IES990894A2 - Single dose package for semisolid pharmaceutical products - Google Patents

Abstract

A single dose package for a semisolid pharmaceutical product comprises multiple multi-faceted receptacles (1), each receptacle (1) having a mouth or exit (2) for the product and which is hermetically closed by a sheet of laminated aluminum foil and heat mouldable polymer (3) and a dome-shaped part (4) formed by a base or extreme side (5) of relatively small diameter which is perpendicular to the geometric axis of the receptacle and several frusto-conical surfaces with progressively increasing angles of inclination with respect to the base (5). The package allows for easy expulsion of the product, when desired, without any alteration thereof. <Figure 1>

Description

The present invention relates to a single dose package made of laminated aluminium foil and heat-mouldable polymers specifically conceived to contain semisolid dosage forms for oral administration.

More specifically, the invention conceives a single dose package of laminated aluminium foil and heat-mouldable polymers with a special conformation which enables the extraction of the single doses contained therein, maintaining unaltered their original form and physical characteristics.

The packaging in single dose packages made of laminated aluminium foil and heat-mouldable polymers is not generically new, on the contrary, its use with solid forms, «·* pharmaceutical or other, when the object is to preserve their individuality and to provide effective protection against the action of external agents, such as direct light, environmental moisture or others, make it one of the favourite packaging forms, considering that its barrier effect and impermeable characteristics towards said factors are ideal for the aforementioned objectives.

Because of their rigidity, single dose packages made of laminated aluminium foil and heat-mouldable polymers have also been used for conditioning very fragile solid forms, such as monoliths in pharmaceutical tablet form produced by lyophilisation of concentrated aqueous solutions. In this case the resulting compacted solid is of enormous porosity IE990894 - 2 and consequently very fragile, with a tendency to deliquescence, which can only be maintained stable and with full integrity in a type of package such as that described, in which air-tightness is guaranteed by the impermeability to environmental moisture offered by an aluminium cover in conjunction with the air-tightness assured by a heat-sealing process in which the polymers of the laminate are involved so as to seal the perimeter of the single dose containers mentioned above. Therefore, these packages constitute a secure environment for the conservation of lyophilised tablets, but at the moment of extracting the tablets from them, the frail consistency of the latter makes it impossible to carry out this operation by simply exerting manual pressure against one of the sides of the container. Said pressure should be transmitted to the lyophilised tablet and bring about the rupture of the aluminium/polymer foil on the opposite side of the package, bringing about the corresponding liberation of the lyophilised tablet contained therein. Because of this, packages with desealable opposing faces have to be employed with this kind of product, so as to avoid the use of manual pressure on the fragile lyophilised tablet.

When dealing with single dose semisolid forms, the most widely used one in the pharmaceutical world has been the suppository, which has traditionally been packaged by simply wrapping it individually in aluminium foil, or contained, also individually, in small sachets of a thermoplastic material or, otherwise, made of laminated aluminium foil and heat-mouldable polymers. Also in this case, not so much due to fragility reasons, but to deformation, it is not possible to extract the suppository from its single dose package by simply exerting pressure on any point thereof, it being necessary to proceed to previously tear the package in order IE990894 - 3 to liberate the suppository without exerting any physical damage upon it.

All the possibilities described above are not the most suitable when dealing with a semisolid form for oral administration, in which case the objective is not only to conventionally preserve the contents of the package, but also to facilitate the extraction by the simplest possible manipulation which, at the same time, respects the totality of the dimensional characteristics and the integrity of the product. This is the object of the present invention, which is no other than the design of a special form of single dose package formed by a laminate of aluminium foil and a heatmouldable polymer, which preserves the characteristics of the semisolid product contained within and enables its effective extraction at the moment of use.

