WO2015186786A1 - 薬剤包装用ptpシート - Google Patents
薬剤包装用ptpシート Download PDFInfo
- Publication number
- WO2015186786A1 WO2015186786A1 PCT/JP2015/066180 JP2015066180W WO2015186786A1 WO 2015186786 A1 WO2015186786 A1 WO 2015186786A1 JP 2015066180 W JP2015066180 W JP 2015066180W WO 2015186786 A1 WO2015186786 A1 WO 2015186786A1
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- WIPO (PCT)
- Prior art keywords
- sheet
- thickness
- peripheral wall
- ptp sheet
- Prior art date
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Classifications
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- 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
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- 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
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C51/00—Shaping by thermoforming, i.e. shaping sheets or sheet like preforms after heating, e.g. shaping sheets in matched moulds or by deep-drawing; Apparatus therefor
- B29C51/10—Forming by pressure difference, e.g. vacuum
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C51/00—Shaping by thermoforming, i.e. shaping sheets or sheet like preforms after heating, e.g. shaping sheets in matched moulds or by deep-drawing; Apparatus therefor
- B29C51/26—Component parts, details or accessories; Auxiliary operations
- B29C51/42—Heating or cooling
- B29C51/421—Heating or cooling of preforms, specially adapted for thermoforming
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C51/00—Shaping by thermoforming, i.e. shaping sheets or sheet like preforms after heating, e.g. shaping sheets in matched moulds or by deep-drawing; Apparatus therefor
- B29C51/26—Component parts, details or accessories; Auxiliary operations
- B29C51/42—Heating or cooling
- B29C51/428—Heating or cooling of moulds or mould parts
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B47/00—Apparatus or devices for forming pockets or receptacles in or from sheets, blanks, or webs, comprising essentially a die into which the material is pressed or a folding die through which the material is moved
- B65B47/04—Apparatus or devices for forming pockets or receptacles in or from sheets, blanks, or webs, comprising essentially a die into which the material is pressed or a folding die through which the material is moved by application of mechanical pressure
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- 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
- B65D2575/3254—Integral means for assisting piercing or tearing
-
- 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
- B65D2575/3281—Tear lines dividing the package into a plurality of packages
Definitions
- the present invention relates to a PTP sheet for drug packaging.
- PTP (Press Through Package) packaging is widely used as a packaging for solid drugs such as tablets and capsules in the field of pharmaceutical packaging.
- the PTP sheet for drug packaging forms a pocket containing a solid drug in a resin film, and after the solid drug is loaded in the pocket, the sheet made of aluminum foil or the like is adhered to the resin film to seal the pocket. It is manufactured by. When the solid medicine loaded in the pocket is pushed together with the pocket by the user, the sheet is broken by the solid medicine, and the solid medicine can be taken out from the pocket.
- the user can easily crush the pocket.
- the thickness of the peripheral wall of the pocket tends to increase. Accordingly, the peripheral wall of the pocket is not easily deformed, and the pocket is not easily crushed.
- the user has relatively weak hand or finger strength, such as an elderly person or a child, it may be difficult to take out the fixed medicine from the PTP sheet for medicine packaging.
- the resin film is thinned so that the pocket is easily deformed, the pocket may be damaged by an external force applied inadvertently during transportation or storage.
- the present invention has been made in view of the above-described circumstances, and an object of the present invention is to provide a PTP sheet for drug packaging in which a solid drug can be easily taken out and a pocket part is not easily damaged.
- the PTP sheet for drug packaging according to the present invention includes a first sheet in which a pocket capable of accommodating a solid drug projects on the first surface side which is one of the front and back surfaces, and the first sheet in the first sheet.
- the pocket portion includes a peripheral wall portion having a third surface continuous with the first surface, and a ceiling portion having a fourth surface continuous with the third surface of the peripheral wall portion.
- the wall thickness of the peripheral wall is thinner than the wall thickness of the ceiling.
- the thickness of the peripheral wall portion of the pocket portion is thinner than the thickness of the ceiling portion, when the user presses the ceiling portion of the pocket portion toward the second sheet, the peripheral wall portion is deformed and the pocket portion is crushed. While the pocket part is crushed, the solid medicine accommodated in the pocket part breaks the second sheet. On the other hand, since the thickness of the ceiling portion of the pocket portion is relatively thick, even if a sharp object collides with the ceiling portion, the ceiling portion is hardly damaged.
