, and the bonding part r 2 between the plate-shaped part 2 a and the adhesive layer 4 r 2.
• the part of the sealing sheet 3 that seals the storage recesses 2 b, ..., 2 b breaks, and the divided tablet T a, ..., and Ta can be taken out one tablet at a time, and when the sealing sheet 3 is peeled off and turned up, the sealing sheet 3 breaks on the way. And is adjusted so that it can be easily separated from the storage body 2.
• the method of adjusting the adhesive strength of the sealing sheet 3 will be described below in the case where the adhesive strength constituting the adhesive layer 4 is adjusted by the components of the adhesive, and in the case where the adhesive strength of the adhesive is adjusted by the base material 5 It is explained separately when it is adjusted according to the method of coating.
• an appropriate amount of the adhesion-lowering component is mixed with the adhesive component.
• the adhesive component may be any component as long as it is a component capable of bonding the storage body 2 and the base material 5 of the sealing sheet 3.
• a possible cold seal adhesive may be used.
• the heat-sealable thermoplastic resin is not limited to the following, but, for example, when the storage body 2 is made of polyvinyl chloride, a vinyl chloride-vinyl acetate copolymer
• the storage body 2 is made of polypropylene
• chlorinated polypropylene and carboxylated polypropylene can be mentioned as preferable examples.
• a mixture of a vinyl chloride-vinyl acetate copolymer and an acryl resin can be mentioned as a preferable example.
• examples of the cold seal adhesive include acrylic resin, silicone resin, and rubber.
• the “cold seal adhesive” refers to an adhesive that can be adhered only by pressing the members when the members are adhered to each other.
• the adhesive force reducing component to be mixed with the adhesive is the adhesive strength between the adhesive layer 4 of the sealing sheet 3 and the storage body 2 or the adhesive strength between the adhesive layer 4 of the sealing sheet 3 and the base material 5 of the sealing sheet 3. Any substance that reduces the adhesive strength can be used.
• Preferred examples of such a substance include a resin used as a release agent such as a silicone resin and a fluorine resin, an acrylic resin, a linear polyester resin, and the like.
• fine powders used as fillers of silicon oxide, magnesium silicate, titanium dioxide, zinc white, calcium carbonate, alumina, talc and the like can also be mentioned as preferable examples.
• the mixing ratio of the adhesive component and the adhesive force reducing component of the adhesive is determined by an adhesive strength test, an extrusion test, and a peel test, which will be described later.
• the adhesive strength is adjusted by the method of applying the adhesive to the base material of the sealing sheet.
• the adhesive may be applied to the base material 5 of the sealing sheet 3 entirely or partially, or the adhesive applied to the sealing sheet 3 5 per unit area of the adhesive.
• a desired adhesive strength can be obtained by adjusting the coating amount of the resin.
• the partial coating is performed, for example, as long as each of the divided tablets T a,..., T a stored in each of the storage recesses 2 b of the storage main body 2 can be completely sealed.
• the adhesive may be applied to the surface of the side 3 facing the storage body 2 on the side facing the storage body 2 in a stitch shape or a linear shape, or may be applied in a combination of at least two of them.
• an adhesive appropriately mixed with a diluent may be used, or the base material of the sealing sheet 3 may be used. What is necessary is just to adjust the film thickness per unit area of the adhesive applied to 5.
• the adhesive When the adhesive strength is adjusted by a method of applying the adhesive to the base material 5 of the sealing sheet 3, the adhesive may or may not contain an adhesive force reducing component. Here are some good points.
• each of the storage tablets 2b,..., 2b accommodates each of the divided tablets Ta,.
• the pharmacist, the patient, etc. take out the required number of divided tablets Ta,... Individually from each of the storage recesses 2b,.
• the tablets Ta can be individually grasped and easily divided into two along the dividing line Ld.
• each of the divided tablets Ta, ..., Ta is stored in each of the storage recesses 2b, 2b, and 2b.
• ⁇ ⁇ Each of Ta can be divided into two.