The constitutive materials of the package, the form of which is the object of the present patent application, are aluminium foil laminates and a heatmouldable polymer. Aluminium foil constitutes the most impermeable material to light, gases and vapours, particularly water vapour, known for use in the conformation of semi-flexible packages. Additionally, this material has, as a function of its thickness, selectable rigidity characteristics, which provide an additional safety element when destining it for its use for the objective described above. Likewise, the heat-mouldable polymers which complete the aforementioned laminate correspond without limitation to the groups of the substituted or unsubstituted polyolefins such as polyethylene, polypropylenes and polv (vinyl chlorides).

IE990894 - 4 The form of administration for which this type of packaging is foreseen is a semisolid form or a soft tablet for oral administration, suitable for being chewed or dissolved in the mouth cavity before ingestion; consequently the consistency of such preparations must be carefully defined, and above all, it must be possible to guarantee that the same will not suffer alterations throughout the life of the product in the market.

The dosage forms mentioned above specifically contain a 10 high percentage of hydrophilic components which are crucial in conferring the texture and palatability characteristics ideal for the object proposed. The benefits obtained with the presence of this type of material in the semisolid compositions considered, among which one must contemplate without limitation those which contain one or several medicaments and therefore may become part of the human therapeutic arsenal, may be diminished as a consequence of the difficulties which may arise in their ejection from the package which contains them, due to the ease with which adhesive bonds may be formed between the flat surfaces of the content and the container. As a result of this easy adherence between the semisolid form and the polymeric face of the laminated aluminium foil and heat mouldable polymer package, the extraction of the former is almost always accompanied by the tearing of the latter, to a greater or lesser extent, and, in conclusion, to breakage. This effect is notoriously increased if the geometry of said package comprises figures with walls orthogonal to the upper or lower bases of the same, as in this case, in addition to the aforementioned possible adhesion between materials, there is a clamping effect upon the parts of the semisolid element in the proximity of the active corners of the package, which occurs as soon as one of the bases is pressed externally by IE990894 - 5 the hand of the user, intending to bring about the expulsion of the semisolid contained therein through the tear in the laminate of the opposite side. Among the possible geometric figures for a package which could cause the effect described above, the most remarkable are cylindrical or parallelepipedical packages.

Other polyhedral or curved geometric shapes, such as the frustum of a pyramid or cone, with internal angles greater than a right angle (90°) on the edges between the bases and the vertical sides of the package represent by themselves some degree of improvement to the problem, but not its solution, because in order to effectively avoid the clamping of the semisolid during its extraction, extremely flat shapes are required, with a largest base diameter or diagonal to height ratio greater than 12:1. This would result not only in the semisolid contained being very thin, and consequently fragile, but also in that, by greatly increasing the flat surfaces, the problem of adherence between content and container mentioned earlier arises. A second drawback to this conformation is the limitation on the weight and volume for the semisolid contained in a package as the one described.

In solving the drawbacks pointed out above, a package geometry with a semi-spherical shape or spherical sector is not useful either, as by offering contact without discontinuities between the surfaces of the content and the container, the phenomenon of adherence is favoured. At the same time, the deformation of the dome of the package when pressure is exerted upon it to bring about the expulsion of the semisolid contained therein, results in the formation of either a pressure wedge or a clamping ring on the inner side of said dome, which causes the breakage of the semisoiid at the time of its extraction.

IE990894 - 6 In order to provide a real solution to these practical difficulties, a single dose laminated aluminium foil and heat mouldable polymers package has been designed which are the object of the present invention.

This design includes the progressive sculpting of its dome so that its geometry presents edges on four levels, which have been conceived so as to provide the best possible ejection aerodynamics of the semisolid contained in the package mentioned. In this manner, the part of the package which has the greatest tendency towards forming an adherence dangerous to the integrity of the semisolid at the moment of its ejection, this being the zenithal area of the dome, becomes fragmented into four ring-shaped areas, originating from a minimal flat surface on the apex of the aforementioned dome, each of them having different angles with respect to the horizontal plane which runs along the apex of the package. These different angles increase in an orderly fashion as the inclined areas become further away from the vertex of the dome of the package. It has been demonstrated that the useful sequences are those which have angles of 5°-15°, 15°-30°, 30°-40° and 40°-50°, respectively, in each one of the annular faces described.