- the pocket portion is formed by heating a partial region of the first sheet and sucking a region including the partial region into a decompressed recess.
- the partial area is heated in the process of forming the pocket portion by so-called decompression molding, when the first sheet is sucked into the recess, the partial area is easy to extend compared to the other areas, and the thickness is reduced. Cheap.
- the partial area is an area corresponding to the peripheral wall portion.
- the thickness of the peripheral wall portion of the pocket portion can be made thinner than the thickness of the ceiling portion by decompression molding. Moreover, since the ceiling part of a pocket part escapes a heating and it becomes difficult to be extended so that thickness may become thin at the time of pressure reduction molding, the transparency of a ceiling part improves. Thereby, it becomes easy to visually recognize the marking of the solid medicine accommodated in the pocket portion through the ceiling portion.
- the external shape of the pocket portion is a cylindrical shape.
- the main component of the first sheet is a thermoplastic resin.
- the second sheet is mainly composed of aluminum.
- the thickness of the peripheral wall portion is 40 to 160 ⁇ m, and the thickness of the ceiling portion is 200 to 400 ⁇ m.
- the wall thickness of the peripheral wall portion of the pocket portion is thinner than the wall thickness of the ceiling portion, it is easy to take out the solid medicine from the pocket portion and the ceiling portion is not easily damaged. Moreover, the transparency of the ceiling part of the pocket part is improved, and the solid medicine accommodated in the pocket part is easily visible through the ceiling part.
- FIG. 1 is an external perspective view of a PTP sheet 10 in which a solid medicine 11 is accommodated, in which (A) shows a state seen from diagonally above, and (B) shows a state seen from diagonally below. It is shown.
- FIG. 2 is an enlarged cross-sectional view of the pocket portion 16 of the PTP sheet 10.
- FIG. 3 is an enlarged cross-sectional view of the state in which the pocket portion 16 is crushed and the second sheet 15 is broken.
- 4A is a view showing the first sheet 14 in a state before the pocket portion 16 is formed in the reduced pressure molding
- FIG. 4B is a state in which the pocket portion 16 is formed in the reduced pressure molding. It is a figure which shows the 1st sheet
- the vertical direction 5 is defined on the basis of the state in which the PTP sheet 10 is disposed with the surface on which the pocket portion 16 is provided on the upper side, and the short direction in the surface is defined as the front-rear direction 6.
- a direction perpendicular to the up-down direction 5 and the front-rear direction 6 is defined as the left-right direction 7.
- the PTP sheet 10 (an example of a PTP sheet for drug packaging) is a generally rectangular sheet in plan view.
- the shape of the PTP sheet 10 is not limited to a rectangle.
- the PTP sheet 10 may be a square, a rhombus, a circle, or the like in plan view.
- the PTP sheet 10 has a solid drug 11 such as a tablet or a capsule sealed in a pocket portion 16.
- the dimensions of the PTP sheet 10 in the front-rear direction 6 and the left-right direction 7 can be appropriately determined depending on the number and size of the solid medicines 11 sealed in one PTP sheet 10.
- the PTP sheet 10 is configured by arranging five cells 12 that are sections for sealing two solid medicines 11 in the left-right direction 7. A total of ten solid drugs 11 are sealed in one PTP sheet 10 shown in FIG. In addition, it cannot be overemphasized that the number of the solid chemical
- a cell 21 in which the solid drug 11 is not sealed is provided on the right side of the rightmost cell 12.
- the cell 21 is used as a region for the user to hold the PTP sheet 10 or to fill in or print information on the solid medicine 11.
- the position where the cell 21 is provided is not limited to the right side of the rightmost cell 12, but may be, for example, the left side of the leftmost cell 12, or between the two cells 12, or on the PTP sheet 10.
- the cell 21 may not be provided.
- a slit 13 is formed in the first sheet 14 at the boundary between the cells 12 and the boundary between the cells 12 and 21.
- the PTP sheet 10 can be separated for each unit of the cells 12 and 21 by being bent along the slit 13 by a user such as a pharmacist or a patient.
