WO2009125465A1 - Process for producing medicinal preparation for oral administration and apparatus for producing medicinal preparation for oral administration - Google Patents

Process for producing medicinal preparation for oral administration and apparatus for producing medicinal preparation for oral administration Download PDF

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Publication number
WO2009125465A1
WO2009125465A1 PCT/JP2008/056868 JP2008056868W WO2009125465A1 WO 2009125465 A1 WO2009125465 A1 WO 2009125465A1 JP 2008056868 W JP2008056868 W JP 2008056868W WO 2009125465 A1 WO2009125465 A1 WO 2009125465A1
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WO
WIPO (PCT)
Prior art keywords
bag
drug
crimping
opening
oral administration
Prior art date
Application number
PCT/JP2008/056868
Other languages
French (fr)
Japanese (ja)
Inventor
月岡　忠夫
美佐夫 西村
Original Assignee
株式会社ツキオカ
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社ツキオカ filed Critical 株式会社ツキオカ
Priority to PCT/JP2008/056868 priority Critical patent/WO2009125465A1/en
Publication of WO2009125465A1 publication Critical patent/WO2009125465A1/en

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    • 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
    • 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
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/078—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of wafers or cachets
    • 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
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • 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
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/74—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area
    • B29C65/745—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area using a single unit having both a severing tool and a welding tool
    • B29C65/7461—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area using a single unit having both a severing tool and a welding tool for making welds and cuts of other than simple rectilinear form
    • 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
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/004—Preventing sticking together, e.g. of some areas of the parts to be joined
    • 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
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/03—After-treatments in the joint area
    • B29C66/032—Mechanical after-treatments
    • B29C66/0326—Cutting, e.g. by using waterjets, or perforating
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112—Single lapped joints
    • B29C66/1122—Single lap to lap joints, i.e. overlap joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/20—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/22—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being in the form of recurring patterns
    • B29C66/221—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being in the form of recurring patterns being in the form of a sinusoidal wave
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/345—Progressively making the joint, e.g. starting from the middle
    • B29C66/3452—Making complete joints by combining partial joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43—Joining a relatively small portion of the surface of said articles
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43—Joining a relatively small portion of the surface of said articles
    • B29C66/431—Joining the articles to themselves
    • 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
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81427—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined comprising a single ridge, e.g. for making a weakening line; comprising a single tooth
    • 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
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81431—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined comprising a single cavity, e.g. a groove
    • 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
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
    • B29C66/834—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools moving with the parts to be joined
    • B29C66/8341—Roller, cylinder or drum types; Band or belt types; Ball types
    • B29C66/83421—Roller, cylinder or drum types; Band or belt types; Ball types band or belt types
    • B29C66/83423—Roller, cylinder or drum types; Band or belt types; Ball types band or belt types cooperating bands or belts
    • 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
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
    • B29C66/834—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools moving with the parts to be joined
    • B29C66/8351—Jaws mounted on rollers, cylinders, drums, bands, belts or chains; Flying jaws
    • B29C66/83521—Jaws mounted on rollers, cylinders, drums, bands, belts or chains; Flying jaws jaws mounted on bands or belts
    • B29C66/83523—Cooperating jaws mounted on cooperating bands or belts and moving in a closed path
    • 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
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/84—Specific machine types or machines suitable for specific applications
    • B29C66/849—Packaging machines
    • 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
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/02—Machines characterised by the incorporation of means for making the containers or receptacles
    • 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
    • B65B43/00—Forming, feeding, opening or setting-up containers or receptacles in association with packaging
    • B65B43/04—Forming flat bags from webs
    • B65B43/06—Forming flat bags from webs from more than one web
    • 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
    • B65B43/00—Forming, feeding, opening or setting-up containers or receptacles in association with packaging
    • B65B43/12—Feeding flexible bags or carton blanks in flat or collapsed state; Feeding flat bags connected to form a series or chain
    • B65B43/123—Feeding flat bags connected to form a series or chain
    • 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
    • B65B51/00—Devices for, or methods of, sealing or securing package folds or closures; Devices for gathering or twisting wrappers, or necks of bags
    • B65B51/10—Applying or generating heat or pressure or combinations thereof
    • B65B51/14—Applying or generating heat or pressure or combinations thereof by reciprocating or oscillating members
    • B65B51/146—Closing bags
    • 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
    • B65B51/00—Devices for, or methods of, sealing or securing package folds or closures; Devices for gathering or twisting wrappers, or necks of bags
    • B65B51/10—Applying or generating heat or pressure or combinations thereof
    • B65B51/18—Applying or generating heat or pressure or combinations thereof by endless bands or chains
    • 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
    • B65B61/00—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
    • B65B61/04—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for severing webs, or for separating joined packages
    • B65B61/06—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for severing webs, or for separating joined packages by cutting
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/90—Measuring or controlling the joining process
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    • B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
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    • B29K2995/0059—Degradable

