ES2197075T3 - CONTAINER WITH SEPARATE LABEL. - Google Patents

Abstract

A product comprising a container having a body (11) defined by a container wall (12) made of a plastics material, at least part of the container wall comprising spaced apart inner (15) and outer (16) walls, a label being located on the outer surface of the outer wall, the body having an internal cavity containing a medicament content and being bounded at least in part by the inner wall. Examples of containers are described, as are examples of typical medicament contents.

Description

Container with separate label.

This invention relates to containers and, in in particular, to containers with plastic walls whose content may, undesirably, infiltrate through the container walls or may be sensitive to the entrance of materials, through the walls of the container. In particular This invention relates to such containers when used. for medications

It is common to use material containers plastics such as polyethylene, polypropylene, polyethylene terephthalate, so that they contain medicines. Yes at outer wall of such containers a label or a shrink sleeve the adhesive that sticks the label or cover on the outer surface or, otherwise, the printing ink, the which is used when, directly, information is printed on the surface of the container, can infiltrate through the wall of the same, contaminating the contents of the container, which, potentially leads to harmful effects. The term `` label '', as used in this document and unless distinguish you in a specific way, include attached tags by means of any adhesive, to the shrink sleeves and everything printed, directly, on the vessel wall.

It may be necessary, when the content of the container is a medication, carry out a study and / or a stability test of any new labeling material that is applied to the wall of the container to ensure that the medication is not compromised by the appearance of the packaging, including the properties of printing inks. Such tests They can be expensive and time consuming. They may have to look for new adhesives, printing inks or materials plastics that do not give rise to the problem indicated above, although this solution is expensive and takes a long time in particular if require clinical tests to prove that the new adhesive, or the New ink, do not cause contamination to the content. Conversely, the content of such a container of plastic walls, in particular  solvents, it can infiltrate the walls and produce a deleterious effect on the label that is on the outer surface of the container, for example, by having a label fixed by by means of an adhesive, get peeled off or have the ink Printed fade. Materials are already known for vessel walls that are not permeable, in particular, glass and metal, but these have the disadvantage of their fragility and cost.

In US Patent 4,367,821 it is given to know a container in which a tag attached to a skirt exterior that is placed apart from the vessel wall, but in it does not contemplate the possible contents for the container, or the problems caused by the material that infiltrates through the walls of the container ..

In the document WO-A-9.711.003 discloses a double wall container.

An object of this invention is to provide at least in part, a solution to the pollution problem that arises from the infiltration, through the walls of the container, of contaminants such as label or ink adhesives or printing and / or infiltration inks, in the reverse direction, by the contents of the container.

According to this invention a product of according to claim 1.

The construction of the container of this invention allows the contents of the container to be directly enclosed by the inner wall and that is in contact with the surface of the inner wall, and thus is not vulnerable to pollution by of the label material such as adhesives or inks of printing, applied to the outer wall, if this material were prone to infiltrate through the outer wall. By consequently, the adhesive or ink cannot contaminate the content by penetrating the wall, and, vice versa, the Content cannot penetrate the wall and affect the tag.

The internal cavity can, at some points, be directly enclosed by some parts of the outer wall and may be in contact with the outer wall, but it is not it is necessary to apply the label to the outer surface of those parts of the outer wall, but only those parts of the wall outside whose inner surface is not in contact with the content.

In a first embodiment of this invention the outer wall of the container may comprise a skirt portion attached to, for example member with or embedded within, the wall inside, and with a skirt wall separated from the wall inside.

The skirt portion can be a skirt upper, for example, surrounding an upper part of the wall inside. In this embodiment the inner wall may comprise the upper body and may include the mouth opening of the container, for example, the inner wall can define and surround the opening of the mouth of the container. Moreover, the part of skirt can be a bottom skirt that surrounds the part bottom, for example, the bottom of the container body. In this realization the container can have both upper skirts and lower.

In the first embodiment the tag may be attached to the outer surface of the skirt part, either a upper skirt or lower skirt, or both skirts upper and inner, in a place where the skirt part is separated from the inner wall.

The top or bottom of the skirt can have a label attached to the outer surface by means of a adhesive or, otherwise, information can be printed directly on the part of the skirt. The upper e skirts lower, mentioned above, can hang from a part of the body wall which, directly, encloses the content of the container, that is, so that the contents of the container is in direct contact with the inner surface of this part of the body wall, but is not in contact with the inner surface of the top and / or bottom of the flap.

