EP2412357A1 - Conditionnement de composition médicinale - Google Patents

Conditionnement de composition médicinale Download PDF

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Publication number
EP2412357A1
EP2412357A1 EP10756162A EP10756162A EP2412357A1 EP 2412357 A1 EP2412357 A1 EP 2412357A1 EP 10756162 A EP10756162 A EP 10756162A EP 10756162 A EP10756162 A EP 10756162A EP 2412357 A1 EP2412357 A1 EP 2412357A1
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical composition
encapsulating
swallowing
item
aforementioned
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP10756162A
Other languages
German (de)
English (en)
Other versions
EP2412357A4 (fr
Inventor
Shuji Morimoto
Yutaka Sakuma
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Morimoto Pharma Co Ltd
Original Assignee
Morimoto Pharma Co Ltd
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 Morimoto Pharma Co Ltd filed Critical Morimoto Pharma Co Ltd
Publication of EP2412357A1 publication Critical patent/EP2412357A1/fr
Publication of EP2412357A4 publication Critical patent/EP2412357A4/fr
Withdrawn legal-status Critical Current

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Classifications

    • 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
    • A61J7/0046—Cups, bottles or bags
    • 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
    • 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
    • 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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3261—Flexible containers having several compartments
    • B65D81/3266—Flexible containers having several compartments separated by a common rupturable seal, a clip or other removable fastening device
    • 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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2024—Separating means having peelable seals

Definitions

  • This invention relates to a pharmaceutical composition container; more specifically, to a pharmaceutical composition container so configured as to allow the reduction of the residual quantity of the pharmaceutical composition.
  • Patent document 1 discloses a multi-chamber container.
  • This multi-chamber container is so partitioned into a plurality of spaces as to enable the spaces to be interconnected with each other.
  • the spaces are sealed in such a state that they can be interconnected with each other by means of force applied from the outside.
  • a granular agent is stored in a tightly sealed state in any of the spaces.
  • a thick fluid substance is stored in a tightly sealed state in one or more other spaces. After interconnecting the spaces with each other and gathering and mixing the granular agent with the thick fluid substance, it is possible to take out the mixture from a take-out port provided on any of the spaces.
  • the technical issue addressed by this invention was drafted to solve the abovementioned problem, and the purpose of the invention is to provide a pharmaceutical composition container that allows the reduction of the residual quantity of the pharmaceutical composition.
  • the pharmaceutical composition containers (10, 11, 12, 14, 15, 16, 18) are equipped with a plurality of spaces (30, 32, 34, 36, 38, 100, 102, 104, 106, 110, 112, 114, 116, 150).
  • the portions (70, 72, 76) between two adjoining spaces are sealed.
  • the portions (70, 72, 76) between two adjoining spaces open when force is applied from the outside of the pharmaceutical composition containers (10, 11, 12, 14, 15, 16, 18).
  • a swallowing-aid substance (40) is stored in swallowing-aid substance storing chambers (30, 100, 102, 104, 106) which are at least one of the spaces.
  • Encapsulating items (42, 120) are stored in encapsulating-item storing chambers (32, 110, 112, 114) which each are at least one of the spaces.
  • the encapsulating items (42, 120) contain the pharmaceutical composition (80) .
  • At least the surface of the encapsulating items (42, 120) melts in the ingredients of the swallowing-aid substance (40).
  • the pharmaceutical composition containers (10, 11, 12, 14, 15, 16, 18) are provided with a predetermined aperture part (60) .
  • the predetermined aperture part (60) is a portion where an aperture is to be formed.
  • the aperture interconnects the outside of the pharmaceutical composition containers (10, 11, 12, 14, 15, 16, 18) with the spaces (30, 32, 34, 36, 38, 100, 102, 104, 106, 110, 112, 114, 116, 150).
  • the portions (70, 71, 72, 76) between two adjoining spaces are sealed.
  • the portions (70, 71, 72, 76) between two adjoining spaces open when force is applied from the outside of the pharmaceutical composition containers (10, 11, 12, 14, 15, 16, 18) .
  • By the opening of the portions (70, 71, 72, 76) between two adjoining spaces it is possible to guide the swallowing-aid substance (40) from the swallowing-aid substance storage chambers (30, 100, 102, 104, 106) to the encapsulating-item storage chambers (32, 110, 112, 114) .
  • the encapsulating items (42, 120) will enter the mouth of the person with swallowing difficulties while being enclosed in swallowing-aid substance (40).
  • the encapsulating items (42, 120) are swallowed. Since the pharmaceutical composition (80) is inside the encapsulating items (42, 120), the pharmaceutical composition (80) inside the encapsulating items (42, 120) is pushed out at the same time when the encapsulating items (42, 120) are pushed out.
  • the residual quantity of the pharmaceutical composition (80) in the encapsulating-item storage chambers (32, 110, 112, 114) is reduced as compared to the case where the pharmaceutical composition is not inside the encapsulating items (42, 120) .
  • the surface of the encapsulating items (42, 120) melts in the ingredients of the swallowing-aid substance (40)
  • the surface of the encapsulating items (42, 120) will melt after the swallowing-aid substance (40) is guided into the encapsulating-item storage chambers (32, 110, 112, 114).
