JP2007524492A - Capsule manufacturing method and related capsule filling apparatus - Google Patents

Abstract

  In a method for manufacturing a sealed capsule (C) defined by a body (1) each coupled to a lid (2) and a capsule filling device associated therewith, the body (1) of the capsule contains a large amount Alternatively, the lid (2) is filled with a single material, in particular liquid or powdered pharmaceutical material (3), and the capsule (C) covers the body (1) so that its annular ends (1a, 2a) overlap. ) Is closed. The sealing material is applied to at least one of the overlapping ends (1a, 2a) of the capsule body (1) and lid (2) before the capsule (C) is closed.

Description

  The present invention relates to a method for producing a sealed capsule and a capsule filling apparatus related thereto.

  In particular, the present invention is advantageous for the production of hard gelatin capsules comprising a lid and a body, and including solid or liquid pharmaceutical materials such as powders, tablets, microtablets, pellets and the like. Applied. Reference is made specifically to such manufacture herein, but is not intended to limit the invention.

  The operation of a capsule filling apparatus in recent years basically includes a series of steps including the following main steps. Opening a closed empty capsule in a station that separates the body of the capsule from the lid to form two separate rows of body and lid; and a dose of pharmaceutical in the body of each capsule at the dose station A step of filling the material and a step of closing the filled capsule by attaching a lid to each body.

  Once closed, each capsule is individually checked at a suitable inspection and weighing station and finally delivered from the device into a suitable container.

  There is a great need to seal pharmaceutical capsules manufactured in the manner described above by another process that is utilized after the capsules are closed in the manufacturing process. The seal not only ensures that the liquid pharmaceutical material does not leak through the joint between the capsule body and lid, but also improperly manipulates the capsule contents and undetected impurities. It is intended to prevent the risk of mixing.

  Currently, there are various ways to produce such a seal. These methods can be roughly divided into two types.

  According to the first type, a sealing coating is applied to the entire outer surface of each capsule, for example as described in WO 02/060372.

  In this method, a predetermined amount of capsules produced in a capsule filling device is collected in a rotary drum and sprayed with a sealing material such as an organic solvent (eg, aqueous ethanol solution) to form a sealing coating. Form. The formation of the sealing coating is completed by a step of drying the coating which is performed almost simultaneously with the spraying while the capsule is in the drum.

  This method gives satisfactory results, but of course has the disadvantage that it is necessary to use a rotary drum in addition to the capsule filling device in which the capsule itself is produced.

  According to the second type, the seal is applied only to the discontinuous outer part of the capsule that defines the joint between the lid and body when they are fitted together, with an organic solvent or other solvent. By applying a uniform substance).

  In a known solution for carrying out this method, each capsule is sprayed (or more generally sprayed) with a sealing liquid in a self-contained sealing device in which these capsules are delivered by a filling device that produces closed capsules. Is coated).

  This second type of method is implemented by two structurally different solutions described in US Pat. No. 4,793,119 and US Pat. No. 5,094,184.

  In these solutions, fully closed packed capsules are individually transferred on a suitable conveyor from a capsule filling device to a type of sealing device comprising a station for horizontally positioning each capsule.

  According to the aforementioned US patent, each capsule is brought into contact with a sealing roller. The sealing roller is partially immersed in a tank containing the sealing material and is rotated about the longitudinal axis so as to apply a “band” of sealing material to the joint between the lid and the body. This outer sealing band is dried by a subsequent drying station.

  However, such a method of externally sealing a limited area of the capsule has significant drawbacks.

  In the first solution, it is difficult to control the sealing material so that it is uniformly dispersed, which means that there is no guarantee that an effective seal can be created. The relative positional relationship between the spray nozzle and the capsule requires that an excessive amount of sealing material be sprayed, which can cause the sealing material to drip onto the parts of the device or damage the device. Or with frequent maintenance and cleaning.

  The second solution involves transferring capsules from the filling device and positioning them on the conveyor in addition to the inevitably slow passage of individual capsules around the drum to accurately disperse the sealing material. Since the process takes time, it has a disadvantage that productivity is lowered.

