WO2022136957A1

WO2022136957A1 - Apparatus and process for manufacturing a disposable inhaler

Info

Publication number: WO2022136957A1
Application number: PCT/IB2021/059857
Authority: WO
Inventors: Qi Wu
Original assignee: Hollycon Italy Pte. Ltd. - S.R.L.
Priority date: 2020-12-23
Filing date: 2021-10-26
Publication date: 2022-06-30
Also published as: IT202000032354A1

Abstract

A process for manufacturing a disposable inhaler (100), wherein said disposable inhaler (100) comprises an inhaler body (101) and a disposable cartridge (102) connected to the inhaler body (101), said disposable cartridge (102) comprising a hollow cartridge body (103) delimiting a closed cartridge compartment in which a powder dose (32) and an opening grid (104) of the hollow cartridge body (103) are housed. Said process comprises the following steps: (I) supplying a first web-like material (30) along a manufacturing direction (X); (II) forming a plurality of cartridge half-compartments (31) in said first web-like material (30) from step (I), wherein said cartridge half-compartments (31) are recessed with respect to at least one substantially planar perimeter surface (33) of said first material (30); (III) arranging at least one opening grid (104) in each cartridge half-compartment (31) obtained from step (II); (IV) loading a powder dose (32) into each cartridge half-compartment (31) of step (III); (V) supplying a second web-like material (34) superimposed with the cartridge half-compartments (31) of step (IV); (VI) joining the second web-like material (34) of step (V) to the at least one perimeter surface (33) of said first web-like material (30) to obtain a semi-finished web (35) comprising a plurality of closed cartridge compartments; (VII) separating individual disposable cartridges (102) from the semi-finished web (35) of step (VI); (VIII) supplying a plurality of inhaler bodies (101); (IX) connecting each disposable cartridge (102) obtained from step (VII) with an inhaler body (101) of step (VIII) to obtain said disposable cartridge (100). Furthermore, forming an object of the present invention is an apparatus (200) for manufacturing a disposable inhaler (100), configured to implement said process.

Description

DESCRIPTION of the invention having the title:

“Apparatus and process for manufacturing a disposable inhaler'

Forming an object of the present invention is a process for manufacturing a disposable inhaler.

Furthermore, forming an object of the present invention an apparatus for manufacturing a disposable inhaler.

Disposable inhalers for administering doses of medicinal products in powdered form are known in the art. By way of example, document WO 2018/051266 A1 discloses a known disposable inhaler.

Document WO 2018/051266 A1 discloses that a powdered medicinal product cartridge is positioned on a respective disposable inhaler by means of a production line.

Furthermore, document US 2005/053553 A1 discloses a method and dry powder drug of combined doses of powder for the inhalation administration of finely divided dry drug doses.

Following a long and intense research and development activity, the Applicant developed a process and an apparatus for manufacturing a disposable inhaler that are extremely efficient and reliable, capable of automating the complex manufacture of the disposable cartridges of a disposable inhaler, the connection of such cartridges to the respective disposable inhaler and, preferably, also all the subsequent packing steps up to obtaining a finished product. In particular, all the above considering production times, production waste and the reduction of machine downtime.

Therefore, forming an object of the present invention is a process for manufacturing a disposable inhaler, having the characteristics as defined in the attached claims.

Furthermore, forming an object of the present invention is apparatus for manufacturing a disposable inhaler, having the characteristics as defined in the attached claims.

Preferred embodiments of the present invention will be described hereinafter by way of non-limiting example, with the aid of the drawings, wherein:

- figure 1 shows a block diagram of the various stations that form the manufacturing apparatus subject of the present invention, according to a possible embodiment;

- figures 2 to 29 illustrate the various stations or the various semi-finished products at the Roman numerals (respectively numbered from II to XXIX) indicated in figure 1. More precisely:

- figure 2 shows a first supply station, according to a possible embodiment;

- figure 3 shows the first web-like material after passing through the forming station;

- figure 4 illustrates an arrangement station, according to a possible embodiment; - figure 4.A illustrates a grid-supply station, according to a possible embodiment;

- figure 5 shows an enlargement of the area to the right of figure 4;

- figures 6A and 6B illustrate plan views from opposite directions of an opening grid, according to a possible embodiment;

- figures 7, 8, 9: views of a loading station, according to a possible embodiment from different angles;

- figure 10 shows a grinding station, according to a possible embodiment;

- figure 11 shows a second station for supplying the second web-like material, according to a possible embodiment;

- figure 12 shows a first joining station, according to a possible embodiment;

- figure 13 shows a first separation station and a pick-up station, according to a possible embodiment;

- figure 13. A shows a first discarding station, according to a possible embodiment;

- figure 14 shows a bottom view of a disposable cartridge;

- figure 15 illustrates a second unit for storing the inhaler bodies, according to an embodiment;

- figure 16 illustrates a second unit for orienting the inhaler bodies, according to an embodiment;

- figure 17 shows two units for transporting the inhaler bodies, arranged in series, according to an embodiment;

- figure 17.B shows a fourth transportation unit and a connection station, according to an embodiment;

- figure 18 illustrates a top view of an inhaler body 101, without the disposable cartridge;

- figure 19 shows a top plan view of a disposable inhaler subject of the present invention, according to a possible embodiment;

- figure 20 and figure 21 respectively illustrate a compression station and a completion station, according to possible embodiments;

- figure 22 illustrates an inhaler receptacle according to an embodiment;

- figure 23 and figure 23.A illustrate a station for transporting the inhalers inside the inhaler receptacles, according to an embodiment;

- figure 24 shows an assembly of a disposable inhaler in an inhaler receptacle, wherein the receptacle is open;

- figure 25 shows an assembly of a disposable inhaler in an inhaler receptacle, wherein the receptacle is closed by a fourth web-like material;

- figure 26 shows a second joining station, according to an embodiment;

- figure 27 illustrates a second separation and printing station, according to an embodiment;

- figure 27.A shows a detail of the longitudinal weakening lines 82;

- figure 28 shows a third separation station, according to an embodiment; and

- figure 29 illustrates closed receptacles, separated transversely by rows, prior to packaging. With reference to the aforementioned drawings, the reference numeral 200 indicates - in its entirety - an apparatus for manufacturing a disposable inhaler 100.

