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(11) | EP 2 578 199 A1 |
| (12) | EUROPEAN PATENT APPLICATION |
| published in accordance with Art. 153(4) EPC |
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| (54) | ENVELOPE FOR SINGLE DRUG DOSE |
| (57) The invention relates to an envelope consisting of a flexible heat-sealable sheet,
which includes a front surface and a rear surface laterally closed by at least one
longitudinal weld, and on the other ends by a transversal weld, defining an inner
cavity containing the drug in question, the front and rear surfaces of the envelope
having on least one of the ends of the inner cavity protrusions consisting of a flap,
separated from the inner cavity by a weld line or area. Said flap provides a surface
for incorporating Braille markings in impact printing or ink printing, without affecting
the air-tightness of the inner cavity. In one embodiment, said flap includes a precut
line in an area adjacent to the inner cavity for tearing and removing the portion
of the flap that incorporates the name of the drug, while preserving the integrity
of the inner cavity. |
Object of the invention
Field of the invention
Background of the invention
[0003] Presently, envelopes are known which are used for the marketing of single dose drugs, generally formed starting from heat-sealable complex webs consisting in multiple layers of materials which are appropriate to provide the envelope with predetermined features which are aimed at the preservation of the properties of the drug until the moment of its administration. Said layers may provide to the complex web certain specific properties, among others: mechanical resistance, opacity, impermeability and heat-sealing properties.
[0004] These envelopes are marketed in a variable number of units within a box or container bearing multiple informations which are required for its marketing, such as the name of the product, caducity date and active components. In this way, the manufacturer of the drug has only to label the box, showing the essential information in the envelope.
[0005] This kind of marketing format is used in the pharmaceutic field to market powder drugs. The drugs are contained within envelopes included in a main container from which they are extracted when needed, not being possible to dispense the envelopes in an individual form as the envelope does not bear the legally required informations, among others the Braille writing which is needed to allow blind people to identify the drug in question.
[0006] Said envelopes generally have a front surface and a back surface closed together at the sides by means of at least a longitudinal weld defining a tubular configuration, which will be closed at the upper and lower ends delimiting an inner cavity containing the drug.
[0007] In other words, after defining the tubular configuration by means of the web or webs conforming the front and back surfaces of the envelope, this latter is closed at the lower end introducing the product to be packed in its interior before carrying out the closing operation by means of heat-sealing and cutting of its upper end.
[0008] The individual marketing of these envelopes would require the incorporation on each of them of the text and other writings in Braille as legally required. The incorporation of the texts is not a problem in itself as the envelopes may be formed out of pre-printed webs using known techniques. However, the incorporation on the envelope of Braille writings is a problem which is not presently solved because the stamping of the web before or after forming the envelope to include the Braille writings, brings an unacceptable risk of perforation of the web or to originate pores or micropores in the same which would prevent to guaranty the stability of the atmosphere within the envelope and the keeping of the pharmaceutical product in adequate conditions for its posterior administration to humans.
[0009] This problem is still more complicate when the packed product consists in one or two pills (or capsules) because as they do not maintaining an stable position within the inner cavity there is the risk, in the step of putting the Braille writings or printing the caducity date, that the pills or capsules could be damaged because of the impacts.
[0010] Additionally, in the individual marketing of single dose drugs, there is another problem associated to the control of its distribution. Thus, when drugs are purchased which are subsidized by Public Health organizations it is necessary that the pharmacist removes the identification coupon from the drug and incorporates the same on the corresponding prescription, with the aim to justify the dispensing of the drug to recover the subsidized quantity from the Health Authorities.
[0011] In this case, the single dose envelopes are not appropriate as they cannot be opened or torn out in a portion of the same for the removal of the coupon which is printed in the surface of the envelope, because it is necessary to tear out the envelopes, thus violating the conservation and hygienic requirements for the drug contained inside.