  • the encapsulating items (42, 120) can easily be swallowed even by a person with swallowing difficulties because the encapsulating items (42, 120) are enclosed in the swallowing-aid substance (40) and the surface of encapsulating items (42, 120) has melted. That being the case, the pharmaceutical composition (80) is also swallowed with the swallowing of the encapsulating items (42, 120).
  • the abovementioned swallowing-aid substance (40) contain water.
  • the material of the encapsulating items (42, 120) is a water-soluble substance. This reduces the probability that swallowing becomes difficult because the surfaces of the encapsulating items (42, 120) have not sufficiently melted.
  • the abovementioned swallowing-aid substance (40) be a water-containing jelly.
  • the water-soluble substance be starch.
  • a chamber (116) which is at least one of the abovementioned spaces, is disposed between the swallowing-aid substance storage chamber (102) and the encapsulating-item storage chamber (114). This is because the provision of a chamber (116) reduces the probability that the swallowing-aid substance (40) comes into contact with the encapsulating item (42) when the two adjoining spaces (102, 114) are interconnected against the will of the user or handler of the pharmaceutical composition container (15). Reducing that probability also lowers the probability that the encapsulating item (42) melts before the ingestion of the pharmaceutical composition (80). As a result, the pharmaceutical composition container (15) will be easy to preserve and easy to handle.
  • the abovementioned encapsulating item (42) be tightly sealed.
  • tight sealed in this description means being sealed in such a manner that no gaps exist.
  • the pharmaceutical composition containers (210, 260, 400, 500) are equipped with at least three spaces (230, 232, 234, 236, 280, 282, 284, 286, 422, 424, 426, 520, 522, 524, 526).
  • the portions (240, 242, 244, 300, 302, 304, 440, 442, 444, 540, 542, 544) between two adjoining spaces are sealed.
  • the portions (240, 242, 244, 300, 302, 304, 440, 442, 444, 540, 542, 544) between two adjoining spaces open when force is applied from the outside of the pharmaceutical composition containers (210, 260, 400, 500).
  • a swallowing-aid substance (40) is stored in swallowing-aid substance storage chambers (230, 280, 520) which each are at least one of the spaces.
  • An encapsulating item (212) is stored in encapsulating-item storage chambers (232, 234, 282, 284, 422, 424, 522, 524) which each are at least one of the spaces.
  • the encapsulating item (212) contains the pharmaceutical composition (80). At least the surface of the encapsulating item (212) melts in the ingredients of the swallowing-aid substance (40).
  • the aperture chambers (236, 286, 426, 526), which each are at least one of the spaces, are equipped with an aperture.
  • the aperture interconnects the outside of the pharmaceutical composition containers (210, 260, 400, 500) with the spaces (230, 232, 234, 236, 280, 282, 284, 286, 422, 424, 426, 520, 522, 524, 526).
  • FIG. 1 is a partial cross section of the pharmaceutical composition container 10 of this embodiment.
  • FIG. 2 shows how the pharmaceutical composition container 10 of this embodiment is used.
  • the pharmaceutical composition container 10 of this embodiment is formed by adhering the peripheries of two synthetic-resin (preferably a soft synthetic resin that can be folded, such as low-density polyethylene) sheets 20 and 20 to each other.
  • the pharmaceutical composition 10 has a swallowing-aid substance storage chamber 30, an encapsulating-item storage chamber 32 and an outlet chamber 34 formed therein.
  • the swallowing-aid substance chamber 30, the encapsulating-item storage chamber 32 and the outlet chamber 34 are so formed as to maintain air tightness against the external space.
  • the swallowing-aid substance storage chamber 30, the encapsulating-item storage chamber 32 and the outlet chamber 34 are arranged in one row.
  • a swallowing-aid substance 40 is stored inside the swallowing-aid substance storage chamber 30.
  • the swallowing-aid substance 40 in this embodiment is a sterilized jelly containing water.
  • the water content of the jelly in this embodiment is set in such a manner that it is possible to provide at least two minutes of time from when the swallowing-aid substance 40 covers the surface of the encapsulating item 42, which will be explained later, until the encapsulating item 42 has completely melted.
  • the outlet chamber 34 is an empty chamber until the second weak seal portion 72, which will be explained later, is broken.
  • An encapsulating item 42 made of a wafer is stored inside the encapsulating-item storage chamber 32.
  • a granular drug or another pharmaceutical composition 80 is stored inside the encapsulating item 42.
  • the encapsulating item 42 of this embodiment is made by placing the pharmaceutical composition 80 into a commercially available wafer and twisting the portion corresponding to the inlet for the pharmaceutical composition 80. Thereby the encapsulating item 42 is tightly sealed.
  • a wafer made of starch and having a thickness of 10 ⁇ m is used. This is to provide at least two minutes of time from when the swallowing-aid substance 40 covers the surface of the encapsulating item 42 until the encapsulating item 42 has completely melted.
  • the thickness of the wafer should be selected as appropriate depending on the material properties thereof.
  • a gas for example, nitrogen gas which does not have any effect on the pharmaceutical composition 80 or the swallowing-aid substance 40 is filled into the encapsulating-item storage chamber 32 and the swallowing-aid substance storage chamber 30.
  • the portion between the swallowing-aid substance storage chamber 30 and the encapsulating-item storage chamber 32 is partitioned by a first weak seal portion 70.
  • the portion between the encapsulating-item storage chamber 32 and the outlet chamber 34 is partitioned by a second weak seal portion 72.