  In addition, both of the above solutions involve handling individual capsules that have already been produced when delivered from one capsule filling device to another, in addition to reducing the production rate as described above. In particular, there is a risk of the product leaking from the capsule before it is sealed, especially if the material in the capsule is a liquid.

  The object of the present invention is therefore to overcome the significant drawbacks of the prior art.

  More particularly, the main object of the present invention is to produce a lid-body type capsule that is completely sealed by a quick and reliable process carried out in the same device as that for filling and closing the capsule. This not only eliminates the need for an additional sealing device outside the capsule filling device, but also eliminates the need for complex operating devices required to deliver the capsule to an external sealing device without damaging the capsule. There is to be.

  Accordingly, the present invention is a method of manufacturing a sealed capsule defined by a body combined with a lid, the step of filling a capsule body with a large amount or a portion of a material, and an annular shape of the lid and the body. And closing the capsule by positioning the lid on the body so that the ends overlap each other, wherein a sealing substance is applied to at least one of the capsule body and the overlapping annular end of the lid. The method further comprises the step of applying, wherein the sealing step is performed before the capsule is closed.

  The present invention also provides a capsule filling apparatus for producing a hard gelatin capsule having a lid and a body containing a pharmaceutical material, the capsule body and the lid sending station, and a dose of material in each capsule body. A capsule filling apparatus comprising: a dosing station for filling; and a station for closing the capsule by placing the lid on each body so that the annular ends of the lid and the body overlap each other. In the meantime, it relates to a capsule filling device, characterized in that at least one intermediate working station is provided in the vicinity of the end for applying a sealing substance to the lid and body of the capsule.

  The technical features of the present invention are clearly set forth in the following claims in connection with the above objects, and the advantages thereof are provided by way of example only and are not intended to limit the scope of the invention. The preferred embodiments will be apparent from the detailed description with reference to the accompanying drawings, in which:

  FIG. 1 is a diagram showing a series of steps constituting the method of the present invention for producing a sealed capsule C of the type comprising a lid 2 and a body 1 in two different stages of change. The lid 2 and the body 1 are bonded to each other so that the end portions 1a and 1b overlap with each other, and preferably include a liquid or powdery pharmaceutical material, but is not limited thereto. 2 to 6 show a capsule filling device 4 for carrying out the above method.

  The method shown in FIG. 1 consists of filling (in accordance with direction K) the body 1 of each capsule C with a dose of pharmaceutical material 3 (arrow F3) and the ends of the body 1 and lid 2 to be overlapped. The step of applying a sealing substance to at least a part of the parts 1a and 1b, and then the capsule C is closed by moving the body 1 and the lid 2 together so that the lid 2 overlaps the body 1 (arrow F100). And a step of simultaneously closing and sealing the capsule C.

  Empty capsules C are closed when they are fed into the device at the start of processing. Before the capsules C are filled, the capsules C are opened by moving the body 1 and the lid 2 away (arrow F101 in FIG. 1).

  As shown in FIG. 1, the step of applying the sealing material is performed before the capsule C is completely closed.

  In particular, the step of applying the sealing substance is performed while the body 1 is rotated about its longitudinal axis Z so that the sealing substance is applied to the circular end 1a of the outer surface of the body 1 (see the arrow in FIG. 1). F102), which is performed during or immediately after the lid 2 is partially overlapped by covering the body 1 at the ends 1a and 2a.

  Alternatively, the step of applying the sealing material is performed while the sealing material is being rotated around the longitudinal axis Z of the lid 2 so that the sealing material is applied to the circular end 2a of the outer surface of the body 1, and the end portion This is performed during or immediately after the lid 2 is partially overlapped with the body 1 in 1a and 2a.

  Preferably, the step of applying the sealing material is during or after the body 1 is partially overlapped, and the sealing material is applied to the circular ends 1a, 1b of the outer surfaces of both the body 1 and the lid 2. In this way, the entire capsule of the body 1 and the lid 2 is rotated around the longitudinal axis Z.

  In another form of applying the sealing substance, the body 1 and the lid 2 are moved toward each other along the longitudinal axis Z so that the body 1 and the lid 2 are coupled and the capsule C is closed (see FIG. 1 arrow F100), the capsule body 1 and the lid 2 are rotated about the longitudinal axis Z.

