EP3395319B1 - Dispositif d'emballage de médicament(s) solide(s), dispositif de stockage et de distribution et procédé de distribution de tel(s) médicament(s) - Google Patents

Dispositif d'emballage de médicament(s) solide(s), dispositif de stockage et de distribution et procédé de distribution de tel(s) médicament(s) Download PDF

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Publication number
EP3395319B1
EP3395319B1 EP18162620.1A EP18162620A EP3395319B1 EP 3395319 B1 EP3395319 B1 EP 3395319B1 EP 18162620 A EP18162620 A EP 18162620A EP 3395319 B1 EP3395319 B1 EP 3395319B1
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EP
European Patent Office
Prior art keywords
drug
opening
tray
cup
cups
Prior art date
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EP18162620.1A
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German (de)
English (en)
French (fr)
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EP3395319A1 (fr
EP3395319A8 (fr
Inventor
Michel FOUBET
Grégory FOUBET
Olivier FOUBET
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Distraimed SARL
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Distraimed SARL
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Publication of EP3395319A1 publication Critical patent/EP3395319A1/fr
Publication of EP3395319A8 publication Critical patent/EP3395319A8/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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/02—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
    • 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
    • A61J7/0007—Pill breaking or crushing devices
    • 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
    • A61J7/0069—Trays for holding or distributing medicines