  • the first weak seal potion 70 and the second weak seal portion 72 are those parts of the portion where the two sheets 20 and 20 are adhered to each other which correspond to the portions between two adj oining spaces.
  • the strength of the first weak seal portion 70 and the second weak seal portion 72 is weaker than the strength of the circumferential strong seal portion 74 (the portion where the two sheets 20 and 20 are adhered to each other excluding the first weak seal portion 70 and the second weak seal portion 72).
  • the first weak seal portion 70 and the second weak seal portion 72 are easily broken by the force applied by the swallowing-aid substance 40 to the swallowing-aid substance storage chamber 30 or the encapsulating-item storage chamber 32 when the swallowing-aid substance storage chamber 30 or the encapsulating-item storage chamber 32 is pressed from the outside of the pharmaceutical composition container 10. That is to say, the swallowing-aid substance storage chamber 30 and the encapsulating-item storage chamber 32 are sealed in such a state that they can be interconnected with each other by means of force applied from the outside of pharmaceutical composition container 10.
  • a pair of cutout portions 50 which each comprise a V-shaped cutout, are formed on the two sides of the outlet chamber 34.
  • the predetermined aperture part 60 which is sandwiched between the cutout portions 50, is the portion where an aperture is to be formed. This aperture interconnects the inside of the outlet chamber 34 with the outside.
  • the caretaker etc. presses the swallowing-aid substance storage chamber 30 from the outside of the pharmaceutical composition container 10 to break the first weak seal portion 70 by means of the pressure from inside the swallowing-aid substance storage chamber 30.
  • the swallowing-aid substance 40 is pushed out into the encapsulating-item storage chamber 32.
  • the swallowing-aid substance 40 that was pushed out spreads inside of the encapsulating-item storage chamber 32 and fills the surroundings of the encapsulating item 42. From this time, the surface of the encapsulating item 42 starts to melt in the swallowing-aid substance 40.
  • the caretaker or patient 90 or the like squeezes the pharmaceutical composition container 10 from the swallowing-aid substance storage chamber 30 towards the encapsulating-item storage chamber 32.
  • the second weak seal portion 72 breaks as a result from the pressure applied to the swallowing-aid substance 40.
  • the second weak seal portion 72 is broken, the swallowing-aid substance 40 and the encapsulating item 42 are pushed out into the outlet chamber 34.
  • the caretaker or patient 90 or the like apply a shearing force to the cutouts 50 to form an aperture on the outlet chamber 34.
  • FIG. 2 shows the state in which the patient 90 squeezes the pharmaceutical composition container 10.
  • the surface of the encapsulating item 42 has melted in the ingredients of the swallowing-aid substance 40, and therefore the surface of the encapsulating item 42 is slippery. Because the surface of the encapsulating item 42 is slippery, the encapsulating item 42 is swallowed smoothly.
  • the pharmaceutical composition container 10 of this embodiment produces the following effects.
  • the first effect is that it is possible to easily swallow a granular drug or another pharmaceutical composition 80.
  • the second effect is that tastes such as the bitter taste of drugs are suppressed.
  • the third effect is that it is possible to suppress the scattering of the pharmaceutical composition 80 in the mouth.
  • the fourth effect is that concerns regarding the stability of the drug become unnecessary.
  • the fifth effect is that it is possible to let patients with swallowing difficulties ingest solids of various types.
  • the sixth effect is that it is possible to reduce the residual quantity of the pharmaceutical composition 80 inside the pharmaceutical composition container 10 (in this embodiment, it is possible to reduce the residual quantity close to zero).
  • the encapsulating item 42 enters the mouth of the patient 90 while being covered by the swallowing-aid substance 40. At this time, the surface of encapsulating item 42 has melted.
  • the encapsulating item 42 can easily be swallowed even by the patient 90, who has swallowing difficulties, because the encapsulating item 42 is enclosed in the swallowing-aid substance 40 and the surface of the encapsulating item 42 has melted. Since the pharmaceutical composition 80 is inside the encapsulating item 42, the pharmaceutical composition 80 is also swallowed with the swallowing of the encapsulating item 42. Thereby it is possible to easily swallow the pharmaceutical composition 80.
  • the encapsulating item 42 enters the mouth of the patient 90 while being covered by the swallowing-aid substance 40.
  • the pharmaceutical composition 80 which is contained in the encapsulating item 42, is doubly enclosed by the swallowing-aid substance 40 and the encapsulating item 42.
  • the pharmaceutical composition 80 is a drug
  • the probability that the tongue of the patient 90 senses the bitter taste thereof is low because the pharmaceutical composition 80 is doubly enclosed.
  • the bitter taste or other tastes of the drugs are suppressed.
  • the pharmaceutical composition 80 is doubly enclosed by the swallowing-aid substance 40 and the encapsulating item 42. This reduces the probability that the pharmaceutical composition 80 scatters in the mouth of the patient 90. As a result, it is possible to suppress the scattering of the pharmaceutical composition 80 in the mouth.
  • Drugs are chemical substances. When chemical substances come into contact with each other, chemical reactions occur in many cases. Due to the occurrence of chemical reactions, the pharmacological effect of the drug is lost. For this reason, it is not possible to preserve a plurality of drugs in a mixed state in many cases. If the pharmaceutical compositions are to be preserved in a mixed state, it is necessary to research in advance whether the chemical substances lose their pharmacological effect.
