WO2024017545A1

WO2024017545A1 - An applicator system and a blister package for the applicator system

Info

Publication number: WO2024017545A1
Application number: PCT/EP2023/066119
Authority: WO
Inventors: Stella Rudkjaer Rasmussen; Majbritt THORSGAARD; Ebbe Kiilerich
Original assignee: Novo Nordisk A/S
Priority date: 2022-07-19
Filing date: 2023-06-15
Publication date: 2024-01-25

Abstract

The present invention relates to a disposable applicator system for inserting a solid dosage form into a body canal such as a vaginal or rectal canal. The applicator system consists of an applicator unit and a blister pack from which the individual solid dosage forms are picked up by the applicator unit. The applicator unit is geometrically shaped to engage with the cavities in the blister pack and simultaneously also to engage with the solid dosage forms allowing a solid dosage form to be picked up and removed from the blister pack and subsequently applied into the body canal.

Description

AN APPLICATOR SYSTEM AND A BLISTER PACKAGE FOR THE APPLICATOR SYSTEM

THE TECHNICAL FIELD OF THE INVENTION:

The invention relates to an applicator system for inserting a solid dosage form into a body canal, such as a vaginal or rectal canal. The applicator system comprises an applicator unit made up from a hollow elongated hollow tube having a lumen wherein a plunger is movable arranged in combination with a blister package containing the solid dosage form to be applied. With such applicator system it is made possible for a user to pick up a solid dosage form from the dedicated blister package using the appropriate applicator unit and to subsequently insert and release the solid dosage form inside the body canal.

The invention further relates to a blister package for such applicator system and to a method of picking up and inserting the solid dosage form into a body canal, such as the vaginal or rectal canal using the applicator system.

The term Solid Dosage Form (hereafter abbreviated as “SDF”) as used throughout this description is meant to be any kind of suppository, tablet, pill, capsule or the like which is formulated in a solid form and comprises a pharmaceutical or therapeutically active ingredient.

DESCRIPTION OF RELATED ART:

Vaginal or rectal solid dosage forms (SDFs) are used to administer a predetermined drug dosage to treat a variety of diseases or symptoms. To deliver such solid dosage form into the vaginal or rectal canal a variety of different applicator systems has been developed.

WO 1998/01180 discloses a vaginal applicator unit produced and sold by the pharmaceutical company Novo Nordisk A/S under the tradename Vagifem®. In this applicator unit, a hollow tube is formed with distal flexible tongues for securing a solid dosage form such as a suppository and a plunger is slidable mounted inside the hollow tube. Once the hollow tube is placed correctly inside the vaginal canal, the user presses the plunger to thereby release the suppository. Both the hollow tube and the plunger are moulded from a polymer plastic material and the suppository is secured to the distal end of the hollow tube by the manufacturer. This applicator unit is hence pre-loaded and the applicator unit including the attached suppository are packed individually in a blister pack wrapping. In the commercialized version each blister pack has 6 longitudinal cavities, each cavity containing one applicator unit holding one tabletshaped SDF. In use, the user removes the applicator unit from the individual cavity in the blister packing, inserts the distal part of the applicator unit into the vaginal canal, releases the SDF by pressing the plunger and thereafter removes and discards the entire applicator unit i.e. both the hollow tube and the plunger.

By using such pre-loaded applicator units wherein the user disposes each plastic applicator unit after use a large amount of plastic are disposed of on a worldly basis which has a negative impact on the global environment. A common regimen of treatment is to insert one SDF twice every week leading to a high amount of plastic being disposed.

In a different example, a pre-loaded applicator unit is made from paper, paperboard or cardboard. Such a pre-loaded applicator unit is disclosed in US 2,516,846. However, vaginal SDFs are often formulated such that they more easily absorb water and moist to thereby become sticky such that the SDF when inserted into the vaginal canal can better adhere to the vaginal mucosa lining and release the active ingredient. Often the SDFs have a high (up to 75 %) HMPC load i.e. Hydroxypropyl Methylcellulose in order to dissolve properly when in contact with the vaginal mucosa lining and hence release the active ingredient e.g. oestradiol.

Since paper pulp-based materials has a higher water content than polymer plastic materials, the SDF when pre-packed in a paper pulp-based applicator unit will have a higher risk of taking up water from the paper pulp-based applicator unit and stick to the applicator unit which could have a negative impact on the performance of the SDF. Especially, the release of the SDF from the hollow tube could be compromised. This risk increases with longer storage time.