Definitions

  • the invention relates to a device for packaging medicaments in solid non-pulverulent divided dosage form, such as, for example, tablets, tablets, capsules, capsules, pills, lozenges, sugar-coated tablets, etc.
  • the invention also relates to a device for storing and dispensing such drugs and a method of dispensing such drugs.
  • FR 2,876,024 a weekly pill dispenser for storing and dispensing solid drugs to a patient, having 28 thermoformed drug storage cells in a PVC holder.
  • Each cell of the weekly pill pillar is sized to receive medicine (s) and is detachable weekly pill pillar.
  • the cells of the weekly pill organizer FR 2,876,024 are rectangular in shape. They are formed of a tray of cuvettes closed by a film stuck on the rim of each bowl, forming sealing labels. Each sealing label is adapted to be torn, allowing the extraction of drugs from the cell and taking medication by the patient.
  • the cells of such a weekly pill pillar are divided into four columns of seven cells, each column corresponding to one of four times of daily medication, each line corresponding to four doses of medication on the same day of the week.
  • the shape and dimensions of the cells of the weekly pillbox of FR 2,876,024 do not actually allow to prepare by grinding and / or crushing and / or crushing drugs in powder form.
  • This pillbox also does not allow to mix such drugs in powder form with a flowing food composition nor to make such a mixture available to the patient without the need for transfer of the drugs in an auxiliary device grinding and / or crushing and / or crushing, separate from the weekly pillbox, for their grinding and mixing in powder form with a flowing food composition.
  • Such methods and devices require placing a drug in the bowl of such a device, grinding by any appropriate means, and then collecting the drug powder formed for administration to a patient, for example in a mixture with a flowing food composition.
  • a method can be implemented by the patient himself if his state of health allows it. However, the patient is not always able to correctly perform these successive operations himself and the drug treatment may not be administered under optimal conditions.
  • Such a method can also be implemented by a nursing staff. However, the implementation of such a method takes time and requires the mobilization of greater human resources.
  • the contact for a long time of the active ingredients of several drugs in the powdered state can lead to undesirable drug interactions and / or reducing the effectiveness of the treatment so that such grinding can be achieved 'extemporaneously.
  • the implementation of such a method requires taking at least one drug in a pill box, (s) place in a grinding device, to proceed with its grinding, to collect the powder formed in the device of grinding for mixing with a flowing food composition.
  • the implementation of such a process requires many manipulations and transfers of drugs and / or powder of drugs leading to losses of active ingredients and in fact to a sub-dosage of the treatment.
  • the invention therefore aims to overcome all of these disadvantages.
  • the invention aims in particular to provide a device for packaging drugs in non-pulverulent divided solid dosage form, such as for example tablets, cachets, capsules, capsules, pills, lozenges, dragees, etc. , a storage and dispensing device and a method of dispensing such drugs to facilitate the taking of drugs by a patient.
  • the invention also aims to provide a packaging device, a storage and dispensing device and a method of dispensing such drugs that improve the regularity of drug intake and the effectiveness of a drug treatment.
  • the invention aims in particular to provide a packaging device, a storage and dispensing device and a method of dispensing drugs that do not require the use of an auxiliary container such as a cup separate from the pillbox for the distribution to the patient of such drugs.
  • the invention also aims at providing a packaging device, a storage and dispensing device and a method of dispensing medicaments making it possible to limit-in particular to completely eliminate-the risk of selection of medicinal products by the patient during a treatment. of drugs.
  • the expression "globally symmetrical revolution” qualifies a general form described by the rotation of a curve about an axis of rotation.
  • Such a general shape can be perfectly symmetrical of revolution.
  • Such a shape may also have non-symmetrical surface irregularities of revolution, the general shape remaining however symmetrical of revolution.
  • Such surface irregularities may be in the form of grooves, spikes, corrugations, ribs, corrugations or non-symmetrical roughness of revolution.
  • the general shape is symmetrical of revolution and the surface irregularities are of insufficient dimensions so that the surface irregularities can receive entirely a drug in non-pulverulent solid dosage form and prevent its grinding in the bowl.
  • any solid dosage form divided into little powdery or non-powdery form can be stored in a device for storing and dispensing medicament (s) according to the invention, then ground and / or crushed and / or crushed and then distributed in pulverulent form to a patient. and optionally mixed with a flowable composition such as compote or jam for ingestion by a patient.
  • the non-pulverulent solid dosage form may be selected from the group consisting of tablets, cachets, capsules, capsules, pills, lozenges, lozenges, etc.
  • a packaging device is adapted to contain drugs and form a device for storing and dispensing drugs according to the invention.
  • a packing device according to the invention is free of drugs.
  • each bowl of a packaging device according to the invention is adapted - particularly sized - to receive and contain a plurality of drugs, including a plurality of different drugs containing different active ingredients.
  • Each cuvette of a packaging device has a bottom wall forming a medicament grinding mortar (s) of generally symmetrical shape of revolution about an axis passing through the opening of the cuvette.
  • each bowl is shaped to be able to receive a grinding member, to allow the grinding member to exert on a drug (s) resting on the bottom wall a pressure of a nature to cause a crushing drug (s) and to allow a movement of the grinding member in rotation along the axis of symmetry of revolution of the bottom wall improving the grinding of drug (s) in contact with the bottom wall.
  • the bottom wall is shaped to be able to cooperate with the grinding member and allow grinding of drugs between the bottom wall and a portion of the grinding member of complementary shape of the shape of the wall of the background.
  • the bottom wall has a rounded, concave and concavity oriented towards the opening of the bowl.
  • the bottom wall may also, in other embodiments, be of conical shape and of decreasing section towards the bottom of the bowl.
  • the bottom wall has a plurality of concentric bearings and decreasing section towards the bottom of the bowl.
  • the bottom wall is of circular shape in any straight section orthogonal to the axis of symmetry of revolution of the bottom wall.
  • any section of the bottom wall orthogonal to the axis of symmetry of revolution is of value less than the opening section of the bowl orthogonal to the axis of symmetry of revolution of the bottom wall.
  • each bowl being delimited by an edge, said opening edge, extending in a plane, said opening plane, and opening on said opening face of said tray of cuvettes, the axis of symmetry of revolution of the bottom wall is orthogonal to said opening plane.
  • each cuvette is free of any longitudinal section (along the axis of symmetry of revolution) of bowl of cross-section right parallel to said plane of increasing opening towards the bottom of the bowl.
