Device and method for packaging solid medicaments, device for storing and dispensing such medicaments, and dispensing method

10806677 ยท 2020-10-20

Assignee

Inventors

Cpc classification

International classification

Abstract

The invention relates to a device (1) for packaging at least one unit dose of medicaments in a divided solid pharmaceutical dosage form forming at least one cell for storing and dispensing such a unit dose, each cell comprising: a dish (11) delimiting a volume (15) for storing such a unit dose; a cover (12) adapted to close the storage volume; a partition (13) adapted to be able to extend into the storage volume of the dish and to delimit a plurality of compartments (20) therein for keeping the medicaments of the unit dose separate from one another, characterised in that the partition (13) extending into the dish (11) is able to be removed from the dish (11). The invention also relates to a packaging method, to a device for storing and dispensing such medicaments and to a method for dispensing such medicaments to a patient.

Claims

1. Device for packaging at least one unit dose of medicaments in a divided solid pharmaceutical dosage form forming at least one cell for storing and dispensing such a unit dose, each cell comprising: a dish delimiting a volume for storing such a unit dose; a cover adapted to close the storage volume; a removable partition adapted to be able to extend into the storage volume of the dish and to delimit a plurality of compartments therein for keeping the medicaments of the unit dose separate from one another, the partition extending into the dish being able to be removed from the dish; wherein the removable partition is a bottomless partition, and wherein said removable partition is removed from said dish, said medicaments of the unit dose are not separate from one another upon removal of the removable partition.

2. Device according to claim 1, wherein the dish has a peripheral shoulder delimiting an opening of the dish, the cover being formed by a sealing film adapted to be able to adhere to the peripheral shoulder of the dish.

3. Device according to claim 2, wherein the sealing film has a main face, named adhesive face, having at least one adhesive zone disposed in order to be able to adhere to the peripheral shoulder of the dish.

4. Device according to claim 3, wherein the sealing film has a second main face, named printed face, opposite said adhesive face and having at least one inscription.

5. Device according to claim 1, wherein the dish is of elongated shape in a main elongation direction and has: a larger dimension parallel to the main elongation direction of the dish with a value between 60 mm and 150 mm; and a width in a direction perpendicular to the main elongation direction with a value between 20 mm and 50 mm.

6. Device according to claim 5, wherein the dish has a depth extending perpendicular to the main elongation direction, perpendicular to the width and with a value that is lower than the width, in particular between 10 mm and 20 mm.

7. Device according to claim 1, wherein the device is adapted to be able to form a plurality of cells for storing a plurality of unit doses of such medicaments, the cells of the plurality of storage cells being connected to one another in the form of a tray for storing and dispensing medicaments.

8. Device according to claim 1, wherein the device comprises: a perforated tray for receiving medicaments, forming a plurality of juxtaposed dishes; a perforated sheet of sealing films; and a perforated set of removable partitions.

9. Device according to claim 1, wherein a bottom part of the dish forms an indentation for collecting medicaments of the unit dose of medicaments that is adapted to be able to receive and contain the medicaments and to allow them to be crushed in the indentation.

10. Device according to claim 9, wherein the indentation is an indentation that can deform between a retracted form, in which the indentation does not allow the medicaments to be crushed, and a deployed form, in which the depth of the indentation is adapted to receive the medicaments and to allow them to be crushed.

11. Method for packaging at least one unit dose of medicaments in a divided solid pharmaceutical dosage form, wherein: a packaging device according to claim 1 is selected; a removable partition is placed in a dish of the packaging device; medicaments in a divided solid pharmaceutical dosage form are divided into at least two storage compartments formed by the removable partition placed in the dish; and the dish of the device comprising the medicaments is closed by applying the cover.

12. Method according to claim 11, wherein: a removable partition is placed in each dish of the packaging device; medicaments in a divided solid pharmaceutical dosage form are divided into at least two storage compartments formed by the removable partition placed in each dish; and each dish of the device comprising the medicaments is closed by applying the cover.