  • the pharmaceutical composition container 10 of this embodiment is equipped with a plurality of spaces. Storing one type of drug each in those spaces is substantially identical with separately preserving a plurality of drugs. This is the reason why concerns regarding the stability of the drug are unnecessary when the pharmaceutical composition container 10 of this embodiment is used. Since concerns regarding the stability of the drug are unnecessary, the advance research on whether the pharmacological effects of the plurality of drugs are lost also becomes unnecessary.
  • the fifth effect will now be explained in detail.
  • the activity of the pharmaceutical composition 80 per se will not have a significant effect on the difficulty or easiness of swallowing any more. Thereby it is possible to let patients with swallowing difficulties ingest solids of various types.
  • the encapsulating item 42 of this embodiment is tightly sealed. Since the encapsulating item 42 is tightly sealed, the probability of the pharmaceutical composition 80 leaking from the encapsulating item 42 is extremely low. Since this probability is extremely low, it is possible to reduce the residual quantity of the pharmaceutical composition 80 inside the pharmaceutical composition container 10 (actually, it is possible to reduce the residual quantity close to zero).
  • the pharmaceutical composition container 10 explained in this embodiment is presented as an example to concretize the technical concept of this invention.
  • the material properties of the sheet 20 are not limited to the abovementioned embodiment.
  • the shape of sheet 20, the shape of the spaces, the shape of the aperture, the dimensions, structures and positioning thereof are not limited to those mentioned in the abovementioned embodiment. It is possible to apply various changes to the pharmaceutical composition container 10 explained in this embodiment within the scope of the technical concept of this invention.
  • FIG. 3 is a partial cross section of the pharmaceutical composition container 12 of the alternative embodiment 1.
  • a first tapered portion 130 which faces the encapsulating-item storage chamber 110, gradually becomes narrower towards the encapsulating-item storage chamber 110.
  • a second tapered portion 140 which faces the swallowing-aid substance storage chamber 100, gradually becomes narrower towards the swallowing-aid substance storage chamber 100.
  • a bag-like encapsulating item 120 like that shown in FIG. 3 may also be stored.
  • the encapsulating item 120 may also be stored in the pharmaceutical composition container 10 shown in FIG. 1 .
  • the shape of the encapsulating item is not limited to those shown in FIG. 1 and 3 .
  • a publicly known capsule may also be stored as the encapsulating item.
  • the swallowing-aid substance 40 in this embodiment is a sterilized jelly containing water.
  • FIG. 4 is a partial cross section of the pharmaceutical composition container 14 of the alternative embodiment 2.
  • the pharmaceutical composition container 14 has a swallowing-aid substance storage chamber 102, a first encapsulating-item storage chamber 112, a second encapsulating-item storage chamber 114 and an outlet chamber 150 formed therein.
  • the swallowing-aid substance storage chamber 102, the first encapsulating-item storage chamber 112, the second encapsulating-item storage chamber 114 and the outlet chamber 150 are arranged in one row.
  • the end of the first encapsulating-item storage chamber 112 on the side of the second encapsulating-item storage chamber 114 becomes narrower towards the second encapsulating-item storage chamber 114, and the encapsulating item 42 is stored in the first encapsulating-item storage chamber 112; therefore it is possible to smoothly push out the encapsulating item 42 by means of the swallowing-aid substance 40.
  • the end of the second encapsulating-item storage chamber 114 on the side of the outlet chamber 150 becomes narrower towards the outlet chamber 150, and the encapsulating item 42 is stored in the second encapsulating-item storage chamber 114; therefore this encapsulating item 42 is also pushed out smoothly in the same way.
  • a bag-like encapsulating-item 120 like that shown in FIG. 3 may be stored in the first encapsulating-item storage chamber 112 and the second encapsulating-item storage chamber 114.
  • an empty chamber may be provided between the swallowing-aid substance storage chamber and the encapsulating-item storage chamber.
  • An empty chamber is a space in which nothing is stored, or in which a gas is stored that does not have any effect on the pharmaceutical composition 80 or the swallowing-aid substance 40.
  • FIG. 5 is a partial cross section of the pharmaceutical composition container 15 of the alternative embodiment 3.
  • an empty chamber 116 is provided as an alternative to the first encapsulating-item storage chamber 112 shown in FIG. 4 .
  • Providing an empty chamber 116 can, to a certain extent, reduce the probability that the swallowing-aid substance 40 is mixed with the pharmaceutical composition 80 even if the sealing properties between the spaces are damaged due to an unintentional accident. If the pharmaceutical composition container 15 is foldable at the portion of the empty chamber 116, folding that portion can further reduce the probability that the swallowing-aid substance 40 and the pharmaceutical composition 80 are mixed.
  • the pharmaceutical composition container is not limited to one made by adhering two sheets to each other.
  • FIG. 6 is a partial cross section of the pharmaceutical composition container 16 of the alternative embodiment 4.
  • FIG. 7 is a partial cross section of the pharmaceutical composition container 18 of the alternative embodiment 5.
  • the containers are formed by double-folding one sheet.
  • double-folding one sheet By forming the pharmaceutical composition containers 16 and 18 by double-folding one sheet for each, it is possible to increase the volume of the swallowing-aid substance storage chambers 104 and 106 compared to a pharmaceutical composition container formed by adhering two sheets of the same outer dimensions to each other.
  • the pharmaceutical composition container may also be made by adhering the walls of one tube to each other here and there.
