JP2013203523A - Web position adjustment method, web bonding method, manufacturing method of orally administered drug, and manufacturing device of orally administered drug - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a web position adjustment method which can facilitate adjustment of a web conveying position, a web bonding method which can improve accuracy of a bonding position between webs, and a manufacturing method and a manufacturing device of an orally administered drug, which can improve the manufacturing yield.SOLUTION: In a web position adjustment method, a notch 130 crossing to the conveying direction of a web (a first laminated body) 10 is formed at one or more positions along the width direction of the web 10 in more inside than the end portion of the width direction of the web 10. The web 10 formed with the notch 130 is applied with tension toward at least either more upstream or downstream in the conveying direction of the web 10 than the notch 130 to adjust a position of the conveying direction of the web 10.

Description

  The present invention relates to a web position adjustment method, a web bonding method, a method for producing an oral administration agent, and an apparatus for producing an oral administration agent.

Conventionally, it has been demanded to improve the ease of swallowing and to completely mask the taste, smell, etc. of drugs contained in oral administration agents. Oral administration agents in which a drug is encapsulated between two water-swellable gel-forming layers have been developed (see, for example, Patent Document 1 and Patent Document 2).
Patent Document 1 discloses a method for producing an orally administered drug in which a drug-containing layer containing a drug or the like is enclosed. Specifically, a first laminate in which a first water-swellable gel-forming layer is laminated on a holding substrate, a second water-swellable gel-forming layer on another holding substrate, and this second water-swelling An orally-administered agent is produced by laminating a second laminate obtained by laminating a drug-containing layer on an adhesive gel-forming layer and punching it into a circular shape or the like to obtain individual pieces.
In Patent Document 2, a recess is formed in the first water-swellable gel-forming layer, a drug is accommodated in the formed recess, and a second water-swellable gel-forming layer is formed on the first water-swellable gel-forming layer. And the manufacturing method which joins a crevice peripheral part and encloses a medicine is indicated.

In addition to the method for producing the oral administration agent described in Patent Document 1 and Patent Document 2, as a third production method, the first water-swellable gel-forming layer is previously press-molded together with the holding substrate to form the recess. After preparing the first laminated body formed and the second laminated body in which the second water-swellable gel-forming layer was formed in advance by press molding together with the holding base material, and containing the drug in one concave part, A manufacturing method has also been developed in which the first laminate and the second laminate are bonded together with the recesses facing each other, and the drug is enclosed in a housing space formed by the recesses.
The third method for producing such an orally administered agent is carried out using a laminate (web) in which a water-swellable gel-forming layer is formed on a long support substrate. Specifically, while intermittently transporting the long laminate, press forming step for forming the recesses, bonding step between the laminates, punching step for individualization, To implement.

JP 2005-289868 A International Publication No. 2008/129730

By the way, in the 3rd manufacturing method of an oral administration agent, when bonding a 1st laminated body and a 2nd laminated body, it is necessary to match | combine the position of a mutual recessed part with a sufficient precision. If the positions of the recesses are not precisely matched and bonded, there is a risk that the recesses may be punched out or the drug may protrude from the recesses in the step of separating into pieces. That is, there is a possibility that the production yield of the orally administered agent is lowered.
For this reason, conventionally, the first laminated body and the second laminated body are formed by forming a through hole in the laminated body to be conveyed, and inserting a positioning pin formed on the conveying conveyor of the laminated body into the through hole. And positioning of the pasting. Positioning is performed by applying a tension to one of the first laminate and the second laminate, and inserting the through holes of both laminates into the same positioning pin.
However, in such a positioning method, the laminated body to which tension is applied extends and the shape of the concave portion is deformed, or the position of the opposing concave portion is shifted, and the drug is exposed when separated into pieces. There is a problem. Since the level of positional accuracy of the laminated body required as an oral administration agent is high, the conventional manufacturing method does not have sufficient positional accuracy of the laminated body, and further improvement in accuracy is desired.
Moreover, not only the manufacturing method of the above-mentioned oral administration agent, When sticking together the web supplied and conveyed intermittently or continuously, or when performing printing several times in the same position on a web However, there is a demand for improving the alignment accuracy by making it easy to adjust the position of the web in the conveyance direction.