  • the transverse cross section of the bowl parallel to said opening plane does not increase towards the bottom of the bowl.
  • the transverse cross section of the bowl parallel to said opening plane may be constant.
  • the bowl is itself cylindrical in shape of revolution.
  • the transverse cross section of the bowl parallel to said opening plane may be decreasing.
  • the bowl is itself frustoconical in shape and of cross section parallel to said opening plane decreasing towards the bottom of the bowl.
  • each bowl delimits a drug receiving volume (s) extending laterally within a projection of said opening edge, orthogonal to said aperture plane.
  • the drug receiving volume (s) does not extend laterally beyond the opening edge of the cuvette so that access to the bottom wall is facilitated and the grinding of the drugs is facilitated.
  • the bottom wall of the bowl may be smooth towards the interior of the bowl.
  • the bottom wall of the bowl has no undulation, no groove, no rib, no corrugation or roughness towards the inside of the bowl.
  • Such a smooth bottom wall is adapted to minimize losses of drug (s) after grinding.
  • the bottom wall of the bowl may have surface irregularities towards the inside of the bowl.
  • Such surface irregularities can be of any shape. These may be grooves, pins, ripples, ribs, corrugations or roughness.
  • the bottom wall may have surface irregularities of dimension-in particular of depth-between between of the order of a few micrometers and of the order of one millimeter, the bottom wall being symmetrical with revolution.
  • each bowl is cylindrical in shape of revolution.
  • each bowl has, in any straight section parallel to said opening plane, a diameter of constant value.
  • each bowl comprises a side wall and a bottom defining the drug receiving volume (s).
  • the side wall of each bowl is cylindrical in shape of revolution.
  • the bottom wall of each bowl is cylindrical of revolution.
  • each bowl may have any size.
  • each cuvette has a height, orthogonal to the opening plane and of dimension between 20 mm and 50 mm.
  • the diameter of the side wall is between 20 mm and 50 mm, in particular of the order of 35 mm.
  • the side wall of each bowl is orthogonal to said opening plane.
  • the side wall of each bowl extends from said opening edge of the bowl.
  • the bottom of the bowl is flat and substantially parallel to said opening face.
  • the side wall has a decreasing cross section towards the bottom of the bowl according to any cross section parallel to said opening plane.
  • the side wall may be frustoconical in shape (truncated cone) and decreasing section towards the bottom of the bowl.
  • the side wall is adapted to receive the grinding member and guide it to the bottom of the bowl and to allow grinding of drugs in contact with the bottom wall.
  • each bowl is flared towards the opening.
  • the bottom of the bowl has a rounded, concave and concavity oriented towards the opening of the bowl.
  • the bottom can also, according to other embodiments, be of conical shape and of decreasing section towards the bottom of the bowl.
  • Nothing prevents the bottom has a plurality of concentric bearings and decreasing section towards the bottom of the bowl.
  • the bottom of the bowl may be smooth towards the inside of the bowl.
  • the bottom of the bowl has no undulation, no groove, no rib, no corrugation, or roughness towards the inside of the bowl.
  • a smooth bottom is adapted to minimize drug losses (s) after grinding.
  • the bottom of the cuvette may have surface irregularities inwardly of the cuvette.
  • Such surface irregularities can be of any shape. It can be grooves, pins, ripples, ribs, corrugations or roughness.
  • the bottom of the cuvette may have surface irregularities of size-notably of depth-ranging between of the order of a few micrometers and of the order of a few hundred micrometers -in particular from 1 to 5 hundreds of microns.
  • At least one -particularly each bowl of the packaging device has a wall section, said blocking section, lateral connecting said opening edge and the bottom wall, said blocking section having a non-circular external shape.
  • Said blocking section may have any non-circular external shape. It may have an outer flat. It can have any regular polygonal shape - for example regular pentagonal - or irregular, symmetrical or not. Such a non-circular shape for locking the bowl in rotation during the grinding of medicine (s) in the bowl.
  • Said blocking section allows the passage of the grinding member to the bottom wall and the grinding of drugs.
  • said opening edge of at least one part of each bowl has a circular shape.
  • Said circular opening edge is dimensioned to allow the passage of a drug grinding member (s).
  • the opening of at least a -notamment each cuvette has an opening edge of polygonal shape -particularly of rectangular shape, in particular of square shape-.
  • At least one-each-row (or column) of cuvettes of said tray of cuvettes comprises seven cuvettes.
  • Each bowl of such a row of cuvettes may be intended to contain a daily dosage of medication (s) of a weekly treatment.
  • Said tray cuvettes can also, according to some other embodiments of the invention, have one or more row (s) of bowls with more than 7 cuvettes. There is nothing to prevent one or more rows of bowls having more than 10, in particular more than 15 bowls.
  • said tray of cuvettes comprises between 1 and 8 (inclusive terminals) -notance between 3 and 6 (inclusive), preferably between 4 and 5 (inclusive) - row (s) ) of bowls.
  • each row (or column) of cuvettes of said tray of cuvettes has the same number of cuvettes.
  • said tray of cuvettes has 4 rows of cuvettes.
  • said tray of bowls is formed of 28 bowls in the form of 4 rows (columns) of bowls, each row of bowls comprising seven bowls each.
  • said bowl tray is formed of 28 cups in the form of 4 adjacent rows (columns) of 7 cuvettes, the cuvettes of each row (column) forming groups of 4 cuvettes aligned with each other, the 4 cuvettes of cuvettes. the same group being intended to receive the drugs corresponding to the four setting times (for example, setting time of the morning, setting time of the noon, setting time of the evening, setting time of the bedtime) of drugs of the same day of the week.
  • the 7 cuvettes of the same column are adapted to contain the drugs of 7 single doses of drugs, each unit dose of drugs corresponding to one of the four setting times (for example, time morning catch, noon time, evening setting time, bedtime) 7 days of the week.
  • a same tray of cuvettes comprises a number of cuvettes greater than 7 in each row (column).
  • Such a tray of cuvettes can be used to form a tray of drug storage and dispensing cells corresponding to a treatment duration greater than 7 days and less than 14 days (duration for which two tray of cuvettes can be used).
  • a same tray of cuvettes comprises a number of rows (columns) greater than 4 corresponding to a number of setting times greater than 4, for example 5 times setting (corresponding, for example, to a setting time in the morning, to a setting time of noon, to a setting time of the snack, to a setting time of the evening and to a set time of bedtime).
  • the same tray of cuvettes comprises a number of rows (columns) equal to 5 (5 taps), equal to 6 (6 taps), equal to 7 (7 taps). taken) or equal to 8 (8 taps).
  • said tray of cuvettes is formed of 28 cuvettes, each cuvette of said tray of cuvettes being adapted to be able to receive a unit dose of drug (s) daily.
  • said tray of bowls is a tray of bowls of a storage and dispensing device (or pillbox) monthly containing 28 unit doses of medication (s) daily.
  • each bowl can have any dimension.
  • each bowl having a rim extending in the opening plane, the rims of the cuvettes of the cuvette plate forming the opening face of the packaging device, the rim of each cuvette is square.