  • the cutout portions 50 are composed of a V-shaped cutout, but the shape of the cutout in this invention may be another one than a V-shape.
  • the pharmaceutical composition is a powdered or granular preparation and the swallowing-aid substance is a jelly; however, it is needless to say that the pharmaceutical composition and swallowing-aid substance applied to this invention are not limited thereto.
  • the pharmaceutical composition apart from a powdered or granular preparation, the pharmaceutical composition may be a tablet, a capsule or a simple block.
  • the swallowing-aid substance may be an aqueous solution, or may also be honey, custard cream, peanut spread, cheese spread or the like.
  • the item formed as the pharmaceutical composition is not limited to an item that is usually treated as a medical drug.
  • the item formed as the pharmaceutical composition may also be a food which is recognized for its effect of improving the health state.
  • a wafer made of starch with a thickness of 10 ⁇ m as mentioned above, or a variety of other materials conventionally known as edible film materials can be used.
  • the types of the materials include polysaccharides (for example, pullulan, arabinoxylan, decomposition products of guar gum, sodium alginate, carrageenan, agar-agar, pectin, cellulose etc.) and peptide-based substances (for example, gelatin, decomposition products of silk protein, decomposition products of casein etc.).
  • Those materials may be used on a standalone basis or as a combination of two or more types.
  • outlet chambers 34 and 150 were provided, however, it is also possible to not provide an outlet chamber 34, but to provide the cutouts 50 on the encapsulating-item storage chamber 32 or the like, open an aperture by applying shearing force to those cutouts 50 and hold that aperture against the mouth of the patient.
  • the structure of the portions 70, 71 and 72 between two adjoining spaces may be different than that mentioned above.
  • a thin film may be formed in the portions 70, 71 and 72 between two adjoining spaces. This kind of film can be formed by sandwiching the member that serves as the film between the two sheets 20 and 20, and adhering same to each other.
  • the structure of the portions 70, 71, and 72 between two adjoining spaces must be a structure that is sealed in such a state that the spaces are interconnected by a force that is applied from the outside of the pharmaceutical composition container 10.
  • This "force that is applied from the outside of the pharmaceutical composition container 10" may be a force that is directly applied to the portions 70, 71 and 72 between adjoining spaces, or may be a force that is indirectly applied to any one thereof.
  • FIG. 8 is a partial cross section of the pharmaceutical composition container 11 of the alternative embodiment 6.
  • the pharmaceutical composition container 11 of this embodiment has a first bag storage chamber 36, a second bag storage chamber 38, an encapsulating-item storage chamber 32 and an outlet chamber 34 formed therein. Same as the encapsulating-item storage chamber 32 and the outlet chamber 34, the first bag storage chamber 36 and the second bag storage chamber 38 are so formed as to maintain air tightness against the external space.
  • the first bag storage chamber 36 and the second storage bag chamber 38 store and fix the aid-substance storage bag 22.
  • the aid-substance storage bag 22 is directly fixed by the circumferential strong seal portion 74 and the third weak seal portion 76.
  • the strength of the third weak seal portion 76 against breakage is roughly the same as that of the circumferential strong seal portion 74.
  • a swallowing-aid substance 40 is stored inside the aid-substance storage bag 22.
  • the strength of the aid-substance storage bag 22 on the end at the side facing the first weak seal portion 70 is such that the end is broken by a force applied from the outside of the pharmaceutical composition container 11.
  • the swallowing-aid substance 40 is sterilized together with the aid-substance storage bag 22, then sandwiched between the sheets 20 and 20 and adhered thereto.
  • the outer circumferential strong seal portion 74 etc. are formed. Thereby one end of the aid-substance storage bag 22 breaks when force is applied from the outside of the pharmaceutical composition container 11. When the end breaks, the swallowing-aid substance 40 leaks out into the first bag storage chamber 36.
  • the first weak seal portion 70 is broken by the force received from the swallowing-aid substance 40.
  • the encapsulating item 42 is enclosed in the swallowing-aid substance 40.
  • FIG. 9 is a partial cross section of the pharmaceutical composition container 260 of this embodiment.
  • the pharmaceutical composition container 260 of this embodiment is formed by double-folding one sheet made of a synthetic resin (low-density polyethylene, PET (polyethylene terephthalate) or another resin that is soft so as to be foldable and is heat-sealable, like composite resin), adhering the ends of the double-folded sheet to each other and aligning the outer shape by cutting the adhered portion.
  • a synthetic resin low-density polyethylene, PET (polyethylene terephthalate) or another resin that is soft so as to be foldable and is heat-sealable, like composite resin
  • the portion where the ends of the sheet are adhered to each other is the circumferential strong seal portion 270.
  • the inside of the pharmaceutical composition container 260 is provided with a plurality of spaces. The portions between the plurality of spaces are sealed by a first weak seal portion 300, a second weak seal portion 302 and a third weak seal portion 304.
  • the first weak seal portion 300 comprises a first weak-seal zone 310, an intermediate chamber 312 and a second weak-seal zone 314.
  • One of the spaces inside the pharmaceutical composition container 260 is the swallowing-aid substance storage chamber 280.
  • a swallowing-aid substance 40 is stored inside the swallowing-aid substance storage chamber 280.