The disposable inhaler 100 is for example shown in figure 19 in a top plan view.

The disposable inhaler 100 comprises an inhaler body 101 and a disposable cartridge 102 connected to said inhaler body 101. Preferably, the inhaler body 101 and the disposable cartridge 102 are connected in a snap-like fashion.

The inhaler body 101 is preferably a substantially pipe-shaped hollow body.

More preferably, the inhaler body 101 comprises a first portion or housing portion 108 for housing the disposable cartridge 102, and a second portion or dispensing portion 109 for dispensing a content (hereinafter: "powder dose”) of the disposable cartridge 102 into the mouth of a user or patient. For example, the inhaler body 101, without the disposable cartridge, is shown in figure 18 in a top view.

The dispensing portion 109 is therefore fluidically connected to the housing portion 108, and it comprises a free end 109' configured to be arranged in the mouth of the user.

Unless otherwise specified in this description, the substantially pipe-shaped hollow body preferably is made according to the teaching of the prior document WO 2018/051266 A1, in particular as described on page 5, line 12 to page 9, line 4, such passages being considered as fully incorporated in the present description for reference.

The disposable cartridge 102 comprises a hollow cartridge body 103 which delimits a closed cartridge compartment in which a powder dose 32 (only schematically shown in figure 8) and an opening grid 104 of the hollow cartridge body 103 are housed.

The powder dose is preferably a dose of a medicinal product in powdered form.

Preferably, the powder dose consists of a dry powder, more preferably a dry powder by aspiration through the mouth. In the present description the expression "dry powder” means a powder with a moisture content comprised from 0.01% to 20%, preferably comprised from 3.0% to 15%, even more preferably comprised from 3.5% to 12%, for example 4%, 5%, 6%, 7%, 8%, 9%, 10% or 11%, with respect to the total weight of said powder. This moisture content varies as a function of the type or nature of the powder dose contained in the hollow cartridge body 103.

The opening grid 104 preferably comprises a substantially planar annular grid base 105, and a plurality of branches 106 extending moving away from the annular grid base 105 and converging so as to delimit a perforated cap 107. For example, figure 6A and figure 6B illustrate plan views from mutually opposite directions of the opening grid.

The opening grid 104 has the function of ensuring a correct opening of the hollow cartridge body, and of facilitating an outflow of the powder dose from the cartridge compartment 31 in a disintegrated form and, as such, easy to be aspirated by the user of the disposable inhaler. In this description, the expression "correct opening” is used to indicate such when the hollow cartridge body is torn to quantitatively discharge the powder dose 32 into the inhaler body 101, in particular into a drop region 113 of the powder dose delimited by said body 101 (figure 18). More precisely, the drop region 113 is arranged on the bottom of the first portion or housing portion 108.

Preferably, the annular grid base 105 is delimited by a sharp annular edge 110 or it is provided with a sharp edge.

The manufacturing apparatus 200 comprises - arranged in series - a first station 1 for supplying a first web-like material 30 along a manufacturing direction X, a forming station 2, an arrangement station 3, a loading station 5, a second station 8 for supplying a second web-like material 34, a first joining station 9, a first separation station 10, a third supply station 13, and a connection station 14.

In the present description, the expression "manufacturing direction X” is used to indicate the direction for making the disposable cartridge 102, unless otherwise specified.

Preferably, the first supply station 1, the forming station 2, the first joining station 9 and the first separation station 10 are aligned along a main extension axis of the first web-like material 30. More preferably, the arrangement station 3, the loading station 5 and the second supply station 8 are movable or they operate in orthogonal planes with respect to said main extension axis. Preferably, the main extension axis of the first web-like material 30 is arranged along or parallel to the manufacturing direction X.

The first supply station 1, for example shown in figure 2, comprises at least a first reel 41 for supplying the first web-like material 30, which is unwound in the manufacturing direction X and which is preferably advanced in such direction X by means of at least one motor-driven roller 42 and a compression roller 43, preferably idle, which keeps said first web-like material 30 at contact with the motor-driven roller 42. The rotation axis R41 of the first supply reel 41 is preferably orthogonal to the manufacturing direction X.

In the first supply station 1, the first web-like material 30 forms at least one loop 51 of first material, which forms a reserve of material during the manufacture. Preferably, in the loop 51, the first web-like material 30 is not stretched, or a lower stretch with respect to the stretch upstream of said loop 51 is applied to such first material so as to form said material reserve.

The first web-like material 30 is preferably a material which can be formed at room temperature ("cold forming” in technical jargon), without applying heating from the external.

Preferably, the first web-like material 30 comprises or, alternatively, consists of at least one barrier metal layer (more preferably made of aluminium) against air and/or moisture.

A plurality of cartridge half-compartments 31 are formed (or impressed) in the first web-like material 30, in the forming station 2. Such cartridge half-compartments 31 are recessed with respect to at least one substantially planar perimeter surface 33 of the first web-like material 30.

