WO2014064840A1 - Device for oral drug administration - Google Patents

Device for oral drug administration Download PDF

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Publication number
WO2014064840A1
WO2014064840A1 PCT/JP2012/077757 JP2012077757W WO2014064840A1 WO 2014064840 A1 WO2014064840 A1 WO 2014064840A1 JP 2012077757 W JP2012077757 W JP 2012077757W WO 2014064840 A1 WO2014064840 A1 WO 2014064840A1
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WO
WIPO (PCT)
Prior art keywords
drug
medium
viscous medium
administration device
oral
Prior art date
Application number
PCT/JP2012/077757
Other languages
French (fr)
Japanese (ja)
Inventor
修司 盛本
豊 作間
Original Assignee
株式会社モリモト医薬
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 株式会社モリモト医薬 filed Critical 株式会社モリモト医薬
Priority to PCT/JP2012/077757 priority Critical patent/WO2014064840A1/en
Priority to JP2014543107A priority patent/JP5897145B2/en
Publication of WO2014064840A1 publication Critical patent/WO2014064840A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093Containers having several compartments for products to be mixed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015Devices specially adapted for taking medicines
    • A61J7/0053Syringes, pipettes or oral dispensers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06Ampoules or carpules
    • A61J1/067Flexible ampoules, the contents of which are expelled by squeezing