13. Device for storing and dispensing at least one unit dose of medicaments in a divided solid pharmaceutical dosage form, each unit dose being intended to be administered to a patient at a predetermined time and being distributed in a cell for storing and dispensing such a unit dose, each cell comprising: a dish delimiting a volume for storing such a unit dose and containing such a unit dose; a cover adapted to close the storage volume; a removable partition extending into the storage volume of the dish and delimiting a plurality of storage compartments therein for keeping the medicaments of the unit dose separate from one another, the partition extending into the dish; the partition being able to be removed from the disk; wherein the removable partition is a bottomless partition, and wherein when said removable partition is removed from said dish, said medicaments of the unit dose are not separate from one another upon removal of the removable partition.

14. Device according to claim 13, wherein the removable partition is secured to the cover so as to allow, during the opening of the storage cell, simultaneous extraction of the removable partition from the dish and random distribution of the medicaments in the dish, such random distribution being a distribution of the medicaments in the dish wherein the medicaments of the unit dose of medicaments are not separated from each other in the dish.

15. Device according to claim 13, wherein the removable partition is separated from the cover so that opening the storage cell necessitates delayed extraction of the removable partition from the dish, so as to form a random distribution of the medicaments in the dish, such random distribution being a distribution of the medicaments in the dish wherein the medicaments of the unit dose of medicaments are not separated from each other in the dish.

16. Device according to claim 13, wherein a bottom part of the dish forms an indentation for collecting medicaments of the unit dose of medicaments that is adapted to be able to receive and contain the medicaments and to allow them to be crushed in the indentation.

17. Method for dispensing at least one unit dose of medicaments in a divided solid pharmaceutical dosage form to a patient, wherein: a device for storing and dispensing at least one unit dose of medicaments in a divided solid pharmaceutical dosage form according to claim 13 is selected; a cell for storing and dispensing such a unit dose is separated from the storage device; the cover of this cell of the storage and dispensing device corresponding to the unit dose of medicaments is removed; and the removable partition is extracted from this cell so that the medicaments are no longer separated from one another in the dish; and the unit dose of medicaments is dispensed to the patient.

18. Method according to claim 17, wherein the cover is removed and the removable partition is extracted simultaneously, with the removable partition being secured to the cover.

19. Method according to claim 17, wherein a bottom part of the dish forming an indentation for collecting and crushing medicaments of the unit dose of medicaments is sized to be able to receive and contain the medicaments, the medicaments are moved into the indentation following the extraction of the removable partition and the medicaments of the unit dose of medicaments are crushed in the indentation.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Further aims, features and advantages of the invention will become apparent upon reading the following description, which is provided by way of a non-limiting example, and with reference to the accompanying figures, in which:

(2) FIG. 1 is a perspective view of a packaging device according to a first variant of the invention adapted to form a single cell and shown in the disconnected state before packaging a unit dose of medicaments;

(3) FIG. 2 is a perspective view of a packaging device according to a second variant of the invention adapted to form a plurality of cells and shown in the disconnected state before packaging a plurality of unit doses of medicaments;

(4) FIG. 3 is a longitudinal section view perpendicular to the median plane of the dish of a first variant of a packaging device according to the invention, as shown in FIG. 1;

(5) FIG. 4 is a perspective view with a cut-out of a storage and dispensing device according to the invention obtained by assembling a packaging device, as shown in FIG. 1, and a unit dose of medicaments;

(6) FIG. 5 is a longitudinal section view perpendicular to the median plane of the dish of a cell of a device for storing and dispensing a unit dose of medicaments according to the invention in a state of dispensing a unit dose of medicaments;

(7) FIG. 6 is a perspective view of a packaging device according to a particular aspect of the invention adapted to form a single cell and shown in the disconnected state before packaging a unit dose of medicaments;

(8) FIG. 7 is a longitudinal section view perpendicular to the median plane of the dish of a cell of a particular aspect of a device for storing and dispensing a unit dose of medicaments according to the invention; and

(9) FIG. 8 is an illustration of a particular aspect of a method for dispensing a unit dose of medicaments according to the invention. The packaging devices and the devices for storing and dispensing at least one unit dose of medicaments according to the invention shown in FIGS. 1 to 8 are provided solely by way of non-limiting examples. Throughout these figures, the relative scales and dimensions are not necessarily followed.