  • the rim of each cuvette is of square shape and side between 20 mm and 100 mm, in particular between 20 mm and 50 mm, preferably between 30 mm and 40 mm.
  • each cuvette has a height, orthogonal to the opening plane and of dimension between 20 mm and 50 mm.
  • the bottom wall has a transverse cross section of diameter less than 50 mm.
  • the diameter of the bottom wall may be between 20 mm and 50 mm, in particular of the order of 35 mm.
  • the cuvettes of said tray of cuvettes are interconnected by breakable bonds comprising precuts.
  • the separable links separating adjacent rows (columns) are in the form of precut lines parallel to each other.
  • the separable bonds separating adjacent troughs of the same row (column) of troughs are in the form of precut lines parallel to each other, orthogonal to the precut lines of adjacent rows (columns).
  • the precut lines form a grid of precuts for subsequent cutting of each cell of the device for storing and dispensing unit doses of drugs.
  • each bowl of said tray of cuvettes forms a flange extending in said opening plane of the bowl and delimiting this opening, the edges of the plurality of cups forming said face of the bowl. opening the tray of bowls.
  • the precut lines of cuvettes of the same row of cuvettes are orthogonal to the precut lines of two rows of adjacent cuvettes.
  • a drug storage and dispensing cell formed from said tray of cuvettes has a peripheral edge of generally polygonal shape, in particular rectangular, in particular square (optionally having rounded corners).
  • the precut lines extending between two adjacent bowls are continuous precut lines, that is to say extending over the entire length and / or over the entire width of said tray of bowls.
  • said plateau of cuvettes is formed of a material selected from the group consisting of transparent polymeric materials, translucent polymeric materials, and opaque polymeric materials.
  • said tray of cuvettes is formed of a material selected from the group consisting of thermoplastic materials and thermosetting materials.
  • a thermoplastic material may be selected from the group consisting of polystyrene (PS), polyethylene (PE), polyethylene terephthalate (PET), low density polyethylene (LDPE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), high impact polystyrene (SB), and mixtures thereof.
  • PS polystyrene
  • PE polyethylene
  • PET low density polyethylene
  • PP polypropylene
  • PC polycarbonate
  • ABS acrylonitrile butadiene styrene
  • PVC polyvinyl chloride
  • PMMA polymethyl methacrylate
  • SB high impact polystyrene
  • the material forming said tray of cuvettes and the thickness of this material forming the bottom wall, the side wall and / or the bottom of the bowl are chosen so that each bowl and the bottom wall exhibit a mechanical strength - in particular a flexural rigidity - allowing a grinding of drugs in contact with the bottom wall.
  • the bottom wall and the bottom of the bowl are formed of a material whose mechanical compressive strength, mechanical resistance to abrasion and thickness are chosen to allow the grinding of drugs.
  • nothing prevents the grinding by placing the cup in support in a mold of concave shape complementary to the shape of the bowl.
  • the tray of cuvettes according to the invention has suspension lights in vertical position adapted to cooperate with a plurality of arches -in particular two arches- a suspension -notance a wall hung- the arches being spaced horizontally the each other.
  • the tray of cuvettes according to the invention has at least one attachment eye of a drug storage and dispensing device including such a tray tray.
  • the packaging device comprises a plurality of covers forming a lid tray connected to each other by breakable connections comprising precuts, each lid of the lid tray being adapted to be able to close a bowl of said tray of cuvettes and form a drug storage and dispensing cell (s).
  • At least one lid is a removable lid adapted to be able to close the opening of a bowl by reversible securing means selected from the group consisting of fastening means by screwing and means for securing by reversible clipping. Any other means for reversibly securing the lid and the bowl is appropriate.
  • the lid tray is formed of at least one row of at least 7 covers connected to each other by breakable connections having pre-cuts.
  • the lid tray is formed of 28 lids connected to each other by breakable connections having pre-cut and in the form of 4 rows (columns) of 7 lids each.
  • the lid tray is a sheet of sealing caps formed of a plurality of sealing caps connected to each other by breakable connections -particularly tear-breakable bonds having pre-cuts, the closure sheet and the sealing caps being dimensioned so as to seal the cuvettes of said tray of cuvettes, the pre-cuts of the sheet of covers being arranged to be able to lie opposite pre-cuts of said tray of cuvettes.
  • each drug storage and dispensing cell can be detached from a tray of drug storage and dispensing cells by simultaneously detaching the cuvette and the sealing cap, the storage and dispensing cell. remaining closed.
  • the sealing sheet is adapted to be able to adhere to at least one part, called the adhesion zone, of the rim formed by the cuvettes of said tray of cuvettes and bordering the opening of each cuvette on said opening face.
  • the closure sheet is formed of at least one row of at least 7 sealing caps linked to each other by breakable bonds - in particular by tearing - having knockouts.
  • the closure sheet is formed of 28 opercules bonded to each other by breakable bonds having pre-cuts and in the form of 4 rows (columns) of 7 caps each. The pre-cuts are positioned on the sealing sheet in the form of pre-cut lines forming a regularly distributed grid for separating the sealing caps.
  • the closure sheet has a first main face, called the adhesive face, having at least one adhesive zone arranged to extend facing said adhesion zone of said tray of cuvettes and to be able to adhere to said adhesion zone.
  • the sealing sheet also has non-adhesive areas extending opposite each dish opening of said tray of cuvettes. Thus, the drugs placed in each bowl of said tray of cuvettes do not adhere to the sealing sheet.
  • said adhesive face of the sealing sheet may be coated with an adhesive material.
  • the sealing sheet may also be formed of an adhesive material in itself, in particular an adhesive cellulosic material, in particular adhesive paper.
  • the closure sheet is provided with a removable protective film of the adhesive zone when the protective sheet is not positioned on said tray of cuvettes, at least a portion of removable protective film being removed in order to placing the closure sheet on said tray of cuvettes.
  • any type of adhesive material can be used. However, it must be ensured that the removable film is compatible with contact with single drug medication taken from the drug storage and dispensing device.
  • the closure sheet has a plurality of pre-cuts, called opening cut-outs, each opening pre-cut being intended to extend opposite the opening of a bowl of said tray of bowls and allow the opening of the storage cell.
  • Each opening precut allows the opening of a storage cell for drug delivery (s) by tearing the portion of the sealing sheet closing the opening of the bowl.
  • the sealing sheet is formed of an essentially cellulosic material - especially paper - of which said adhesive face is self-adhesive and coated with a removable protective film.
  • the closure sheet has a second main face, called printed face, opposite to said adhesive face and having at least one inscription.
  • said printed face has at least one inscription intended to identify the patient, and / or to identify the drug (s) and / or the drug (s) of each unit dose of drugs, and / or identify the date of medication (s) (or setting time) and / or identify the time of medication (s).