A re-usable pincer-shaped applicator unit for vaginal insertion of a suppository wherein the user manually pre-loads the suppository before use is suggested in US 6,669,703. Such applicator system however has the draw back that the user manually needs to remove the individual suppository from a separate package in which the suppositories are delivered and manually load the individual suppository to the applicator unit which must be carefully cleaned before attaching the suppository. This handling process strongly increases the risk of bacteria being transferred from the fingers of the user and onto the suppository and/or the applicator unit and further to the vaginal canal which hence increases the risk for vaginal infections. Further, moist from the fingers and water from the cleaning could negatively impact the release of the suppository from the applicator unit inside the vaginal canal.

Examples of containers such as blister packs for storing the SDFs are disclosed in US 6,155,423, in US 2005/211 ,597 and in WO 2008/069,960.

DESCRIPTION OF THE INVENTION:

It is henceforth an object of the present invention to provide an applicator system for picking up and inserting a SDF into a body canal such as the vaginal or rectal canal which applicator system can be manufactured from a vide range of natural biodegradable materials and wherein the adherence of the SDF to the applicator unit is removed or at least strongly reduced to thereby improve the release of the SDFs from the applicator unit. It is further an object to simultaneously provide an applicator system wherein transferral of bacteria to the body canal is avoided or at least reduced.

The invention is defined in claim 1. Advantageous embodiments are further defined in the dependent claims. Accordingly, in one aspect of the present invention an applicator system for inserting a solid dosage form (Hereafter “SDF”) into a body canal, comprises:

An applicator unit for inserting into the body canal which applicator unit comprises an elongated hollow tube with a passage extending in a longitudinal direction along a longitudinal axis “X” and having a distal end with a distal opening adapted to engage the SDF and an opposite proximal end, and a plunger slidable mounted in the passage of the hollow tube and adapted to move the SDF distally out of the engagement with the hollow tube upon a force being applied onto a proximal end of the plunger, and

A blister package for storing one or more SDFs and adapted to cooperate with the applicator unit and which blister pack comprises a base part having one or more cavities each containing one SDF and each having an entrance located at an upper surface of the base part, and wherein: the distal end of the hollow tube is insertable through the entrance of the cavity and has an outer dimension allowing the distal end of the hollow tube to enter into the cavity and wherein the distal opening of the hollow tube has an inner dimension allowing the distal opening of the hollow tube to engage the SDF inside the cavity, such that the SDF is engaged by the distal opening of the hollow tube when the distal end of the hollow tube is inserted into the cavity and the SDF is removed from the cavity together with the hollow tube when the hollow tube is subsequently removed from the cavity.

The applicator system basically comprises an applicator unit and a blister package wherein the applicator unit are individually packed without the SDF being attached and the SDFs are packed in individual cavities in the blister pack. When the user wants to apply the SDF to a body canal, the applicator unit is first inserted into the relevant cavity in the blister package whereby the inner dimension of the applicator unit surrounds the SDF such that a frictional grip between the SDF and the inner dimension of the applicator unit is established. The SDF will hereafter be removed from the cavity together with the applicator unit. Once the SDF is attached to the applicator unit, the applicator unit is inserted into the body canal and the SDF is released inside the body canal by the user applying a pressure onto the proximal end of the plunger.

When the applicator unit is delivered without the SDF being pre-attached to the applicator unit it is possible to use a larger variety of different natural materials to produce the applicator unit since moist will not be significantly transferred between the SDF and the applicator unit due to the very limited time the two elements are in contact with each other. Hence, the risk of the SDF adhering to the applicator unit is dramatically reduced. Further, as there is no physical contact between the fingers of the user and the distal part of the applicator unit nor the SDF, there will be no or only very limited contamination of the distal end of the applicator unit or the SDF. Hence, the risk of transferring bacteria to the body canal is strongly reduced.

The blister package containing the SDFs are preferably produced from a thermo plastic material or from a paper pulp-based material. Blister packs are generally made from one or more layers of a thin material laminated together in a sandwich structure. However, for the purpose of the disclosed invention, the blister pack can be made from a thicker material if wanted and form a tray-like package. Each cavity in the blister package wherein only one needs to be provided is covered by a removable or breakable cover foil layer which is typically made from a paper sheet, a plastic sheet or a metal foil. The removable or breakable cover is preferably removed before inserting the applicator unit into the cavity. Alternatively, the applicator unit can be pressed against the removable or breakable cover without removing the cover such that the applicator unit breaks through the cover. This can further be facilitated by providing the cover with a matrix of tear lines or the like making the penetration of the cover by the applicator unit easier

In order to enhance the engagement between the applicator unit and the SDF, the distal end of the hollow tube of the applicator unit is preferably provided with a radial resiliency. In one example this radial resiliency can be created by bending or folding the material making up the hollow tube at least at the distal end and preferably inwardly. The distal part being bended or folded can in one example be bended or folded to a position being approximately parallel to the surface of the hollow tube. However, the fold or bend could also have an open angle to the hollow tube whereby a lager frictional engagement can be accomplished. By open fold is meant that the angle of the folded part is more than 0° (parallel) and below 90° (perpendicular) to the centre axis “X”. In a further example the resiliently can be obtained by having an inner shape slightly smaller than the outer contour of the SDF and provide the hollow tube with axial slits.