Definitions

  • the present invention relates to a method for producing an orally administered preparation and an apparatus for producing an orally administered preparation suitable for the production method.
  • the present inventors have advanced research and development and proposed a film-form preparation in which a drug component is contained in a thin edible film.
  • the film-form preparation proposed by the present inventors disintegrates or dissolves rapidly in the oral cavity and has a practical strength that does not cause any problems in handling. It is a formulation that is easy to take even for people with low swallowing function such as children.
  • the film-form preparation it is necessary to go through a step of dissolving or suspending the drug component in a solvent containing a film forming agent in the production stage, and in some cases, heating is also necessary. For this reason, it has been difficult to incorporate components such as lactic acid bacteria and enzymes that may be altered or deteriorated by mixing with a solvent or heating, into a film-form preparation.
  • some drugs react with film formers to inhibit film formation.
  • a drug containing calcium ions reacts with sodium alginate, which is a film forming agent, to form a gel that does not dissolve even when heated, making it difficult to form a film.
  • the film-form preparation has a limitation on the types of drugs that can be contained.
  • the present invention is capable of containing a large amount of drug while using a thin edible film, and is capable of containing an oral administration preparation that is easy to take and is not limited in type of drug. It is an object of the present invention to provide a method for producing a preparation and an apparatus for producing an oral preparation suitable for the production method.
  • the method for producing an oral administration preparation is described as follows: “Pressing the edible film doubly overlapped in a state of interposing a flat plate, the three sides are blocked and unidirectional A first crimping step of forming a bag-shaped housing portion having an opening in the flat plate body extracting step of pulling out the flat plate body from the bag-shaped housing portion formed in the first crimping step through the opening; A drug filling step of filling the inside of the bag-shaped housing portion with the drug from the opening, and a second pressure-bonding step of crimping the opening of the bag-shaped housing portion filled with the drug in the drug filling step. To do.
  • the “edible film” can be formed with a water-soluble, gastric or enteric film-forming agent.
  • water-soluble film forming agents include gelatin, pectin, arabinoxylan, soybean polysaccharide, sodium alginate, carrageenan, xanthan gum, guar gum, pullulan, hypromellose (HPMC; former Japanese Pharmacopoeia “hydroxypropylmethylcellulose”), hydroxy Propyl cellulose (HPC), water-soluble hydroxyethyl cellulose (HEC), methyl cellulose (MC), propyl cellulose, carboxymethyl cellulose (CMC), polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), polyethylene glycol polyethylene oxide (PEO), polyethylene glycol (PEG) etc.
  • HPMC former Japanese Pharmacopoeia “hydroxypropylmethylcellulose”
  • HPC hydroxy Propyl cellulose
  • HEC water-soluble hydroxyethyl cellulose
  • MC methyl cellulose
  • gastric soluble film forming agents examples include polyvinyl acetal diethylaminoacetate, polyvinylaminoacetal, methyl methacrylate, butyl methacrylate, dimethylaminoethyl methacrylate copolymer, aminoalkyl methacrylate copolymer and the like.
  • enteric film forming agents include hydroxypropyl methylcellulose acetate succinate (AQOAT), hydroxypropylmethylcellulose phthalate (HP), hydroxymethylethylcellulose phthalate, carboxymethylethylcellulose (CMEC), cellulose acetate trimellitate, cellulose acetate phthalate.
  • the edible film may contain other components.
  • the edible film may contain other components.
  • the flexibility of the edible film can be increased and the occurrence of cracks and tears can be prevented.
  • it can be seasoned or scented by containing sweeteners such as sucralose, aspartame, saccharin and stevia, flavoring agents such as xylitol and licorice, and flavors such as spearmint flavor, lemon flavor and menthol.
  • the film by coloring the film with a colorant, the film itself or the contents accommodated therein can be prevented from being modified or deteriorated by light or heat.
  • the coloring of the film can be used to identify the type of drug.
  • Examples of the mode in which the edible film is “double overlapped” include a mode in which two films are overlapped and a mode in which a single film is folded and overlapped.
  • the “flat plate” for example, a thin plate made of paper, plastic, metal, glass, or ceramic can be used.
  • the thickness of the flat plate can be set to 0.5 mm to 5 mm, for example.
  • the “crimping” of the edible film can be thermocompression bonding (heat sealing) by external heating or thermocompression bonding by internal heating using radio waves or ultrasonic waves. Or it can be set as non-heat-bonded pressure bonding, such as pressure bonding using gelatinized high-viscosity starch or the like as an adhesive.
  • emboss press-bonding can also be performed by sealing using a concave type and a convex type.
  • a plurality of pressure bonding methods can be used in combination.
  • the dosage form of “drug” is not particularly limited, and examples thereof include powders (powder), granules, pills, tablets, liquids, and paste preparations.
  • the type of drug is not particularly limited as long as it is for oral consumption, and it may be a so-called western medicine or a herbal medicine or a herbal medicine combined with a herbal medicine.
  • the “drug” of the present invention is intended to include nutritional supplements that are not in the form of normal foods such as granules and tablets among foods intended to supplement nutrients that are often deficient, such as vitamins and minerals. Used.
  • the drug filling step is not limited to the one performed after the flat plate extraction step, and may be performed in a state where the flat plate is interposed between the edible films that are double-layered as described later. . That is, the drug filling process of the present invention may be performed after the flat plate sampling process or may be performed before the flat plate sampling process.
  • the bag-shaped accommodation part is closed on the three sides in the first pressure-bonding step and the remaining one is closed in the second pressure-bonding step, but the outer shape of the bag-shaped storage part is not necessarily limited to a quadrangle.
  • the three sides can be closed by pressing in a substantially U shape or a substantially arc shape.
  • compression-bonding process can further be equipped with the process of cut
  • examples of the outer shape of the oral administration preparation include polygonal shapes such as a quadrangle, a triangle, a pentagon, and a hexagon, a circle, an ellipse, and the like in a plan view.
  • a polygonal shape such as a quadrangle
  • the oral feel will be soft when taking an oral preparation, and the user will feel safe. It is preferable because it can give a feeling.
  • the edible film layered twice is pressed in a state in which the flat plate is interposed, so that the edible film is expanded by the thickness of the flat plate.
  • a bag-like accommodation part is formed.
  • the internal space more than the volume of a flat body is formed in the inside of a bag-shaped accommodating part. Therefore, the internal space of the bag-shaped housing portion can be widened as compared with the case where the edible film is simply overlapped and the periphery is crimped to form a bag shape.
  • the bag-like accommodation portion is formed so as to swell widely by the thickness of the flat plate, so that the operation of filling the drug is easy and the drug can be filled in a short time.
  • the bag-shaped accommodation part is formed by crimping three sides of the edible film that is simply overlapped without using a flat plate, the opening is expanded when filling the drug. There is a need. If it does so, both sides which are crimped
  • the opening is formed by forming the bag-like accommodation portion by pressure bonding with the flat plate interposed, it is necessary to widen the opening when filling the drug. There is no.
  • the present invention is also suitable for a method for producing an orally administered preparation in which a plurality of bag-like accommodation portions are continuously formed.
  • the internal space of the bag-like storage part is narrow, so if you try to fill as much drug as possible The drug reaches near the edge of the opening.
  • the internal space of the bag-like storage part is narrow, it can reach the edge of the opening immediately after filling with a small amount of drug, and it is difficult to control the space near the opening to have a margin. . For this reason, when the opening is pressure-bonded after filling the drug, the powdered drug may rise or the granular drug may jump out depending on the pressure of the pressure-bonding.
  • the present invention since the internal space of the bag-like storage portion is formed wide, even if a large amount of drug is filled, a space can be provided in the vicinity of the opening. Thereby, in the 2nd process of crimping
  • the bag-shaped container is filled with a drug, even a drug that inhibits film formation can be applied to a preparation for oral administration. Unlike the case where a drug is contained in the film itself, there is no need to dissolve or suspend the drug in a solvent in the production process or there is no heating step, and the drug may be altered or deteriorated by mixing with the solvent or heating. Even if it exists, it can accommodate in a bag-shaped accommodating part. That is, according to the present invention, a preparation for oral administration can be produced without limiting the types of applicable drugs.
  • the discarded part when the drug is contained in the film itself, if the film is cut into a rounded shape that does not feel uncomfortable in the oral cavity, the discarded part also contains the drug, which is not preferable for the environment. It becomes useless.
  • the present invention since a sufficient amount of drug can be stored in the bag-shaped storage part having a wide internal space, it is not necessary to include the drug in the edible film. Therefore, even if the end portion of the edible film is cut to form a rounded shape, since the drug is not contained in the discarded portion, it is environmentally preferable and the drug can be effectively used.
  • the edible film is not affected by the hygroscopicity of the drug in addition to the higher film strength than when the drug component is contained. Thereby, the property of a bag-shaped accommodating part can be stabilized.
  • the bag-shaped container is formed of an edible film
  • the bag-shaped container is dissolved or disintegrated by moisture in the oral cavity, and the edible film is a jelly liquid.
  • the jelly-like film envelops or entangles the drug, making it easier for the drug to pass through the throat.
  • the drug is a fine powder or granule, it can be taken with reduced risk of peeling.
  • even a drug with strong bitterness, smell, or irritation can be taken without strongly feeling the bitterness or irritation by wrapping the drug in a film that has become a jelly liquid. Therefore, according to the present invention, an easily administrable oral administration preparation can be produced.
  • the bag-like container when the edible film is gastric or enteric, since the bag-like container does not dissolve or disintegrate in the oral cavity, the bag-like container can mask the bitterness, smell and irritation of the drug.
  • the bag-like container since the bag-like container can be thinly formed with an edible film, it is not bulky in the oral cavity, and is an oral dosage formulation that is easier to take than when encapsulated and folded with an oblate and taken in a capsule. Can be manufactured.
  • the method for producing an orally administered preparation according to the present invention is as follows: “The plate body has a through-hole penetrating in a direction substantially coinciding with the direction in which the plate body is pulled out, and the drug filling step is performed by overlapping the plate body twice. It is carried out by filling a drug through the through-hole while being interposed between the edible films. "
  • the drug can be filled immediately after the bag-like container is formed in the first pressure bonding step, the first pressure bonding step and the drug filling step can be performed almost simultaneously.
  • an oral administration formulation can be manufactured efficiently.
  • the through-hole of the flat plate plays a guiding action when the drug is filled, the drug can be more easily and surely filled into the bag-shaped container.
  • the method for producing an orally administered preparation according to the present invention is as follows: “In the first pressure-bonding step and the second pressure-bonding step, the edible film is formed along at least a part of the outer periphery of a pressure-bonded portion formed by pressure-bonding the edible film. The non-crimped part is formed without crimping the edible film ”.
  • the non-crimping part is formed along “at least a part of the outer periphery of the crimping part”, and may be formed along the entire outer circumference of the crimping part.
  • only the pressure-bonding portion is provided between the adjacent bag-like storage portions even if a non-pressure-bonding portion is formed between the adjacent bag-like storage portions.
  • a non-crimped portion may not be formed with a gap interposed therebetween.
  • a non-crimped part that is, a part that is opened as it is without being crimped by a non-crimped part, that is, a film superimposed in a double manner.
  • a film is easy to melt
  • the non-crimped part can be provided with a width of 0.5 mm to 5 mm, for example.
  • an apparatus for producing an orally administered preparation is described as follows.
  • a flat plate inserted between a pair of three-way crimping molds forming a bag-shaped housing part having an opening in the edible film and the edible film superimposed in a double manner and extracted from the bag-shaped housing part through the opening
  • a body a drug filling device that fills the inside of the bag-shaped container from the opening
  • a pair of opening crimping molds that crimp the opening close to each other.
  • Three-way crimping type” and the “opening crimping type” each have a pair of opposing edible films sandwiched between them and pressed from both sides, corresponding to the shape to be crimped A relief-like configuration can be obtained.
  • the “three-way crimping type” and the “opening crimping type” can be configured by an electric conductor that generates heat when energized or a thermal conductor with a built-in heater. .
  • the “drug filling device” is a device that contains a drug and drops a predetermined amount, for example, a funnel-like configuration that contains a drug from the upper receiving port, and opens and closes the lower small dropping port to drop the drug. can do. Moreover, it can also be set as the structure which the whole drug filling device or the dropping port advances / retreats with respect to the opening part of a bag-shaped accommodating part.
  • the device for producing an oral administration preparation of the present invention is suitable for the above-described method for producing an oral administration preparation.
  • the device for producing an oral dosage form further comprises "a pair of first endless belts rotating in opposite directions, and a pair of second endless belts rotating in the same direction as the first endless belt,"
  • the three-way crimping die is provided with a plurality of pairs, and in each of the plurality of pairs, one of the three-way crimping dies is provided on one of the first endless belts and the other of the three-way crimping dies. Is provided on the other first endless belt, and a plurality of pairs of the opening crimping molds are provided, and in each of the plurality of pairs, one opening crimping mold is the second one of the pair. It is provided on the endless belt, and the other opening crimping die is provided on the other second endless belt. "
  • an oral administration preparation sheet can be produced. That is, with the rotation of the pair of first endless belts, the pair of three-way crimping molds approach each other and sandwich the edible film that is double-layered, and the opening crimping mold while crimping the three sides As the pair of second endless belts are rotated, a pair of the plurality of opening crimping molds approach each other, sandwich the bag-shaped accommodation section fed from the three-way crimping mold, and crimp the opening It can be configured. Therefore, according to the production apparatus of the present invention, an oral administration preparation can be produced efficiently. Moreover, the structure of the manufacturing apparatus of this invention is suitable for automation.
  • the crimping die (three-way crimping die and opening crimping die) is not an endless belt but a pair of rollers that rotate in opposite directions.
  • the pressure bonding of the edible film accompanying the rotation of the pair of rollers is due to linear contact between the pressure bonding mold and the edible film.
  • the crimping die by providing the crimping die to the endless belt, the edible film can be kept pressed by the crimping die while the pair of endless belts travel a certain distance. . Therefore, according to the present invention, the stacked edible films can be reliably crimped to form a bag-like container, and the risk of drug leakage from the manufactured oral dosage form can be reduced. .
  • the production apparatus of the present invention may be configured to further include a cutting device that separates a single dose of the oral administration preparation from a sheet in which a large number of oral administration preparations are continuously provided.
  • a cutting device that separates a single dose of the oral administration preparation from a sheet in which a large number of oral administration preparations are continuously provided.
  • an oral administration preparation that can contain a large amount of drug while using a thin edible film, and that can produce an oral administration preparation that is easy to take without being restricted in the type of drug.
  • an apparatus for producing an oral dosage preparation suitable for the production method that can produce an oral dosage preparation suitable for the production method.
  • FIG. 2 is a sectional view taken along line XX in FIG. It is process drawing of the manufacturing method which is 1st embodiment of this invention.
  • FIG. 2 is a sectional view taken along line XX in FIG. It is process drawing of the manufacturing method which is 1st embodiment of this invention.
  • It is a perspective view which shows (a) three-way crimping
  • FIG. 19 is a sectional view taken along line YY in FIG.
  • a method for producing an oral administration preparation (hereinafter simply referred to as “manufacturing method”), which is the first embodiment of the present invention, and an apparatus for producing an oral administration preparation suitable for the production method (hereinafter simply referred to as “manufacturing device”).
  • manufacturing method a method for producing an oral administration preparation
  • manufacturing device an apparatus for producing an oral administration preparation suitable for the production method
  • the orally administered preparation 1 has a substantially rectangular shape in which two bag-like storage portions 11 and 12a are connected, and is formed in a waveform along the outer periphery.
  • a space closed inside is formed by crimping the periphery of the water-soluble edible film 10 that is doubled.
  • the drug Da is stored in the internal space, and in the other bag-shaped storage portion 11, a water-insoluble layer 21 is laminated inside the water-soluble edible film 10, An aqueous liquid W is accommodated in the internal space.
  • the production method of the present embodiment for producing the oral administration preparation 1 having the above-described configuration mainly includes a solution preparation step S1 for preparing a solution of a water-soluble film forming agent and an adjusted solution as shown in FIG.
  • Casting step S2 for casting drying step S3 for drying the cast solution to form a water-soluble edible film 10, and a water-insoluble layer 21 partially on the upper surface of the water-soluble edible film 10
  • Water-insoluble layer laminating step S4 for laminating, two water-soluble edible films 10 facing each other, a flat body inserting step S5 for inserting a flat body therebetween, and two edible films are pressure-bonded,
  • a first pressure-bonding step S6 for forming a bag-shaped housing portion having an opening in one direction while being closed on three sides; and a plate body extraction step S7 for extracting a flat plate body from the formed bag-shaped housing portion through the opening.
  • Bag-like accommodation from the opening from which the flat plate is removed The base film is peeled from the filling step S8 for filling the inside of the container, the second crimping step S9 for crimping the opening of the bag-like housing portion filled with the drug, and the bag-like housing portion having the closed opening.
  • compression-bonding part are comprised.
  • the bag-shaped storage portion adjacent to the bag-shaped storage portion 12a is simultaneously filled with the drug Da into the bag-shaped storage portion 12a (corresponding to the “drug filling step” of the present invention).
  • 11 is filled with the aqueous liquid W at the same time.
  • the manufacturing apparatus of the present embodiment for manufacturing the orally administered preparation 1 includes an edible film forming apparatus (not shown) for forming an edible film, and a bag filled with a drug or an aqueous liquid by pressing the edible film.
  • the molding / filling device presses the edible films that are double-stacked close to each other, closes the three sides, and opens the opening 15 in one direction.
  • the three-way crimping die 71 and the opening crimping die 73 of this embodiment are both made of metal. Further, in the present embodiment, tempered glass is used as the flat plate 72, but other materials such as paper may be used. Further, the three-way crimping die 71 of the present embodiment has a configuration in which a total of six of each pair is integrated in six pairs of three-way crimping die, and the opening crimping die 73 is a six-pair opening crimping die. In the configuration, a total of six of each pair is integrated. Furthermore, in this embodiment, the six flat plates 72 are connected via the connection bar 72b.
  • the six bag-shaped accommodating portions are continuously formed by the six pairs of three-way crimping dies 71, the six flat plates 72, and the six pairs of opening crimping dies 73, in other words, If it does so, the structure by which the bag-shaped accommodating part 11 and the bag-shaped accommodating part 12a will be alternately provided by three each is illustrated.
  • the number of the bag-shaped accommodating parts formed is not limited to the illustration in this embodiment.
  • the water-soluble film forming agent and the liquid medium are mixed and sufficiently stirred and dissolved. At this time, it can also be dissolved under heating. Additives such as plasticizers, flavoring agents, and emulsifiers can also be added.
  • the liquid medium water, warm water, dilute acidic aqueous solution, dilute alkaline aqueous solution or the like can be used depending on the type of the water-soluble film forming agent, and an organic solvent such as alcohol can also be added.
  • the base film is fixed on a smooth plane, and the solution prepared in the solution preparation step S1 is cast on the upper surface thereof.
  • the base film for example, a film made of PP or PET can be used.
  • the cast solution can be dried by, for example, convection of warm air with adjusted humidity and irradiation with far infrared rays.
  • the water-insoluble layer 21 is partially laminated on the upper surface of the water-soluble edible film 10 at a position to be the bag-like accommodation portion 11 that later contains the aqueous liquid W.
  • the water-insoluble layer 21 can be formed using, for example, a water-soluble polymer that is crosslinked with a metal salt, a water-insoluble polymer, or a hydrophobic material.
  • the water-insoluble polymer include ethyl cellulose, propyl cellulose, acetyl cellulose, cellulose acetate propionate, hydroxypropyl cellulose phthalate, and cellulose acetate phthalate.
  • hydrophobic material shellac, beeswax, sugar cane wax, carnauba wax, natural resins such as rosin, sandalac, zein, petrolatum, paraffin, and silicone resin can be used.
  • “lamination” of the water-insoluble layer 21 can be performed by printing such as coating, spraying, gravure printing, silk printing or the like by a coater machine.
  • the water-insoluble layer 21 is a layer for imparting water-insolubility to the water-soluble edible film 10 so that the water-soluble edible film 10 is not dissolved by the aqueous liquid W. Therefore, when the water-soluble edible film 10 is dissolved, if the water-soluble edible film 10 is a thin layer that does not have sufficient strength to maintain the internal space for containing the aqueous liquid W, the water-soluble edible film 10 If it dissolves with water, the liquid container 11 will naturally collapse. On the other hand, when the water-insoluble layer 21 is a layer having a certain degree of strength, the water-insoluble layer 21 holding the internal space for storing the aqueous liquid W is ruptured by applying a tooth to the liquid storage portion 11. As the water-soluble edible film 10 dissolves, the liquid container collapses.
  • FIG. 7 and FIG.8 is an end elevation of the cutting
  • the aqueous liquid W is placed in the bag-like container 11 by the aqueous liquid filling device 75w. And the bag-like container 12a is filled with the drug Da by the drug filling device 75a.
  • examples of the aqueous liquid W include water, an aqueous solution, a suspension using water as a medium, and an emulsion using water as a medium. More specifically, water, sugar water, salt water, tea, fruit juice, gelatin solution, milk and drink yogurt can be exemplified.
  • flavor may be made
  • the upper portions of the bag-like storage portions 11 and 12a are pressed by a pair of opening crimping molds 73, and the opening 15 is crimped and closed. Then, when the two base films 60 are peeled from the bag-like storage portions 11 and 12a in the peeling step S10, as shown in FIGS. 12 to 14, the bag-like storage portion 12a enclosing the drug Da and the aqueous liquid W Orally administrable preparation sheet 51 in which bag-like storage portions 11 in which are encapsulated are alternately arranged is manufactured.
  • the oral administration preparation sheet 51 is cut at the crimping portion by using a cutting device having a corrugated blade portion indicated by the alternate long and short dash line 31 in FIG. 14, using FIG. 1 and FIG.
  • the oral administration preparation 1 having the above-described configuration is manufactured.
  • a chain line 41 is provided between the bag-shaped container 12a filled with the drug Da and the bag-shaped container 11 filled with the aqueous liquid W.
  • the perforation 41 shown is provided.
  • the perforation 41 can be formed prior to the cutting along the alternate long and short dash line 31 or simultaneously with the cutting along the alternate long and short dash line 31.
  • the obtained oral administration preparation 1 can be individually packaged with a pack formed of a metal foil such as an aluminum foil or a transparent plastic film having a high gas barrier property, for example.
  • pressure bonding heat sealing
  • the external thermocompression bonding can be performed by, for example, crimping the edible film 10 at a temperature of 150 to 300 ° C. for 1 to 5 seconds.
  • the crimping time and temperature depend on the type of the edible film and the like. Can be set as appropriate.
  • This layer excellent in heat sealability can be formed using, for example, gelatin, sodium caseinate, zein, polyvinyl alcohol, polyvinyl pyrrolidone, starch, modified starch, pullulan, arabinoxylan, soybean protein and the like.
  • stacking of the layer excellent in heat-sealing property can be performed before or after water-insoluble layer lamination process S4, or simultaneously with water-insoluble layer lamination process S4, for example.
  • the two edible films 10 are pressure-bonded by the three-way pressure-bonding die 71 with the flat plate 72 interposed in the first pressure-bonding step S6.
  • the bag-shaped accommodating parts 11 and 12a are formed in the state which the edible film 10 expanded by the thickness of the flat plate 72.
  • the internal space of the bag-shaped storage portions 11 and 12a can be widened, and a large amount of the drug Da and the aqueous liquid W can be contained while being an oral administration preparation using a thin edible film.
  • the content of the drug Da can be easily secured by adjusting the thickness of the flat plate 72. It becomes.
  • the opening 15 of the bag-like storage portions 11 and 12a is largely opened by the thickness of the flat plate 72. This facilitates the filling step S8 in which the drug Da is dropped into the bag-shaped container 12a and the aqueous liquid W is dropped into the bag-shaped container 11a to be filled in the filling step S8.
  • the opening 15 is pushed to fill the drug Da and the aqueous liquid W in the filling step S8.
  • compression-bonding part between the adjoining bag-shaped accommodation parts inclines naturally inside. For this reason, the adjacent bag-like accommodation portions are pulled, and wrinkles and tears may occur.
  • the opening 15 is greatly opened, and it is not necessary to spread the opening 15 for filling with the drug Da or the aqueous liquid W, so that wrinkles and tears occur as described above. There is no fear of doing it.
  • a plurality of drug filling devices 75a and a plurality of aqueous liquid filling devices 75w are arranged in parallel in the filling step S8.
  • the filling device 75 can be used to fill the plurality of bag-like storage portions 11 and 12a with the drug Da or the aqueous liquid W at the same time.
  • the bag-shaped container 12a is filled with the drug Da, it is possible to manufacture the oral administration preparation 1 by containing a drug that inhibits the formation of a film. Or, unlike the case where the drug is contained in the film itself, there is no need to dissolve and suspend the drug in a solvent and there is no heating step, so the drug may be altered or deteriorated by mixing with the solvent or heating. Can also be accommodated in the bag-like accommodation portion 12a. That is, the preparation 1 for oral administration can be produced without limiting the types of applicable drugs.
  • the oral administration preparation 1 in order to make the oral administration preparation 1 into a rounded shape without a sense of incongruity in the oral cavity, in the cutting step S11, using a cutting device having a corrugated blade, The periphery is excised.
  • the edible film 10 since a sufficient amount of the drug Da can be stored in the bag-shaped storage portion 12a having a wide internal space, the edible film 10 itself does not need to contain a drug. Therefore, since the excised edible film 10 contains no drug, it is environmentally preferable and the drug can be effectively used. Furthermore, since the drug is not contained in the edible film 10, the edible film 10 is not affected by the hygroscopic property of the drug in addition to the higher film strength than when the drug component is contained. Thereby, the property of the bag-shaped accommodation part 12a can be stabilized.
  • the drug Da when the bag-shaped container 12a is dissolved by moisture in the oral cavity, the drug Da is encapsulated by the edible film 10 that becomes a jelly liquid.
  • the edible film 10 that has become a jelly liquid is entangled with the drug Da. This makes it easier for the drug Da to pass through the throat than when the drug Da is taken directly. Therefore, even if the drug Da is a fine powder or granule, it can be taken with reduced risk of peeling.
  • the bitterness, smell, and irritation of the drug Da are strong, it can be taken without feeling bitterness, smell, or irritation by being wrapped in a jelly-like film.
  • the orally-administered preparation 1 has a configuration in which a bag-like container 11 containing an aqueous liquid W and a bag-like container 12a containing a drug Da are adjacent to each other. Therefore, both the bag-shaped accommodation part 11 and the bag-shaped accommodation part 12a formed of the water-soluble edible film 10 are dissolved or disintegrated by moisture in the oral cavity. As a result, the drug Da stored in the bag-shaped storage portion 12a can be swallowed easily with the help of the aqueous liquid W stored in the bag-shaped storage portion 11. In addition, since the oral administration preparation 1 can be taken without the necessity of preparing water separately, it can be taken easily and has excellent portability.
  • the oral administration preparation 1 by producing the oral administration preparation 1 using the flat plate 72, the internal space of the bag-like container 12a can be formed widely, and a large amount of drug Da can be filled.
  • the aqueous liquid W is supplied from the bag-shaped storage unit 11, even a large amount of the drug Da is easily swallowed.
  • the internal space of the bag-shaped accommodation part 11 can be formed widely by producing the oral administration preparation 1 using the flat body 72, the amount of the aqueous liquid W to be supplied can be increased. Da can be swallowed more easily.
  • the aqueous liquid W has a taste or fragrance such as sugar water or fruit juice, or when the aqueous liquid W is seasoned or scented, the bitterness, smell or stimulation of the drug Da is more effective by the aqueous liquid W. Can be masked. Further, by sweetening the aqueous liquid W, an oral preparation 1 that is easy to take even for children can be obtained. In addition, the rough feeling of the drug Da can be alleviated by the aqueous liquid W.
  • a taste or fragrance such as sugar water or fruit juice
  • the aqueous liquid W is seasoned or scented
  • the bitterness, smell or stimulation of the drug Da is more effective by the aqueous liquid W. Can be masked.
  • an oral preparation 1 that is easy to take even for children can be obtained.
  • the rough feeling of the drug Da can be alleviated by the aqueous liquid W.
  • the oral preparation 1 is cut with a corrugated blade and has an outer shape, the mouth feels soft and the mouth feels uncomfortable. In addition, since the oral preparation 1 does not have sharp corners or straight portions, the user can take it with a sense of security.
  • the inner peripheral shape of the pressing surface 71p on which the three-way crimping die 71 presses the edible film 10 and the pressing surface 73p on which the opening crimping die 73 presses the edible film 10 is the oral dosage form 1.
  • the shape corresponds to the waveform of the outer shape.
  • the external shape and the inner peripheral shape of the crimping part correspond to a corrugated shape, giving a softer impression and a beautiful appearance.
  • a perforation 41 is provided between the bag-like container 12 a containing the drug Da and the bag-like container 11 containing the aqueous liquid W, and it is easy to fold along the perforation 41.
  • bonded along the outer periphery of the oral administration formulation 1 is manufactured by cut
  • the present invention is not limited to such an embodiment, and in the first pressure-bonding step S6 and the second pressure-bonding step S9, the edible film is not pressure-bonded along at least a part of the outer periphery of the pressure-bonding portion. 39 can be formed, and in the cutting step S11, cutting can be performed at the non-compression bonding portion.
  • Such a manufacturing method can be realized, for example, by using a manufacturing apparatus including a pair of three-way crimping molds 81 and a pair of opening crimping molds 83 configured as illustrated in FIG. That is, the outer shape of the outer periphery of the pressing surface 81p of the three-way crimping die 81 and the outer periphery of the pressing surface 83p of the opening crimping die 83 is smaller than the outer shape of the cutter of the cutting device and smaller than the outer shape of the edible film. The shape is formed into a waveform corresponding to the waveform shape of the blade portion of the cutting device. In FIG. 15, only one of the pair of the three-way crimping die 81 and the opening crimping die 83 is illustrated.
  • two edible films are pressure-bonded to the outside of the pressure-bonding portion of the bag-shaped storage portion 11 and the pressure-bonding portion of the bag-shaped storage portion 12a.
  • An oral administration preparation 2 having no non-crimped part 39 can be produced.
  • the two edible films are left open without being crimped. Therefore, when the oral administration preparation 2 is taken, the water-soluble edible film 10 is formed in the non-crimped portion 39 by moisture in the oral cavity. Easy to dissolve. Thereby, the touch in the oral cavity of the orally administered preparation 2 is softened.
  • a non-crimp part 39 is also formed at the boundary between the bag-like container 11 and the bag-like container 12a, and a perforation 41 is provided in the non-crimp part 39. Therefore, it is easier to fold along the perforation 41 than in the case where the perforation is formed in the crimping portion. Thereby, it can take in the state which folded the bag-shaped accommodating part 11 and the bag-shaped accommodating part 12a, and the oral administration formulation 2 will not become bulky in the oral cavity.
  • the manufacturing apparatus in which the predetermined number of bag-shaped storage portions 11 and 12a are continuously provided and the oral administration preparation sheet 51 having a predetermined length is manufactured is illustrated, but the bag-shaped storage portions are continuously formed to be infinite.
  • the present invention can be applied as a manufacturing apparatus 90 capable of manufacturing the oral administration preparation sheet 55 having a length.
  • the manufacturing apparatus 90 includes a pair of first endless belts 91 that rotate in opposite directions and a pair of second endless belts 92 that rotate in the same direction as the first endless belt 91.
  • the three-way crimping die 96 is provided with a plurality of pairs, and in each of the plurality of pairs, one three-way crimping die 96 is provided on one first endless belt 91 of the pair and the other three sides A crimping die 96 is provided on the other first endless belt 91, a plurality of pairs of opening crimping die 98 are provided, and one opening crimping die 98 in each of the plurality of pairs is one of the pair.
  • the second endless belt 92 is provided with the other opening crimping die 98 and the other second endless belt 92.
  • first endless belt 91 and the second endless belt 92 of the present embodiment have a flat annular configuration. Therefore, a pair of three-way crimping dies 96 provided on the pair of first endless belts 91 and a pair of opening crimping dies 98 provided on the pair of second endless belts 92 respectively edible film 10 ′ from both sides. Drive a certain distance in the pressed state.
  • the manufacturing apparatus 90 includes a third endless belt 93 that rotates on a surface orthogonal to the rotation surface of the first endless belt 91, and a plurality of flat plates 97 are attached to the third endless belt 93.
  • the manufacturing apparatus 90 includes a filling apparatus 75 in which a drug filling apparatus 75a and an aqueous liquid filling apparatus 75w are alternately provided, a peeling apparatus (not shown) for peeling the base film, and one point in FIG. And a cutting device 95 having a blade portion having the same shape as the wave shape indicated by the chain line 31.
  • a water-soluble film forming agent solution is cast on the long base film 60 ′ as described above, and the water-insoluble layer 21 is partially laminated.
  • Two of the formed long edible films 10 ′ are introduced between the pair of first endless belts 91 with the base film 60 ′ facing outward.
  • the three sides are closed by the three-way crimping die 96 that approaches and separates with the rotation of the first endless belt 91 and the flat plate body 97 that is inserted between the two edible films 10 ′ with the rotation of the third endless belt 93.
  • the bag-like storage portions 11 and 12a having openings in one direction are continuously formed.
  • the drug-like Da or the aqueous liquid W is filled into the bag-like storage portions 11 and 12 a fed from the pair of endless belts 91 by the filling device 75.
  • the bag-like container 12a is filled with the drug Da by the drug filling device 75a
  • the bag-like container 11 is filled with the aqueous liquid W by the aqueous liquid filling device 75w.
  • the opening part 15 of the bag-shaped accommodating parts 11 and 12a is continuously crimped
  • the base film 60 ′ is peeled from the continuous bag-shaped storage portions 11 and 12 a by the peeling device, whereby the oral administration preparation sheet 51 of FIG. 13 is continuous (endless). ) Orally administered preparation sheet 55 is manufactured.
  • the oral administration preparation sheet 55 is cut into a corrugated shape by the cutting device 95, so that the same oral administration preparation 1 as that shown in FIGS. 1 and 2, that is, the bag-shaped container 12a filled with the drug is contained. And the oral administration preparation 1 each comprising the bag-like container 11 filled with the aqueous liquid W are manufactured continuously.
  • the manufacturing apparatus 90 configured as described above, by using the first endless belt 91 and the second endless belt 92, the edible film 10 ′ is continuously pressed and an infinite number of oral administration preparations 1 are continuously added. Can be manufactured. Thereby, the oral administration preparation 1 can be efficiently manufactured, and the manufacturing apparatus 90 can be automated.
  • first endless belt 91 and the second endless belt 92 have a flat annular configuration, and the edible film 10 ′ is pressed by the three-way crimping die 96 while the pair of endless belts 91 travel a certain distance.
  • the edible film 10 ′ is maintained in a state where it is pressed by the opening crimping die 98 while the pair of endless belts 92 travels a certain distance.
  • the manufacturing method and manufacturing apparatus of the oral administration formulation 1 and 2 comprised from one of the bag-shaped accommodating parts 11 which accommodated the aqueous liquid W, and one of the bag-shaped accommodating parts 12a which accommodated the medicine Da.
  • FIGS. 18 to 20 a manufacturing method and a manufacturing method for manufacturing an orally-administered preparation 3 including one bag-shaped container 11 and two bag-shaped containers 12 a and 12 b. Will be described.
  • FIG. 18 is a plan view of the orally-administered preparation 3
  • FIG. 19 is a cross-sectional view taken along line YY in the figure
  • FIG. 20 is a plan view of the orally-administered preparation sheet 53.
  • the dimension in the thickness direction is exaggerated to clearly show the configuration.
  • the shaded portions in FIGS. 18 and 20 illustrate the crimping portion to which the edible film 10 is crimped.
  • the orally administered preparation 3 has a configuration in which a bag-like accommodation portion 12 b that accommodates the drug Db is further connected to the oral administration preparation 1, and the bag-like accommodation portion 12 b is a bag-like accommodation portion 11. On the other hand, it is provided on the opposite side to the bag-like storage portion 12a. Moreover, in the bag-shaped accommodating part 12b, the enteric layer 22 is laminated
  • the enteric layer 22 is laminated on the base film at a position where the bag-like accommodation portion 12b is to be formed. It can be formed by partially coating a solution of a soluble material by coating, spraying, printing or the like.
  • a drug filling device for filling the drug Da In the production of the orally administered preparation 3, in the filling step S8, a drug filling device for filling the drug Da, an aqueous liquid filling device for filling the aqueous liquid, and a drug filling device for filling the drug Db were connected in this order.
  • the filling device By using the filling device, it is possible to manufacture an orally-administered preparation sheet 53 in which the bag-shaped container 12a, the bag-shaped container 11 and the bag-shaped container 12b are repeatedly arranged as one unit in this order.
  • the cutting step S11 using a cutting device having a corrugated blade portion of a size surrounding the three bag-like storage portions 11, 12a, 12b, as shown by a one-dot chain line 32 in FIG.
  • the oral administration preparation 3 By orally cutting the oral administration preparation sheet 53, the oral administration preparation 3 can be produced.
  • a perforation 41 can be provided between the bag-shaped storage portion 12a and the bag-shaped storage portion 11, and between the bag-shaped storage portion 11 and the bag-shaped storage portion 12b.
  • the enteric layer 22 is provided on the outside of the bag-like container 12b, so that the drug Db is insoluble in the intestine even if the drug Db itself is water-soluble. Can be absorbed.
  • the bag-like container 12b with the enteric layer 22 laminated on the outside does not dissolve or collapse in the oral cavity, so it is difficult to swallow as it is, but from the bag-like container 11 containing the adjacent aqueous liquid W Since moisture is supplied, the bag-like container 12b can be swallowed easily without preparing water or the like separately. Furthermore, the different types of drugs Da and Db respectively stored in the two bag-shaped storage portions 12a and 12b can be simultaneously taken by the aqueous liquid W stored in the single bag-shaped storage portion 11.
  • the enteric layer 22 is accommodated in the laminated bag-shaped accommodating portion 12b, and in the case of a drug that requires immediate effect, It can be accommodated in the water-soluble bag-like accommodation portion 12a.
  • a gastric layer may be laminated instead of the enteric layer 22.
  • the manufacturing method of the first embodiment in which the drug filling step of filling the bag-shaped container with the drug from the opened opening is performed after the flat plate extraction step.
  • the manufacturing method will be described with reference to FIG.
  • the difference between the manufacturing method of the second embodiment and the manufacturing method of the first embodiment is that the plate body extraction step is performed after the drug filling step, and the drug filling step is immediately after the first pressure bonding step (the first pressure bonding step). It is performed at almost the same time as the process.
  • the same components as those in the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.
  • a flat plate having a through-hole 72 p that penetrates in a direction substantially coinciding with the direction to be extracted. 72 ' is used.
  • an example is shown in which six flat plates 72 'are connected via a connecting bar 72d.
  • the flat plate 72 ′ By using the flat plate 72 ′ having such a configuration, the flat plate 72 ′ is interposed between the two edible films 10 and pressed by the pair of three-way crimping molds 71. Immediately after being formed, the filling device 75 can fill the drug and the aqueous liquid. That is, the first pressure bonding step and the filling step for filling the drug and the aqueous liquid can be performed almost simultaneously. Thereby, according to the manufacturing method of this embodiment, an oral administration formulation can be manufactured efficiently. In addition, when filling the bag-shaped container with the drug and aqueous liquid, the through-hole 72p of the flat plate 72 'has a guiding action, so that the drug and aqueous liquid can be more easily contained in the bag-shaped container. It can be filled reliably.
  • the shape of the pressing surface of the three-way crimping die and the opening crimping die and the shape of the blade of the cutting device are not limited to the corrugated shape as described above.
  • the inner peripheral shape of the pressing surface of the three-way crimping die and the opening crimping die and the shape of the blade portion of the cutting device can be made substantially rectangular.
  • seat 54 by which the substantially square liquid storage part 15 and the medicine storage part 16 were alternately connected by each can be manufactured.
  • the liquid containing part 15 and the drug containing part 16 are respectively outside the crimping part. It is preferable to provide a non-crimped portion 39. Further, even if the preparation sheet 54 is cut along the dotted line 34 in the cutting process and the unit dosage preparation 4 is cut off, the dotted line 34 may be used as a perforation or a cut line for cutting. Moreover, the perforation 41 for folding can also be provided at a cutting process.
  • the feel of the oral dosage form 4 in the oral cavity becomes soft, and at the same time, the hand feel when taking it And it looks softer.
  • the oral administration preparation 4 that is easy to take without resistance can be produced.
  • the shape of the three-way crimping die and the opening crimping die is a simple quadrangle, the die can be easily manufactured and the cost can be reduced.
  • the oral dosage form has a corrugated or rounded shape, it is not necessary to cut and discard the edges and corners of the film, so resources should be used effectively without waste. Can do.
  • Oral administration by adding additional steps to the edible film, such as printing with edible ink, stamping with edible metals such as gold and silver, and foil pressing with edible color foil. Character information, symbols, etc. can be displayed on the preparation. Thereby, for example, even when a drug that is difficult to distinguish in appearance, such as a white powder, is contained, it can be identified by display, and misuse of the oral administration preparation can be prevented.
  • foil pressing of edible color foil is performed by heat-pressing a foil pressing material provided with a colored layer in which an edible dye or the like is mixed in an edible adhesive material such as shellac or zein to a edible film. It can be carried out.