In other words, the cartridge half-compartments 31 are depressions obtained in the first web-like material 30, where such depressions are delimited by the at least one perimeter surface 33. Therefore, the perimeter surface 33 (or the plurality thereof) preferably represents the unformed (or unimpressed) surface of the first web-like material 30. Preferably, the first material web-like material 30 delimits a single perimeter surface 33 which extends substantially continuously along the main extension axis.

Given that it is a first web-like material 30, the formation of the cartridge half-compartments 31 will produce several protrusions or bulges at a lower surface 52 of the first web-like material 30.

Preferably, the forming station 2 comprises a punching unit (preferably cold punching) comprising a pair of moulds (or jigs) shaped in a manner complementary to the cartridge half-compartments 31 . At least one of said moulds is preferably movable with respect to the other between a position for translating said first web-like material 30 (wherein said moulds are mutually spaced) and a forming position, wherein said moulds cooperate to form the cartridge half-compartments 31.

Preferably, the shaped moulds or jigs can be replaced in the forming station 2 to modify the amount, size, cross-section and/or depth of the cartridge half-compartments 31.

By way of example, cartridge half-compartments 31 arranged by rows and by columns are formed (or impressed) in the forming station 2, wherein the number of rows and columns is determined by the shaped jigs. For example, 1 to 4 rows and 2 to 6 columns of cartridge half-compartments 31 are formed at each forming cycle.

By way of further example, the cartridge half-compartments 31 observable in figure 3 have a substantially ellipse-shaped or oval-shaped cross-section.

At least one opening grid 104 is arranged in each cartridge half-compartment 31, in the arrangement station 3.

Preferably, the arrangement station 3 arranges the perforated cap 107 on the bottom of the cartridge halfcompartments 31 (with the convexity thereof facing downwards) and with the annular grid base 105 facing upwards, in proximity of the perimeter surface 33.

The arrangement station 3 preferably comprises at least one first conveyor belt 53 which receives the opening grids 104 from a grid-supply station 4 and which loads such grids into the cartridge halfcompartments 31 .

Preferably, the first conveyor belt 53 comprises several grid seats 54 housing a plurality of opening grids 104.

More preferably, the first conveyor belt 53 has parallel rotation axes R53 with respect to the manufacturing direction X.

The embodiment of figure 4 illustrates an arrangement station 3 comprising a pair of first conveyor belts 53 arranged side by side.

Figure 5 shows an enlargement of the area to the right of figure 4, wherein the opening grids 104 are only schematically shown in some cartridge half-compartments.

The grid-supply station 4 (for example see figure 4.A) preferably comprises a first storage unit 86, a first orientation unit 87 and a first transportation unit. The first storage unit 86 preferably comprises at least one grid container 88, preferably a pair of containers 88 arranged side by side.

A discharge mouth 89 which can be closed by an adjustable gate 90 is preferably present in each grid container 88. The adjustable gate 90 can preferably be rotated or translated to adjust an amplitude of the discharge mouth 89, and therefore an amount of opening grids 104 supplied to the first orientation unit 87. The opening grids 104 drop by gravity from the discharge mouth 89 into the first orientation unit 87, in particular a vibrating orientation device. In the first orientation unit 87, the opening grids 104 are preferably displaced along an ascending helical trajectory 91 and they are subsequently inserted - according to a predefined direction - into the first transportation unit.

The first transportation unit preferably comprises at least one channel along which the opening grids 104 are displaced pneumatically, up to reaching the first conveyor belt 53, and in particular to the grid seats 54 into which said grids 104 are loaded.

Preferably, the arrangement station 3 comprises a first robotic arm (not illustrated) for displacing the opening grids 104 from the first conveyor belt 53 to the cartridge half-compartments 31.

In the loading station 5, a powder dose 32 is loaded into each cartridge half-compartment 31 wherein an opening grid 104 was previously arranged.

Preferably, the loading station 5 comprises:

(5.A) a powder container 37 delimiting a substantially cylindrical container compartment 38 housing a volume 36 of said powder;

(5.B) a rotary mixer (not illustrated), at least partly inserted into said powder volume 36 and rotatably mounted with respect to the powder container 37 so as to homogeneously mix said powder volume 36 with an ascending motion component (that is with a bottom-upward motion);

(5.C) a unit 39 for loading the powder dose 32, reciprocating from the powder container 37 to the cartridge half-compartments 31 (along a translation axis T39; preferably orthogonal to the manufacturing direction X) and comprising a plurality of cannulas or cylinders 40 protruding so as to pick up said powder dose 32 from a bottom of said powder volume 36, wherein each cannula or each cylinder 40 preferably comprises - therein - a slidable plunger which can be actuated to aspirate said powder dose 32 from the powder container 37 and to load it into a cartridge half-compartment 31 .

Preferably, the rotary mixer comprises a rotary comb comprising comb teeth inclined with respect to a substantially planar bottom surface of said powder container 37. Said comb teeth are preferably inclined forward (in the direction of the angular motion of said rotary comb) with an acute angle, so as to generate said ascending motion during the rotation thereof.

More preferably, the rotatable comb is actuated so as to carry out an angular stroke (for example comprised from 120° to 180°) after each pick up of the loading unit 39 from the powder container 37. Preferably, a stroke of the slidable plunger can be adjusted so as to aspirate a powder dose 32 of desired volume. In particular, a greater stroke of the sliding piston will correspond to a greater volume of the powder dose 32, and a smaller stroke of the slidable plunger will correspond to a smaller volume of the powder dose 32.

The loading station 5 preferably comprises aeration and air conditioning means configured to maintain the volume 36 of said powder under controlled temperature and humidity conditions, with a forced flow of air under laminar motion.