(10) A packaging device 1 according to the invention, shown in FIG. 1, comprises a dish 11 for storing a unit dose of medicaments. The dish 11 shown in FIG. 1 is devoid of medicaments. The dish 11 is formed by a material that is compatible with being able to be placed in contact with the medicaments of the unit dose. The dish 11 preferably is formed as a single piece from a thermoplastic material, for example, polyvinyl chloride (PVC), or from a thermosetting material. The dish 11 can be obtained, for example, by thermoforming the thermoplastic material. The thermoplastic material preferably is transparent and allows the unit dose of medicaments packed in the device 1 to be viewed, in the assembled state, provided with medicaments and ready to be used by a patient.

(11) The dish 11 has a volume 15 for storing a unit dose of medicaments that is limited by substantially flat lateral walls 14 and by a bottom 16, which is also substantially flat. The lateral walls 14 and the bottom 16 provide an opening emerging from the dish 11 and the storage volume 15. With the dish 11 shown in FIG. 1 being of substantially rectangular parallelepiped shape, the opening of the dish 11 is of rectangular shape and has an internal edge 17 for receiving and centring the removable partition 13 and a peripheral shoulder 18 for adhering the cover 12 to the substantially flat upper face of the peripheral shoulder 18. The internal edge 17 has a substantially flat upper face capable of cooperating with a matching lower face of a peripheral edge 19 of the removable partition 13. The peripheral shoulder 18 can have a discontinuity 3 that is adapted and sized to be able to receive a tab 2 for gripping the removable partition 13. With the peripheral shoulder 18 of the opening of the dish 11 being of rectangular shape, the discontinuity 3 preferably extends to one of the longitudinal ends of the dish 11. It is possible that the peripheral shoulder 18 has at least one other lateral discontinuity 4 extending over the length of the dish and being adapted to receive a breakable link tab 5 extending between two adjacent removable partitions 13.

(12) The device shown in FIG. 1 has a removable partition 13 that is adapted and sized to be able to be positioned in the storage volume 15 of the dish 11. The removable partition 13 has a plurality of transverse partitions 6 adapted to provide, with the dish 11 and the cover 12, a plurality of compartments 20 for storing medicaments of a unit dose of medicaments. The medicaments of the unit dose of medicaments are then separated from one another by the transverse partitions 6 when they are stored. Each transverse partition 6 shown in FIG. 1 has two main faces that are not parallel and form, in the dish 11, compartments 20 that are flared towards the bottom 16 of the dish, increasing the surface of the bottom of the dish that is accessible to the medicaments of the unit dose and improving the distribution of these medicaments on the bottom of the dish. However, it is possible that, with each transverse partition having two main faces that are not parallel, they form upwardly flared compartments in the dish, i.e. compartments in which the opening has a surface area that is greater than the surface area of the bottom. Such upwardly flared compartments grant easier access to the compartments when they are filled. By combining these two advantages, there is nothing preventing each transverse partition from having two parallel main faces.

(13) The removable partition 13 has an edge 19 on the periphery of the removable partition that is adapted to cooperate with the internal edge 17 of the dish 11 and in such a way that the substantially flat upper face of the peripheral shoulder 18 and the upper face of the peripheral edge 19 of the removable partition are coplanar and can, where necessary, together form the adhesion surface of the cover 12.

(14) The device shown in FIG. 1 has a cover 12 that is sized to close the storage volume 15. This cover 12 can be formed by an adhesive material on only one of its main faces, named adhesive face. It can involve an adhesive cellulose material, in particular adhesive paper. One of the main faces of the cover 12 is adapted to be placed facing the storage volume 15 and is provided with a layer of adhesive material protected by a protective film over the entire surface of the cover 12 when the device 1 according to the invention is in the disconnected state (in kit form), with the dish 11, the cover 12 and the removable partition 13 being adapted to be able to form a closed storage cell of a unit dose of medicaments containing the unit dose of medicaments, or when the device 1 according to the invention is in the partially assembled state, i.e. in which the removable partition 13 is disposed in the storage volume 15 by forming, together with the dish 11, compartments 20 for storing medicaments, with the cover 12 not sealing the opening of the dish 11.