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Abstract

An apparatus for producing a medicinal preparation for oral administration which comprises: a pair of three-side press-bonding dies (71) which are separated from and approach each other to press-bond two edible films facing each other to thereby form bag-form holder parts which each is closed on three sides and has an opening on the remaining one side; flat members (72) which are inserted between the two edible films facing each other and are pulled out of the bag-form holder parts through the openings; a drug-charging device which charges a drug into the bag-form holder parts through the openings; and a pair of opening press-bonding dies (73) which are separated from and approach each other to press-bond the openings.

Description

経口投与製剤の製造方法及び経口投与製剤の製造装置Method for producing orally administered preparation and apparatus for producing orally administered preparation
　本発明は、経口投与製剤の製造方法、及び、該製造方法に適した経口投与製剤の製造装置に関するものである。 The present invention relates to a method for producing an orally administered preparation and an apparatus for producing an orally administered preparation suitable for the production method.
　近年、高齢化の進行に伴って嚥下困難者が増加する傾向にある。そのため、薬を飲み込みにくい患者に対しても経口投与し易い製剤の開発が、強く要望されている。そこで、本発明者らは、薄い可食性フィルムに薬物成分を含有させたフィルム状製剤について研究開発を進め、提案を行っている。本発明者らの提案によるフィルム状製剤は、口腔内で速やかに崩壊または溶解すると共に、ハンドリング上問題のない実用的な強度を有しており、老化や疾病等によって嚥下機能が低下した人や、小児など嚥下機能の低い人にとっても、服用し易い製剤となっている。 In recent years, with the progress of aging, the number of people with difficulty in swallowing tends to increase. Therefore, there is a strong demand for the development of a preparation that can be easily administered orally even to patients who are difficult to swallow the drug. Therefore, the present inventors have advanced research and development and proposed a film-form preparation in which a drug component is contained in a thin edible film. The film-form preparation proposed by the present inventors disintegrates or dissolves rapidly in the oral cavity and has a practical strength that does not cause any problems in handling. It is a formulation that is easy to take even for people with low swallowing function such as children.
　上記のフィルム状製剤にかかる発明は、出願公開前であるため文献公知発明に該当しない。 The invention relating to the film-form preparation described above does not fall under the literature known invention since it was before publication of the application.
　しかしながら、上記のフィルム状製剤では、製造段階でフィルム形成剤を含む溶媒に薬物成分を溶解または懸濁させる工程を経ることが必要であり、場合によっては加熱も必要となる。そのため、例えば乳酸菌や酵素など、溶媒との混合や加熱によって変質・劣化するおそれのある成分は、フィルム状製剤に含有させることは困難であった。更に、薬物の中にはフィルム形成剤と反応して、フィルムの形成を阻害するものが存在する。例えば、カルシウムイオンを含有する薬物は、フィルム形成剤であるアルギン酸ナトリウムと反応して加熱しても溶解しないゲルとなり、フィルム化することが困難となる。そのため、上記のフィルム状製剤は、含有させることができる薬物の種類に制限があった。 However, in the above film-form preparation, it is necessary to go through a step of dissolving or suspending the drug component in a solvent containing a film forming agent in the production stage, and in some cases, heating is also necessary. For this reason, it has been difficult to incorporate components such as lactic acid bacteria and enzymes that may be altered or deteriorated by mixing with a solvent or heating, into a film-form preparation. In addition, some drugs react with film formers to inhibit film formation. For example, a drug containing calcium ions reacts with sodium alginate, which is a film forming agent, to form a gel that does not dissolve even when heated, making it difficult to form a film. For this reason, the film-form preparation has a limitation on the types of drugs that can be contained.
　また、フィルム状製剤の場合は、薄いフィルムの一枚に、多量の薬物を含有させることは困難であった。そのため、上記のフィルム状製剤は、微量の摂取で薬効が得られる薬物の場合には極めて有効であったが、薬効を得るための必要量が多い薬物の場合は、一回量として多数枚のフィルム状製剤を服用しなくてはならないという問題があった。 In the case of a film-form preparation, it was difficult to contain a large amount of drug in one thin film. Therefore, the film-form preparation described above was extremely effective in the case of a drug that has a medicinal effect with a small amount of ingestion. There was a problem that a film-form preparation had to be taken.
　そこで、本発明は、上記の実情に鑑み、薄い可食性フィルムを用いながら、多量の薬物を含有させることができると共に、薬物の種類が制限されず、服用し易い経口投与製剤を製造できる経口投与製剤の製造方法、及び、該製造方法に適した経口投与製剤の製造装置の提供を課題とするものである。 Therefore, in view of the above circumstances, the present invention is capable of containing a large amount of drug while using a thin edible film, and is capable of containing an oral administration preparation that is easy to take and is not limited in type of drug. It is an object of the present invention to provide a method for producing a preparation and an apparatus for producing an oral preparation suitable for the production method.
　上記の課題を解決するため、本発明にかかる経口投与製剤の製造方法は、「平板体を介在させた状態で二重に重ね合わされた可食フィルムを圧着し、三方が閉塞されると共に一方向に開口部を有する袋状収容部を形成する第一圧着工程と、該第一圧着工程で形成された前記袋状収容部から前記開口部を介して前記平板体を抜き取る平板体抜取工程と、前記開口部から袋状収容部の内部に薬物を充填する薬物充填工程と、該薬物充填工程で薬物が充填された前記袋状収容部の前記開口部を圧着する第二圧着工程とを」具備するものである。 In order to solve the above-mentioned problems, the method for producing an oral administration preparation according to the present invention is described as follows: “Pressing the edible film doubly overlapped in a state of interposing a flat plate, the three sides are blocked and unidirectional A first crimping step of forming a bag-shaped housing portion having an opening in the flat plate body extracting step of pulling out the flat plate body from the bag-shaped housing portion formed in the first crimping step through the opening; A drug filling step of filling the inside of the bag-shaped housing portion with the drug from the opening, and a second pressure-bonding step of crimping the opening of the bag-shaped housing portion filled with the drug in the drug filling step. To do.
　「可食フィルム」は水溶性、胃溶性、または腸溶性のフィルム形成剤により形成することができる。ここで、水溶性のフィルム形成剤としては、ゼラチン、ペクチン、アラビノキシラン、大豆多糖類、アルギン酸ナトリウム、カラギーナン、キサンタンガム、グアーガム、プルラン、ヒプロメロース（ＨＰＭＣ；旧日本薬局方名「ヒドロキシプロピルメチルセルロース」）、ヒドロキシプロピルセルロース（ＨＰＣ）、水溶性ヒドロキシエチルセルロース（ＨＥＣ）、メチルセルロース（ＭＣ）、プロピルセルロース、カルボキシメチルセルロース（ＣＭＣ）、ポリビニルアルコール（ＰＶＡ）、ポリビニルピロリドン（ＰＶＰ）、ポリエチレングリコールポリエチレンオキサイド（ＰＥＯ）、ポリエチレングリコール（ＰＥＧ）等を例示することができる。 The “edible film” can be formed with a water-soluble, gastric or enteric film-forming agent. Here, examples of water-soluble film forming agents include gelatin, pectin, arabinoxylan, soybean polysaccharide, sodium alginate, carrageenan, xanthan gum, guar gum, pullulan, hypromellose (HPMC; former Japanese Pharmacopoeia “hydroxypropylmethylcellulose”), hydroxy Propyl cellulose (HPC), water-soluble hydroxyethyl cellulose (HEC), methyl cellulose (MC), propyl cellulose, carboxymethyl cellulose (CMC), polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), polyethylene glycol polyethylene oxide (PEO), polyethylene glycol (PEG) etc. can be illustrated.
　また、胃溶性のフィルム形成剤としては、ポリビニルアセタールジエチルアミノアセテート、ポリビニルアミノアセタール、メタアクリル酸メチル、メタアクリル酸ブチル、メタクリル酸ジメチルアミノエチルコポリマー、アミノアルキルメタクリレートコポリマー等を例示することができる。更に、腸溶性のフィルム形成剤としては、ヒドロキシプロピルメチルセルロースアセテートサクシネート（ＡＱＯＡＴ）、ヒドロキシプロピルメチルセルロースフタレート（ＨＰ）、ヒドロキシメチルエチルセルロースフタレート、カルボキシメチルエチルセルロース（ＣＭＥＣ）、セルロースアセテートトリメリテート、セルロースアセテートフタレート、セルロースアセテートサクシネート、メチルセルロースフタレート、エチルヒドロキシエチルセルロースフタレート、メタアクリル酸コポリマーＬ、メタアクリル酸コポリマーＬＤ、メタクリル酸・アクリル酸エチルエステルコポリマー、メタクリル酸・メタクリル酸メチルエステルコポリマー、スチレン・アクリル酸コポリマー、メタアクリル酸・メタアクリル酸メチルコポリマー、メタアクリル酸・アクリル酸エチルコポリマー等を例示することができる。なお、「可食フィルム」は、複数種類のフィルム形成剤を適宜配合して形成することもできる。 Examples of gastric soluble film forming agents include polyvinyl acetal diethylaminoacetate, polyvinylaminoacetal, methyl methacrylate, butyl methacrylate, dimethylaminoethyl methacrylate copolymer, aminoalkyl methacrylate copolymer and the like. Furthermore, enteric film forming agents include hydroxypropyl methylcellulose acetate succinate (AQOAT), hydroxypropylmethylcellulose phthalate (HP), hydroxymethylethylcellulose phthalate, carboxymethylethylcellulose (CMEC), cellulose acetate trimellitate, cellulose acetate phthalate. , Cellulose acetate succinate, methyl cellulose phthalate, ethyl hydroxyethyl cellulose phthalate, methacrylic acid copolymer L, methacrylic acid copolymer LD, methacrylic acid / acrylic acid ethyl ester copolymer, methacrylic acid / methacrylic acid methyl ester copolymer, styrene / acrylic acid copolymer, Methacrylic acid / methyl methacrylate copolymer It can be exemplified ethyl methacrylate-acrylic acid copolymer and the like. The “edible film” can also be formed by appropriately blending a plurality of types of film forming agents.
　可食フィルムには、上記のフィルム形成剤に加えて、他の成分を含有させることもできる。例えば、可塑剤として、クエン酸トリエチル、グリセリン、ソルビトール、トリアセチン、プロピレングリコール、ポリオキシエチレン（１０５）ポリオキシプロピレン（５）グリコール、ポリソルベート、マクロゴール、モノステアリン酸グリセリン、マンニトール等を含有させることにより、可食フィルムの柔軟性を高め、ひび割れや破れ等の発生を防止することができる。また、スクラロース、アスパルテーム、サッカリン、ステビア等の甘味料、キシリトール、カンゾウ等の矯味剤、スペアミントフレーバー、レモンフレーバー、メントール等の香料を含有させることにより、味付けや香り付けをすることができる。或いは、着色剤でフィルムを着色することにより、フィルム自体或いは内部に収容された内容物について、光や熱による変性や劣化を抑制することができる。また、薬物の種類の識別に、フィルムの着色を利用することもできる。 In addition to the above film forming agent, the edible film may contain other components. For example, by adding triethyl citrate, glycerin, sorbitol, triacetin, propylene glycol, polyoxyethylene (105) polyoxypropylene (5) glycol, polysorbate, macrogol, glyceryl monostearate, mannitol, etc. as a plasticizer The flexibility of the edible film can be increased and the occurrence of cracks and tears can be prevented. Moreover, it can be seasoned or scented by containing sweeteners such as sucralose, aspartame, saccharin and stevia, flavoring agents such as xylitol and licorice, and flavors such as spearmint flavor, lemon flavor and menthol. Alternatively, by coloring the film with a colorant, the film itself or the contents accommodated therein can be prevented from being modified or deteriorated by light or heat. In addition, the coloring of the film can be used to identify the type of drug.
　可食フィルムが「二重に重ね合わされた」態様としては、二枚のフィルムが重ね合わされた態様、一枚のフィルムが折り返されて重ね合わされた態様を例示することができる。 Examples of the mode in which the edible film is “double overlapped” include a mode in which two films are overlapped and a mode in which a single film is folded and overlapped.
　「平板体」は、例えば、紙製、プラスチック製、金属製、ガラス製、セラミックス製の薄い板状体を使用することができる。また、平板体の厚さは、例えば、０．５ｍｍ～５ｍｍとすることができる。 As the “flat plate”, for example, a thin plate made of paper, plastic, metal, glass, or ceramic can be used. The thickness of the flat plate can be set to 0.5 mm to 5 mm, for example.
　可食フィルムの「圧着」は、外部加熱による加熱圧着（ヒートシール）、電波や超音波を用いた内部加熱による加熱圧着とすることができる。或いは、糊化した高粘度のデンプン等を接着剤として圧着する等、非加熱の圧着とすることができる。なお、凹型と凸型を用いてシールすることにより、エンボス圧着加工を行うこともできる。また、複数の圧着方法を併用することもできる。 The “crimping” of the edible film can be thermocompression bonding (heat sealing) by external heating or thermocompression bonding by internal heating using radio waves or ultrasonic waves. Or it can be set as non-heat-bonded pressure bonding, such as pressure bonding using gelatinized high-viscosity starch or the like as an adhesive. In addition, emboss press-bonding can also be performed by sealing using a concave type and a convex type. A plurality of pressure bonding methods can be used in combination.
　「薬物」の剤形は特に限定されず、粉末剤（散剤）、顆粒剤、丸剤、錠剤、液剤、ペースト状製剤を例示することができる。また、薬物の種類も経口摂取用であれば特に限定されず、いわゆる西洋薬であっても、生薬や生薬を組み合わせた漢方薬であっても良い。更に、本発明の「薬物」は、ビタミンやミネラル等不足しがちな栄養成分の補給を目的とした食品のうち、顆粒剤、錠剤など通常の食品の形態ではない栄養補助食品をも含む意で用いている。 The dosage form of “drug” is not particularly limited, and examples thereof include powders (powder), granules, pills, tablets, liquids, and paste preparations. Also, the type of drug is not particularly limited as long as it is for oral consumption, and it may be a so-called western medicine or a herbal medicine or a herbal medicine combined with a herbal medicine. Furthermore, the “drug” of the present invention is intended to include nutritional supplements that are not in the form of normal foods such as granules and tablets among foods intended to supplement nutrients that are often deficient, such as vitamins and minerals. Used.
　なお、薬物充填工程は平板体抜取工程の後に行われるものに限定されず、後述のように、平板体を二重に重ね合わされた可食フィルムの間に介在させた状態で行われることもある。すなわち、本発明の薬物充填工程は、平板体抜取工程の後に行われる場合と、平板体平板体抜取工程の前に行われる場合がある。 The drug filling step is not limited to the one performed after the flat plate extraction step, and may be performed in a state where the flat plate is interposed between the edible films that are double-layered as described later. . That is, the drug filling process of the present invention may be performed after the flat plate sampling process or may be performed before the flat plate sampling process.
　また、袋状収容部は第一圧着工程で三方が閉塞され、第二圧着工程で残る一方が閉塞されるものであるが、袋状収容部の外形は必ずしも四角形に限定されるものではない。例えば、略Ｕ字状や略円弧状に圧着することによっても、三方が閉塞された状態にすることができる。また、第二圧着工程を経て製造された経口投与製剤を、型抜きするように切断する工程を更に具備することにより、経口投与製剤の外形を種々の形状とすることができる。ここで、経口投与製剤の外形としては、平面視で四角形、三角形、五角形、六角形等の多角形状や、円形、楕円形などを例示することができる。また、四角形等の多角形状とする場合も、角に丸みを設け、或いは輪郭を波形にすることにより、経口投与製剤を服用した際に口腔内での感触がやわらかくなり、且つ、使用者に安心感を与えることができるため好適である。 In addition, the bag-shaped accommodation part is closed on the three sides in the first pressure-bonding step and the remaining one is closed in the second pressure-bonding step, but the outer shape of the bag-shaped storage part is not necessarily limited to a quadrangle. For example, the three sides can be closed by pressing in a substantially U shape or a substantially arc shape. Moreover, the oral dosage form manufactured through the 2nd crimping | compression-bonding process can further be equipped with the process of cut | disconnecting so that a mold may be cut | released, and can make the external shape of an oral dosage form various. Here, examples of the outer shape of the oral administration preparation include polygonal shapes such as a quadrangle, a triangle, a pentagon, and a hexagon, a circle, an ellipse, and the like in a plan view. Also, in the case of a polygonal shape such as a quadrangle, by providing rounded corners or corrugated contours, the oral feel will be soft when taking an oral preparation, and the user will feel safe. It is preferable because it can give a feeling.
　上記の構成により、第一圧着工程では、二重に重ね合わされた可食フィルムが、平板体を介在させた状態で圧着されるため、平板体の厚みの分だけ可食フィルムが膨らんだ状態で袋状収容部が形成される。そして、平板体を抜き取った後には、袋状収容部の内部に平板体の体積以上の内部空間が形成される。従って、単に可食フィルムを二重に重ね合わせ、その周縁を圧着して袋状に形成する場合に比べて、袋状収容部の内部空間を広くすることができる。これにより、本発明によれば、薄い可食性フィルムを用いた経口投与製剤でありながら、多量の薬物を含有させることができる。また、口腔内での違和感を小さいものとするために、経口投与製剤の平面積を小さいものとしても、平板体の厚さを調整することにより、薬物の含有量を確保し易いものとなる。 With the above configuration, in the first press-bonding step, the edible film layered twice is pressed in a state in which the flat plate is interposed, so that the edible film is expanded by the thickness of the flat plate. A bag-like accommodation part is formed. And after extracting a flat body, the internal space more than the volume of a flat body is formed in the inside of a bag-shaped accommodating part. Therefore, the internal space of the bag-shaped housing portion can be widened as compared with the case where the edible film is simply overlapped and the periphery is crimped to form a bag shape. Thereby, according to this invention, although it is an oral administration formulation using a thin edible film, a large amount of drugs can be contained. Moreover, in order to make the sense of incongruity in the oral cavity small, it is easy to ensure the content of the drug by adjusting the thickness of the plate even if the flat area of the oral administration preparation is small.
　また、仮に、平板体を介在させずに、単に二重に重ね合わされた可食フィルムの三方を圧着して袋状収容部を形成した場合は、内部空間が狭いため薬物が移動しにくく、薬物の充填に時間がかかる。これに対し、本発明では平板体の厚みの分だけ袋状収容部が広く膨らんで形成されるため、薬物を充填する操作がし易いと共に、短時間で薬物を充填することができる。 In addition, if a bag-shaped housing part is formed by crimping three sides of an edible film that is simply overlapped without using a flat plate, the drug is difficult to move because the internal space is narrow. Takes time to fill. On the other hand, in the present invention, the bag-like accommodation portion is formed so as to swell widely by the thickness of the flat plate, so that the operation of filling the drug is easy and the drug can be filled in a short time.
　加えて、仮に、平板体を介在させずに、単に二重に重ね合わされた可食フィルムの三方を圧着して袋状収容部を形成した場合は、薬物を充填する際に開口部を押し広げる必要がある。そうすると、開口部を押し広げる操作に伴って、圧着されている両側辺が自ずと内側に傾く。従って、複数の袋状収容部が連続的に形成される場合は、一つの袋状収容部に薬物を充填するために開口部を押し広げることによって、両隣りの袋状収容部が引張られてしまい、しわや破れの原因となる。これに対し、本発明では、平板体を介在させた状態で圧着して袋状収容部を形成することにより、開口部が大きく形成されるため、薬物を充填する際に開口部を押し広げる必要がない。これにより、連続的に袋状収容部が形成される場合であっても、ある袋状収容部に対する薬物の充填操作が他の袋状収容部に影響を及ぼすことがない。すなわち、本発明は、複数の袋状収容部が連続的に形成される経口投与製剤の製造方法にも適している。 In addition, if the bag-shaped accommodation part is formed by crimping three sides of the edible film that is simply overlapped without using a flat plate, the opening is expanded when filling the drug. There is a need. If it does so, both sides which are crimped | bonded will naturally incline with operation which spreads an opening part. Therefore, when a plurality of bag-shaped storage portions are formed continuously, the bag-shaped storage portions adjacent to each other are pulled by expanding the opening to fill one bag-shaped storage portion with the drug. It will cause wrinkles and tears. On the other hand, in the present invention, since the opening is formed by forming the bag-like accommodation portion by pressure bonding with the flat plate interposed, it is necessary to widen the opening when filling the drug. There is no. Thereby, even if it is a case where a bag-shaped accommodating part is formed continuously, the filling operation of the medicine with respect to a certain bag-shaped accommodating part does not affect another bag-shaped accommodating part. That is, the present invention is also suitable for a method for producing an orally administered preparation in which a plurality of bag-like accommodation portions are continuously formed.
　また、平板体を介在させずに、単に二重に重ね合わされた可食フィルムの三方を圧着して袋状収容部を形成した場合は、内部空間が狭いため、薬物をなるべく多く充填しようとすると薬物が開口部の縁近くにまで達してしまう。加えて、袋状収容部の内部空間が狭いため、微量の薬物の充填ですぐに開口部の縁近くまで達してしまい、開口部付近の空間に余裕を持たせるよう制御することは困難である。そのため、薬物を充填した後に開口部を圧着する際、圧着の圧力によって、粉末状の薬物が舞い上がったり、顆粒状の薬物が飛び出したりすることがあった。これに対し、本発明では、袋状収容部の内部空間が広く形成されるため、多量の薬物を充填しても、開口部付近の空間に余裕を持たせることができる。これにより、開口部を圧着する第二工程において、薬物が舞い上がったり飛び出したりすることがなく、かかる従来の問題を回避することができる。 In addition, when the bag-shaped container is formed by crimping the three sides of the edible film that is simply double-layered without interposing a flat plate, the internal space is narrow, so if you try to fill as much drug as possible The drug reaches near the edge of the opening. In addition, since the internal space of the bag-like storage part is narrow, it can reach the edge of the opening immediately after filling with a small amount of drug, and it is difficult to control the space near the opening to have a margin. . For this reason, when the opening is pressure-bonded after filling the drug, the powdered drug may rise or the granular drug may jump out depending on the pressure of the pressure-bonding. On the other hand, in the present invention, since the internal space of the bag-like storage portion is formed wide, even if a large amount of drug is filled, a space can be provided in the vicinity of the opening. Thereby, in the 2nd process of crimping | bonding an opening part, a drug does not soar or jump out, and this conventional problem can be avoided.