In other words, the aeration and air conditioning means are configured to prevent a turbulent flow of air into the powder container 37 which, as a result of such turbulent flow, would be transported in an uncontrolled manner outside the container 37.

For example, figures 7, 8, 9 show views of the loading station 5 from different angles. In figure 9 four cannulas or cylinders are clearly visible.

The powder dose 32 is loaded into the cartridge half-compartments in the form of powder candles, given that the cannulas or cylinders impress such shape.

As a matter fact, so as to aspirate the desired volume of the powder dose 32 precisely, it is preferable that the slidable plunger exerts a pre-compression force on said powder. Therefore, such pre-compression force compacts the powder volume, and therefore the formation of the powder candles.

Preferably, the powder container 37 is supplied by a powder-supply station 6 comprising a powder silo 55 (for example see figure 7; preferably with vertical extension) and an auger for transporting said powder from the powder silo to the powder container 37.

Preferably, downstream of the loading station 5 with respect to the manufacturing direction X, the manufacturing apparatus 200 comprises a station 7 for grinding the powder candles which, through a mechanical compression action, grinds said candles so as to obtain a disintegrated powder. According to the orientation of figure 7, the grinding station 7 is arranged to the right of the loading unit 39 (that is: downstream with respect to the manufacturing direction X), and it is shown in greater detail in figure 10. The grinding station 7 preferably comprises a bracket or frame 56 which extends above the first web-like material 30 and from which one or more members 57 for the movable compression of the powder candles protrude, for example one or more compression plungers. Such one or more movable compression members 57 are preferably actuated intermittently when the powder candle/s passes/pass through, so as to disintegrate it/them. More precisely, before a powder candle passes at a respective movable compression member 57, said member is moved away from the cartridge half-compartment 31 so as to allow such candle to be arranged along an operating direction L of the movable compression member 57. When said powder candle reaches such arrangement, said member disintegrates the candle with the compression force thereof. From the second supply station 8 (preferably from a second supply reel 58; figure 11) there is supplied a second web-like material 34 superimposed with the (that is, to cover the) cartridge half-compartments 31 coming from the loading station 5 or from the grinding station 7. The rotation axis R58 of the second supply reel 58 is preferably orthogonal to the manufacturing direction X.

Preferably, the second web-like material 34 comprises or, alternatively, consists of at least one barrier metal layer (more preferably made of aluminium) against air and/or moisture.

Preferably, at least one of the first web-like material 30 and second web-like material 34 comprises a heat- meltable polymer layer. In the first joining station 9, the second web-like material 34 is joined to the at least one perimeter surface 33 of the first web-like material 30 to obtained a semi-finished web 35 comprising a plurality of closed cartridge compartments.

In the semi-finished web 35 the cartridge compartments are closed, but the hollow cartridge bodies 103 are still mutually connected in the form of a continuous web by the material of the first web-like material 30 and of the second web-like material 34 which are mutually joined.

Preferably, the first joining station 9 comprises at least one heating plate 92 (preferably electrically heated) of the heat-meltable polymer layer of the first web-like material 30 and/or of the second web-like material 34, so as to at least partially soften said adhesive layer.

The first joining station 9 preferably comprises a compression unit (preferably a compression plate 93) of the first web-like material 30 and of the second web-like material 34, in particular, the heat-meltable polymer layer of the second web-like material 34 on the perimeter surface 33, or of the heat-meltable polymer layer of the perimeter surface 33 on the second web-like material 34. Preferably, at least one from the heating plate 92 and compression plate 93 is movable with respect to the other (approaching and moving away) to join longitudinal sections of the web-like materials 30, 34 intermittently.

In the subsequent first separation station 10, individual disposable cartridges 102 are separated from the semi-finished web 35. A waste product of the semi-finished web is instead preferably conveyed to a waste product collection station 11. An individual disposable cartridge is shown in figure 14 in a bottom view (from the planar side, without the protrusions or bulges). The protrusion or bulge is faced to the opposite side, not visible, of said disposable cartridge.

The first separation station 10 preferably comprises a cutting unit 59 comprising a die-cut 60 for separating said individual disposable cartridges 102.

The manufacturing apparatus 200 preferably comprises a station 50 for picking up individual disposable cartridges 102 at the first separation station 10.

The pick-up station 50 preferably comprises:

(50. A) a rotary handling device 49 comprising a plurality of pick-up units 48 spaced angularly with respect to a rotation axis RM of said rotary handling device 49, wherein each pick-up unit 48 comprises a plurality of first hollow suctioning fingers 47 fluidically connected to a vacuum source of said manufacturing apparatus 200, wherein said first hollow suctioning fingers 47 are configured to pick up the individual disposable cartridges 102 from the first separation station 10;

(50. B) a shuttle 46 for transporting the disposable cartridges 102, which can be translated (along a translation axis T46) in a reciprocating motion between the rotary handling device 49 and the connection station 14 and, more precisely, between the rotary handling device and the transportation pallets 75 (described in greater detail below) of said connection station 14 at which the connection between the disposable cartridges 102 and the inhaler bodies 101 occurs.

Therefore, the transportation shuttle 46 is configured to receive the individual disposable cartridges 102 from the rotary handling device 49, and to transport them to the connection station 14.

For example, the embodiment of figure 13 shows a rotary handling device 49 comprising four pick-up units 48 spaced angularly at about 90°.

In the embodiment illustrated in figure 13, each pick-up unit 48 carries out an angular movement of about 180° from the first separation station 10 to the transportation shuttle 46. Therefore, downstream of the first separation station 10, the individual disposable cartridges 102 are reversed (or inverted) before reaching the connection station 14 with the inhaler body 101.

