The present invention is in the field of dispensers for topical solutions, for example liquid pharmaceuticals. In particular, the invention is, for example, in the field of dispensers for dispensing a specific amount of a topical solution from a container with minimal wastage.

Background of the Invention

Many liquid products are held within containers prior to use, and when required are dispensed from the container through a variety of mechanisms. Many of these mechanisms allow most of the liquid product to be dispensed from the container, but residual product often remains in the container and is therefore wasted. This can particularly be the case where the product is dispensed by squeezing the container since part of the product can become trapped in a section of the container, such as in the shoulders formed between a tube and an opening, and cannot be squeezed out of the container. Whilst this may not be particularly problematic for low cost products and products which need not be dispensed in an accurate volume, it can be costly when dispensing expensive products and should be avoided when dispensing products which need to be dispensed in accurate amounts, such as pharmaceutical products and in particular high-potent pharmaceuticals.

An additional limitation of available dispensers is that even if a majority of the product held in a container is capable of being dispensed, it can often be very difficult to dispense the last portion of the product from the container. In particular, it can be particularly difficult for elderly or disabled people to dispense the last portion of the product from a dispenser, particularly where the container is relatively small.

It is an object of the present invention to provide a dispensing device which overcomes the limitations of the dispensers discussed above. Such a dispensing device would be able to dispense substantially all the contained product, and would be easy to use, especially for elderly or disabled users. Summary of the Invention

In a first aspect, the present invention provides a dispensing device for a topical solution comprising a support structure having a dispensing surface; a dispensing recess disposed within the dispensing surface for holding and providing access to the topical solution for dispensing; a cover adapted to cover at least a portion of the dispensing surface and moveable between an open position in which the topical solution can be accessed for dispensing and a closed position in which at least a portion of the dispensing surface is covered and access to the topical solution via the dispensing recess is prevented.

The dispensing device may have a cover which is movable between a closed position and open position once (for example, a single-use device). The cover may be wholly or partially detachable from the remainder of the dispensing device as it moves between the closed position and the open position, or as it sits in the open position. The detachment may be by means of a frangible connection. The cover may further be re-closable and re-openable more than once. The dispensing device may further comprise a first gripping recess disposed on the support structure and adapted to provide a grip for gripping the dispensing device. The dispensing device may further comprise a second gripping recess disposed on the support structure. The dispensing devices may have one or more retaining surfaces which at least partially cover at least one of the gripping recesses. The retaining surface may be a resilient structure designed to enhance gripping of the dispensing device.

The dispensing device may have a cover which further comprises a projecting tab adapted to assist the opening of the cover. The projecting tab may project over at least a part of the first gripping recess to aid the user in getting a finger or thumb under the tab to assist opening.

The dispensing device may have a dispensing surface which comprises a rim at least partially surrounding the dispensing recess. The cover may further comprise a recessed portion for receiving the rim when the cover is in its closed position. The rim may directly contact the cover in the closed position.

The dispensing device may have a cover comprising at least one cover component and may have multiple cover components. Each cover component may be joined to one or more other cover components, or to another part of the dispensing device. The joins may be frangible connections. Alternatively each cover component may be separate from any other cover component. When the cover of the dispensing device comprises a plurality of individual cover components, at least one of the plurality of cover components covers the dispensing recess when the cover is in its closed position to prevent access to the topical solution.

One or more the cover components may comprise a flexible cover component. The flexible cover component may join at least two further cover components of the plurality of individual cover components to each other. The components may be a permanently joined or temporarily joined. The connection between any two cover components may be frangible, which may or may not break as the cover component moves to or arrives in the open position. The first further cover component may substantially surround the dispensing recess when the cover is in its closed position, and the second further cover component may be positioned

substantially within the rim of the dispensing recess when the cover is in its closed position, and wherein the flexible cover component may be positioned over the rim when the cover is in its closed position.

The device may further comprise a flexible member. The flexible member may be attached to one or more cover components. The flexible member may be the means by which the cover is joined to the support structure. Any join may be a frangible join. The flexible member may optionally comprise a label.

One or more of the flexible member and flexible cover component may further comprise a flexible foil. The dispensing device may further comprise a cover is adapted to prevent release of the topical solution contained in the dispensing recess when the cover is in its closed position. This may permit a precise amount of topical solution to be dispensed and ensure there is minimal waste.

