WO2014064840A1 - Dispositif pour l'administration orale de médicament - Google Patents

Dispositif pour l'administration orale de médicament 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
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English (en)
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
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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 JP2014543107A priority Critical patent/JP5897145B2/ja
Priority to PCT/JP2012/077757 priority patent/WO2014064840A1/fr
Publication of WO2014064840A1 publication Critical patent/WO2014064840A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015—Devices specially adapted for taking medicines
    • A61J7/0053—Syringes, pipettes or oral dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/067—Flexible 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention vise à proposer un dispositif pour l'administration orale de médicament, dans lequel un médicament et un milieu visqueux sont reçus dans un état séparé et sont portables. Lorsqu'une administration orale doit être réalisée, chaque médicament est revêtu et un milieu visqueux de revêtement de médicament, dans lequel le médicament revêtu a été intégré au milieu visqueux, est alors facilement formé et peut être administré oralement. L'invention porte sur un dispositif (100) pour une administration orale de médicament, qui a une partie d'encapsulation de médicament (101), une partie d'encapsulation de milieu (103), une partie d'introduction d'extrémité distale (105), une partie de couvercle (107) et une partie de fusion de médicament/milieu visqueux (109). La partie de fusion de médicament/milieu visqueux est fusionnée à une intensité allant de 15 gf/15 mm à 300 gf/15 mm. La partie d'encapsulation de milieu (103), dans laquelle est encapsulé le milieu visqueux, est pincée avec les doigts, ce par quoi le milieu visqueux et le médicament sont mélangés et le milieu visqueux de revêtement de médicament peut être facilement formé. Un médicament peut être facilement administré oralement par l'utilisation du milieu visqueux de revêtement de médicament, même pour une personne qui a des difficultés pour avaler un médicament seul.
PCT/JP2012/077757 2012-10-26 2012-10-26 Dispositif pour l'administration orale de médicament WO2014064840A1 (fr)

Priority Applications (2)

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JP2014543107A JP5897145B2 (ja) 2012-10-26 2012-10-26 薬剤経口投与装置
PCT/JP2012/077757 WO2014064840A1 (fr) 2012-10-26 2012-10-26 Dispositif pour l'administration orale de médicament

Applications Claiming Priority (1)

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PCT/JP2012/077757 WO2014064840A1 (fr) 2012-10-26 2012-10-26 Dispositif pour l'administration orale de médicament

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009154024A (ja) * 2009-04-16 2009-07-16 Terumo Corp 複室容器
WO2011122640A1 (fr) * 2010-03-29 2011-10-06 株式会社モリモト医薬 Récipient pour composition pharmaceutique s'administrant par voie orale
JP2011200261A (ja) * 2008-07-22 2011-10-13 Morimoto Iyaku:Kk 服用物収容容器

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5633051B2 (ja) * 2009-09-11 2014-12-03 株式会社大塚製薬工場 医療用複室容器及びその使用方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011200261A (ja) * 2008-07-22 2011-10-13 Morimoto Iyaku:Kk 服用物収容容器
JP2009154024A (ja) * 2009-04-16 2009-07-16 Terumo Corp 複室容器
WO2011122640A1 (fr) * 2010-03-29 2011-10-06 株式会社モリモト医薬 Récipient pour composition pharmaceutique s'administrant par voie orale

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