  • the registration may include at least one personal data relating to the patient and / or at least one data relating to a medical prescription.
  • the registration can take any form identifiable by the patient, by the prescriber, by a caregiver or by means of an identifier reader. It can be for example writing characters, a color code, a bar code or a QR code. It may be, for visually impaired patients, inscriptions in Braille.
  • Said printed face has inscriptions relating to the patient and / or the medical prescription.
  • the blanking sheet is formed by printing the required inscriptions on said printed face. This printing is carried out by any appropriate means, especially with any type of printer.
  • the packaging device comprises at least one grinding member of medicament (s) adapted to cooperate with the bottom wall and grind the drug (s) in the bowl.
  • any suitable grinding member may be used. It may be a grinding member by crushing, shear, abrasion or by any other means or combination of these effects. It may be a manual grinding member, that is to say a grinding member mu by a human force.
  • the grinding member is a pestle, the bottom wall in contact with which the grinding of drugs is performed as a mortar.
  • the grinding member has an effective grinding surface of complementary shape of the bottom wall. The complementary shape of the effective grinding surface of the grinding member - in particular the pestle - and the bottom wall allows a confinement of the drugs in a grinding volume and a grinding of the drugs.
  • the circular shape of the bottom wall is adapted to cooperate with the effective grinding surface of the grinding member and crush the drug (s), the grinding member being also subjected to a rotational movement according to the longitudinal axis of the grinding member during this crushing.
  • the grinding member may also be a grinding member provided with electrical assistance.
  • the packaging kit comprises at least one drug grinding member adapted to cooperate with the bottom wall and grind the drug (s) in the bowl.
  • a packaging kit (or kit) according to the invention may also comprise a medicinal grinding member (s) adapted to cooperate with the bottom wall of the bowl and to grind the drug (s) in contact with the bottom wall.
  • a medicinal grinding member adapted to cooperate with the bottom wall of the bowl and to grind the drug (s) in contact with the bottom wall.
  • kits (or kit) for packaging drug (s) in solid dosage form divided according to the invention is devoid of drug. It may be a kit in which said tray of cuvettes, (the) cover (s), the tray of covers and the (the) member (s) grinding are separated from each other.
  • said tray of cuvettes of the packaging device may have a storage housing of a grinding member.
  • the invention also relates to such a device for storing and dispensing unit doses of drug (s) in solid dosage form divided each unit dose being intended to be administered to a patient at a predetermined time.
  • Said tray of bowls is pre-cut so as to allow the separation of the bowls from each other manually (by tearing pre-cuts).
  • the closure sheet is pre-cut so as to allow the shutters to be separated from each other manually (by tearing pre-cuts).
  • the different precuts are adapted to allow the separation of a bowl and a sealing cap of the same cell manually simultaneously (by simultaneous tearing of the different pre-cuts) in a single gesture. It is thus possible to separate a storage cell from a storage and dispensing device according to the invention obtained with such a packaging device, this cell containing medicaments.
  • the superposition of the pre-cuts of said tray of cuvettes and pre-cuts of the sealing sheet allows the facilitated separation of a storage cell by simultaneous tearing of the different pre-cuts in a single gesture, manually.
  • the bottom wall is of decreasing dimension towards the bottom of the bowl according to any straight section parallel to said plane of opening.
  • a storage and dispensing device comprises at least one drug disposed in a storage and dispensing cell, said storage cell being formed of a bowl having a generally symmetrical bottom wall of revolution around a 'a axis of symmetry passing through said opening -particularly about an axis of symmetry orthogonal to the opening plane of the bowl- (forming a grinding mortar of drugs) and a lid ensuring the protection and integrity of the drugs when their secure storage.
  • the storage and dispensing device comprises at least one grinding member adapted to cooperate with the bottom wall and grinding, in cooperation with the bottom wall, the (s) medicine (s) in the bowl.
  • the bowl is a disposable bowl.
  • Single-use cuvette is treated after use as waste.
  • the constituent material of the bowl may also be recycled.
  • the bottom wall being of decreasing dimension towards the bottom of the bowl according to any straight section parallel to said plane of opening, the drug (s) are maintained by gravity in contact with the wall of background during their grinding.
  • the grinding of the drug (s) is carried out by any appropriate means.
  • a grinding of medicament (s) is carried out in the bowl having a fundamentally symmetrical bottom wall of revolution about an axis passing through the opening of the cuvette.
  • a grinding of medicament (s) is carried out in the bowl having a generally symmetrical bottom wall of revolution about an axis of symmetry orthogonal to said aperture plane.
  • a grinding of medicament (s) is carried out in the bowl having a bottom wall of circular shape along any straight section parallel to said plane of opening.
  • the bottom wall may be cylindrical of revolution.
  • the bottom wall may be circular in shape and decreasing in size towards the bottom of the bowl according to any straight section parallel to said opening plane.
  • the dose of powdered medicament (s) and a flowing food composition are mixed into the cuvette for administration of this mixture to a patient.
  • the invention also relates to a device for packaging medicaments, a device for storing and dispensing medicaments and a method for dispensing medicinal products to a patient, characterized in combination by all or some of the characteristics mentioned above or below. .
  • the invention may relate to only one of those structural or functional features, or only some of these structural or functional features, or only part of one of these structural or functional features, or any grouping, combination or juxtaposition of all or part of these structural or functional features .
  • Packaging devices and devices for storing and dispensing drugs according to the invention shown in Figures 1 to 9 are given only by way of non-limiting examples. In these figures, the scales and the relative dimensions are not necessarily respected.
  • a packaging device 1 according to the invention shown in figure 1 comprises a plate 9 of 28 cuvettes 4 formed of four rows 14a, 14b, 14c and 14d of seven cuvettes 4 for storing drugs connected to each other by the breakable connections comprising pre-cuts 10.
  • the tray 9 of cuvettes 4 is also formed seven alignments 70a, 70b, 70c, 70d, 70e, 70f and 70g of four cuvettes 4 each.
  • the packaging device 1 represented in figure 1 is free of medication.
  • the tray 9 of cuvettes 4 is formed in one piece. It can be formed by thermoforming a thermoplastic material, for example polyvinyl chloride (PVC).
  • the cuvettes 4 of the tray 9 of cuvettes are formed of a material chosen to be put in contact with drugs.
  • the cuvettes 4 of the tray 9 of cuvettes are formed of a transparent material.
  • the transparent material of the tray 9 of cuvettes allows a control of the filling of the cuvettes 4 of the tray 9 of cuvettes and a visualization of the drugs stored in a drug storage device (s) comprising the device 1 packaging.