Preferably, the transportation shuttle 46 is movable approaching and moving away with respect to the pick-up units 48, in particular with respect to the first hollow suction fingers 47.

Preferably, the manufacturing apparatus 200 comprises a first station 12 for discarding one or more faulty disposable cartridges 102 wherein at least one from the opening grid 104 and the powder dose 32 is absent.

Preferably, the first discarding station 12 comprises a comb-like member 45 comprising a plurality of prongs 44 mutually spaced so as to allow the first hollow suction fingers 47 to pass through (for example see figure 13. A) and to prevent said one or more faulty disposable cartridge/s 102 from passing through. In this manner, the rotation of the rotary handling device 49 around the axis RM through said prongs 44 mechanically detaches said one or more faulty disposable cartridges 102 from the first hollow suction fingers 47.

Preferably, the faulty disposable cartridge or cartridges 102 are detected by means of detection means TC1, TC2 (preferably video cameras) arranged downstream of the arrangement station 3 and downstream of the loading station 5 (for example see figure 1). Such video cameras are functionally connected to a memory unit 61 and to a programmable logic controller (PLC) 98 which, based on the signals received from the detection means TC1, TC2, controls the rotary handling device 49 to the transportation shuttle 46 or to the first discarding station 12.

Therefore, preferably, the manufacturing apparatus comprises:

- means TC1, TC2 for detecting the presence of said opening grid 104 and said powder dose 32 in each cartridge half-compartment 31; - the memory unit 61 for storing the faulty disposable cartridge 102 or the plurality of disposable cartridges 102 wherein at least one from the opening grid 104 and powder dose 32 is absent;

- the programmable logic controller (PLC) 98 which, based on the signals received from the detection means TC1, TC2, controls the rotary handling device 49 to the transportation shuttle 46 or to the first discarding station 12.

A plurality of inhaler bodies 101 is supplied from a third supply station 13.

Preferably, the third supply station 13 comprises a second storage unit 62, a second orientation unit 63 and three transportation units 64, 65, 94 arranged in series.

The second storage unit 62 preferably comprises at least one inhaler body container 66, preferably a pair of containers 66 arranged side by side. Preferably, each inhaler body container 66 is movable on rolling means 67.

In each inhaler body container 66 there is preferably present a second oblique conveyor belt 68 configured to displace the inhaler bodies 101 from inside said container 66 toward an outlet mouth 70 thereof, arranged at the top. In this regard, the second conveyor belt 68 is preferably provided with protruding transverse steps 69. These steps allow a certain number of inhaler bodies 101 to rise up to the outlet mouth 70.

The inhaler bodies 101 drop by gravity from the outlet mouth 70 into the second orientation unit 63, in particular a vibrating orientation device. In the second orientation unit 63, the inhaler bodies are preferably displaced along an ascending helical trajectory 71 and they are subsequently inserted - according to a predefined direction - into the second transportation unit 64.

The second transport unit 64 preferably comprises at least one channel 72 along which the inhaler bodies are displaced pneumatically, until they reach the third transportation unit 65.

The third transportation unit 65 preferably comprises a third conveyor belt 73 comprising a plurality of seats 74 for housing the inhaler bodies. Such seats can be translated integrally with the motion of the third conveyor belt 73 toward the fourth transportation unit 94.

For example, the fourth transportation unit 94 and the connection station 14 are illustrated in figure 17. B.

The fourth transport unit 94 comprises a second robotic arm 95 configured to move the inhaler bodies 101 from the third conveyor belt 73 to the transportation pallets 75 of the connection station 14. The inhaler bodies 101 are preferably arranged by rows in the transportation pallets 75 In other words, each transportation pallet 75 comprises a plurality of pallet seats 96 each at least partly housing an inhaler body 101.

Preferably, the second robotic arm 95 comprises second hollow suction fingers 96, fluidically connected to a vacuum source of said manufacturing apparatus 200 and configured to pick up the inhaler bodies 101 from the third conveyor belt 73 and arrange them to the transportation pallets 75. In this manner, at the transportation pallets 75 of the subsequent connection station 14, each disposable cartridge 102 coming from the first separation station 10 is connected with an inhaler body 101 supplied from the third supply station 13, to obtain said disposable inhaler 100.

In this regard, each inhaler body 101 preferably comprises elastic regions 111 movable and configured to engage a perimeter edge 112 of the disposable cartridge 102.

In particular, after the inhaler bodies 101 are positioned on the transportation pallets 75, said pallets are displaced (for example by means of one or more drive belts 76) in the direction of the transportation shuttle 46, so that said shuttle can position the disposable cartridges 102 on the inhaler bodies 101 (figure 17. B, on the left).

Preferably, the manufacturing apparatus 200 comprises a compression station 15 in which the disposable cartridges 102 are pressed onto the inhaler bodies 101 to complete the connection therebetween, preferably by snap-coupling (for example, figure 20).

Preferably, the compression station 15 comprises several compression plungers of the disposable cartridges 102.

In subsequent completion stations 18, 19, the transportation pallets 75, possibly imperfect (wherein in one or more pallet seats 96 disposable inhalers are absent or comprising incomplete or damaged disposable inhalers) are completed by means of disposable inhalers 101 picked up from a storage unit 77 and positioned in the empty pallet seats 96. For example, such completion is carried out by means of one or more robotic arms 78 which are displaced from the storage unit 77 to the transportation pallet 75, and vice versa.