Both the hollow tube and the plunger, or each individual of them, can be made from a variety of different natural materials. The materials used are preferably natural materials which can be recycled such as paper pulp-based materials, e.g. paper, paperboard, cardboard, carton or the like. However, other biodegradable materials such as polymers produced from sugar, e-methanol i.e. methanol produced from renewable energy sources such as wind or solar energy or other fossil replacement materials as well as other naturally biological degradable materials could be used. Further, natural materials such as wool, cotton, wood or bamboo could be envisaged. The hollow tube and/or the plunger making up the applicator unit could be coated with a suitable coating which could be a polymer coating e.g. made from a natural biological degradable polymer material or the coating could be made from a vegetable oil product, a sugar product or the like. In one example, only the distal inner surface of the hollow tube contacting the SDF is coated. As an alternative to coating, a film layer could be applied to the inner surface or at least to the distal part of the inner surface of the hollow tube. Such film layer could be produced from any biodegradable material as e.g. referred to above.

As the SDFs are removed from the blister pack using the applicator unit and not the force of the user pressing the blister, the blister pack can be made relatively stiff which encourage the use of a wide range of different degradable materials as mentioned above such as e.g. wood, bamboo, paper pulp materials or the like. As the SDF can have a variety of different shapes, so can the cavities in the blister package. In one example, the cavities in the blister package forms cylindrical compartments having a height “h” or depth measured from the upper surface to the bottom of the cavity. In a different example the cavities in the blister package forms a concave compartment having a height “h” or depth measured from the upper surface to the bottom of the cavities. The height “h” or depth of the cavities are usually the same or larger than the thickness of the SDF located inside the cavities.

In order to secure that the hollow tube of the applicator unit can be correctly inserted into the cavity, each cavity in the blister package can be provided with radial means adapted for positioning the SDF in the cavity, preferably, but not necessarily, in the centre of the cavity. These radial means can in one example be shaped in the material making up the base part of the blister pack and are preferably shaped such that the hollow tube of the applicator unit is able to press the radial means outwardly when being inserted into the cavity. Further, the bottom of each cavity can be provided with one or more raised portions adapted to support the SDF in the cavity. These raised portions are preferably also shaped in the material making up the base part of the blister package.

When the cavity is concave, the concave sidewall slopes and thus indirectly makes up the radial means positioning the SDF.

Each cavity has one, and preferable only one, entrance which is located in the proximity of the upper surface of the blister package. In one example, the entrance has a circular shape defining a cavity inner diameter “DC”. Further, the entrance can be provided with a sloped indentation guiding the hollow tube through the entrance and into the cavity.

In one example, the SDFs provided in the cavities can be circular shaped tablets having a specific diameter “dt” and a specific thickness “t” . The diameter “dt” of the tablets are preferably around 2 to 12 mm more preferably around 4 to 10 mm and most preferably around 6 to 8 mm and the thickness is preferably around 2 to 4 mm and more preferably around 2,8 to 3,2 mm.

Not only can the individual SDF have any form required, the SDF can also be provided in any random position in the cavity. All though the SDF disclosed in the examples are formed as a circular tablet it can easily be shaped as triangular, square, ball, oval, almond, bullet or any shape desired. Further, the individual SDF can be fixated in an upright standing position in the cavity or in a laying down position or in any desired position.

In one specific example, the hollow tube of the applicator unit has an outer tube diameter “DO” at least at the distal end and the distal opening has an inner tube diameter “DI” engaging the SDF. In the embodiments wherein the distal end of the hollow tube is folded, the term inner tube diameter “DI” relates to the inner diameter in the distal folded area. The outer tube diameter “DO” is thus smaller than, or equal to, the cavity inner diameter “DC”, and the inner tube diameter “DI” is substantial the same as the tablet diameter “dt”. By keeping the various diameters within these relations, it is possible to push the hollow tube of the applicator unit into the cavity of the dedicated blister pack and at the same time have the inner diameter of the hollow tube to engage around the diameter of the SDF.

In one example, the various diameters are as follows:

Outer tube diameter, “DO” = 6 to 8 mm.

Inner tube diameter, “DI” = 5,0 to 6,5 mm.

