WO2016042457A1

WO2016042457A1 - Support for a medicament, in particular in a unitary dose

Info

Publication number: WO2016042457A1
Application number: PCT/IB2015/057038
Authority: WO
Inventors: Flavio Este; Lorenzo SPAGNA; Luca NATALI
Original assignee: Swisslog Italia S.P.A.
Priority date: 2014-09-16
Filing date: 2015-09-14
Publication date: 2016-03-24
Also published as: SG11201702652SA; EP3194293A1

Abstract

A support for a medicament, in particular in a unitary dose, comprises a support member (2) which is provided with at least one opening (4) or a diaphragm zone (11''), in the region of which there can be associated a blister type containment element (8) which contains a medicament. At least one adhesive sheet (5, 5') is provided with an opening (6, 6' ) capable of at least partially being superimposed on the opening (4) of the support member (2).

Description

SUPPORT FOR A MEDICAMENT, IN PARTICULAR IN A UNITARY DOSE

The present invention relates to the field of automated control of medicaments. The invention has been developed with particular regard to a support for a medicament, in particular in a unitary dose.

There are known various systems for packaging, storing and dispensing medicaments.

In Europe, the packaging of medicaments in blister packs with multiple doses is very widespread. The blister packs with multiple doses are constituted by a first layer of plastics material in which there are formed cavities or blisters, each one being capable of containing a single dose of medicament, for example, a single tablet, pill or capsule of a medicament. There is joined to the first layer of plastics material a second closure layer, usually of aluminium or cardboard, which closes the cavities or blisters in order to retain the medicaments therein and to maintain the integrity thereof over time, until the time at which they are administered. The pieces of information relating to the medicament contained in the cavities or blisters of the blister pack are usually printed on the second closure layer.

In the U.S.A., however, packaging of medicaments in loose form inside packagings having large dimensions on which the pieces of information relating to the medicament are set out is very widespread.

For use in the field of hospitals, it is increasingly widespread to use automated systems which control the medicaments in unitary doses. The medicaments are stored in unitary doses in stores, from which they are taken in the quantities precisely necessary for administration to the individual patients, so as to avoid waste and errors.

In accordance with the initial packaging thereof, in multi- dose blister packs or in bulk form in the containers having large dimensions, there are known systems for isolating the single medicaments, for example, single tablets, pills or capsules, and for re-packaging them, for example, in blister packs, each one containing a single dose of medicament. The information relating to the medicament which is difficult to see or only partially visible in the isolated portion of the blister pack, or which is no longer available in the single dose of medicament taken from the container having large dimensions, is reproduced on the re-packaging packet or on a separate label.

The packets used as support systems for a medicament in a unitary dose have been used for some time with success in automated systems which are produced by the present Applicant, and which are described, for example, in EP1346929, EP1346931, EP2671068.

There have been proposed other support systems for unitary doses of medicament, to which the market has been turning in order to reduce the re-packaging costs.

According to the document WO 2008/135825, there is removed from the original packaging of the multi-dose blister pack a portion of blister pack containing a unitary dose of medicament. The blister pack portion is adhesively bonded to a support card having a hole in which there is inserted the blister of the blister pack portion, or through which it is possible to remove the medicament from the blister pack portion at the time of use. The pieces of information relating to the medicament are reproduced on a label which is applied to the support card or printed directly thereon.

According to the document EP2690032, the cavity or blister of a blister pack portion with a unitary dose of medicament is inserted in a hole formed in a first sheet of flexible material, on which there is then bonded a second sheet so as to fix the blister pack portion. In place of the blister pack portion there can be used a blister type container which does not have the closure layer of aluminium or cardboard and which can receive a bulk medicament which is, for example, taken from a container having large dimensions. In that case, the blister type container is inserted in the hole of the first sheet of flexible material. Afterwards, there is placed in the blister type container a unitary dose of medicament and then the second sheet is bonded to the first sheet so as to close the blister type container in order to retain therein the medicament in a unitary dose. Finally, the pieces of information relating to the medicament are set out on the second sheet.