A third web-like material is supplied from a third supply station 16 (in particular from a third storage reel) to a receptacle-forming station 17, wherein said third material is formed or thermo-formed to obtain a web 79 of inhaler receptacles 80.

An inhaler receptacle (isolated) is shown in figure 22.

In the belt 79 the inhaler receptacles 80 are arranged in columns and in rows, the rows having a number of receptacles 80 equal to or greater than the number of disposable inhalers present on the transportation pallet 75 (for example see figure 23. A, wherein only a part of the inhaler receptacles 80 houses disposable inhalers 100).

In the subsequent assembly station 20 (figure 23 and figure 23. A), the rows of disposable inhalers 101 present on the transportation pallet 75 are inserted into the rows of inhaler receptacles, preferably by means of a third robotic arm 97. Figure 24 shows a disposable inhaler 101 housed in an inhaler receptacle 80 thereof which is still open in this station.

A fourth web-like material is supplied from a fourth supply station 21 superimposed with the inhaler receptacles 80 coming from the assembly station 20. The fourth web-like material is joined to perimeter edges 81 of the inhaler receptacles 80 in a second joining station 22 (figure 26), so as to obtain closed receptacles (figure 25).

More precisely, the second joining station 22 comprises a unit (not illustrated) for heating the fourth weblike material so as to partly soften it, and a unit for pressing the fourth web-like material softened on the perimeter edges. In this station, the inhaler receptacles 80 are closed, but mutually connected in the form of a continuous web by the material of the third web-like material and of the fourth web-like material.

In a subsequent second separation station 23, longitudinal weakening lines 82 - configured to weaken the material of adjacent closed receptacles and so as to be able to open each receptacle individually without opening the adjacent receptacle - are formed between each pair of closed inhaler receptacles 80 (figure 27 and figure 27.A).

At the second separation station 23 there is also provided for a unit 83 for printing product information (for example, batch number, expiration date, type of medicinal product contained in the cartridge, or the like) on the closed inhaler receptacles 80.

In a subsequent third separation station 24 (figure 28) the closed inhaler receptacles 80 are separated transversely by rows (as shown in figure 29), for example rows comprising from 2 to 10 receptacles, preferably from 3 to 7 receptacles.

The third separation station 24 preferably comprises a cutting unit 84 comprising a die-cut 85 for separating said rows of inhaler receptacles 80.

Downstream of the third separation station 24 there is arranged a second discarding station 25 which picks up the row or rows of faulty closed receptacles (for example not perfectly closed, or in which one or more disposable inhalers are missing, or where the product information is printed incorrectly or illegibly.) Preferably, the row or rows of faulty closed receptacles are detected by means of detection means TC3, TC4, TC5, TC6 (preferably video cameras) respectively arranged downstream of the connection station 14, upstream of the completion stations 18, 19, downstream of the assembly station 20 and downstream of the printing unit 83 (for example see figure 1). Such video cameras are functionally connected to the memory unit 61 and to the programmable logic controller (PLC) 98 which, based on the signals received from the detection means TC3, TC4, TC5, TC6 conveys the row or the rows of closed receptacles to a subsequent packaging station 27 or to the second discarding station 25.

Secondary packagings in which, in a packaging station 27, the rows of qualitatively acceptable closed receptacles are arranged are supplied from a packaging-supply station 26. The secondary packagings are then closed to obtain finished products.

Furthermore, forming an object of the present invention is a process for manufacturing a disposable inhaler 100.

Since such method is implemented by means of the manufacturing apparatus 200 described above, such method will comprise any process step outlined in structural terms in the description outlined above. Said manufacturing process comprises the following steps:

(I) supplying a first web-like material 30 along a manufacturing direction X;

(II) forming a plurality of cartridge half-compartments 31 in said first web-like material 30 of step (I), wherein said cartridge half-compartments 31 are recessed with respect to at least one substantially planar perimeter surface 33 of said first material 30;

(III) arranging at least one opening grid 104 in each cartridge half-compartment 31 obtained from step (II);

(IV) loading a powder dose 32 into each cartridge half-compartment 31 of step III;

(V) supplying a second web-like material 34 superimposed with the cartridge half-compartments 31 of step (IV);

(VI) joining the second web-like material 34 of step (V) to the at least one perimeter surface 33 of said first web-like material 30 to obtain a semi-finished web 35 comprising a plurality of closed cartridge compartments;

(VII) separating individual disposable cartridges 102 from the semi-finished web 35 of step (VI);

(VIII) supplying a plurality of inhaler bodies 101;

(IX) connecting each disposable cartridge 102 obtained from step (VII) with an inhaler body 101 of step (VIII) to obtain said disposable inhaler 100.

Preferably, said process comprises the following steps:

(A.IV) maintaining a volume 36 of said powder in an environment with controlled temperature and humidity conditions, with a forced flow of air under laminar motion;

(B.IV) homogeneous mixing of said powder volume 36 of step (A.IV) with an ascending motion component;

(C.IV) picking up said powder dose 32 from the bottom of said powder volume 36 of step (B.IV); wherein said step (C.IV) is followed by said step (IV) for loading the powder dose 32 into each cartridge half-compartment 31.

Said process preferably comprises:

- steps for detecting the presence of said opening grid 104 and of said powder dose 32 in each cartridge half-compartment 31, said detection steps being subsequent to the step (III) for arranging said opening grid 104 and to the step (IV) for loading said powder dose 32 into each cartridge half-compartment 31;

- a step for storing a faulty disposable cartridge 102 or a plurality of faulty disposable cartridges 102 wherein at least one from the opening grid 104 and the powder dose 32 is absent; and

- a step for discarding said faulty cartridge or said faulty disposable cartridges 102, said discarding step being subsequent to the step (VI I) of separating said individual disposable cartridges 102 from the semifinished web 35.