The dispensing device may have a dispensing recess in the dispensing surface which has an open side of substantially hemi-ellipsoidal shape. The open side of the dispensing recess through which the topical solution can be dispensed may also include an elongated side portion. The cross-section of the dispensing recess taken in a direction from its open side to its base at the elongated side portion may have a substantially U-shaped cross-section. The shape of the dispensing recess is adapted to aid the user in removing all the topical solution during dispensing. The shape of the recess in a plan view may be substantially oval. There is further provided a dispensing device which may comprise one or more additional dispensing recesses for holding and providing access to the topical solution and being disposed on the dispensing surface of the support structure. The dispensing device may further comprise one or more additional covers for covering at least a portion of the one or more additional dispensing recesses within the dispensing surface when in the closed position, wherein the one or more additional covers are each adapted to be opened to access the topical solution for dispensing. The one or more additional covers may comprise a single additional cover for covering a least a portion of the one or more additional dispensing recesses. The one or more additional covers may each comprise a plurality of cover components, whereby at least one of the plurality of cover components covers at least a portion of the one or more additional dispensing recesses in the closed position. Further, the one or more additional covers may each comprise a plurality of cover sections, whereby at least one of the plurality of cover sections covers at least a portion of the one or more additional dispensing recesses in the closed position. Further still, the one or more additional covers may each comprise a plurality of cover sections and each cover section may comprise a plurality of cover components, whereby at least one of the plurality of cover components covers at least a portion of the one or more additional dispensing recesses in the closed position. The dispensing device may contain a topical solution which is a pharmaceutical product. This pharmaceutical product may comprise Ingenol mebutate, Ingenol 3-(3, 5-diethylisoxazole-4- carboxylate) in a topical formulation. More generally, the topical solution may be any gels, lotions, creams, ointments, suspensions which can be held in the dispensing recess.

The dispensing device may comprise a topical solution where the mass of the topical solution to be dispensed is less than 5g, preferably is less than 2g, or more preferably is less than 1 g and most preferably less than 0.5g.

The support structure and cover of the dispensing device may comprise a variety of materials. One or more of the support structure and cover comprise at least one of the following materials: polyethylene terephthalate, high-density polyethylene, polyvinyl chloride, low-density polyethylene, EVOH, cyclic olefin copolymer (COC), polypropylene, polystyrene, polyamides, acrylonitrile butadiene styrene, polycarbonate, or polyacetal.

The support structure or cover of the dispensing device may alternatively comprise at least one of the support structure and cover comprise hard aluminium foil, soft aluminium foil,

paper/aluminium foil combination, paper/PET/aluminium foil laminations, any thermoplastic raw material, any mono or multi-layer thermoplastic film, optionally containing an aluminium layer or a metalized film.

The dispensing device or any part thereof may comprise any combination of the materials described herein. Where appropriate, materials can either be used as homo-polymers, copolymers, or in combination by using for example, multi component injection moulding or In- Mould Labeling. The final selection of materials for the dispensing device will depend on the compatibility of the topical solution and the dispensing device and the stability of the topical solution to be stored within the dispensing device and have sufficient shelf life. The dispensing device may comprise a cover which is adapted to aid the user in accessing the topical solution. The cover may assist access as the cover is moved between the closed position and the open position, or may assist access exclusively in the open position. In either case, the cover may be attached, partially detached or fully detached from the remainder of the dispensing device when it is aiding the user in accessing the topical solution. The projecting tab adapted to assist opening of the cover may be further adapted to assist in accessing the topical solution (for example by scooping the solution out of the dispensing recess).

In a second aspect, there is further provided a system comprising a plurality of dispensing devices as described herein, each dispensing device being one of the dispensing devices according to any dispensing device previously described and wherein each one of the dispensing devices is joined to at least one other of the plurality of dispensing devices. The join between one dispensing device and at least one other of the plurality of dispensing devices may be a frangible connection.

In a third aspect, the present invention further relate to a single-use dispensing device comprising: - a blister comprised of a support structure, a dispensing surface and a dispensing recess;

- a removable lid or foil or combination thereof forming a cover for the dispensing device; and an optional bottom section, wherein the single-use dispensing device is used for safe storage and patient friendly administration of small amount of a liquid pharmaceutical product for topical use ensuring minimal waste.

In a fourth aspect, the present invention provides a dispensing device comprising a blister comprised of a support structure, a dispensing surface and a dispensing recess, covered with a removable lid/cover and/or a peel off foil for holding a small volume of high potent liquid pharmaceutical product for topical use. In an embodiment of the dispensing device, the pharmaceutical product is placed in a foil or lid covered indentation in a sheet of variable size and contained one or more indentions, each indention containing one dosage.

In an embodiment of the dispensing device the blister comprises polyethylene terephthalate, high-density polyethylene, polyvinyl chloride, low-density polyethylene, EVOH, cyclic olefin copolymer (COC) polypropylene, polystyrene, polyamides, acrylonitrile butadiene styrene, polycarbonate, polyacetal or other suitable thermoplastic polymers, which materials can either be used as homo-polymers, copolymers, or in combination with e.g. multi component injection moulding or by In-Mould Labeling. Some embodiments of the dispensing device, the blister comprises hard aluminium foil, soft aluminium foil, paper/aluminium foil combination, paper/PET/aluminium foil laminations, any thermoplastic raw material, any mono or multi-layer thermoplastic film which might contain aluminium layer or metalized film or a combination of types of aluminium mentioned above, and/or with the above mentioned plastic materials. In other embodiments of the dispensing device the lid (cover) comprises hard aluminium foil, soft aluminium foil, paper/aluminium foil combination, paper/PET/aluminium foil laminations any thermoplastic raw material, any mono or multi-layer thermoplastic film which might contain aluminium layer or metalized film.