• the storage tablets 2b and 2' in which the divided tablets Ta and Each of the convex portions 2 c, Each of the divided tablets T a,..., T a separately divided into two can be taken out from each.
• the sealing sheet 3 when the sealing sheet 3 is peeled off and turned up, the sealing sheet 3 can be easily separated from the storage body 2 without being broken on the way. If the sealing sheet 3 is peeled off from 2 and turned up, all the divided tablets Ta, ..., Ta contained in the press-through pack 1 can be removed from the press-through pack 1 at once. .
• this press-through pack 1 accommodates divided tablets Ta, ..., Ta, which are not restricted in direction when they are divided into two, as shown in Fig. 4.
• the sealing sheet 3 side is brought into contact with a flat surface of a table or the like, and each of the convex portions 2 c,. , Crush it with a finger or a jig, etc., and divide tablets T a from each of storage recesses 2 b,
• the divided tablets Ta,... can be divided into two before being taken out of the storage recesses 2 b,.
• the tablet Ta is divided into two by fingers, etc., it is not contaminated by the tablet Ta force s, bacteria and mold attached to the fingers, etc.
• dispensing the tablets peel off the sealing sheet 3 from the storage body 2 and turn it up to remove all the divided tablets T a,..., T a contained in the press-through pack 1.
• FIGS. 5 to 7 are views exemplarily showing modified examples of the present invention.
• FIG. 5 is a diagram schematically showing another example of the divided tablet according to the present invention, in which FIG. 5 (a) is a plan view, FIG. 5 (b) is a bottom view, and FIG. Shows side views, respectively.
• This divided tablet Tb is different from the divided tablet Ta in that the dividing line Ld is formed larger than the divided tablet Ta.
• the divided tablet Tb is wider than the divided tablet Ta by the width between the two starting lines Ld 2 and Ld 2 forming the dividing line Ld (the width w 2 shown in FIG. 5 (a)). Is larger than the width between the two starting lines Ld 2 and Ld 2 forming the dividing line Ld of the divided tablet Ta (width wl shown in FIG. 1 (a)) (w2 > wl).
• the divided tablet Tb has a vertical distance (distance Y 8 shown in FIG. 5 (c)) from the two starting lines Ld 2 and Ld 2 forming the dividing line Ld to the deepest part Ld 1.
• the divided tablet Tb has a larger size of the dividing line Ld than the divided tablet Ta, and therefore can be easily divided into two with a smaller force than the divided tablet Ta.
• the vertical direction from the position H3 of the upper surface Sa of the upper portion E of the tablet Tb to the lines Ld2 and Ld2 which are the starting points of the dividing line Ld
• the distance in the direction (distance Y10 shown in Fig. 5 (c)) is the vertical direction from the position H3 of the upper surface Sa of the edge E of the tablet Ta to the lines Ld2 and Ld2 which are the starting points of the dividing line Ld.
• FIG. 6 is a diagram schematically showing another example of the divided tablet according to the present invention, in which FIG. 6 (a) is a plan view, FIG. 6 (b) is a bottom view, and FIG. Shows side views, respectively.
• This divided tablet Tc is different from the divided tablet Ta in which the dividing line Ld is a V-shaped groove in that the dividing line Ld is a U-shaped groove.
• the dividing line Ld is a U-groove, so that within the area of the dividing line Ld, the thickness of the tablet Tc is from the deepest portion Ld1 of the dividing line Ld to the line Ld2 which is the starting point of the dividing line Ld, The thickness gradually increases to each of Ld 2, and rapidly increases in the vicinity of each of the lines Ld 2 and Ld 2 which are the starting ends of the secant line Ld.
• the surface from each of the lines Ld2, Ld2, which is the starting point of the scored line Ld, to each of the ridgelines Ll, L2, to each of the two regions R1, R2, is convex. Therefore, in the vicinity of each of the starting lines Ld2, Ld2 in the direction of each of the ridgelines L1, L2 from each of the starting lines Ld2, Ld2 of the dividing line Ld, The thickness of the tablet Tc increases rapidly.