Cavity inner diameter, “DC” = 6 to 8 mm.

SDF diameter, “dt” = 5,5 to 6,5 mm.

SDF thickness, “t” = 2,5 to 3,5 mm.

In a second aspect of the present invention or at least in addition to the invention, a blister package for an applicator unit is provided. In such blister package each cavity is provided with an entrance which is sealed by an individually removable or breakable cover layer at least partly connected to the upper surface of the base part of the blister package. The cover layer is typically made from paper, plastic sheet (including plastic laminated sheet) or a metal foil and is preferably attached to the base part of the blister package by gluing or welding the cover layer to the upper surface of the base part of the blister package. Each cavity is thus fully sealed, but a part of the cover layer outside the cavity can be allowed not to be attached to the base part such that a user can grip this part in order to peel off the cover layer. This non-connected portion or grip part to peel off preferably points away from the outer boundaries of the blister pack. It is thus possible for the user to peel of the cover layer in a direction away from the centre of the blister package. The cover layer is preferably provided with perforations between the cavities to make sure that only one cavity is opened at the time. Fur- ther, the base part of the blister package can be provided with tear lines such that one blister package can divided into smaller units by breaking off one or more cavities.

The non-connected portion or grip part is preferably coloured in a different colour and/or provided with indicia in order to better identify the part to be engaged by the user.

In a third aspect of the invention, a method of picking up and inserting a Solid Dose Form (SDF) into a body canal preferably a vaginal canal using the applicator system is provided. The method comprises using the applicator system as defined in the claims, wherein the method further comprises the steps of:

(i) Removing or penetrating the removable or breakable cover layer on the base part of the blister pack to expose at least one entrance of one cavity,

(ii) inserting the distal end of the hollow tube of the applicator unit through the entrance of the cavity and into the cavity, such that the SDF is received by the distal opening of the hollow tube,

(iii) removing the hollow tube of the applicator unit and the SDF from the cavity,

(iv) inserting at least the distal end of the hollow tube of the applicator unit with the SDF into the body canal,

(v) releasing the SDF from the hollow tube by applying a pressure onto the proximal end of the plunger of the applicator unit,

(vi) Removing the applicator unit from the body canal.

Once the SDF has been deployed in the body canal and the applicator unit has been retracted, the user discards the applicator unit preferably as biodegradable litter such that the applicator unit can be recycled to thereby reduce the impact on the global environment.

The method could alternatively be used to pick up and release a solid dose form (SDF) in other places than into a body canal. The steps of picking up the SDF from the blister pack is hence the same but instead of inserting the distal end of the hollow tube of the applicator unit with the SDF into the body canal, the distal end of the hollow tube can be inserted into or held above an alternative location where the SDF could be released. After the SDF has been released from the hollow tube by applying a pressure onto the proximal end of the plunger of the applicator unit, the applicator unit is disposed of in an environmentally safe manner.

All references, including publications, patent applications, and patents, cited herein are incorporated by reference in their entirety and to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

All headings and sub-headings are used herein for convenience only and should not be constructed as limiting the invention in any way.

The use of any and all examples, or exemplary language (e.g. such as) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention. The citation and incorporation of patent documents herein is done for convenience only and does not reflect any view of the validity, patentability, and/or enforceability of such patent documents.

This invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law.

BRIEF DESCRIPTION OF THE DRAWINGS:

The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which:

Figure 1 Show a perspective view of the applicator system.

Figure 2 Show a perspective view of the applicator unit without the SDF.

Figure 3 Show a cross-sectional view of the applicator unit in figure 2.

Figure 4 Show a perspective view of the blister package.

Figure 5 Show a cut-open view of a part of the blister package. Figure 6 Show a cross-sectional view of a part of the blister package.

Figure 7 show a perspective view of the applicator unit about to be inserted into the blister package.

Figure 8 show a cross-sectional view of a part of figure 7.

Figure 9 show a perspective view of the applicator unit inserted into the blister package.

Figure 10 show a cross-sectional view of a part of figure 9.

Figure 11 A show a perspective view of the applicator unit holding the SDF.

Figure 11 B show a cross-sectional view of a part of figure 11 A.

Figure 12A show a perspective view of the applicator unit releasing the SDF.

Figure 12B show a cross-sectional view of a part of figure 12A.

Figure 13 show the applicator system with the SDF in an upright position

Figure 14 show a cut-open view of the applicator unit about to be inserted into a different embodiment of the blister package.

Figure 15 show an example of a concave cavity.

Figure 16A-B show a different example of a blister package shown with (16A) and without

(16B) the cover layer.

The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts.