  • the first weak-seal zone 310 of the first weak seal portion 300 easily opens by means of the pressure received from the swallowing-aid substance 40 when force is applied to the swallowing-aid substance 40 from the outside of the pharmaceutical composition container 260.
  • the first weak-seal zone 310 opens, the swallowing-aid substance 40 is pushed out into the intermediate chamber 312. Thereafter, the second weak-seal zone 314, the second weak seal portion 302 and the third weak seal portion 304 sequentially open in the same way.
  • the first encapsulating-item storage chamber 282 and the second encapsulating-item storage chamber 284 exist.
  • An encapsulating item 212 is stored in each of the encapsulating-item storage chambers.
  • the pharmaceutical composition encapsulated by the encapsulating item 212 stored in the first encapsulating-item storage chamber 282 and the pharmaceutical composition encapsulated by the encapsulating item 212 stored in the second encapsulating-item storage chamber 284 are of different types.
  • one of the spaces inside the pharmaceutical composition container 260 is an aperture chamber 286.
  • the aperture chamber 286 is provided on one end of the pharmaceutical composition container 260 and serves as the chute (in other words, the device for dropping the encapsulating item 212 into the mouth of the patient) for the ingestion of the encapsulating item 212.
  • the cover 288 Of the two ends of the pharmaceutical composition container 260, the end on the opposite side of the end on which the aperture chamber 286 is provided, is the cover 288.
  • the boundary between the swallowing-aid substance storage chamber 280 and the cover 288 is the bottom strong seal portion 272.
  • the strength of the bottom strong seal portion 272 is the same as that of the circumferential strong seal portion 270; therefore the bottom strong seal portion 272 is not broken even when force is applied to the swallowing-aid substance 40 from the outside of the pharmaceutical composition container 260.
  • the portion which is more to the side of the second encapsulating-item storage chamber 284 than the cover 288 is referred to as the "container body.”
  • FIG. 10 is an external view of the portion of the pharmaceutical composition container 260 of this embodiment which corresponds to the rear surface when viewed as shown in FIG. 9 .
  • a label 262 is adhered to the pharmaceutical composition container 260 of this embodiment.
  • the features unique to the pharmaceutical composition container 260 of this embodiment as compared to the pharmaceutical composition containers of the other embodiments are that: the cover 288 is disposed on one end and a cover insert portion 320 which is inserted into this cover 288 is disposed on the other end; the width of the pharmaceutical composition container 260 is larger on the base 330 of the portion which is inserted into the cover 238; the bottom strong seal portion 272 and a portion of the second weak seal portion 302 or a portion of the third weak seal portion 304 are folded over to insert the tip of the cover insert portion 320 into the cover 238, and the base 330 is on the outside of the cover 238.
  • FIG. 11 shows the state where the cover insert portion 320 is inserted into the cover 238 and the base 330 is on the outside of the cover 238.
  • the portion of the base 330 is depressed; therefore it is possible to easily to pull out the cover insert portion 320 by inserting a finger thereinto.
  • FIG. 12 is a view of the portion which corresponds to the rear surface when viewed as shown in FIG. 11 , in the state shown in FIG. 11 .
  • the major part of the rear surface of the pharmaceutical composition container 260 is occupied by the label 262.
  • a finger is engaged with the abovementioned base 330 and the abovementioned cover insert portion 320 is pulled out of the cover 238 in this state.
  • the cover insert portion 320 is pulled out, the cover insert portion 320 is placed into the mouth of the patient.
  • the subsequent usage method is the same as in the other embodiments or alternative embodiments thereof.
  • the cover insert portion 320 can easily be pulled out because a finger can be engaged with the base 330 of the cover insert portion 320.
  • composition container 260 of this embodiment produces the same effects like that of the embodiment 1.
  • FIG. 13 is a partial cross section of the pharmaceutical composition container 400 of this embodiment.
  • the pharmaceutical composition container 400 of this embodiment is formed by double-folding one sheet made of a synthetic resin, adhering the ends of the double-folded sheet to each other and aligning the outer shape by cutting the adhered portion.
  • the portion where the ends of the sheet are adhered to each other is the circumferential strong seal portion 410.
  • the inside of the pharmaceutical composition container 400 is provided with a plurality of spaces. The portions between the plurality of spaces are sealed by a first weak seal portion 440, a second weak seal portion 442 and a third weak seal portion 444.
  • the first weak seal portion 440 comprises a first weak-seal zone 450, an intermediate chamber 452 and a second weak-seal zone 454.
  • One of the spaces is the swallowing-aid substance storage chamber 420.
  • a swallowing-aid substance 40 is stored inside the swallowing-aid substance storage chamber 420.
  • the first weak seal zone 450 and the second weak seal zone 454 sequentially open in the same way as the first weak seal portion 300, the second weak seal portion 302 and the third weak seal portion 304 in the embodiment 2.
  • the reason why the first weak seal zone 450 and the second weak seal zone 454 open in this way is the same as that in the embodiment 2.
  • the first encapsulating-item storage chamber 422 and the second encapsulating-item storage chamber 424 exist.
  • An encapsulating item 212 is stored in each of the encapsulating-item storage chambers.
  • the pharmaceutical composition encapsulated by the encapsulating item 212 stored in the first encapsulating-item storage chamber 422 and the pharmaceutical composition encapsulated by the encapsulating item 212 stored in the second encapsulating-item storage chamber 424 are of different types.
  • One of the spaces is an aperture chamber 426.