Definitions

  • the present invention relates to a drug oral administration device for orally administering a drug, and particularly to a device for forming a drug-coated medium in which a plurality of coated drugs are integrated after coating each drug.
  • the container 11 of the viscous drug product 10 is a container in which the surface and the back of a pair of sheets made of, for example, polypropylene or polyethylene are bonded together, and a sealed space 12 is formed between the pair of sheets.
  • the structure of the container 11 is not restricted to said thing, What is necessary is just to have the space sealed in the inside.
  • the sealed space of the container 11 is divided into a liquid compartment 12a and a medicine compartment 12b by a separator 13.
  • a separator 13 For example, when the pressure in the liquid separating section 12a increases, the separating section 13 is formed so that the liquid compartment 12a and the medicine compartment 12b communicate with each other.
  • Liquid compartment 12a For example, a liquid 5 such as purified water, soft drinks such as tea and juice is accommodated in the container.
  • the medicine compartment 12b Contains the above-mentioned viscous pharmaceutical preparation 1 of the present invention.
  • the aforementioned viscous drug product 10 has the following points to be improved.
  • Liquid compartment 12a When the container 11 is strongly grasped by hand, the isolation part 13 is destroyed and the liquid 5 contained in the container 5 and the viscous drug preparation 1 contained in the medicine compartment 12b are mixed. That is, the isolation part 13 is formed so as to be in close contact with a force that can be gripped with a hand.
  • the present invention provides a drug coating in which a drug and a viscous medium are separately stored and portable, and each drug is coated and integrated with a plurality of drugs when orally administered. It is an object of the present invention to provide an oral drug administration device that can easily form a medium and can be administered orally.
  • a device for oral administration of a drug according to the present invention is a viscous medium for coating drugs including for replenishing drugs and predetermined nutrients, and forms a drug-coated medium integrated with the coated drugs.
  • a viscous medium, a medium enclosing portion for enclosing the viscous medium, and a drug-viscosity medium fusion portion located adjacent to the medium enclosing portion and closed at a strength of 15 gf / 15 mm to 300 gf / 15 mm -It has a fusion
  • each drug is coated with the drugs and the viscous medium, and a drug-coated medium integrated with the coated drugs can be easily formed. Can do. By using a drug-coated medium, even if it is difficult for a person who is difficult to swallow the drug alone, the drug can be easily administered orally.
  • the oral drug administration device is a cover portion disposed at a first end portion formed on a side where the cover portion is disposed, and has a second end different from the first end portion.
  • a cover portion having an opening for storing an end portion for storing the portion.
  • the first end and the second end can be folded in two. Therefore, the pharmaceutical oral administration device can be miniaturized.
  • the oral drug administration device has a tip insertion portion that forms the second end portion, and has a tip insertion portion that is inserted into and stored in the end portion storage opening.
  • the oral drug administration device can be easily folded in two.
  • the oral drug administration device is bent at the boundary between the medicinal / viscous medium fusion portion and the medium enclosing portion when the tip insertion portion is inserted into the end storage opening.
  • the oral drug administration device is folded at the boundary between the fusion part between the drug and the viscous medium and the medium enclosing part, and is in a folded state. There is no movement in the direction of the fusion part between viscous media. Therefore, it is possible to prevent the viscous medium from breaking the fusion of the drug-viscous medium fusion part in the folded state.
  • the cover part further overlaps the medium enclosure part and the medicine enclosure part formed in a state where the tip insertion part is housed in the end housing opening.
  • the medicine encapsulating part further includes a compensation fusion part that is closed with a strength of 15 gf / 15 mm to 300 gf / 15 mm.
  • the viscous medium breaks the fusion of the fusion part between the drug and the viscous medium, the viscous medium can be prevented from reaching the position where the drugs are present.
  • the viscous medium is a frustoconical measuring container
  • the diameter of the upper base is 58 mm
  • the diameter of the lower base is 43 mm
  • the height is 30 mm
  • the measurement container made of polyethylene having a predetermined line at the position of the side surface is arranged on the surface of the viscous medium, and a predetermined weight is slowly placed on the measurement container, and the measurement container
  • the withstand load measured by reading the weight of the weight when the line is the same height as the surface of the viscous medium is 10 to 1000 g.
  • the viscous medium is filled in the entire medium enclosing part by filling the medium enclosing part with the liquid viscous medium and then gelling the medium after a predetermined cooling period.
  • the load resistance is 20 g to 1000 g.
  • the viscous medium is formed as one lump in the whole medium enclosing part, it is possible to easily form a drug-coated medium that is easy for a user to swallow during oral administration.
  • the viscous medium is filled with the liquid viscous medium in a predetermined container, gelled after a predetermined cooling period, and then cut into a predetermined size.
  • the load resistance is 10 g to 150 g.
  • any of the oral drug administration devices according to the present invention has predetermined drugs.
  • FIG. 1 is an external view of an oral drug administration device 100 that is an embodiment of an oral drug administration device according to the present invention. It is a figure which shows the shape and usage method of the load bearing container P, A is a top view of the load bearing container P, B is a front view of the load bearing container P, C is a bottom view of the load bearing container P, D is The figure which shows the usage method of the load-bearing container P is shown, respectively. It is a figure which shows the dosing experiment of a viscous medium, A is the kind of viscous medium to be used, B is the result of an experiment, C is the relationship between the load resistance in an experiment, and take-out property, D is the load resistance and residual property in an experiment The relationship is shown respectively.
  • FIG. 1 is an external view of an oral drug administration device 200 that is an embodiment of an oral drug administration device according to the present invention.
  • FIG. It is a figure which shows the usage method of the chemical
  • medical agent oral administration apparatus. 1 is an external view of an oral drug administration device 300 that is an embodiment of an oral drug administration device according to the present invention.
  • FIG. 1 is an external view of an oral drug administration device 400 that is an embodiment of an oral drug administration device according to the present invention.
  • FIG. It is an experimental result for determining the appropriate fusion strength of the fusion
  • FIG. It is a figure which shows the prior art of a chemical
  • a drug oral administration device 100 which is an embodiment of a drug oral administration device according to the present invention, will be described with reference to FIG.
  • the oral drug administration device 100 is formed by forming a single sheet into a cylindrical shape by fusing the ends located opposite to each other by heat.
  • the sheet used is made of, for example, polypropylene or polyethylene.
  • the drug oral administration device 100 includes a drug enclosure 101, a medium enclosure 103, a tip insertion part 105, a cover 107, and a drug / viscous medium fusion part 109.
  • the medicine enclosure part 101, the medium enclosure part 103, the tip insertion part 105, and the cover part 107 are positioned in a straight line.
  • the medicine enclosure part 101 and the medium enclosure part 103 are located adjacent to the vicinity of the center of the oral medicine administration device 100.
  • Tip insertion portion The tip insertion portion 105 forms an end portion different from the end portion formed by the cover portion 107 in the oral medicine administration device 100.
  • the cover unit 107 is located adjacent to the medium enclosure unit 103.
  • the cover part 107 forms the other edge part different from the edge part which the front-end
  • the encapsulated drug may have any shape such as a tablet, a capsule, or a granule.
  • the tablet T is illustrated as a chemical
  • a viscous medium having a predetermined viscosity and covering each individual drug and forming a drug-coated medium integrated with the coated drug is encapsulated.
  • so-called jelly is used as the viscous medium.
  • the drug enclosing part 101 and the viscous medium enclosing part 103 are adjacent to each other via the drug / viscous medium fusion part 109.
  • the drug / viscous medium fusion part 109 is formed by placing the viscous medium in the medium sealing part 103 and then fusing the sheet with heat.
  • the drug / viscous medium fusion part 109 is formed to have such a fusion strength that the fusion is peeled off when the internal pressure of the viscous medium enclosing part 103 becomes higher than a predetermined value.
  • the viscous medium enclosing part 103 and the cover part 107 are adjacent to each other through the adhesive part 113 between the viscous medium and the cover part. Similar to the drug / viscous medium fusion part 109, the viscous medium / cover fusion part 113 is formed by fusing a sheet with heat. However, the viscous medium / cover fusion part 113 is fused before the viscous medium is placed in the medium sealing part 103.
  • the fusion part 113 between the viscous medium and the cover part is fused so as to have a stronger strength than the fusion part 109 between the drug and the viscous medium.
  • the viscous medium sealing portion 103 to a predetermined internal pressure, the fusion between the viscous medium / cover portion fusion portion 113 is maintained and the fusion between the drug / viscous medium fusion portion 109 is peeled off. Can do.
  • the viscous medium located in the viscous medium enclosing part 103 can be moved in the direction of the medicine enclosing part 103 instead of in the direction of the cover part 107.
  • the tip insertion portion 105 is formed so as to be inclined toward an end portion different from the end portion adjacent to the medicine enclosure portion 101. Thereby, the front-end
  • the tip insertion portion 105 can be easily inserted into the oral cavity of a patient who is orally administering a drug. Furthermore, when the distal end insertion part 105 is inserted into the patient's oral cavity, the distal end insertion part 105 can be made into a shovel shape, so that the medicine-coated medium of the medicine and the viscous medium can be easily inserted into the patient's oral cavity.
  • tip insertion part 105 is formed in the length of the grade which does not touch a throat when it inserts in an oral cavity so that it can insert in a patient's oral cavity.
  • the distal end insertion part 105 is inserted into the distal end insertion part storage opening 117 during storage, maintaining the folded state of the oral drug administration device 100, and bringing the pharmaceutical coating medium into the oral cavity. It is designed for easy oral administration.
  • the cover portion 107 has an opening 117 for storing the distal end insertion portion.
  • the leading end insertion portion storage opening 117 is formed on one side of the cover portion 117, which is one of the sheets positioned opposite to each other.
  • the distal end insertion portion storage opening 117 is formed as a semicircular cutout.
  • the viscous medium If the viscosity or load resistance is too small or too large, the viscous medium tends to cause some problems when swallowing the orally administered drug-coated medium. Therefore, the viscous medium needs to have an appropriate load capacity. Therefore, a dosing experiment was conducted to determine an appropriate load capacity of the viscous medium.
  • the following load-bearing experiment was performed on the viscous medium.
  • the medium enclosure 103 is filled with a liquid test viscous medium after filling the medium enclosure 103, and then gelled after a predetermined cooling period.
  • the medium is cut into a predetermined size and placed in the medium enclosure 103 Some are enclosed.
  • the former is described as an integrated viscous medium, and the latter is described as a cutting-type viscous medium.
  • a predetermined viscous medium (hereinafter referred to as a test viscous medium) is placed in a predetermined container.
  • the viscosity of the test viscous medium is measured in advance using a B-type viscometer.
  • the load-bearing measurement container P with a red line on the side surface is placed on the test viscous medium placed in the container.
  • the load resistance measuring container P will be described with reference to FIG. In FIG.
  • A is a top view of the load-bearing measuring container P
  • B is a front view of the load-bearing measuring container P
  • C is a bottom view of the load-bearing measuring container P.
  • the load-bearing measurement container P has a truncated cone shape with an upper bottom diameter of 58 mm, a lower bottom diameter of 43 mm, and a height of 30 mm, and has a predetermined red line L at a side surface position of 10 mm from the bottom.
  • the load resistance measuring container P is made of polyethylene and has a weight of 1.9 g. (3) The weight W is slowly placed on the load resistance measurement container P. (4) As shown in FIG.
  • Dosing experiment 1 (1) Prepare integrated viscous media G1 to G7 having load resistance shown in FIG. 3A. (2) The oral drug administration device 100 (hereinafter referred to as “the medicine oral administration device 100”) in which each of the integrated viscous media G1 to G7 is enclosed in the medium enclosing unit 103, and the drug enclosing a predetermined powdery drug in a predetermined oblate is disposed in the medium enclosing unit 103 A predetermined number of test drug oral administration devices A) are prepared for each of the integrated viscous media G1 to G7. (3) A predetermined number of users take the drug using the test drug oral administration device A, and each user evaluated the test drug oral administration device A from the viewpoint of the ability to remove from the medium enclosure 103.
  • the take-out property is an evaluation of the ease of taking-out when the user moves the medicine-coated medium formed in the medicine-filling part 101 toward the tip insertion part 105 by the sense of the user. In the evaluation, the evaluation is made in five steps based on 5: easy to take out to 1: difficult to take out.
  • Each user further evaluated the test drug oral administration device A from the viewpoint of the persistence from the medium enclosure 103.
  • the persistence is an evaluation based on the sensation of the user whether or not the sensation remains in the mouth and throat after the user has taken the drug-coated medium. Shows the percentage of people judged to be.
  • the average value of each user's evaluation is calculated. As for the persistence, the ratio of the number of users who have a feeling of persistence for each of the integrated viscous media G1 to G7 is calculated as the residual rate.
  • FIG. 3B shows the result of the experiment.
  • FIG. 3C shows the relationship between the load resistance and the take-out property in FIG. 3B
  • FIG. 3D shows the relationship between the load resistance and the persistence in FIG. 3B.
  • the viscous medium G7 is particularly inferior in terms of take-out property. As shown in FIG. 3D, the viscous medium G7 is also inferior in terms of persistence. Therefore, it is considered appropriate that the lower limit of the load resistance in the integrated viscous medium is 20 g.
  • Dosing experiment 2 (1) Prepare integrated viscous media H1 to H5 having load resistance shown in FIG. 4A. (2) Oral drug administration device 100 (hereinafter referred to as test drug oral administration device B) in which each integrated viscous medium H1 to H7 is enclosed in medium enclosing unit 103 and a predetermined tablet or capsule drug is arranged in medium enclosing unit 103. ) Is prepared for each of the integrated viscous media H1 to H5. (3) A prescribed name of a user takes a drug using the test drug oral administration device B, and each doser evaluates the test drug oral administration device A from the viewpoint of the ingestibility from the medium enclosure 103. .
  • the ingestion refers to the feeling of resistance over the throat when the user swallows the drug-coated medium.
  • 5 no resistance at all
  • 4 almost no resistance
  • 3 sensation in the throat, but normal drinking
  • 2 resistance, slightly large but can be swallowed
  • 1 resistance is very large or can not be drunk .
  • Each user further evaluated the test drug oral administration device B from the viewpoint of the persistence from the medium enclosure 103.
  • the dosing property and the residual rate are calculated.
  • FIG. 4B The result of the experiment is shown in FIG. 4B. Further, FIG. 4C shows the relationship between the load resistance and the take-out property in FIG. 4B, and FIG. 4D shows the relationship between the load resistance and the persistence in FIG. 4B.
  • the drug is a tablet or a capsule, the dosing property, the persistence, and the load resistance of the viscous medium are related. Furthermore, if the load bearing capacity of the viscous medium is too low or too high, the ingestibility and persistence tend to be poor. As shown in FIG. 4C and FIG. 4D, it is considered appropriate that the upper limit value of the load resistance in the integrated viscous medium is 1000 g from the viewpoint of dosing and persistence.
  • Dosing experiment 3 (1) Prepare cutting-type viscous media I1 to I13 having load resistance shown in FIG. (2) A drug oral administration device 100 (hereinafter referred to as a test drug oral administration device C) in which each of the cutting-type viscous media I1 to I13 is enclosed in the medium enclosure 103 and a predetermined tablet is placed in the medium enclosure 103 is A predetermined number is created for each of the body-shaped viscous media I1 to I13. (3) Using the test drug oral administration device C, a prescribed name of the user takes the drug, and each user evaluates the test drug oral administration device C from the viewpoint of the ingestibility from the medium enclosure 103 did. (4) The doseability is calculated in the same manner as in dose experiment 1.
  • FIG. 6 shows the relationship between the load resistance and the dose in FIG.
  • the ingestibility and the load resistance of the viscous medium are related. As the load resistance of the viscous medium increases, the dosing property improves, and when it increases, the dosing property tends to deteriorate. Based on FIG. 6, it is considered appropriate that the load resistance in the cut-type viscous medium is 10 g to 150 g from the viewpoint of dosing. In addition, the allowable lower limit value in the dosing property is set to “2”.
  • the viscous medium used in the oral drug administration device 100 is considered to have an allowable range of load resistance of 10 to 1000 g.
  • the load resistance is particularly preferably 20 to 1000 g.
  • the load resistance is particularly preferably 10 to 150 g.
  • the drug / viscous medium fusion part 109 is formed for the purpose of preventing leakage of the viscous medium from the medium enclosing part 103 when the drug oral administration device 100 is carried or transported. However, when the drug oral administration device 100 is used, it is necessary to form the drug / viscous medium fusion part 109 so that the viscous medium can be easily taken out from the medium enclosing part 103.
  • the viscous medium does not leak from the medium enclosing part 103 during carrying and transportation, and the viscous medium can be easily taken out from the medium enclosing part 103 during use. It is necessary to fuse the sheet.
  • test drug oral administration devices 100 The following four types of predetermined drug oral administration devices 100 (hereinafter referred to as test drug oral administration devices) are prepared.
  • Medium enclosure 103 width (inner diameter) 25 mm
  • Enclosed amount of viscous medium 3.5ml
  • Fusing strength of the drug-viscous medium fusion part 109 10 gf / 15 mm, 15 gf / 15 mm, 18 gf / 15 mm, 35 gf / 15 mm
  • FIG. 8 shows a graph of the experimental results.
  • a load of 10 kg may be applied to the medium enclosing portion 103 of the drug oral administration device 100 in a folded state. Therefore, it can be seen from FIG. 8 that when the fusion strength of the drug-viscous medium fusion part 109 is 10 gf / 15 mm or less, the viscous medium may leak from the medium enclosure part 103 during carrying and transportation.
  • the fusion strength of the drug-viscous medium fusion part 109 needs to be 15 gf / 15 mm or more, preferably 20 gf / 15 mm or more.
  • the take-out property is an evaluation of the ease with which the user moves the drug-coated medium formed in the drug enclosure part 101 toward the tip insertion part 105 by the user's sense.
  • the following six types of predetermined drug oral administration devices 100 (hereinafter referred to as test drug oral administration devices) are prepared.
  • Medium enclosing part 103 width (inner diameter) 25 mm ⁇
  • Enclosed amount of viscous medium 3.5ml -Fusion strength of the drug-viscous medium fusion part 109: 13 gf / 15 mm, 28 gf / 15 mm, 56 gf / 15 mm, 95 gf / 15 mm, 171 gf / 15 mm, 600 gf / 15 mm Cut to 15mm width and use the tensile strength measured by tensile test)
  • the take-out property is an evaluation of the ease with which the user moves the drug-coated medium formed in the drug enclosure part 101 toward the tip insertion part 105 by the user's sense. With respect to the take-out property, as a five-step evaluation, it is evaluated that 1: fusion strength is too small to 3: proper to 5: fusion strength is too large. (3) In the test drug oral administration device in the folded state, the load when the viscous medium leaks from the medium enclosure 103 via the drug / viscous medium fusion part 109 is applied to the medium enclosure 103. Measured as take-off load.
  • FIG. 8 and FIG. 8 and FIG. 10 are graphs showing the experimental results.
  • the appropriate range of takeout is considered to be 2-4. Therefore, from FIG. 8 and FIG. 10, it can be determined that 200 to 800 g for the take-out load and 30 to 300 gf / 15 mm for the tensile strength are appropriate. Preferably, it is considered that 3 to 3.5 is an appropriate range for the take-out property. Accordingly, it is considered that the take-out load is preferably 400 to 600 g and the tensile strength is preferably 80 to 160 gf / 15 mm, respectively.
  • the fusion strength of the drug-viscous medium fusion part 109 can be evaluated as appropriate with a fusion strength of 50 gf / 15 mm or more from the viewpoint of leakage of the viscous medium from the medium enclosure 103.
  • 20 gf / 15 mm or more can be evaluated as an allowable range.
  • the fusion strength of the drug / viscous medium fusion part 109 can be evaluated as appropriate from the viewpoint of the take-out property of the viscous medium from the medium enclosing part 103 with a fusion strength of 30 gf / 15 mm to 120 gf / 15 mm. From the user's feeling of use, 20 gf / 15 mm to 200 gf / 15 mm can be evaluated as an allowable range.
  • the drug oral administration device 100 needs to satisfy both the viewpoint of leakage of the viscous medium and the viewpoint of takeout property of the viscous medium. Therefore, the target Sena fusion strength of the drug / viscous medium fusion portion 109 can be determined to be 15 to 300 gf / 15 mm.
  • the oral medicine administration device 100 is provided to a user (hereinafter, encapsulator) who encapsulates the medicine in a state where a predetermined viscous medium is encapsulated in the viscous medium enclosure 103 in advance.
  • encapsulator who encapsulates the medicine in a state where a predetermined viscous medium is encapsulated in the viscous medium enclosure 103 in advance.
  • FIGS. 11 shows a state in which the oral drug administration device 100 is folded in half, A showing the state seen from the side, and B showing the state seen from above.
  • the encapsulator who intends to encapsulate the tablet T, which is a drug, in the drug oral administration device 100 puts the tablet T into the drug enclosing unit 101 via the tip insertion unit 115.
  • the tip insertion part 105 is expanded in a shovel shape, and the tablet T is put into the medicine enclosure part 101.
  • the enclosing person folds the medicine enclosing portion 101 and the distal end insertion portion 105 in the direction of the arrow a5, and the distal end of the distal end insertion portion 105 is notched for the distal end insertion portion 117a of the cover portion 107.
  • the pharmaceutical oral administration device 100 can be in a folded state as shown in FIG. 11B.
  • Oral administration stage The oral administration person who orally administers the drug stored in the drug oral administration device 100 or makes others oral, uses the drug oral administration device 100 in a folded state as shown in FIG. A planar state as shown in FIG.
  • the oral administration person pinches the viscous medium enclosing part 103 with a finger.
  • the pressure inside the viscous medium enclosure 103 increases.
  • the internal pressure of the viscous medium enclosing part 103 becomes higher than a predetermined level, the fusion between the drug / viscous medium fusion part 109 is peeled off, and the viscous medium located inside the medium enclosing part 103 moves toward the medicine enclosing part 101. .
  • a medicine covering medium can be generated by the medicine and the viscous medium located inside the medicine enclosure 101.
  • the medicine-coated medium in which the medicine is uniformly contained in the viscous medium can be generated by swallowing the medicine and the viscous medium.
  • the medicine coating medium is moved in the direction of the tip insertion part 105.
  • the drug-coated medium is orally administered from the tip of the tip insertion part 105.
  • the oral drug administration device 100 in Example 1 described above was miniaturized by folding in half when stored.
  • the oral drug administration device 200 in this embodiment is folded into four when stored and further downsized.
  • a drug oral administration device 200 which is an embodiment of a drug oral administration device according to the present invention, will be described with reference to FIG.
  • the oral drug administration device 200 includes a drug enclosure 201, a medium enclosure 103, a tip insertion section 205, and a cover 207.
  • the structure and function of the drug enclosure 201 are the same as those of the drug enclosure 101 in the first embodiment.
  • the medicine enclosure 201 has a notch 211 for cutting out the distal end insertion part.
  • the notch 211 for storing insertion excision is formed to excise the tip insertion part 205 when orally administering the drug-coated medium.
  • the structure and function of the tip insertion portion 205 are the same as those of the tip insertion portion 105 in the first embodiment. However, the tip insertion portion 205 is longer than the tip insertion portion 105. This is because the distal end insertion portion 205 is provided mainly for the purpose of maintaining the folded state of the oral drug administration device 200 by being inserted into the distal end insertion portion storage opening 117 during storage. is there.
  • the distal end insertion part 205 is formed longer than the distal end insertion part 105, the distal end of the distal end insertion part 205 may get caught in the throat during oral administration. In this case, it is possible to facilitate oral administration of the drug-coated medium by excising the distal end insertion part 205 from the storage insertion excision cutout 211 of the drug enclosure part 201.
  • the cover portion 207 has a tip insertion portion storage opening 117 and a medicine medium portion storage opening 217.
  • the medicine medium portion storage opening 217 is formed on a sheet different from the sheet on which the tip insertion portion storage opening 117 is formed.
  • the opening 217 for storing the medicine medium part is formed as a quarter oval cutout.
  • the overlapping part of the medicine enclosure part 201 and the medium enclosure part 103 can be easily inserted and accommodated in the medicine medium part accommodation opening 217 from above (see FIG. 15).
  • Second Usage Method When the drug oral administration device 200 is used, there are a preparation stage in which a drug such as a tablet T is enclosed in the drug enclosure 103 and an oral administration stage in which the drug-coated medium is orally administered. Hereinafter, each stage will be described.
  • the oral medicine administration device 200 is provided to a user (hereinafter, encapsulator) who encapsulates the medicine in a state where a predetermined viscous medium is encapsulated in the viscous medium enclosure 103 in advance.
  • encapsulator who encapsulates the medicine in a state where a predetermined viscous medium is encapsulated in the viscous medium enclosure 103 in advance.
  • FIGS. 13 shows a state in which the oral drug administration device 200 is folded in half, A showing the state seen from the side, and B showing the state seen from above.
  • FIG. 14 shows a state in which the oral medicine administration device 200 is folded in four.
  • the encapsulator who intends to encapsulate the tablet T, which is a drug, in the drug oral administration device 200 puts the tablet T into the drug encapsulating part 201 via the tip insertion part 215.
  • the tip insertion part 205 is expanded in a shovel shape, and the tablet T is put into the medicine enclosure part 201.
  • the enclosing person folds the medicine enclosing portion 201 and the distal end insertion portion 205 in the direction of the arrow a5, and the distal end of the distal end insertion portion 205 is notched for the distal end insertion portion of the cover portion 207.
  • the pharmaceutical oral administration device 200 can be in a folded state as shown in FIG. 13B.
  • the folding is performed along the end of the viscous medium enclosing portion 103 on the side of the drug / viscous medium fusion portion 109.
  • the enclosing person further sets the encapsulating part 201 and the medium enclosing part 103 around the viscous medium / cover fusion part 113 as shown in FIG. 14A.
  • the pharmaceutical oral administration device 200 can be in a four-fold state as shown in FIG. 14B.
  • FIG. 15 shows a state when the oral drug administration device 200 is to be folded into four from the direction of arrow a61 in FIG. 14A.
  • Oral administration stage The oral administration person who orally administers the medicine stored in the medicine oral administration apparatus 200 or makes another person orally use the medicine oral administration apparatus 200 in a four-fold state as shown in FIG. 14A.
  • a planar state as shown in FIG. 14A A planar state as shown in FIG.
  • the oral administration person pinches the viscous medium enclosing part 103 with a finger.
  • the pressure inside the viscous medium enclosure 103 increases.
  • the internal pressure of the viscous medium enclosing part 103 becomes higher than a predetermined level, the fusion between the drug / viscous medium fusion part 109 is peeled off, and the viscous medium located inside the medium enclosing part 103 moves toward the medicine enclosing part 201. .
  • a medicine covering medium can be generated by the medicine and the viscous medium located inside the medicine enclosure 201.
  • the drug-coated medium in which the drug is uniformly included in the viscous medium can be generated by swallowing the drug and the viscous medium.
  • the storage insertion excision cutout 211 formed in the medicine enclosure 201 is cut in the direction of the arrow a7, and the distal insertion part 205 is excised.
  • the drug coating medium is moved toward the tip of the drug enclosure 201.
  • the drug-coated medium is orally administered from the tip of the drug enclosure 201.
  • the oral drug administration device 200 in Example 2 described above formed the fusion part 109 between the drug and the viscous medium.
  • the drug oral administration device 300 in the present embodiment further forms a leakage compensation fusion part 311.
  • a drug oral administration device 300 which is an embodiment of a drug oral administration device according to the present invention, will be described with reference to FIG.
  • the drug oral administration device 300 includes a drug enclosure 301, a medium enclosure 103, a tip insertion part 205, and a cover 207.
  • the structure and function of the drug enclosure 301 are the same as those of the drug enclosure 201 in the second embodiment.
  • the medicine enclosure part 301 has a leakage compensation fused part 311.
  • the leakage compensation fusion part 311 the viscous medium sealed in the medium sealing part 103 by the medicine / viscous medium fusion part 109 breaks the fusion of the medicine / viscous medium fusion part 109 and leaks out. However, it is formed so as not to come into contact with the medicine located in the medicine enclosure 201.
  • the formation method, physical properties, etc. of the leakage compensation fused part 311 are the same as those of the drug-viscous medium fused part 109.
  • the oral medicine administration device 100 is formed in the side surface of the cover portion 107 with the distal end insertion portion opening 117 and accommodates the distal end insertion portion 105, so that it is folded into two when being accommodated and is downsized. It was something to do.
  • the drug oral administration device 400 in this embodiment is formed into a tri-fold state when stored by forming a tip insertion part opening 417 at the end of the cover part 407 and storing the end of the drug enclosure 401. It is to become.
  • An oral drug administration device 400 which is an embodiment of an oral drug administration device according to the present invention, will be described with reference to FIG.
  • the oral drug administration device 400 includes a drug enclosure 401, a medium enclosure 103, a cover 407, and an intermedia fusion part 109.
  • the medicine enclosure part 401, the medium enclosure part 103, and the cover part 407 are located in a straight line.
  • the drug enclosure 401 is located adjacent to the medium enclosure 103 and is located at one end of the oral drug administration device 100.
  • the distal end insertion part 105 is adjacent to the medium enclosing part 103 and is located at one end of the oral drug administration device 100.
  • the cover part 107 is located adjacent to the medium enclosing part 103 and is located at the other end different from the end where the medicine enclosing part 401 is located.
  • the drug enclosure part 401 and the viscous medium enclosure part 103 are adjacent to each other via the drug / viscous medium fusion part 109.
  • the viscous medium sealing portion 103 and the cover portion 407 are adjacent to each other via the viscous medium / cover portion fusion portion 113.
  • the cover part 407 has an opening 417 for storing a medicine enclosure at the end. By inserting the medicine enclosure 401 from the medicine enclosure storage opening 417, the oral medicine administration device 100 can be folded in three.
  • the discharge property of the drug-coated medium differs depending on the fusion strength of the drug / viscous medium fusion part 109.
  • the fusion strength of the end part fusion part 419 is 30 g / 15 mm, the fusion strength of the end part fusion part 419 hardly affects the discharge property of the drug-coated medium. Overall, the drainage of the drug-coated media is great. However, it is difficult to set the discharge property of the drug-coated medium to 100%.
  • the fusion strength of the end fusion part 419 with respect to the fusion strength of the drug / viscous medium fusion part 109 is As long as the fusion strength between the drug / viscous medium fusion part 109 is -40 g to ⁇ 0 g, 100% of the drug-coated medium can be discharged.
  • the fusion strength of the end fusion part 419 is greater than the fusion strength of the drug-viscous medium fusion part 109, the discharge property of the drug-coated medium is deteriorated.
  • the fusion strength of the end fusion part 419 is 60 g or more larger than the fusion strength of the drug-viscous medium fusion part 109, the drug-coated medium cannot be discharged.
  • the fusion strength of the drug / viscous medium fusion part 109 is 120 g / 15 mm, if the fusion strength of the end fusion part 419 is less than 0, almost all of the drug-coated medium can be discharged. It becomes. However, if the drug-viscous medium fusion part 109 and the end part fusion part 419 have the same fusion strength, the discharge property relating to the drug-coated medium is drastically reduced, and at +80 g / 15 mm, no discharge occurs.
  • the end fusion part 419 is -170 g compared to the fusion strength of the drug / viscous medium fusion part 109. If it is / 15 mm, it is possible to discharge all drug-coated media. However, when the fusion strength of the end fusion portion 419 is larger than the fusion strength of the drug-viscous medium fusion portion 109, the discharge property of the drug-coated medium is dramatically reduced. Further, if the fusion strength of the end fusion portion 419 and the fusion strength of the drug / viscous medium fusion portion 109 are equal, the drug-coated medium cannot be discharged at all.
  • the fusion strength of the drug-viscous medium fusion part 109 is 30 g / 15 mm to 120 g / 15 mm, and the fusion strength of the end part fusion part 419 is the drug.
  • -It is considered that the case where it is ⁇ 0 g / 15 mm to +60 g / 15 mm as compared with the fused portion 109 between viscous media is appropriate.
  • the fusion strength of the drug-viscous medium fusion part 109 is 20 g / 15 mm or more and less than 200 g / 15 mm and the fusion strength of the end fusion part 419 is 0 g / 15 mm or more and less than 100 g / 15 mm It is considered acceptable.
  • the oral medicine administration device 400 is provided to a user (hereinafter, encapsulator) who encapsulates the medicine in a state where a predetermined viscous medium is encapsulated in the viscous medium enclosure 103 in advance.
  • encapsulator a user who encapsulates the medicine in a state where a predetermined viscous medium is encapsulated in the viscous medium enclosure 103 in advance.
  • the preparation stage of the oral drug administration device 100 will be described with reference to FIGS. 17 and 19.
  • the encapsulator who wants to encapsulate the tablet T, which is the drug, in the drug oral administration device 400 puts the tablet T into the drug enclosing unit 401.
  • the end of the medicine enclosure 401 is widened and the tablet T is put into the medicine enclosure 401.
  • the enclosing person fuses the end portion of the medicine enclosing portion 401 to form the end fused portion 419.
  • the enclosing person folds the cover portion 407 in the direction of the arrow a41.
  • the single end of the medicine enclosure 401 is inserted into the inside of the cover 407 from the medicine enclosure storage opening 417 formed at the end of the cover 407.
  • the medicine oral administration device 400 can be in a three-fold state as shown in FIG. 19B.
  • the drug enclosing portion 401 when the drug enclosing portion 401 is folded, as in the first embodiment, it is folded along the end of the viscous medium enclosing portion 103 on the drug-viscosity medium fusion portion 109 side.
  • Oral administration stage The oral administration person who orally administers the medicine stored in the medicine oral administration device 400 or makes it oral by another person uses the medicine oral administration device 400 in a tri-fold state as shown in FIG. 19B. A planar state as shown in FIG.
  • the oral administration person pinches the viscous medium enclosing part 103 with a finger.
  • the pressure inside the viscous medium enclosure 103 increases.
  • the internal pressure of the viscous medium enclosing part 103 becomes higher than a predetermined level, the fusion between the drug / viscous medium fusion part 109 is peeled off, and the viscous medium located inside the medium enclosing part 103 moves toward the medicine enclosing part 101. .
  • a medicine covering medium can be generated by the medicine and the viscous medium located inside the medicine enclosure 101.
  • the medicine-coated medium in which the medicine is uniformly contained in the viscous medium can be generated by swallowing the medicine and the viscous medium.
  • the storage insertion cutout 411 formed in the medicine enclosure 401 is cut in the direction of arrow a47, and the end fused portion 419 is cut off.
  • the drug coating medium is moved in the direction of the distal end of the drug enclosure 401.
  • the drug-coated medium is orally administered from the tip of the drug enclosure 401.
  • Example 1 in Example 1 described above, so-called jelly was used as the viscous medium.
  • the viscous medium has a predetermined viscosity and a predetermined strength, is coated with a drug, and a plurality of coated drugs are integrated.
  • the present invention is not limited to the examples as long as the formed drug-coated medium is formed.
  • tablet T is shown as the drug, but the drug is not limited to the illustrated one as long as it is a drug.
  • the drug may be a mini tablet, pellet, hard capsule, soft capsule, inclusion, granule, powder, API.
  • a supplement for supplementing a predetermined nutrient may be used instead of the drug.
  • Material Polypropylene or the like is shown as the material of the sheet forming the oral drug administration device 100 to oral drug administration device 400 in Examples 1 to 4 described above. As long as it can be formed and a predetermined pressure can be applied to the medium sealing portion 103 by hand, it is not limited to the example. For example, you may make it form with soft materials, such as aluminum. Further, it may be transparent or translucent.
  • Example 2 In Example 2 described above, the quarter-elliptical drug medium storage opening 217 was formed, but the drug enclosure 201 and the medium enclosure 103 overlap. If it can accommodate a part, it is not limited to the example of illustration. For example, it may be a diagonally straight opening.
  • the medicine medium portion storage opening 217 may not be formed.
  • Shape of the distal end insertion portion 105 The distal end insertion portion 105 of the oral drug administration device 100 in Example 1 described above is inclined toward an end portion different from the end portion adjacent to the pharmaceutical encapsulation portion 101.
  • the shape is not limited to the illustrated example as long as the tip insertion portion 105 can be inserted into the tip insertion portion storage opening 117.
  • distal end insertion portion 105 can be formed into a shovel when inserted into the patient's mouth, it is not limited to the illustrated example as long as the drug-coated medium can be inserted into the patient's mouth.
  • it may have a rectangular shape, with the tip and upper end open and the lower end closed.
  • the present invention stores a drug and a viscous medium in a separated state so that they can be carried, and when orally administered, a drug-coated medium formed by the viscous medium and the drug is formed and orally administered. Can be used as a device.
  • DESCRIPTION OF SYMBOLS 100 ... Oral medicine administration apparatus 101 ... Drug enclosure 103 ... Medium enclosure 105 ... Tip insertion part 107 ... Cover part 117 ... For tip insertion part Opening 109 ⁇ Drug / viscous medium fusion portion 113 ⁇ Viscous medium / cover fusion portion 200 ⁇ Drug oral administration device 201 ⁇ Drug enclosure portion 211 ⁇ Notch for storing insertion excision 205... Distal end inserting portion 207... Cover portion 217... Medicine medium portion storing opening 300. 311 ... Leakage compensation fusion part 400 ... Drug oral administration device 401 ... Drug containment part 407 ... Cover part