DETAILED DESCRIPTION OF EMBODIMENT: When in the following terms as “upper” and “lower”, “right” and “left”, “horizontal” and “vertical”, “clockwise” and “counter-clockwise” or similar relative expressions are used, these only refer to the appended figures and not necessarily to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as their relative dimensions are intended to serve illustrative purposes only.

In that context it may be convenient to define that the term “distal end” in the appended figures is meant to refer to the end of the applicator unit supporting the SDF in use, whereas the term “proximal end” is meant to refer to the opposite end as depicted in figure 2 and in figure 3. Distal and proximal are meant to be along an axial orientation extending along the longitudinal axis “X” of the applicator unit as also shown in figure 2 and figure 3. As disclosed in figure 8 and in figure 10 the longitudinal axis “X” is also used as a reference axis for the cavities in the blister pack.

In the following example the abbreviation “SDF” is used for Solid Dosage Form, which is meant to be any kind of suppository, tablet, pill, capsule or the like which is formulated in a solid form and which comprises a pharmaceutical or therapeutically active ingredient.

When referring to clock-wise and anti or counter clock-wise in the following examples it is understood that the applicator unit is viewed from a position distal to the unit. Clock-wise is thus a rotation following the arms on an ordinary clock and counter clock-wise is a rotation towards in the opposite direction.

To explain the various movements which take place in the handling process described in the example, the following terminology are used throughout the following detailed description;

“Translational movement” is meant to be a strictly linear movement without any rotation.

“Rotational movement” is any movement of rotation around a centre which centre can be a centre point i.e. in one planar or a centre axis i.e. having a longitudinal extension.

“Axial movement” means any movement in an axial direction. Such movement can be a strictly translational movement or include a rotational movement which thus makes it a “Heli- cally movement” as this is meant to be the combination of an axial movement and a rotational movement.

“Telescopic” is meant to cover the situation in which a movable element moves out from, and/or into, a base element. The telescopic movement can be either translational or include a rotation thus making the telescopic movement helical.

The applicator system disclosed in figure 1 comprises a number of applicator units 10 which is individually wrapped in a paper wrapping 40 and a blister package 50 containing one or more SDFs 70. The individually paper wrapping 40 is similar to the type used for drinking straws and similar products and is removed prior to inserting the hollow tube 20 of the applicator unit 10 into the cavity 52 in the blister pack 50 as will be explained.

The applicator unit 10 which is disclosed without the paper wrapping 40 in figure 2 and in figure 3 comprises an elongated hollow tube 20 having a distal end 21 and a proximal end 23. Between the two opposite ends 21 , 23 the hollow tube 20 has an internal longitudinal passage 24 along the centre axis “X” wherein a movable plunger 30 is arranged as will be explained. One applicator unit 10 thus comprises one hollow tube 20 with one movable plunger 30 inserted into the hollow tube 20.

Both the hollow tube 20 and the plunger 30 are preferably made from a paper pulp-based material like e.g. paper, carton, paperboard or cardboard. In one embodiment, both the hollow tube 20 and the plunger 30 are preferably made from three or more layers of paper which are rolled, preferably spiral wounded onto a mandrel, to thereby form stiff longitudinal tubes.

The internal longitudinal passage 24 is in one example coated on the inner surface or a film layer is applied. In a further example only the inner surface at the distal end 21 physically contacting the SDF is covered by the coating or the film layer.

The distal end 21 is provided with a distal opening 22 which is shaped to frictionally grip the SDF 70 as will be explained.

The movable plunger 30 is slidable arranged inside the passage 24 of the hollow tube 20 and has a proximal end 31 which extend out from the proximal end 23 of the hollow tube 20. The distal end 32 of the plunger 30 preferably abuts the SDF 70 when such is mounted to the hollow tube 20 as will be explained. The figures disclose the plunger 30 as being hollow, however, it could be solid or partly solid with the same functionality. In the disclosed embodiment, both the proximal end 31 and the distal end 32 of the plunger 30 has been folded to almost close off the inner of the plunger 30. However, a minor opening is maintained in both ends 31 , 32.