In embodiments of the dispensing device, the lid comprises polyethylene terephthalate, high- density polyethylene, polyvinyl chloride, low-density polyethylene, EVOH, cyclic olefin copolymer (COC) polypropylene, polystyrene, polyamides, acrylonitrile butadiene styrene, polycarbonate, polyacetal or other suitable thermoplastic polymers. Plastic materials can either be used as homo-polymers, copolymers, or in combination with e.g. multi component injection moulding or by In-Mould Labeling. In an embodiment of the dispensing device, plastic materials and hard foil, metalized foil or any film combination of one or more thermoplastic film and aluminum or metalized thermoplastic film, or film manufactured as cast film or blown film monolayer or multilayer from any thermoplastic. Raw materials can be used in combination for example by multi-component injection-moulding or by In-Mould Labeling. In embodiments of the dispensing device the pharmaceutical product to be administered is less than 5 g, such as less than 2 g, such as less than 1 g and such as less than 0.5 g.

In an embodiment of the dispensing device, the pharmaceutical product is Ingenol mebutate, Ingenol 3-(3, 5-diethylisoxazole-4-carboxylate) in a topical formulation. It is to be understood that other aspects of the present invention will become readily apparent to those skilled in the art from the following detailed description, wherein various embodiments of the invention are shown and described by way of illustration. As will be realized, the invention is applicable for other and different embodiments and its several details are capable of modification in various other respects, all without departing from the spirit and scope of the present invention. Accordingly the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

Brief Description of the Drawings

These and other features and advantages of the present invention will be better understood by reference to the following detailed description of specific embodiments of the present invention and the accompanying drawings. It is understood that the embodiments shown in the drawings are intended for illustrative purposes and are not to be considered limiting on the present invention. In the drawings:

Figure 1 is an exploded perspective view of a first embodiment of the present invention. Figure 2 is side cross-sectional view of an embodiment of the dispensing device of Figure 1 in the closed position.

Figure 3A is a perspective view of an embodiment of the dispensing device of Figure 1 in an open position and Figure 3B is a perspective view of the same embodiment of a dispensing device in the closed position. Figure 4A is an underside view of the cover of a dispensing device according to the dispensing device of Figure 1 and Figure 4B is a side cross-sectional view through the line Y— Y of the same cover.

Figure 5A is a cross-sectional view through the line X— X of the dispensing device in Figure 2. Figure 5B is a detail of the rim and cover of Figure 5A. Figures 6A-6C are perspective views of a series of different embodiments of dispensing devices similar to that in Figure 1 , but containing more than one dispensing recess on the dispensing surface of the support structure.

Figures 7A and 7B are perspective views of an embodiment of a dispensing system containing a plurality of dispensing devices of Figure 1 . Figure 8 is a plan view of an alternative embodiment of the support structure of a dispensing device according to an embodiment of the present invention.

Figures 9A-9E are plan views and side elevations of variations of the projecting tabs, support structures, gripping recesses and covers of the dispensing devices of Figure 1 . Figures 10A-1 OH are perspective views of further embodiments of the dispensing device of Figure 1 with different shaped dispensing recesses.

Detailed Description of the Invention

According to the present invention and as is shown in an exemplary embodiment in Figure 1 , there is provided a dispensing device 10 for a topical solution. This dispensing device comprises a support structure 12 having a dispensing surface 14 and a dispensing recess 16 disposed within the dispensing surface 14. There is further provided a cover 18 adapted to cover at least a portion of the dispensing surface 14 and the dispensing recess 16. Dispensing device also comprises a base 20 and a flexible member 22 which may or may not be connected to or form a portion of cover 18. The exemplary embodiment of Figure 1 is designed to be substantially different in appearance and different in function to structures which are used for dispensing contact lenses. The skilled person will recognise that it would be undesirable for the dispensing device to have the same appearance as contact lenses for safety reasons. If the dispensing device 10 were similar in appearance to contact lens dispensers known in the art, a user might risk applying a potent pharmaceutical product intended for the topical application into the eye. The outward

appearance of dispensing device 10 is designed in such a way that it does not resemble contact lenses, and the operation is very different as a result of the provision of the dispensing surface 14, dispensing recess 16 and cover 18 in combination.

In the depicted embodiment, base member 20 and support structure 12 comprise two snap-fit components which form an integral body when the dispensing device 10 is assembled.