Abstract

[Problem] To provide a device for oral drug administration in which a drug and a viscous medium are accommodated in a separated state and are portable, and when oral administration is to be carried out, each drug is coated and a drug-coating viscous medium in which the coated drug has been integrated with the viscous medium is then readily formed and can be orally administered. [Solution] A device (100) for oral drug administration has a drug encapsulation part (101), a medium encapsulation part (103), a distal end insertion part (105), a cover part (107), and a drug/viscous medium interfusion part (109). The drug/viscous medium interfusion part is fused at an intensity of 15 gf/15 mm to 300 gf/15 mm. The medium encapsulation part (103) in which the viscous medium is encapsulated is pinched with fingers, whereby the viscous medium and the drug are mixed and the drug-coating viscous medium can be readily formed. A drug can readily be orally administered by the use of the drug-coating viscous medium, even for a person who has difficulty swallowing a drug alone.

Description

薬剤経口投与装置Drug oral administration device
 本発明は、薬剤を経口投与するための薬剤経口投与装置に関し、特に、個々の薬剤を被覆した上で、複数の被覆した薬剤を一体化した薬剤被覆媒体を形成するものに関する。 The present invention relates to a drug oral administration device for orally administering a drug, and particularly to a device for forming a drug-coated medium in which a plurality of coated drugs are integrated after coating each drug.
 従来の粘体状薬品調製製品10について図20を用いて説明する。粘体状薬品調製製品10の容器11は、素材が例えばポリプロピレンやポリエチレン等である一対のシートの表面と背面が貼り合わされ、一対のシートの間に密閉した空間12が形成されたものである。なお、容器11の構成は上記のものに限られず、その内部に密閉した空間を有するものであればよい。 A conventional viscous drug product 10 will be described with reference to FIG. The container 11 of the viscous drug product 10 is a container in which the surface and the back of a pair of sheets made of, for example, polypropylene or polyethylene are bonded together, and a sealed space 12 is formed between the pair of sheets. In addition, the structure of the container 11 is not restricted to said thing, What is necessary is just to have the space sealed in the inside.
 前記容器11の密閉した空間には、隔離部13によって液体用隔室12a と薬剤用隔室12bとに分割されている。この隔離部13は、例えば液体用隔離部12a内の圧力が高くなると、液体用隔室12aと薬剤用隔室12bとの間が連通するように形成されている。 The sealed space of the container 11 is divided into a liquid compartment 12a and a medicine compartment 12b by a separator 13. For example, when the pressure in the liquid separating section 12a increases, the separating section 13 is formed so that the liquid compartment 12a and the medicine compartment 12b communicate with each other.
 前記液体用隔室12a
には、例えば精製水やお茶、ジュース等の清涼飲料水などの液体5が収容されている。一方、薬剤用隔室12b
には、上述した本発明の粘体状薬品調製剤1が収容されている。
Liquid compartment 12a
For example, a liquid 5 such as purified water, soft drinks such as tea and juice is accommodated in the container. On the other hand, the medicine compartment 12b
Contains the above-mentioned viscous pharmaceutical preparation 1 of the present invention.
 粘体状薬品調製製品10の容器11を手で強く握ると、液体用隔室12aや薬剤用隔室12bが圧迫され、その内部の圧力が高くなる。すると、容器11の隔離部13が液体用隔室12aと薬剤用隔室12bとを分割しておくことができなくなり、液体用隔室12a と薬剤用隔室12b とが連通される。このため、液体用隔室12a内の液体5と薬剤用隔室12b内の粘体状薬品調製剤1とが混じり合うので、粘体状薬品調製剤1が粘体状に調製される。(特許文献1) If the container 11 of the viscous drug product preparation product 10 is squeezed by hand, the liquid compartment 12a and the medicine compartment 12b are compressed, and the internal pressure increases. Then, the isolation part 13 of the container 11 cannot separate the liquid compartment 12a and the medicine compartment 12b, and the liquid compartment 12a and the medicine compartment 12b are communicated with each other. For this reason, since the liquid 5 in the liquid compartment 12a and the viscous chemical preparation 1 in the pharmaceutical compartment 12b are mixed, the viscous chemical preparation 1 is prepared in a viscous form. (Patent Document 1)
特開2003-137817号公報JP 2003-137817 A
 前述の粘体状薬品調製製品10には、以下に示すような改善すべき点がある。液体用隔室12a
に収容されている液体5と、薬剤用隔室12b に収容されている粘体状薬品調製剤1とは、容器11を手で強く握ると、隔離部13が破壊されて、混じり合う。すなわち、隔離部13は、手で強く握る程度の力で密着するように形成されている。
The aforementioned viscous drug product 10 has the following points to be improved. Liquid compartment 12a
When the container 11 is strongly grasped by hand, the isolation part 13 is destroyed and the liquid 5 contained in the container 5 and the viscous drug preparation 1 contained in the medicine compartment 12b are mixed. That is, the isolation part 13 is formed so as to be in close contact with a force that can be gripped with a hand.
 一方、薬剤をゼリー等の粘性媒体と一緒に飲み込むことによって、薬剤の経口投与を補助する場合、薬剤と粘性媒体とを隣接して配置し、前述の隔離部13を配置したとしても、両者を混合するには手で強く握るほどの相当の力を要する。また、粘性媒体に強く握るほどの力を加えると、粘性媒体が勢いよく飛び散ってしまうという不具合が生ずる可能性がある。 On the other hand, in the case of assisting oral administration of the drug by swallowing the drug together with a viscous medium such as jelly, even if the drug and the viscous medium are arranged adjacent to each other, Mixing requires a considerable amount of force to hold it with your hand. In addition, when a force is applied to the viscous medium so as to be strongly gripped, there is a possibility that the viscous medium scatters vigorously.
 そこで、本発明は、薬剤と粘性媒体とを分離した状態で収納して、携行可能とし、経口投与する際に、個々の薬剤を被覆した上で、複数の被覆した薬剤を一体化した薬剤被覆媒体を容易に形成して、経口投与できる薬剤経口投与装置を提供することを目的とする。 Accordingly, the present invention provides a drug coating in which a drug and a viscous medium are separately stored and portable, and each drug is coated and integrated with a plurality of drugs when orally administered. It is an object of the present invention to provide an oral drug administration device that can easily form a medium and can be administered orally.
 本発明に係る薬剤経口投与装置は、薬剤及び所定の栄養素を補給するためのを含む薬剤類を被覆するための粘性媒体であって、被覆した前記薬剤類と一体化した薬剤被覆媒体を形成する粘性媒体、前記粘性媒体を封入する媒体封入部、前記媒体封入部に隣接して位置する薬剤・粘性媒体間融着部であって、15gf/15mm~300gf/15mmの強度で閉じられている薬剤・粘性媒体間融着部、前記薬剤類を封入する薬剤封入部であって、前記薬剤・粘性媒体間分離部に隣接して位置する薬剤封入部、を有する。 A device for oral administration of a drug according to the present invention is a viscous medium for coating drugs including for replenishing drugs and predetermined nutrients, and forms a drug-coated medium integrated with the coated drugs. A viscous medium, a medium enclosing portion for enclosing the viscous medium, and a drug-viscosity medium fusion portion located adjacent to the medium enclosing portion and closed at a strength of 15 gf / 15 mm to 300 gf / 15 mm -It has a fusion | melting part between viscous media, and the chemical | medical agent enclosure part which encloses the said chemical | medical agent, Comprising: The chemical | medical agent enclosure part located adjacent to the said chemical | medical agent / viscous medium separation part.
 これにより、媒体封入部に封入されている粘性媒体に指でつまむ程度の力を加えるだけで、薬剤・粘性媒体間融着部の融着を破り、粘性媒体を薬剤封入部の方向へ移動させることができる。したがって、薬剤封入部に薬剤類を封入しておけば、薬剤類と粘性媒体とによって、個々の薬剤類を被覆した上で、被覆した薬剤類と一体化した薬剤被覆媒体を容易に形成することができる。薬剤被覆媒体を用いることによって、薬剤類だけでは飲み込むことが難しい者であっても、容易に薬剤類を経口投与することができる。 By this, it is possible to break the fusion of the fusion part between the drug and the viscous medium and move the viscous medium in the direction of the drug enclosure only by applying a force enough to pinch the viscous medium enclosed in the medium enclosure. be able to. Therefore, if drugs are encapsulated in the drug enclosure, each drug is coated with the drugs and the viscous medium, and a drug-coated medium integrated with the coated drugs can be easily formed. Can do. By using a drug-coated medium, even if it is difficult for a person who is difficult to swallow the drug alone, the drug can be easily administered orally.
 本発明に係る薬剤経口投与装置は、前記カバー部が配置される側に形成される第1の端部に配置されるカバー部であって、前記第1の端部とは異なる第2の端部を収納する端部収納用開口を有するカバー部、を有する。 The oral drug administration device according to the present invention is a cover portion disposed at a first end portion formed on a side where the cover portion is disposed, and has a second end different from the first end portion. A cover portion having an opening for storing an end portion for storing the portion.
 これにより、薬剤経口投与装置において、第1の端部と第2の端部とを合わせた2つ折り状態とすることができる。よって、薬剤経口投与装置を小型化することができる。 Thereby, in the drug oral administration device, the first end and the second end can be folded in two. Therefore, the pharmaceutical oral administration device can be miniaturized.
 本発明に係る薬剤経口投与装置は、前記第2の端部を形成する先端差込部であって、前記端部収納用開口に差し込まれて収納される先端差込部、を有する。 The oral drug administration device according to the present invention has a tip insertion portion that forms the second end portion, and has a tip insertion portion that is inserted into and stored in the end portion storage opening.
 これにより、容易に薬剤経口投与装置を2つ折り状態とすることができる。 Thereby, the oral drug administration device can be easily folded in two.
 本発明に係る薬剤経口投与装置は、前記端部収納用開口に前記先端差込部を差し込む際に、前記薬剤・粘性媒体間融着部と前記媒体封入部との境目で折り曲げられる。 The oral drug administration device according to the present invention is bent at the boundary between the medicinal / viscous medium fusion portion and the medium enclosing portion when the tip insertion portion is inserted into the end storage opening.
 これにより、薬剤経口投与装置は、薬剤・粘性媒体間融着部と媒体封入部との境目で折り曲げられて、2つ折りにした状態となっているため、2つ折り状態において、粘性媒体が薬剤・粘性媒体間融着部の方向に移動することがない。よって、2つ折り状態において、粘性媒体が薬剤・粘性媒体間融着部の融着を破ってしまうことを防止することができる。 Accordingly, the oral drug administration device is folded at the boundary between the fusion part between the drug and the viscous medium and the medium enclosing part, and is in a folded state. There is no movement in the direction of the fusion part between viscous media. Therefore, it is possible to prevent the viscous medium from breaking the fusion of the drug-viscous medium fusion part in the folded state.
 本発明に係る薬剤経口投与装置では、前記カバー部は、さらに、前記先端差込部が前記端部収納用開口に収納された状態で形成される前記媒体封入部と前記薬剤封入部との重なり部を収納するための薬剤媒体部収納用開口を有する。 In the oral medicine administration device according to the present invention, the cover part further overlaps the medium enclosure part and the medicine enclosure part formed in a state where the tip insertion part is housed in the end housing opening. An opening for storing a medicine medium part for storing the part.
 これにより、薬剤経口投与装置を容易に4つ折り状態にすることができる。つまり、薬剤経口投与装置を容易に小型化することができる。 This allows the oral drug administration device to be easily folded into four. That is, the pharmaceutical oral administration device can be easily downsized.
 本発明に係る薬剤経口投与装置では、前記薬剤封入部は、さらに、15gf/15mm~300gf/15mmの強度で閉じられる補償融着部、を有する。 In the oral medicine administration device according to the present invention, the medicine encapsulating part further includes a compensation fusion part that is closed with a strength of 15 gf / 15 mm to 300 gf / 15 mm.
 これにより、粘性媒体が薬剤・粘性媒体間融着部の融着を破った場合であっても、粘性媒体が薬剤類が存在する位置まで到達することを防止することができる。 Thereby, even when the viscous medium breaks the fusion of the fusion part between the drug and the viscous medium, the viscous medium can be prevented from reaching the position where the drugs are present.
 本発明に係る薬剤経口投与装置では、前記粘性媒体は、円錐台形状の測定容器であって、上底面の直径が58mm、下底面の直径が43mm、高さが30mmであり、下底面から10mmの側面の位置に所定の線を有している、ポリエチレン製である前記測定容器を、前記粘性媒体の表面上に配置し、前記測定容器に所定の分銅をゆっくりと載置し、前記測定容器の前記線が前記粘性媒体の表面と同じ高さになった時の前記分銅の重量を読みとることによって計測した耐荷重が、10g~1000gであること、を特徴とする。 In the pharmaceutical oral administration device according to the present invention, the viscous medium is a frustoconical measuring container, the diameter of the upper base is 58 mm, the diameter of the lower base is 43 mm, the height is 30 mm, and 10 mm from the lower base. The measurement container made of polyethylene having a predetermined line at the position of the side surface is arranged on the surface of the viscous medium, and a predetermined weight is slowly placed on the measurement container, and the measurement container The withstand load measured by reading the weight of the weight when the line is the same height as the surface of the viscous medium is 10 to 1000 g.
 これにより、経口投与の際に使用者が飲み込みやすい薬剤被覆媒体を容易に形成することができる。 This makes it possible to easily form a drug-coated medium that is easy for a user to swallow during oral administration.
 本発明に係る薬剤経口投与装置は、前記粘性媒体は、液状の前記粘性媒体を前記媒体封入部に充填した後、所定の冷却期間を経過させてゲル化させることによって前記媒体封入部全体に1つの塊として形成されるものである場合には、前記耐荷重が20g~1000gであること、を特徴とする。 In the oral drug administration device according to the present invention, the viscous medium is filled in the entire medium enclosing part by filling the medium enclosing part with the liquid viscous medium and then gelling the medium after a predetermined cooling period. When it is formed as one lump, the load resistance is 20 g to 1000 g.
 これにより、粘性媒体が前記媒体封入部全体に1つの塊として形成されるものであっても、経口投与の際に使用者が飲み込みやすい薬剤被覆媒体を容易に形成することができる。 Thereby, even if the viscous medium is formed as one lump in the whole medium enclosing part, it is possible to easily form a drug-coated medium that is easy for a user to swallow during oral administration.
 本発明に係る薬剤経口投与装置は、前記粘性媒体は、液状の前記粘性媒体を所定の容器に充填した後、所定の冷却期間を経過させてゲル化させた後、所定の大きさに裁断し、前記媒体封入部に封入されるものである場合には、前記耐荷重が10g~150gであること、を特徴とする。 In the oral medicine administration device according to the present invention, the viscous medium is filled with the liquid viscous medium in a predetermined container, gelled after a predetermined cooling period, and then cut into a predetermined size. In the case where the medium is enclosed in the medium enclosure, the load resistance is 10 g to 150 g.
 これにより、粘性媒体が所定の大木債に裁断されて前記媒体封入部に封入されるものであっても、経口投与の際に使用者が飲み込みやすい薬剤被覆媒体を容易に形成することができる。 本発明に係るいずれかの薬剤経口投与装置は、所定の薬剤類、を有する。 Thereby, even if the viscous medium is cut into a predetermined large wooden bond and sealed in the medium sealing portion, a drug-coated medium that can be easily swallowed by a user during oral administration can be easily formed. Any of the oral drug administration devices according to the present invention has predetermined drugs.
 これにより、使用者に自ら薬剤類を封入する手間をかけることがない。
 