The blister pack 50 disclosed in figure 4, 5 and 6 is formed as a base part 51 in which a number of cavities 52 are formed. Each cavity 52 preferably houses one SDF 70. All though a plurality of cavities 52 are usually present as disclosed in figure 4 only one cavity 52 needs to be provided. The base part 51 has an upper surface 53 to which a removable cover layer 60 is attached. Each cavity 52 has an entrance 54 at the upper surface 53 of the base part 51 and lies along the centre axis X when the applicator unit 10 is being inserted as best seen in figure 8 and in figure 10. The entrance 54 is revealed when the cover layer 60 is removed and is preferably the only opening into the cavity 52. The removable cover layer 60 is attached to the upper surface 53 of the blister pack 50 after the SDF 70 has been placed into the cavity 52 and is preferably attached to the upper surface 53 using glue or welding. The removable cover layer 60 is typically made from a thin paper sheet, plastic sheet or metal (e.g. AL) foil. A grip part 61 of the removable cover layer 60, preferably a grip part 61 pointing away from the outer parameters of the blister pack 50 is in one example not fully attached to the upper surface 53 which allows the user to grip the grip part 61 of the cover layer 60 and peel it off in a direction away from the centre of the blister pack 50. This grip part 61 can be coloured in a different colour as indicated on figure 4, or alternatively be provided with some kind of indicia e.g. an arrow indicating where and in which direction to pull. In order to ensure that only one cavity 52 is exposed at the time, the cover layer 60 is preferably provided with perforations 62 between the cavities 52.

As disclosed in figure 5 and in figure 6, the cavities 52 can in one example be provided with support protrusions 55 on the sidewalls of each cavity 52. These support protrusions 55, of which three or more would usually be provided, support the individual SDF 70 in a centre position inside the cavity 52. The support protrusions 55 are preferably shaped into the material making up the base part 51 of the blister pack 50. Further, the bottom of the cavities 52 can be provided with a similar raised portion 58 as indicated in figure 5. The base part 51 of the blister pack 50 is in one example made from a thermo plastic material by moulding or by pressing/punching the cavities 52. The height “h” or depth of the cavities 52 measured from the inside of the bottom to the upper surface 53 are usually the same or slightly larger than the thickness “t” of the SDF 70 (see e.g. figure13). The support protrusions 55 are made as very thin tracks or ridges formed in the thermo plastic material making up the blister pack 50. In a different example, the blister pack 50 is made from a paper pulpbased material as the applicator unit 10.

Further, as also seen in figure 3, the hollow tube 20 is at the distal end 21 provided with an inwardly fold 25 which increases the friction to the SDF 70 when such is mounted. This inwardly fold 25 can be made as a radially open fold as disclosed in figure 14. By open fold is meant that the fold 25 is not fully parallel to the inner surface of the hollow tube 20.

The cavities 52 can be shaped as concave cavities 52 as also disclosed in figure 14. The angle of the concave wall is preferably in the area of more than 0° and less than 30° in relation to the centre axis “X”. When the cavities 52 are concave, the SDF 70 is self-centred and there is no need for support protrusions as seen in figure 14. Further, the bottom of each cavity can be rounded which further increases the ability of the SDF 70 to self-centre in the cavity 52. This is illustrated in figure 15 which also indicates the SDF diameter “dt”. The concave shape thus centres the SDF 70 and makes room for the hollow tube 20 of the applicator unit 10 to enter into the cavities 52.

A short distance from the distal end 21 of the hollow tube 20, a small circular embossment 26 is made in the outer surface which embossment 26 on the inside of the hollow tube 20 fric- tionally secures a ring-shaped valley 33 on the plunger 30 such that the plunger 30 is releasable secured to the hollow tube 20 in a specific position.

The SDF 70 illustrated in the examples are shaped as a circular tablet having an outer diameter “dt” and a thickness “t” as illustrated in figure 14. However, many different shapes of the SDF 70 can be imagined. When the SDF 70 is shaped as a circular tablet, the inner diameter “DC” of each cavity 52 in the blister package 50 would be larger than the diameter “dt” of the tablet in order to allow the hollow tube 20 to be inserted into the cavity 52.

When a user wants to apply a SDF 70, the cover layer 60 is peeled off from one cavity 52 as disclosed in figure 7 and figure 8, whereafter the user inserts the distal end 21 of the appli- cator unit 20 through the entrance 54 and into the cavity 52 as disclosed in figure 9 and figure 10. The distal end 21 of the hollow tube 20 has an outer diameter “DO” which allows the hollow tube 20 to enter into the cavity 52 and an inner diameter “DI” which inner diameter “DI” of the hollow tube 20 engages around the SDF 70. This is best seen in figure 14 wherein the inner diameter “DI” of the hollow tube 20 can either be the inner diameter of the full hollow tube 20 when no fold 25 is present, or it can be the inner diameter “DI” of the distal folded part when a distal fold 25 is present. All together “DI” represents the inner diameter of the hollow tube 20 at the distal end 21, which inner diameter engages the outer diameter “dt” of the SDF 70.

When the hollow tube 20 is inserted into the cavity 52, the hollow tube 20 presses the support protrusions 55 outwardly such that the hollow tube 20 can engage around the SDF 70 as disclosed in figure 10. For this purpose, the support protrusions 55 are rather small and flexible.