Alternatively the dispensing device 10 does not require base component 20 and support structure 12 to join together by a snap-fit. They could be joined together by any joining method, such as adhesive glue, melting, welding or some other joining mechanism. Further the two separate components could be formed integrally as a single support structure component 12 and not require any joining at all. The use of two separate components in this example is for ease of fabrication. The dispensing device 10 of the embodiment of Figure 1 contains two gripping recesses 24, 26. This embodiment is not limiting and the dispensing device may contain one or more gripping recesses disposed on either the support structure 12 or base 20 to aid in gripping of the device. In the present embodiment, the two gripping recesses 24, 26 are disposed on adjacent sides of support structure 12 and base 20 as shown in Figure 1 . The two recesses shown are adapted to be gripped by a finger and thumb, but the recesses could straightforwardly be adapted to be gripped by two or more fingers. Alternatively, the recesses could be disposed on non-adjacent sides or on the same side of the support structure and base and still achieve an enhanced grip.

In the exemplary embodiment, cover 18 collectively comprises three cover components (shown further in Figure 3A and Figure 4A): a flexible cover component 32 and two cover components 36, 38. Cover component 38 further comprises a projecting tab 28. However, the number of cover components is not limiting. Furthermore, the use of one or more flexible cover

components is also not limiting. For example, in an alternative embodiment, the cover 18 may comprise a single cover component. In a further alternative embodiment, the cover 18 may comprise a single flexible cover component. The arrangement of the cover components 32, 36 38 will be described in further detail below.

In the depicted embodiment, flexible cover component 32 comprises four guides 25. The guides 25 are for guiding the positioning of flexible cover component 32 during fabrication of dispensing device 10. For example, they allow correct positioning of flexible cover component 32 within a mould. Alternative embodiments could have a different number of guides or no guides at all.

Figure 2 shows a side profile of exemplary assembled dispensing device 10 in the closed position. Support structure 12 and base 20 are snapped together. Cover 18 closes dispensing recess 16 and gripping recesses 24 and 26 are shown. Gripping recess 26 is shown with a retaining surface 27 (such as a fillet) to enhance further the ability of a user to grip the dispensing device. The use of a retaining surface 27 is an optional feature which could be applied to any of the gripping recesses. The retaining surface 27 may be a resilient surface.

As is shown in Figure 1 and in Figure 2, there is further provided a projecting tab 28 adapted to assist the opening of cover 18. In the present embodiment, the projecting tab 28 projects over gripping recess 24 and comprises a portion of cover component 38. The function of the projecting tab 28 is to aid in the user in opening the device. Positioning the projecting tab 28 over a recess can aid the user in getting a finger or thumb under the projecting tab 28 to assist opening. Alternatively, the projecting tab 28 may project over one or more other recesses or over one or more other edges of the support structure 12 or base 20. The projecting tab 228, cover 218, support structure 212 and gripping recesses 224 can have variety of further configurations as shown in the various embodiments of the dispensing device 10 in Figure 9 and will be described in detail later.

As is shown in Figure 1 and more clearly in Figure 3A, the dispensing surface 14 of the dispensing device 10 may further comprise a rim 30 surrounding the dispensing recess 16. The rim 30 protrudes above the dispensing surface 14 and aids in the access of the topical solution once dispensing device 10 is open. Cover 18 comprises a recessed portion 34 for receiving rim 30 when the cover 18 is in the closed position. In one embodiment, this recessed portion 34 is collectively defined by flexible cover component 32 and cover components 36, 38.

The rim 30 may be a continuous rim as is shown in Figure 3A, or may feature one or more notches along its surface. The recessed portion 34 may be a continuously recessed portion as is shown in Figure 3A, or may comprise a series of recessed and non-recessed portions adapted to be complimentary to the one or more notches of the rim. In the closed position shown in Figure 3B, the rim 30 and recessed portion 34 are aligned.

As is shown in Figure 3B, both the dispensing surface 14 and the dispensing recess 16 are covered by the cover 18 in the closed position. In alternative embodiments, the entire dispensing surface 14 would not be covered in the closed position; however access to the topical solution is still prevented in the closed position. However, covering dispensing surface 14 may prevent any contamination of the topical solution during dispensing as the solution may otherwise contact an exposed portion of the dispensing surface 14 during dispensing. When the cover 18 is in the open position, the topical solution contained within the dispensing recess 16 on the dispensing surface 14 is accessible to the user.

Cover 18 may comprise one or more frangible joins between the cover 18 and another part of the dispensing device 10. Upon moving the cover from the closed position to the open position, one or more of the frangible joins may break. The joins may be heat-sealed, welded, adhesively attached. Such joins may comprise an anti-tampering mechanism for dispensing device 10, whereby one or more compromised joins indicates possible tampering with the dispensing device 10 or the topical solution contained within.

In the depicted embodiment, cover 18 comprises three components 32, 36, 38, of which cover component 32 comprises a flexible cover component. At least one of the cover components prevents access to the dispensing recess 16 in the closed position. The invention requires only a cover 18, which may not comprise multiple components. However, if there are one or more cover components, then at least one cover component at least partially covers the dispensing recess 16 when in the closed position. If two or more cover components are used, the two or more cover components may be connected to each other using a further cover component, may be integral with at least one further cover component, or may have a frangible connection with at least one further cover component, and may comprise the flexible cover component.