An object of the present invention is to provide a medicament support in a unitary dose which is simple and economic. Another object of the invention is to provide a medicament support in a unitary dose which can be used for bulk medicaments or for medicaments in a single or isolated blister pack. Another object of the present invention is to provide a support for a unitary dose from which the medicament can be readily taken at the time of use, and on which there are clearly set out the pieces of information relating to the medicament itself. Another object of the invention is to provide a support for a medicament in a unitary dose which is simple to handle and store, for example, via an automated medicament control system. Those objects are achieved by means of a support for a medicament in a unitary dose having the features defined in the independent claims.

The medicament container element, both in blister pack form and in the form of an open blister type element, is readily fixed in the region of the openings provided in the support and readily taken by passing through the openings. According to a particular aspect, the article is taken following the breaking of a thin diaphragm of paper or similar material. The diaphragm is produced to be integral with the support member in the region of a mark in the support body, or is constructed by means of a separate layer of diaphragm which is applied to an opening of the support member. The diaphragm forms a protection for the medicament contained in the open blister type element or in the blister type element of the blister pack in a unitary dose. In the case of a medicament contained in a blister pack in a unitary dose, the diaphragm protects the closure of the blister pack, and assists in preventing occurrences of accidental opening thereof during the storage and transport to the location of the administration .

The application of the diaphragm layer to the support member may be brought about by means of adhesive bonding or the like, or with the interposition of an adhesive sheet, preferably bi-adhesive sheet, between the support and the diaphragm.

Preferably, the support member and the adhesive sheet have the same form and dimensions. In particular, the openings formed in the support member and in the adhesive sheet also have the same form and dimensions. This simplifies the production of the support for a unitary dose.

Preferably, the diaphragm layer is of a material which is lighter, thinner or less resistant than the material of the support member, so as to be able to readily remove the medicament at the time of use without it being necessary to apply excessive force.

According to an advantageous embodiment, the adhesive sheet has two adhesive faces and is interposed between the support member and the diaphragm layer so as to fix the diaphragm layer to the support member in a secure manner. Preferably, the adhesive sheet, the support member and the diaphragm layer have the same form and dimensions, so as to make the construction of the support for unitary doses easier.

Advantageously, the blister type element has an edge zone which is capable of being fixed to the support member by means of the adhesive sheet. Preferably, the blister type element is capable of being inserted into the opening of the support member, with the edge zone being interposed between the support member and the adhesive sheet. In this manner, there is produced a compact support in which the medicament is securely fixed.

According to another advantageous embodiment, the blister type element is capable of being fixed to the support member by means of a second adhesive sheet. The second adhesive sheet is preferably provided with an opening for inserting the blister type element.

Advantageously, the blister type element is capable of being arranged on a face of the support member in the region of the opening thereof, with the edge zone being interposed between the support member and the second adhesive sheet.

Preferably, informative indications concerning the medicament are printed on the adhesive sheet, on the second adhesive sheet, on the diaphragm layer or on the support member.

Additional features and advantages will be appreciated from the following detailed description of some preferred embodiments of the invention, given purely by way of non- limiting example, with reference to the appended drawings, in which :

- Figure 1 is an exploded view of a support for a medicament according to the present invention,

- Figure 2 is a cross-section in accordance with the plane of section II-II in Figure 1,

- Figure 3 is a cross-section of a variant of the support for a medicament according to the present invention,

Figure 4 is a cross-section of another variant of the support for a medicament according to the present invention,

Figure 5 is a cross-section of another variant of the support for a medicament according to the present invention,

Figure 6 is a cross-section of another variant of the support for a medicament according to the present invention,

- Figure 7 is an exploded view of another variant of the support for a medicament according to the present invention, and

- Figure 8 is a cross-section in accordance with the plane of section VIII-VIII of Figure 7.