Thereby, it does not take time and effort to enclose the medicine by itself to the user.
本発明に係る薬剤経口投与装置の一実施例である薬剤経口投与装置100の外観図である。1 is an external view of an oral drug administration device 100 that is an embodiment of an oral drug administration device according to the present invention. 耐荷重容器Pの形状及び使用方法を示す図であり、Aは耐荷重容器Pの上面図を、Bは耐荷重容器Pの正面図を、Cは耐荷重容器Pの底面図を、Dは耐荷重容器Pの使用方法を示す図を、それぞれ示している。It is a figure which shows the shape and usage method of the load bearing container P, A is a top view of the load bearing container P, B is a front view of the load bearing container P, C is a bottom view of the load bearing container P, D is The figure which shows the usage method of the load-bearing container P is shown, respectively. 粘性媒体の服用実験を示す図であり、Aは使用する粘性媒体の種類を、Bは実験の結果を、Cは実験における耐荷重と取り出し性の関係を、Dは実験における耐荷重と残留性の関係を、それぞれ示している。It is a figure which shows the dosing experiment of a viscous medium, A is the kind of viscous medium to be used, B is the result of an experiment, C is the relationship between the load resistance in an experiment, and take-out property, D is the load resistance and residual property in an experiment The relationship is shown respectively. 粘性媒体の服用実験を示す図であり、Aは使用する粘性媒体の種類を、Bは実験の結果を、Cは実験における耐荷重と服用性の関係を、Dは実験における耐荷重と残留性の関係を、それぞれ示している。It is a figure which shows the dosing experiment of a viscous medium, A is the kind of viscous medium to be used, B is the result of an experiment, C is the relationship between the load resistance and dosing property in an experiment, D is the load resistance and residual property in an experiment. The relationship is shown respectively. 粘性媒体の服用実験を示す図であり、Aは使用する粘性媒体の種類及び実験の結果を、Bは実験における耐荷重と服用性の関係を、それぞれ示している。It is a figure which shows the dosing experiment of a viscous medium, A has shown the kind of viscous medium to be used, and the result of experiment, and B has each shown the relationship between the load resistance and dosing property in experiment. 粘性媒体の適正な強度を決めるための実験結果である。It is an experimental result for determining the suitable intensity | strength of a viscous medium. 薬剤・粘性媒体間融着部109の適正な融着強度を決めるための実験結果である。It is an experimental result for determining the appropriate fusion strength of the fusion | bonding part 109 between a chemical | medical agent and a viscous medium. 薬剤・粘性媒体間融着部109の適正な融着強度を決めるための実験結果である。It is an experimental result for determining the appropriate fusion strength of the fusion | bonding part 109 between a chemical | medical agent and a viscous medium. 薬剤・粘性媒体間融着部109の適正な融着強度を決めるための実験結果である。It is an experimental result for determining the appropriate fusion strength of the fusion | bonding part 109 between a chemical | medical agent and a viscous medium. 薬剤・粘性媒体間融着部109の適正な融着強度を決めるための実験結果である。It is an experimental result for determining the appropriate fusion strength of the fusion | bonding part 109 between a chemical | medical agent and a viscous medium. 薬剤経口投与装置100の使用方法を示す図である。It is a figure which shows the usage method of the chemical | medical agent oral administration apparatus 100. FIG. 本発明に係る薬剤経口投与装置の一実施例である薬剤経口投与装置200の外観図である。1 is an external view of an oral drug administration device 200 that is an embodiment of an oral drug administration device according to the present invention. FIG. 薬剤経口投与装置200の使用方法を示す図である。It is a figure which shows the usage method of the chemical | medical agent oral administration apparatus. 薬剤経口投与装置200の使用方法を示す図である。It is a figure which shows the usage method of the chemical | medical agent oral administration apparatus. 薬剤経口投与装置200の使用方法を示す図である。It is a figure which shows the usage method of the chemical | medical agent oral administration apparatus. 本発明に係る薬剤経口投与装置の一実施例である薬剤経口投与装置300の外観図である。1 is an external view of an oral drug administration device 300 that is an embodiment of an oral drug administration device according to the present invention. FIG. 本発明に係る薬剤経口投与装置の一実施例である薬剤経口投与装置400の外観図である。1 is an external view of an oral drug administration device 400 that is an embodiment of an oral drug administration device according to the present invention. FIG. 薬剤・粘性媒体間融着部109の適正な融着強度を決めるための実験結果である。It is an experimental result for determining the appropriate fusion strength of the fusion | bonding part 109 between a chemical | medical agent and a viscous medium. 薬剤経口投与装置400の使用方法を示す図である。It is a figure which shows the usage method of the chemical | medical agent oral administration apparatus 400. FIG. 薬剤経口投与装置の従来技術を示す図である。It is a figure which shows the prior art of a chemical | medical agent oral administration apparatus.
 以下、本発明の実施例について、図面を参照しながら詳細に説明していく。 Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
第1 構成
 本発明に係る薬剤経口投与装置の一実施例である薬剤経口投与装置100について、図1を用いて説明する。
First Configuration A drug oral administration device 100, which is an embodiment of a drug oral administration device according to the present invention, will be described with reference to FIG.
 薬剤経口投与装置100は、一枚のシートを、対向して位置する端部を熱によって融着し、筒状にし、さらに平面状にして形成したものである。使用するシートは、例えば、ポリプロピレンやポリエチレン等を素材としている。 The oral drug administration device 100 is formed by forming a single sheet into a cylindrical shape by fusing the ends located opposite to each other by heat. The sheet used is made of, for example, polypropylene or polyethylene.
 薬剤経口投与装置100は、薬剤封入部101、媒体封入部103、先端差込部105、カバー部107、及び、薬剤・粘性媒体間融着部109を有している。薬剤封入部101、媒体封入部103、先端差込部105、及びカバー部107は、直線状に位置している。薬剤封入部101及び媒体封入部103は、薬剤経口投与装置100の中央付近に隣接して位置する。先端差込部先端差込部105は、薬剤経口投与装置100において、カバー部107が形成する端部とは異なる端部を形成する。カバー部107は、媒体封入部103に隣接して位置する。また、カバー部107は、先端差込部101が形成している端部とは異なる、もう一方の端部を形成する。 The drug oral administration device 100 includes a drug enclosure 101, a medium enclosure 103, a tip insertion part 105, a cover 107, and a drug / viscous medium fusion part 109. The medicine enclosure part 101, the medium enclosure part 103, the tip insertion part 105, and the cover part 107 are positioned in a straight line. The medicine enclosure part 101 and the medium enclosure part 103 are located adjacent to the vicinity of the center of the oral medicine administration device 100. Tip insertion portion The tip insertion portion 105 forms an end portion different from the end portion formed by the cover portion 107 in the oral medicine administration device 100. The cover unit 107 is located adjacent to the medium enclosure unit 103. Moreover, the cover part 107 forms the other edge part different from the edge part which the front-end | tip insertion part 101 forms.
 薬剤封入部101には、所定の薬剤が封入される。封入する薬剤は、錠剤、カプセル剤、顆粒等、いずれの形状であってもよい。なお、図1においては、封入する薬剤として、錠剤Tを例示している。 A predetermined medicine is enclosed in the medicine enclosure 101. The encapsulated drug may have any shape such as a tablet, a capsule, or a granule. In addition, in FIG. 1, the tablet T is illustrated as a chemical | medical agent to enclose.
 粘性媒体封入部103には、所定の粘性を有し、個々の薬剤を被覆した上で、被覆した薬剤と一体化した薬剤被覆媒体を形成する粘性媒体が封入される。本実施例においては、粘性媒体として、いわゆるゼリーを用いている。粘性媒体を用いることによって、薬剤の状態では飲み込むことが難しい患者に対しても、容易に経口投与できるようになる。なお、粘性媒体については後述する。 In the viscous medium enclosing unit 103, a viscous medium having a predetermined viscosity and covering each individual drug and forming a drug-coated medium integrated with the coated drug is encapsulated. In this embodiment, so-called jelly is used as the viscous medium. By using a viscous medium, it can be easily administered orally even to patients who are difficult to swallow in the state of drugs. The viscous medium will be described later.
 薬剤封入部101と粘性媒体封入部103とは、薬剤・粘性媒体間融着部109を介して、隣接する。薬剤・粘性媒体間融着部109は、粘性媒体を媒体封入部103に配置した後、シートを熱によって融着することによって形成する。薬剤・粘性媒体間融着部109は、粘性媒体封入部103の内圧が所定以上高くなると融着が剥がれる程度の融着強度を持つように形成する。 The drug enclosing part 101 and the viscous medium enclosing part 103 are adjacent to each other via the drug / viscous medium fusion part 109. The drug / viscous medium fusion part 109 is formed by placing the viscous medium in the medium sealing part 103 and then fusing the sheet with heat. The drug / viscous medium fusion part 109 is formed to have such a fusion strength that the fusion is peeled off when the internal pressure of the viscous medium enclosing part 103 becomes higher than a predetermined value.
 粘性媒体封入部103とカバー部107とは、粘性媒体・カバー部間融着部113を介して隣接する。粘性媒体・カバー部間融着部113は、薬剤・粘性媒体間融着部109と同様、シートを熱によって融着させることによって形成する。ただし、粘性媒体・カバー部間融着部113は、粘性媒体を媒体封入部103に配置する前に融着しておく。 The viscous medium enclosing part 103 and the cover part 107 are adjacent to each other through the adhesive part 113 between the viscous medium and the cover part. Similar to the drug / viscous medium fusion part 109, the viscous medium / cover fusion part 113 is formed by fusing a sheet with heat. However, the viscous medium / cover fusion part 113 is fused before the viscous medium is placed in the medium sealing part 103.
 なお、粘性媒体・カバー部間融着部113は、薬剤・粘性媒体間融着部109よりも強い強度となるように融着する。これにより、粘性媒体封入部103を所定の内圧にすることによって、粘性媒体・カバー部間融着部113の融着を維持しつつ、薬剤・粘性媒体間融着部109の融着を剥がすことができる。また、粘性媒体封入部103に位置する粘性媒体を、カバー部107の方向ではなく、薬剤封入部103の方向に移動させることができる。 It should be noted that the fusion part 113 between the viscous medium and the cover part is fused so as to have a stronger strength than the fusion part 109 between the drug and the viscous medium. Thus, by setting the viscous medium sealing portion 103 to a predetermined internal pressure, the fusion between the viscous medium / cover portion fusion portion 113 is maintained and the fusion between the drug / viscous medium fusion portion 109 is peeled off. Can do. Further, the viscous medium located in the viscous medium enclosing part 103 can be moved in the direction of the medicine enclosing part 103 instead of in the direction of the cover part 107.
 先端差込部105は、薬剤封入部101と隣接する端部とは異なる端部に向かって傾斜するように形成されている。これにより、先端差込部105を、先端差込部収納用開口117に容易に挿入できる。 The tip insertion portion 105 is formed so as to be inclined toward an end portion different from the end portion adjacent to the medicine enclosure portion 101. Thereby, the front-end | tip insertion part 105 can be inserted easily in the opening 117 for front-end | tip insertion part accommodation.
 また、先端差込部105を、薬剤を経口投与しようとする患者の口腔内に容易に挿入できる。さらに、先端差込部105を患者の口腔内に挿入した際に、先端差込部105をショベル状にできるため、薬剤と粘性媒体との薬剤被覆媒体を患者の口腔内に容易に挿入できる。なお、先端差込部105は、患者の口腔内に挿入することができるように、口腔内に挿入した際に喉に当たらない程度の長さに形成されている。 Also, the tip insertion portion 105 can be easily inserted into the oral cavity of a patient who is orally administering a drug. Furthermore, when the distal end insertion part 105 is inserted into the patient's oral cavity, the distal end insertion part 105 can be made into a shovel shape, so that the medicine-coated medium of the medicine and the viscous medium can be easily inserted into the patient's oral cavity. In addition, the front-end | tip insertion part 105 is formed in the length of the grade which does not touch a throat when it inserts in an oral cavity so that it can insert in a patient's oral cavity.
 このように、先端差込部105は、収納の際に先端差込部収納用開口117に挿入され、薬剤経口投与装置100の2つ折り状態を維持すること、及び、薬剤被覆媒体を口腔内に容易に経口投与することを目的として形成されている。 In this way, the distal end insertion part 105 is inserted into the distal end insertion part storage opening 117 during storage, maintaining the folded state of the oral drug administration device 100, and bringing the pharmaceutical coating medium into the oral cavity. It is designed for easy oral administration.
 カバー部107は、先端差込部収納用開口117を有している。先端差込部収納用開口117は、互いに対向して位置するシートの一つ、カバー部117の側面に形成される。先端差込部収納用開口117は、半円形状の切り欠きとして形成されている。先端差込部収納用開口117に、先端差込部105を挿入することによって、薬剤経口投与装置100を2つ折りの状態にすることができる。 The cover portion 107 has an opening 117 for storing the distal end insertion portion. The leading end insertion portion storage opening 117 is formed on one side of the cover portion 117, which is one of the sheets positioned opposite to each other. The distal end insertion portion storage opening 117 is formed as a semicircular cutout. By inserting the distal end insertion part 105 into the distal end insertion part storing opening 117, the oral medicine administration device 100 can be folded in two.
第2 粘性媒体
 粘性媒体は、粘度や耐荷重が小さすぎても大きすぎても、経口投与された薬剤被覆媒体を飲み込む際に、何らかの問題を発生しやすくなる。したがって、粘性媒体は、適切な耐荷重とする必要がある。そこで、粘性媒体の適正な耐荷重を決めるべく服用実験を行った。
Second Viscous Medium If the viscosity or load resistance is too small or too large, the viscous medium tends to cause some problems when swallowing the orally administered drug-coated medium. Therefore, the viscous medium needs to have an appropriate load capacity. Therefore, a dosing experiment was conducted to determine an appropriate load capacity of the viscous medium.
1.耐荷重実験
 服用実験を行う前に、粘性媒体の耐荷重を計測すべく、粘性媒体に対して下記の耐荷重実験を行った。ここで、媒体封入部103に封入する粘性媒体としては、液状の被験粘性媒体を媒体封入部103に充填した後、所定の冷却期間を経過させてゲル化させることによって媒体封入部103全体に1つの塊として形成されるものと、液状の被験粘性媒体を所定の容器に充填した後、所定の冷却期間を経過させてゲル化させた後、所定の大きさに裁断し、媒体封入部103に封入されるものとがある。以下においては、前者を一体型の粘性媒体とし、後者を裁断型の粘性媒体と記述する。
(1)所定の粘性媒体(以下、被験粘性媒体)を所定の容器に配置する。なお、予め被験粘性媒体の粘度を、B型粘度計を用いて計測しておく。
(2)容器に配置した被験粘性媒体上に、側面に赤線が記された耐荷重測定容器Pを載置する。耐荷重測定容器Pについて図2を用いて説明する。図2において、Aは耐荷重測定容器Pの上面図を、Bは耐荷重測定容器Pの正面図を、Cは耐荷重測定容器Pの底面図を、ぞれぞれ示している。耐荷重測定容器Pは、上底面の直径が58mm、下底面の直径が43mm、高さが30mmの円錐台形状であり、下から10mmの側面の位置に所定の赤線Lを有している。また、耐荷重測定容器Pは、ポリエチレン製であり、重量は1.9gである。
(3)耐荷重測定容器Pに分銅Wをゆっくりと載置する。
(4)図2Dに示すように、耐荷測定重容器Pの赤線Lが粘性媒体の表面と同じ高さになった時の分銅Wの重量を読みとる。このとき、耐荷重測定容器Pの重量は無視する。
(5)5回の繰返しを行い、平均値を算出する。
1. Load-bearing experiment Before the dosing experiment, in order to measure the load-bearing capacity of the viscous medium, the following load-bearing experiment was performed on the viscous medium. Here, as the viscous medium to be enclosed in the medium enclosure 103, the medium enclosure 103 is filled with a liquid test viscous medium after filling the medium enclosure 103, and then gelled after a predetermined cooling period. After filling a predetermined container with a liquid test viscous medium that is formed as one lump and gelling after a predetermined cooling period, the medium is cut into a predetermined size and placed in the medium enclosure 103 Some are enclosed. In the following, the former is described as an integrated viscous medium, and the latter is described as a cutting-type viscous medium.
(1) A predetermined viscous medium (hereinafter referred to as a test viscous medium) is placed in a predetermined container. In addition, the viscosity of the test viscous medium is measured in advance using a B-type viscometer.
(2) The load-bearing measurement container P with a red line on the side surface is placed on the test viscous medium placed in the container. The load resistance measuring container P will be described with reference to FIG. In FIG. 2, A is a top view of the load-bearing measuring container P, B is a front view of the load-bearing measuring container P, and C is a bottom view of the load-bearing measuring container P. The load-bearing measurement container P has a truncated cone shape with an upper bottom diameter of 58 mm, a lower bottom diameter of 43 mm, and a height of 30 mm, and has a predetermined red line L at a side surface position of 10 mm from the bottom. . The load resistance measuring container P is made of polyethylene and has a weight of 1.9 g.
(3) The weight W is slowly placed on the load resistance measurement container P.
(4) As shown in FIG. 2D, the weight of the weight W when the red line L of the load-bearing measurement heavy container P becomes the same height as the surface of the viscous medium is read. At this time, the weight of the load resistance measuring container P is ignored.
(5) Repeat 5 times and calculate the average value.
 次に、粘性媒体の適正な耐荷重を決めるべく、粘性媒体を用いた以下の服用試験1~服用実験3を実施した。 Next, in order to determine an appropriate load resistance of the viscous medium, the following dosing tests 1 to 3 using the viscous medium were performed.
2.服用実験1
(1)図3Aに示す耐荷重を有する一体型の粘性媒体G1~G7を用意する。
(2)各一体型の粘性媒体G1~G7を媒体封入部103に封入し、所定の粉末状の薬を所定のオブラートで包んだ薬剤を媒体封入部103に配置した薬剤経口投与装置100(以下、被験薬剤経口投与装置A)を一体型の粘性媒体G1~G7毎に、所定数、作成する。
(3)被験薬剤経口投与装置Aを用いて所定数の服用者が薬剤を服用し、媒体封入部103からの取り出し性の観点の観点から、各服用者が被験薬剤経口投与装置Aを評価した。ここで、取り出し性とは、服用者が薬剤封入部101において形成した薬剤被覆媒体を先端差込部105に向かって移動させる際の取り出し易さを、服用者の感覚によって評価したものである。なお、評価に当たっては、5:取り出し易い~1:取り出しにくいを基準に5段階で評価する。
(4)各服用者は、さらに、媒体封入部103からの残留性の観点の観点から、各服用者が被験薬剤経口投与装置Aを評価した。ここで、残留性とは、服用者が薬剤被覆媒体を服用した後に、口内及び喉内に残留感が残るか否かを、服用者の感覚によって評価したものである。あると判断した人数の割合を示す。(5)取り出し性については、各服用者の評価の平均値を算出する。残留性については、一体型の粘性媒体G1~G7毎に、残留感があるとした服用者の人数の割合を残留率として算出する。
2. Dosing experiment 1
(1) Prepare integrated viscous media G1 to G7 having load resistance shown in FIG. 3A.
(2) The oral drug administration device 100 (hereinafter referred to as “the medicine oral administration device 100”) in which each of the integrated viscous media G1 to G7 is enclosed in the medium enclosing unit 103, and the drug enclosing a predetermined powdery drug in a predetermined oblate is disposed in the medium enclosing unit 103 A predetermined number of test drug oral administration devices A) are prepared for each of the integrated viscous media G1 to G7.
(3) A predetermined number of users take the drug using the test drug oral administration device A, and each user evaluated the test drug oral administration device A from the viewpoint of the ability to remove from the medium enclosure 103. . Here, the take-out property is an evaluation of the ease of taking-out when the user moves the medicine-coated medium formed in the medicine-filling part 101 toward the tip insertion part 105 by the sense of the user. In the evaluation, the evaluation is made in five steps based on 5: easy to take out to 1: difficult to take out.
(4) Each user further evaluated the test drug oral administration device A from the viewpoint of the persistence from the medium enclosure 103. Here, the persistence is an evaluation based on the sensation of the user whether or not the sensation remains in the mouth and throat after the user has taken the drug-coated medium. Shows the percentage of people judged to be. (5) For the take-out property, the average value of each user's evaluation is calculated. As for the persistence, the ratio of the number of users who have a feeling of persistence for each of the integrated viscous media G1 to G7 is calculated as the residual rate.
 実験の結果を図3Bに示す。また、図3Bにおける耐荷重と取り出し性の関係を図3Cに、図3Bにおける耐荷重と残留性の関係を図3Dに、それぞれ示す。 The result of the experiment is shown in FIG. 3B. FIG. 3C shows the relationship between the load resistance and the take-out property in FIG. 3B, and FIG. 3D shows the relationship between the load resistance and the persistence in FIG. 3B.
 図3Cに示すように、取出し性については、粘性媒体G7が特に劣っている。また、図3Dに示すように、残留性についても、粘性媒体G7が劣っている。よって、一体型の粘性媒体における耐荷重の下限値は、20gとすることが妥当と考えられる。 As shown in FIG. 3C, the viscous medium G7 is particularly inferior in terms of take-out property. As shown in FIG. 3D, the viscous medium G7 is also inferior in terms of persistence. Therefore, it is considered appropriate that the lower limit of the load resistance in the integrated viscous medium is 20 g.
3.服用実験2
(1)図4Aに示す耐荷重を有する一体型の粘性媒体H1~H5を用意する。
(2)各一体型の粘性媒体H1~H7を媒体封入部103に封入し、所定の錠剤又はカプセルの薬剤を媒体封入部103に配置した薬剤経口投与装置100(以下、被験薬剤経口投与装置B)を、一体型の粘性媒体H1~H5毎に、所定数、作成する。
(3)被験薬剤経口投与装置Bを用いて所定名の服用者が薬剤を服用し、媒体封入部103からの服用性の観点の観点から、各服用者が被験薬剤経口投与装置Aを評価した。ここで、服用性とは、服用者が薬剤被覆媒体を飲み込む際の喉越しの抵抗感を評価する。なお、評価に当たっては、5:抵抗感全くない、4:抵抗感ほとんどなし、3:喉に感ずるが普通に飲める、2:抵抗感やや大きいが飲める、1:抵抗感が非常に大きいか飲めない、を基準に評価する。
(4)各服用者は、さらに、媒体封入部103からの残留性の観点の観点から、各服用者が被験薬剤経口投与装置Bを評価した。
(5)服用実験1と同様に、服用性及び残留率を算出する。
3. Dosing experiment 2
(1) Prepare integrated viscous media H1 to H5 having load resistance shown in FIG. 4A.
(2) Oral drug administration device 100 (hereinafter referred to as test drug oral administration device B) in which each integrated viscous medium H1 to H7 is enclosed in medium enclosing unit 103 and a predetermined tablet or capsule drug is arranged in medium enclosing unit 103. ) Is prepared for each of the integrated viscous media H1 to H5.
(3) A prescribed name of a user takes a drug using the test drug oral administration device B, and each doser evaluates the test drug oral administration device A from the viewpoint of the ingestibility from the medium enclosure 103. . Here, the ingestion refers to the feeling of resistance over the throat when the user swallows the drug-coated medium. In the evaluation, 5: no resistance at all, 4: almost no resistance, 3: sensation in the throat, but normal drinking, 2: resistance, slightly large but can be swallowed, 1: resistance is very large or can not be drunk , Based on the criteria.
(4) Each user further evaluated the test drug oral administration device B from the viewpoint of the persistence from the medium enclosure 103.
(5) In the same manner as in Dosing Experiment 1, the dosing property and the residual rate are calculated.
 実験の結果を図4Bに示す。また、図4Bにおける耐荷重と取り出し性の関係を図4Cに、図4Bにおける耐荷重と残留性の関係を図4Dに、それぞれ示す。 The result of the experiment is shown in FIG. 4B. Further, FIG. 4C shows the relationship between the load resistance and the take-out property in FIG. 4B, and FIG. 4D shows the relationship between the load resistance and the persistence in FIG. 4B.
 図4C及び図4Dから、薬剤が錠剤であっても、カプセルであっても、服用性、残留性と粘性媒体の耐荷重とは関連性があるといえる。さらに、粘性媒体の耐荷重が低すぎても高すぎても、服用性及び残留性が悪くなる傾向がある。図4C及び図4Dに示すように、服用性及び残留性の観点から、一体型の粘性媒体における耐荷重の上限値は、1000gとすることが妥当と考えられる。 From FIG. 4C and FIG. 4D, it can be said that whether the drug is a tablet or a capsule, the dosing property, the persistence, and the load resistance of the viscous medium are related. Furthermore, if the load bearing capacity of the viscous medium is too low or too high, the ingestibility and persistence tend to be poor. As shown in FIG. 4C and FIG. 4D, it is considered appropriate that the upper limit value of the load resistance in the integrated viscous medium is 1000 g from the viewpoint of dosing and persistence.
4.服用実験3
(1)図5に示す耐荷重を有する裁断型の粘性媒体I1~I13を用意する。
(2)各裁断型の粘性媒体I1~I13を媒体封入部103に封入し、所定の錠剤を媒体封入部103に配置した薬剤経口投与装置100(以下、被験薬剤経口投与装置C)を、一体型の粘性媒体I1~I13毎に、所定数、作成する。
(3)被験薬剤経口投与装置Cを用いて、所定名の服用者が薬剤を服用し、媒体封入部103からの服用性の観点の観点から、各服用者が被験薬剤経口投与装置Cを評価した。
(4)服用実験1と同様に、服用性を算出する。
4). Dosing experiment 3
(1) Prepare cutting-type viscous media I1 to I13 having load resistance shown in FIG.
(2) A drug oral administration device 100 (hereinafter referred to as a test drug oral administration device C) in which each of the cutting-type viscous media I1 to I13 is enclosed in the medium enclosure 103 and a predetermined tablet is placed in the medium enclosure 103 is A predetermined number is created for each of the body-shaped viscous media I1 to I13.
(3) Using the test drug oral administration device C, a prescribed name of the user takes the drug, and each user evaluates the test drug oral administration device C from the viewpoint of the ingestibility from the medium enclosure 103 did.
(4) The doseability is calculated in the same manner as in dose experiment 1.
 実験の結果を図5の服用性欄に示す。また、図5における耐荷重と服用性の関係を図6に、それぞれ示す。 The results of the experiment are shown in the administration property column of FIG. In addition, FIG. 6 shows the relationship between the load resistance and the dose in FIG.
 図6から、裁断型の粘性媒体において、服用性と粘性媒体の耐荷重とは関連性があるといえる。粘性媒体の耐荷重の上昇と共に服用性が良くなり、更に、上昇すると服用性は悪くなる傾向がある。図6に基づき、服用性の観点から、裁断型の粘性媒体における耐荷重は、10g~150gとすることが妥当と考えられる。なお、服用性における許容下限値は、「2」に設定している。 From FIG. 6, it can be said that in the cut-type viscous medium, the ingestibility and the load resistance of the viscous medium are related. As the load resistance of the viscous medium increases, the dosing property improves, and when it increases, the dosing property tends to deteriorate. Based on FIG. 6, it is considered appropriate that the load resistance in the cut-type viscous medium is 10 g to 150 g from the viewpoint of dosing. In addition, the allowable lower limit value in the dosing property is set to “2”.
5.まとめ
 上記服用実験から、薬剤経口投与装置100で用いる粘性媒体としては、耐荷重が10~1000gの範囲が許容範囲と考えられる。また、粘性媒体が一体型の粘性媒体である場合には、特に、耐荷重が20~1000gであることが好ましい。さらに、粘性媒体が裁断型の粘性媒体である場合には、特に、耐荷重が10g~150gであることが好ましい。
5. Summary From the above dose experiment, the viscous medium used in the oral drug administration device 100 is considered to have an allowable range of load resistance of 10 to 1000 g. In addition, when the viscous medium is an integrated viscous medium, the load resistance is particularly preferably 20 to 1000 g. Further, when the viscous medium is a cut-type viscous medium, the load resistance is particularly preferably 10 to 150 g.
第3 薬剤・粘性媒体間融着部109
 薬剤・粘性媒体間融着部109は、薬剤経口投与装置100の携帯時、搬送時に、媒体封入部103から粘性媒体が漏洩しないようにする漏洩防止を目的として形成される。ただし、薬剤経口投与装置100の使用時には、媒体封入部103から粘性媒体を取り出しやすいように、薬剤・粘性媒体間融着部109を形成する必要がある。したがって、薬剤・粘性媒体間融着部109を形成するにあたっては、携帯時、搬送時に媒体封入部103から粘性媒体が漏洩しないようにするとともに、使用時に媒体封入部103から粘性媒体を取り出しやすいようにシートを融着する必要がある。
Third drug-viscous medium fusion part 109
The drug / viscous medium fusion part 109 is formed for the purpose of preventing leakage of the viscous medium from the medium enclosing part 103 when the drug oral administration device 100 is carried or transported. However, when the drug oral administration device 100 is used, it is necessary to form the drug / viscous medium fusion part 109 so that the viscous medium can be easily taken out from the medium enclosing part 103. Therefore, when forming the fusion part 109 between the medicine and the viscous medium, it is ensured that the viscous medium does not leak from the medium enclosing part 103 during carrying and transportation, and the viscous medium can be easily taken out from the medium enclosing part 103 during use. It is necessary to fuse the sheet.
1.粘性媒体の漏洩
 薬剤・粘性媒体間融着部109の融着強度が小さいと、2つ折り状態(図11A、図11B参照)で携行、搬送する際に、媒体封入部103に負荷が掛かり、媒体封入部103から粘性媒体が漏洩する。そこで、薬剤・粘性媒体間融着部109の適正な融着強度を決めるべく、粘性媒体の漏洩の観点の観点から、以下の実験を行った。
(1)以下の4種類の所定の薬剤経口投与装置100(以下、被験薬剤経口投与装置)を用意する。
媒体封入部103:幅(内径)25mm
粘性媒体の封入量:3.5ml
薬剤・粘性媒体間融着部109の融着強度:10gf/15mm、15gf/15mm、18gf/15mm、35gf/15mm(融着強度は、被験薬剤経口投与装置を15mm幅に切断し、引張り試験にて測定した引っ張り強度を使用)
(2)2つ折り状態における被験薬剤経口投与装置において、媒体封入部103に荷重をかけて、媒体封入部103から薬剤・粘性媒体間融着部109を介して粘性媒体が漏洩したときの荷重(耐荷重)を計測する。
1. Leakage of viscous medium When the fusion strength of the drug-viscous medium fusion part 109 is small, a load is applied to the medium enclosing part 103 when carrying and transporting in a folded state (see FIGS. 11A and 11B), and the medium A viscous medium leaks from the enclosure 103. Therefore, in order to determine an appropriate fusion strength of the drug-viscous medium fusion part 109, the following experiment was performed from the viewpoint of leakage of the viscous medium.
(1) The following four types of predetermined drug oral administration devices 100 (hereinafter referred to as test drug oral administration devices) are prepared.
Medium enclosure 103: width (inner diameter) 25 mm
Enclosed amount of viscous medium: 3.5ml
Fusing strength of the drug-viscous medium fusion part 109: 10 gf / 15 mm, 15 gf / 15 mm, 18 gf / 15 mm, 35 gf / 15 mm Using the tensile strength measured by
(2) In the test drug oral administration device in the folded state, the load when the viscous medium leaks from the medium encapsulating part 103 through the drug-viscous medium fusion part 109 by applying a load to the medium enclosing part 103 ( Measure load capacity.
 実験の結果を図7に示す。また、実験結果をグラフ化したものを図8に示す。 The experimental results are shown in FIG. FIG. 8 shows a graph of the experimental results.
 携行、搬送時、2つ折り状態の薬剤経口投与装置100の媒体封入部103には、10kgの荷重がかかることもある。よって、図8から、薬剤・粘性媒体間融着部109の融着強度が10gf/15mm以下では、携行、搬送時に媒体封入部103から粘性媒体が漏洩する可能性があることが分かる。 During carrying and transporting, a load of 10 kg may be applied to the medium enclosing portion 103 of the drug oral administration device 100 in a folded state. Therefore, it can be seen from FIG. 8 that when the fusion strength of the drug-viscous medium fusion part 109 is 10 gf / 15 mm or less, the viscous medium may leak from the medium enclosure part 103 during carrying and transportation.
 一方、図8から、薬剤・粘性媒体間融着部109の融着強度が13gf/15mm以上で耐荷重が上昇を始め、15gf/15mmあたりで耐荷重が大幅に上昇する。融着強度が15gf/15mm以上では、ほぼ液漏れの心配は無くなる。 On the other hand, from FIG. 8, when the fusion strength of the drug-viscous medium fusion part 109 is 13 gf / 15 mm or more, the load resistance starts increasing, and the load resistance increases significantly around 15 gf / 15 mm. When the fusion strength is 15 gf / 15 mm or more, there is almost no fear of liquid leakage.
 以上から、薬剤・粘性媒体間融着部109の融着強度については、15gf/15mm以上、好ましくは20gf/15mm以上が必要である。 From the above, the fusion strength of the drug-viscous medium fusion part 109 needs to be 15 gf / 15 mm or more, preferably 20 gf / 15 mm or more.
2.粘性媒体の取り出し
 薬剤・粘性媒体間融着部109の適正な融着強度を決めるべく、媒体封入部103からの取り出し性の観点の観点から、以下の実験を行った。ここで、取り出し性とは、ユーザが薬剤封入部101において形成した薬剤被覆媒体を先端差込部105に向かって移動させる際の取り出し易さを、ユーザの感覚によって評価したものである。
(1)以下の6種類の所定の薬剤経口投与装置100(以下、被験薬剤経口投与装置)を用意する。
・媒体封入部103:幅(内径)25mm
・粘性媒体の封入量:3.5ml
・薬剤・粘性媒体間融着部109の融着強度:13gf/15mm、28gf/15mm、56gf/15mm、95gf/15mm、171gf/15mm、600gf/15mm(融着強度は、被験薬剤経口投与装置を15mm幅に切断し、引張り試験にて測定した引っ張り強度を使用)
(2)個々の被験薬剤経口投与装置について、媒体封入部103からの粘性媒体の取り出し性について評価する。ここで、取り出し性とは、ユーザが薬剤封入部101において形成した薬剤被覆媒体を先端差込部105に向かって移動させる際の取り出し易さを、ユーザの感覚によって評価したものである。取り出し性については、5段階評価として、1:融着強度が小さすぎる~3:適正~5:融着強度が大きすぎる、として評価する。
(3)2つ折り状態における被験薬剤経口投与装置において、媒体封入部103に荷重をかけて、媒体封入部103から薬剤・粘性媒体間融着部109を介して粘性媒体が漏洩したときの荷重を取り出し荷重として計測する。
2. Taking out the viscous medium In order to determine the appropriate fusion strength of the fusion part 109 between the drug and the viscous medium, the following experiment was conducted from the viewpoint of the take-out property from the medium enclosing part 103. Here, the take-out property is an evaluation of the ease with which the user moves the drug-coated medium formed in the drug enclosure part 101 toward the tip insertion part 105 by the user's sense.
(1) The following six types of predetermined drug oral administration devices 100 (hereinafter referred to as test drug oral administration devices) are prepared.
Medium enclosing part 103: width (inner diameter) 25 mm
・ Enclosed amount of viscous medium: 3.5ml
-Fusion strength of the drug-viscous medium fusion part 109: 13 gf / 15 mm, 28 gf / 15 mm, 56 gf / 15 mm, 95 gf / 15 mm, 171 gf / 15 mm, 600 gf / 15 mm Cut to 15mm width and use the tensile strength measured by tensile test)
(2) About each test drug oral administration apparatus, the extraction property of the viscous medium from the medium enclosure part 103 is evaluated. Here, the take-out property is an evaluation of the ease with which the user moves the drug-coated medium formed in the drug enclosure part 101 toward the tip insertion part 105 by the user's sense. With respect to the take-out property, as a five-step evaluation, it is evaluated that 1: fusion strength is too small to 3: proper to 5: fusion strength is too large.
(3) In the test drug oral administration device in the folded state, the load when the viscous medium leaks from the medium enclosure 103 via the drug / viscous medium fusion part 109 is applied to the medium enclosure 103. Measured as take-off load.
 実験の結果を図8図9に示す。また、実験結果をグラフ化したものを図8図10に示す。 Results of the experiment are shown in FIG. 8 and FIG. FIG. 8 and FIG. 10 are graphs showing the experimental results.
 取り出し性の適正範囲は2~4と考えられる。したがって、図8図10から、取り出し荷重については200~800gが、引っ張り強度については30~300gf/15mmが、それぞれ適正と判断できる。なお、好ましくは、取り出し性については3~3.5が適正範囲と考えられる。よって、取り出し荷重については400~600gが、引っ張り強度は80~160gf/15mmが、それぞれ好まし適正範囲と考えられる。        The appropriate range of takeout is considered to be 2-4. Therefore, from FIG. 8 and FIG. 10, it can be determined that 200 to 800 g for the take-out load and 30 to 300 gf / 15 mm for the tensile strength are appropriate. Preferably, it is considered that 3 to 3.5 is an appropriate range for the take-out property. Accordingly, it is considered that the take-out load is preferably 400 to 600 g and the tensile strength is preferably 80 to 160 gf / 15 mm, respectively.
3.まとめ
 上記2つの実験から、薬剤・粘性媒体間融着部109の融着強度は、媒体封入部103からの粘性媒体の漏れの観点からすると、融着強度50gf/15mm以上が適正と評価できる。なお、上記実験で生じた粘性媒体の漏れは微量であるため、20gf/15mm以上は許容範囲と評価できる。
3. Conclusion From the above two experiments, the fusion strength of the drug-viscous medium fusion part 109 can be evaluated as appropriate with a fusion strength of 50 gf / 15 mm or more from the viewpoint of leakage of the viscous medium from the medium enclosure 103. In addition, since the leakage of the viscous medium produced in the experiment is very small, 20 gf / 15 mm or more can be evaluated as an allowable range.
 また、薬剤・粘性媒体間融着部109の融着強度は、媒体封入部103からの粘性媒体の取り出し性の観点からすると、融着強度30gf/15mm~120gf/15mmが適正と評価できる。なお、使用者の使用感から、20gf/15mm~200gf/15mmは許容範囲と評価できる。 Further, the fusion strength of the drug / viscous medium fusion part 109 can be evaluated as appropriate from the viewpoint of the take-out property of the viscous medium from the medium enclosing part 103 with a fusion strength of 30 gf / 15 mm to 120 gf / 15 mm. From the user's feeling of use, 20 gf / 15 mm to 200 gf / 15 mm can be evaluated as an allowable range.
  薬剤経口投与装置100は、粘性媒体の漏れの観点及び粘性媒体の取り出し性の観点の両者を満足する必要がある。よって、薬剤・粘性媒体間融着部109の的瀬名融着強度は、15~300gf/15mmと判断できる。 The drug oral administration device 100 needs to satisfy both the viewpoint of leakage of the viscous medium and the viewpoint of takeout property of the viscous medium. Therefore, the target Sena fusion strength of the drug / viscous medium fusion portion 109 can be determined to be 15 to 300 gf / 15 mm.
第4 使用方法
 薬剤経口投与装置100を使用する際には、錠剤T等の薬剤を薬剤封入部103に封入する準備段階と、薬剤被覆媒体を経口投与する経口投与段階とがある。以下に、段階毎に説明する。
Fourth Method of Use When using the drug oral administration device 100, there are a preparation stage in which a drug such as a tablet T is enclosed in the drug enclosure 103 and an oral administration stage in which the drug-coated medium is orally administered. Below, it demonstrates for every step.
1.準備段階
 準備段階においては、薬剤経口投与装置100は、粘性媒体封入部103に所定の粘性媒体が予め封入された状態で、薬剤を封入する使用者(以下、封入者)に提供される。以下において、薬剤経口投与装置100の準備段階を図1、図11を用いて説明する。なお、図11は、薬剤経口投与装置100を2つ折りにした状態を示し、Aは横から見た状態を、Bは上から見た状態を、それぞれ示している。
1. Preparation Stage In the preparation stage, the oral medicine administration device 100 is provided to a user (hereinafter, encapsulator) who encapsulates the medicine in a state where a predetermined viscous medium is encapsulated in the viscous medium enclosure 103 in advance. Hereinafter, the preparation stage of the oral drug administration device 100 will be described with reference to FIGS. FIG. 11 shows a state in which the oral drug administration device 100 is folded in half, A showing the state seen from the side, and B showing the state seen from above.
 図1に示すように、薬剤経口投与装置100を薬剤である錠剤Tを封入しようとする封入者は、錠剤Tを、先端差込部115を介して、薬剤封入部101へ投入する。このとき、先端差込部105をショベル状に広げて、錠剤Tを薬剤封入部101へ投入する。 As shown in FIG. 1, the encapsulator who intends to encapsulate the tablet T, which is a drug, in the drug oral administration device 100 puts the tablet T into the drug enclosing unit 101 via the tip insertion unit 115. At this time, the tip insertion part 105 is expanded in a shovel shape, and the tablet T is put into the medicine enclosure part 101.
 次に、図11A示すように、封入者は、薬剤封入部101及び先端差込部105を矢印a5方向へ折り返し、先端差込部105の先端をカバー部107の先端差込部用切り欠き117aからカバー部107の内部に挿入する。これにより、薬剤経口投与装置100を、図11Bに示すような2つ折りの状態とすることができる。 Next, as shown in FIG. 11A, the enclosing person folds the medicine enclosing portion 101 and the distal end insertion portion 105 in the direction of the arrow a5, and the distal end of the distal end insertion portion 105 is notched for the distal end insertion portion 117a of the cover portion 107. To be inserted into the cover 107. Thereby, the pharmaceutical oral administration device 100 can be in a folded state as shown in FIG. 11B.
 また、折り返す際には、粘性媒体封入部103の薬剤・粘性媒体間融着部109側の端部に沿って折り返す。これにより、粘性媒体封入部103に圧力がかかったとしても、粘性媒体封入部103に封入される粘性媒体の移動を薬剤・粘性媒体間融着部109の手前に制限できるため、薬剤・粘性媒体間融着部109の破損を防止できる。 Also, when folding back, it is folded back along the end of the viscous medium enclosing portion 103 on the side of the drug / viscous medium fusion portion 109. As a result, even if pressure is applied to the viscous medium enclosure 103, the movement of the viscous medium enclosed in the viscous medium enclosure 103 can be limited to the front of the drug / viscous medium fusion portion 109. Breakage of the interfuse portion 109 can be prevented.
2.経口投与段階
 薬剤経口投与装置100に収納されている薬剤を自ら経口する、又は、他の者に経口させる経口投与者は、図11に示すような2つ折り状態とされた薬剤経口投与装置100を、図1に示すような平面状態とする。
2. Oral administration stage The oral administration person who orally administers the drug stored in the drug oral administration device 100 or makes others oral, uses the drug oral administration device 100 in a folded state as shown in FIG. A planar state as shown in FIG.
 図1に示すような平面状態において、経口投与者は、粘性媒体封入部103を指でつまむ。これにより、粘性媒体封入部103の内部の圧力が高くなる。粘性媒体封入部103の内圧が所定以上高くなると、薬剤・粘性媒体間融着部109の融着が剥がれ、媒体封入部103の内部に位置する粘性媒体が、薬剤封入部101の方向へ移動する。これにより、薬剤封入部101の内部に位置する薬剤及び粘性媒体によって薬剤被覆媒体を生成できる。なお、粘性媒体が薬剤封入部101の方向へ移動した段階で、薬剤と粘性媒体とを揉み込むようにすることによって、粘性媒体に薬剤が均一に包含された薬剤被覆媒体を生成できる。 In the planar state as shown in FIG. 1, the oral administration person pinches the viscous medium enclosing part 103 with a finger. As a result, the pressure inside the viscous medium enclosure 103 increases. When the internal pressure of the viscous medium enclosing part 103 becomes higher than a predetermined level, the fusion between the drug / viscous medium fusion part 109 is peeled off, and the viscous medium located inside the medium enclosing part 103 moves toward the medicine enclosing part 101. . Thereby, a medicine covering medium can be generated by the medicine and the viscous medium located inside the medicine enclosure 101. In addition, when the viscous medium moves in the direction of the medicine enclosure 101, the medicine-coated medium in which the medicine is uniformly contained in the viscous medium can be generated by swallowing the medicine and the viscous medium.
 そして、薬剤被覆媒体を、先端差込部105の方向へ移動させる。最終的には、先端差込部105の先端から薬剤被覆媒体を経口投与する。
 