  • Each bowl 4 of the tray 9 of cups may have any size, the dimensions of the cups 4 being adapted to the dimensions of the drugs. All the bowls 4 of the tray 9 of bowls may have the same dimensions (length, width, height).
  • Each bowl 4 has a flange 26 extending in the opening plane 13 of each bowl 4, the flanges 26 of the cups 4 of the tray 9 of cups forming one of the faces, called the opening face 11, principal of said tray 9 of bowls.
  • Each rim 26 is connected to the rims 26 of adjacent cuvettes by a breakable connection comprising pre-cuts 10.
  • Each rim 26 has a peripheral edge 28 of substantially square shape and side of dimension between 20 mm and 100 mm, in particular between 20 mm and 50 mm, preferably between 30 mm and 40 mm.
  • Each bowl 4 has a height, orthogonal to the plane 13 of opening and of dimension between 20 mm and 50 mm.
  • Each bowl 4 of the tray 9 of cuvettes has a volume 5 of drug storage adapted to receive drugs.
  • Each bowl 4 has an opening 6 limited by an edge 12 opening of the bowl 4.
  • Each of the opening edges 12 of the 28 cuvettes of the tray 9 of cuvettes 4 extends in the same plane, said plane 13 of opening, forming with the flanges 26 said face 11 opening of the packaging device 1.
  • Each opening 6 and each opening edge 12 has a cross section in circular cross section.
  • Each cuvette 4 has a side wall 24 symmetrical in revolution about an axis of symmetry orthogonal to said opening plane 13 and a base 15 forming a bottom wall 8 for grinding drug (s).
  • the bottom wall 8 is of circular shape along any straight section parallel to said opening plane 13.
  • the bottom wall 8 has a transverse cross section with a diameter of less than 50 mm.
  • the diameter of the cylindrical bottom wall 8 of revolution may be between 20 mm and 50 mm, in particular of the order of 35 mm.
  • the bottom wall 8 forms in the bowl 4 a volume 37 of grinding drug (s).
  • the side wall 24 of each bowl 4 has an internal face (facing the storage volume 5) which is smooth. It has no longitudinal groove or transverse groove.
  • tray 9 of cuvettes 4 represented in figure 1
  • the bottom wall 8 formed of a side wall section 24 and the bottom 15 extends opposite the opening 6 of the bowl 4.
  • Such tray 9 bowl is simple in its manufacture and use.
  • the packaging device represented in figure 1 also comprises a sheet 17 of covers having 28 covers 18 connected to each other by the breakable connections comprising precuts 19 in the form of 4 rows of 7 caps 18 each.
  • a sheet 17 of lids 18 has a face, said face 32 printed, main having inscriptions 43.
  • the inscriptions 43 are carried on each lid 18 and are adapted to allow identification of a patient and / or (s) drug (s) contained in a drug storage cell 3 formed by combining a tray 9 of cuvettes and a sheet 17 of operculas 18 and / or any other information necessary for the implementation of a drug treatment .
  • Such inscriptions 43 can take any form.
  • the inscriptions 43 may relate to the identity of the patient and / or the date and time of taking the drug (s) and / or the medical prescription, including the nature, dose and dosage of the drug (s).
  • the packaging device 1 represented in figure 1 comprises a sheet 17 of lids 18 sized so that each lid 18 of the sheet 17 of lids can close the storage volume 5 of one of the bowls 4 of the tray 9 of bowls 4.
  • This leaf 17 of lids 18 can present an adhesive material on one of its main faces, said adhesive face 31, opposite said printed face 32. It may be an adhesive cellulosic material, in particular adhesive paper protected by a removable protective film on the entire surface of said adhesive face.
  • a portion of removable protective film is adapted to be detached from the sheet 17 of caps so that the sheet 17 of caps can be glued to the plurality of flanges 26 of the cups 4 of the plate 9 of cuvettes.
  • the other portion of the protective film is held in protection so that this other portion of the protective film is held against the storage volume of drug (s) and the drug (s) do not adhere on the leaf 17 of opercules.
  • Each lid 18 of the leaf 17 of the lids has a pre-cut opening 33 of the cell for storing and dispensing drug (s) allowing an easier opening of the cell 3 when taking medicine (s).
  • each lid 18 of the sheet 17 of lids has a tongue 41 gripping for tearing of the lid 18 according to the pre-cut 33 opening and the opening of the cell 3.
  • the tray 9 of cuvettes is formed of four rows 14a, 14b, 14c and 14d of seven cuvettes each connected to each other by breakable connections comprising precuts 10.
  • the tray 9 of cuvettes 4 is also formed of seven alignments 70a, 70b, 70c, 70d, 70e, 70f and 70g of four cuvettes 4 each.
  • Each bowl 4 has an opening 6 having an opening edge 12 of polygonal square shape.
  • the bottom wall 8 of each bowl 4 is symmetrical in revolution about an axis of symmetry orthogonal to said opening plane 13 of each bowl 4 and of circular shape along any straight section parallel to said plane 13 of opening.
  • Each cuvette 4 also has a lateral wall section 24, said blocking section 34, distinct from the bottom wall 8 and connecting the bottom wall 8 and the opening edge 12 of the bowl 4.
  • Said section 34 blocking is symmetrical around an axis of symmetry orthogonal to said plane 13 of opening and square outer shape according to any cross section parallel to said plane 13 of opening.
  • Said section 34 of blocking is adapted to be able to oppose the rotation of the bowl 4 during the grinding of (the) drug (s), when the bowl 4 is placed in a grinding crucible having a hollow recess of internal shape complementary to the external shape of the bowl 4.
  • the figure 3 is a representation of a preferred embodiment of a device 100 for storing and dispensing drug (s) according to the invention.
  • the device 100 for storing and dispensing drug (s) according to the invention is formed of a plate 90 of cells 3 comprising four rows 140a, 140b, 140c and 140d of seven cells 3 each, linked to each other by means of breakable bonds.
  • the tray 90 of cells is formed by combining a tray of cuvettes 4, drugs 2 distributed in the cuvettes 4 of this tray of cuvettes and a sheet 17 of opercules 18 adherent on the edges of the cuvettes 4 of the tray. cuvettes and closing each cell 3 of the cell tray 90.
  • Such a device 100 for storing and dispensing drug (s) formed of a plate 90 of 28 cells 3 can form a weekly pillbox, each row 140a, 140b, 140c and 140d of seven cells 3 containing drugs to be taken at a same time of the day (same setting time) during the 7 days of a week.
  • the row (column) 140a corresponds to the setting time of each morning of the 7 days of the week
  • the row 140b (column) corresponds to the setting time of each noon of the 7 days of the week
  • the row 140c (column ) corresponds to the setting time of each evening of the 7 days of the week
  • row 140d (column) corresponds to at the set time of each bed of 7 days of the week.
  • Such a device 100 for storing and dispensing drug (s) is formed of a plate 90 of 28 cells 3 forming a weekly pill pillar, each alignment 80a, 80b, 80c, 80d, 80e, 80f and 80g of 4 cells 3 being intended to receive the drug (s) of the four doses of medicine (s) to be taken in a day.
  • the alignment 80a of cells 3 corresponds to the first day of treatment
  • the alignment 80b of cells 3 corresponds to the second day of treatment
  • the alignment 80c of cells 3 corresponds to the third day of treatment
  • the alignment 80d of cells 3 corresponds to at the fourth day of treatment
  • the alignment 80e of cells 3 corresponds to the fifth day of treatment
  • the alignment 80f of cells 3 corresponds to the sixth day of treatment
  • the alignment 80g of cells 3 corresponds to the seventh day of treatment.
