WO2009125465A1 - Procédé de production d'une préparation médicinale pour administration orale et appareil de production d'une préparation médicinale pour administration orale - Google Patents

Procédé de production d'une préparation médicinale pour administration orale et appareil de production d'une préparation médicinale pour administration orale 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
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English (en)
Japanese (ja)
Inventor
月岡　忠夫
美佐夫 西村
Original Assignee
株式会社ツキオカ
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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/fr
Publication of WO2009125465A1 publication Critical patent/WO2009125465A1/fr

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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
    • 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
    • B29C66/05—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
    • 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
    • B29C66/40—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
    • 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
    • B29C66/40—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
    • 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
    • B29C66/70—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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    • B29K2995/0037—Other properties
    • 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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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un appareil de production d'une préparation médicinale pour administration orale, qui comprend : deux moules (71) à trois côtés de liaison à la presse, écartés l'un de l'autre et approchés l'un de l'autre pour relier par compression deux films comestibles tournés l'un vers l'autre et ainsi former des parties de retenue en forme de sac fermées sur trois côtés et présentant une ouverture sur le côté restant, des éléments plats (72) insérés entre les deux films comestibles placés l'un en face de l'autre et extraits des parties de retenue en forme de sac à travers les ouvertures, un dispositif de chargement de médicament qui charge un médicament dans les parties de retenue en forme de sac par les ouvertures et deux moules (73) de fermeture à la presse des ouvertures, qui sont écartés et approchés l'un de l'autre pour fermer les ouvertures par compression.
PCT/JP2008/056868 2008-04-07 2008-04-07 Procédé de production d'une préparation médicinale pour administration orale et appareil de production d'une préparation médicinale pour administration orale WO2009125465A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2008/056868 WO2009125465A1 (fr) 2008-04-07 2008-04-07 Procédé de production d'une préparation médicinale pour administration orale et appareil de production d'une préparation médicinale pour administration orale

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2008/056868 WO2009125465A1 (fr) 2008-04-07 2008-04-07 Procédé de production d'une préparation médicinale pour administration orale et appareil de production d'une préparation médicinale pour administration orale

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016520483A (ja) * 2013-04-19 2016-07-14 リデュー マシーナリー インク 水溶性パウチの作成
WO2020245593A1 (fr) * 2019-06-06 2020-12-10 Pa Knowledge Limited Sachets et dosettes d'infusion de thé, et procédé de fabrication associé
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 (fr) * 1979-02-21 1980-08-27
JP2007269408A (ja) * 2006-01-27 2007-10-18 Topack Co Ltd 充填包装装置及び充填包装方法

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 (fr) * 1979-02-21 1980-08-27
JP2007269408A (ja) * 2006-01-27 2007-10-18 Topack Co Ltd 充填包装装置及び充填包装方法

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016520483A (ja) * 2013-04-19 2016-07-14 リデュー マシーナリー インク 水溶性パウチの作成
US20210030668A1 (en) * 2018-01-26 2021-02-04 Lts Lohmann Therapie-Systeme Ag Multi-layer oral thin film
WO2020245593A1 (fr) * 2019-06-06 2020-12-10 Pa Knowledge Limited Sachets et dosettes d'infusion de thé, et procédé de fabrication associé

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