  • the aperture chamber 426 serves as a chute for the ingestion of the encapsulating item 212.
  • the cover 428 Of the two ends of the pharmaceutical composition container 400, the end on the opposite side of the end on which the aperture chamber 426 is provided, is the cover 428.
  • the boundary between the swallowing-aid substance storage chamber 420 and the cover 478 is the bottom strong seal portion 412.
  • the strength of the bottom strong seal portion 412 is the same as that of the circumferential strong seal portion 410; therefore the bottom strong seal portion 412 is not broken even when force is applied to the swallowing-aid substance 40 from the outside of the pharmaceutical composition container 400.
  • the cover 478 is disposed on one end; the bottom strong seal portion 412 and the base of the portion where the aperture chamber 426 is disposed are folded over to insert the portion where the aperture chamber 426 is disposed into the cover 478; the tip 480 of the portion where the aperture chamber 426 is disposed is round; and a part of the edge 482 of the cover 478 is cut out.
  • the portion which is more to the side of the second encapsulating-item storage chamber 424 than the cover 478 is referred to as the "container body.”
  • the one of the two ends of the pharmaceutical composition container 400 on which the aperture chamber 426 is disposed is pulled out of the cover 478.
  • the subsequent usage method is the same as in the other embodiments.
  • FIG. 14 shows the state in which pharmaceutical composition container 400 is folded over during production. After the pharmaceutical composition container 400 is folded over, the portion where the aperture chamber 426 is disposed is inserted into the cover 478. At this time, the tip 480 of the portion where the aperture chamber 426 is disposed gets caught at any position of the cut-out edge 482 of the cover 478 and opens the mouth of the cover 478. Since the mouth of the cover 478 is opened, the tip 480 smoothly enters the inside of the cover 478.
  • FIG. 15 shows the pharmaceutical composition container 400 after the portion where the aperture chamber 426 is disposed is inserted into the cover 478.
  • composition container 400 of this embodiment produces the same effects like that of the embodiment 1.
  • FIG. 16 is a partial cross section of the pharmaceutical composition container 500 of this embodiment.
  • the pharmaceutical composition container 500 of this embodiment is formed by double-folding one sheet made of a synthetic resin, adhering the ends of the double-folded sheet to each other and aligning the outer shape by cutting the adhered portion.
  • the portion where the ends of the sheet are adhered to each other is the circumferential strong seal portion 510.
  • the inside of the pharmaceutical composition container 500 is provided with a plurality of spaces. The portions between the plurality of spaces are sealed by a first weak seal portion 540, a second weak seal portion 542 and a third weak seal portion 544.
  • the first weak seal portion 540 comprises a first weak-seal zone 550, an intermediate chamber 552 and a second weak-seal zone 554.
  • One of the spaces inside the pharmaceutical composition container 500 is the swallowing-aid substance storage chamber 520.
  • a swallowing-aid substance 40 is stored inside the swallowing-aid substance storage chamber 520.
  • the first weak seal zone 550 and the second weak seal zone 554 sequentially open in the same way as the first weak seal portion 300, the second weak seal portion 302 and the third weak seal portion 304 in the embodiment 2.
  • the reason why the first weak seal zone 550 and the second weak seal zone 554 open in this way is the same as that in the embodiment 2.
  • the first encapsulating-item storage chamber 522 and the second encapsulating-item storage chamber 524 exist.
  • An encapsulating item 212 is stored in each of the encapsulating-item storage chambers.
  • the pharmaceutical composition encapsulated by the encapsulating item 212 stored in the first encapsulating-item storage chamber 522 and the pharmaceutical composition encapsulated by the encapsulating item 212 stored in the second encapsulating-item storage chamber 524 are of different types.
  • One of the spaces is an aperture chamber 526.
  • the aperture chamber 526 serves as a chute for the ingestion of the encapsulating item 212.
  • the cover 528 Of the two ends of the pharmaceutical composition container 500, the end on the opposite side of the end on which the aperture chamber 526 is provided, is the cover 528.
  • the boundary between the swallowing-aid substance storage chamber 520 and the cover 528 is the bottom strong seal portion 512.
  • the strength of the bottom strong seal portion 512 is the same as that of the circumferential strong seal portion 510; therefore the bottom strong seal portion 512 is not broken even when force is applied to the swallowing-aid substance 40 from the outside of the pharmaceutical composition container 500.
  • the portion which is more to the side of the second encapsulating-item storage chamber 524 than the cover 528 is referred to as the "container body.”
  • FIG. 17 is a partial cross section showing one end of the pharmaceutical composition container 500 during the production thereof.
  • FIG. 18 is a perspective view showing one end of the pharmaceutical composition container 500 during the production thereof.
  • the features unique to the pharmaceutical composition container 500 of this embodiment as compared to the pharmaceutical composition containers of the other embodiments will be explained while referring to FIG. 17 and FIG. 18 .
  • the features thereof are that: the bottom strong seal portion 512 and the base of the portion where the aperture chamber 526 is disposed are folded over to insert the portion where the aperture chamber 526 is disposed into the cover 528; and a melt-bonding margin 514 is disposed on the tip portion 516 which is inserted into the cover 528 on the circumferential strong seal portion 510. This melt-bonding margin 514 is folded back like shown in FIG. 18 and melt-bonded to the tip portion 516.
  • the usage method of the pharmaceutical composition container 500 of this embodiment is the same as that of the embodiment 3.