Collectively the two or more cover components prevent access to the topical solution in the dispensing recess 16 in the closed position, and permit access to the topical solution in the dispensing recess 16 in the open or partially open position. The two or more cover components may comprise the same material, or of different materials. Cover 18, comprising one or more cover components as described herein, is adapted to prevent the release of the topical solution from the dispensing recess 16 (for example, by evaporation) when cover 18 is in the closed position. In the depicted embodiment in Figure 2, when dispensing device 10 is in the closed position, rim 30 and flexible cover component 32 of cover 18 may aid in preventing the release of the topical solution by assisting in creating a seal.

In the depicted embodiment in Figures 1 , 3A-B and 4A-B, the cover 18 comprises three cover components 32, 36 and 38. In this embodiment, one of the cover components comprises a flexible cover component 32 joined to the two other cover components 36 and 38. In this embodiment, cover component 36 is positioned substantially within the rim 30 of the dispensing recess 16 in the closed position as is further shown in Figures 5A and 5B, whereas cover component 38 substantially surrounds both the dispensing recess 16 and cover component 36 in the closed position, and cover component 36 in the open position. The flexible cover component 32 directly abuts with the rim 30 as is shown in Figures 5A and 5B. Cover component 38 abuts the dispensing surface 14 of dispensing device 10. Alternatively, one or more other components may directly abut the rim 30 or dispensing surface 14. Direct abutment is not required, and positioning the cover components over the dispensing recess 16 and the dispensing surface 14 in the closed position is sufficient to prevent access to the topical solution.

In the embodiment of Figures 5A-B, the flexible cover component 32 is joined by injection mould labeling to the cover components 36 and 38 and may maintain the relative configuration of cover components 36 and 38 in the closed and open positions. Alternative joining mechanisms for joining flexible cover component 32 to cover components 36 and 38, such as adhesively (for example by a solvent or glue), welding or heat sealing, would also be suitable. Alternatively, the relative configuration of the cover components 36 and 38 may change in the open position, or during the movement between the closed position and the open position. In the present embodiment, flexible member 22 is adhesively joined to flexible cover component 32.

Alternatively, flexible member 22 could be joined to one or more other cover components. Alternative joining mechanisms are suitable, such as moulding, welding or heat-sealing. In the exemplary embodiment, flexible member 22 forms a label for dispensing device 10.

However, one or more of flexible cover component 32 and flexible member 22 may comprise a label and may comprise a flexible foil. Flexible member 22 may be attached to one or more of the support structure 12, the base 20, the dispensing surface 14 and the cover 18, or to another part of dispensing device 10. In the present embodiment shown in Figure 1 and Figure 2, the flexible member 22 is attached to the cover 18, the base 20 and the support structure 12 but other configurations are possible. In some embodiments, the connection between the flexible member 22 and the other components to which the flexible member 22 is attached may be a frangible or partially frangible connection. As shown in Figure 2 and in Figure 5A, the dispensing recess 16 of dispensing device 10 when viewed from the open side has a substantially hemi-ellipsoidal shape and may have elongated side portions. When viewed through a cross section taken in a direction from its open side to its base at the elongated side portion along line X— X of Figure 2, as is shown in Figure 5A, the cross-section is substantially U-shaped. This shape of the dispensing recess 16 is optimised to ensure that all topical solution is removable without spillage. Other shapes are possible, such as those shown in Figure 10 (which will be referred to later). Furthermore the dispensing recess 16 can be adapted to the users, for example users with larger fingers may require a deeper dispensing recess 16. The function of the dispensing recess 16 is to hold the topical solution when the dispensing device 10 is closed, and provide easy access to the topical solution as it is dispensed with the minimum of wastage.

Figures 6A-C show a series of embodiments of a dispensing device 10, wherein the dispensing surface 14 contains an additional dispensing recess 16. Further embodiments with yet further dispensing recesses 16 would also be possible. In the embodiment of Figure 6A, all the dispensing recesses 16 are covered by cover 18. In the embodiment of Figure 6B, the dispensing recesses are covered by a cover 18 comprising multiple cover sections 18A, 18B. These sections may be joined such as by a flexible member 22, and the join may be frangible. Each cover section 18A, 18B comprises multiple cover components 32, 36, 38, (of which 32 may be a flexible cover component) wherein one or more cover components 32, 36, 38, when opened, reveal a dispensing recess 16 and a dispensing surface 14. The multiple cover components 32, 36, 38 may be joined as shown in Figure 6B (any join may be frangible).