　更に、袋状収容部に薬物を充填する構成であるため、フィルムの形成を阻害する薬物であっても、経口投与製剤に適用することができる。また、フィルム自体に薬物を含有させる場合とは異なり、製造工程において薬物を溶媒に溶解・懸濁させる必要や加熱する工程がなく、溶媒との混合や加熱によって変質や劣化のおそれのある薬物であっても、袋状収容部に収容することができる。すなわち、本発明によれば、適用可能な薬物の種類が制限されることなく、経口投与製剤を製造することができる。 Furthermore, since the bag-shaped container is filled with a drug, even a drug that inhibits film formation can be applied to a preparation for oral administration. Unlike the case where a drug is contained in the film itself, there is no need to dissolve or suspend the drug in a solvent in the production process or there is no heating step, and the drug may be altered or deteriorated by mixing with the solvent or heating. Even if it exists, it can accommodate in a bag-shaped accommodating part. That is, according to the present invention, a preparation for oral administration can be produced without limiting the types of applicable drugs.
　また、フィルム自体に薬物を含有させる場合は、口腔内で違和感のない丸みを帯びた形状にフィルムをカットしようとすると、廃棄部分にも薬物が含まれてしまい、環境上好ましくないと共に、薬物も無駄となる。これに対し、本発明では、広い内部空間を有する袋状収容部に十分な量の薬物を収容できるため、可食フィルムには薬物を含有させる必要がない。そのため、丸みを帯びた形状にするために可食フィルムの端部をカットしたとしても、廃棄部分には薬物が含有されないため、環境上好ましいと共に、薬物を有効に活用することができる。更に、可食フィルムに薬物を含有させないため、薬物成分を含有させた場合よりもフィルム強度が高いことに加えて、薬物の吸湿性等に可食フィルムが影響を受けることがない。これにより、袋状収容部の性状を安定させることができる。 In addition, when the drug is contained in the film itself, if the film is cut into a rounded shape that does not feel uncomfortable in the oral cavity, the discarded part also contains the drug, which is not preferable for the environment. It becomes useless. On the other hand, in the present invention, since a sufficient amount of drug can be stored in the bag-shaped storage part having a wide internal space, it is not necessary to include the drug in the edible film. Therefore, even if the end portion of the edible film is cut to form a rounded shape, since the drug is not contained in the discarded portion, it is environmentally preferable and the drug can be effectively used. Furthermore, since the drug is not contained in the edible film, the edible film is not affected by the hygroscopicity of the drug in addition to the higher film strength than when the drug component is contained. Thereby, the property of a bag-shaped accommodating part can be stabilized.
　更に、本発明では袋状収容部を可食フィルムで形成するため、可食フィルムが水溶性の場合は、口腔内の水分によって袋状収容部が溶解または崩壊し、可食性フィルムがゼリー液状となる。その結果、ゼリー液状となったフィルムが薬物を包み込み、或いは、薬物と絡み合うため、薬物が喉を通り易いものとなる。これにより、薬物が細かな粉末や顆粒であっても、むせるおそれを低減して服用することができる。また、苦味、匂い、刺激の強い薬物であっても、ゼリー液状となったフィルムに薬物が包み込まれることにより、その苦味や刺激を強く感じることなく服用することができる。従って、本発明によれば、服用し易い経口投与製剤を製造することができる。 Furthermore, in the present invention, since the bag-shaped container is formed of an edible film, when the edible film is water-soluble, the bag-shaped container is dissolved or disintegrated by moisture in the oral cavity, and the edible film is a jelly liquid. Become. As a result, the jelly-like film envelops or entangles the drug, making it easier for the drug to pass through the throat. Thereby, even if the drug is a fine powder or granule, it can be taken with reduced risk of peeling. Moreover, even a drug with strong bitterness, smell, or irritation can be taken without strongly feeling the bitterness or irritation by wrapping the drug in a film that has become a jelly liquid. Therefore, according to the present invention, an easily administrable oral administration preparation can be produced.
　一方、可食フィルムが胃溶性または腸溶性の場合は、袋状収容部は口腔内では溶解または崩壊しないため、袋状収容部によって薬物の苦味、匂い、刺激をマスキングすることができる。また、袋状収容部は可食フィルムによって薄く形成することが可能であるため、口腔内で嵩張らず、オブラートで薬物を包み折り畳んで服用する場合やカプセル剤に比べて、服用し易い経口投与製剤を製造することができる。 On the other hand, when the edible film is gastric or enteric, since the bag-like container does not dissolve or disintegrate in the oral cavity, the bag-like container can mask the bitterness, smell and irritation of the drug. In addition, since the bag-like container can be thinly formed with an edible film, it is not bulky in the oral cavity, and is an oral dosage formulation that is easier to take than when encapsulated and folded with an oblate and taken in a capsule. Can be manufactured.
　本発明にかかる経口投与製剤の製造方法は、「前記平板体は抜き取られる方向と略一致する方向に貫通した貫通孔を具備し、前記薬物充填工程は、前記平板体を二重に重ね合わされた前記可食フィルムの間に介在させた状態で、前記貫通孔を介して薬物を充填することにより行われる」ものとすることができる。 The method for producing an orally administered preparation according to the present invention is as follows: “The plate body has a through-hole penetrating in a direction substantially coinciding with the direction in which the plate body is pulled out, and the drug filling step is performed by overlapping the plate body twice. It is carried out by filling a drug through the through-hole while being interposed between the edible films. "
　上記の構成により、第一圧着工程で袋状収容部が形成された直後に薬物を充填することができるため、第一圧着工程と薬物充填工程とをほぼ同時に行うことができる。これにより、本発明によれば、効率的に経口投与製剤を製造することができる。また、薬物を充填する際に、平板体の貫通孔がガイド的な作用を奏するため、袋状収容部の内部に薬物をより容易に、確実に充填することができる。 With the above configuration, since the drug can be filled immediately after the bag-like container is formed in the first pressure bonding step, the first pressure bonding step and the drug filling step can be performed almost simultaneously. Thereby, according to this invention, an oral administration formulation can be manufactured efficiently. Moreover, since the through-hole of the flat plate plays a guiding action when the drug is filled, the drug can be more easily and surely filled into the bag-shaped container.
　本発明にかかる経口投与製剤の製造方法は、「前記第一圧着工程及び前記第二圧着工程では、前記可食フィルムの圧着により形成される圧着部の外周の少なくとも一部に沿って、前記可食フィルムを圧着せず非圧着部を形成する」ものとすることができる。 The method for producing an orally administered preparation according to the present invention is as follows: “In the first pressure-bonding step and the second pressure-bonding step, the edible film is formed along at least a part of the outer periphery of a pressure-bonded portion formed by pressure-bonding the edible film. The non-crimped part is formed without crimping the edible film ”.
　非圧着部は、「圧着部の外周の少なくとも一部」に沿って形成するものであり、圧着部の全外周に沿って形成しても良い。また、複数の袋状収容部が連設される場合は、隣接する袋状収容部の間に非圧着部を形成するものであっても、隣接する袋状収容部の間には圧着部のみを介在させ非圧着部を形成しないものであっても良い。 The non-crimping part is formed along “at least a part of the outer periphery of the crimping part”, and may be formed along the entire outer circumference of the crimping part. In addition, when a plurality of bag-like storage portions are continuously provided, only the pressure-bonding portion is provided between the adjacent bag-like storage portions even if a non-pressure-bonding portion is formed between the adjacent bag-like storage portions. A non-crimped portion may not be formed with a gap interposed therebetween.
　圧着部ではフィルムが二枚分の厚さとなるため、人によっては口腔内で違和感を覚えるおそれがある。これに対し、本発明では、圧着部の外側に非圧着部、すなわち、二重に重ね合わされたフィルムが圧着されずに、そのままひらひらしている部分が存在する。そして、圧着されている場合に比べて、非圧着部では口腔内の水分によってフィルムが溶解または軟化し易い。これにより、経口投与製剤の口腔内での感触がやわらかいものとなり、より服用し易いものとなる。また、ひらひらしている部分が存在すると、手に取ったときの感触や見た目の印象もわらかいものとなるため、仮にフィルムが直線的で角部を有する外形であったとしても、口腔内を傷付けるのではないかという不安感や抵抗感のないものとなる。なお、非圧着部は、例えば、０．５ｍｍ～５ｍｍ幅に設けることができる。 で は Since the film is two sheets thick at the crimping part, some people may feel uncomfortable in the oral cavity. On the other hand, in the present invention, there is a non-crimped part, that is, a part that is opened as it is without being crimped by a non-crimped part, that is, a film superimposed in a double manner. And compared with the case where it is crimped | bonded, in a non-crimping part, a film is easy to melt | dissolve or soften with the water | moisture content in an oral cavity. Thereby, the feel in the oral cavity of the oral administration preparation becomes soft, and it becomes easier to take. Also, if there is a fluttering part, the feel when picked up by the hand and the impression of appearance will be soft, so even if the film is linear and has an outer shape with corners, There is no anxiety or resistance to hurting. The non-crimped part can be provided with a width of 0.5 mm to 5 mm, for example.
　次に、上記の課題を解決するため、本発明にかかる経口投与製剤の製造装置は、「互いに離隔接近して二重に重ね合わされた可食フィルムを圧着し、三方が閉塞されると共に一方向に開口部を有する袋状収容部を形成する一対の三方圧着型と、二重に重ね合わされた前記可食フィルムの間に挿入され、前記開口部を介して前記袋状収容部から抜き取られる平板体と、前記開口部から袋状収容部の内部に薬物を充填する薬物充填装置と、互いに離隔接近して前記開口部を圧着する一対の開口部圧着型とを」具備するものである。 Next, in order to solve the above-mentioned problems, an apparatus for producing an orally administered preparation according to the present invention is described as follows. A flat plate inserted between a pair of three-way crimping molds forming a bag-shaped housing part having an opening in the edible film and the edible film superimposed in a double manner and extracted from the bag-shaped housing part through the opening A body, a drug filling device that fills the inside of the bag-shaped container from the opening, and a pair of opening crimping molds that crimp the opening close to each other.
　「三方圧着型」及び「開口部圧着型」は、それぞれ一対が対向し、その間に二重に重ね合わされている可食フィルムを介在させ両側から押圧するものであり、圧着しようとする形状に対応した凸版状の構成とすることができる。また、「圧着」が外部加熱圧着である場合、「三方圧着型」及び「開口部圧着型」は、通電により発熱する電気伝導体、或いは、ヒータを内蔵した熱伝導体で構成させることができる。 "Three-way crimping type" and "opening crimping type" each have a pair of opposing edible films sandwiched between them and pressed from both sides, corresponding to the shape to be crimped A relief-like configuration can be obtained. When “crimping” is external thermocompression bonding, the “three-way crimping type” and the “opening crimping type” can be configured by an electric conductor that generates heat when energized or a thermal conductor with a built-in heater. .
　「薬物充填装置」は、薬物を収容して所定量を投下する装置であり、例えば、上部の受け口から薬物を収容し、下部の小さな投下口を開閉して薬物を投下する漏斗状の構成とすることができる。また、薬物充填装置全体または投下口が、袋状収容部の開口部に対して進退・昇降する構成とすることもできる。 The “drug filling device” is a device that contains a drug and drops a predetermined amount, for example, a funnel-like configuration that contains a drug from the upper receiving port, and opens and closes the lower small dropping port to drop the drug. can do. Moreover, it can also be set as the structure which the whole drug filling device or the dropping port advances / retreats with respect to the opening part of a bag-shaped accommodating part.
　上記の構成により、本発明の経口投与製剤の製造装置は、上述の経口投与製剤の製造方法に適している。 With the above configuration, the device for producing an oral administration preparation of the present invention is suitable for the above-described method for producing an oral administration preparation.
　本発明にかかる経口投与製剤の製造装置は、「それぞれ相反する方向に回転する一対の第一無端ベルトと、該第一無端ベルトと同一方向に回転する一対の第二無端ベルトを更に具備し、前記三方圧着型は複数対が設けられ、複数対の各対では、一方の前記三方圧着型が、一対のうちの一方の前記第一無端ベルトに設けられていると共に、他方の前記三方圧着型が他方の第一無端ベルトに設けられており、前記開口部圧着型は複数対が設けられ、複数対の各対では、一方の前記開口部圧着型が、一対のうちの一方の前記第二無端ベルトに設けられていると共に、他方の前記開口部圧着型が他方の第二無端ベルトに設けられている」ものとすることができる。 The device for producing an oral dosage form according to the present invention further comprises "a pair of first endless belts rotating in opposite directions, and a pair of second endless belts rotating in the same direction as the first endless belt," The three-way crimping die is provided with a plurality of pairs, and in each of the plurality of pairs, one of the three-way crimping dies is provided on one of the first endless belts and the other of the three-way crimping dies. Is provided on the other first endless belt, and a plurality of pairs of the opening crimping molds are provided, and in each of the plurality of pairs, one opening crimping mold is the second one of the pair. It is provided on the endless belt, and the other opening crimping die is provided on the other second endless belt. "
　上記の構成により、本発明によれば、無端ベルトを使用することにより、長尺の可食フィルムから袋状収容部を連続的に形成し、無限数の経口投与製剤が連設された無端の経口投与製剤シートを製造することが可能となる。すなわち、一対の第一無端ベルトの回転に伴って、複数対の三方圧着型のうちの一対が接近して二重に重ね合わされた可食フィルムを挟み込み、三方を圧着しつつ開口部圧着型の方向に送り出すと共に、一対の第二無端ベルトの回転に伴って複数対の開口部圧着型のうちの一対が接近し、三方圧着型から送り出された袋状収容部を挟み込み、開口部を圧着する構成とすることができる。従って、本発明の製造装置によれば、経口投与製剤を効率的に製造することができる。また、本発明の製造装置の構成は、自動化に適している。 With the above configuration, according to the present invention, by using an endless belt, a bag-shaped container is continuously formed from a long edible film, and an endless number of orally administered preparations are continuously provided. An oral administration preparation sheet can be produced. That is, with the rotation of the pair of first endless belts, the pair of three-way crimping molds approach each other and sandwich the edible film that is double-layered, and the opening crimping mold while crimping the three sides As the pair of second endless belts are rotated, a pair of the plurality of opening crimping molds approach each other, sandwich the bag-shaped accommodation section fed from the three-way crimping mold, and crimp the opening It can be configured. Therefore, according to the production apparatus of the present invention, an oral administration preparation can be produced efficiently. Moreover, the structure of the manufacturing apparatus of this invention is suitable for automation.
　ところで、圧着型（三方圧着型及び開口部圧着型）を無端ベルトではなく、相反する方向に回転する一対のローラに設ける構成も想定し得る。その場合は、一対のローラの回転に伴う可食フィルムの圧着は、圧着型と可食フィルムとの線的な接触によるものとなる。これに対し、本発明では無端ベルトに圧着型を設けたことにより、一対の無端ベルトがある程度の距離を走行する間、可食フィルムが圧着型によって押圧される状態を維持することが可能である。従って、本発明によれば、重ね合わされた可食フィルムを確実に圧着して、袋状収容部を形成することができ、製造された経口投与製剤から薬物が漏出するおそれを低減することができる。 By the way, it is also possible to envisage a configuration in which the crimping die (three-way crimping die and opening crimping die) is not an endless belt but a pair of rollers that rotate in opposite directions. In that case, the pressure bonding of the edible film accompanying the rotation of the pair of rollers is due to linear contact between the pressure bonding mold and the edible film. On the other hand, in the present invention, by providing the crimping die to the endless belt, the edible film can be kept pressed by the crimping die while the pair of endless belts travel a certain distance. . Therefore, according to the present invention, the stacked edible films can be reliably crimped to form a bag-like container, and the risk of drug leakage from the manufactured oral dosage form can be reduced. .
　なお、本発明の製造装置は、多数の経口投与製剤が連設されたシートから、一回量の経口投与製剤ごとに切り離す切断装置を更に備える構成とすることもできる。また、袋状収容部が形成される前後の可食フィルムは、第一無端ベルト及び第二無端ベルトの回転のみによって搬送されるものであっても、可食フィルムの搬送機構を別に備え、その搬送機構と第一無端ベルト及び第二無端ベルトの回転が同期していることによって搬送されるものであっても良い。 In addition, the production apparatus of the present invention may be configured to further include a cutting device that separates a single dose of the oral administration preparation from a sheet in which a large number of oral administration preparations are continuously provided. Moreover, even if the edible film before and after the bag-shaped housing portion is formed is transported only by the rotation of the first endless belt and the second endless belt, the edible film has a separate transport mechanism for the edible film, It may be transported by the rotation of the transport mechanism, the first endless belt and the second endless belt being synchronized.
　以上のように、本発明の効果として、薄い可食性フィルムを用いながら、多量の薬物を含有させることができると共に、薬物の種類が制限されず、服用し易い経口投与製剤を製造できる経口投与製剤の製造方法、及び、該製造方法に適した経口投与製剤の製造装置を提供することができる。 As described above, as an effect of the present invention, an oral administration preparation that can contain a large amount of drug while using a thin edible film, and that can produce an oral administration preparation that is easy to take without being restricted in the type of drug. And an apparatus for producing an oral dosage preparation suitable for the production method.
本発明の第一実施形態である製造方法及び製造装置により製造される経口投与製剤の構成を示す平面図である。It is a top view which shows the structure of the oral administration formulation manufactured with the manufacturing method and manufacturing apparatus which are 1st embodiment of this invention. 図１におけるＸ－Ｘ線断面図である。FIG. 2 is a sectional view taken along line XX in FIG. 本発明の第一実施形態である製造方法の工程図である。It is process drawing of the manufacturing method which is 1st embodiment of this invention. 本発明の第一実施形態である製造装置の主要な構成である（ａ）三方圧着型、（ｂ）平板体、（ｃ）開口部圧着型を示す斜視図である。It is a perspective view which shows (a) three-way crimping | compression-bonding type | mold, (b) flat plate body, and (c) opening part crimping type | mold which are the main structures of the manufacturing apparatus which is 1st embodiment of this invention. 図３の製造方法及び図４の製造装置による経口投与製剤の製造を説明する斜視図である。It is a perspective view explaining manufacture of the oral administration formulation by the manufacturing method of FIG. 3, and the manufacturing apparatus of FIG. 図３の製造方法及び図４の製造装置による経口投与製剤の製造を説明する斜視図である。It is a perspective view explaining manufacture of the oral administration formulation by the manufacturing method of FIG. 3, and the manufacturing apparatus of FIG. 図３の製造方法及び図４の製造装置による経口投与製剤の製造を説明する端面図である。It is an end view explaining manufacture of the oral administration formulation by the manufacturing method of FIG. 3, and the manufacturing apparatus of FIG. 図３の製造方法及び図４の製造装置による経口投与製剤の製造を説明する端面図である。It is an end view explaining manufacture of the oral administration formulation by the manufacturing method of FIG. 3, and the manufacturing apparatus of FIG. 図３の製造方法及び図４の製造装置による経口投与製剤の製造を説明する斜視図である。It is a perspective view explaining manufacture of the oral administration formulation by the manufacturing method of FIG. 3, and the manufacturing apparatus of FIG. 図３の製造方法及び図４の製造装置による経口投与製剤の製造を説明する斜視図である。It is a perspective view explaining manufacture of the oral administration formulation by the manufacturing method of FIG. 3, and the manufacturing apparatus of FIG. 図３の製造方法及び図４の製造装置による経口投与製剤の製造を説明する斜視図である。It is a perspective view explaining manufacture of the oral administration formulation by the manufacturing method of FIG. 3, and the manufacturing apparatus of FIG. 図３の製造方法及び図４の製造装置により製造された経口投与製剤シートの斜視図である。It is a perspective view of the oral administration preparation sheet manufactured by the manufacturing method of FIG. 3, and the manufacturing apparatus of FIG. 図１２の経口投与製剤シートの平面図である。It is a top view of the oral administration formulation sheet | seat of FIG. 図１２及び図１３の経口投与製剤シートの切断による経口投与製剤の製造を説明する平面図である。It is a top view explaining manufacture of the oral administration formulation by the cutting | disconnection of the oral administration formulation sheet | seat of FIG.12 and FIG.13. 他の実施形態の製造装置の主要な構成である（ａ）三方圧着型、（ｂ）開口部圧着型を示す斜視図である。It is a perspective view which shows the (a) three-way crimping | compression-bonding type | mold and (b) opening part crimping | molding die which are the main structures of the manufacturing apparatus of other embodiment. 図１５の製造装置により製造される経口投与製剤の構成を示す平面図である。It is a top view which shows the structure of the oral administration formulation manufactured with the manufacturing apparatus of FIG. 他の実施形態の製造装置の構成を模式的に示した説明図である。It is explanatory drawing which showed typically the structure of the manufacturing apparatus of other embodiment. 他の実施形態の製造方法により製造される経口投与製剤の構成を示す平面図である。It is a top view which shows the structure of the oral administration formulation manufactured by the manufacturing method of other embodiment. 図１８におけるＹ－Ｙ線断面図である。FIG. 19 is a sectional view taken along line YY in FIG. 経口投与製剤シートの切断による図１８及び図１９の経口投与製剤の製造を説明する平面図である。It is a top view explaining manufacture of the oral administration formulation of FIG.18 and FIG.19 by the cutting | disconnection of an oral administration formulation sheet | seat. 第二実施形態の製造方法を説明する斜視図である。It is a perspective view explaining the manufacturing method of 2nd embodiment. 他の実施形態の製造方法により製造される経口投与製剤の構成を示す平面図である。It is a top view which shows the structure of the oral administration formulation manufactured by the manufacturing method of other embodiment.