Then, the medicine coating medium is moved in the direction of the tip insertion part 105. Finally, the drug-coated medium is orally administered from the tip of the tip insertion part 105.
 前述の実施例1における薬剤経口投与装置100は、収納時に2つ折り状態にして小型化するものであった。本実施例における薬剤経口投与装置200は、収納時に4つ折り状態にし、さらに小型化するものである。 The oral drug administration device 100 in Example 1 described above was miniaturized by folding in half when stored. The oral drug administration device 200 in this embodiment is folded into four when stored and further downsized.
 以下においては、実施例1と同じ構成については実施例1と同じ符号を付し、その詳細な記述を省略する。 In the following, the same components as those in the first embodiment are denoted by the same reference numerals as those in the first embodiment, and detailed description thereof is omitted.
第1 構成
 本発明に係る薬剤経口投与装置の一実施例である薬剤経口投与装置200について、図12を用いて説明する。
First Configuration A drug oral administration device 200, which is an embodiment of a drug oral administration device according to the present invention, will be described with reference to FIG.
 薬剤経口投与装置200は、薬剤封入部201、媒体封入部103、先端差込部205、及びカバー部207を有している。 The oral drug administration device 200 includes a drug enclosure 201, a medium enclosure 103, a tip insertion section 205, and a cover 207.
 薬剤封入部201の構造、機能については実施例1における薬剤封入部101と同様である。ただし、薬剤封入部201は、先端差込部切除用切り欠き211を有している。収納差込切除用切り欠き211は、薬剤被覆媒体を経口投与する際に、先端差込部205を切除するために形成されている。 The structure and function of the drug enclosure 201 are the same as those of the drug enclosure 101 in the first embodiment. However, the medicine enclosure 201 has a notch 211 for cutting out the distal end insertion part. The notch 211 for storing insertion excision is formed to excise the tip insertion part 205 when orally administering the drug-coated medium.
 先端差込部205の構造、機能については、実施例1における先端差込部105と同様である。ただし、先端差込部205は、先端差込部105に比して、長さが長くなっている。これは、先端差込部205は、主として、収納の際に先端差込部収納用開口117に挿入され、薬剤経口投与装置200の2つ折り状態を維持することを目的として設けられているからである。 The structure and function of the tip insertion portion 205 are the same as those of the tip insertion portion 105 in the first embodiment. However, the tip insertion portion 205 is longer than the tip insertion portion 105. This is because the distal end insertion portion 205 is provided mainly for the purpose of maintaining the folded state of the oral drug administration device 200 by being inserted into the distal end insertion portion storage opening 117 during storage. is there.
 なお、先端差込部205は、先端差込部105に比して長く形成されているため、経口投与の際に、先端差込部205の先端が喉にひっかかる場合が生ずる。この場合には、薬剤封入部201の収納差込切除用切り欠き211から先端差込部205を切除することによって、薬剤被覆媒体を経口投与し易くできる。 In addition, since the distal end insertion part 205 is formed longer than the distal end insertion part 105, the distal end of the distal end insertion part 205 may get caught in the throat during oral administration. In this case, it is possible to facilitate oral administration of the drug-coated medium by excising the distal end insertion part 205 from the storage insertion excision cutout 211 of the drug enclosure part 201.
 カバー部207は、先端差込部収納用開口117、及び、薬剤媒体部収納用開口217を有している。薬剤媒体部収納用開口217は、先端差込部収納用開口117が形成されているシートとは異なるシートに形成される。薬剤媒体部収納用開口217に、薬剤経口投与装置200を2つ折りにすることによって形成される薬剤封入部201と媒体封入部103との重なり部を挿入することによって、薬剤経口投与装置200を4つ折りの状態にすることができる。 The cover portion 207 has a tip insertion portion storage opening 117 and a medicine medium portion storage opening 217. The medicine medium portion storage opening 217 is formed on a sheet different from the sheet on which the tip insertion portion storage opening 117 is formed. By inserting an overlapping portion of the medicine enclosure 201 and the medium enclosure 103 formed by folding the medicine oral administration device 200 in two into the medicine medium storage opening 217, 4 of the medicine oral administration device 200 is obtained. Can be folded.
 なお、薬剤媒体部収納用開口217は、4分の1楕円形状の切り欠きとして形成されている。これにより、薬剤封入部201と媒体封入部103との重なり部を、上側から薬剤媒体部収納用開口217に容易に挿入して、収納することができる(図15参照)。 In addition, the opening 217 for storing the medicine medium part is formed as a quarter oval cutout. Thereby, the overlapping part of the medicine enclosure part 201 and the medium enclosure part 103 can be easily inserted and accommodated in the medicine medium part accommodation opening 217 from above (see FIG. 15).
第2 使用方法
 薬剤経口投与装置200を使用する際には、錠剤T等の薬剤を薬剤封入部103に封入する準備段階と、薬剤被覆媒体を経口投与する経口投与段階とがある。以下に、各段階について説明する。
Second Usage Method When the drug oral administration device 200 is used, there are a preparation stage in which a drug such as a tablet T is enclosed in the drug enclosure 103 and an oral administration stage in which the drug-coated medium is orally administered. Hereinafter, each stage will be described.
1.準備段階
 準備段階においては、薬剤経口投与装置200は、粘性媒体封入部103に所定の粘性媒体が予め封入された状態で、薬剤を封入する使用者(以下、封入者)に提供される。以下において、薬剤経口投与装置200の準備段階を図12~図15を用いて説明する。なお、図13は、薬剤経口投与装置200を2つ折りにした状態を示し、Aは横から見た状態を、Bは上から見た状態を、それぞれ示している。図14も同様である。但し、図14は、薬剤経口投与装置200を4つ折りにした状態を示している。
1. Preparation Stage In the preparation stage, the oral medicine administration device 200 is provided to a user (hereinafter, encapsulator) who encapsulates the medicine in a state where a predetermined viscous medium is encapsulated in the viscous medium enclosure 103 in advance. Hereinafter, the preparation stage of the oral drug administration device 200 will be described with reference to FIGS. FIG. 13 shows a state in which the oral drug administration device 200 is folded in half, A showing the state seen from the side, and B showing the state seen from above. The same applies to FIG. However, FIG. 14 shows a state in which the oral medicine administration device 200 is folded in four.
 図12に示すように、薬剤経口投与装置200を薬剤である錠剤Tを封入しようとする封入者は、錠剤Tを、先端差込部215を介して、薬剤封入部201へ投入する。このとき、先端差込部205をショベル状に広げて、錠剤Tを薬剤封入部201へ投入する。 As shown in FIG. 12, the encapsulator who intends to encapsulate the tablet T, which is a drug, in the drug oral administration device 200 puts the tablet T into the drug encapsulating part 201 via the tip insertion part 215. At this time, the tip insertion part 205 is expanded in a shovel shape, and the tablet T is put into the medicine enclosure part 201.
 次に、図13A示すように、封入者は、薬剤封入部201及び先端差込部205を矢印a5方向へ折り返し、先端差込部205の先端をカバー部207の先端差込部用切り欠き117からカバー部207の内部に挿入する。これにより、薬剤経口投与装置200を、図13Bに示すような2つ折りの状態とすることができる。なお、折り返す際には、実施例1と同様に、粘性媒体封入部103の薬剤・粘性媒体間融着部109側の端部に沿って折り返す。 Next, as shown in FIG. 13A, the enclosing person folds the medicine enclosing portion 201 and the distal end insertion portion 205 in the direction of the arrow a5, and the distal end of the distal end insertion portion 205 is notched for the distal end insertion portion of the cover portion 207. Into the cover 207. Thereby, the pharmaceutical oral administration device 200 can be in a folded state as shown in FIG. 13B. In the case of folding, as in the first embodiment, the folding is performed along the end of the viscous medium enclosing portion 103 on the side of the drug / viscous medium fusion portion 109.
 薬剤経口投与装置200を2つ折りにした状態から、封入者は、さらに、図14Aに示すように、粘性媒体・カバー部間融着部113を中心に、薬剤封入部201及び媒体封入部103を矢印a6方向へ折り返し、図15に示すように、薬剤封入部201と媒体封入部103との重なり部を、上側から、カバー部107の薬剤媒体部収納用開口217からカバー部207の内部に挿入する。これにより、薬剤経口投与装置200を、図14Bに示すような4つ折りの状態とすることができる。なお、図15は、図14Aにおける矢印a61方向から薬剤経口投与装置200を4つ折り状態にしようとする際の状態を見ている。このように、薬剤経口投与装置200を4つ折り状態とすることによって、コンパクトに収納できるとともに、形態を安定させることができる。 From the state in which the oral drug administration device 200 is folded in half, the enclosing person further sets the encapsulating part 201 and the medium enclosing part 103 around the viscous medium / cover fusion part 113 as shown in FIG. 14A. Folded in the direction of the arrow a6, as shown in FIG. 15, the overlapping portion of the drug enclosure 201 and the medium enclosure 103 is inserted into the cover 207 from the drug medium compartment storage opening 217 of the cover 107 from above. To do. Thereby, the pharmaceutical oral administration device 200 can be in a four-fold state as shown in FIG. 14B. FIG. 15 shows a state when the oral drug administration device 200 is to be folded into four from the direction of arrow a61 in FIG. 14A. Thus, by making the oral drug administration device 200 into a four-fold state, it can be stored compactly and the form can be stabilized.
2.経口投与段階
 薬剤経口投与装置200に収納されている薬剤を自ら経口する、又は、他の者に経口させる経口投与者は、図14Aに示すような4つ折り状態とされた薬剤経口投与装置200を、図12に示すような平面状態とする。
2. Oral administration stage The oral administration person who orally administers the medicine stored in the medicine oral administration apparatus 200 or makes another person orally use the medicine oral administration apparatus 200 in a four-fold state as shown in FIG. 14A. A planar state as shown in FIG.
 図12に示すような平面状態において、経口投与者は、粘性媒体封入部103を指でつまむ。これにより、粘性媒体封入部103の内部の圧力が高くなる。粘性媒体封入部103の内圧が所定以上高くなると、薬剤・粘性媒体間融着部109の融着が剥がれ、媒体封入部103の内部に位置する粘性媒体が、薬剤封入部201の方向へ移動する。これにより、薬剤封入部201の内部に位置する薬剤及び粘性媒体によって薬剤被覆媒体を生成できる。なお、粘性媒体が薬剤封入部201の方向へ移動した段階で、薬剤と粘性媒体とを揉み込むようにすることによって、粘性媒体に薬剤が均一に包含された薬剤被覆媒体を生成できる。 In the planar state as shown in FIG. 12, the oral administration person pinches the viscous medium enclosing part 103 with a finger. As a result, the pressure inside the viscous medium enclosure 103 increases. When the internal pressure of the viscous medium enclosing part 103 becomes higher than a predetermined level, the fusion between the drug / viscous medium fusion part 109 is peeled off, and the viscous medium located inside the medium enclosing part 103 moves toward the medicine enclosing part 201. . Thereby, a medicine covering medium can be generated by the medicine and the viscous medium located inside the medicine enclosure 201. In addition, when the viscous medium moves in the direction of the drug enclosure 201, the drug-coated medium in which the drug is uniformly included in the viscous medium can be generated by swallowing the drug and the viscous medium.
 そして、薬剤封入部201に形成されている収納差込切除用切り欠き211を矢印a7方向へ切り裂き、先端差込部205を切除する。 Then, the storage insertion excision cutout 211 formed in the medicine enclosure 201 is cut in the direction of the arrow a7, and the distal insertion part 205 is excised.
 その後、薬剤被覆媒体を、薬剤封入部201の先端方向へ移動させる。最終的には、薬剤封入部201の先端から薬剤被覆媒体を経口投与する。
 