Alternatively each section 18A, 18B comprises only a single cover component, and together the sections 18A, 18B make up cover 18. The individual cover sections need not comprise the same type or number of cover components, but may do so. In a further alternative arrangement, there are multiple covers 18 (each may comprise multiple components 32, 36, 38) as shown in Figure 6C. The individual covers need not comprise the same type, number of cover components or sections, but may do so. Additional configurations of the cover components are possible and those shown in Figures 6A, 6B and 6C are exemplary only. In these embodiments, there may further be frangible or partially frangible joins as described herein, between one or more cover components 32, 36, 38 and the remainder of the dispensing device 10, one or more cover sections 18A, 18B and the remainder of the dispensing device 10, or one or more covers 18 and the remainder of the dispensing device 10, or a combination thereof, as appropriate.

The topical solution contained in the dispensing device of the exemplary embodiment is Ingenol Mebutate. Alternatively the topical solution may comprise Ingenol 3-(3, 5-diethylisoxazole-4- carboxylate). However the dispensing devices 10 are suitable for any pharmaceutical product in a topical formulation. The mass of the topical solution to be dispensed is less than 0.5g but other masses less than 5g are possible.

In the present embodiments, the cover components 36, 38, base 20 and the support structure 12 comprise high density polyethylene and/or cyclic olefin copolymer (COC). Alternative embodiments may use a variety of suitable materials, provided they do not contaminate, leak or otherwise react with the topical solution. The flexible cover component 32 comprises soft aluminium foil, but various other materials would also be suitable. Flexible member 22 may be aluminium foil, paper, or any other material that may be suitably attached to support structure 12 and cover 18 (via one or more cover components 32, 36, 38). If comprising a label, flexible member 22 may be adapted to be printed upon. In a further embodiment, a dispensing system 1000 comprising a plurality of the dispensing devices 10 is shown in Figures 7A and 7B. In this embodiment, a plurality of dispensing devices are joined to each other by a frangible connection 1002 between the support structures 12 of each dispensing device 10. Breaking or partially breaking the frangible connection 1002 permits a dispensing device 10 to be separated from the neighbouring dispensing devices 10.

Alternatively, the connection 1002 between one dispensing device 10 and its neighbour need not be frangible. In further alternatives, the connection 1002 could be between other parts of the dispensing devices 10, for example the covers 18.

Figure 8 shows yet a further embodiment of the dispensing device 1 10 comprising a

substantially teardrop-shaped dispensing recess 1 16 and a support structure 1 12 according to the present invention. The teardrop-shaped dispensing recess is adapted to aid in removal of the topical solution when the cover 1 18 (not shown) of the dispensing device 1 10 is in the open position. According to further embodiments of the invention shown in Figures 9 and 10, there is disclosed a single-use dispensing device 10 comprising: a blister comprised of a support structure 212, a dispensing surface 214 and a dispensing recess 216; a removable lid or foil or combination thereof forming a cover 218 for the dispensing device 10; and a bottom section 220, wherein the single-use dispensing device is used for safe storage and patient friendly administration of small amount of a liquid pharmaceutical product for topical use ensuring minimal waste.

The liquid pharmaceutical product includes any semi-solid pharmaceutical products like gels, lotions, creams, ointments, suspensions etc.

Packaging of the single-use contact lenses a blister is known in the art; these packages allow a user to easily access the contact lens by using one finger. The contact lens is stored in indentions in a sheet comprising a suitable material and maintained wet in a liquid-filled recess (referred to as a blister), which is closed by a foil or a lid. The recess allows the user to access the contact lens due to the larger size of the opening.

The dispensing device 10 of this further embodiment discloses a new use of a storage system like the contact lens storage. Furthermore, the blister developed for holding a liquid

pharmaceutical product is designed so it differentiates both with respect of appearance and in functionality compared to single-use contact lenses. It is highly important that the invention does not have the same appearance as contact lenses due to safety reasons and the risk of applying a potent pharmaceutical product intended for the topical application into the eye. The dispensing device 10 is designed in such a way that it does not resemble a container for contact lenses. Like the contact lens storage, the dispensing device 10 can be closed by a cover 218 comprising a lid, a removable foil or combination thereof. In prior art contact lens systems, the blisters are cast with supports allowing the entire contact lens container to stand freely and allowing the user to use both hands for application.