Figure 1 illustrates an embodiment of a support for a medicament in a unitary dose according to the present invention. Figure 2 is a cross-section of the support of Figure 1 in accordance with the plane of section II-II in Figure 1.

The support 1 for a medicament in a unitary dose has a support member 2, which is planar in a preferable but non- limiting manner, which is substantially rectangular in a preferable but non-limiting manner, which is produced from relatively rigid material, for example, a card, a plastics sheet or the like, which is provided with an opening 4, which is circular in a preferable but non-exclusive manner. The thickness of the support member 2 may be selected so as to confer on the support 1 a greater or lesser level of flexibility, in accordance with the intended application and the use of the support for a medicament in a unitary dose, for example, for the storage thereof and the handling thereof in an automated medicament control system.

The support 1 for a medicament in a unitary dose further comprises an adhesive sheet 5 which is provided with an opening 6 and which is superimposed on the support member 2. In particular, the support member 2 and the adhesive sheet 5 preferably have the same form and dimensions. Preferably, the dimensions of the opening 4 produced in the support member 2 and the opening 6 produced in the adhesive sheet 5 are similar and the adhesive sheet 5 is associated with the support member 2 in such a manner that the two openings 5, 6 are substantially superimposed and coincident.

In the embodiment shown in Figures 1 and 2, the medicament F in a unitary dose (which is schematically illustrated only in Figure 2) is contained in a blister pack 7 comprising a blister type containment element 8 which defines a containment cavity 8a for the medicament F in a unitary dose. The mouth 8b of the blister type containment element 8 extends in a substantially annular edge 9. The mouth 8b of the blister type containment element 8 is closed by a base cover 10, which is usually of a material such as aluminium or cardboard, which also extends at the edge 9 to which it is welded. Preferably, the support 1 comprises a diaphragm layer 11 of a material which is lighter, thinner or in any case less resistant than the material of the support member 2, for example, of light or thin paper. The edge 9 of the containment element 8 is positioned on the diaphragm layer 11.

The adhesive sheet 5 is advantageously bi-adhesive, that is to say, provided with both faces 5a, 5b in an adhesive state, and is interposed between the diaphragm layer 11 and the support member 2. Preferably, the support member 2, the diaphragm layer 11 and the adhesive sheet 5 have the same form and dimensions. The diaphragm layer 11 provides additional protection for the base cover 10 which closes the cavity 8a of the blister type containment element 8 of the blister pack 7. In an alternative embodiment, which is advantageous for use with bulk medicaments, the blister type containment element 8 does not have the base cover 10 and the medicament in a unitary dose contained therein is retained inside it by the diaphragm layer 11 which acts as a base closure member for the mouth 8b of the blister type containment element 8. It will be understood, therefore, that the detailed description of the embodiments of the present invention, unless otherwise indicated, relate both to the use of a blister pack containing a medicament in a unitary dose which is single or isolated, and the use of an open blister type containment element which does not have a base closure member and which is capable of receiving a loose medicament which is taken, for example, from a large container. The blister type containment element 8 is fixed to the diaphragm layer 11, and therefore to the support member 2, by means of another adhesive sheet or label 12, which is provided with an opening 13 in which the blister type containment element 8 of the blister pack 7 is inserted. Advantageously, there are printed on the adhesive sheet or label 12 informative indications concerning the medicament, such as, for example, the characteristics of the medicament itself and where applicable the prescription for a specific patient. Those indications may also be set out on other portions of the support member 2, the diaphragm layer 11 or on other labels which are applied thereto.

In order to remove the medicament in a unitary dose from the support 1, it is simply necessary to apply a pressure to the blister type containment element 8 so as to break the diaphragm layer 11 and, if the support 1 comprises a blister pack 7, also the base cover 10 thereof. In this manner, the medicament F in a unitary dose can pass through the opening 6 of the adhesive sheet 5 and the opening 4 of the support member 2, for the administration thereof.