(15) A peripheral part of the protective film of the cover 12 is able to be removed so that the corresponding peripheral part of the cover 12 can be adhered to the peripheral shoulder 18 of the opening of the dish 11, with the unit dose of medicaments being distributed in the compartments 20 for storing medicaments. After the cover 12 is adhered to the dish 11 containing the removable partition 13 and the unit dose of medicaments, the device 1 is a device for storing a unit dose of medicaments, provided with medicaments and ready to be used by a patient.

(16) A peripheral part of the protective film of the cover 12 is able to be removed so that the corresponding peripheral part of the cover 12 can be adhered to the peripheral shoulder 18 of the opening of the dish 11, with the unit dose of medicaments being distributed in the compartments 20 for storing medicaments.

(17) The cover also has a main face opposite the adhesive face having inscriptions 9 able to be read by the patient, by medical staff or by a barcode or QR code reader. The inscriptions 9 can relate to the identity of the patient and/or to the date and to the time for taking the unit dose of medicaments and/or to the medical prescription, in particular the type, the dose and the dosing schedule of the medicament(s).

(18) The cover 12 has a perforation 8 adapted to allow the cell 10 for storing the unit dose of medicaments to be opened. The cover 12 also has a tab 7 for opening the cell 10 that is adapted to allow the patient to grip the end of the cover 12, tear the cover 12 along the perforation 8, remove the removable partition 13 from the dish 11, and form the unit dose of medicaments.

(19) In a first particular embodiment of the invention, the cover 12 is only adhered to the peripheral shoulder 18 of the dish 11 and, where necessary, to the end of the tab 2 for gripping the removable partition 13. In this embodiment, opening the cell 10 by tearing the cover 12 along the perforation 8 is not accompanied by the simultaneous extraction of the removable partition 13. In this embodiment, a subsequent step of extracting the removable partition 13 is required to form the unit dose of medicaments in the dish 11. Of course, the perforation 8 is selected and sized to allow the subsequent step of extracting the removable partition 13 without requiring additional tearing of the cover 12.

(20) In a second particular embodiment of the invention, the cover 12 is adhered to the peripheral shoulder 18 of the dish 11 and to the peripheral edge 19 of the removable partition 13. In this second embodiment, tearing the cover 12 along the perforation 8 located between the zone for adhering the peripheral shoulder 18 of the dish 11 and the zone for adhering the peripheral edge 19 of the removable partition 13 is accompanied by the opening of the storage cell 10, but also, and simultaneously, by the extraction of the removable partition 13.

(21) A second variant of a device 1 according to the invention, shown in FIG. 2, comprises a plurality of storage dishes 21 connected to one another. In this second shown variant, the storage dishes 21 are devoid of medicaments. The plurality of storage dishes 21 is organised in the form of a column of 7 dishes 11, with each dish 11 corresponding to a daily dose of medicaments. The device 1 according to the invention shown in FIG. 2 therefore allows a unit and daily dose of medicaments to be provided, once-a-day, for 7 days. Of course, there is nothing preventing the device 1 according to the invention from having 4 columns of 7 dishes 11, with each column of 7 dishes 11 corresponding to one of the 4 daily doses (breakfast, lunch, dinner and bedtime) of medicaments. The device 1 according to the invention therefore can be a weekly pill container.

(22) Each dish 11 of the plurality of dishes 21 for storing medicaments is separated from the adjacent dishes 11 by a link provided with a perforation 24 for separating the dishes 11. Each removable partition 13 of the plurality of removable partitions 23 is separated from the adjacent removable partitions 13 by a tab 5 with a breakable link and for separating the removable partitions 13. Each cover 12 of the plurality of covers 22 is separated from the adjacent covers 12 by a perforation 27 for separating the covers 12. Thus, each cell formed by a dish 11, a removable partition 13, a cover 12 and comprising a unit dose of medicaments can be separated from the other cells of the plurality of cells simply by cutting, by benefiting from the combined effect of the perforation 24 for separating the dishes 11, the breakable link tab 5 and the perforation 27 of the cover 12.