The container can have any shape appropriate for the intended use, for example, may In general, be cylindrical, for example, in the form of a bottle. The cylindrical term, as used herein, includes the true cylinders, that is, a shape with longitudinal sides straight and a circular cross section, with the longitudinal axis of the cylinder passing through the center of the circular section, and also distorted cylinders, for example convex sides longitudinally pumped, for example, `` barrel '' shapes, shapes  with concave sides, that is to say wider at the ends of the cylinder than at the waist. Also the term `` cylinder '' includes the shapes with oval or circular cross section flattened.

When the container has a shape, in general, cylindrical, then the upper and lower skirts may have a generally cylindrical shape, for example, almost the same shape transverse than that of the container. When the container is provided with upper or lower skirts these can be part integral with the body of the container or they may be fitted separately in the container body, for example by welding or by means of a fixed connection, for example, placement quickly.

The container of this invention may, by example, be of a construction that includes several pieces, for example, upper and lower container parts that fit together with a closure which does not allow escape or contamination of the content, and such upper and lower parts of the container can comprise their respective parts of walls upper and lower inner and outer container which fit together when the top and bottom of the container They fit together. In such construction the respective parts of the upper and lower walls can fit together by means of said closing.

The container of this invention can be manufactured with conventional plastics, for example, polyethylene, polypropylene or polyethylene terephthalate. The proper thickness of the inner wall can be approximately 1 to 2 mm., and that of the outer wall from 1 to 2.5 mm., approximately. Wall Interior can benefit from exterior wall protection and therefore can, relatively, be fine.

The container of this invention is suitable for a wide variety of medicinal contents, in particular, fluids such as medicines in a liquid state, gel or suspension, cream, or paste, that is, incorporating a solvent vehicle. Such medications may, for example, be suitable for topical applications or for selected applications of the body such as a nasal medication. Such medications are they can apply in the form of aerosol, drops or superficial rub to said selected part of the body. Examples of such medications they are liquid formulations based on oily vehicles acceptable and known in the pharmaceutical industry such as monoglycerides, for example monoolein and monolinolein, phospholipids such as phosphatidylcholines, and galactolipids such as glyceryl glycerides. It is typical that such monoglycerides can be monoglycerides of chain fatty acids long, being optional that also contain a diglyceride of long chain. Such mono and diglycerides can be, for example, combinations of different mono and diglycerides of fatty acids of long chain. In the examples of such acid monoglycerides Fatty include glycerol monooleate, monopalmitate glycerol and glycerol monostearate. In the examples of such products, which are commercially available, are include those found under the MYVEROL trademarks, such as MYVEROL, MYVATEX, MYVAPLEX and GMORPHIC 80, respectively. Another example of such products is the ARLACEL 186, which, in addition to glycerol monooleate has included propylene glycol. It is typical that, in such chain monoglycerides long, the main component of fatty acid is a fatty acid saturated, monounsaturated or polyunsaturated of C 18. Such Oily vehicle based medications may also include triglycerides of fatty acids, a vegetable oil being typical, for example, as diluents of acid triglycerides Fatty mentioned above. Among the examples thereof are include, for example, coconut oil, for example, fractionated coconut. In the examples of such diluent materials commercially available triglycerides, the caprylic / capric triglyceride (Tricaprylin). In the examples of such products, which are commercially available, are include those that are available with the registered trademark MYRITOL, CAPTEX and MIGLYOL. Examples of such oily vehicles are given to know, for example, in WO98 / 14189A (SmithKline Beecham PLC), whose Content is included here for reference. The vessel of This invention is suitable for use with a wide range of active compositions dissolved or dispersed in such a vehicle. A particular example of such active compositions is the mixture of Mupirocin antibiotic (pseudomonic acid, Bactroban ™) that is typical that is in the form of calcium mupirocin. An example of such mupirocin formulation, appropriate for use as Nasopharyngeal spray formulation, is also disclosed in WO98 / 14189A, which is typical for coconut oil fractionated (i.e. a medium chain length triglyceride), for example, the product of the registered trademark MIGLYOL, glycerol monooletato, for example, the brand product Registered MYVEROL 18-99, lemon juice aroma in Micronized calcium mupirocin powder. The vessel of this invention is provided, for example for, or containing, such formulation.