  The sealing material is preferably applied by spraying and consists of a mixture of different materials depending on the operating requirements and on the type of capsule C in which the body 1 and lid 2 are usually formed of hard gelatin.

  The sealing material is typically an aqueous mixture of water and ethanol, its equivalent, a cellulose-based liquid material, or the same type of gelatin-based liquid material that forms the lid 2 and body 1.

  In the process of closing the body 1 and the lid 2, in order to eliminate or minimize the risk of dripping or leakage of the substance from the capsule C, the sealing substance is applied while firmly holding the capsule C in the closed position. The drying process continues.

  It is preferable that the drying process is performed while the sealed capsule C is sent to the capsule collecting station.

  As clearly shown in FIG. 2, the capsule filling device 4 for producing the sealed capsule C essentially comprises the same operating unit as a conventional capsule filling device for producing the capsule C. That is, the capsule filling device 4 covers the body 1 of each capsule C so that the end 1a and 2a overlap each other, the station 5 for sending the body 1 and the lid 2, the dose station 6 for filling the body 2 with the material. Station 7 for closing the capsule C by positioning the lid 2 in this manner.

  Stations 5, 6, and 7 are of a known type and are not described in detail, and are only partially shown in FIGS.

  In particular, the feeding station 5 preferably sends closed empty capsules C and opens them in a known manner before they reach the dose station 6 (not shown).

  In addition to the stations described above, the capsule filling device 4 includes a station 40 that detects the presence of the body 1 and the lid 2, and a station 41 that selects the failed capsule C.

  2-5, a new intermediate station 8 is provided between the dosing station 6 and the closing station 7, where the ends 1a and 2a are already partially overlapped. The body 1 and the lid 2 are preliminarily joined together and a sealing material is applied to the overlapping area between the body 1 and the lid 2.

  In more detail, the intermediate station 8 comprises, in succession, a station 9 for preliminarily joining the capsule body 1 and lid 2 to each other, a substation 10 for applying a sealing substance, and the closing station described above. 7.

  As shown in FIG. 2, the capsule filling device 4 rotates in a continuous or alternating motion along a circular path P to reliably send the capsule C to the feeding, opening and dosing stations 5, 6. A capsule operating turret 11 and a second rotating turret 12 constituting the intermediate station 8 and the closing station 7 are provided.

  The second turret 12 is independent and rotates about its axis of rotation Z ′, the capsule C along another circular path P1, a pre-bonding station 9, a substation 10 for applying a sealing substance, and a closure. Position to station 7 (FIG. 2).

  The second turret 12 includes a plurality of means 13 for holding the capsules C. The means 13 is attached in the radial direction of the turret 12 and interlocked with the means 14 for operating the body 1 and the lid 2 forming each capsule C. Act.

  For convenience, the following description shows the case where one capsule C is formed and sealed, but it is obvious that it can be expanded to a plurality of groups of capsules C.

  As shown in FIGS. 3 to 6, the holding means 13 includes a concave end sheet 13 a disposed on the second turret 12 for each capsule C.

  The concave end sheet 13a contains a capsule body 1 and lid 2 and has a central cavity 13b separating the two parts of the sheet 13a, through which the respective conduits 16, 17 extend in the radial direction. These conduits 16, 17 are such that the two parts can hold the parts of the body 1 and lid 2 respectively when the body 1 and lid 2 move to the substations 9 and 10 and to the closing station 7. Is communicated to a second means (illustrated as block 18).

  The operation means 14 described above is disposed in the vicinity of the holding means 13, moves in both vertical directions, and is a first means for generating a vacuum that performs the following steps along the rotation path P <b> 1 of the second turret 12. 15 (illustrated as a block in the figure). That is, the step of taking out the body 1 and the lid 2 and transferring the body and the lid 2 from the first turret 11 to the second turret 12 in a state where the body 1 and the lid 2 are preliminarily positioned so as to partially overlap each other. (FIG. 3) and in the substation 10 for applying the sealing substance, the capsule body 1 and lid so as to spread the sealing substance uniformly along the closed annular surface of height S in the overlapping area. 2 is a step of rotating 2 (FIG. 4), and a step of closing the capsule C by moving the body 1 and the lid 2 closer to each other (FIG. 5).