(23) An exploded longitudinal section view in the median plane of a storage cell 10 devoid of medicaments is shown in FIG. 3. The storage cell 10 comprises a dish 11 determining a dedicated volume 15 for storing medicaments, which is limited by flat lateral walls 14 and by a bottom 16, which is also flat. The dish 11 has an internal edge 17 that is shaped to be able to support and centre, in combination with a shoulder 18, the removable partition 13 in the dish 11. The dish 11 also has a peripheral shoulder 18 for adhering the cover 12 to the flat upper face of the peripheral shoulder 18. The removable partition 13 has a plurality of transverse partitions 6 adapted to be able to, together with the dish 11 when the peripheral edge 19 of the removable partition 13 rests on the internal edge 17 of the dish 11, form a plurality of compartments 20 for storing medicaments of a unit dose of medicaments, the medicaments being separated from one another.

(24) A peripheral part of the protective film of the cover 12 is able to be removed so that the corresponding peripheral part of the cover 12 forms an adhesion edge 25 and can be adhered to the peripheral shoulder 18 of the opening of the dish 11, with the unit dose of medicaments being distributed in the compartments 20 for storing medicaments. In this embodiment, the removable partition 13 does not adhere to the cover 12, so that it is not extracted from the dish upon opening the cell 10.

(25) FIG. 4 shows a device according to a first variant of the invention formed by a single cell 10 in the state in which it is provided with a unit dose of medicaments. The cell 10 comprises a storage dish 11, a removable partition 13 disposed in the volume formed by the dish 11 and a cover 12 adhered to the peripheral shoulder 18 of the dish 11. Medicaments 26 in a divided solid pharmaceutical dosage form, in particular not entirely in powdered form, preferably not in powdered form, are disposed in at least two storage compartments 20. The medicaments 26 are able to be in contact with the protective film of the adhesive layer over the entire surface of the cover 12 without adhering to the cover and without altering the properties of the medicaments 26. The medicaments 26 are not able to be in contact with the adhesive layer part of the cover 12 devoid of a protective film and adhered to the peripheral shoulder 18 of the dish 11.

(26) A device 1 according to the invention in a state of providing a patient with a unit dose of medicaments is shown as a longitudinal section view in the median plane in FIG. 5. This device 1 is formed from a cell 10, as shown in FIG. 4 comprising a unit dose of medicaments. In this dispensing state, the cover 12 is associated with the removable partition 13 by peripheral adhesion, so that opening the cell by tearing the cover 12 along the perforations for opening the cover 12 is accompanied by the extraction of the removable partition 13 from the dish 11 and the release of the medicaments of the unit dose of medicaments in the dish 11.

(27) A particular aspect of a packaging device 1 according to the invention is shown in FIG. 6. In such a packaging device 1, the cover 12 and the removable partition 13 are as described in FIG. 1. The packaging device 1 shown in FIG. 6 has a dish 11 that is devoid of medicaments. The dish 11 is formed as a single part from a thermoplastic material, for example, polyvinyl chloride (PVC). The dish 11 can be obtained by thermoforming the thermoplastic material, for example.

(28) The dish 11 delimits a volume 15 for storing the unit dose of medicaments that is limited by substantially flat lateral walls 14 and by a bottom 16, which is also substantially flat. The dish 11 shown in FIG. 6 has a bottom 16 comprising a bottom 30 for storing medicaments. The bottom 30 for storing medicaments is substantially flat and extends, when the removable partition 13 is placed in the storage volume of the dish 11, facing the transverse partitions 6 of the partition and forms, with these transverse partitions 6, compartments 20 for keeping the medicaments of the unit dose separate from one another.

(29) The bottom 16 of the dish 11 shown in FIG. 6 has an indentation 31 forming a receptacle for the medicaments of a unit dose of medicaments. The indentation 31 can assume any form. Preferably, the indentation 31 is of rotationally symmetrical shape. The indentation 31 exhibits mechanical resistance that is selected to allow crushing and/or grinding of the medicaments contained in the indentation. The indentation 31 is formed by a material, for which the mechanical resistance, in particular the mechanical abrasion resistance, and the thickness are selected to allow crushing and/or grinding. The material forming the indentation 31 is selected to be able to be in contact with a food product and to allow crushed/ground medicaments to be mixed with a soft consistency food product and the resulting mixture to be taken by the patient. The indentation 31 forms a crushing and/or grinding mortar for the medicaments of the unit dose of medicaments. The type and the thickness of the material forming the indentation is adapted to allow the medicaments to be crushed. The type and the thickness of this material is adapted according to the procedure for crushing the medicaments using either a pestle or an external electrical crushing device. The indentation can have a substantially smooth internal surface. However, there is nothing preventing at least one part of the internal surface of the indentation from having asperities (or teeth) cooperating with the pestle in order to crush the medicaments.