  An object of the present invention is to provide a web position adjusting method capable of easily adjusting the position in the conveyance direction of the web. The second object of the present invention is to provide a web bonding method capable of improving the accuracy of the bonding position between webs. The third object of the present invention is to provide a method for producing an oral administration agent and an apparatus for producing the oral administration agent that can suppress a decrease in production yield.

The web position adjusting method of the present invention includes:
Forming at least one notch extending in the width direction of the web on the inside of the width direction end of the web, extending in a direction intersecting the web conveyance direction;
A tension is applied to the web in which the incision is formed toward at least one of an upstream side and a downstream side in the web conveyance direction with respect to the notch, and the position in the web conveyance direction is adjusted. And

In the web position adjusting method of the present invention,
Forming the incisions at a plurality of locations along the width direction of the web;
Of the plurality of cuts, it is preferable that the direction in which one cut extends and the direction in which the other cut extends do not coincide with each other.

The web laminating method of the present invention is
A web laminating method for laminating a first web and a second web,
Forming a cut in a direction intersecting with the conveyance direction of the first web at one or more locations along the width direction of the first web, inside the width direction end of the first web;
A tension is applied to the first web in which the incision is formed toward at least one of the upstream side and the downstream side in the transport direction of the first web from the notch, and the transport direction position of the first web is determined. Adjusting, and
A step of bonding the first web whose transport direction position is adjusted and the second web to each other.

The method for producing the orally administered agent of the present invention comprises:
A method for producing an oral administration agent, wherein a drug is contained in a recess formed in at least one of a first web and a second web, and an oral administration agent is produced by laminating both webs,
Forming a recess for accommodating the drug in at least one of the first web and the second web to be conveyed;
Forming a cut in a direction intersecting with the conveyance direction of the first web at one or more locations along the width direction of the first web, inside the width direction end of the first web;
Containing the drug in the recess;
A tension is applied to the first web in which the incision is formed toward at least one of the upstream side and the downstream side in the transport direction of the first web from the notch, and the transport direction position of the first web is determined. Adjusting, and
Bonding the first web and the second web, the position of which is adjusted in the conveying direction, and sealing the drug contained in the recess with the first web and the second web;
After the first web and the second web are bonded together, the peripheral portion of the recess is punched out, and the drug is sealed and separated into individual pieces.

An apparatus for producing an orally administered agent of the present invention comprises:
An apparatus for producing an orally administered agent that contains a drug in a recess formed in at least one of a first web and a second web, and produces an orally administered agent by bonding both webs,
A concave portion forming device having a convex shape and a concave shape, and forming a concave portion for accommodating the drug by pressing at least one of the first web and the second web;
It has a cutting blade attached along the direction crossing the conveyance direction of the first web, and is one or more along the width direction of the first web inside the width direction end of the first web. An incision forming device for inserting the incision blade into,
A drug storage device for storing the drug in the recess;
A tension applying mechanism that applies tension to at least one of an upstream side and a downstream side in the transport direction of the first web with respect to the first web in which the cut is formed; and the first web; A bonding device having a pressing device for pressing and bonding the second web;
A punching blade having a shape along the peripheral edge of the recess, and after the first web and the second web are bonded together, the peripheral edge of the recess is punched out and the drug is sealed in an individual state. And a punching device for separating.

In the web position adjusting method of the present invention, a notch in a predetermined direction is formed in the web. Specifically, the notch is formed in one or more locations along the width direction of the web, in the direction intersecting with the web conveyance direction and inside the width direction end of the web. In the present invention, tension is applied to the web in which the cut is formed toward at least one of the upstream side and the downstream side in the web conveyance direction with respect to the cut.
According to the present invention, the portion in which the cut is formed is easily stretched. Therefore, when tension is applied to the web, the portion in which the cut is formed is stretched, and the web conveyance direction position is easily adjusted.
In addition, in the present invention, the notch includes not only a linear notch but also a narrow through hole, a dot-like through hole, and the like, so that the portion of the web where the notch is formed is easily stretched. Any shape is acceptable.