Figure 3 is a cross-section of a support for a medicament in a unitary dose according to a different embodiment, in which the blister type containment element 8, as an independent container which does not have a base cover or which forms part of the blister pack 7 which is provided with the base cover 10, is arranged directly on the rigid support member 2 at the opening 4 thereof. The adhesive sheet 5, still in the bi-adhesive form with both the faces 5a, 5b thereof in an adhesive state, is interposed between the support member 2 and the diaphragm layer 11, which is located at the side of the support 1 opposite the side at which the blister type containment element 8 is arranged. Preferably, the support member 2, the diaphragm layer 11 and the adhesive sheet 5 have the same form and dimensions. The blister type containment element 8 is fixed to the support member 2 by means of the additional adhesive sheet or label 12, in the same manner as that described above with reference to the embodiment of Figure 1.

In this embodiment, in order to remove the medicament in a unitary dose from the support 1, it is simply necessary to apply a pressure to the blister type containment element 8 so as to break the base cover 10 if the support 1 comprises a blister pack 7. The pressure on the containment element 8 urges the medicament in a unitary dose through the opening 4 of the support member 2 and the opening 6 of the adhesive sheet 5, until it reaches the diaphragm layer 11 which in a forced state breaks so as to allow the discharge of the medicament for the administration thereof.

In an alternative form which is not illustrated, when the support 1 provides for only use with a blister pack 7 which is provided with a base cover 10, the diaphragm layer 11 may not be present. In this case, the adhesive sheet 5 has the only adhesive face 5a, for the fixing thereof in contact with the support member 2. The pressure on the blister type containment element 8 determines the breaking of the base cover 10 and the immediate discharge of the medicament in a unitary dose through the opening 4 of the support member 2 and the opening 6 of the adhesive sheet 5.

Figure 4 is a cross-section of a support for a medicament in a unitary dose according to a different embodiment, in which the diaphragm layer 11 is arranged directly on the support member 2 without the interposition of the adhesive sheet. The fixing of the diaphragm layer 11 to the support member 2 may be brought about by means of adhesive bonding, thermoforming, spot welding, punching, stapling, shrinking, or any other method known to a person skilled in the art who is learning about the invention from the present description. Preferably, the support member 2 and the diaphragm layer 11 have the same form and dimensions. The blister type containment element 8, as an independent container which does not have the base cover or which forms part of the blister pack 7 which is provided with the base cover 10, is arranged on the diaphragm layer 11 at the opening 4 in the support member 2. The blister type containment element 8 is fixed to the diaphragm layer 11, and therefore also generally to the support member 2, by means of the adhesive sheet or label 12, in the same manner as that described above with reference to the embodiments of Figures 1 to 3.

In this embodiment, in order to remove the medicament in a unitary dose from the support 1 it is simply necessary to apply a pressure to the blister type containment element 8 so as to break the diaphragm layer 11 and, if the support 1 comprises a blister pack 7, also the base cover 10 thereof. In this manner, the medicament F in a unitary dose can pass through the opening 4 of the support member 2 for the administration thereof.

In the alternative embodiment illustrated in Figure 5 of a support 1' for a medicament which can be used only for a medicament in a unitary dose contained in a blister pack 7 which is provided with a base cover 10, the adhesive sheet 5 has both the faces 5a, 5b in an adhesive state and it is interposed between the base cover 10 of the blister pack 7 and the support member 2. Preferably, the adhesive sheet 5 has dimensions which are smaller than the support member 2 and which are substantially similar to the dimensions of the edge 9 of the blister pack 7. The adhesive sheet 5 allows fixing of the blister pack 7 directly to the support member 2 without any need for additional adhesive sheets or labels. The informative indications concerning the medicament may be printed on the portions of the support member 2 which are not covered by the adhesive sheet 5 or may be set out on additional labels which are fixed to the support member 2.