  More specifically, the operation means 14 varies depending on the positioning work and the operation work required to be executed.

  In the pre-coupling substation 9 (FIG. 3), the operating means 14 (FIG. 3) includes a pair of hollow cylindrical pins 19 and 20 disposed on both sides of the second turret 12.

  The two pins 19 and 20 make stable contact on both sides with the first means for generating a vacuum to hold the body 1 and the lid 2 and the body 1 and the lid 2 arranged on the first turret 11. The body 1 and the lid 2 are provided with operating means 21 (arrow F21) for transferring the arrow 1 to the second turret 12 while partially overlapping (arrow F12).

  When the capsule body 1 and lid 2 reach the sheet 13a, the second vacuum means 18 holds the body 1 and lid 2 in a stable position so that the second turret 12 can move along the path P1. .

  In the seal substation 10, the operating means 14 (FIG. 4) comprises at least one cylindrical pin 22. The cylindrical pin 22 is brought into contact with the lower portion of the body 1 by the first vacuum means 15, and the body 1 and the lid 2 that are partially overlapped with each other by a force larger than the force applied by the holding means 13. Rotate around.

  In other words, referring to FIG. 4, the cylindrical pin 22 is disposed so as to be in contact with the lower portion of the body 1 and held by suction, and the portion of the second vacuum means 18 that holds the lid 2 is temporarily cut. Thus, the pin 22 can rotate the entire capsule C while the sealing material is applied (arrow F22) (in the figure, the portion to which a vacuum is applied is indicated by a directional arrow).

  The seal substation 10 (FIG. 4) includes at least one spray nozzle 23 that faces the body 1 and the lid 2 when they are rotated by the second turret 12.

  The spray nozzle 23 is disposed in an overlapping portion of the body 1 and the lid 2 so that the sealing material is sprayed uniformly on the regions 1a and 2a while the body 1 and the lid 2 are rotated.

  Depending on the position of the nozzle 23 relative to the body 1 and the lid 2, the sealing substance is sprayed onto the annular band S of the body 1 during the rotation of the body 1.

  As shown in FIG. 5, the operating means 14 comprises another pair of hollow cylindrical pins 24, 25 arranged on both sides of the second turret 12 at the closing station 7.

  The two pins 24 and 25 overlap the first vacuum means 15 for holding the body 1 and the lid 2 with the body 1 and the lid 2 as well as stably contacting the body 1 and the lid 2 on both sides. A linear operating means 21 for applying a reverse force (arrows F24 and F25) to the body 1 and the lid 2 so as to completely close the capsule C by combining them is provided.

  At least one of the pins 24 and 25 imparts a twisting motion to the capsule C while the capsule C is closed so that the sealing material spreads more evenly over the overlapping area (arrow 26). Is provided.

  The capsule filling device 4 further comprises a station 27 for drying and delivering the capsule C. This station 27 is arranged downstream of the closing station 7 in the circular path P1 (FIGS. 2 and 6).

  In more detail, the drying / delivery station 27 comprises a capsule conveyor belt 12 located, for example, in the vicinity of and below the second turret 28 for sealing and closing the capsules C.

  The surface of the belt 28 has a plurality of sheets 29 each containing one capsule C so as to remain in a stable position until the capsule C is released, and the capsule C extends from the sheet 13a to the sheet 29 in the vertical direction V ( (See the arrows in FIG. 6).

  Of course, the capsule filling device manufactured in this way and carrying out the method described above ensures that the capsule is sealed in the capsule filling device before the capsule is closed. To achieve.

  More specifically, the sealing method according to the present invention produces a sealed capsule by operating in an appropriate manner before being sent out from a capsule filling apparatus that performs the method without leakage of the material in the capsule. This provides a particularly significant advantage with respect to the speed at which the sealing process is carried out.

  Furthermore, since the capsule filling, closing and sealing are performed in the same apparatus, the space occupied for manufacturing is greatly reduced, and the cost can be reduced.

  In addition, the method of the present invention can be used for various types of sealing materials depending on the operating requirements depending on, for example, the specific prescription or type of material filled in the capsule.

  It should be understood that the invention described in this specification can be modified and applied in various forms without departing from the scope of the present invention. Moreover, all technical details can be replaced by equivalent elements.