[0012] Therefore, the technical problem to be addressed is the development of a single dose envelope for drugs having appropriate characteristics to permit the incorporation of impact printings, Braille writings and other informations which are needed to permit its individualized marketing, all of it without endangering the integrity of the product contained within the envelopes and without making perforations or pores in the same which could eventually affect the correct conservation of the packed product. Furthermore, a problem has to be solved as to the capacity to remove coupons or control portions or identification parts of said envelopes preventing at the same time that the cavity to store the drugs may be altered in its integrity.
Description of the invention
[0013] The envelope of the present invention is of the type of envelopes which start from a flexible sheet which includes a front surface and a rear surface laterally closed by at least one longitudinal weld and closed at the opposing ends by means of two transversal welds, defining an inner cavity containing the drug in question and has constructive peculiarities aimed at defining a surface for the incorporation of Braille writings or printings by impact without affecting the sealing characteristics of the inner cavity and the integrity of the product contained within the envelope.
[0014] According to the invention, both the front and rear surfaces of the envelope have at least at one of the ends of the inner cavity a protrusion forming a flap separate from the inner cavity by a weld area or line, forming a surface for the incorporation of Braille writings or printings by impact without affecting the sealing of the inner cavity.
[0015] The definition of the above mentioned flap out of the area which corresponds to the cavity to contain the product or drug permits to form an adequate surface to support any type of printing or marking including stamping as in the case of the Braille writing, without the risk of forming pores in the area of the envelope which defines the inner cavity and without affecting the conservation of the drug contained in the inner cavity or the integrity of the product.
[0016] In one embodiment of the invention, the envelope is formed by means of a sheet which is pre-printed at least in the areas aimed at forming the front and rear surfaces of the inner cavity which permits, in combination with the definition of the above explained flap, to include in the envelope all the specifications needed for the individual marketing of the envelope containing the drug.
[0017] In one embodiment of the invention, said flap has at least a flat portion forming the surface aimed at the incorporation of Braille writings or for impact printing, so that these writings may be readable by touch, by blind persons. It has to be mentioned that the protrusions on the front and rear surfaces forming the flap may be simply superimposed and laterally adapted or secured to each other by heat-sealing, gluing or any other securing means, as these do not affect the essence of the invention.
[0018] In an alternative embodiment, the envelope has a peculiarity which consists in having in the flap and in an area near to the inner cavity, a precut line for tearing and separating the portion of the flap incorporating the identification of the drug, preserving the integrity of the inner cavity of the envelope.
[0019] The incorporation of said precut line permits to separate in a secure and convenient manner the portion of the flap bearing the information on the drug, preventing the risk of affecting the inner cavity which contains the drug.
Description of the figures
[0020] To complete the present description and with the aim to facilitate the understanding of the features of the invention a set of drawings is annexed to this description, in which the following has been shown with an illustrative and non limitative character:
Figure 1 shows a front view of an example of an embodiment of the single dose envelope for drugs according to the invention, in which the flap defined on the envelope for the incorporation of Braille writings or impact printings may be appreciated.
Figure 2 shows a side view of the envelope of the previous figure with a cross section along a vertical plane and an enlarged detail view of the flap, formed in this case by two protrusions joined by heat-sealing in all of its extension showing a flat surface for the incorporation of Braille writings or impact printings.
Figure 3 shows a front elevation view of a variant of the envelope of the previous figure in which the protrusions forming the flap are superimposed and secured by heat-sealing in a part of its surface.
Figure 4 shows a side view of the envelope of figure 3 with a cross section along a vertical plane.
Figure 5 shows a front elevation view of an alternative embodiment of the single dose envelope for drugs according to the invention in which a precut line is to be seen, aimed at permitting the separation of the flap from the rest of the envelope.
Figure 6 shows a side view of the envelope according to the previous figure with a cross section along a longitudinal plane.
Figure 7 shows a front elevation view of an improved single dose envelope after tearing out along the precut line, in which the flap has been shown separated from the rest of the envelope.
Preferred embodiment of the invention
[0021] In the embodiments shown as examples in the annexed figures, the envelope (1) has a front surface (11) and a rear surface (12) formed by heat-sealable sheets secured and closed at its sides by means of longitudinal welds (13) and at the opposed ends by means of transversal welds (14) delimitating an inner cavity (15) aimed at containing the drug, which has been represented in this case by capsules (2).