- the dimensions of the cell 12 in the front-rear direction 6 and the left-right direction 7 are appropriately set depending on the number and size of the solid drug 11 sealed in the cell 12.
- the dimensions of the cell 21 in the front-rear direction 6 and the left-right direction 7 are appropriately set according to the amount of information written in the cell 21.
- the PTP sheet 10 is obtained by sticking a first sheet 14 that is a thermoplastic resin and a second sheet 15 that is a laminate sheet in which an aluminum sheet and a tree sheet are laminated.
- the solid medicine 11 is accommodated in the pocket portion 16 formed in the first sheet 14.
- the opening of the pocket portion 16 is closed by the second sheet 15.
- the solid drug 11 packaged in the PTP sheet 10 is pressed from the pocket part 16 by pressing the pocket part 16 of the first sheet 14 by the user's finger and the solid drug 11 pushing the second sheet 15 along with this. It can be taken out.
- each component of the PTP sheet 10 will be described in more detail.
- the upper surface and the lower surface of each sheet are defined with reference to the above-described vertical direction 5.
- the upper surface 31 of the first sheet 14 corresponds to the first surface
- the lower surface 32 (see FIG. 2) of the first sheet 14 corresponds to the second surface.
- the vertical relationship between the upper surface and the lower surface in the following description is a relative one determined for convenience of description, and the vertical relationship between the upper surface and the lower surface may be reversed.
- the first sheet 14 is obtained by molding a thermoplastic resin under reduced pressure.
- the thermoplastic resin include polypropylene (PP), polyvinyl chloride (PVC), polyethylene terephthalate (PET), cyclic polyolefin (COC, COP), and the like.
- PP polypropylene
- PVC polyvinyl chloride
- PET polyethylene terephthalate
- COC, COP cyclic polyolefin
- the first sheet 14 may have a laminate structure in which two or more types of resin sheets are laminated.
- seat 14 may not necessarily consist only of a thermoplastic resin, but the sheet
- the thickness of the sheet-shaped portion other than the pocket portion 16 in the first sheet 14 varies depending on the type of resin used, but is preferably in the range of 200 ⁇ m to 400 ⁇ m.
- a slit 13 is formed at the boundary of the cell 12.
- the slit 13 is formed on the upper surface 31 side of the first sheet 14, and is a groove having a substantially V-shaped cross section perpendicular to the upper surface 31.
- the depth along the vertical direction 5 of the slit 13 is slightly deeper than half the thickness of the first sheet 14.
- the slit 13 may be a perforation in which minute holes are periodically formed.
- the slit 13 may be provided by overlapping a groove and a perforation.
- the roller having the blade formed on the periphery is relatively moved while being pressed against the upper surface 31 of the first sheet 14, whereby the slit 13 is formed in the first sheet 14.
- Two pocket portions 16 are formed in each cell 12 of the first sheet 14.
- the outer shape of the pocket portion 16 is a substantially cylindrical shape protruding toward the upper surface 31 side of the first sheet 14.
- the solid medicine 11 is accommodated in the internal space formed by the pocket portion 16 on the lower surface 32 side of the first sheet 14.
- the lower surface 32 side of the pocket portion 16 is an opening for inserting or removing the solid medicine 11.
- the shape of the pocket portion 16, the volume of the internal space, the size of the opening, and the like are appropriately determined according to the external dimensions and volume of the solid medicine 11.
- the pocket portion 16 may have an elliptical dome shape in plan view.
- the pocket portion 16 includes a peripheral wall portion 17 having a peripheral surface 33 (corresponding to the third surface) continuous with the upper surface 31, and a top surface 34 (on the fourth surface) continuous with the peripheral surface 33. And a ceiling portion 18 having an equivalent).
- the peripheral surface 33 is a surface that forms a side peripheral surface of the cylindrical pocket portion 16, and intersects the upper surface 31 at an angle that is orthogonal or close to 90 °.
- the top surface 34 is a surface forming the upper end surface of the cylindrical pocket portion 16, and is substantially parallel to the upper surface 31, but has a dome shape in which the central portion swells upward.