  • each cell 3 has with the adjacent cells breakable bonds.
  • Each breakable connection between two adjacent cells 3 comprises a breakable connection comprising on the one hand a pre-cut 10 formed between two cups 4 of the tray 9 of cups 4 and on the other hand a precut 19 formed between two operculas 18 of the sheet 17 of opercules, the tray 9 of cuvettes 4 and the sheet 17 of operculas forming with the drugs the tray 90 of cells 3.
  • the pre-cuts 19 of the sheet 17 of the covers 18 and the pre-cuts 10 of the tray 9 of cuvettes are superimposed to form the plate 90 of cells 3 connected to each other by breakable bonds.
  • each drug storage cell 3 formed by a cuvette 4, a lid 18 and at least one drug can be manually separated from said storage cell tray by tearing the pre-cuts.
  • Each operculum 18 of the leaf 17 of lids also has a pre-cut opening 33 of cell 3 for storing medicine (s).
  • Each cuvette 4 forming the cells 3 of the cell plate 90 has a bottom wall 8 adapted to be able to cooperate with a grinding member and grind medicaments in the cuvette 4.
  • FIG. 4 A sectional view of a bowl 4 of a tray of bowls represented in figure 1 is represented in figure 4 .
  • the bowl 4 has a flange 26 adapted to be able to receive a lid 18 and to be secured, in particular by adhesion, with this cover 18, the flange 26 extending in the plane 13 of opening.
  • the bowl 4 has a bottom wall 8 of cylindrical shape of revolution limited by a side wall section 24 of transparent material and a flat bottom 15 also of transparent material.
  • the bowl 4 has an opening 6 limited by an opening edge 12 opening towards the outside of the bowl 4.
  • the lateral wall section 24 and the bottom 15 have a mechanical strength allowing the grinding of medicine (s) in the bowl 4.
  • a sectional view of a bowl 4 of a tray of bowls represented in figure 2 is represented in figure 6 .
  • the bowl 4 has a flange 26 adapted to receive a lid 18 and be secured, in particular by adhesion, with this lid 18, the flange 26 extending in the plane 13 of opening.
  • the bowl 4 has a bottom wall 8 of cylindrical shape of revolution limited by a side wall section 24 of transparent material and a bottom 15 also of transparent material.
  • the side wall 24 and the bottom 15 have a mechanical strength allowing the grinding of medicine (s) in the bowl 4.
  • the bowl 4 also has a blocking section 34 having in all cross-section a polygonal outer shape and a dimension at least equal to the diameter of the side wall 24.
  • the locking section 34 does not prevent the passage of a grinding member to the bottom 15 of the bowl and the bottom wall 8.
  • the blocking section 34 allows rotational locking of the bowl 4 containing medicaments subjected to grinding by a rotary grinding member, when the bowl is placed in a grinding crucible of internal shape complementary to the external shape of the bowl 4 .
  • a cell 3 for storing and dispensing drug (s) of a device 100 for storing and dispensing medicament (s) according to the invention formed from a tray of cuvettes 4 as represented in FIG. figure 1 is represented in figure 5 .
  • the cell 3 for storing and dispensing medicament (s) is shown in the detached state of the device 100 for storing and dispensing medicament (s) according to the invention by separation according to pre-cuts 44 formed by superposition of precuts 10 d a tray of cuvettes 4 and precuts 19 of a sheet of operculum 18.
  • the cell 3 for storing and dispensing drug (s) is a cell 3 of dispensing drug (s) in which the lid 18 has been opened by tearing along precut lines 33, the tearing being facilitated by a recess 39 formed on the rim 26 of the bowl 4 and allowing the gripping of the operculum 18 with a view to his removal.
  • the storage volume 5 of the distribution cell 3 is open and allows access to the drug (s) for grinding in the dish 4.
  • a cell 3 for storing and dispensing drug (s) of a device 100 for storing and dispensing medicament (s) according to the invention formed from a tray of cuvettes 4 as represented in FIG. figure 2 is represented in figure 7 .
  • the cell 3 for storing and dispensing medicament (s) is shown in the detached state of the device 100 for storing and dispensing medicament (s) according to the invention by separation according to pre-cuts 44 formed by superposition of precuts 10 d a tray of cuvettes 4 and precuts 19 of a sheet of opercules 18.
  • the cell 3 for storing and dispensing drug (s) is a cell 3 for dispensing drug (s) in which the lid 18 has was opened by tearing along pre-cut lines 33, the tearing being facilitated by the withdrawal 39 formed on the rim 26 of the bowl 4 for gripping the lid 18.
  • the storage volume 5 of the distribution cell 3 is open and allows access to the drug (s) for grinding in the bowl 4.
  • the bowl 4 has a locking section 34 having a polygonal outer shape and an internal section at least equal to the diameter of the side wall 24 and the bottom wall 8.
  • the blocking section 34 does not prevent the passage of a grinding member towards the bottom 15 of the bowl 4. It advantageously allows rotation locking of the bowl 4 containing medicaments subjected to grinding by a grinding member rotating, when the bowl is placed in a grinding crucible having a hollow cavity of internal shape complementary to the outer shape of the bowl 4.
  • Cell 3 for storing and dispensing drug (s) represented in figure 8 is a drug delivery cell 3 in which the drug (s) is (are) being grinded.
  • the distribution cell 3 is placed in a grinding crucible 35 having a hollow recess of complementary shape to the external shape of the bowl 4.
  • the grinding crucible 35 has a recess 42 intended to receive the rim 26 of the bowl 4 and preventing the rotation of the bowl 4 during grinding.
  • the lateral wall 24 and the bottom 15 of the dish 4 of the drug delivery cell 3 are placed in abutment on the wall of the recessed cavity of the grinding crucible 35 so that the grinding is carried out efficiently and without deterioration. of the bowl 4, by rotary compression of the drug (s) exerted by a pestle 40 in contact with the bottom wall 8.
  • the pestle 40 has a shape and dimensions adapted to cooperate with the bottom wall 8 and a grinding end having an abrasive grinding end 36 for obtaining drugs in the form of powder.
  • a cell 3 for storing and dispensing drug (s) of a device 100 for storing and dispensing medicine (s) according to a variant of the invention is represented in FIG. figure 9 .
  • the cell 3 for storing and dispensing medicine (s) is a cell 3 for dispensing medicine (s) in which the drug (s) is (are) being milled.
  • the cell 3 of drug delivery (s) comprises a bowl 4 having a flange 26 and a frustoconical side wall and decreasing in size towards the bottom 15 of the bowl 4 along any straight section parallel to said opening plane of the bowl. 4.
  • the lateral wall 24 also of frustoconical shape and the bottom 15 of the bowl 4 of the drug delivery cell 3 (s) are adapted to be placed in abutment on the wall of the recessed cavity of the grinding crucible so that the grinding is carried out efficiently and without deterioration of the bowl 4, by rotary compression of (the) drug (s) exerted by the pestle 40.
  • the pestle 40 has a shape and dimensions adapted to cooperate with the bottom wall 8 . Such an adaptation makes it possible to confine the drugs 2 at the bottom of the bowl 4 during grinding and to form drugs in the form of powder.
  • the powdered medicaments can be mixed with a flowing food composition for delivery to a patient without requiring transfer of drug (s) from the storage cell to an adjunct grinding device, and then to a patient.
  • ancillary device for mixing with a flowing food composition for delivery to a patient without requiring transfer of drug (s) from the storage cell to an adjunct grinding device, and then to a patient.