(30) The bottom 16 of the dish 11 is flat, smooth and allows the medicaments of the unit dose of medicaments to slide from the bottom 30 for storing medicaments towards the indentation 31 simply by inclining the dish.

(31) A device 1 according to a particular aspect of the invention in a state of providing a patient with a unit dose of medicaments is shown as a longitudinal section view in the median plane in FIG. 7. This device 1 is formed from a cell 10, as shown in FIG. 5. In this dispensing state, the cover 12 is associated by peripheral adhesion to the removable partition 13, so that opening the cell by tearing the cover 12 along the perforations for opening the cover 12 is accompanied by the extraction of the removable partition 13 from the dish 11, the release of the medicaments of the unit dose of medicaments into the dish 11 and the sliding of the medicaments of the unit dose of medicaments from the bottom 30 for storing medicaments towards the indentation 31 simply by inclining the dish 11. The medicaments of the unit dose of medicaments contained in the indentation 31 are able to be crushed in the indentation 31 so as to form a powder, with the powder being subsequently mixed with a soft consistency food product, such as a jam or a compote, in order to be more easily consumed by the patient.

(32) The medicaments of the plurality of medicaments are crushed and/or ground by any suitable means, for example by means of a pestle 40, as shown in FIG. 8, with the indentation 31 acting as a crushing mortar. The pestle 40 is used normally, by using the pestle 40 to exert a pressure on the medicaments kept between the indentation 31 and the pestle 40 and by imposing a rotary movement on the pestle 40, causing the crushing/grinding of the medicaments. The crushing/grinding duration is adapted according to the particle size desired for the unit dose of crushed medicaments.

(33) In one variant, not shown, of a device according to the invention, in which the cover is not associated with the removable partition by peripheral adhesion, opening the cell by tearing the cover along the perforations for opening the cover is not accompanied by simultaneous extraction of the removable partition from the dish. In this variant, the removable partition needs to be extracted by means of the tab for gripping the removable partition in order to release the medicaments of the unit dose of medicaments into the dish.

(34) The invention also relates to a method for packaging at least one unit dose of medicaments in a divided solid pharmaceutical dosage form with a view to it being stored and dispensed. In such a method, a device according to the invention is selected comprising at least one dish for storing a unit dose of medicaments, at least one removable partition and at least one cover. Each removable partition is placed in a dish so as to provide, in each dish, a plurality of compartments adapted to be able to keep the medicaments of the unit dose separate from one another. The medicaments corresponding to a medical prescription are then disposed in each compartment of each cell, then the cell(s) is/are closed by applying a cover onto the opening of each cell. The unit dose of medicaments and the device according to the invention provided with the unit dose of medicaments are then ready to be dispensed to a patient.

(35) In particular, such packaging of a unit dose of medicaments can be carried out in a device according to the invention using a method adapted from the method disclosed in prior document FR 2942132. A tray, named weekly tray, of dishes is selected, with the dishes being associated with one another by detachable links and being distributed in 4 columns and 7 rows corresponding to four daily doses (breakfast, lunch, dinner, bedtime) for 7 days. A removable partition is disposed in each dish. This can involve a plurality of removable partitions associated with one another by breakable links in a configuration that is selected so that each removable partition of the plurality of removable partitions is disposed in the volume of a dish. The tray of dishes equipped with removable partitions is surface mounted on a monitor of a computer system equipped with software for analysing a medical prescription, for two-dimensionally representing the dispensing of the medicaments of this medical prescription in each compartment of each dish of the tray of dishes and for assisting the dispensing of the medicaments according to the medical prescription. In this way, the compartments in which the medicaments of the unit dose of medicaments must be placed can be clearly seen through the dish(es).

(36) Of course, this description is provided solely by way of an illustrative example and a person skilled in the art could apply various amendments thereto. Clearly, the invention can be the subject of various variants and applications. In particular, the sizing, the number and the shape of the dishes, the covers and the cells, the type of materials for the constituent elements of the packaging device and of the storage and dispensing device can vary without departing from the scope of protection of the invention.