In order to increase safety and minimize risk of waste of a potent pharmaceutical product, grip grooves 223 are applied on the side of the blister of this embodiment of the dispensing device 10 and a gripping recesses 224, 226 in the bottom 220 and in the front of support structure 212 ensure improved grip as well as aiding in opening of the blister together with a protruding tab 228. Furthermore, the dispensing recess 216 of the dispensing device 10 holds and allows the user to access the pharmaceutical product. The dispensing recess 216 is adapted to minimize the risk of obtaining product under the finger nail and still be suitable for width fingers to take out the product in a safe manner. Figure 9 shows a series of variations of the shape of projecting tab 228, the gripping recess 224, support structure 212, bottom section 220 and the cover 218 of dispensing device 10. The variations are alternatives for the dispensing device 10 of Figure 1 , which is repeated in Figure 9A for reference. Figure 9B comprises an alternative projecting tab with a substantially semi-circular shape and an alternative gripping recess 224 which provides continuity of movement for the finger during opening. Figure 9C comprises an alternative projecting tab 228 with a substantially semi-circular shape which is elevated with respect to the plane of the cover 218, and a gripping recess 224 as in Figure 1 . Figure 9D shows yet a further alternative projecting tab 228 similar to that of Figure 1 but with a in increased lateral extent, wherein the gripping recess 224 is adapted for users with larger fingers or thumbs. Figure 9E shows a further alternative projecting tab 228, projecting over the edge of support structure 212. In an alternative embodiment, a sheet of blisters similar to those used for the packing of tablets, capsules etc. in the pharmaceutical industry can be provided. The blister sheets contain a number of individual recesses 216, which are covered by one or more closing foils 218.

Whereas the administration of tablets and capsules are performed by the user, by pressing the tablet or capsule through the closing foil, in this embodiment of the present invention, during dispensing, the closing foil 218 is moved to its open position and the topical formulation can be accessed from the dispensing recess 216 by a fingertip. Again, the large opening in the blister sheets which provides a dispensing surface 214 allows for easy access to the small amount of pharmaceutical to be administered and the blister sheets and dispensing recess 216 can be designed in such a way so the product can be taken out in a safely manner with a minimum of waste insuring the correct dose.

Figure 10 shows a series of embodiments of the dispensing device 10 of Figure 1 , with a variety of shapes of dispensing recess 16. Figure 10A shows a support structure 212 containing a dispensing surface 214 and a substantially half-egg-shaped dispensing recess 216 with a capacity of about 0.71 ml or about 1 .09ml. Figure 10B shows a support structure 212 containing a dispensing surface 214 and a substantially hemi-ellipsoidal-shaped dispensing recess 216 with elongated edges and with a capacity of about 0.70ml or about 1 .10ml. Figure 10C shows a support structure 212 containing a dispensing surface 214 and a substantially hemi-spherical- shaped dispensing recess 216 with a capacity of about 0.71 ml or about 1 .03ml. Figure 10D shows a support structure 212 containing a dispensing surface 214 and a substantially hemi- ellipsoidal-shaped dispensing recess 216 with a capacity of about 0.66ml or about 1 .08ml. Figure 10E shows a support structure 212 containing a dispensing surface 214 and a substantially trapezoidal-shaped dispensing recess 216 with a capacity of about 0.72ml or about 1 .06ml. Figure 10F shows a support structure 212 containing a dispensing surface 214 and a substantially kidney-shaped dispensing recess 216 with a capacity of about 0.69ml or about 1 .07ml. Figure 10G shows a support structure 212 containing a dispensing surface 214 and a substantially hemi-ellipsoidal-shaped dispensing recess 216 with a capacity of about 0.69ml or about 1 .08ml. Figure 10H shows a support structure 212 containing a dispensing surface 214 and a substantially hemi-ellipsoidal-shaped dispensing recess 216 with a capacity of about 0.75ml or about 1 .06ml. Any of these dispensing recesses 216 may be incorporated into the dispensing device 10 of Figure 1 .

The present embodiment provides the use of a dispensing device 10 as described herein, for dispensing single-use, small volume, high potent topical pharmaceutical products in a safe manner whilst ensuring the minimum of waste and the correct dosing. The performance achieved by the dispensing device 10 in this embodiment is outlined in the table below.

Standard tube, 1 ml Blister, 1.10 ml Blister, 1.10 ml

(10G in Figure 10) (10G in Figure 10)

Filled amount 0.490 g 0.250 g 0.461 g

(g)

(target)

mass emptied

from

dispensing 320 tested 12 tested 12 tested

device 0.250 g 0.250 g 0.461 g

0.230 g 0.249 g 0.461 g

Average 0.280 g 0.250 g 0.461 g

Min. - 0.02 % 0.02 %

Max.

Srel (%)

% left over in

dispensing 49 % < 1 % < 1 %

device after

dispensing. By a small volume means an amount of a liquid pharmaceutical product less than 5 g, preferably less than 2g, more preferably less than 1 g and most preferably less than 0.5 g.

In the context of the present invention the pharmaceutical product embraces the active ingredient in a final pharmaceutical formulation. The dispensing device 10 can comprise plastic or composites, the plastic could be selected from polyethylene terephthalate, high-density polyethylene, polyvinyl chloride, low-density polyethylene, EVOH, cyclic olefin copolymer (COC), polypropylene, polystyrene, polyamides, acrylonitrile butadiene styrene, polycarbonate, polyacetal or other suitable thermoplastic polymers. Plastic materials can either be used as homo-polymers, copolymers, or in

combination, fabricated with e.g. multi component injection moulding or by In-Mould Labeling.