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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)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
EP18162620.1A 2017-04-28 2018-03-19 Dispositif d'emballage de médicament(s) solide(s), dispositif de stockage et de distribution et procédé de distribution de tel(s) médicament(s) Active EP3395319B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR1753767A FR3065640B1 (fr) 2017-04-28 2017-04-28 Dispositif d'emballage de medicament(s) solide(s), dispositif de stockage et de distribution et procede de distribution de tel(s) medicament(s)

Publications (3)

Publication Number Publication Date
EP3395319A1 EP3395319A1 (fr) 2018-10-31
EP3395319A8 EP3395319A8 (fr) 2019-03-13
EP3395319B1 true EP3395319B1 (fr) 2019-05-15

Family

ID=59070946

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18162620.1A Active EP3395319B1 (fr) 2017-04-28 2018-03-19 Dispositif d'emballage de médicament(s) solide(s), dispositif de stockage et de distribution et procédé de distribution de tel(s) médicament(s)

Country Status (3)

Country Link
EP (1) EP3395319B1 (es)
ES (1) ES2741900T3 (es)
FR (1) FR3065640B1 (es)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9902795L (sv) * 1999-07-26 2000-09-25 Ragnar Winberg Blisterförpackning
EP1468935A1 (de) * 2003-04-16 2004-10-20 Alcan Technology & Management Ltd. Blisterverpackung
JP4938456B2 (ja) * 2003-10-22 2012-05-23 ニコメッド ゲゼルシャフト ミット ベシュレンクテル ハフツング 新規の薬剤パック
DE102004034024A1 (de) * 2004-04-26 2006-02-09 Klingel, Hans, Dr.-Ing. h.c. Verpackungseinheit für den wöchentlichen Medikamentenbedarf eines Patienten
FR2957520B1 (fr) * 2010-03-22 2012-04-27 Hospices Civils Lyon Dispositif et procede de mise en solution ou suspension de produits pharmaceutiques ou alimentaires

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None *

Also Published As

Publication number Publication date
EP3395319A1 (fr) 2018-10-31
FR3065640A1 (fr) 2018-11-02
EP3395319A8 (fr) 2019-03-13
ES2741900T3 (es) 2020-02-12
FR3065640B1 (fr) 2019-07-05

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