Thereafter, the drug coating medium is moved toward the tip of the drug enclosure 201. Finally, the drug-coated medium is orally administered from the tip of the drug enclosure 201.
 前述の実施例2における薬剤経口投与装置200は、薬剤・粘性媒体間融着部109を形成するものであった。本実施例における薬剤経口投与装置300は、さらに、漏洩補償融着部311を形成するものである。 The oral drug administration device 200 in Example 2 described above formed the fusion part 109 between the drug and the viscous medium. The drug oral administration device 300 in the present embodiment further forms a leakage compensation fusion part 311.
 以下においては、実施例2と同じ構成については実施例2と同じ符号を付し、その詳細な記述を省略する。 In the following, the same components as those in the second embodiment are denoted by the same reference numerals as those in the second embodiment, and detailed description thereof is omitted.
第1 構成
 本発明に係る薬剤経口投与装置の一実施例である薬剤経口投与装置300について、図12を用いて説明する。
First Configuration A drug oral administration device 300, which is an embodiment of a drug oral administration device according to the present invention, will be described with reference to FIG.
 薬剤経口投与装置300は、薬剤封入部301、媒体封入部103、先端差込部205、及びカバー部207を有している。 The drug oral administration device 300 includes a drug enclosure 301, a medium enclosure 103, a tip insertion part 205, and a cover 207.
 薬剤封入部301の構造、機能については実施例2における薬剤封入部201と同様である。ただし、薬剤封入部301は、漏洩補償融着部311を有している。漏洩補償融着部311は、薬剤・粘性媒体間融着部109によって媒体封入部103に封入されていた粘性媒体が、薬剤・粘性媒体間融着部109の融着を破って漏れ出してきたとしても、薬剤封入部201に位置する薬剤に接触しないようにするために形成される。 The structure and function of the drug enclosure 301 are the same as those of the drug enclosure 201 in the second embodiment. However, the medicine enclosure part 301 has a leakage compensation fused part 311. In the leakage compensation fusion part 311, the viscous medium sealed in the medium sealing part 103 by the medicine / viscous medium fusion part 109 breaks the fusion of the medicine / viscous medium fusion part 109 and leaks out. However, it is formed so as not to come into contact with the medicine located in the medicine enclosure 201.
 なお、漏洩補償融着部311の形成方法、物理的性質等に関しては、薬剤・粘性媒体間融着部109と同様である。
 