　以下、本発明の第一実施形態である経口投与製剤の製造方法（以下、単に「製造方法」と称する）、及び、該製造方法に適した経口投与製剤の製造装置（以下、単に「製造装置」と称する）について、図１乃至図１４を用いて説明する。なお、構成を明確にするため、可食フィルムの厚さを誇張して図示している。また、網掛けを施した部分は、可食フィルムが圧着されている圧着部を図示したものである。 Hereinafter, a method for producing an oral administration preparation (hereinafter simply referred to as “manufacturing method”), which is the first embodiment of the present invention, and an apparatus for producing an oral administration preparation suitable for the production method (hereinafter simply referred to as “manufacturing device”). Will be described with reference to FIGS. In addition, in order to clarify a structure, the thickness of the edible film is exaggerated and illustrated. In addition, the shaded portion shows the crimped portion where the edible film is crimped.
　まず、本実施形態の製造方法及び製造装置によって製造される経口投与製剤１について、図１及び図２を用いて説明する。経口投与製剤１は、二つの袋状収容部１１，１２ａが連設された略四角形であり、外周に沿って波形に形成されている。袋状収容部１１，１２ａでは、それぞれ二重に重ね合わされた水溶性の可食フィルム１０の周縁が圧着されることにより内部に閉塞された空間が形成されている。また、一方の袋状収容部１２ａでは内部の空間に薬物Ｄａが収容されており、他方の袋状収容部１１では、水溶性の可食フィルム１０の内側に非水溶性層２１が積層され、内部の空間に水系液体Ｗが収容されている。 First, the oral administration preparation 1 manufactured by the manufacturing method and manufacturing apparatus of this embodiment will be described with reference to FIGS. 1 and 2. The orally administered preparation 1 has a substantially rectangular shape in which two bag- like storage portions 11 and 12a are connected, and is formed in a waveform along the outer periphery. In the bag-shaped storage portions 11 and 12a, a space closed inside is formed by crimping the periphery of the water-soluble edible film 10 that is doubled. Further, in one bag-shaped storage portion 12a, the drug Da is stored in the internal space, and in the other bag-shaped storage portion 11, a water-insoluble layer 21 is laminated inside the water-soluble edible film 10, An aqueous liquid W is accommodated in the internal space.
　上記の構成の経口投与製剤１を製造する本実施形態の製造方法は、主に図３に示すように、水溶性のフィルム形成剤の溶液を調製する溶液調製工程Ｓ１と、調整された溶液を流延する流延工程Ｓ２と、流延された溶液を乾燥させ水溶性の可食フィルム１０を形成させる乾燥工程Ｓ３と、水溶性の可食フィルム１０の上面に非水溶性層２１を部分的に積層する非水溶性層積層工程Ｓ４と、二枚の水溶性の可食フィルム１０を向かい合わせ、その間に平板体を挿入する平板体挿入工程Ｓ５と、二枚の可食フィルムを圧着し、三方が閉塞されると共に一方向に開口部を有する袋状収容部を形成する第一圧着工程Ｓ６と、形成された袋状収容部から開口部を介して平板体を抜き取る平板体抜取工程Ｓ７と、平板体が抜き取られた開口部から袋状収容部の内部に薬物を充填する充填工程Ｓ８と、薬物が充填された袋状収容部の開口部を圧着する第二圧着工程Ｓ９と、開口部が閉塞された袋状収容部からベースフィルムを剥離する剥離工程Ｓ１０と、袋状収容部が連設された経口投与製剤シートを圧着部の内周より外側で切断する切断工程Ｓ１１とを具備している。なお、本実施形態の充填工程Ｓ８では、袋状収容部１２ａへの薬物Ｄａの充填（本発明の「薬物充填工程」に相当する）と同時に、袋状収容部１２ａに隣接する袋状収容部１１への水系液体Ｗの充填が同時に行われる。 The production method of the present embodiment for producing the oral administration preparation 1 having the above-described configuration mainly includes a solution preparation step S1 for preparing a solution of a water-soluble film forming agent and an adjusted solution as shown in FIG. Casting step S2 for casting, drying step S3 for drying the cast solution to form a water-soluble edible film 10, and a water-insoluble layer 21 partially on the upper surface of the water-soluble edible film 10 Water-insoluble layer laminating step S4 for laminating, two water-soluble edible films 10 facing each other, a flat body inserting step S5 for inserting a flat body therebetween, and two edible films are pressure-bonded, A first pressure-bonding step S6 for forming a bag-shaped housing portion having an opening in one direction while being closed on three sides; and a plate body extraction step S7 for extracting a flat plate body from the formed bag-shaped housing portion through the opening. , Bag-like accommodation from the opening from which the flat plate is removed The base film is peeled from the filling step S8 for filling the inside of the container, the second crimping step S9 for crimping the opening of the bag-like housing portion filled with the drug, and the bag-like housing portion having the closed opening. The peeling process S10 and the cutting process S11 which cut | disconnects the oral administration formulation sheet | seat with which the bag-shaped accommodating part was provided continuously outside the inner periphery of a crimping | compression-bonding part are comprised. In the filling step S8 of the present embodiment, the bag-shaped storage portion adjacent to the bag-shaped storage portion 12a is simultaneously filled with the drug Da into the bag-shaped storage portion 12a (corresponding to the “drug filling step” of the present invention). 11 is filled with the aqueous liquid W at the same time.
　また、経口投与製剤１を製造する本実施形態の製造装置は、可食フィルムを形成する可食フィルム形成装置（図示しない）と、可食フィルムを圧着し、薬物または水系液体が充填された袋状収容部が連設された経口投与製剤シートを製造する成形・充填装置と、経口投与製剤シートを一回量の経口投与製剤ごとに切断する切断装置（図示しない）を具備している。ここで、成形・充填装置は、図４乃至図１１に示すように、互いに離隔接近して二重に重ね合わされた可食フィルムを圧着し、三方が閉塞されると共に一方向に開口部１５を有する袋状収容部１１，１２ａを形成する一対の三方圧着型７１と、二重に重ね合わされた可食フィルム１０の間に挿入され、開口部１５を介して袋状収容部１１，１２ａから抜き取られる平板体７２と、開口部１５から袋状収容部１２ａの内部に薬物Ｄａを充填する薬物充填装置７５ａ及び開口部１５から袋状収容部１１の内部に水系液体Ｗを充填する水系液体充填装置７５ｗを備えた充填装置７５と、互いに離隔接近して開口部１５を圧着する一対の開口部圧着型７３とを具備している。 In addition, the manufacturing apparatus of the present embodiment for manufacturing the orally administered preparation 1 includes an edible film forming apparatus (not shown) for forming an edible film, and a bag filled with a drug or an aqueous liquid by pressing the edible film. A molding / filling device for producing an orally-administered preparation sheet having a continuous container, and a cutting device (not shown) for cutting the orally-administered preparation sheet for each dose of the orally-administered preparation. Here, as shown in FIGS. 4 to 11, the molding / filling device presses the edible films that are double-stacked close to each other, closes the three sides, and opens the opening 15 in one direction. It is inserted between the pair of three-way crimping molds 71 forming the bag-shaped storage portions 11 and 12a and the edible film 10 that is doubled and extracted from the bag-shaped storage portions 11 and 12a through the opening 15. A flat plate body 72, a drug filling device 75a for filling the inside of the bag-like containing portion 12a from the opening 15 and an aqueous liquid filling device for filling the aqueous liquid W into the inside of the bag-like containing portion 11 from the opening 15. And a pair of opening crimping molds 73 that crimp the opening 15 while being spaced apart from each other.
　なお、本実施形態の三方圧着型７１及び開口部圧着型７３は、共に金属製である。また、本実施形態では平板体７２として強化ガラス製を使用しているが、紙など他の素材のものでも良い。また、本実施形態の三方圧着型７１は、六対の三方圧着型において、各対の片方の計六つがそれぞれ一体となった構成であり、開口部圧着型７３は六対の開口部圧着型において、各対の片方の計六つがそれぞれ一体となった構成である。更に、本実施形態では、六枚の平板体７２が連結バー７２ｂを介して連結されている。すなわち、本実施形態では、六対の三方圧着型７１、六枚の平板体７２、及び、六対の開口部圧着型７３によって、六つの袋状収容部が連続的に形成される構成、換言すれば、袋状収容部１１と袋状収容部１２ａが交互にそれぞれ三つずつ連設される構成を例示している。なお、形成される袋状収容部の数は、本実施形態での例示に限定されるものではない。 Note that the three-way crimping die 71 and the opening crimping die 73 of this embodiment are both made of metal. Further, in the present embodiment, tempered glass is used as the flat plate 72, but other materials such as paper may be used. Further, the three-way crimping die 71 of the present embodiment has a configuration in which a total of six of each pair is integrated in six pairs of three-way crimping die, and the opening crimping die 73 is a six-pair opening crimping die. In the configuration, a total of six of each pair is integrated. Furthermore, in this embodiment, the six flat plates 72 are connected via the connection bar 72b. That is, in the present embodiment, the six bag-shaped accommodating portions are continuously formed by the six pairs of three-way crimping dies 71, the six flat plates 72, and the six pairs of opening crimping dies 73, in other words, If it does so, the structure by which the bag-shaped accommodating part 11 and the bag-shaped accommodating part 12a will be alternately provided by three each is illustrated. In addition, the number of the bag-shaped accommodating parts formed is not limited to the illustration in this embodiment.
　本実施形態の製造装置を用いた製造方法についてより詳細に説明すると、溶液調製工程Ｓ１では水溶性フィルム形成剤と液媒体とを混合し、充分撹拌して溶解させる。このとき、加熱下で溶解させることもできる。また、可塑剤、矯味剤、乳化剤等の添加剤を添加することもできる。ここで、液媒体としては、水溶性フィルム形成剤の種類により、水、温水、希酸性水溶液、希アルカリ性水溶液等を使用することができ、アルコール等の有機溶媒を添加することもできる。 The production method using the production apparatus of the present embodiment will be described in more detail. In the solution preparation step S1, the water-soluble film forming agent and the liquid medium are mixed and sufficiently stirred and dissolved. At this time, it can also be dissolved under heating. Additives such as plasticizers, flavoring agents, and emulsifiers can also be added. Here, as the liquid medium, water, warm water, dilute acidic aqueous solution, dilute alkaline aqueous solution or the like can be used depending on the type of the water-soluble film forming agent, and an organic solvent such as alcohol can also be added.
　流延工程Ｓ２では、平滑な平面上にベースフィルムを固定し、溶液調製工程Ｓ１で調製された溶液をその上面に流延する。ここで、ベースフィルムとしては、例えば、ＰＰ製、ＰＥＴ製のフィルムを使用することができる。乾燥工程Ｓ３では、例えば、湿度が調整された温風の対流、遠赤外線の照射によって、流延された溶液を乾燥させることができる。 In the casting step S2, the base film is fixed on a smooth plane, and the solution prepared in the solution preparation step S1 is cast on the upper surface thereof. Here, as the base film, for example, a film made of PP or PET can be used. In the drying step S3, the cast solution can be dried by, for example, convection of warm air with adjusted humidity and irradiation with far infrared rays.
　非水溶性層積層工程Ｓ４では、水溶性の可食フィルム１０の上面において、後に水系液体Ｗを収容する袋状収容部１１となる位置に、部分的に非水溶性層２１を積層する。ここで、非水溶性層２１は、例えば、水溶性高分子を金属塩で架橋構造化したもの、非水溶性高分子、或いは、疎水性材料を用いて形成することができる。非水溶性高分子としては、エチルセルロース、プロピルセルロース、アセチルセルロース、セルロースアセテートプロピオネート、ヒドロキシプロピルセルロースフタレート、酢酸フタル酸セルロース等を例示することができる。また、疎水性材料としては、セラック、蜜蝋、サトウキビ蝋、カルナウバ蝋、ロジン、サンダラック、ツェイン等の天然樹脂、ワセリン、パラフィン、シリコーン樹脂を使用することができる。なお、非水溶性層２１の「積層」は、コーター機による塗布、吹付け、グラビア印刷、シルク印刷等の印刷によって行うことができる。 In the water-insoluble layer laminating step S4, the water-insoluble layer 21 is partially laminated on the upper surface of the water-soluble edible film 10 at a position to be the bag-like accommodation portion 11 that later contains the aqueous liquid W. Here, the water-insoluble layer 21 can be formed using, for example, a water-soluble polymer that is crosslinked with a metal salt, a water-insoluble polymer, or a hydrophobic material. Examples of the water-insoluble polymer include ethyl cellulose, propyl cellulose, acetyl cellulose, cellulose acetate propionate, hydroxypropyl cellulose phthalate, and cellulose acetate phthalate. As the hydrophobic material, shellac, beeswax, sugar cane wax, carnauba wax, natural resins such as rosin, sandalac, zein, petrolatum, paraffin, and silicone resin can be used. In addition, “lamination” of the water-insoluble layer 21 can be performed by printing such as coating, spraying, gravure printing, silk printing or the like by a coater machine.
　なお、この非水溶性層２１は水溶性の可食フィルム１０が水系液体Ｗによって溶解しないように、水溶性の可食フィルム１０に非水溶性を付与するための層である。従って、水溶性の可食フィルム１０が溶解した場合に、水系液体Ｗを収容する内部空間を維持するほどの強度を有しない程度の薄層である場合は、水溶性可食フィルム１０が口腔内の水分によって溶解すれば、液体収容部１１は自然に崩壊する。一方、非水溶性層２１がある程度の強度を有する層である場合は、液体収容部１１に歯を当てることにより、水系液体Ｗを収容する内部空間を保持している非水溶性層２１が破裂するように壊れ、水溶性可食フィルム１０の溶解と共に液体収容部は崩壊する。 The water-insoluble layer 21 is a layer for imparting water-insolubility to the water-soluble edible film 10 so that the water-soluble edible film 10 is not dissolved by the aqueous liquid W. Therefore, when the water-soluble edible film 10 is dissolved, if the water-soluble edible film 10 is a thin layer that does not have sufficient strength to maintain the internal space for containing the aqueous liquid W, the water-soluble edible film 10 If it dissolves with water, the liquid container 11 will naturally collapse. On the other hand, when the water-insoluble layer 21 is a layer having a certain degree of strength, the water-insoluble layer 21 holding the internal space for storing the aqueous liquid W is ruptured by applying a tooth to the liquid storage portion 11. As the water-soluble edible film 10 dissolves, the liquid container collapses.
　平板体挿入工程Ｓ５では、図５に示すように、ベースフィルム６０が接着したままの水溶性の可食フィルム１０の二枚を、ベースフィルム６０を外側にして向かい合わせ、その間に平板体７２を挿入する。本実施形態では、第一圧着工程Ｓ６で形成される開口部１５が上方に開口するように、フィルム面がほぼ鉛直方向となり、長手方向が水平方向に延びるように、二枚の可食フィルムを向かい合わせている。第一圧着工程Ｓ６では、図６乃至図８に示すように、ベースフィルム６０の両外側から一対の三方圧着型７１で押圧することにより、平板体７２を介在させた状態で二枚の可食フィルム１０をベースフィルム６０ごと圧着する。ここで、図７及び図８は、図６に二点鎖線で図示した仮想平面Ｐによる切断部の端面図である。 In the flat body insertion step S5, as shown in FIG. 5, two water-soluble edible films 10 with the base film 60 adhered are faced to each other with the base film 60 facing outside, and the flat body 72 is interposed therebetween. insert. In the present embodiment, two edible films are attached so that the film surface is substantially vertical and the longitudinal direction extends in the horizontal direction so that the opening 15 formed in the first pressure bonding step S6 opens upward. Facing each other. In the first press-bonding step S6, as shown in FIGS. 6 to 8, two edible sheets are sandwiched by pressing the pair of three-way press dies 71 from both outer sides of the base film 60 with the flat plate 72 interposed therebetween. The film 10 is pressed together with the base film 60. Here, FIG.7 and FIG.8 is an end elevation of the cutting | disconnection part by the virtual plane P illustrated with the dashed-two dotted line in FIG.
　そして、平板体抜取工程Ｓ７において、開口部１５を介して袋状収容部１１，１２ａから平板７２体を抜き取ると、図９に示すように、三方が閉塞された袋状収容部１１，１２ａにおいて、開口部１５が開放される。なお、図９では、ベースフィルムの図示を省略している。 And in flat plate body extraction process S7, when the flat plate 72 body is extracted from the bag-shaped accommodating parts 11 and 12a through the opening part 15, as shown in FIG. 9, in the bag-shaped accommodating parts 11 and 12a by which three sides were obstruct | occluded. The opening 15 is opened. In FIG. 9, the base film is not shown.
　充填工程Ｓ８では、図１０に示すように、薬物充填装置７５ａと水系液体充填装置７５ｗが交互に並設された充填装置７５を用い、水系液体充填装置７５ｗによって袋状収容部１１に水系液体Ｗを充填し、薬物充填装置７５ａによって袋状収容部１２ａに薬物Ｄａを充填する。ここで、水系液体Ｗとしては、水、水溶液、水を媒体とした懸濁液、水を媒体とした乳化液を例示することができる。より具体的には、水、砂糖水、塩水、茶、果汁、ゼラチン液、牛乳、ドリンクヨーグルトを例示することができる。また、矯味剤や香料によって、水系液体に味付けや香り付けがなされていても良い。 In the filling step S8, as shown in FIG. 10, using the filling device 75 in which the drug filling device 75a and the aqueous liquid filling device 75w are alternately arranged, the aqueous liquid W is placed in the bag-like container 11 by the aqueous liquid filling device 75w. And the bag-like container 12a is filled with the drug Da by the drug filling device 75a. Here, examples of the aqueous liquid W include water, an aqueous solution, a suspension using water as a medium, and an emulsion using water as a medium. More specifically, water, sugar water, salt water, tea, fruit juice, gelatin solution, milk and drink yogurt can be exemplified. Moreover, seasoning and fragrance | flavor may be made | formed to the aqueous liquid with the flavoring agent or the fragrance | flavor.
　その後、第二圧着工程Ｓ９では、図１１に示すように、一対の開口部圧着型７３で袋状収容部１１，１２ａの上部を押圧し、開口部１５を圧着して閉塞する。そして、剥離工程Ｓ１０において二枚のベースフィルム６０を袋状収容部１１，１２ａから剥離すれば、図１２乃至図１４に示すように、薬物Ｄａが封入された袋状収容部１２ａと水系液体Ｗが封入された袋状収容部１１とが交互に連設された経口投与製剤シート５１が製造される。 Thereafter, in the second crimping step S9, as shown in FIG. 11, the upper portions of the bag- like storage portions 11 and 12a are pressed by a pair of opening crimping molds 73, and the opening 15 is crimped and closed. Then, when the two base films 60 are peeled from the bag- like storage portions 11 and 12a in the peeling step S10, as shown in FIGS. 12 to 14, the bag-like storage portion 12a enclosing the drug Da and the aqueous liquid W Orally administrable preparation sheet 51 in which bag-like storage portions 11 in which are encapsulated are alternately arranged is manufactured.
　最後に、切断工程Ｓ１１において、図１４において一点鎖線３１で示した波形形状の刃部を有する切断装置を用い、圧着部において経口投与製剤シート５１を切断すれば、図１及び図２を用いて上述した構成の経口投与製剤１が製造される。また、本実施形態では、経口投与製剤１を折り畳み易くするために、薬物Ｄａが充填された袋状収容部１２ａと水系液体Ｗが充填された袋状収容部１１との間に、鎖線４１で図示したミシン目４１を設けている。このミシン目４１の形成は、一点鎖線３１に沿った切断に先立って行うことも、一点鎖線３１に沿った切断と同時に行うこともできる。なお、得られた経口投与製剤１は、例えば、アルミ箔等の金属箔やガスバリア性の高い透明プラスチックフィルムで形成されたパックで、個別に包装することができる。 Finally, in the cutting step S11, if the oral administration preparation sheet 51 is cut at the crimping portion by using a cutting device having a corrugated blade portion indicated by the alternate long and short dash line 31 in FIG. 14, using FIG. 1 and FIG. The oral administration preparation 1 having the above-described configuration is manufactured. Moreover, in this embodiment, in order to make the oral administration formulation 1 easy to fold, a chain line 41 is provided between the bag-shaped container 12a filled with the drug Da and the bag-shaped container 11 filled with the aqueous liquid W. The perforation 41 shown is provided. The perforation 41 can be formed prior to the cutting along the alternate long and short dash line 31 or simultaneously with the cutting along the alternate long and short dash line 31. The obtained oral administration preparation 1 can be individually packaged with a pack formed of a metal foil such as an aluminum foil or a transparent plastic film having a high gas barrier property, for example.
　なお、本実施形態の第一圧着工程Ｓ６及び第二圧着工程Ｓ９では、外部加熱による圧着（ヒートシール）を行っている。ここで外部加熱圧着は、例えば、１５０～３００℃の温度で１～５秒間、可食フィルム１０を圧着することにより行うことができるが、圧着時間や温度は可食フィルムの種類等に応じて、適宜設定することができる。また、可食フィルム１０の圧着部となる部分に、予めヒートシール性に優れた層を積層しておいても良い。このヒートシール性に優れた層は、例えば、ゼラチン、カゼインナトリウム、ツェイン、ポリビニルアルコール、ポリビニルピロリドン、デンプン、加工デンプン、プルラン、アラビノキシラン、大豆タンパク等を用いて形成することができる。また、ヒートシール性に優れた層の積層は、例えば、非水溶性層積層工程Ｓ４の前または後、或いは、非水溶性層積層工程Ｓ４と同時に行うことができる。 In the first pressure-bonding step S6 and the second pressure-bonding step S9 of the present embodiment, pressure bonding (heat sealing) is performed by external heating. Here, the external thermocompression bonding can be performed by, for example, crimping the edible film 10 at a temperature of 150 to 300 ° C. for 1 to 5 seconds. The crimping time and temperature depend on the type of the edible film and the like. Can be set as appropriate. Moreover, you may laminate | stack the layer excellent in heat-sealing property previously in the part used as the crimping | compression-bonding part of the edible film 10. FIG. This layer excellent in heat sealability can be formed using, for example, gelatin, sodium caseinate, zein, polyvinyl alcohol, polyvinyl pyrrolidone, starch, modified starch, pullulan, arabinoxylan, soybean protein and the like. Moreover, lamination | stacking of the layer excellent in heat-sealing property can be performed before or after water-insoluble layer lamination process S4, or simultaneously with water-insoluble layer lamination process S4, for example.