  In the web position adjusting method of the present invention, cuts are formed at a plurality of locations along the width direction of the web, and the direction in which one cut extends and the direction in which the other cut extends is collinear. Do not become. Therefore, it is possible to make the web difficult to tear when tension is applied to at least one of the upstream side and the downstream side in the web conveyance direction. In other words, if it is formed so that the direction in which the cut extends is on the same straight line, it will be easily perforated as a perforation, but by forming it so as not to be on the same straight line as in the present invention, When tension is applied, the web is less likely to tear. Furthermore, by making a plurality of cuts, not only a certain position is extended in the width direction, but adjustment can be made so as to extend more uniformly in the width direction.

In the web bonding method of the present invention, a step of forming a cut in a predetermined direction is performed on the first web bonded to the second web. Specifically, the cut in the direction intersecting with the conveyance direction of the first web is formed at one or more locations along the width direction of the first web, inside the width direction end of the first web. And the tension | tensile_strength which goes to at least any one of the upstream and downstream of the conveyance direction of a 1st web rather than a notch is provided with respect to the 1st web in which the cut was formed, and the conveyance direction position of a 1st web is adjusted. . Then, the 1st web by which the conveyance position was adjusted, and the 2nd web are bonded together.
Therefore, as in the description of the web position adjusting method of the present invention described above, the first web is easily extended toward at least one of the upstream side and the downstream side in the transport direction by forming the cut in the predetermined direction. . Therefore, according to the present invention, the position of the first web in the conveyance direction can be easily adjusted, and the accuracy of the bonding position between the first web and the second web can be improved.
The web bonding method of the present invention can also be applied when three or more webs are bonded. In addition, the cut in the direction intersecting the web conveyance direction is not limited to the first web, and may be formed on other webs such as the second web.

In the method for producing an orally administered agent of the present invention, a cut in a predetermined direction is formed in the first web, as in the above-described method of laminating a web of the present invention. Therefore, the accuracy of the bonding position between the first web and the second web can be improved.
Further, in the case where a recess is formed in the first web in addition to the notch and the drug is accommodated in the recess, according to the present invention, the position of the recess is, for example, relative to the supply port of the drug supply nozzle of the drug storage device The position can be adjusted accurately.
Furthermore, when the first web and the second web have recesses, the drug is accommodated in an accommodation space formed by bonding together to form the recesses. In this case, if the position of the concave portion of the first web and the position of the concave portion of the second web are not precisely matched and bonded, the concave portion is not punched in the step of separating into pieces. There is a risk that the drug may protrude from the recess. That is, there is a possibility that the production yield of the orally administered agent is lowered.
However, in the present invention, since the first web can be easily extended in the transport direction, the alignment accuracy between the concave portions of the first web and the second web can be improved. Therefore, according to this invention, the fall of the manufacturing yield of an oral administration agent can be suppressed.
In addition, the manufacturing method of the oral administration agent of this invention is applicable also when manufacturing by bonding together 3 or more webs. In addition, the cut in the direction intersecting the web conveyance direction is not limited to the first web, and may be formed on other webs such as the second web.

  The apparatus for producing an orally administered agent of the present invention can implement the above-described method for producing an orally administered agent of the present invention. Therefore, according to this invention, there exists an effect similar to the manufacturing method of the above-mentioned oral administration agent, and the fall of the manufacturing yield of an oral administration agent can be suppressed.

1 is a schematic cross-sectional view of an orally administered agent produced by a production method according to a first embodiment of the present invention. It is the schematic of the manufacturing apparatus of the oral administration agent which concerns on said 1st embodiment. It is a top view of the 1st laminated body used with the manufacturing method which concerns on said 1st embodiment. It is the schematic which shows the incision forming apparatus with which the manufacturing apparatus of the oral administration agent which concerns on said 1st embodiment is provided. It is a top view of the 2nd layered product used with the manufacturing method concerning said 1st embodiment. It is a cross-sectional schematic diagram which shows the state by which said 1st laminated body and said 2nd laminated body are bonded together and conveyed. It is a top view of the 1st laminated body and the 2nd laminated body after the medicine was enclosed. It is a top view of the laminated body which shows the variation of the shape of a notch.