• the change of the thickness of the tablet Tc at the position near each of the starting lines Ld 2 and Ld 2 is significantly different, and the starting line Ld 2 of the dividing line Ld is Starting lines Ld2, Ld2 in the directions of ridgelines L1, L2 from each of Ld2
• the thickness of the tablet TC at each of the adjacent positions is rapidly increased, and the force acting from the outside of the tablet Tc per unit angle is large in the area of the dividing line Ld, and the starting point of the dividing line Ld Tablet L per unit volume in the area of the dividing line Ld at the position near each of the starting lines Ld2 and Ld2 in the direction of each of the ridge lines L1 and L2 from each of the lines Ld2 and Ld2 Since the tablet T
• FIG. 7 is a diagram schematically showing another example of the divided tablet according to the present invention, wherein FIG. 7 (a) is a plan view, FIG. 7 (b) is a bottom view, and FIG. Shows side views, respectively.
• This divided tablet Td is assumed to have an oval shape when viewed in a plan view (see Fig. 7 (a)), and a circular shape when viewed in a plan view. Is different from the divided tablet Ta (see Fig. 1 (a)).
• a dividing line Ld is formed along the minor axis L4.
• the curvature of the curve L6 on the bottom surface is the radius of the curve (the radius of the curve Ds shown in Fig. 7 (c)) is the major axis of the tablet Td ( It is preferable that the ratio (D s / Do) to the length of the major axis L5 (the major axis Do of the tablet Td shown in FIG. 7 (b)) is in the range of 1.25 to 2.5.
• This divided tablet Td also has the same effect as the divided tablet Ta. Furthermore, in the divided tablet Td, the shape of the tablet is elliptical when viewed in a plan view, and the dividing line Ld is provided along the short axis L4, so that the two regions R1, R formed by the dividing line Ld.
• the distance from the dividing line Ld to the intersections A4 and A4 where the edge E of the tablet Td and the major axis L5 intersect is the length Do / 2, which is one half of the major axis, and is longer. This makes it possible to increase the moment when the finger or the like is split into two parts, so that the finger or the like can be split into two without much force.
• the dividing line Ld may be provided along the long axis L5. Not even.
• the shape of the dividing line provided in the divided tablet according to the present invention is shown in FIG.
• the shape may be the V-groove shape shown in (a) or the U-groove shape shown in Fig. 8 (d). Even if the shape has a portion R 11 or a parabolic (quadratic curve) shape, a rounded round portion R 11 near the long angle of the V-groove is formed into a smooth curve as shown in FIG. 8 (c). Instead, a polygonal shape having one or more bent portions Lb (see region R12 shown in FIG.
• FIG. 8 (c) may be used, or a regular U-shaped groove as shown in FIG. 8 (e).
• a polygonal shape having one or more bent parts Lb may be used. Referring to region R 14 shown in FIG. 8 (e)).
• the dividing line Ld is formed into a polygonal shape having one or more bent portions Lb, the force concentrates on one of the bent portions Lb when the divided tablet is divided into two, and therefore, along one of the bent portions Lb. In addition, since it is easy to be divided into two, it becomes possible to further clearly divide along the vertical line Ld.
• all of the tablets Ta, Tb, Tc, and Td have tablets Ta, Tb, Tc, and Td from each of the ridge lines L1 and L2 of the upper surface Sa of each of the tablets.
• the shape of the steep slopes R 3 and R 4 up to each edge E of Td was described as a convex curve when viewed in cross section, but the shape of the steep slopes R 3 and R 4 When viewed from a cross-section, a flat shape may be used.
• the surface of the tablet Ta, Tb, Tc, Td has a convex (gently raised curve) surface from each of the lines Ld2, Ld2, which is the starting point of the dividing line Ld, to each of the ridgelines L1, L2.
• the tablet Ta, Tb, Tc, Td it is preferable to provide the tablet Ta, Tb, Tc, Td at a position closer to the edge E of each of the tablets than the ridge lines Ll, L2 and at a position lower than the ridge lines Ll, L2 in the vertical direction.
• whether the shape from the ridgeline of the upper surface of the tablet to the edge of the tablet is a steep slope, or a straight or convex curve is determined from the design surface of the tablet. it can.