　上記のように本実施形態の製造方法及び製造装置によれば、第一圧着工程Ｓ６において二枚の可食フィルム１０が、平板体７２を介在させた状態で三方圧着型７１によって圧着されるため、平板体７２の厚みの分だけ可食フィルム１０が膨らんだ状態で袋状収容部１１，１２ａが形成される。これにより、袋状収容部１１，１２ａの内部空間を広くすることができ、薄い可食性フィルムを用いた経口投与製剤でありながら、多量の薬物Ｄａ及び水系液体Ｗを含有させることができる。また、口腔内での違和感を小さいものとするために、経口投与製剤１の平面積を小さいものとしても、平板体７２の厚さを調整することにより、薬物Ｄａの含有量を確保し易いものとなる。 As described above, according to the manufacturing method and the manufacturing apparatus of the present embodiment, the two edible films 10 are pressure-bonded by the three-way pressure-bonding die 71 with the flat plate 72 interposed in the first pressure-bonding step S6. And the bag-shaped accommodating parts 11 and 12a are formed in the state which the edible film 10 expanded by the thickness of the flat plate 72. Thereby, the internal space of the bag-shaped storage portions 11 and 12a can be widened, and a large amount of the drug Da and the aqueous liquid W can be contained while being an oral administration preparation using a thin edible film. In addition, in order to reduce the discomfort in the oral cavity, even if the flat area of the oral administration preparation 1 is small, the content of the drug Da can be easily secured by adjusting the thickness of the flat plate 72. It becomes.
　例えば、厚さ約５０μｍの可食フィルムを用い、外形約２ｃｍ×３ｃｍという小型の袋状収容部を形成した場合で比較すると、二枚の可食フィルムの間に平板体を介在させることなく、単に可食フィルムの周縁を圧着して袋状収容部を形成したときは、内部に収容できた粉末状の薬物は約２００ｍｇであった。これに対し、厚さ約２ｍｍの平板体を介在させて二枚の可食フィルムを圧着して袋状収容部を形成したときは、同一種類の粉末状の薬物を約５００ｍｇ収容することができた。 For example, when using a edible film having a thickness of about 50 μm and forming a small bag-shaped container having an outer shape of about 2 cm × 3 cm, a flat body is not interposed between the two edible films, When the bag-shaped container was formed by simply crimping the periphery of the edible film, the amount of powdered drug that could be stored inside was about 200 mg. On the other hand, when a bag-shaped container is formed by crimping two edible films with a flat plate having a thickness of about 2 mm, about 500 mg of the same kind of powdered drug can be stored. It was.
　また、平板体抜取工程Ｓ７で平板体７２を抜き取った後は、平板体７２の厚みの分、袋状収容部１１，１２ａの開口部１５が大きく開放される。これにより、充填工程Ｓ８で袋状収容部１２ａの内部に薬物Ｄａを、袋状収容部１１ａの内部に水系液体Ｗを、落下させて充填する充填工程Ｓ８が行い易いものとなっている。 In addition, after the flat plate 72 is extracted in the flat plate extraction step S7, the opening 15 of the bag- like storage portions 11 and 12a is largely opened by the thickness of the flat plate 72. This facilitates the filling step S8 in which the drug Da is dropped into the bag-shaped container 12a and the aqueous liquid W is dropped into the bag-shaped container 11a to be filled in the filling step S8.
　加えて、本実施形態では複数の袋状収容部１１，１２ａが連続して形成される構成であるため、仮に、充填工程Ｓ８で薬物Ｄａや水系液体Ｗを充填するために開口部１５を押し広げようとすると、隣接している袋状収容部間の圧着部が自ずと内側に傾く。そのため、隣接する袋状収容部が引張られ、しわや破れが発生するおそれがある。これに対し、本実施形態では、開口部１５が大きく開放されており、薬物Ｄａや水系液体Ｗの充填のために開口部１５を押し広げる必要がないため、上記のようにしわや破れが発生するおそれがないものとなっている。また、一つの袋状収容部に対する充填操作が他の袋状収容部に影響を及ぼすことがないため、充填工程Ｓ８において複数の薬物充填装置７５ａと複数の水系液体充填装置７５ｗが並設された充填装置７５を使用し、同時に複数の袋状収容部１１，１２ａに対して薬物Ｄａまたは水系液体Ｗを充填することができる。 In addition, since the plurality of bag- like storage portions 11 and 12a are continuously formed in the present embodiment, the opening 15 is pushed to fill the drug Da and the aqueous liquid W in the filling step S8. When it tries to spread, the crimping | compression-bonding part between the adjoining bag-shaped accommodation parts inclines naturally inside. For this reason, the adjacent bag-like accommodation portions are pulled, and wrinkles and tears may occur. On the other hand, in the present embodiment, the opening 15 is greatly opened, and it is not necessary to spread the opening 15 for filling with the drug Da or the aqueous liquid W, so that wrinkles and tears occur as described above. There is no fear of doing it. Moreover, since the filling operation with respect to one bag-shaped container does not affect other bag-shaped containers, a plurality of drug filling devices 75a and a plurality of aqueous liquid filling devices 75w are arranged in parallel in the filling step S8. The filling device 75 can be used to fill the plurality of bag- like storage portions 11 and 12a with the drug Da or the aqueous liquid W at the same time.
　更に、袋状収容部１２ａに薬物Ｄａを充填するため、フィルムの形成を阻害する薬物を含有させて経口投与製剤１を製造することができる。或いは、フィルム自体に薬物を含有させる場合とは異なり、薬物を溶媒に溶解・懸濁させる必要や加熱する工程がないため、溶媒との混合や加熱によって変質や劣化のおそれのある薬物であっても、袋状収容部１２ａに収容することができる。すなわち、適用可能な薬物の種類が制限されることなく、経口投与製剤１を製造することができる。 Furthermore, since the bag-shaped container 12a is filled with the drug Da, it is possible to manufacture the oral administration preparation 1 by containing a drug that inhibits the formation of a film. Or, unlike the case where the drug is contained in the film itself, there is no need to dissolve and suspend the drug in a solvent and there is no heating step, so the drug may be altered or deteriorated by mixing with the solvent or heating. Can also be accommodated in the bag-like accommodation portion 12a. That is, the preparation 1 for oral administration can be produced without limiting the types of applicable drugs.
　また、本実施形態では、経口投与製剤１を口腔内で違和感のない丸みを帯びた形状とするために、切断工程Ｓ１１では波形の刃部を有する切断装置を用いて、経口投与製剤シート５１の周縁を切除している。しかしながら、本実施形態では上記のように、広い内部空間を有する袋状収容部１２ａに十分な量の薬物Ｄａを収容できるため、可食フィルム１０自体には薬物を含有させる必要がない。そのため、切除された可食フィルム１０に薬物が含有されないため、環境上好ましいと共に、薬物を有効に活用することができる。更に、可食フィルム１０に薬物を含有させないため、薬物成分を含有させた場合よりもフィルム強度が高いことに加えて、薬物の吸湿性等に可食フィルム１０が影響を受けることがない。これにより、袋状収容部１２ａの性状を安定させることができる。 Moreover, in this embodiment, in order to make the oral administration preparation 1 into a rounded shape without a sense of incongruity in the oral cavity, in the cutting step S11, using a cutting device having a corrugated blade, The periphery is excised. However, in the present embodiment, as described above, since a sufficient amount of the drug Da can be stored in the bag-shaped storage portion 12a having a wide internal space, the edible film 10 itself does not need to contain a drug. Therefore, since the excised edible film 10 contains no drug, it is environmentally preferable and the drug can be effectively used. Furthermore, since the drug is not contained in the edible film 10, the edible film 10 is not affected by the hygroscopic property of the drug in addition to the higher film strength than when the drug component is contained. Thereby, the property of the bag-shaped accommodation part 12a can be stabilized.
　更に、本実施形態の製造方法及び製造装置で製造された経口投与製剤１では、口腔内の水分によって袋状収容部１２ａが溶解した際、ゼリー液状となった可食性フィルム１０によって薬物Ｄａが包み込まれ、或いは、ゼリー液状となった可食フィルム１０が薬物Ｄａと絡み合う。これにより、薬物Ｄａを直接服用した場合に比べ、薬物Ｄａが喉を通り易い。そのため、薬物Ｄａが細かな粉末や顆粒であっても、むせるおそれを低減して服用することができる。また、薬物Ｄａの苦味、匂い、刺激が強い場合であっても、ゼリー液状となったフィルムに包み込まれることにより、苦味、匂い、刺激を強く感じることなく服用することができる。 Furthermore, in the oral administration preparation 1 manufactured with the manufacturing method and manufacturing apparatus of this embodiment, when the bag-shaped container 12a is dissolved by moisture in the oral cavity, the drug Da is encapsulated by the edible film 10 that becomes a jelly liquid. Alternatively, the edible film 10 that has become a jelly liquid is entangled with the drug Da. This makes it easier for the drug Da to pass through the throat than when the drug Da is taken directly. Therefore, even if the drug Da is a fine powder or granule, it can be taken with reduced risk of peeling. Moreover, even if the bitterness, smell, and irritation of the drug Da are strong, it can be taken without feeling bitterness, smell, or irritation by being wrapped in a jelly-like film.
　加えて、経口投与製剤１は、水系液体Ｗが収容された袋状収容部１１と、薬物Ｄａが収容された袋状収容部１２ａとが隣接している構成である。そのため、口腔内の水分によって水溶性の可食フィルム１０で形成された袋状収容部１１及び袋状収容部１２ａが、共に溶解または崩壊する。その結果、袋状収容部１１に収容されていた水系液体Ｗの助けによって、袋状収容部１２ａに収容されていた薬物Ｄａを容易に嚥下することができる。また、経口投与製剤１は、水などを別途用意する必要なく服用できるため、手軽に服用できることに加え、携帯性に優れている。 In addition, the orally-administered preparation 1 has a configuration in which a bag-like container 11 containing an aqueous liquid W and a bag-like container 12a containing a drug Da are adjacent to each other. Therefore, both the bag-shaped accommodation part 11 and the bag-shaped accommodation part 12a formed of the water-soluble edible film 10 are dissolved or disintegrated by moisture in the oral cavity. As a result, the drug Da stored in the bag-shaped storage portion 12a can be swallowed easily with the help of the aqueous liquid W stored in the bag-shaped storage portion 11. In addition, since the oral administration preparation 1 can be taken without the necessity of preparing water separately, it can be taken easily and has excellent portability.
　特に、本実施形態では平板体７２を用いて経口投与製剤１を製造することにより、袋状収容部１２ａの内部空間を広く形成することができ、多量の薬物Ｄａを充填することが可能であるが、袋状収容部１１から水系液体Ｗが供給されることによって、多量の薬物Ｄａであっても嚥下し易いものとなっている。また、平板体７２を用いて経口投与製剤１を製造することにより、袋状収容部１１の内部空間も広く形成できるため、供給される水系液体Ｗの量も多くすることが可能であり、薬物Ｄａをより容易に嚥下することができる。 In particular, in the present embodiment, by producing the oral administration preparation 1 using the flat plate 72, the internal space of the bag-like container 12a can be formed widely, and a large amount of drug Da can be filled. However, since the aqueous liquid W is supplied from the bag-shaped storage unit 11, even a large amount of the drug Da is easily swallowed. Moreover, since the internal space of the bag-shaped accommodation part 11 can be formed widely by producing the oral administration preparation 1 using the flat body 72, the amount of the aqueous liquid W to be supplied can be increased. Da can be swallowed more easily.
　更に、水系液体Ｗが砂糖水や果汁など味や香りを有する場合や、水系液体Ｗに味付けや香り付けがなされている場合は、薬物Ｄａの苦味、匂い、刺激を、水系液体Ｗによってより効果的にマスキングすることができる。また、水系液体Ｗに甘味付けをすることにより、小児であっても服用し易い経口投与製剤１となる。加えて、薬物Ｄａのざらつき感を、水系液体Ｗによって緩和することができる。 Furthermore, when the aqueous liquid W has a taste or fragrance such as sugar water or fruit juice, or when the aqueous liquid W is seasoned or scented, the bitterness, smell or stimulation of the drug Da is more effective by the aqueous liquid W. Can be masked. Further, by sweetening the aqueous liquid W, an oral preparation 1 that is easy to take even for children can be obtained. In addition, the rough feeling of the drug Da can be alleviated by the aqueous liquid W.
　また、経口投与製剤１は、波形の刃部で切断して外形を波形としているため、口腔内での感触がやわらかく、口腔内で違和感を覚えにくいものとなっている。また、経口投与製剤１には鋭利な角部や直線部がないため、使用者が安心感を持って服用することができる。 In addition, since the oral preparation 1 is cut with a corrugated blade and has an outer shape, the mouth feels soft and the mouth feels uncomfortable. In addition, since the oral preparation 1 does not have sharp corners or straight portions, the user can take it with a sense of security.
　更に、本実施形態では、三方圧着型７１が可食フィルム１０を押圧する押圧面７１ｐ、及び開口部圧着型７３が可食フィルム１０を押圧する押圧面７３ｐの内周形状は、経口投与製剤１の外形の波形と対応する形状となっている。これにより、経口投与製剤１においては、外形と圧着部の内周形状とが対応した波形となっており、より柔らかな印象を与えると共に美しい外観となっている。 Furthermore, in this embodiment, the inner peripheral shape of the pressing surface 71p on which the three-way crimping die 71 presses the edible film 10 and the pressing surface 73p on which the opening crimping die 73 presses the edible film 10 is the oral dosage form 1. The shape corresponds to the waveform of the outer shape. Thereby, in the oral administration formulation 1, the external shape and the inner peripheral shape of the crimping part correspond to a corrugated shape, giving a softer impression and a beautiful appearance.
　加えて、薬物Ｄａが収容された袋状収容部１２ａと水系液体Ｗが収容された袋状収容部１１との間にミシン目４１を設けており、ミシン目４１に沿って折り畳み易い。これにより、袋状収容部１１と袋状収容部１２とａとを折り重ねた状態で、経口投与製剤１を服用することができるため、経口投与製剤１が口腔内で嵩張らないものとなっている。 In addition, a perforation 41 is provided between the bag-like container 12 a containing the drug Da and the bag-like container 11 containing the aqueous liquid W, and it is easy to fold along the perforation 41. Thereby, since the oral administration formulation 1 can be taken in the state which folded the bag-shaped accommodating part 11, the bag-shaped accommodating part 12, and a, the oral administration formulation 1 becomes a thing which is not bulky in an oral cavity. Yes.
　上記の製造方法では、切断工程Ｓ１１で圧着部において切断することにより、経口投与製剤１の全外周に沿って二枚の可食フィルム１０が圧着されている構成の経口投与製剤１が製造される場合を例示した。本発明はかかる実施形態に限定されるものではなく、第一圧着工程Ｓ６及び前記第二圧着工程Ｓ９で、圧着部の外周の少なくとも一部に沿って可食フィルムを圧着せずに非圧着部３９を形成しておき、切断工程Ｓ１１では非圧着部において切断を行うものとすることができる。 In said manufacturing method, the oral administration formulation 1 of the structure by which the two edible films 10 are crimped | bonded along the outer periphery of the oral administration formulation 1 is manufactured by cut | disconnecting in a crimping | compression-bonding part by cutting process S11. The case was illustrated. The present invention is not limited to such an embodiment, and in the first pressure-bonding step S6 and the second pressure-bonding step S9, the edible film is not pressure-bonded along at least a part of the outer periphery of the pressure-bonding portion. 39 can be formed, and in the cutting step S11, cutting can be performed at the non-compression bonding portion.
　このような製造方法は、例えば、図１５に例示する構成の一対の三方圧着型８１、及び一対の開口部圧着型８３を備える製造装置を用いることにより実現することができる。すなわち、三方圧着型８１の押圧面８１ｐの外周と開口部圧着型８３の押圧面８３ｐの外周とを合わせた外形は、切断装置の刃物の外形より小さいと共に可食フィルムの外形より小さく、外周の形状は切断装置の刃部の波形形状と対応する波形に形成されている。なお、図１５では、三方圧着型８１及び開口部圧着型８３について、それぞれ一対のうちの一方のみを図示している。 Such a manufacturing method can be realized, for example, by using a manufacturing apparatus including a pair of three-way crimping molds 81 and a pair of opening crimping molds 83 configured as illustrated in FIG. That is, the outer shape of the outer periphery of the pressing surface 81p of the three-way crimping die 81 and the outer periphery of the pressing surface 83p of the opening crimping die 83 is smaller than the outer shape of the cutter of the cutting device and smaller than the outer shape of the edible film. The shape is formed into a waveform corresponding to the waveform shape of the blade portion of the cutting device. In FIG. 15, only one of the pair of the three-way crimping die 81 and the opening crimping die 83 is illustrated.
　このような製造方法及び製造装置によれば、図１６に示すように、袋状収容部１１の圧着部及び袋状収容部１２ａの圧着部の外側に、二枚の可食フィルムが圧着されていない非圧着部３９を有する経口投与製剤２を製造することができる。非圧着部３９では、二枚の可食フィルムが圧着されずにそのままひらひらとしているため、経口投与製剤２を服用した際、口腔内の水分によって非圧着部３９で水溶性の可食フィルム１０が溶解し易い。これにより、経口投与製剤２の口腔内での感触がやわらかなものとなる。 According to such a manufacturing method and manufacturing apparatus, as shown in FIG. 16, two edible films are pressure-bonded to the outside of the pressure-bonding portion of the bag-shaped storage portion 11 and the pressure-bonding portion of the bag-shaped storage portion 12a. An oral administration preparation 2 having no non-crimped part 39 can be produced. In the non-crimped portion 39, the two edible films are left open without being crimped. Therefore, when the oral administration preparation 2 is taken, the water-soluble edible film 10 is formed in the non-crimped portion 39 by moisture in the oral cavity. Easy to dissolve. Thereby, the touch in the oral cavity of the orally administered preparation 2 is softened.
　加えて、経口投与製剤２では、袋状収容部１１と袋状収容部１２ａとの境界にも非圧着部３９が形成され、非圧着部３９にミシン目４１が設けられている。そのため、圧着部にミシン目が形成されている場合に比べて、ミシン目４１に沿って折り畳み易い。これにより、袋状収容部１１と袋状収容部１２ａを折り重ねた状態で服用することができ、経口投与製剤２が口腔内で嵩張らないものとなる。 In addition, in the orally administered preparation 2, a non-crimp part 39 is also formed at the boundary between the bag-like container 11 and the bag-like container 12a, and a perforation 41 is provided in the non-crimp part 39. Therefore, it is easier to fold along the perforation 41 than in the case where the perforation is formed in the crimping portion. Thereby, it can take in the state which folded the bag-shaped accommodating part 11 and the bag-shaped accommodating part 12a, and the oral administration formulation 2 will not become bulky in the oral cavity.
　上記では、所定数の袋状収容部１１，１２ａが連設され、所定長さの経口投与製剤シート５１が製造される製造装置を例示したが、袋状収容部を連続的に形成して無限長さの経口投与製剤シート５５を製造できる製造装置９０として、本発明を適用することができる。この製造装置９０は、図１７に模式的に示すように、それぞれ相反する方向に回転する一対の第一無端ベルト９１と、第一無端ベルト９１と同一方向に回転する一対の第二無端ベルト９２を具備し、三方圧着型９６は複数対が設けられ、複数対の各対では一方の三方圧着型９６が、一対のうちの一方の第一無端ベルト９１に設けられていると共に、他方の三方圧着型９６が他方の第一無端ベルト９１に設けられており、開口部圧着型９８は複数対が設けられ、複数対の各対では一方の開口部圧着型９８が、一対のうちの一方の第二無端ベルト９２に設けられていると共に、他方の開口部圧着型９８が他方の第二無端ベルト９２に設けられている。 In the above description, the manufacturing apparatus in which the predetermined number of bag-shaped storage portions 11 and 12a are continuously provided and the oral administration preparation sheet 51 having a predetermined length is manufactured is illustrated, but the bag-shaped storage portions are continuously formed to be infinite. The present invention can be applied as a manufacturing apparatus 90 capable of manufacturing the oral administration preparation sheet 55 having a length. As schematically shown in FIG. 17, the manufacturing apparatus 90 includes a pair of first endless belts 91 that rotate in opposite directions and a pair of second endless belts 92 that rotate in the same direction as the first endless belt 91. The three-way crimping die 96 is provided with a plurality of pairs, and in each of the plurality of pairs, one three-way crimping die 96 is provided on one first endless belt 91 of the pair and the other three sides A crimping die 96 is provided on the other first endless belt 91, a plurality of pairs of opening crimping die 98 are provided, and one opening crimping die 98 in each of the plurality of pairs is one of the pair. The second endless belt 92 is provided with the other opening crimping die 98 and the other second endless belt 92.
　ここで、本実施形態の第一無端ベルト９１及び第二無端ベルト９２は、偏平な環状の構成とされている。そのため、一対の第一無端ベルト９１に設けられた三方圧着型９６の一対、及び一対の第二無端ベルト９２に設けられた開口部圧着型９８の一対は、それぞれ可食フィルム１０’を両側から押圧した状態である程度の距離を走行する。 Here, the first endless belt 91 and the second endless belt 92 of the present embodiment have a flat annular configuration. Therefore, a pair of three-way crimping dies 96 provided on the pair of first endless belts 91 and a pair of opening crimping dies 98 provided on the pair of second endless belts 92 respectively edible film 10 ′ from both sides. Drive a certain distance in the pressed state.