The container may, otherwise, be, in general, conventional and be provided with a means of closure appropriate such as a cap that fits quickly or with thread. The container can also comprise outlet means for feeding the fluid content to, for example, a nozzle, comprised by the opening of the mouth of the container, such as a tube of feeding which leads from the opening of the mouth to the container bottom neighborhood. Such output means can understand, for example, a bomb, being typical that the latter be of the type known for pumping liquid medications, such as a liquid lift by air, which leads to an outlet for the medication such as a spray nozzle.

The container may, for example, be a nasal spray container equipped with means to stock your medicinal content to the nasal area of a consumer.

The container can be manufactured by means of conventional methods such as air blow molding tablet or injection molding. Another aspect of this invention is which provides molds to manufacture the containers of the present invention and, even more, a process, for example, a molding process by injection or blow molding of compressed air, using such molds for manufacturing the container of this invention.

The container will now be described, only by title as an example, taking as reference the attached drawings in the which figure shows a container that is not part of this invention and, only, figure 2 illustrates a container of this invention

Taking as reference the figure 1 in it shows a container that is not part of this invention. East container comprises a bottle-shaped container 11, so in general, cylindrical with a conical bottom, in general, with its side tapered into the container, defined by the wall of the container 12. The container 11 is provided with pairs of walls separate interior and exterior, being a lower pair of the inner wall 13 and outer wall 14, and an upper pair of the inner 15 and outer walls 16. The outer wall of each one of these pairs 13, 14, 15, 16, respectively, has the form of a bottom skirt part 17 and a part of the skirt upper 18. The lower skirt portion 17 hangs from the wall of the container 12 and surrounds the conical bottom of container 11. consequently, the conical bottom comprises the wall 13

To the surface of the outer wall 14 is attached a label 19 attached by means of an adhesive. A part of upper skirt 18 extends from the wall of the container 12 and it also carries a tag 19 attached thereto by means of adhesive. The liquid content 110 is inside the wall of the container 12. Placing the label 19 only on the wall exterior 14 of the lower skirt portion 17 and / or the skirt upper 18, and not on the outer surface of the wall of the container 12, of which the inner surface is in contact with content 110, liquid content 110 and the label are not found therefore the one facing the another on opposite sides of the same region of the wall of the container 12. Therefore the adhesive from the label 19 cannot infiltrate through the wall of the container 12 and contaminate content 110 and, vice versa, content 110 cannot escape through the wall of the container 12 and affect the tag 19.

The lower skirt portion 17 is made of integral way with the wall of the container 12 and, integrally It attaches to the wall of the container at its upper extremity. The part of skirt 18 is manufactured separately and is made to fit in the part top of the wall of the container 12 by means of an accessory that it is placed quickly 111.

Otherwise, the bottom skirt 17 can be make separately and fit to container 11, or the skirt upper 18 can be manufactured integrally with the container 11. The container 11 is provided with a mouth opening 112 the which has an edge defined by the top of the wall inside 15 of the wall of the container 12. The container 11 is It is also equipped with means of supply 113 (in general) which comprise a nozzle 114 and a feeder tube 115. The nozzle 14 fits very well in the opening of the mouth 112 of the container by means of a quick installation accessory. The tube feeder goes down to the bottom of the conical bottom of the container and feeds liquid to the nozzle 114 from the body 11, in a manner already known, for example, by means of a mechanism of pumping 116, or manufacturing the wall of the container 12 with a material compressible and squeezing the container. The container 12 is closed by means of a closure lid 117. As illustrated in the view in  cut of figure 1B, on the line of cut B-B, The container 11 is oval in its cross section.

Taking now as reference the figure 2 in it it is shown that the container of this invention comprises a bottom container 21 (overall) which has a wall base 22 and side walls of the bottom 23 and 24 which extend upward from the base wall to an opening upper of the mouth 25 of the container 21. The side walls 23 and 24 are a continuous double wall which comprises the inner wall 23 and the outer wall, separated from each other, extending from the base wall 22 to the height of the upper opening of the mouth 25. The inner wall 23 and the outer wall 24 are cylindrical, in essence (as seen in figure 2B have a cross section oval, and they are almost concentric and coaxial). The base wall 22 is a continuous base wall that joins interior walls 23 and exterior 24 and close the space 26 between them. The construction of container this invention allows the content (which is not illustrates), in the internal cavity 27 of the container, be directly enclosed by the inner wall 23, and in contact with the inner surface of the inner wall 23, whereby no It is vulnerable to the action of label materials 28 such as adhesives or ink or printing inks that are apply to the outer wall 24. The internal cavity 27 is also It is enclosed, directly, by the base wall 22 where this forms a part of the outer wall 24, but the label is not applied to the outer surface of the base wall 22. The container 21 is made of polypropylene and the inner wall has 1 to 1.5 mm. approximately thick while the wall thickness Outside is 1.5 to 2.0 mm. Approximately. The volume of the Internal cavity 27 is approximately 10 to 25 ml. in the example That has been illustrated.