• the split tablet according to the present invention should have a tablet shape based on its medicinal properties, efficacy, effects, etc., so that the shape of the tablet can be impressed to doctors, pharmacists, patients, etc. Can be.
• the product is characterized by sharp sharpness, for example, if it is made into the form of an oral antimicrobial preparation or an analgesic anti-inflammatory, the parent can impress the sharpness of these drugs.
• lactose DMV: 200M
• corn starch Japanese food 29.0% by weight
• hydroxyprovir was used as a binder for these powders.
• a 7% by weight aqueous solution of cellulose manufactured by Nippon Soda Co., Ltd .: HP C-L
• HP C-L HP C-L
• the dried powder produced as described above is sized by a granulator (Randel Mill RMI, manufactured by Tokuju Kosakusho), and a lubricant (magnesium stearate (manufactured by Sakai Kagaku)) is added to the obtained rectified product. 0.5% by weight was added, and the mixture was mixed for 5 minutes with a blender (manufactured by Tokuju Kogakusho): Mix well mixer VI-60) to obtain a molding material.
• a granulator Randel Mill RMI, manufactured by Tokuju Kosakusho
• a lubricant magnesium stearate (manufactured by Sakai Kagaku)
• upper punch pa1, upper punch pa2 and upper punch pa3, and lower punch pb1 and lower punch pb2 shown in FIG. 10 Produced.
• the upper punch pa 1 and the upper punch pa 2 form chamfered regions (regions R 5, R 6, R 7, R 8 shown in FIG. 1) near the intersection of the dividing line L d and the edge of the tablet.
• the upper punch pa3 is used to produce a tablet without splitting, and the upper punch pa3 is a chamfered area near the intersection of the dividing line Ld and the edge of the tablet (R5, R6, R7 R8 shown in Fig. 1). This is an upper punch for producing a divided tablet formed with).
• Each of the upper punches pa l, pa 2 and pa 3 has a female mold of the upper surface of the divided tablet to be molded
• each of the lower punches pbl and pb 2 has a female mold of the lower surface of the divided tablet to be molded You are.
• the reference numerals corresponding to the parts of the shape of the divided tablet are attached, and the dimensions of the prepared upper punches pa1, pa2, pa3 and lower punches pbl, pb2 are entered.
• the upper punch pa1 and the lower punch pb1 were combined, and these were mounted on a high-speed single-shot tableting machine (VIRGO 12 manufactured by Kikusui Seisakusho), and the molding material produced as described above was tableted.
• a combination of the upper punch pa 1 and the lower punch pb 2 a combination of the upper punch pa 2 and the lower punch pb 1, and a combination of the upper punch pa 2 and the lower punch pb 2.
• Tableting machine manufactured by Kikusui Seisakusho: VI RGO 12). Locked.
• the weight per tablet was 13 O mg.
• the evaluation is easy to break: 3 points, hard to break: 2 points, very hard to break: 1 point, no cracks: 0 points, and a full score of 15 points.
• the dividing direction indicates whether the direction of the score line of the tablet is upward or downward.
• Fig. 12 (a) As shown in Fig. 12 (a), three parts Fl, F2, F3 on the upper surface Sa of the split tablet, and as shown in Fig. 12 (b), as the lower surface Sb of the split tablet. A total of four locations, F4, were selected.
• Table 2 shows the results of the drop test.
• a split tablet according to the present invention was produced in the same manner as in Experimental Example 1, using an upper punch pa3 shown in FIG. 9 (c) and a lower punch pb1 shown in FIG. 10 (a).
• a split tablet according to the present invention was produced in the same manner as in Experimental Example 1, using an upper punch pa3 shown in FIG. 9 (c) and a lower punch pb2 shown in FIG. 10 (b).
• a conventionally known curved lower punch karate tablet was produced in the same manner as in Experimental Example 1, using the upper punch pa4 and the lower punch pb1 shown in FIG.