　更に、製造装置９０は、第一無端ベルト９１の回転面と直交する面上を回転する第三無端ベルト９３を具備し、第三無端ベルト９３には複数の平板体９７が取り付けられている。また、製造装置９０は、上記と同様に、薬物充填装置７５ａと水系液体充填装置７５ｗが交互に設けられた充填装置７５と、ベースフィルムを剥離する剥離装置（図示しない）と、図１４において一点鎖線３１で示した波形形状と同一の形状の刃部を有する切断装置９５とを具備している。 Furthermore, the manufacturing apparatus 90 includes a third endless belt 93 that rotates on a surface orthogonal to the rotation surface of the first endless belt 91, and a plurality of flat plates 97 are attached to the third endless belt 93. Similarly to the above, the manufacturing apparatus 90 includes a filling apparatus 75 in which a drug filling apparatus 75a and an aqueous liquid filling apparatus 75w are alternately provided, a peeling apparatus (not shown) for peeling the base film, and one point in FIG. And a cutting device 95 having a blade portion having the same shape as the wave shape indicated by the chain line 31.
　このような構成の製造装置９０では、まず、上記と同様に水溶性のフィルム形成剤溶液が長尺のベースフィルム６０’上に流延され、更に非水溶性層２１が部分的に積層されて形成された長尺の可食フィルム１０’の二枚が、ベースフィルム６０’を外側にして向かい合わされた状態で、一対の第一無端ベルト９１間に導入される。そして、第一無端ベルト９１の回転に伴い離隔接近する三方圧着型９６と、第三無端ベルト９３の回転に伴い二枚の可食フィルム１０’間に挿入される平板体９７によって、三方が閉塞されると共に一方向に開口部を有する袋状収容部１１，１２ａが連続的に形成される。 In the manufacturing apparatus 90 having such a configuration, first, a water-soluble film forming agent solution is cast on the long base film 60 ′ as described above, and the water-insoluble layer 21 is partially laminated. Two of the formed long edible films 10 ′ are introduced between the pair of first endless belts 91 with the base film 60 ′ facing outward. Then, the three sides are closed by the three-way crimping die 96 that approaches and separates with the rotation of the first endless belt 91 and the flat plate body 97 that is inserted between the two edible films 10 ′ with the rotation of the third endless belt 93. At the same time, the bag- like storage portions 11 and 12a having openings in one direction are continuously formed.
　次に、一対の無端ベルト９１から繰り出された袋状収容部１１，１２ａに、充填装置７５によって薬物Ｄａまたは水系液体Ｗが充填される。このとき、袋状収容部１２ａには薬物充填装置７５ａによって薬物Ｄａが充填され、袋状収容部１１には水系液体充填装置７５ｗによって水系液体Ｗが充填される。そして、一対の第二無端ベルト９２の回転に伴い離隔接近する開口部圧着型９８によって、袋状収容部１１，１２ａの開口部１５が連続的に圧着される。そして、連設された袋状収容部１１，１２ａから、剥離装置によってからベースフィルム６０’が剥離されることにより、図１３の経口投与製剤シート５１が連続する構成である長尺の（無端の）経口投与製剤シート５５が製造される。 Next, the drug-like Da or the aqueous liquid W is filled into the bag- like storage portions 11 and 12 a fed from the pair of endless belts 91 by the filling device 75. At this time, the bag-like container 12a is filled with the drug Da by the drug filling device 75a, and the bag-like container 11 is filled with the aqueous liquid W by the aqueous liquid filling device 75w. And the opening part 15 of the bag-shaped accommodating parts 11 and 12a is continuously crimped | bonded by the opening crimping | compression-bonding type | mold 98 which approaches a separation | spacing with rotation of a pair of 2nd endless belt 92. FIG. Then, the base film 60 ′ is peeled from the continuous bag-shaped storage portions 11 and 12 a by the peeling device, whereby the oral administration preparation sheet 51 of FIG. 13 is continuous (endless). ) Orally administered preparation sheet 55 is manufactured.
　その後、切断装置９５によって経口投与製剤シート５５が波形形状に切断されることにより、図１及び図２で示した構成と同一の経口投与製剤１、すなわち、薬物が充填された袋状収容部１２ａと水系液体Ｗが充填された袋状収容部１１とを一つずつ具備する経口投与製剤１が、連続的に製造される。 Thereafter, the oral administration preparation sheet 55 is cut into a corrugated shape by the cutting device 95, so that the same oral administration preparation 1 as that shown in FIGS. 1 and 2, that is, the bag-shaped container 12a filled with the drug is contained. And the oral administration preparation 1 each comprising the bag-like container 11 filled with the aqueous liquid W are manufactured continuously.
　上記の構成の製造装置９０によれば、第一無端ベルト９１及び第二無端ベルト９２を使用することにより、可食フィルム１０’を連続的に圧着し、無限数の経口投与製剤１を連続的に製造することができる。これにより、経口投与製剤１を効率的に製造することができると共に、製造装置９０を自動化することが可能となる。 According to the manufacturing apparatus 90 configured as described above, by using the first endless belt 91 and the second endless belt 92, the edible film 10 ′ is continuously pressed and an infinite number of oral administration preparations 1 are continuously added. Can be manufactured. Thereby, the oral administration preparation 1 can be efficiently manufactured, and the manufacturing apparatus 90 can be automated.
　加えて、第一無端ベルト９１及び第二無端ベルト９２が偏平な環状の構成であり、一対の無端ベルト９１がある程度の距離を走行する間、可食フィルム１０’が三方圧着型９６によって押圧される状態が維持されると共に、一対の無端ベルト９２がある程度の距離を走行する間、可食フィルム１０’が開口部圧着型９８によって押圧される状態が維持される。これにより、二枚の可食フィルム１０’が確実に圧着されるため、製造された経口投与製剤１から薬物Ｄａや水系液体Ｗが漏出するおそれを低減することができる。 In addition, the first endless belt 91 and the second endless belt 92 have a flat annular configuration, and the edible film 10 ′ is pressed by the three-way crimping die 96 while the pair of endless belts 91 travel a certain distance. The edible film 10 ′ is maintained in a state where it is pressed by the opening crimping die 98 while the pair of endless belts 92 travels a certain distance. Thereby, since the two edible films 10 ′ are securely pressed, the risk of leakage of the drug Da and the aqueous liquid W from the manufactured oral administration preparation 1 can be reduced.
　上記の実施形態では、水系液体Ｗを収容した袋状収容部１１の一つと薬物Ｄａを収容した袋状収容部１２ａの一つとから構成される経口投与製剤１，２の製造方法及び製造装置を例示したが、以下では、図１８乃至図２０に例示するように、一つの袋状収容部１１と二つの袋状収容部１２ａ，１２ｂとからなる経口投与製剤３を製造する製造方法及び製造方法について説明する。ここで、図１８は経口投与製剤３の平面図であり、図１９は図におけるＹ－Ｙ線断面図であり、図２０は経口投与製剤シート５３の平面図である。なお、図１９では、構成を明示するため厚さ方向の寸法を誇張して表している。また、図１８及び図２０において網掛けを施した部分は、可食フィルム１０が圧着されている圧着部を図示したものである。 In said embodiment, the manufacturing method and manufacturing apparatus of the oral administration formulation 1 and 2 comprised from one of the bag-shaped accommodating parts 11 which accommodated the aqueous liquid W, and one of the bag-shaped accommodating parts 12a which accommodated the medicine Da. Although illustrated, in the following, as illustrated in FIGS. 18 to 20, a manufacturing method and a manufacturing method for manufacturing an orally-administered preparation 3 including one bag-shaped container 11 and two bag-shaped containers 12 a and 12 b. Will be described. Here, FIG. 18 is a plan view of the orally-administered preparation 3, FIG. 19 is a cross-sectional view taken along line YY in the figure, and FIG. 20 is a plan view of the orally-administered preparation sheet 53. In FIG. 19, the dimension in the thickness direction is exaggerated to clearly show the configuration. Further, the shaded portions in FIGS. 18 and 20 illustrate the crimping portion to which the edible film 10 is crimped.
　この経口投与製剤３は、図１８に示すように、経口投与製剤１に更に薬物Ｄｂを収容する袋状収容部１２ｂが連設された構成であり、袋状収容部１２ｂは袋状収容部１１に対して袋状収容部１２ａとは反対側に設けられている。また、袋状収容部１２ｂでは、水溶性の可食フィルム１０の外側に腸溶性層２２が積層されている。また、袋状収容部１２ｂには薬物Ｄｂが収容されている薬物Ｄｂと、袋状収容部１２ａに収容されている薬物Ｄａとでは、薬物成分の種類が異なっている。 As shown in FIG. 18, the orally administered preparation 3 has a configuration in which a bag-like accommodation portion 12 b that accommodates the drug Db is further connected to the oral administration preparation 1, and the bag-like accommodation portion 12 b is a bag-like accommodation portion 11. On the other hand, it is provided on the opposite side to the bag-like storage portion 12a. Moreover, in the bag-shaped accommodating part 12b, the enteric layer 22 is laminated | stacked on the outer side of the water-soluble edible film 10. FIG. The type of drug component is different between the drug Db containing the drug Db in the bag-shaped container 12b and the drug Da stored in the bag-shaped container 12a.
　上記構成の経口投与製剤３を製造するためには、図３を用いて説明した製造方法に、腸溶性層２２を積層する工程を付加する必要がある。腸溶性層２２の積層は、水溶性のフィルム形成剤溶液をベースフィルム上に流延する流延工程Ｓ２に先立ち、袋状収容部１２ｂが形成されることとなる位置のベースフィルム上に、腸溶性の材料の溶液を塗布、吹き付け、印刷等によって部分的にコーティングすることにより形成することができる。 In order to manufacture the oral administration preparation 3 having the above-described configuration, it is necessary to add a step of laminating the enteric layer 22 to the manufacturing method described with reference to FIG. Prior to the casting step S2 in which a water-soluble film forming agent solution is cast on the base film, the enteric layer 22 is laminated on the base film at a position where the bag-like accommodation portion 12b is to be formed. It can be formed by partially coating a solution of a soluble material by coating, spraying, printing or the like.
　また、経口投与製剤３の製造にあたっては、充填工程Ｓ８において、薬物Ｄａを充填する薬物充填装置、水系液体を充填する水系液体充填装置、薬物Ｄｂを充填する薬物充填装置がこの順に連設された充填装置を用いることにより、袋状収容部１２ａ、袋状収容部１１、袋状収容部１２ｂが、この順に一単位として繰り返し連設された経口投与製剤シート５３を製造することができる。更に、切断工程Ｓ１１において、図２０に一点鎖線３２で示したような、三つの袋状収容部１１，１２ａ，１２ｂを囲繞する大きさの波形形状の刃部を有する切断装置を使用して、経口投与製剤シート５３の切断を行うことにより、経口投与製剤３を製造することができる。なお、袋状収容部１２ａと袋状収容部１１、袋状収容部１１と袋状収容部１２ｂとの間に、ミシン目４１を設けることができる。 In the production of the orally administered preparation 3, in the filling step S8, a drug filling device for filling the drug Da, an aqueous liquid filling device for filling the aqueous liquid, and a drug filling device for filling the drug Db were connected in this order. By using the filling device, it is possible to manufacture an orally-administered preparation sheet 53 in which the bag-shaped container 12a, the bag-shaped container 11 and the bag-shaped container 12b are repeatedly arranged as one unit in this order. Further, in the cutting step S11, using a cutting device having a corrugated blade portion of a size surrounding the three bag- like storage portions 11, 12a, 12b, as shown by a one-dot chain line 32 in FIG. By orally cutting the oral administration preparation sheet 53, the oral administration preparation 3 can be produced. A perforation 41 can be provided between the bag-shaped storage portion 12a and the bag-shaped storage portion 11, and between the bag-shaped storage portion 11 and the bag-shaped storage portion 12b.
　上記のように製造された経口投与製剤３によれば、袋状収容部１２ｂの外側に腸溶性層２２が設けられていることにより、薬物Ｄｂ自体は水溶性であっても、薬物Ｄｂを腸で吸収させることができる。 According to the orally administered preparation 3 produced as described above, the enteric layer 22 is provided on the outside of the bag-like container 12b, so that the drug Db is insoluble in the intestine even if the drug Db itself is water-soluble. Can be absorbed.
　また、腸溶性層２２が外側に積層された袋状収容部１２ｂは、口腔内では溶解または崩壊しないため、そのままでは飲み込みにくいが、隣接している水系液体Ｗを収容した袋状収容部１１から水分が供給されるため、別途水などを用意しなくても、容易に袋状収容部１２ｂを嚥下することができる。更に、二つの袋状収容部１２ａ，１２ｂにそれぞれ収容された異なる種類の薬物Ｄａ，Ｄｂを、一つの袋状収容部１１に収容された水系液体Ｗによって同時に服用することができる。 In addition, the bag-like container 12b with the enteric layer 22 laminated on the outside does not dissolve or collapse in the oral cavity, so it is difficult to swallow as it is, but from the bag-like container 11 containing the adjacent aqueous liquid W Since moisture is supplied, the bag-like container 12b can be swallowed easily without preparing water or the like separately. Furthermore, the different types of drugs Da and Db respectively stored in the two bag-shaped storage portions 12a and 12b can be simultaneously taken by the aqueous liquid W stored in the single bag-shaped storage portion 11.
　加えて、同時に服用された薬物Ｄａ，Ｄｂであっても、一方の薬物Ｄａを口腔内の粘膜から吸収させ、他方の薬物Ｄｂを腸から吸収させることができる。ここで、薬物が口腔内の粘膜から吸収される場合は、胃や腸など体内で薬物が吸収される場合よりも急激に薬効が現れることがある。そのため、薬物成分を人体に徐々に作用させる方が適している薬物の場合は、腸溶性層２２が積層された袋状収容部１２ｂに収容し、即効性が必要とされる薬物の場合は、水溶性の袋状収容部１２ａに収容させることができる。なお、腸溶性層２２の代わりに胃溶性層を積層することもできる。 In addition, even if the drugs Da and Db are taken at the same time, one drug Da can be absorbed from the mucous membrane in the oral cavity and the other drug Db can be absorbed from the intestine. Here, when the drug is absorbed from the mucous membrane in the oral cavity, the drug effect may appear more rapidly than when the drug is absorbed in the body such as the stomach or intestine. Therefore, in the case of a drug that is more suitable for the drug component to act gradually on the human body, the enteric layer 22 is accommodated in the laminated bag-shaped accommodating portion 12b, and in the case of a drug that requires immediate effect, It can be accommodated in the water-soluble bag-like accommodation portion 12a. A gastric layer may be laminated instead of the enteric layer 22.
　上記では平板体抜取工程の後、開放された開口部から袋状収容部に薬物を充填する薬物充填工程が行われる第一実施形態の製造方法について説明したが、次に、第二実施形態の製造方法について、図２１を用いて説明する。第二実施形態の製造方法が第一実施形態の製造方法と相違する点は、薬物充填工程の後に平板体抜取工程が行われる点と、薬物充填工程が第一圧着工程の直後（第一圧着工程とほぼ同時）に行われる点である。なお、以下では、第一実施形態と同一の構成については同一の符号を付し、詳細な説明は省略する。 In the above description, the manufacturing method of the first embodiment in which the drug filling step of filling the bag-shaped container with the drug from the opened opening is performed after the flat plate extraction step. The manufacturing method will be described with reference to FIG. The difference between the manufacturing method of the second embodiment and the manufacturing method of the first embodiment is that the plate body extraction step is performed after the drug filling step, and the drug filling step is immediately after the first pressure bonding step (the first pressure bonding step). It is performed at almost the same time as the process. In the following, the same components as those in the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.
　第二実施形態の製造方法では、図４乃至図６で例示した平板体７２に換えて、図２１に示すように、抜き取られる方向と略一致する方向に貫通した貫通孔７２ｐを具備する平板体７２’を使用する。本実施形態では、六枚の平板体７２’が連結バー７２ｄを介して連結されているものを例示する。 In the manufacturing method of the second embodiment, instead of the flat plate 72 illustrated in FIGS. 4 to 6, as shown in FIG. 21, a flat plate having a through-hole 72 p that penetrates in a direction substantially coinciding with the direction to be extracted. 72 'is used. In the present embodiment, an example is shown in which six flat plates 72 'are connected via a connecting bar 72d.
　このような構成の平板体７２’を用いることにより、二枚の可食フィルム１０の間に平板体７２’を介在させた状態で、一対の三方圧着型７１で押圧し、袋状収容部が形成された直後に、充填装置７５によって薬物及び水系液体を充填することができる。すなわち、第一圧着工程と、薬物及び水系液体を充填する充填工程とを、ほぼ同時に行うことができる。これにより、本実施形態の製造方法によれば、効率的に経口投与製剤を製造することができる。また、薬物及び水系液体を袋状収容部に充填する際、平板体７２’の貫通孔７２ｐがガイド的な作用を奏するため、袋状収容部の内部に薬物及び水系液体を、より容易に、確実に充填することができる。 By using the flat plate 72 ′ having such a configuration, the flat plate 72 ′ is interposed between the two edible films 10 and pressed by the pair of three-way crimping molds 71. Immediately after being formed, the filling device 75 can fill the drug and the aqueous liquid. That is, the first pressure bonding step and the filling step for filling the drug and the aqueous liquid can be performed almost simultaneously. Thereby, according to the manufacturing method of this embodiment, an oral administration formulation can be manufactured efficiently. In addition, when filling the bag-shaped container with the drug and aqueous liquid, the through-hole 72p of the flat plate 72 'has a guiding action, so that the drug and aqueous liquid can be more easily contained in the bag-shaped container. It can be filled reliably.
　以上、本発明について好適な実施形態を挙げて説明したが、本発明は上記の実施形態に限定されるものではなく、以下に示すように、本発明の要旨を逸脱しない範囲において、種々の改良及び設計の変更が可能である。 The present invention has been described with reference to the preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various improvements can be made without departing from the scope of the present invention as described below. And design changes are possible.
　例えば、三方圧着型及び開口部圧着型の押圧面の形状や、切断装置の刃部の形状は、上記のような波形の形状に限定されるものではない。例えば、三方圧着型及び開口部圧着型の押圧面の内周形状や、切断装置の刃部の形状を略四角形にすることができる。これにより、図２２に示すように、それぞれ略四角形の液体収容部１５と薬物収容部１６とが交互に連設された製剤シート５４を製造することができる。このとき、三方圧着型及び開口部圧着型の押圧面を合わせた形状の外形を可食フィルムの外形より小さくすることにより、液体収容部１５及び薬物収容部１６のそれぞれにおいて、圧着部の外側に非圧着部３９を設けると好適である。また、切断工程で図示一点鎖線３４に沿って製剤シート５４をカットし、一単位の経口投与製剤４を切り離しても、図示一点鎖線３４をカット用のミシン目や切込み線としても良い。また、切断工程で折畳み用のミシン目４１を設けることもできる。 For example, the shape of the pressing surface of the three-way crimping die and the opening crimping die and the shape of the blade of the cutting device are not limited to the corrugated shape as described above. For example, the inner peripheral shape of the pressing surface of the three-way crimping die and the opening crimping die and the shape of the blade portion of the cutting device can be made substantially rectangular. Thereby, as shown in FIG. 22, the formulation sheet | seat 54 by which the substantially square liquid storage part 15 and the medicine storage part 16 were alternately connected by each can be manufactured. At this time, by reducing the outer shape of the combined shape of the pressing surfaces of the three-sided crimping type and the opening crimping type to the outer shape of the edible film, the liquid containing part 15 and the drug containing part 16 are respectively outside the crimping part. It is preferable to provide a non-crimped portion 39. Further, even if the preparation sheet 54 is cut along the dotted line 34 in the cutting process and the unit dosage preparation 4 is cut off, the dotted line 34 may be used as a perforation or a cut line for cutting. Moreover, the perforation 41 for folding can also be provided at a cutting process.
　このように、液体収容部１５及び薬物収容部１６の周縁に非圧着部３９を設けることにより、経口投与製剤４の口腔内での感触がやわらかなものとなると同時に、服用する際の手の感触や見た目もやわらかくなる。これにより、経口投与製剤１，２，３のように外形を波形や丸みを帯びた形状にしなくても、抵抗感なく、服用し易い経口投与製剤４を製造することができる。また、三方圧着型及び開口部圧着型の形状は単純な四角形であるため、型の製造が容易であると共に、コストを抑えることができる。加えて、経口投与製剤の外形を波形や丸みを帯びた形状にする場合とは異なり、フィルムの端部や角部を切除して廃棄する必要がないため、資源を無駄なく有効に利用することができる。 Thus, by providing the non-crimping part 39 at the periphery of the liquid storage part 15 and the drug storage part 16, the feel of the oral dosage form 4 in the oral cavity becomes soft, and at the same time, the hand feel when taking it And it looks softer. Thereby, even if it does not make the external shape into a waveform or a round shape like the oral administration preparations 1, 2, and 3, the oral administration preparation 4 that is easy to take without resistance can be produced. Moreover, since the shape of the three-way crimping die and the opening crimping die is a simple quadrangle, the die can be easily manufactured and the cost can be reduced. In addition, unlike the case where the oral dosage form has a corrugated or rounded shape, it is not necessary to cut and discard the edges and corners of the film, so resources should be used effectively without waste. Can do.
　また、製造工程に、可食インキを用いた印刷、金・銀等の可食性金属の箔押し加工、可食性の色箔の箔押し加工を可食フィルムに施す工程を更に付加することにより、経口投与製剤に文字情報や記号等を表示することができる。これにより、例えば、白い粉末剤など外見上で区別し難い薬物が収容される場合であっても、表示によって識別することが可能となり、経口投与製剤の誤用を防止することができる。なお、可食性の色箔の箔押しは、セラック、ツェイン等の可食性の接着材に可食性の色素等が混合された着色層が設けられた箔押し材を、可食フィルムに加熱圧着することにより行うことができる。 Oral administration by adding additional steps to the edible film, such as printing with edible ink, stamping with edible metals such as gold and silver, and foil pressing with edible color foil. Character information, symbols, etc. can be displayed on the preparation. Thereby, for example, even when a drug that is difficult to distinguish in appearance, such as a white powder, is contained, it can be identified by display, and misuse of the oral administration preparation can be prevented. In addition, foil pressing of edible color foil is performed by heat-pressing a foil pressing material provided with a colored layer in which an edible dye or the like is mixed in an edible adhesive material such as shellac or zein to a edible film. It can be carried out.