Embodiments of the present invention will be described below.
In this embodiment, a web position adjusting method and a web laminating method of the present invention will be described by taking a production apparatus and a production method of an oral administration agent as examples.

(Oral administration)
FIG. 1 is a cross-sectional view of an oral administration agent 1 produced by the method for producing an oral administration agent according to the first embodiment.
As shown in FIG. 1, the oral administration agent 1 includes a first water-swellable gel-forming layer 11 and a second water-swellable gel-forming layer 21 provided in the outermost layer, and water-swellable gel-forming layers 11 and 21. And drug 3 encapsulated in between. A recess 110 is formed in the first water-swellable gel-forming layer 11, and a recess 210 is formed in the second water-swellable gel-forming layer 21. The drug 3 is enclosed in the accommodation space S formed by bonding the conductive gel forming layer 21 together. Further, around the drug 3, the first water-swellable gel-forming layer 11 and the second water-swellable gel-forming layer 21 are joined.

  The drug 3 is usually stored in a state where it is formulated into an appropriate dosage form such as a tablet, powder, film, etc. In this embodiment, the case where the drug 3 is a tablet will be described as an example. . The drug 3 is a drug to be administered to a patient or the like, and is not particularly limited as long as it is a drug that can be administered orally. One type or two or more types can be selected and sealed according to the purpose of treatment / prevention.

The water-swellable gel-forming layers 11 and 21 are layers that contain a water-swellable gel-forming agent and can swell with moisture to form a gel.
The thickness dimensions of the water-swellable gel-forming layers 11 and 21 can be appropriately adjusted within a range that can be administered orally, but are preferably 10 μm or more and 1000 μm or less, and more preferably 20 μm or more and 500 μm or less. . When the thickness of the water-swellable gel-forming layers 11 and 21 is less than 10 μm, the masking action such as the taste and odor of the drug by the water-swellable gel-forming layers 11 and 21 becomes insufficient, and the mechanical strength is further increased. (Tensioning, rupture, tearing, etc.) may be insufficient, and may be broken during the manufacturing process to reduce the yield. On the other hand, if the thickness dimension of the water-swellable gel-forming layers 11 and 21 exceeds 1000 μm, the saliva alone will swell enough to form a gel when administered into the oral cavity of a patient, etc. In addition, since the thickness of the whole oral administration agent is increased, it becomes difficult to take it over the throat.

The type of the water-swellable gel-forming agent contained in the water-swellable gel-forming layers 11 and 21 is not particularly limited as long as it can swell with water to form a gel, and is a crosslinked one. Or it may not be crosslinked.
Examples of the water-swellable gel-forming agent include carboxyvinyl polymer, starch, starch derivative, agar, alginic acid, arabinogalactan, galactomannan, cellulose, cellulose derivative, carrageen, dextran, tragacanth, gelatin, pectin, hyaluronic acid, gellan gum , Collagen, casein, xanthan gum, etc., and one or more of these can be selected and used.

The water-swellable gel-forming agent contained in the water-swellable gel-forming layers 11 and 21 is preferably a crosslinked carboxyvinyl polymer, and particularly preferably a crosslinked polyacrylic acid. Cross-linked carboxyvinyl polymers, particularly cross-linked polyacrylic acid, do not adversely affect the film-forming ability of the film-forming agent and can exhibit a moderate gel strength when swollen.
Crosslinking can be performed with a crosslinking agent depending on the type of molecule to be crosslinked. The carboxyvinyl polymer can be crosslinked by, for example, a polyvalent metal compound. Specific examples of such polyvalent metal compounds include calcium chloride, magnesium chloride, aluminum chloride, aluminum sulfate, potassium alum, iron chloride alum, ammonium alum, ferric sulfate, aluminum hydroxide, aluminum silicate, and phosphoric acid. Aluminum, iron citrate, magnesium oxide, calcium oxide, zinc oxide, zinc sulfate and the like can be mentioned, and one or more of these can be selected and used.