The formation method, physical properties, etc. of the leakage compensation fused part 311 are the same as those of the drug-viscous medium fused part 109.
 前述の実施例1における薬剤経口投与装置100は、カバー部107の側面に先端差込部用開口117を形成し、先端差込部105を収納することによって、収納時に2つ折り状態にして小型化するものであった。本実施例における薬剤経口投与装置400は、カバー部407の端部に先端差込部用開口417を形成し、薬剤封入部401の端部を収納することによって、収納時に3つ折り状態にして小型化するものである。 The oral medicine administration device 100 according to the first embodiment described above is formed in the side surface of the cover portion 107 with the distal end insertion portion opening 117 and accommodates the distal end insertion portion 105, so that it is folded into two when being accommodated and is downsized. It was something to do. The drug oral administration device 400 in this embodiment is formed into a tri-fold state when stored by forming a tip insertion part opening 417 at the end of the cover part 407 and storing the end of the drug enclosure 401. It is to become.
 以下においては、実施例1と同じ構成については実施例1と同じ符号を付し、その詳細な記述を省略する。 In the following, the same components as those in the first embodiment are denoted by the same reference numerals as those in the first embodiment, and detailed description thereof is omitted.
第1 構成
 本発明に係る薬剤経口投与装置の一実施例である薬剤経口投与装置400について、図17を用いて説明する。
First Configuration An oral drug administration device 400, which is an embodiment of an oral drug administration device according to the present invention, will be described with reference to FIG.
 薬剤経口投与装置400は、薬剤封入部401、媒体封入部103、カバー部407、及び、媒体間融着部109を有している。薬剤封入部401、媒体封入部103、及びカバー部407は、直線状に位置している。薬剤封入部401は、媒体封入部103に隣接して位置し、薬剤経口投与装置100の一端部に位置する。また、先端差込部105は、媒体封入部103に隣接し、薬剤経口投与装置100の一端部に位置する。カバー部107は、媒体封入部103に隣接して位置し、薬剤封入部401が位置する端部とは異なる、もう一方の端部に位置する。 The oral drug administration device 400 includes a drug enclosure 401, a medium enclosure 103, a cover 407, and an intermedia fusion part 109. The medicine enclosure part 401, the medium enclosure part 103, and the cover part 407 are located in a straight line. The drug enclosure 401 is located adjacent to the medium enclosure 103 and is located at one end of the oral drug administration device 100. Further, the distal end insertion part 105 is adjacent to the medium enclosing part 103 and is located at one end of the oral drug administration device 100. The cover part 107 is located adjacent to the medium enclosing part 103 and is located at the other end different from the end where the medicine enclosing part 401 is located.
 薬剤封入部401と粘性媒体封入部103とは、薬剤・粘性媒体間融着部109を介して、隣接する。粘性媒体封入部103とカバー部407とは、粘性媒体・カバー部間融着部113を介して隣接する。 The drug enclosure part 401 and the viscous medium enclosure part 103 are adjacent to each other via the drug / viscous medium fusion part 109. The viscous medium sealing portion 103 and the cover portion 407 are adjacent to each other via the viscous medium / cover portion fusion portion 113.
 カバー部407は、端部に薬剤封入部収納用開口417を有している。薬剤封入部収納用開口417から薬剤封入部401を挿入することによって、薬剤経口投与装置100を3つ折りの状態にすることができる。 The cover part 407 has an opening 417 for storing a medicine enclosure at the end. By inserting the medicine enclosure 401 from the medicine enclosure storage opening 417, the oral medicine administration device 100 can be folded in three.
第2 薬剤・粘性媒体間融着部109及び端部融着部419の融着強度
 次に、薬剤経口投与装置400における薬剤・粘性媒体間融着部109及び端部融着部419の融着強度について考察する。まず、以下の実験により、薬剤経口投与装置400における薬剤被覆媒体をどの程度排出できるか(以下、排出性)を評価した上で、薬剤経口投与装置400における薬剤・粘性媒体間融着部109及び端部融着部419の融着強度を決定する。
(1)端部融着部419の融着強度及び薬剤・粘性媒体間融着部109の融着強度の様々な組合せの被験薬剤経口投与装置を用意する。
(2)粘性媒体に圧力を加えて、薬剤被覆媒体を生成し、生成した薬剤被覆媒体を排出させる。
(3)薬剤被覆媒体をどの程度排出できたのかを評価する。
Fusing Strength of Second Drug / Viscous Medium Fusion Portion 109 and End Fused Portion 419 Next, Fusion of Drug / Viscous Medium Fusion Portion 109 and End Fused Portion 419 in Oral Drug Administration Device 400 Consider strength. First, after evaluating how much the drug-coated medium in the drug oral administration device 400 can be discharged (hereinafter referred to as dischargeability) by the following experiment, the drug-viscous medium fusion portion 109 in the drug oral administration device 400 and The fusion strength of the end fusion part 419 is determined.
(1) The test drug oral administration device of various combinations of the fusion strength of the end fusion part 419 and the fusion strength of the drug / viscous medium fusion part 109 is prepared.
(2) Pressure is applied to the viscous medium to generate a drug-coated medium, and the generated drug-coated medium is discharged.
(3) Evaluate how much the drug-coated medium can be discharged.
 実験の結果を図18に示す。この実験結果から、以下のことが分かる。
(1)端部融着部419の融着強度以外に薬剤・粘性媒体間融着部109の融着強度により薬剤被覆媒体の排出性が異なってくる。
(2)薬剤・粘性媒体間融着部109の融着強度が30g/15mmの場合、薬剤被覆媒体の排出性に、端部融着部419の融着強度が影響することは少ない。全体的に、薬剤被覆媒体の排出性は大きい。ただし、薬剤被覆媒体の排出性を100%とすることは難しい。
(3)薬剤・粘性媒体間融着部109の融着強度が60g/15mmの場合、薬剤・粘性媒体間融着部109の融着強度に対し端部融着部419の融着強度が、薬剤・粘性媒体間融着部109の融着強度に比して-40g~±0gとなる範囲で、100%の薬剤被覆媒体の排出性を確保できる。一方、端部融着部419の融着強度が、薬剤・粘性媒体間融着部109の融着強度より大きくなると薬剤被覆媒体の排出性が悪くなる。また、端部融着部419の融着強度が、薬剤・粘性媒体間融着部109の融着強度より60g以上大きくなると、薬剤被覆媒体を排出できない。
(4)薬剤・粘性媒体間融着部109の融着強度が120g/15mmの場合、端部融着部419の融着強度が0より小さいと、概ね薬剤被覆媒体を全量排出することが可能となる。ただし、薬剤・粘性媒体間融着部109と端部融着部419とが同等の融着強度を有するとすると、薬剤被覆媒体に関する排出性が激減し、+80g/15mmでは全く排出しなくなる。
(5)薬剤・粘性媒体間融着部109の融着強度が200g/15mmの場合、端部融着部419が薬剤・粘性媒体間融着部109の融着強度に比して、-170g/15mmでとなると、全ての薬剤被覆媒体を排出することも可能とある。ただし、端部融着部419の融着強度が薬剤・粘性媒体間融着部109の融着強度に比して、大きくなると薬剤被覆媒体の排出性は劇的に減少する。また、端部融着部419の融着強度と薬剤・粘性媒体間融着部109の融着強度とが同等であれば、薬剤被覆媒体を全く排出させることができない。
The result of the experiment is shown in FIG. From this experimental result, the following can be understood.
(1) In addition to the fusion strength of the end fusion part 419, the discharge property of the drug-coated medium differs depending on the fusion strength of the drug / viscous medium fusion part 109.
(2) When the fusion strength of the drug-viscous medium fusion part 109 is 30 g / 15 mm, the fusion strength of the end part fusion part 419 hardly affects the discharge property of the drug-coated medium. Overall, the drainage of the drug-coated media is great. However, it is difficult to set the discharge property of the drug-coated medium to 100%.
(3) When the fusion strength of the drug / viscous medium fusion part 109 is 60 g / 15 mm, the fusion strength of the end fusion part 419 with respect to the fusion strength of the drug / viscous medium fusion part 109 is As long as the fusion strength between the drug / viscous medium fusion part 109 is -40 g to ± 0 g, 100% of the drug-coated medium can be discharged. On the other hand, when the fusion strength of the end fusion part 419 is greater than the fusion strength of the drug-viscous medium fusion part 109, the discharge property of the drug-coated medium is deteriorated. Further, when the fusion strength of the end fusion part 419 is 60 g or more larger than the fusion strength of the drug-viscous medium fusion part 109, the drug-coated medium cannot be discharged.
(4) When the fusion strength of the drug / viscous medium fusion part 109 is 120 g / 15 mm, if the fusion strength of the end fusion part 419 is less than 0, almost all of the drug-coated medium can be discharged. It becomes. However, if the drug-viscous medium fusion part 109 and the end part fusion part 419 have the same fusion strength, the discharge property relating to the drug-coated medium is drastically reduced, and at +80 g / 15 mm, no discharge occurs.
(5) When the fusion strength of the drug / viscous medium fusion part 109 is 200 g / 15 mm, the end fusion part 419 is -170 g compared to the fusion strength of the drug / viscous medium fusion part 109. If it is / 15 mm, it is possible to discharge all drug-coated media. However, when the fusion strength of the end fusion portion 419 is larger than the fusion strength of the drug-viscous medium fusion portion 109, the discharge property of the drug-coated medium is dramatically reduced. Further, if the fusion strength of the end fusion portion 419 and the fusion strength of the drug / viscous medium fusion portion 109 are equal, the drug-coated medium cannot be discharged at all.
 以上のことから、薬剤経口投与装置400では、薬剤・粘性媒体間融着部109の融着強度が30g/15mm~120g/15mmであり、かつ、端部融着部419の融着強度が薬剤・粘性媒体間融着部109に比して±0g/15mm~+60g/15mmとなる場合が適正と考えられる。ただし、薬剤・粘性媒体間融着部109の融着強度が20g/15mm以上200g/15mm未満であり、端部融着部419の融着強度が0g/15mm以上100g/15mm未満である場合は許容範
囲と考えられる。
From the above, in the drug oral administration device 400, the fusion strength of the drug-viscous medium fusion part 109 is 30 g / 15 mm to 120 g / 15 mm, and the fusion strength of the end part fusion part 419 is the drug. -It is considered that the case where it is ± 0 g / 15 mm to +60 g / 15 mm as compared with the fused portion 109 between viscous media is appropriate. However, when the fusion strength of the drug-viscous medium fusion part 109 is 20 g / 15 mm or more and less than 200 g / 15 mm and the fusion strength of the end fusion part 419 is 0 g / 15 mm or more and less than 100 g / 15 mm It is considered acceptable.
第3 使用方法
 薬剤経口投与装置400を使用する際には、錠剤T等の薬剤を薬剤封入部103に封入する準備段階と、薬剤被覆媒体を経口投与する経口投与段階とがある。以下に、段階毎に説明する。
Third Method of Use When using the drug oral administration device 400, there are a preparation stage in which a drug such as a tablet T is enclosed in the drug enclosure 103 and an oral administration stage in which the drug-coated medium is orally administered. Below, it demonstrates for every step.
1.準備段階
 準備段階においては、薬剤経口投与装置400は、粘性媒体封入部103に所定の粘性媒体が予め封入された状態で、薬剤を封入する使用者(以下、封入者)に提供される。以下において、薬剤経口投与装置100の準備段階を図17、図19を用いて説明する。
1. Preparation Stage In the preparation stage, the oral medicine administration device 400 is provided to a user (hereinafter, encapsulator) who encapsulates the medicine in a state where a predetermined viscous medium is encapsulated in the viscous medium enclosure 103 in advance. Hereinafter, the preparation stage of the oral drug administration device 100 will be described with reference to FIGS. 17 and 19.
 図17に示すように、薬剤経口投与装置400を薬剤である錠剤Tを封入しようとする封入者は、錠剤Tを、薬剤封入部401へ投入する。このとき、薬剤封入部401の端部を広げて、錠剤Tを薬剤封入部401へ投入する。そして、封入者は、薬剤封入部401の端部を融着し、端部融着部419を形成する。 As shown in FIG. 17, the encapsulator who wants to encapsulate the tablet T, which is the drug, in the drug oral administration device 400 puts the tablet T into the drug enclosing unit 401. At this time, the end of the medicine enclosure 401 is widened and the tablet T is put into the medicine enclosure 401. Then, the enclosing person fuses the end portion of the medicine enclosing portion 401 to form the end fused portion 419.
 次に、図19A示すように、封入者は、カバー部407を矢印a41方向へ折り返す。次に、薬剤封入部401の単端をカバー部407の端部に形成されている薬剤封入部収納用開口417からカバー部407の内部に挿入する。これにより、薬剤経口投与装置400を、図19Bに示すような3つ折りの状態とすることができる。 Next, as shown in FIG. 19A, the enclosing person folds the cover portion 407 in the direction of the arrow a41. Next, the single end of the medicine enclosure 401 is inserted into the inside of the cover 407 from the medicine enclosure storage opening 417 formed at the end of the cover 407. Thereby, the medicine oral administration device 400 can be in a three-fold state as shown in FIG. 19B.
 なお、薬剤封入部401を折り返す際には、実施例1と同様に、粘性媒体封入部103の薬剤・粘性媒体間融着部109側の端部に沿って折り返す。 Note that, when the drug enclosing portion 401 is folded, as in the first embodiment, it is folded along the end of the viscous medium enclosing portion 103 on the drug-viscosity medium fusion portion 109 side.
2.経口投与段階
 薬剤経口投与装置400に収納されている薬剤を自ら経口する、又は、他の者に経口させる経口投与者は、図19Bに示すような3つ折り状態とされた薬剤経口投与装置400を、図17に示すような平面状態とする。
2. Oral administration stage The oral administration person who orally administers the medicine stored in the medicine oral administration device 400 or makes it oral by another person uses the medicine oral administration device 400 in a tri-fold state as shown in FIG. 19B. A planar state as shown in FIG.
 図17に示すような平面状態において、経口投与者は、粘性媒体封入部103を指でつまむ。これにより、粘性媒体封入部103の内部の圧力が高くなる。粘性媒体封入部103の内圧が所定以上高くなると、薬剤・粘性媒体間融着部109の融着が剥がれ、媒体封入部103の内部に位置する粘性媒体が、薬剤封入部101の方向へ移動する。これにより、薬剤封入部101の内部に位置する薬剤及び粘性媒体によって薬剤被覆媒体を生成できる。なお、粘性媒体が薬剤封入部101の方向へ移動した段階で、薬剤と粘性媒体とを揉み込むようにすることによって、粘性媒体に薬剤が均一に包含された薬剤被覆媒体を生成できる。 In the planar state as shown in FIG. 17, the oral administration person pinches the viscous medium enclosing part 103 with a finger. As a result, the pressure inside the viscous medium enclosure 103 increases. When the internal pressure of the viscous medium enclosing part 103 becomes higher than a predetermined level, the fusion between the drug / viscous medium fusion part 109 is peeled off, and the viscous medium located inside the medium enclosing part 103 moves toward the medicine enclosing part 101. . Thereby, a medicine covering medium can be generated by the medicine and the viscous medium located inside the medicine enclosure 101. In addition, when the viscous medium moves in the direction of the medicine enclosure 101, the medicine-coated medium in which the medicine is uniformly contained in the viscous medium can be generated by swallowing the medicine and the viscous medium.
 そして、薬剤封入部401に形成されている収納差込切除用切り欠き411を矢印a47方向へ切り裂き、端部融着部419を切除する。 Then, the storage insertion cutout 411 formed in the medicine enclosure 401 is cut in the direction of arrow a47, and the end fused portion 419 is cut off.
 その後、薬剤被覆媒体を、薬剤封入部401の先端方向へ移動させる。最終的には、薬剤封入部401の先端から薬剤被覆媒体を経口投与する。 Thereafter, the drug coating medium is moved in the direction of the distal end of the drug enclosure 401. Finally, the drug-coated medium is orally administered from the tip of the drug enclosure 401.
[その他の実施例]
 (1)粘性媒体 : 前述の実施例1においては、粘性媒体として、いわゆるゼリーを用いたが、所定の粘度、所定の強度を有し、薬剤を被覆し、被覆された複数の薬剤が一体となった薬剤被覆媒体を形成するものであれば例示のものに限定されない。
[Other Examples]
(1) Viscous medium: In Example 1 described above, so-called jelly was used as the viscous medium. However, the viscous medium has a predetermined viscosity and a predetermined strength, is coated with a drug, and a plurality of coated drugs are integrated. The present invention is not limited to the examples as long as the formed drug-coated medium is formed.
 (2)薬剤 : 前述の実施例1においては、薬剤として錠剤Tを示したが、薬剤であれば例示のものに限定されない。例えば、ミニタブレット、ペレット、ハードカプセル、ソフトカプセル、包蔵物、顆粒、粉剤、APIであってもよい。 (2) Drug: In Example 1 described above, tablet T is shown as the drug, but the drug is not limited to the illustrated one as long as it is a drug. For example, it may be a mini tablet, pellet, hard capsule, soft capsule, inclusion, granule, powder, API.
 また、薬剤の代わりに、所定の栄養素を補給するためのものであるサプリメントを用いるようにしてもよい。 Further, a supplement for supplementing a predetermined nutrient may be used instead of the drug.
 (3)材質 : 前述の実施例1~実施例4における薬剤経口投与装置100~薬剤経口投与装置400を形成するシートの材質としてポリプロピレン等を示したが、薬剤・粘性媒体間融着部109を形成でき、媒体封入部103を手によって所定の圧力をかけることができるものであれば、例示のものに限定されない。例えば、アルミニウム等、軟質の材料によって形成するようにしてもよい。また、透明、半透明であってもよい。 (3) Material: Polypropylene or the like is shown as the material of the sheet forming the oral drug administration device 100 to oral drug administration device 400 in Examples 1 to 4 described above. As long as it can be formed and a predetermined pressure can be applied to the medium sealing portion 103 by hand, it is not limited to the example. For example, you may make it form with soft materials, such as aluminum. Further, it may be transparent or translucent.
 (4)薬剤媒体部収納用開口217 : 前述の実施例2においては、4分の1楕円形状の薬剤媒体部収納用開口217を形成したが、薬剤封入部201と媒体封入部103との重なり部を収納することができるものであれば、例示のものに限定されない。例えば、斜め直線状の開口であってもよい。 (4) Drug medium storage opening 217: In Example 2 described above, the quarter-elliptical drug medium storage opening 217 was formed, but the drug enclosure 201 and the medium enclosure 103 overlap. If it can accommodate a part, it is not limited to the example of illustration. For example, it may be a diagonally straight opening.
 また、薬剤経口投与装置200及び薬剤経口投与装置300において、薬剤媒体部収納用開口217を形成しなくともよい。 Further, in the oral medicine administration device 200 and the oral medicine administration device 300, the medicine medium portion storage opening 217 may not be formed.
  (5)先端差込部105の形状 : 前述の実施例1における薬剤経口投与装置100の先端差込部105は、薬剤封入部101と隣接する端部とは異なる端部に向かって傾斜するように形成されているとしたが、先端差込部105を、先端差込部収納用開口117に挿入できる形状であれば、例示のものに限定されない。 (5) Shape of the distal end insertion portion 105: The distal end insertion portion 105 of the oral drug administration device 100 in Example 1 described above is inclined toward an end portion different from the end portion adjacent to the pharmaceutical encapsulation portion 101. However, the shape is not limited to the illustrated example as long as the tip insertion portion 105 can be inserted into the tip insertion portion storage opening 117.
 また、先端差込部105では、患者の口腔内に挿入した際にショベル状にできるとしたが、薬剤被覆媒体を患者の口腔内に挿入できるものであれば、例示のものに限定されない。例えば、長方形状で、先端及び上端が開放され、下端が閉じられているものであってもよい。
 