• the friability test was conducted by placing 20 divided tablets according to the present invention and 20 comparative examples (lower punch curved karate tablets) in a fly aviator, and rotating at 25 rpm for 10 minutes or 20 minutes. This was done by measuring the degree.
• Table 3 shows the results of the friability test.
• the coating liquid (OPADRY-II (available from Colorcon Corporation: OY-LS-22813) aqueous solution) was coated on 1 kg of the split tablet of the present invention prepared in Experimental Example 3 with a coating machine (FCT-HCT-30 ⁇ ). And coated.
• a coating liquid (aqueous solution of OPADRY-II (produced by Colorcon Corporation: OY-LS-22813)) was added to 1 kg of the conventionally known lower punch-shaped karate tablet prepared as a comparative example.
• the coating was performed using a filing machine (FCT: HCT-3ON).
• a divided tablet (coated) according to the present invention which is housed in the storage recess of the press-through pack, wherein the tablet is housed in a state where the score is upward, and 10 tablets.
• the divided tablets (coated) according to the present invention each of which is divided into 10 tablets, each of which is separated from the storage recess, without being taken out of the storage recess, are divided into two by the finger.
• Each of the divided tablets was precisely weighed with a chemical balance, and when divided into two, the weight variation coefficient of the tablets generated in the divided tablets (coated) according to the present invention was determined. .
• a commercially available tablet katsuyuichi (manufactured by Kobayashi Pharmaceutical Co., Ltd.) is used as a split tablet (coated) according to the present invention, wherein the score line is directed upward.
• the 10 tablets and the divided tablets (coated) according to the present invention are cut along the score line and divided into two.
• Each of the tablets thus obtained was precisely weighed with an analytical balance, and when divided into two, the weight variation coefficient of the tablets generated in the divided tablet (coated) according to the present invention was determined. Table 4 shows the results.
• the divided tablet according to the present invention shows that the weight variation coefficient of the tablet after being divided into two, whether the dividing line faces upward or downward, along the dividing line by the tablet cutting unit
• the weight difference coefficient of the tablet after splitting is not much different from that of the tablet.
• the split tablet according to the present invention is accurately divided into two by a finger, regardless of whether the score is upward or downward. What you can do It is clear.
• the tablet manufactured using the lower punch pb2 having a larger radius of curvature than the lower punch pbl has a further coefficient of variation in comparison with the tablet manufactured using the lower punch pb1. It became clear that it would be smaller. This is considered to be because the fracture area at the time of division becomes smaller.
• the split tablet according to the present invention prepared in Example 2 was stored in a press-through pack, and the tablet required for splitting was measured in a state where the split tablet was stored in the storage recess of the press-through knock.
• PTB-311 / P manufactured by Japan Machinery Co., Ltd.
• a commercially available lower punch curled karate tablet (trade name: Norpasque Tablets, manufactured by FAIZAICHI PHARMACEUTICAL CO., LTD.) was used for splitting with the split tablets stored in the recess of the press-through pack.
• a tablet hardness tester manufactured by Japan Machinery Co., Ltd., PTB-311 / P.
• the press-through pack used in the comparative example is the same as the breath-through pack used to store the divided tablet according to the present invention, and the packaging method according to the comparative example also includes the divided tablet according to the present invention. Was carried out in the same manner as in the case of storing in a press-through pack.
• dividable tablet according to the present invention this and force 5 can be divided in one force of about 4 minutes in the comparative example, it was revealed.
• the divided tablet according to the present invention has a shape that is easier to be divided than conventionally known divided tablets.
• each of the two ridge line peripheral regions is formed by a convex curved surface.
• the sharp edges are eliminated from the upper surface of the tablet, when a force is applied from above to below the tablet, the tablet can be divided neatly along the score line without chipping.
• tablets are not easily chipped during the tableting process, during pneumatic transportation, or when transported in a breath-through pack or bottle.
• the sealing sheet is provided in the storage recess of the storage body of the press-through pack.
• the convex part that becomes the storage recess of the storage body of the press-through pack is pressed by a finger, and the convex shape of the lower surface of the tablet is pressed.