[0022] According to this invention, the front and rear surfaces (11, 12) have at one of the ends of the inner cavity (15) protrusions forming a flap (16) separate from the inner cavity (15) by a transversal line or area of welding (14) which forms a surface for the incorporation of Braille writings (3) or impact printings, although in other embodiments, the printings may be ink printings.
[0023] In the example shown in figures 1 and 2, the protrusions of the front and rear surfaces (11, 12) forming the flap (16) are superimposed and secured by heat-sealing in all of its extension showing a flat portion (17), that is, a portion without the typical serration profile of the heat-sealed union lines, precisely forming said flat portion (17) the surface aimed at the incorporation of Braille writings (3) or impact printings. In this way, it is obtained that the writings (3) may be read by touch, without the typical reliefs of the heat-sealed areas or lines interfering in the reading.
[0024] In the embodiment shown in figure 2, the protrusions of the front and rear surfaces (11, 12) forming the flap (16) are superimposed and secured by heat-sealing only at the longitudinal welding lines (13) of the side borders and by the line or area of transversal welding (14) which separates said surfaces from the inner cavity (15) of the envelope. In this case, the flap (16) shows as well a flat surface (16) permitting the definition and subsequent reading by touch of the Braille writings (3) or impact printings.
[0025] In any case, as it has been previously mentioned, the flaps (16) define a surface appropriate for the definition of the writings (3) made by means of reliefs or by impact printing without the risk of harming the area which corresponds to the inner cavity (15) or the drugs themselves contained therein.
[0026] In the embodiment which has been shown, the envelope (1) is formed by means of a pre-printed heat-sealable sheet, which permits the envelope to incorporate, apart from the Braille writings (3) or impact printings defined in the flap (16), at least on one of its front and rear surfaces (11, 12) the specifications (4) which are necessary for the individual marketing of the envelope (1).
[0027] In figures 5 to 7 a further alternative embodiment of the envelope (1) has been shown which comprises in an area near to the inner cavity (15) of the flap (16) a precut line (5) for the tearing and separation of the part of the flap (16) incorporating the information concerning the drug, without harming said inner cavity (15).
[0028] In the example which has been shown in figures 5 to 7 the precut line (5) is located in an intermediate area of the transversal weld (14) separating the flap (16) from the inner cavity (15), so that after the precut line (5) has been torn out and the flap (16) has been separated, the inner cavity (15) keeps sealed along its periphery, all as has been shown in figure 7.
[0029] After having sufficiently described the nature of the invention as well as a preferred embodiment of the same, it is stated to all effects that the materials, shape, size and arrangement of the described elements may be modified provided it does not mean an alteration of the essential characteristics of the invention as defined in the following claims.
1. Envelope for single drug dose of the type formed by a flexible heat-sealable sheet
which includes a front surface (11) and a rear surface (12) laterally closed by at
least one longitudinal weld (13) and on the opposed ends by means of two transversal
welds (14) defining an inner cavity (15) containing the drug, characterised in that the front and rear surfaces (11, 12) of the envelope (1) have at least on one of
the ends of the inner cavity (15) protrusions forming a flap (16) separated from the
inner cavity (15) by a transversal weld line or area (14) providing a surface for
the incorporation of Braille markings (3) or impact printings without affecting the
air tightness of the inner cavity (15).
2. Envelope, according to claim 1, characterised in that the envelope (1) is formed out of a sheet which is pre-printed at least in the areas
aimed at forming the front and rear surfaces (11, 12) of the inner cavity (15).
3. Envelope, according to claim 1, characterised in that the flap (16) has at least a flat portion (17) forming the surface for the incorporation
of Braille markings (3) or impact printings.
4. Envelope, according to claim 1, characterised in that said flap (16) has in an area near to the inner cavity (15) a precut line (5) for
tearing and removing the portion of the flap (16) incorporating the identification
of the drug, preserving at the same time the integrity of the inner cavity (15).