EP2690032A1

EP2690032A1 - Improved device for singularizing pharmaceuticals and medical articles and relative method for making it

Info

Publication number: EP2690032A1
Application number: EP20130177329
Authority: EP
Inventors: Marco D'Inca'
Original assignee: Sinteco SpA
Current assignee: Sinteco SpA
Priority date: 2012-07-24
Filing date: 2013-07-19
Publication date: 2014-01-29
Also published as: ITPN20120042A1

Abstract

The present invention refers to an improved device to singularize pharmaceuticals and medical articles comprising a flexible ribbon-like support (2) perforated with a plurality of suitably spaced openings (3); each opening (3) containing a protective element (4) which in turn contains a single pharmaceutical product or medical article (10); the protective element (4) comprises a cap (5) protruding from the opening (3) so as to make the pharmaceutical or medical article (10) visible from outside; on the ribbon-like support (2) is applied, from the side opposite to the cap (5), a sheet (8) to retain and lock the protective element (4) therein.

Description

TECHNICAL FIELD OF INVENTION

The present invention refers to a device that allows the separation of products used in the health field, such as pharmaceuticals, vials, syringes and like products, and their repackaging in manners more suitable for their final use.

STATE OF THE ART

Health products of the most diverse type, in particular pharmaceuticals but also other products to be used in the health field, such as syringes, adhesive bandages and similar products are normally produced and packaged by the pharmaceutical firms piece by piece but are then sold in multiple packages. In practice, it is a common general experience that when asking at a chemist's shop for a certain medicine in a tablet or similar form, one is given a case or a box containing a given quantity of such tablets, which are held in a single common blister pack.
Such a blister pack is provided with a plurality of small pockets or recesses, separated from each other and not intercommunicating, in each of which is introduced, and then hermetically sealed, a relative tablet or a medical article as may be the case.
This manner of packaging, which is convenient and effective for the pharmaceutical industry, has however some serious drawbacks for the management and distribution of such medical products in fields that are major users of such medical articles and that make widespread use of them, and specifically both the normal chemist's shops catering to the public and in-house pharmacies in health facilities such as hospitals, clinics, old people's homes and other similar services.
A case in point, for example, is a central pharmacy in a large hospital; in such a dispensary are normally sent, generally on a daily basis, the therapeutic prescriptions for each patient.
In practice, for a complete understanding, the hospital dispensary must prepare, daily and for each patient, a single medicinal preparation, such as for example a holding case, arranged with various sections wherein are contained the medicines corresponding to the therapy prescribed for that given day and for that specific patient. This procedure must be repeated daily for every patient.
Therefore said dispensary must:

select the package of the prescribed medicine;
remove the blister;
extract the pharmaceutical product from the blister, thus having the pharmaceutical free from any holding or protection package;
insert said pharmaceutical in a final package, in said specific holder, relative to a particular patient;
insert in the same final package also the other pharmaceuticals/medical articles that are to be administered to the same patient.

Such operations are in themselves conceptually easy and simple, although they could create certain disadvantages in a working environment in which every day it is necessary to deal with and prepare large amounts of pharmaceutical products for hundreds of patients.
First, from the hygienic and sanitary point of view, the removal of a pharmaceutical product from the relative blister interrupts its preservation in a protected and controlled environment; in fact, the packaging of the pharmaceuticals by the pharmaceutical firms is carried out in a sterile or controlled environment.
The removal of the individual pharmaceutical product from its blister pack makes it completely impossible to identify; thus it can be confused with a quantity of other pharmaceuticals of similar appearance.
Also lost in the process is other essential information for the correct use of the pharmaceutical, like in particular the expiry date, but also any usage prescriptions or dosage limits, or special handling suggestions, such as the preservation of the pharmaceutical product at a specific temperature.
On the other hand, for what concerns regular chemist's shops, there may be a particular problem caused by the following requirement: it is a known fact that medical prescriptions normally or almost always prescribe a certain pharmaceutical product to take for a specific length of time, and therefore in a precisely specified and calculated amount: for example, if the doctor prescribes a certain medicine to take three times a day for seven days, the exact total quantity prescribed is 21 doses or individual units of the same medicine.
The ideal solution would then be for the manufacturers of the prescribed pharmaceutical product to provide the required pharmaceutical product in packages containing exactly the quantities of doses of the medicine prescribed by the doctor, but for obvious production and commercial reasons this is not normally the case.
Thus, it becomes necessary to provide more multiple packages of the medicine so that they generally include the total quantity of prescribed doses.
It is evident from this that the patient is inevitably given a quantity of doses that exceeds the total prescribed quantity.
This situation leads to two kinds of serious problems:

the first problem is one of specifically medical nature: in fact, the patient may be tempted to self-prescribe an over-dosage, in the not uncommon conviction that a larger dosage amounts to a greater effectiveness of the therapy, or to a faster acting therapy. It is obvious that this situation could lead to serious consequences of medical nature, often ignored or ascribed to other causes. The doctor could in fact not suspect any over-dosage, and could look for other causes to explain any complaints expressed by the patient;
the second problem is exclusively economical: in fact, it is obvious that, since medicines have a cost, and often have considerable costs, the fact that these pharmaceuticals are made and sold in doses exceeding the prescribed useful amounts results in a net economic burden for the payer, be it the patient or the health or social service responsible for providing these products.

SUMMARY OF THE INVENTION

Thus it would be desirable, and is the main objective of the present invention, to achieve a means and a method for introducing a possibility of repackaging that is intermediate between:

the type of industrial packaging provided by the pharmaceutical firms, and
the simple elimination of said packaging, that leads to having the individual dose in the final "bare" form, in other words, without any protection or identification.

Basically, the idea is to "singularize" the plurality of doses or units of the pharmaceutical or medical product packaged by the pharmaceutical company in a single holder - be it a blister pack, a box or a bottle - that is to say, the production, beginning from the initial multiple packaging provided by the pharmaceutical company, of packages or single doses that still maintain the peculiarities and the advantages of the initial package, namely:

the maintenance of the protection from the external environment;
its identification, together with other pertinent information, as explained above.

The above-mentioned objective and purposes, and others that will become more evident later, are achieved by an improved device for the singularization of pharmaceutical and medical articles, and by the relative method of achieving the same, made according to the enclosed claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Further characteristics and advantages of the present invention will become evident from the following description of a particular, but not exclusive, embodiment illustrated purely by way of non-limiting example with reference to the following figures, wherein:

figure 1 illustrates, in a perspective view from above, an improved device for singularizing pharmaceutical and medical articles according to the present invention;
figure 2 shows the device of fig. 1 according to a perspective view from below;
figures 3 and 4 show the packaging of a single dose of pharmaceutical product, according to the perspective views from above and from below respectively, taken from the device of figures 1 and 2;
figures from 5 to 8 show the device and the single dose of the previous figures wherein are formed suitable openings for accommodating one or more doses of the pharmaceutical product;
figure 9 shows a conventional blister pack for packaging a plurality of doses of pharmaceutical product;
figure 10 is the blister pack of the previous figure from which is separated a single dose of pharmaceutical product for the subsequent singularization process;
figure 11 shows, in an exploded cross-sectional view, a first embodiment of a device according to the present invention;
figure 12 illustrates an assembly in cross section of the device of figure 11;
figure 13 illustrates, in an exploded cross-sectional view, a second embodiment of a device according to the present invention;
figure 14 illustrates an assembly in cross section of the device of figure 13;
figures 15 and 16 illustrate two possible modes of storing the device according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