- the wall thickness d1 of the peripheral wall portion 17 is thinner than the wall thickness d2 of the ceiling portion 18. Specifically, when the thickness (thickness) of the sheet other than the pocket portion 16 in the first sheet 14 is about 200 ⁇ m to 400 ⁇ m, the thickness of the peripheral wall portion 17 is 40 to 160 ⁇ m, and the ceiling portion 18 The wall thickness is preferably 200 to 400 ⁇ m.
- the pocket portion 16 is molded under reduced pressure as follows. As shown in FIG. 4A, the first sheet 14 before the pocket portion 16 is molded is a flat sheet having a constant thickness. On the upper surface 31 side of the flat first sheet 14, a mold 50 having a concave portion 51 in the shape of the pocket portion 16 is disposed, and at the position facing the concave portion 51 on the lower surface 32 side of the first sheet 14. A heating plug 52 is disposed. The heating plug 52 has an annular end surface 53, and a portion inside the end surface 53 is a cylindrical space recessed from the end surface 53. The end surface 53 corresponds to the partial region 19 of the first sheet 14 that becomes the peripheral wall portion 17 of the pocket portion 16. Note that the partial region 19 and the peripheral wall portion 17 do not necessarily correspond exactly. For example, the partial region 19 may be a part of the peripheral wall portion 17 instead of the whole.
- the partial region 19 of the flat first sheet 14 is heated when the end face 53 of the heating plug 52 approaches.
- the heating temperature of the partial region 19 by the heating plug 52 varies depending on the resin used as the first sheet 14, but is preferably about 120 to 150 ° C.
- the recess 51 is provided with an opening of a ventilation passage through which gas flows, and the recess 51 is decompressed by sucking air in the recess 51 from the opening.
- the recess 51 is depressurized, the first sheet 14 approaching or in contact with the recess 51 is sucked into the recess 51 and molded along the shape of the recess 51.
- the partial region 19 heated from the other region of the first sheet 14 extends from the other region and becomes thinner. Thereby, the pocket part 16 in which the thickness of the peripheral wall part 17 is thinner than the thickness of the ceiling part 18 is molded.
- the second sheet 15 is a laminated sheet that is laminated so that an aluminum sheet is sandwiched between resin sheets.
- One of the resin sheets is an acrylic resin, and the other is a vinyl chloride resin.
- seat 15 may consist only of an aluminum sheet, and metal sheets other than aluminum may be sufficient as it.
- the sheet used as the laminate sheet may be a resin other than an acrylic resin or a vinyl chloride resin, but a vinyl chloride resin is suitable if it is thermally welded to the first sheet 14, and characters and An acrylic resin is suitable for printing symbols and the like.
- seat 15 may be a resin sheet which does not contain a metal sheet, as long as the airtightness of the pocket part 16 can be ensured to some extent.
- the second sheet 15 is adhered to the lower surface 32 of the first sheet 14 in a state where the solid medicine 11 is accommodated in the pocket portion 16.
- the opening of the pocket portion 16 is closed by the second sheet 15, and the solid medicine 11 is held in the internal space of the pocket portion 16.
- the pocket portion 16 is pressed by the user's finger. Accordingly, the peripheral wall portion 17 of the pocket portion 16 is deformed so as to be bent and the pocket portion 16 is crushed, and the solid medicine 11 pressed through the ceiling portion 18 breaks the second sheet 15. Then, the solid medicine 11 can be taken out from the opening of the pocket portion 16 through the broken second sheet 15.
- the thickness of the second sheet 15 is a thickness that can be broken by a certain pressing force from the solid medicine 11.
- the thickness of the second sheet 15 is appropriately set according to the material of the second sheet 15 and the hardness of the solid drug 11, for example, whether the solid drug 11 is a tablet or a capsule.
- the thickness of the second sheet 15 is preferably in the range of 20 ⁇ m to 25 ⁇ m.
- the second sheet 15 is thermocompression bonded to the first sheet 14 in which the solid drug 11 is accommodated in the pocket portion 16.
- the first sheet 14 and the second sheet 15 are in a state where one roller mounted on the manufacturing apparatus for the PTP sheet 10 is overlapped between the heated roller pairs. Passes while being pressed by a pair.
- seat 15 are thermocompression-bonded.