Even more preferably, the individual disposable cartridges 102 obtained from the separation step (VII) are reversed in the connection (IX) of each disposable cartridge 102 with the inhaler body 101, the second web-like material 34 facing said inhaler body 101 and the cartridge half-compartment 31 formed in said first web-like material 30 facing toward the opposite side with respect to the inhaler body 101 .

LIST OF REFERENCE NUMBERS

1 first supply station

2 forming station

3 arrangement station

4 grid-supply station

5 loading station

6 powder-supply station

7 grinding station

8 second supply station

9 first joining station

10 first separation station

11 waste product collection station

12 first discarding station

13 third supply station

14 connection station

15 compression station

16 third supply station

17 receptacle-forming station

18 completion station

19 completion station

20 assembly station

21 fourth supply station

22 second joining station

23 second separation station

24 third separation station

25 second discarding station

26 packaging-supply station

27 packaging station

30 first web-like material

31 cartridge half-compartment

32 powder dose

33 perimeter surface 34 second web-like material

35 semi-finished web

36 powder volume

37 powder container

38 containment compartment

39 loading unit

40 cannula or cylinder

41 first supply reel

42 motor-driven roller

43 compression roller

44 prong

45 comb-like member

46 transportation shuttle

47 hollow suctioning fingers

48 pick-up unit

49 rotary handling device

50 pick-up station

51 first material loop

52 lower surface of the first web-like material

53 first conveyor belt

54 grid seat

55 powder silo

56 bracket or frame

57 movable compression members

58 second supply reel

59 cutting unit

60 die-cut

61 memory unit

62 second storage unit

63 second orientation unit

64 second transportation unit

65 third transportation unit

66 inhaler body container

67 rolling means

68 second conveyor belt 69 protruding transverse steps of the second conveyor belt

70 outlet mouth

71 ascending helical trajectory

72 channel

73 third conveyor belt

74 seats for housing inhaler bodies

75 transportation pallet

76 drive belt

77 disposable inhaler storage unit

78 robotic arm

79 inhaler receptacle web

80 inhaler receptacle

81 perimeter edges of the inhaler receptacles

82 longitudinal weakening lines

83 printing unit

84 cutting unit

85 die-cut

86 first storage unit

87 second orientation unit

88 grid container

89 discharge mouth

90 adjustable gate

91 ascending helical trajectory

92 heating plate

93 compression plate

94 fourth transportation unit

95 second hollow suctioning fingers

96 pallet seat

97 third robotic arm

98 programmable logic controller

100 disposable inhaler

101 inhaler body

102 disposable cartridge

103 hollow cartridge body

104 opening grid 105 grid annular base

106 branch

107 perforated cap

108 first portion or housing portion

109 second portion or dispensing portion

109' free end of the second portion

110 cutting annular edge

111 elastic regions

112 perimeter edge

113 drop region

L operating direction of the movable compression member

R41 rotation axis of the first supply reel

R53 rotation axis of the first conveyor belt

R58 rotation axis of the second supply reel

RM rotation axis of the rotary handling device

T39 translation axis of the loading unit

T46 translation axis of the transportation shuttle

TC1 detection means, preferably video cameras

TC2 detection means, preferably video cameras

X manufacturing direction

Claims

1. A process for manufacturing a disposable inhaler (100); wherein said disposable inhaler (100) comprises an inhaler body (101) and a disposable cartridge (102) connected to said inhaler body (101), said disposable cartridge (102) comprising a hollow cartridge body (103) delimiting a closed cartridge compartment in which a powder dose (32) and an opening grid (104) of the hollow cartridge body (103) are housed; wherein said process comprises the following steps:

(I) supplying a first web-like material (30) along a manufacturing direction (X);

(II) forming a plurality of cartridge half-compartments (31) in said first web-like material (30) of step (I), wherein said cartridge half-compartments (31) are recessed with respect to at least one substantially planar perimeter surface (33) of said first material (30);

(III) arranging at least one opening grid (104) in each cartridge half-compartment (31) obtained from step (ii);

(IV) loading a powder dose (32) into each cartridge half-compartment (31) of step (III);

(V) supplying a second web-like material (34) superimposed with the cartridge half-compartments (31) of step (IV);

(VI) joining the second web-like material (34) of step (V) to the at least one perimeter surface (33) of said first web-like material (30) to obtain a semi-finished web (35) comprising a plurality of closed cartridge compartments;

(VII) separating individual disposable cartridges (102) from the semi-finished web (35) of step (VI);

(VIII) supplying a plurality of inhaler bodies (101);

(IX) connecting each disposable cartridge (102) obtained from step (VII) with an inhaler body (101) of step (VIII) to obtain said disposable inhaler (100).

2. The process according to the preceding claim, wherein said opening grid (104) comprises a substantially planar grid annular base (105), a plurality of branches (106) extending moving away from said grid annular base (105) and converging so as to delimit a perforated cap (107) and wherein, in step (III), said perforated cap (107) is arranged on the bottom of the cartridge half-compartments (31) and said grid annular base (105) is arranged upwards, in proximity of the perimeter surface (33).