The special geometry presented for this single dose laminated aluminium foil and heat mouldable polymers package for semisolid products, which avoids any cylindrical shape and distributes the possible adherence between four conical frustums, with a base greater than the height, which house the semisolid as a whole, effectively distributes the possible adhesive forces between content and container so that these can be gradually overcome when receiving the pressure exerted from the outside, and will expand radially from face to face as a function of the flexion angle of the laminate imposed on each of them, eventually resulting in a IE990894 - Ί faultless extraction of the semisolid contained within, thus converting it into a design of a package beneficial to that object with respect to the existing precedents.

In the accompanying drawings: Figure 1 shows an expanded cross-sectional side view, sectioned in half, of an example of the package of the invention; and Figure 2 shows a top view of package depicted in Figure 1.

By referring to said figures, it can be seen that the package of the present invention consists of a receptacle 1 which comprises an exit area 2 which is air-tightly sealed by a closing sheet of laminated aluminitm foil and heat mouldabie polymer 3, and a rear side shaped like a mount or dome 4 which is constructed so that it presents an extreme or base surface 5 of relatively small diameter which is perpendicular to the geometric axis of receptacle 1, followed by several surfaces in the shape of a conical frustum with progressively increasing angles of inclination with respect to the extreme plane 5.

In the example depicted, 4 is the number of conical frustums in the part of dome 4, with angles of inclination of 8, 19, 38 and 45 degrees.

Receptacle 1 is formed by inlaying into a laminate of aluminium foil 6 and heat mouldable polymers, in which a plurality of orderly arranged identical receptacles will be simultaneously pressed, said laminate being disposed so that the outer convex face of the receptacle corresponds to the surface of the aluminium foil, and the inner concave face to the surface of the heat mouldabie polymer. On the other hand, the aluminium foil laminate and heat mouldable polymer IE990894 - 8 of closing sheet 3 is arranged so that its heat-mouldable surface faces the heat mouldable polymer surface of the laminate which forms receptacle 1, which in this manner will be able to give rise to the polymer-polymer heat-seal as soon as heat is applied upon the flat surfaces of laminate between receptacles and of the laminate of closing sheet 3.

The extraction of the semisolid product contained in receptacle 1 is carried out by pressing upon the apical part 4 in order to produce the rupture of laminate sheet 3, which will allow the easy expulsion of the product, with the advantages mentioned earlier in this document, by virtue of the special configuration of dome 4 of receptacle 1.

Although an illustrative embodiment of the invention has been described and represented, it is evident that modifications and extensions comprised within the scope of the same may be introduced. The invention must not be considered limited to the embodiment described herein, but only to the scope of the content of the following claims.

Claims (3)

1. Claims: 1. A single dose package for a semisolid pharmaceutical product, of the kind constructed to have multiple receptacles starting 5 from a sheet of mouldable material constituted by laminated aluminium foil and heat mouldable polymers, characterised in that each multi-faced receptacle has a mouth or exit for the product which is hermetically closed by a sheet of laminated aluminium foil and heat mouldable polymer, and has, on the opposite side, a dome shaped part formed by a 10 base or extreme side of relatively small diameter and four peripheral conical frustums with increasing inward-looking inclination angles with respect to the plane of said extreme base.

2. A package according to claim 1, characterised in that the inclination of the conical frustums of the dome of the receptacle are 15 comprised within the angular intervals 2-15°, 15-30°, 30-40° and 40-50°, respectively counting from the base plane of the apex of the receptacle.

3. A package according to claim 1, substantially as hereinbefore described with particular reference to and as illustrated in 20 the accompanying drawing.