In order to increase the friction between the SDF 70 and the hollow tube 22, the hollow tube 20 is preferably at the distal end 21 provided with friction increasing means. In the example provided in the figures these means are disclosed as an inwardly fold 25 wherein the most distal part of the hollow tube 20 is folded inwardly, hence the inner diameter DI being the inner diameter of the fold 25 if such is present. In an alternative example, the friction increasing means could be longitudinal slits in the hollow tube 20. However, many different solutions can be envisaged.

Figure 11A-B, discloses the situation wherein the applicator unit 20 has been removed from the blister pack 50 and the resiliency in the material of the hollow tube 20 engages and holds the SDF 70.

Once the SDF 70 has been engaged and secured by the hollow tube 20 of the applicator unit 10, the applicator unit 20 is inserted into the body canal wherein the SDF 70 is to be deposited. The hollow tube 20 can be provided with markings 27 on the outside surface to indicate the depth in which the SDF 70 should be released inside the body canal. These markings could also facilitate a better grip on the applicator unit 10.

Once inserted into the body canal, the user releases the SDF 70 by pressing the plunger 30 in the distal direction as disclosed in figure 12A-B. This releases the SDF 70 from the appli- cator unit 20 which can thereafter be retracted and discarded. Due to the embossment 26 and the valley 33 in the plunger 30, a tactile response is provided to the user as the plunger 30 releases from the hollow tube 20 thus indicating the release of the SDF 70 from the applicator unit 10.

The applicator system as e.g. disclosed in figure 7 and in figure 9 thus consist of one or more blister packs 50 containing a plurality of SDFs 70 individually packed in the cavities 52 together with a plurality of applicator units 10 individually packed in a paper wrapping 40 as disclosed in figure 1. The user is then able to use one SDF 70 and one applicator unit 10 at the time, and to perform the insertion of the SDF 70 into the body canal without physically touching neither the SDF 70 nor the insertable distal end 21 of the hollow tube 20. Hence, neither the distal end 21 of the hollow tube 20 nor the SDF 70 is being contaminated by bacteria prior to the SDF 70 being deposited into the body canal.

Figure 13 discloses an alternative example wherein the SDFs 70 are positioned upright in the cavities 52 such that the longitudinal axis “X” of the applicator unit 10 runs perpendicular to the diameter dt” of the circular tablet-shaped SDF 70. In this example, the support protrusions are shaped as an inwardly support fold 56 which secures the circular tablet-shaped SDF 70 in its upright position. These inwardly support folds 56 can be provided in any suitable numbers but at least two are preferably provided. Upon insertion of the hollow tube 20 into the cavity 70, the distal end 21 of the hollow tube 20 presses these support folds 56 outwardly such that the distal opening 22 is able to engage the SDF 70.

The inner diameter “DI” of the distal opening 22 of the hollow tube 20 is in this example adjusted to a dimension determining the axial position of the SDF 70 in the hollow tube 20. Generally, by adjusting the physical dimension of the distal opening 22 of the hollow tube 20 a large variety of different shapes of the SDF 70 can be accommodated for. A circular tabletshaped SDF 70 is only one example of such shape. Both the SDF 70 and the hollow tube 20 could be square, tri-angled or any wanted shape. Further, the inwardly fold 25 defining the inner diameter “DI “of the hollow tube 20 can be more or less folded in relation to the centre axis “X”.

The blister package 50 having concave cavities 52 is disclosed in figure 16A-B. The grip part 61 is easily identified by the user due to the larger size. When a user wants to get access to the individual SDF 70, the grip part 61 is peeled off in a direction away from the cen- tre of the blister pack 50 and the perforations 62 guards that only one cavity 52 is opened at the time.

In figure 16B, the blister pack 50 is disclosed without the cover layer 60. The base part 51 can also be provided with tear lines 59 matching the perforations 62 of the cover layer 60 such that the user can break off any number of cavities 52 and hence does not need to travel with the full blister package 50.

Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these but may be embodied in other ways within the subject matter defined in the following claims.