FIG. 6 is a schematic diagram showing a series of steps applied to a capsule of the type having a lid and a body, and constituting the method of the present invention. 1 is a plan view of a capsule filling apparatus for carrying out the method of the present invention for producing a sealed capsule, with a portion cut away for clarity. FIG. 3 is a partial cross-sectional side view of the operating region of the capsule filling device of FIG. 2 with a portion removed for clarity. FIG. 4 is a partial cross-sectional side view of another operating region of the capsule filling device of FIG. 2 with a portion cut away for clarity. FIG. 4 is a partial cross-sectional side view of yet another operational region of the capsule filling device of FIG. 2 with a portion cut away for clarity. FIG. 6 is a partial cross-sectional front view of yet another operating region of the capsule filling device of FIG. 2 with a portion cut away for clarity.

Claims (25)

A method for producing a sealed capsule (C) defined by a body (1) coupled with a lid (2), respectively, wherein the body (1) of the capsule is filled with a large amount or a dose of material (3) And closing the capsule (C) by positioning the lid (2) on the body (1) such that the annular end (1a, 2a) of the lid (2) and the body (2) overlap. In a production method comprising at least
The method further comprises applying a sealing material to at least one of the overlapping annular ends (1a, 2a) of the capsule body (1) and lid (2), the sealing step being performed before the capsule is closed. A manufacturing method, wherein the manufacturing method is performed.   2. A method as claimed in claim 1, characterized in that the step of applying the sealing substance is carried out almost simultaneously with when the lid (2) is overlapped with the body (1).   The method according to claim 1, characterized in that the step of applying the sealing substance is performed immediately after the lid (2) is partially overlapped with the body (1).   In the step of applying the sealing substance, at least the body (1) of the capsule rotates about its longitudinal axis (Z) so that the sealing substance is applied to the annular end (1a) of the body (1). The manufacturing method according to claim 1, wherein the manufacturing method is performed during the operation.   The step of applying the sealing material includes the step of applying the body (1) and the lid (2) so that the sealing material is applied to the annular ends (1a, 2a) of the body (1) and the lid (2). The manufacturing method according to claim 1, wherein the manufacturing method is performed while rotating around the longitudinal axis (Z).   The manufacturing method according to claim 1, wherein the step of applying the sealing substance is performed by spraying.   The manufacturing method according to claim 1, wherein the sealing material comprises an aqueous mixture comprising at least water and ethanol.   The manufacturing method according to claim 1, wherein the sealing material comprises a cellulose-based liquid material.   7. The method according to claim 1, wherein the sealing material comprises a gelatin-based liquid material.   The step of closing the capsule (C) is followed by a step of drying the capsule (C) while the sealed capsule (C) is held in a stable position. 10. The production method according to any one of 9 above.   The manufacturing method according to claim 10, wherein the drying step is performed during a step of transferring the capsule toward the capsule collecting container. Capsule filling device (4) for producing a sealed capsule comprising a lid (2) and a body (1) containing a pharmaceutical material, the station (5) delivering the body (1) and lid (2) of the capsule The body (1) of each capsule is filled with a dose of material, and the body (1) is overlapped with the lid (2) and the annular end (2a, 1a) of the body (1). 1) In a capsule filling device comprising a station (7) for closing a capsule (C) by placing a lid (2) thereon
Capsule filling, characterized in that at least one intermediate working station for applying a sealing substance in the vicinity of the end (1a, 2a) is provided between the dose station (6) and the closure station (7) apparatus.   The intermediate working station (8), in turn, comprises a substation (9) for preliminarily joining the capsule body (1) and lid (2) to each other and a substation (10) for applying the sealing substance. The capsule filling device according to claim 12, comprising:   The intermediate station (8) further comprises a first turret (11) for moving the capsule (C) along a circular path (P) extending at least through the feed station (5) and the dose station (6). Is an independent second turret (12) that rotates about the axis (Z ') in the pre-bonding substation (9), the substation (10) for applying the sealing substance and the capsule (C ), And the second turret (12) comprises a plurality of means (13) for holding the capsule (C), the means (13) being the diameter of the second turret (12). 