• the tablet score line is provided in the storage recess of the press-through pack. Even if the side is turned toward the storage body, when the protrusion of the storage recess of the press-through pack is pressed with a finger, the storage recess which is generally crushed into a V-shape when viewed from the side, In the shape of the finger, each of the two areas formed by the dividing line on the upper surface of the tablet has a curved surface facing each other, so that the dividing line is opened even if no force is applied to the finger compared to the conventional divided tablet In the direction, force acts on the pill. As a result, the tablet can be easily divided into two even when the press-through pack is stored in the recessed portion of the press-through pack so as to face the lateral force storage body provided with the tablet dividing line.
• the inside of the storage recess of the storage body of the press-through pack is used.
• they can be divided into two before taking out the tablets from the press-through pack. This makes it possible to realize a press-through pack that can easily divide the divided tablet stored in the storage recess into two before taking out the divided tablet from the storage recess of the press-through pack.
• the split tablet has two convex surfaces on the upper surface and a convex surface on the lower surface, the tablets do not make surface contact with each other, but make point contact. As a result, twinning hardly occurs in the coating process.
• the score line of the tablet is formed deeper than the score line of the normal divided tablet, it can be neatly divided along the score line.
• the change in the thickness of the tablet, and in each direction of the ridge line from the starting line of the dividing line, each of the vicinity of the starting line The thickness of the tablet at each position near the starting line in each direction of the ridge line from the starting line of the secant line, while significantly changing the change in the tablet thickness at the position
• the force acting from the outside of the tablet per unit volume is large within the area of the score line, and the force of the line from the start line of the score line to the start line in each direction of the ridge line is increased.
• the force acting from the outside of the tablet per unit volume in the scored area is made smaller, so if this tablet is divided into two, it can be neatly divided according to the scored line.
• the tablet from the upper surface of the tablet It is possible to enlarge the score line (to increase the depth of the score line) without forming a deep line in the vertical direction.
• the score line can be increased without decreasing the mechanical strength of the tablet (depth of the score line).
• the tablet can be easily split into two, and if it is not intended to be split, the tablet will not be split into two without permission. Can be obtained.
• the shape from each of the two ridges on the upper surface of the tablet to the edge of the tablet is a steep slope, and the shape from the line starting from the dividing line on the upper surface of the tablet to the ridge is formed.
• the shape is gentler than the shape from each of the two ridges to the edge of the tablet Because of the uplift curve, when a force is applied to the tablet from top to bottom, the force tends to be applied in the direction of opening the secant. As a result, it is possible to cleanly separate along the score line with a small force.
• the shape of the tablet can be produced so that the doctor, pharmacist, patient, and the like can impress the shape of the tablet.
• each of the regions near the intersection point intersecting with the edge of the tablet is chamfered into two convex shapes formed so as to sandwich the dividing line, the tablet is less likely to chip. .
• the so-called so-called outside of the pocket does not peel off or float between the storage body and the sealing sheet, and peels off part of the sealing sheet from the storage body and flips it up
• the sealing sheet is adjusted so that the sealing sheet can be peeled off from the storage body without causing breakage of the sealing sheet. Therefore, in this press-through pack, by taking out the divided tablets one by one from the storage recess or by peeling off the sealing sheet from the storage body, the divided tablets stored in the press-through pack can be taken out at once. it can.
• the divided tablets according to any one of claims 1 to 8 are stored in each of the storage recesses of the press-through pack, the direction of the divided tablets is not restricted without restricting the direction of the divided tablets. Even when each of the divided tablets is stored, by pressing the convex part outside the storage recess storing the divided tablets with a finger, the divided tablets can be easily and easily removed before taking out the divided tablets from the storage recess. Can be split into two.
• the divided tablets stored in each of the storage recesses of the press-through pack are Before taking out the split tablet from the storage recess, the split tablet is easily and easily split into two, and then the sealing sheet is peeled off from the storage body to split it into two stored in this press-through pack The taken tablets can be taken out at once.

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• 1999
  • 1999-04-01 JP JP53819499A patent/JP3839065B2/ja not_active Expired - Lifetime
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