The container 21 is suitable for medicines liquids which incorporate a solvent vehicle, such as oily vehicles mentioned above. As illustrated on container 21 is a nasal spray dispenser. The recipient it is equipped with a pump 29 (in general), being typical that the same be a liquid elevator by compressed air, to supply the liquid content to a nozzle 210, through a feeder tube which leads from the mouth opening to the neighborhood of the bottom of the vessel. Pump 29 is provided as part of the top 212 set (in general) including the inner and outer walls 23A and 24A, respectively, of the upper part, and is equipped with 213A accessories that allow  fit it through a push action towards the inside of the container 21, in the corresponding accessories 213B and remaining retained therein by friction or fitting with speed. The fit of accessories 213A and 213B, together, forms a closure which prevents leakage and contamination of the content that there is in cavity 27.

The nozzle 210 is covered by a closure of cap 214 such that the feeder tube 211 fits into the cavity 27 and down to a point near the bottom. As it illustrated in the half-cut view of figure 2B, on the line B-B cutting container 21 is oval in its section cross.

Claims (15)

1. A product comprising a double-wall container (21), with a base wall (22) and side walls (23 and 24), which extend upwardly from the base wall (22) to a mouth opening (25) of the container, and the side walls (23 and 24) have the shape of a double wall comprising the inner (23) and outer (24) walls separated from each other, made of plastic material, a label (28), which is placed on the outer surface of the outer wall (24), the body (21) with an internal cavity (27) which contains a medicament and is limited, at least in part, by the inner wall (23) characterized in that the base wall (22) is a continuous base wall (22) that joins the inner and outer walls (23 and 24) and closes the space (26) between them. 2. A product according to claim 1, characterized in that the internal cavity (27) is directly enclosed by parts of the outer wall (24) and in contact with the outer wall (24), but the label (28) is applied to a part of the outer wall (24) whose inner surface is not in contact with the contents. 3. A product according to claim 1 or claim 2, characterized in that the side walls (23 and 24) are in the form of a continuous double wall (23 and 24) extending over the entire height of the internal cavity (27) , from the base wall (22) to the opening of the mouth (25). 4. A product according to any of the preceding claims, characterized in that the inner and outer walls (23 and 24), essentially cylindrical, are almost concentric and coaxial. 5. A product according to any of the preceding claims, characterized in that the lower (21) and upper (212) parts of the container, which fit together with a closure (213A and 213B), which does not allow escape or contamination of the content, said lower and upper parts (21 and 212) of the container comprising their respective lower (23 and 24) and upper (23A and 24A) parts of the inner and outer walls of the container which fit together when the upper parts (23A and 24A) and lower (23 and 24) fit together. 6. A product according to any of the previous claims made of plastic material and that It has a thickness of 1 to 2 mm., approximately, in the inner wall (23), and approximately 1 to 2.5 mm., On the outer wall. 7. A product according to any of the preceding claims, characterized in that the medicament content is a fluid which carries a incorporated solvent vehicle. 8. A product according to claim 7, characterized in that the solvent carrier is a pharmaceutically acceptable oily liquid excipient. 9. A product according to claim 8, characterized in that the oily carrier is a monoglyceride, phospholipid, or a galactolipid. 10. A product according to claim 9, characterized in that the oily vehicle is selected from glycerol monooleate, glycerol monopalmitate and glycerol monostearate. 11. A product according to claim 8, 9 or 10, which contains a long chain diglyceride. 12. A product according to any of the claims 8 to 10, which contains an acid triglyceride fatty. 13. A product according to claim 12, characterized in that the fatty acid triglyceride is a caprylic and / or capricious triglyceride (trycaprylin). 14. A product according to any of the preceding claims, characterized in that the medicinal content comprises calcium mupirocin, fractionated coconut oil and glycerol monooleate. 15. A product according to any of the previous claims, which is a nasal spray container (21) equipped with means (29 and 210) to supply its content Medicinal to the nasal area a user.