In this embodiment, in order to remove the medicament in a unitary dose from the support 1 it is simply necessary to apply a pressure to the blister type containment element 8 so as to break the base cover 10 of the blister pack 7. In this manner, the medicament F in a unitary dose can pass through the opening 6 of the adhesive sheet 5 and the opening 4 of the support member 2 for the administration thereof.

Figure 6 is a cross-section of a support 1' for a medicament according to a different embodiment, which can be used only for a medicament which is contained in a blister pack 7 which is provided with a base cover 10. The blister type containment element 8 of the blister pack 7 is inserted in the opening 4 of the support member 2 in such a manner that the edge 9 of the blister pack 7 moves into contact with a face 2a of the support member 2. There is applied to that face 2a of the support member 2 an adhesive sheet 5' having an adhesive face 5a' which allows the blister pack 7 to be fixed to the planar member 2. The adhesive sheet 5' has an opening 6' which is arranged in the region of the opening 4 of the planar member 2. In order to remove the medicament in this embodiment, it is simply necessary to apply a pressure to the blister type containment element 8 of the blister pack 7 so as to break the base cover 10, thereby causing the medicament to pass through the opening 6' of the adhesive sheet 5' . The indications concerning the medicament may be printed both on the non-adhesive face 5b' of the adhesive sheet 5' and on the support member 2 or may be set out on other labels which are applied to the support member 2 or the face 5b' of the adhesive sheet 5'

Figures 7 and 8 illustrate a variant of the support 1 for a medicament in a unitary dose according to the present invention .

The support 1'' for a medicament has a support member 2'', which is planar in a preferable but non-limiting manner, which has a substantially rectangular form in a preferable but non-limiting manner, which is constructed from a relatively rigid material, for example, card, a plastics sheet or the like, which is provided with an impression zone 4'', which is circular in a preferable but non-limiting manner, and which has a smaller thickness than the thickness of the remaining portion of the support member 2'' .

Except for the impression zone, the thickness of the support member 2'' may be selected so as to confer on the support 1'' a greater or lesser level of flexibility in accordance with the intended application and use of the support for a medicament in a unitary dose, for example, for the storage and the handling thereof in an automated medicament control system.

The medicament in a unitary dose is contained in a blister type containment element 8, as an independent container which does not have any base cover or which forms part of the blister pack 7 which is provided with the base cover 10 illustrated in Figures 7 and 8. At the side directed towards the blister type containment element 8, the impression zone 4'' on the support member 2'' defines a diaphragm 11'' which is thinner and therefore less resistant with respect to the remainder of the planar member 2 ' ' . The dimension of the impression 4'' corresponds at most to the dimension of the mouth 8b of the blister pack 7, so that the edge 9 of the blister type containment element moves into abutment with the portion of the support member 2'' which has the full thickness and which surrounds the diaphragm 11'' . The diaphragm 11'' advantageously provides additional protection for the closure base 10 of the blister type containment element 8 of the blister pack 7, or constitutes itself the closure of the blister type containment element 8 if it is used in an independent manner, in order to contain a medicament in a unitary dose, for example, taken from a large container .

The blister type containment element 8 is fixed to the support member 2'' by means of an additional adhesive sheet or label 12, which is provided with an opening 13 in which the blister type containment element 8 is inserted. Advantageously, informative indications concerning the medicament are printed on the adhesive sheet or label 12. Those indications may also be set out on other portions of the support member 2'' or on other labels.

During use, a pressure on the blister type containment element 8 brings about the discharge of the medicament in a unitary dose which is contained therein as a result of the diaphragm 11'' breaking in a similar manner to that indicated with reference to the diaphragm layer used in the embodiments of Figures 1 to 4.