- knurls may be formed on the surface of one roller of the roller pair, and fine irregularities of a mesh pattern by the knurls may be formed on the second sheet 15.
- seat 15 is not restricted to what was mentioned above.
- the partial region 19 of the first sheet 14 is heated by the heating plug 52, so that the first sheet 14 is sucked into the concave portion 51 of the mold 50.
- the partial region 19 is easy to extend compared to other regions, and the thickness tends to be thin.
- the thickness of the peripheral wall portion 17 of the pocket portion 16 can be made thinner than the thickness of the ceiling portion 18 by decompression molding.
- the ceiling portion 18 of the pocket portion 16 is not heated by the heating plug 52 and is difficult to be stretched so that the wall thickness d2 becomes thin at the time of decompression molding, so that the transparency of the ceiling portion 18 is improved. Thereby, it becomes easy to visually recognize the marking of the solid medicine 11 accommodated in the pocket portion 16 through the ceiling portion 18.
- seat 14 in pressure reduction molding has the annular
- the cross-sectional shape of the recessed portion inside the end face 53 may be a trapezoid, a shallow lens shape, or a deep lens shape.
- the trapezoid of the comparative example (FIG. 5A) in which the cross-sectional shape inside the end face 53 is relatively deep heat is hardly transmitted to the inside of the end face 53 in the heating plug 52.
- the thickness of the peripheral wall portion 17 of the pocket portion 16 is reduced, and the thickness of the ceiling portion 18 is increased.
- the lens shape (FIGS. 5B and 5C) in which the depth of the cross-sectional shape inside the end surface 53 is relatively shallow, heat is easily transmitted to the inside of the end surface 53 in the heating plug 52.
- the pocket portion Although the thickness of the 16 peripheral wall parts 17 becomes thin, the thickness of the peripheral part of the ceiling part 18, ie, the vicinity of the boundary with the peripheral wall part 17, also becomes thin.
- the first sheet 14 is formed by decompressing a thermoplastic resin, but the first sheet 14 may be formed by a molding method other than the vacuum molding. For example, after the partial region 19 of the first sheet 14 is heated by the heating plug 52, the pocket portion 16 may be molded by press molding using a male and female mold.
- the first sheet 14 is a resin sheet in which polypropylene (PP) and cyclic polyolefin (COC) are laminated
- the second sheet 15 is a laminate sheet in which an aluminum sheet and a resin sheet are laminated.
- the heating plug 52 shown in the example the cross-sectional shape is trapezoidal: see FIG. 5A
- the first sheet 14 was heated to about 150 ° C.
- the PTP sheet 10 was produced by vacuum molding.
- Example 2 A PTP sheet 10 was produced in the same manner as in Example 1 except that each heating plug 52 (see FIGS. 5B and 5C) shown in the above-described modification was used. That is, a lens shape having a shallow cross-sectional shape (see FIG. 5B) at a recessed portion inside the end face 53 of the heating plug 52 is referred to as Example 2, and a lens shape having a deep cross-sectional shape (FIG. 5C )) was taken as Example 3.
- the PTP sheet 10 is the same as in Example 1 except that the end surface of the heating plug does not have a recessed portion inside and the heating plug that can heat the peripheral wall portion 17 and the ceiling portion 18 of the pocket portion 16 as a whole is used. Was made.
- the thickness of the peripheral wall portion 17 of the pocket portion 16 was thinner than the thickness of the ceiling portion 18.
- the comparative example most of the thickness of the peripheral wall portion 17 of the pocket portion 16 is thicker than the thickness of the ceiling portion 18, and in particular, as the second sheet 15 is approached, the thickness of the peripheral wall portion 17 increases. There was a tendency to become. Further, it was confirmed by visual confirmation that the ceiling portion 18 of the pocket portion 16 of Examples 1 to 3 has higher transparency than the comparative example.
- Total peak area of related substances obtained by liquid chromatography that is, individual substances other than losartan and hydrachlorothiazide (total amount), and peak area (maximum individual amount) of the peak areas of each related substance was calculated as a ratio (%) to the peak area of losartan in the standard solution. The results are shown in Table 3.