List of Parts:

Claims

CLAIMS:

1. An applicator system for inserting a SDF (70) into a body canal, comprising:

An applicator unit (10) for inserting into the body canal comprising an elongated hollow tube (20) with a passage (24) extending in a longitudinal direction along a longitudinal axis (X) and having a distal end (21) with a distal opening (22) adapted to engage the SDF (70) and an opposite proximal end (23), and a plunger (30) slidable mounted in the passage (24) of the hollow tube (20) and adapted to move the SDF (70) distally out of the engagement with the hollow tube (20) upon a force being applied onto a proximal end (31) of the plunger (30), and

A blister package (50) for storing one or more SDFs (70) and adapted to cooperate with the applicator unit (10) and which blister pack (50) comprises a base part (51) having one or more cavities (52) each containing at least one SDF (70) and each having an entrance (54) located at an upper surface (53) of the base part (51) and wherein the distal end (21) of the hollow tube (20) is insertable through the entrance (54) of the cavity (52) and has an outer dimension allowing the distal end (21) of the hollow tube (20) to enter into the cavity (52) and wherein the distal opening (22) of the hollow tube (20) has an inner dimension allowing the distal opening (22) of the hollow tube (20) to engage the SDF (70) inside the cavity (52), such that the SDF (70) is engaged by the distal opening (22) of the hollow tube (20) when the distal end (21) of the hollow tube (20) is inserted into the cavity (52) and the SDF (70) is removed from the cavity (52) together with the hollow tube (20) when the hollow tube (20) is subsequently removed from the cavity (52).

2. An applicator system according to claim 1 , wherein each cavity (52) is covered by a removable or breakable cover layer (60).

3. An applicator system according to claim 1 or 2, wherein the distal end (21) of the hollow tube (20) is provided with a radial resiliency.

4. An applicator system according to claim 1, 2 or 3, wherein the hollow tube (20) is made from a paper pulp-based material such as paper, carton, paperboard or cardboard or another biodegradable material.

5. An applicator system according any of the previous claims, wherein the plunger (30) is made from a paper pulp-based material such as paper, carton, paperboard or cardboard or another biodegradable material.

6. An applicator system according to any of the claims 1 to 5, wherein the one or more cavities (52) in the blister package (50) forms a cylindrical compartment having a height (h) measured from the upper surface (53) to a bottom of the cavities.

7. An applicator system according to any of the claims 1 to 5, wherein the one or more cavities (52) in the blister package (50) forms a concave compartment having a height (h) measured from the upper surface (53) to a bottom of the cavities (52).

8. An applicator system according to any of the previous claims, wherein the cavities (52) are provided with means (55) adapted for positioning the SDF (70) in the cavities (52).

9. An applicator system according to any of the previous claims, wherein the bottom of the cavities (52) is provided with one (or more) raised portion(s) (58) adapted to support the SDF (70) in the cavity (52).

10. An applicator system according to any of the previous claims, wherein the entrances (54) of the cavities (52) in the proximity of the upper surface (53) have a circular shape defining a cavity inner diameter (DC).

11. An applicator system according to any of the previous claims, wherein the entrances (54) of the cavities (52) are provided with a sloped indentation (57).

12. An applicator system according to any of the previous claims, wherein the SDFs (70) provided in the cavities (52) are circular-shaped tablets having a diameter (dt) and a thickness (t).

13. An applicator system according to claim 12, wherein the hollow tube (20) at least at the distal end (21) has an outer tube diameter (DO) and the distal opening (22) has an inner tube diameter (DI) and wherein the outer tube diameter (DO) is smaller than, or equal to, the cavity inner diameter (DC), and the inner tube diameter (DI) is substantial the same as the tablet diameter (dt).

14. A blister package for an applicator system according to any of the previous claims, wherein each entrance (54) of each individual cavity (52) is sealed by an individually removable or breakable cover layer (60) at least partly connected to the upper surface (53) of the base part (51) of the blister package (50) to seal the interior of the cavity (52) and wherein each individually removable or breakable cover layer (60) is provided with a non-connected portion (61) to peel off which non-connected portion (61) points away from the outer boundaries of the blister pack (50) and which non-connected portion (61) preferably is coloured in a different colour and/or provided with indicia.

15. A method of picking up and inserting a solid dosage form (SDF) into a body canal using the applicator system of any of the previous claims 2 to 13, wherein the method comprises the steps of

(i) Removing or penetrating the removable or breakable cover layer (60) on the base part (51) of the blister pack (50) to expose at least one entrance (54) of one cavity (52),

(ii) inserting the distal end (21) of the hollow tube (20) of the applicator unit (10) through the entrance (54) of the cavity (52) and into the cavity (54), such that the SDF (70) is received by the distal opening (22) of the hollow tube (20),

(iii) removing the hollow tube (20) of the applicator unit (10) and the SDF (70) from the cavity (52),

(iv) inserting the distal end (21) of the hollow tube (20) of the applicator unit (10) with the

SDF (70) into the body canal.

(v) releasing the SDF (70) by applying a pressure onto the proximal end (31) of the plunger (30) of the applicator unit (10),

(vi) removing the applicator unit (10) from the body canal after the SDF (70) is released.