In the above description, the use of the support according to the present invention for a medicament F in a unitary dose is expressly indicated. However, the term "unitary dose" does not have to be understood to be only a single object, such as a single tablet, capsule or pill, because in some cases a unitary administration dose could comprise two or more objects, for example, two capsules to be taken simultaneously. Furthermore, the invention is not limited to medicaments in the strict sense but may also include any type of medical device. Finally, for specific applications it could be advantageous to also use the support of the present invention for medicaments and the like in multiple doses; in that case, a person skilled in the art could apply all the aspects of teaching and the features of the above description to a plurality of blister type containment elements supported by the same support member.

Naturally, the principle of the invention remaining the same, the embodiments and construction details may vary widely with respect to what has been described and illustrated without thereby departing from the scope of the present invention.

Claims

1. A support for a medicament, in particular in a unitary dose, comprising a support member (2) which is provided with at least one opening (4), in the region of which there can be associated a blister pack (7) which contains a medicament which is enclosed in a blister type containment element (8) closed by a base cover (10), the support further comprising at least one adhesive sheet (5, 5') which has at least one adhesive face (5a, 5a') and which is provided with an opening (6, 6') capable of at least partially being superimposed on the opening (4) of the support member (2) .

2. A support for a medicament according to claim 1, further comprising a diaphragm layer (11) which is associated with the at least one adhesive face (5a, 5a') of the adhesive sheet (5, 5' ) .

3. A support for a medicament, in particular in a unitary dose, comprising a support member (2) which is provided with at least one opening (4) and a blister type containment element (8) which is capable of containing a medicament, the blister type containment element (8) being able to be associated with the support member (2) in the region of the opening (4), the support (2) further comprising at least one adhesive sheet (5, 5') which has at least one adhesive face

(5a, 5a') and which is provided with an opening (6, 6') capable of at least partially being superimposed on the opening (4) of the support member (2), and a diaphragm layer

(11, 11') which is associated with the adhesive face (5a, 5a') of the adhesive sheet (5, 5') .

4. A support for a medicament according to claim 2 or claim 3, wherein the diaphragm layer (11, 11') is of a material which is lighter, thinner or less resistant than the material of the support member (2) .

5. A support for a medicament according to any one of the preceding claims 2 to 4, wherein the adhesive sheet (5) has two adhesive faces (5a, 5b) and is interposed between the support member (2) and the diaphragm layer (11, 11') .

6. A support for a medicament according to any one of the preceding claims, wherein the blister type containment element (8) has an edge (9) which is capable of being fixed to the support member (2) by means of the adhesive sheet (5, 5' ) .

7. A support for a medicament according to any one of the preceding claims, wherein the blister type containment element (8) is capable of being inserted into the opening (4) of the support member (2), the edge (9) being interposed between the support member (2) and the adhesive sheet (5, 5' ) .

8. A support for a medicament, in particular in a unitary dose, comprising a support member (2'') which is provided with at least one diaphragm (11'') for covering a discharge region (4, 4'') of a medicament which is contained in a blister type containment element (8) which is fixed to the support member (2, 2'') .

9. A support for a medicament according to claim 8, wherein the diaphragm is integral with the support member (2'') .

10. A support for a medicament according to claim 9, wherein the diaphragm (11'') which is integral with the support member (2'') corresponds to the thin wall of an impression (4'') which is formed on the support member (2'') .

11. A support for a medicament according to any one of the preceding claims, wherein the blister type containment element (8) is capable of being fixed to the support member (2) by means of an adhesive sheet (12), preferably provided with an opening (13) .

12. A support for a medicament according to claim 11, wherein the blister type containment element (8) is capable of being arranged on a face of the support member (2, 2' ' ) in the region of the opening (4) or impression (4'') of the support member (2, 2''), the edge (9) being interposed between the support member (2, 2' ' ) and the adhesive sheet (12) .

13. A support for a medicament according to any one of the preceding claims, wherein informative indications concerning the medicament are printed on the adhesive sheet (5, 5', 12) .