In addition, although the distal end insertion portion 105 can be formed into a shovel when inserted into the patient's mouth, it is not limited to the illustrated example as long as the drug-coated medium can be inserted into the patient's mouth. For example, it may have a rectangular shape, with the tip and upper end open and the lower end closed.
 本発明は、薬剤と粘性媒体とを分離した状態で収納して、携行可能とし、経口投与する際に、粘性媒体及び薬剤によって形成される薬剤被覆媒体を形成して、経口投与する薬剤経口投与装置として利用できる。
 
The present invention stores a drug and a viscous medium in a separated state so that they can be carried, and when orally administered, a drug-coated medium formed by the viscous medium and the drug is formed and orally administered. Can be used as a device.
 100・・・・・薬剤経口投与装置
  101・・・・薬剤封入部
  103・・・・媒体封入部
   105・・・先端差込部
  107・・・・カバー部
   117・・・先端差込部用開口
  109・・・・薬剤・粘性媒体間融着部
  113・・・・粘性媒体・カバー部間融着部
 200・・・・・薬剤経口投与装置
  201・・・・薬剤封入部
   211・・・収納差込切除用切り欠き
   205・・・先端差込部
  207・・・・カバー部
   217・・・薬剤媒体部収納用開口
 300・・・・・薬剤経口投与装置
  301・・・・薬剤封入部
  311・・・・漏洩補償融着部
 400・・・・・薬剤経口投与装置
  401・・・・薬剤封入部
  407・・・・カバー部
 
DESCRIPTION OF SYMBOLS 100 ... Oral medicine administration apparatus 101 ... Drug enclosure 103 ... Medium enclosure 105 ... Tip insertion part 107 ... Cover part 117 ... For tip insertion part Opening 109 ··· Drug / viscous medium fusion portion 113 ··· Viscous medium / cover fusion portion 200 ··· Drug oral administration device 201 ··· Drug enclosure portion 211 ··· Notch for storing insertion excision 205... Distal end inserting portion 207... Cover portion 217... Medicine medium portion storing opening 300. 311 ... Leakage compensation fusion part 400 ... Drug oral administration device 401 ... Drug containment part 407 ... Cover part

Claims (10)

  1.  薬剤及び所定の栄養素を補給するためのを含む薬剤類を被覆するための粘性媒体であって、被覆した前記薬剤類と一体化した薬剤被覆媒体を形成する粘性媒体、
     前記粘性媒体を封入する媒体封入部、
     前記媒体封入部に隣接して位置する薬剤・粘性媒体間融着部であって、15gf/15mm~300gf/15mmの強度で融着されている薬剤・粘性媒体間融着部、
     前記薬剤類を封入する薬剤封入部であって、前記薬剤・粘性媒体間融着部に隣接して位置する薬剤封入部、
     を有する薬剤経口投与装置。
    A viscous medium for coating a drug, including a drug and for supplementing a predetermined nutrient, forming a drug-coated medium integrated with the coated drug,
    A medium enclosure for enclosing the viscous medium;
    A drug / viscous medium fusion part located adjacent to the medium enclosing part, wherein the drug / viscous medium fusion part is fused at a strength of 15 gf / 15 mm to 300 gf / 15 mm;
    A drug enclosing part for enclosing the drugs, the drug enclosing part located adjacent to the fusion part between the drug and the viscous medium,
    A drug oral administration device.
  2.  請求項1に係る薬剤経口投与装置において、
     前記カバー部が配置される側に形成される第1の端部に配置されるカバー部であって、前記第1の端部とは異なる第2の端部を収納する端部収納用開口を有するカバー部、
     を有する薬剤経口投与装置。
    In the pharmaceutical oral administration device according to claim 1,
    A cover portion disposed at a first end portion formed on the side where the cover portion is disposed, and having an end portion storing opening for storing a second end portion different from the first end portion. Having a cover part,
    A drug oral administration device.
  3.  請求項2に係る薬剤経口投与装置において、
     前記薬剤封入部は、さらに、
     前記第2の端部を形成する先端差込部であって、前記端部収納用開口に差し込まれて収納される先端差込部、
     を有する薬剤経口投与装置。
    In the drug oral administration device according to claim 2,
    The medicine enclosure part further includes
    A tip insertion portion that forms the second end portion, the tip insertion portion that is inserted into and stored in the end storage opening;
    A drug oral administration device.
  4.  請求項3に係る薬剤経口投与装置において、
     前記端部収納用開口に前記先端差込部を差し込む際に、前記薬剤・粘性媒体間融着部と前記媒体封入部との境目で折り曲げられる薬剤経口投与装置。
    In the oral medicine administration device according to claim 3,
    An oral drug administration device that is bent at the boundary between the drug / viscous medium fusion part and the medium enclosing part when the tip insertion part is inserted into the end storage opening.
  5.  請求項4に係る薬剤経口投与装置において、
     前記カバー部は、さらに、
     前記先端差込部が前記端部収納用開口に収納された状態で形成される前記媒体封入部と前記薬剤封入部との重なり部を収納するための薬剤・媒体部収納用開口を有する薬剤経口投与装置。
    In the drug oral administration device according to claim 4,
    The cover portion further includes
    Oral medicine having a medicine / medium part housing opening for housing an overlapping portion of the medium sealing part and the medicine sealing part formed in a state where the tip insertion part is housed in the end part housing opening. Dosing device.
  6.  請求項1~請求項5に係るいずれかの薬剤経口投与装置において、さらに、
     前記薬剤封入部は、さらに、
     15gf/15mm~300gf/15mmの強度で融着される補償融着部、
     を有する薬剤経口投与装置。
    The oral drug administration device according to any one of claims 1 to 5, further comprising:
    The medicine enclosure part further includes
    A compensation fused portion fused at a strength of 15 gf / 15 mm to 300 gf / 15 mm,
    A drug oral administration device.
  7.  請求項1~請求項6に係るいずれかの薬剤経口投与装置において、さらに、
     前記粘性媒体は、
     円錐台形状の測定容器であって、上底面の直径が58mm、下底面の直径が43mm、高さが30mmであり、下底面から10mmの側面の位置に所定の線を有している、ポリエチレン製である前記測定容器を、前記粘性媒体の表面上に配置し、前記測定容器に所定の分銅をゆっくりと載置し、前記測定容器の前記線が前記粘性媒体の表面と同じ高さになった時の前記分銅の重量を読みとることによって計測した耐荷重が、10g~1000gであること、
     を特徴とする薬剤経口投与装置。
    In any of the oral drug administration devices according to claims 1 to 6,
    The viscous medium is
    A frustoconical measuring container having an upper bottom diameter of 58 mm, a lower bottom diameter of 43 mm, a height of 30 mm, and a predetermined line at a side surface of 10 mm from the lower bottom surface The measurement container made of is placed on the surface of the viscous medium, a predetermined weight is slowly placed on the measurement container, and the line of the measurement container is flush with the surface of the viscous medium. The load resistance measured by reading the weight of the weight at the time is 10 g to 1000 g,
    A pharmaceutical oral administration device characterized by the above.
  8.  請求項7に係る薬剤経口投与装置において、
     前記粘性媒体は、
     液状の前記粘性媒体を前記媒体封入部に充填した後、所定の冷却期間を経過させてゲル化させることによって前記媒体封入部全体に1つの塊として形成されるものである場合には、前記耐荷重が20g~1000gであること、
     を特徴とする薬剤経口投与装置。
    The oral drug administration device according to claim 7,
    The viscous medium is
    When the medium encapsulating part is filled with the liquid viscous medium and then gelled after a predetermined cooling period, the medium enclosing part is formed as one lump. The load is 20 to 1000 g,
    A pharmaceutical oral administration device characterized by the above.
  9.  請求項7に係る薬剤経口投与装置において、
     前記粘性媒体は、
     液状の前記粘性媒体を所定の容器に充填した後、所定の冷却期間を経過させてゲル化させた後、所定の大きさに裁断し、前記媒体封入部に封入されるものである場合には、前記耐荷重が10g~150gであること、
     を特徴とする薬剤経口投与装置。
    The oral drug administration device according to claim 7,
    The viscous medium is
    In the case where the liquid viscous medium is filled into a predetermined container, gelled after a predetermined cooling period, and then cut into a predetermined size and enclosed in the medium enclosure. The load capacity is 10 to 150 g,
    A pharmaceutical oral administration device characterized by the above.
  10.  請求項1~請求項9に係るいずれかの薬剤経口投与装置において、
     所定の前記薬剤類、
     を有する薬剤経口投与装置。
     
    In any of the pharmaceutical oral administration devices according to claims 1 to 9,
    Predetermined said drugs,
    A drug oral administration device.
PCT/JP2012/077757 2012-10-26 2012-10-26 Device for oral drug administration WO2014064840A1 (en)

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PCT/JP2012/077757 WO2014064840A1 (en) 2012-10-26 2012-10-26 Device for oral drug administration
JP2014543107A JP5897145B2 (en) 2012-10-26 2012-10-26 Drug oral administration device

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Application Number Priority Date Filing Date Title
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009154024A (en) * 2009-04-16 2009-07-16 Terumo Corp Double-chamber container
WO2011122640A1 (en) * 2010-03-29 2011-10-06 株式会社モリモト医薬 Container for orally ingested pharmaceutical composition
JP2011200261A (en) * 2008-07-22 2011-10-13 Morimoto Iyaku:Kk Dosed article housing container

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5633051B2 (en) * 2009-09-11 2014-12-03 株式会社大塚製薬工場 Medical multi-chamber container and method of use thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011200261A (en) * 2008-07-22 2011-10-13 Morimoto Iyaku:Kk Dosed article housing container
JP2009154024A (en) * 2009-04-16 2009-07-16 Terumo Corp Double-chamber container
WO2011122640A1 (en) * 2010-03-29 2011-10-06 株式会社モリモト医薬 Container for orally ingested pharmaceutical composition

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