14. A device according to claim 12 or 13, characterized in that it is mounted in a direction and acts in conjunction with means (14) for operating the body (1) and the lid (2). Capsule filling device.   The operating means is disposed in the vicinity of the holding means (13), includes a first means (15) that moves in both vertical directions and generates a vacuum, and is provided in a rotation path (P1) of the second turret (12). Along the body (1) and the lid (2) and positioned so as to partially overlap each other in the holding means (13), ie the ends (1a, 1b) of the body (1) and the lid (2) The body (1) and the lid (2) in contact with each other are transferred to the second turret (12), and the body of the capsule so that the sealing material spreads evenly in the station (10) for applying the sealing material. (1) The step of rotating the lid (2) and the step of closing the capsule (C) by bringing the body (1) and the corresponding lid (2) close to each other are performed. To, capsule filling device of claim 14.   The holding means (13) comprises, for each capsule (C), a concave end sheet (13a) which is disposed on the second turret (12) and accommodates the capsule body (1) and lid (2). The sheet (13a) comprises a central cavity (13b) separating the sheet (13a) into two parts and radially extending conduits (16, 17) leading to these parts (16, 17). 17) When the body (1) and the lid (2) move to the sub-station (9, 10) and the closing station (7), the part holds the part of the body (1) and the lid (2). 16. Capsule filling device according to claim 14 or 15, characterized in that it is connected to a second means (18) for creating a vacuum that enables   The operating means (14) is a pair of hollow cylindrical pins (19, 20) arranged on both sides of the second turret (12) and provided with the first vacuum means (15) in the pre-coupling station (9, 10). These cylindrical pins (19, 20) are in contact with the body (1) and the lid (2) disposed on the first turret (11) on both sides, and the body (1) and the lid (2) 17. Capsule filling device according to any one of claims 14 to 16, characterized in that it comprises operating means (21) for transferring in a vertical direction to the second turret (12) while partially overlapping.   The operating means (14) is in contact with the lower part of the body (1) through the first vacuum means (15) and partially overlaps the lower part (1) and the lid in the seal substation (10). Capsule filling device according to any one of claims 14 to 17, characterized in that it comprises at least one cylindrical pin (22) that rotates (2) about a longitudinal axis (Z).   The sealing substation (10) faces the body (1) and / or lid (2) when the second turret (12) is rotating the body (1) and / or lid (2) of each capsule. At least one spray nozzle (23) that sprays the sealing substance onto the overlapping annular ends (1a, 2a) uniformly. Capsule filling device according to any one of claims 14 to 18, characterized in that it is positioned at the overlapping annular ends (1a, 2a) of 2).   Capsule filling device according to claim 19, characterized in that the nozzle (23) is designed to spray an aqueous mixture comprising at least water and ethanol.   Capsule filling device according to claim 19, characterized in that the nozzle (23) is designed to spray a cellulose-based liquid substance.   Capsule filling device according to claim 19, characterized in that the nozzle (23) is designed to spray gelatin based liquid substances.   The operating means (14) is arranged on both sides of the second turret (12) in the closing station (7) and a first vacuum means (15) for holding the body (1) and the lid (2). A pair of hollow cylindrical pins (24, 25) comprising: these cylindrical pins (24, 25) can only stably contact the body (1) and the lid (2) on both sides. Instead, the body (1) and the lid (2) are provided with a linear operating means (21) which applies an opposing force to completely close the capsule (C), and at least one pin (24) closes the capsule. 23. Capsule filling device according to any one of claims 14 to 22, characterized in that it comprises rotational operating means (26) so as to apply a twisting motion to the capsule (C) in between.   It further comprises a station (27) for drying the sealed capsule (C), which is located on the circular feed path (P1) followed by the capsule (C) and downstream of the closing station (7). The capsule filling device according to any one of claims 12 to 23, wherein   The drying station (27) comprises a capsule conveyor belt (28) disposed adjacent to and below the second turret (12) for sealing and closing capsules (C), the conveyor belt (28) has a plurality of sheets (29) each designed to accommodate one capsule (C) on its surface, each capsule (C) being maintained in a stable position 25. Capsule filling device according to claim 24, characterized in that it is transported in the vertical direction (V) from the closing station (7) to the sheet (29) by operating means (14), respectively.

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