3. The process according to any one of the preceding claims, wherein said powder dose (32) consists of a dry powder, that is a powder with a moisture content comprised from 0.01% to 6%, preferably comprised from 0.05% to 3.5%, with respect to the total weight of said powder; wherein said process comprises the following steps:

(A.IV) maintaining a volume (36) of said powder in an environment with controlled temperature and humidity conditions, with a forced flow of air under laminar motion;

(B.IV) homogeneous mixing of said powder volume (36) of step (A.IV) with an ascending motion component;

(C.IV) picking up said powder dose (32) from the bottom of said powder volume (36) of step (B.IV); wherein said step (C.IV) is followed by said step (IV) for loading the powder dose (32) into each cartridge half-compartment (31).

4. The process according to any one of the preceding claims, wherein said process comprises:

- steps for detecting the presence of said opening grid (104) and of said powder dose (32) in each cartridge half-compartment (31), said detection steps being subsequent to the step (III) for arranging said opening grid (104) and to the step (IV) for loading said powder dose (32) into each cartridge halfcompartment (31);

- a step for storing a faulty disposable cartridge (102) or a plurality of faulty disposable cartridges (102) wherein at least one from the opening grid (104) and the powder dose (32) is absent; and

- a step for discarding said faulty cartridge or said faulty disposable cartridges (102), said discarding step being subsequent to the step (VI I) of separating said individual disposable cartridges (102) from the semifinished web (35).

5. The process according to any one of the preceding claims, wherein the individual disposable cartridges

(102) obtained from the separation step (VII) are reversed in the connection (IX) of each disposable cartridge (102) with the inhaler body (101), the second web-like material (34) facing said inhaler body (101) and the cartridge half-compartment (31) formed in said first web-like material (30) facing toward the opposite side with respect to the inhaler body (101).

6. An apparatus (200) for manufacturing a disposable inhaler (100); wherein said disposable inhaler (100) comprises an inhaler body (101) and a disposable cartridge (102) connected to said inhaler body (101), said disposable cartridge (102) comprising a hollow cartridge body

(103) delimiting a closed cartridge compartment in which a powder dose (32) and an opening grid (104) of the hollow cartridge body (103) are housed; wherein said manufacturing apparatus (200) comprises, arranged in series:

- a first station (1) for supplying a first web-like material (30) along a manufacturing direction (X); - a station (2) for forming a plurality of cartridge half-compartments (31) in said first web-like material (30), wherein said cartridge half-compartments (31) are recessed with respect to at least one substantially planar perimeter surface (33) of said first material (30);

- a station (3) for arranging at least one opening grid (104) in each cartridge half-compartment (31);

- a station (5) for loading a powder dose (32) into each cartridge half-compartment (31);

- a second station (8) for supplying a second web-like material (34) superimposed with the cartridge halfcompartments (31) coming from the loading station (5);

- a first station (9) for joining the second web-like material (34) to the at least one perimeter surface (33) of said first web-like material (30) to obtain a semi-finished web (35) comprising a plurality of closed cartridge compartments;

- a first station (10) for separating individual disposable cartridges (102) from the semi-finished web (35);

- a third station (13) for supplying a plurality of inhaler bodies (101);

- a station (14) for connecting each disposable cartridge (102) coming from the first separation station (10) with an inhaler body (101) supplied from the third supply station (13), to obtain said disposable inhaler (100).

7. The manufacturing apparatus (200) according to the preceding claim, wherein the loading station (5) comprises:

(5. A) a powder container (37) delimiting a substantially cylindrical container compartment (38) housing a volume (36) of said powder;

(5. B) a rotary mixer, at least partly inserted into said powder volume (36) and rotatably mounted with respect to the powder container (37) so as to homogeneously mix said powder volume (36) with an ascending motion component;

(5.C) a unit (39) for loading said powder dose (32), reciprocating from the powder container (37) to the cartridge half-compartments (31) and comprising a plurality of cannulas or cylinders (40) protruding so as to pick up said powder dose (32) from a bottom of said powder volume (36), each cannula or each cylinder (40) comprising - therein - a slidable plunger which can be actuated to aspirate said powder dose (32) from the powder container (37) and to load it into said cartridge half-compartment (31).

8. The manufacturing apparatus (200) according to any one of claims 6-7, wherein the loading station (5) comprises a powder container (37) delimiting a substantially cylindrical container compartment (38) housing a volume (36) of said powder; wherein said loading station (5) further comprises aeration and air conditioning means configured to maintain the volume (36) of said powder under controlled temperature and humidity conditions, with a forced flow of air under laminar motion.

9. The manufacturing apparatus (200) according to any one of claims 6-8, comprising a station (50) for picking up the individual disposable cartridges (102) at the first separation station (10); wherein said pick-up station (50) comprises:

(50. A) a rotary handling device (49) comprising a plurality of pick-up units (48) spaced angularly with respect to a rotation axis (RM) of said rotary handling device (49), wherein each pick-up unit (48) comprises a plurality of hollow suctioning fingers (47) fluidically connected to a vacuum source of said manufacturing apparatus (200), wherein said hollow suctioning fingers (47) are configured to pick up the individual disposable cartridges (102) from the first separation station (10);

(50. B) a shuttle (46) for transporting the disposable cartridges (102), which can be translated in a reciprocating motion between the rotary handling device (49) and the connection station (14).

10. The manufacturing apparatus (200) according to the preceding claim, comprising a first station (12) for discarding one or more faulty disposable cartridges (102) wherein at least one from the opening grid (104) and the powder dose (32) is absent, wherein said first discarding station (12) comprises a comb-like member (45) comprising a plurality of prongs (44) mutually spaced so as to allow the hollow suctioning fingers (47) to pass through and to prevent the said one or more faulty disposable cartridges (102) from passing through, so that the rotation of the rotary handling device (49) through said prongs (44) causes a mechanical detachment of said one or more faulty disposable cartridges (102) from the hollow suctioning fingers (47).

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