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Abstract
Description
図1に示されるように、PTPシート10(薬剤包装用PTPシートの一例)は、平面視において概ね長方形のシートである。なお、PTPシート10の形状は、長方形に限られるものではない。たとえば、PTPシート10は、平面視において、正方形や菱形、円形などであってもよい。
図1,2に示されるように、第1シート14は、熱可塑性樹脂が減圧成型されたものである。熱可塑性樹脂としては、例えば、ポリプロピレン(PP)、ポリ塩化ビニル(PVC)、ポリエチレンテレフタレート(PET)、または環状ポリオレフィン(COC,COP)などが挙げられ、ポケット部16に収容された固形薬剤11の視認性を高めるためには透明性が高いものが好適である。なお、第1シート14は、2種類以上の樹脂シートが積層されたラミネート構造であってもよい。また、第1シート14は必ずしも熱可塑性樹脂のみからなるものでなくとも、熱可塑性樹脂を主成分とする樹脂組成物から成型されたシートであってもよい。第1シート14においてポケット部16以外のシート形状の箇所の厚みは、使用される樹脂の種類によっても異なるが、好ましくは200μm~400μmの範囲内である。
第2シート15は、アルミニウムシートが樹脂シートにより挟み込まれるように積層されたラミネートシートである。樹脂シートの一方は、アクリル系樹脂であり、他方は塩化ビニル樹脂である。なお、第2シート15は、アルミニウムシートのみからなるものであってもよいし、アルミニウム以外の金属製シートであってもよい。また、ラミネートシートとして用いられるシートは、アクリル系樹脂や塩化ビニル樹脂以外の樹脂であってもよいが、第1シート14と熱溶着させるのであれば塩化ビニル樹脂が好適であり、また、文字や記号などの印刷を行うのであればアクリル系樹脂が好適である。また、第2シート15は、ポケット部16の気密性をある程度確保できるものであれば、金属製シートを含まない樹脂シートであってもよい。
本実施形態によれば、ポケット部16の周壁部17の肉厚d1が天井部18の肉厚d2より薄いので、ユーザがポケット部16の天井部18を第2シート15へ向かって押すことにより、周壁部17が変形してポケット部16が押し潰される。ポケット部16が押し潰されると共に、ポケット部16に収容されている固形薬剤11が第2シート15を破断する。他方、ポケット部16の天井部18の肉厚d2は比較的厚いので、天井部18に尖鋭な物が衝突しても、天井部18が破損し難い。
なお、減圧成型において第1シート14にポケット部16を形成するときの加熱プラグ52は、円環形状の端面53を有していれば、端面53より内側の箇所の形状が適宜変更されてもよい。例えば、図5(A)~(C)に示されるように、端面53の内側の凹んだ箇所の断面形状が、台形、浅いレンズ形状、深いレンズ形状であってもよい。端面53の内側の断面形状の深さが比較的深い前述の実施形態に係る長方形や比較例の台形(図5(A))では、加熱プラグ52において端面53の内側へ熱が伝わり難く、その結果、ポケット部16の周壁部17の肉厚が薄くなり、かつ天井部18の肉厚が厚くなる。他方、端面53の内側の断面形状の深さが比較的浅いレンズ形状(図5(B),(C))では、加熱プラグ52において端面53の内側へ熱が伝わりやすく、その結果、ポケット部16の周壁部17の肉厚が薄くなるが、天井部18の周縁部分、すなわち周壁部17との境界付近の肉厚も薄くなる。
第1シート14としてポリプロピレン(PP)と環状ポリオレフィン(COC)とが積層された樹脂シートを用い、第2シート15としてアルミニウムシートと樹脂シートとが積層されたラミネートシートを用いて、前述された変形例に示される加熱プラグ52(断面形状が台形:図5(A)参照)を用いて約150℃に第1シート14を加熱して減圧成型によりPTPシート10を作製した。
前述された変形例に示される各加熱プラグ52(図5(B),(C)参照)を用いた他は実施例1と同様にしてPTPシート10を作製した。すなわち、加熱プラグ52の端面53の内側の凹んだ箇所の断面形状が浅いレンズ形状のもの(図5(B)参照)を実施例2とし、断面形状が深いレンズ形状のもの(図5(C)参照)を実施例3とした。
加熱プラグの端面が内側に凹んだ箇所を有しておらず、ポケット部16の周壁部17及び天井部18を全体として加熱できる加熱プラグを用いた他は実施例1と同様にしてPTPシート10を作製した。
実施例1~3及び変形例に係るPTPシート10のポケット部16の周壁部17及び天井部18の厚みを測定した。測定には高精度レーザ変位計(キーエンス社、LT-9000シリーズ)を用いた。なお、周壁部17は上下方向5の位置が異なる5箇所において計測を行った。その結果を表1に示す。