With reference to the previously mentioned figures, an improved device for singularizing pharmaceutical and medical articles according to the present invention, indicated generally with reference number 1, comprises a ribbon-like support 2 of flexible material, such as to be able to be wound in coils, folded upon itself or in any case packaged in compact forms suitable for storage, as shown in figure 2; advantageously, the ribbon-like support 2 can be made in the form of a ribbon of material that can be easily ripped off without the use of cutting devices for a more practical use, such as for example one or more layers of paper or equivalent material.
Along the longitudinal extension of the ribbon-like support 2, which hereafter will be defined in short as ribbon 2, are formed a plurality of openings 3 suitably spaced from each other and shaped such as to accommodate a protective element 4 suitable to contain and protect from bacterial contamination a pharmaceutical product 10, such as one made in the form of a tablet, vial, suppository or the like, or a medical article, such as an adhesive bandage or a similar product.
The description which follows will refer, for clarity of presentation, to a pharmaceutical product 10 in tablet form, however the descriptions provided apply in equal measure to pharmaceuticals and/or medical articles of different forms.
The protective element 4 is made, in a known manner, of a relatively rigid material and comprises a cap 5 from the base of which extends perimetrically an abutment surface 6.
According to a first embodiment, illustrated in figures 9 to 12, the protective element 4 can be made from a multi-dose holder such as a blister pack 7, which includes a plurality of protective elements 4 held on a semi-rigid support generally of aluminium, each protective element 4 containing within it a tablet 10. The blister pack 7 is cut out in single portions as exemplified in figure 10 so that each portion contains a single tablet 10. Thus is obtained the separation of the individual tablets 10 in which the cut-out portion 9 of the semi-rigid support keeps the cap 5 closed at the bottom, so that the pharmaceutical product 10 remains enclosed and protected within it, and extends perimetrically around the cap 5 and contributes to form the abutment surface 6.
Once the separation from the multi-dose holder is accomplished, the portion of the holder comprising a single protective element 4 within which is contained a single dose of pharmaceutical product 10 is inserted, as shown in figure 11, into the corresponding opening 3 in the ribbon 2 so that the cap 5 emerges externally to allow the type of pharmaceutical product contained therein to be seen, with the abutment surface 6 acting as a backing surface on the ribbon 2. When said insertion is completed, on the surface opposite to the one from which the cap 5 protrudes is attached to the ribbon 2, for example by gluing, a sheet 8 having the function of holding and fixing the protective element 4 on the ribbon 2. The assembly thus obtained is shown in figure 12.
The sheet 8 may be of the same material as the ribbon 2, or may be of different material, providing it has similar characteristics of flexibility, strength and, advantageously, can be easily tearable.
If the pharmaceutical product 10 is not contained in a protective multi-dose container but is packaged by measure, for example in bottles, so that it is not provided with a receptacle of its own, the present invention can be implemented according to a different embodiment, exemplified in figures 13 and 14, which includes forming a suitable relative protective element 4, comprising a cap 5 open at the bottom so as to receive within it the pharmaceutical product 10 and a peripheral abutment surface 6, as exemplified in figure 13. The protective element 4 is inserted into a respective opening 3 on the ribbon 2 so that the cap 5 protrudes outward, whereupon the pharmaceutical product 10 is inserted into the cap 5. The application of the sheet 8, in addition to retaining and locking the protective element 4 in place on the ribbon 2, will also perform the function of closing the lower part of the same element 4 to retain the pharmaceutical product 10 within it, as shown in figure 14.
By repeating for every opening 3 along the ribbon 2 the operation of inserting the protective element 4, whether it is included in a portion of blister pack according to the first embodiment, and thus already containing the pharmaceutical product 10, or purpose-made as in the second embodiment, and therefore with the pharmaceutical product 10 inserted subsequently, and by applying the sealing and locking sheet 8, is obtained a device in which the pharmaceutical products 10 are repackaged in a singularized manner so that they can be easily extracted, by tearing or cutting the ribbon 2, in the exact quantity of doses to be administered to the patient, as illustrated in figures 1 to 4. Thanks to its flexibility, the ribbon 2 can be wound in a reel or folded upon itself, as shown in figures 15 and 16, thus allowing its easy storage.
The repackaging on the ribbon 2 can be carried out with a sequence of identical pharmaceutical or medical articles or with a personalized sequence of different pharmaceutical and/or medical articles, depending on the therapy prescribed for the patient. In the latter case, a stretch of ribbon 2 can contain a combination of pharmaceutical and/or medical articles corresponding to the doses to be administered in the space of one day, and this combination will be repeated in sequence for a number of stretches of ribbon corresponding to the number of days covered by the therapy.
To overcome the problem of the loss of data of the pharmaceutical/ medical articles once they are separated from the original packet, it is possible to print on the ribbon 2, in the free space included between one pharmaceutical/medical article and the next, or on the external visible surface of the sheet 8, the data 11 that enable the identification of a specific product contained in a specific protective element 4, in addition to other information such as the name of the patient, the times for administering the medicine, the expiry date, the lot of production, etc., as exemplified in figures 2 and 4.
Still in the free space included between two adjacent products, the ribbon 2 and the sheet 8 can be perforated to make a plurality of holes 12, as shown in figures 5 to 8, to attach a single dose or more doses of product to a support, to which can possibly be attached other products in combination to form the set of pharmaceutical/medical articles necessary for a specific therapy, or for storing one or more doses with known systems.
From the above, it is evident that the present invention achieves the initially foreseen purposes and advantages: in fact, a device has been designed for the singularization of pharmaceuticals and medical articles that overcomes the drawbacks of the prior art, allowing the preparation of single doses of pharmaceutical or medical articles that can be easily obtained in quantities that correspond exactly to the doses prescribed by the doctor in charge.
The method or repackaging in single doses as described above makes it possible to still preserve the protection for those pharmaceutical/medical articles that were originally protected from the external environment, such as for example the tablets in blister packs.
It is also evident that the individual packet can be easily opened by applying a simple pressure on the cap 5, in the same manner as with conventional blister packs, which can also be done for pharmaceuticals that are originally packaged by measure, such as small bottles or vessels.
Another advantage of the device and of the method of achieving the same described above is the possibility of maintaining the identification of the product and the relative information, such as the manner of preservation, expiry date, name of patient, time for administering the medicine, and other information, thanks to the possibility of printing such data on the ribbon 2 for each individual product contained therein.
A further advantage is the easy storage of the device, which can be coiled, folded upon itself, and contain in a relatively small space a large quantity of doses of pharmaceutical or medical product to meet the requirements of the health structures where there is a high daily consumption of such products. The coil or the packet of overlapping folds can also be used in an automatic system for dispensing single or multiple doses.
A further advantage is the possibility of personalizing the repackaging, since the device according to the present invention makes it possible to create along the length of the ribbon 2 a sequence of different pharmaceuticals corresponding to the type and to the daily dosages to administer to a specific patient, based on the prescribed therapy.
Further, the device according to the present invention enables the operator to immediately see the type of pharmaceutical product contained in each protective element 4.
Naturally, the present invention is amenable to many applications, modifications or variations without thereby departing from the scope of patent protection, as defined by the accompanying claims.
In addition, the materials and the equipment used to implement the present invention, as well as the forms and dimensions of the individual components, can be the most suitable to meet the specific requirements.