Claims (5)

  1. 　平板体を介在させた状態で二重に重ね合わされた可食フィルムを圧着し、三方が閉塞されると共に一方向に開口部を有する袋状収容部を形成する第一圧着工程と、
    　該第一圧着工程で形成された前記袋状収容部から前記開口部を介して前記平板体を抜き取る平板体抜取工程と、
    　前記開口部から袋状収容部の内部に薬物を充填する薬物充填工程と、
    　該薬物充填工程で薬物が充填された前記袋状収容部の前記開口部を圧着する第二圧着工程と
    を具備することを特徴とする経口投与製剤の製造方法。     A first crimping step of crimping an edible film that is double-layered with a flat plate interposed therebetween, and forming a bag-shaped accommodation portion having an opening in one direction while being closed on three sides;
    A flat plate extraction step of extracting the flat plate member from the bag-shaped housing portion formed in the first crimping step through the opening;
    A drug filling step of filling a drug into the bag-shaped container from the opening;
    And a second pressure-bonding step for pressure-bonding the opening of the bag-shaped container filled with the drug in the drug-filling step.
  2. 　前記平板体は抜き取られる方向と略一致する方向に貫通した貫通孔を具備し、
    　前記薬物充填工程は、前記平板体を二重に重ね合わされた前記可食フィルムの間に介在させた状態で、前記貫通孔を介して薬物を充填することにより行われる
    ことを特徴とする請求項１に記載の経口投与製剤の製造方法。     The flat plate has a through-hole penetrating in a direction substantially coinciding with the direction of extraction,
    The drug filling step is performed by filling the drug through the through-hole in a state where the flat plate is interposed between the edible films stacked in a double layer. 2. A method for producing the oral administration preparation according to 1.
  3. 　前記第一圧着工程及び前記第二圧着工程では、前記可食フィルムの圧着により形成される圧着部の外周の少なくとも一部に沿って、前記可食フィルムを圧着せず非圧着部を形成する
    ことを特徴とする請求項１または請求項２に記載の経口投与製剤の製造方法。     In the first pressure-bonding step and the second pressure-bonding step, a non-crimped portion is formed without crimping the edible film along at least a part of the outer periphery of the crimped portion formed by crimping the edible film. The method for producing an orally administered preparation according to claim 1 or 2, wherein:
  4. 　互いに離隔接近して二重に重ね合わされた可食フィルムを圧着し、三方が閉塞されると共に一方向に開口部を有する袋状収容部を形成する一対の三方圧着型と、
    　二重に重ね合わされた前記可食フィルムの間に挿入され、前記開口部を介して前記袋状収容部から抜き取られる平板体と、
    　前記開口部から袋状収容部の内部に薬物を充填する薬物充填装置と、
    　互いに離隔接近して前記開口部を圧着する一対の開口部圧着型と
    を具備することを特徴とする経口投与製剤の製造装置。     A pair of three-way crimping molds that crimps edible films that are double-layered close to each other and form a bag-shaped housing portion that is closed in three directions and has an opening in one direction;
    A flat plate inserted between the edible films that are doubled and pulled out from the bag-like accommodation portion through the opening,
    A drug filling device that fills the inside of the bag-like container from the opening with a drug;
    An apparatus for producing an oral administration preparation, comprising: a pair of opening crimping molds for crimping the opening by being spaced apart from each other.
  5. 　それぞれ相反する方向に回転する一対の第一無端ベルトと、
    　該第一無端ベルトと同一方向に回転する一対の第二無端ベルトを更に具備し、
    　前記三方圧着型は複数対が設けられ、複数対の各対では、一方の前記三方圧着型が、一対のうちの一方の前記第一無端ベルトに設けられていると共に、他方の前記三方圧着型が他方の第一無端ベルトに設けられており、
    　前記開口部圧着型は複数対が設けられ、複数対の各対では、一方の前記開口部圧着型が、一対のうちの一方の前記第二無端ベルトに設けられていると共に、他方の前記開口部圧着型が他方の第二無端ベルトに設けられている
    ことを特徴とする請求項４に記載の経口投与製剤の製造装置。     A pair of first endless belts each rotating in opposite directions;
    A pair of second endless belts rotating in the same direction as the first endless belt;
    The three-way crimping die is provided with a plurality of pairs, and in each of a plurality of pairs, one of the three-way crimping die is provided on one of the pair of the first endless belts and the other of the three-way crimping die. Is provided on the other first endless belt,
    The opening crimping die is provided with a plurality of pairs, and in each of the multiple pairs, one opening crimping die is provided on one second endless belt of the pair, and the other opening. The apparatus for producing an oral administration preparation according to claim 4, wherein the partial crimping die is provided on the other second endless belt.
PCT/JP2008/056868 2008-04-07 2008-04-07 Process for producing medicinal preparation for oral administration and apparatus for producing medicinal preparation for oral administration WO2009125465A1 (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016520483A (en) * 2013-04-19 2016-07-14 リデュー マシーナリー インク Creating a water-soluble pouch
WO2020245593A1 (en) * 2019-06-06 2020-12-10 Pa Knowledge Limited Tea bags and the infusion pads and method of making them
US20210030668A1 (en) * 2018-01-26 2021-02-04 Lts Lohmann Therapie-Systeme Ag Multi-layer oral thin film

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2836291A (en) * 1956-08-13 1958-05-27 Pad Y Wax Company Inc Edible strip package and method of making same
US3596428A (en) * 1968-10-07 1971-08-03 American Maize Prod Co Packaging process and apparatus
JPS55121070U (en) * 1979-02-21 1980-08-27
JP2007269408A (en) * 2006-01-27 2007-10-18 Topack Co Ltd Filling and packaging device and filling and packaging method

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2836291A (en) * 1956-08-13 1958-05-27 Pad Y Wax Company Inc Edible strip package and method of making same
US3596428A (en) * 1968-10-07 1971-08-03 American Maize Prod Co Packaging process and apparatus
JPS55121070U (en) * 1979-02-21 1980-08-27
JP2007269408A (en) * 2006-01-27 2007-10-18 Topack Co Ltd Filling and packaging device and filling and packaging method

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016520483A (en) * 2013-04-19 2016-07-14 リデュー マシーナリー インク Creating a water-soluble pouch
US20210030668A1 (en) * 2018-01-26 2021-02-04 Lts Lohmann Therapie-Systeme Ag Multi-layer oral thin film
WO2020245593A1 (en) * 2019-06-06 2020-12-10 Pa Knowledge Limited Tea bags and the infusion pads and method of making them

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