  • composition container 500 of this embodiment produces the same effects like that of the embodiment 1.
  • FIG. 19 is a partial cross section of the pharmaceutical composition container 210 of this embodiment.
  • the pharmaceutical composition container 210 of this embodiment is formed by double-folding one sheet made of a synthetic resin, adhering the ends of the double-folded sheet to each other and aligning the outer shape by cutting the adhered portion.
  • the portions where the ends of the sheet are adhered to each other are the circumferential strong seal portions 220 and 222.
  • the inside of the pharmaceutical composition container 210 is provided with a plurality of spaces.
  • the portions between the plurality of spaces are sealed by a first weak seal portion 240, a second weak seal portion 242 and a third weak seal portion 244.
  • the first weak seal portion 240 comprises a first weak-seal zone 250, an intermediate chamber 252 and a second weak-seal zone 254.
  • One of the spaces inside the pharmaceutical composition container 210 is the swallowing-aid substance storage chamber 230.
  • a swallowing-aid substance 40 is stored inside the swallowing-aid substance storage chamber 230.
  • the first weak seal zone 250 and the second weak seal zone 254 sequentially open in the same way as the first weak seal portion 300, the second weak seal portion 302 and the third weak seal portion 304 in the embodiment 2.
  • the reason why the first weak seal zone 250 and the second weak seal zone 254 open in this way is the same as that in the embodiment 2.
  • the first encapsulating-item storage chamber 232 and the second encapsulating-item storage chamber 234 exist.
  • An encapsulating item 212 is stored in each of the encapsulating-item storage chambers.
  • the pharmaceutical composition encapsulated by the encapsulating item 212 stored in the first encapsulating-item storage chamber 232 and the pharmaceutical composition encapsulated by the encapsulating item 212 stored in the second encapsulating-item storage chamber 234 are of different types. Further, the outer shape of the encapsulating items 212 is different from that of the encapsulating item 42 in the embodiment 1.
  • one of the spaces inside the pharmaceutical composition container 210 is an aperture chamber 236.
  • the aperture chamber 236 serves as a chute for the ingestion of the encapsulating item 212.
  • the pharmaceutical composition 210 of this embodiment is wound in such a manner that the swallowing-aid substance storage chamber 230 surrounds the aperture chamber 236. If the pharmaceutical composition container 210 is only wound, it is likely that the pharmaceutical composition container 210 straightens during the time from the completion until the use of the pharmaceutical composition container 210; therefore end of the swallowing-aid substance storage chamber 230 of the wound pharmaceutical composition container 210 is fixed with a tape 214.
  • FIG. 20 shows the wound pharmaceutical composition container 210.
  • the tape 214 is peeled off and the pharmaceutical composition container 210 is straightened.
  • the aperture chamber 236 is placed into the mouth of the patient. Thereafter the encapsulating item 212 is ingested in the same way as the embodiment 1 or the alternative embodiments thereof.
  • the pharmaceutical composition container 210 of this embodiment produces the same effects like that of the embodiment 1.
  • the pharmaceutical composition container of this invention is suitable for the use as, for example, a container for the ingestion of a drug.
  • the pharmaceutical composition container of this invention is suitable for the use as a container for the ingestion of a drug, wherein the drug is filled into the container by a system as mentioned below.
  • a system is one wherein a plurality of auger filling machines are set up, a transport system and weighing system are added, the filling machines, the transport system and the weighing system are connected to a medical-drug production line and automatic operation is performed over a long time.

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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)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)
EP10756162.3A 2009-03-25 2010-03-25 Conditionnement de composition médicinale Withdrawn EP2412357A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/JP2009/055972 WO2010109610A1 (fr) 2009-03-25 2009-03-25 Conteneur de composition pharmaceutique
PCT/JP2010/055212 WO2010110366A1 (fr) 2009-03-25 2010-03-25 Conditionnement de composition médicinale

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EP2412357A1 true EP2412357A1 (fr) 2012-02-01
EP2412357A4 EP2412357A4 (fr) 2014-10-29

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US (1) US20120012480A1 (fr)
EP (1) EP2412357A4 (fr)
JP (1) JPWO2010110366A1 (fr)
KR (1) KR20110131295A (fr)
CN (1) CN102438575A (fr)
WO (2) WO2010109610A1 (fr)

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EP3064189B1 (fr) * 2013-10-29 2022-04-20 Morimoto-Pharma Co., Ltd. Paquet divisé, procédé pour fabriquer un paquet divisé et dispositif pour fabriquer un paquet divisé
WO2015114749A1 (fr) * 2014-01-29 2015-08-06 株式会社モリモト医薬 Cellule contenant un médicament oral, emballage en chapelets, et procédé de fabrication de cellules contenant un médicament oral
JP6514547B2 (ja) * 2015-03-31 2019-05-15 株式会社Uacj 二重包装体
GB2542630A (en) * 2015-09-28 2017-03-29 Medimauve Ltd Sachet system

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Also Published As

Publication number Publication date
KR20110131295A (ko) 2011-12-06
WO2010109610A1 (fr) 2010-09-30
US20120012480A1 (en) 2012-01-19
CN102438575A (zh) 2012-05-02
EP2412357A4 (fr) 2014-10-29
JPWO2010110366A1 (ja) 2012-10-04
WO2010110366A1 (fr) 2010-09-30

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