実施例1~3及び変形例に係るPTPシート10のポケット部16を天井部18から下向き(第2シート15への向き)へ1軸の圧縮力を負荷して、第2シート15が破断したときの力(N)を上降伏点とし、天井部18が第1シート14のポケット部16以外の領域(平面の領域)まで変形したときの力(N)を最大点として計測した。計測には、錠剤押し出し試験器(島津製作所社、EZ Test)を用いた。その結果を表2に示す。
実施例1及び変形例に係るPTPシート10に、10個のロサルタンカリウム及びヒドロクロロチアジドを含む錠剤を封入した。各PTPシート10及び各PTPシート10をアルミピロー包装したものを40℃、75%RT(相対湿度)で保存して、保存開示時、1ヶ月後、3ヶ月後、6ヶ月後において、各PTPシート10に封入された錠剤に含まれる類縁物質(総量及び個々最大量)の割合を測定した。類縁物質の測定は、液体クロマトグラフィーを用いて行った。液体クロマトグラフィーにより得られた類縁物質、すなわちロサルタン及びヒドラクロロチアジド以外の個々の物質のピーク面積の合計(総量)と、各類縁物質のピーク面積のうち最大であったピーク面積(個々最大量)と、を標準溶液におけるロサルタンのピーク面積に対する割合(%)として算出した。その結果を表3に示す。
11 固形薬剤
14 第1シート
15 第2シート
16 ポケット部
17 周壁部
18 天井部
19 一部領域
31 上面(第1面)
32 下面(第2面)
33 周面(第3面)
34 天面(第4面)
51 凹部
Claims (7)
- 固形薬剤を収容可能なポケット部が表裏面の一方である第1面側に突出された第1シートと、
上記第1シートにおける上記第1面と反対側の第2面に貼着されて、上記ポケット部の開口を塞ぐ第2シートと、を備え、
上記ポケット部は、第1面と連続する第3面を有する周壁部と、当該周壁部の第3面と連続する第4面を有する天井部と、を有しており、
上記周壁部の肉厚が、上記天井部の肉厚より薄い薬剤包装用PTPシート。 - 上記ポケット部は、上記第1シートの一部領域が加熱され、当該一部領域を含む領域が減圧された凹部に吸引されることにより成型されたものである請求項1に記載の薬剤包装用PTPシート。
- 上記一部領域は、上記周壁部に対応する領域である請求項2に記載の薬剤包装用PTPシート。
- 上記ポケット部の外形は、円柱形状である請求項1から3のいずれかに記載の薬剤包装用PTPシート。
- 上記第1シートは、主成分が熱可塑性樹脂である請求項1から4のいずれかに記載の薬剤包装用PTPシート。
- 上記第2シートは、アルミニウムを主成分とするものである請求項1から5のいずれかに記載の薬剤包装用PTPシート。
- 上記周壁部の肉厚が40~160μmであり、上記天井部の肉厚が200~400μmである請求項1から6のいずれかに記載の薬剤包装用PTPシート。
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US15/316,371 US10391029B2 (en) | 2014-06-05 | 2015-06-04 | PTP sheet for drug packaging |
US16/057,915 US10507163B2 (en) | 2014-06-05 | 2018-08-08 | Method of manufacturing a PTP sheet for packaging a pharmaceutical drug |
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US16/057,915 Continuation US10507163B2 (en) | 2014-06-05 | 2018-08-08 | Method of manufacturing a PTP sheet for packaging a pharmaceutical drug |
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US20170209342A1 (en) | 2017-07-27 |
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JP7017159B2 (ja) | 2022-02-08 |
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JP6673201B2 (ja) | 2020-03-25 |
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