Claims

Improved device to singularize pharmaceuticals and medical articles, characterized in that it comprises a flexible ribbonlike support (2), a plurality of adapted and mutually spaced openings (3) being made along the longitudinal extension of said ribbonlike support (2), each opening of said plurality of openings (3) containing a protective member (4) containing a single pharmaceutical or medical article (10), said protective member (4) comprising a cover (5) protruding from said opening (3) such that said pharmaceutical or medical article (10) is made visible from the outside, a sheet (8) for retaining and blocking said protective member (4) being attached to said ribbonlike support (2) at a side opposite said cover (5).
Device as in claim 1, wherein said protective member (4) further comprises an abutment surface (6) extending peripherally at the base of said cover (5), said abutment surface (6) cooperating with said sheet (8) to retain said protective member (4) on said ribbonlike support (2).
Device as in claim 1, wherein said ribbonlike support (2) is made of a material easily tearable without using cutting tools.
Device as in claim 1, wherein said ribbonlike support (2) is adapted to be printed, in the space comprised between two adjacent openings (3), with data (11) related to the pharmaceutical or medical article (10) contained in one of said two openings (3).
Device as in claim 1, wherein said sheet (8) is adapted to be printed, on the surface visible from the outside, with data (11) related to the pharmaceutical or medical article (10) contained in a respective opening (3).
Method for making an improved device to singularize pharmaceutical and medical articles as in claim 1, characterized in that it comprises the following steps:
a. making a plurality of mutually spaced openings (3) along the longitudinal extension of a flexible ribbonlike support (2);

b. separating a single dose of a pharmaceutical or a single medical article (10) from a multidose container (7), said single pharmaceutical or medical article (10) being already contained or being subsequently inserted into a protective member (4) comprising a cover (5);

c. inserting said protective member (4), containing or in which has been inserted said single pharmaceutical or medical article (10), into an opening of said plurality of openings (3) such that said cover (5) protrudes from said opening (3) to the outside;

d. attaching a sheet (8) to said ribbonlike support (2) at a side opposite said cover (5) to retain and block said protective member (4) on said ribbonlike support (2).
Method as in claim 6, further comprising the step of printing on said ribbonlike support (2), in the space comprised between two adjacent openings (3), data (11) related to the pharmaceutical or medical article (10) contained in one of said two openings (3).
Method as in claim 6, further comprising the step of printing on the surface of said sheet (8) visible from the outside data (11) related to the pharmaceutical or medical article (10) contained in a respective opening (3).
Use of an improved device to singularize pharmaceuticals and medical articles as in claim 1.
Use of an improved device to singularize pharmaceuticals and medical articles made according to the method defined in claim 6.