In a further embodiment the dispensing device 10 can comprise forming film which is known from traditional blister packaging material for tablets based on aluminium such as hard aluminium foil, soft aluminium foil, paper/aluminium foil combination, paper/PET/aluminium foil laminations any thermoplastic raw material, any mono or multi-layer thermoplastic film which might contain aluminium layer or metalized film or in combination with any of the above mentioned plastic materials.

In further embodiments of the dispensing device 10 of the present invention, the device can be coated with a coating suitable for the pharmaceutical product to be stored.

In an embodiment of the present invention, the product to be stored is Ingenol Mebutate. The product to be stored could also be Ingenol 3-(3, 5-diethylisoxazole-4-carboxylate). The product may be approved in a number of countries for treatment of actinic keratosis. The final product is administered in an isopropyl alcohol containing gel. For the present invention to include the final product containing a high amount of isopropyl alcohol there is a demand for all material, prints, lacquers, glues etc. to be stable in such environment. Furthermore final choice of materials for the dispensing device 10 as well for the cover 218 will be dependent upon compatibility of the product and dispensing device materials in order to obtain a stable product and sufficient product shelf life.

The dispensing device 10 is closed with a lid/cover 218. The lid may optionally be a foil. The foil can comprise hard aluminium foil, soft aluminium foil, paper/aluminium foil combination, paper/PET/aluminium foil laminations any thermoplastic raw material, any mono or multi-layer thermoplastic film which might contain aluminium layer or metalized film. In a further embodiment the lid can comprise plastic, and the plastic could be selected from any one of polyethylene terephthalate, high-density polyethylene, polyvinyl chloride, low-density polyethylene, EVOH, cyclic olefin copolymer (COC), polypropylene, polystyrene, polyamides, acrylonitrile butadiene styrene, polycarbonate, polyacetal or another suitable thermoplastic polymers. These materials can either be used as homo-polymers, copolymers, in combination or in mixtures thereof as could be produced for example by multi component injection moulding or by In-Mould Labeling.

In an embodiment of the dispensing device plastic materials and hard foil, metalized foil or any film combination of one or more thermoplastic film and aluminum or metalized thermoplastic film, or film manufactured as cast film or blown film monolayer from any thermoplastic. Raw materials can be used in combination for example by multi-component injection-moulding or by In-Mould Labeling.

The final choice of the support material and the foil is both selected with respect to product stability issues as well as obtaining a planar cover 218 insuring optimal welding properties, which provide a tight lid and secure a stable product with respect to evaporation.

The device has a bottom section 220 for improving better grip and handling of the dispensing device 10. The bottom section 220 may optionally be a plastic material. In this embodiment of the dispensing device the bottom section 220 comprises high-density polyethylene, but a variety of polymers and copolymers would be suitable. In further embodiments (not shown) the bottom part could alternatively comprise aluminium, paper, or mono/multi-layer thermoplastic films which contain an aluminium layer or metalized film.

The embodiments described herein and shown in the Figures are intended only to be

exemplary, and are not limiting upon the scope of the disclosure. The skilled person will recognise that various alternative configurations not specifically described herein will still fall within the scope of the present invention.

The following is a further, non-exhaustive list of embodiments which may or may not be claimed:

1 . A dispensing device comprising a blister covered with a removable lid or a peel off foil for holding a small volume of high potent liquid pharmaceutical product for topical use. 2. The dispensing device according to embodiment 1 wherein the pharmaceutical product is placed in a foil or lid covered indentation in a sheet of variable size and containing one or more indentions, each indention containing one dosage of the pharmaceutical. 3. The dispensing device of embodiment 1 wherein the blister comprises polyethylene terephthalate, high-density polyethylene, polyvinyl chloride, low-density polyethylene,

polypropylene, polystyrene, polyamides, acrylonitrile butadiene styrene, polycarbonate, polyacetal or other suitable polymers, which materials can either be used as homo- polymers, copolymers, or in combination with e.g. multi component injection moulding or by In- Mould Labeling.

4. The dispensing device of embodiment 1 wherein the blister comprises aluminium or a combination of aluminium and the above mentioned plastic materials.

5. The dispensing devise of embodiment 1 wherein the lid comprises hard aluminium foil, soft aluminium foil, paper/aluminium foil combination, paper/PET/aluminium foil laminations.

6. The dispensing devise of embodiment 1 wherein the lid are form from polyethylene terephthalate, high-density polyethylene, polyvinyl chloride, low-density polyethylene, polypropylene, polystyrene, polyamides, acrylonitrile butadiene styrene, polycarbonate, polyacetal or other suitable polymers or the plastic materials can either be used as homo- polymers, copolymers, or in combination with e.g. multi component injection moulding or by In- Mould Labeling.

7. The dispensing device according to any of the above embodiments, wherein the pharmaceutical product to be administered is less than 2 g, such as less than 1 g, or such as less than 0.5 g. 8. The dispensing device of embodiment 1 wherein the pharmaceutical product is Ingenol mebutate in a topical formulation.