  The amount of the water-swellable gel-forming agent contained in the water-swellable gel-forming layers 11 and 21 can be appropriately adjusted according to the type of the water-swellable gel-forming agent, but preferably the water-swellable gel-forming agent is formed. It is 15 mass% or more and 70 mass% or less of a layer. If the amount of the water swellable gel-forming agent is less than 15% by mass, the water swellability may be insufficient, and if it exceeds 70% by mass, the storage stability against humidity may decrease due to excessive water swellability. .

  The oral administration agent 1 needs to form the water-swellable gel-forming layers 11 and 21 in a film shape and further form a recess. Therefore, in order to improve the film formability of the water-swellable gel-forming layers 11 and 21, it is preferable that the water-swellable gel-forming layers 11 and 21 contain a film-forming agent.

  The type of the film forming agent is not particularly limited as long as it has film forming ability. Specific examples of the film forming agent include polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl acetate, polyvinyl acetate phthalate, hydroxyalkyl cellulose (for example, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose), alkylcellulose (for example, Methyl cellulose, ethyl cellulose), carboxyalkyl cellulose (for example, carboxymethyl cellulose), (meth) acrylic acid and its ester, xanthan gum, carrageenan, alginic acid, and the like. One or more of these may be selected and used. it can.

  The amount of the film-forming agent contained in the water-swellable gel-forming layers 11 and 21 can be appropriately adjusted according to the type of the film-forming agent, etc. 30% by mass or more and 85% by mass or less. If the amount of the film forming agent is less than 30% by mass, the film formability may be inferior, and if it exceeds 85% by mass, the water swellability may be insufficient.

  The film forming agent contained in the water-swellable gel-forming layers 11 and 21 is preferably water-soluble. When the film-forming agent is water-soluble, moisture easily enters the water-swellable gel-forming layers 11 and 21, and the water-swellable gel-forming layers 11 and 21 are rapidly swollen and gel-formed in the oral cavity. Can do.

  Examples of the water-soluble film forming agent include polyvinyl alcohol, hydroxyalkyl cellulose (for example, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose), polyvinylpyrrolidone, xanthan gum, carrageenan, alginic acid, and the like. More than one type can be selected and used.

  The water-swellable gel-forming layers 11 and 21 may contain a plasticizer in order to impart appropriate flexibility to the water-swellable gel-forming layers 11 and 21. Examples of the plasticizer include propylene glycol, polyethylene glycol, glycerin, sorbitol, glycerin triacetate, diethyl phthalate, triethyl citrate, lauric acid, sucrose, and the like. Can be used.

  The water-swellable gel-forming layers 11 and 21 may contain a masking agent for masking the taste, smell, etc. of the drug 3. When the water-swellable gel-forming layers 11 and 21 contain a masking agent, the masking action such as the taste and smell of the drug by the water-swellable gel-forming layers 11 and 21 can be improved. As the masking agent, for example, those that give acidity such as citric acid, tartaric acid, fumaric acid, sweeteners such as saccharin, glycyrrhizic acid, sucrose, fructose, mannitol, refreshing agents such as menthol, mint oil, peppermint, spearmint, Natural or synthetic fragrance | flavor etc. are mentioned, These 1 type (s) or 2 or more types can be selected and used.

  When the water-swellable gel forming layers 11 and 21 contain polyvinyl alcohol or the like as a film forming agent, these film forming agents can also serve as a masking agent. Thus, it is preferable to use a film forming agent having a masking action, and it is also preferable to use a water-swellable gel forming agent having a masking action.

  The water-swellable gel-forming layers 11 and 21 may contain preservatives such as methyl hydroxybenzoate and propyl hydroxybenzoate and colorants such as edible lake colorants.

  In general, mixing of additives into the water-swellable gel-forming layers 11 and 21 decreases the strength of the water-swellable gel-forming layers 11 and 21, so that water enters the water-swellable gel-forming layers 11 and 21. The water-swellable gel-forming layers 11 and 21 easily cause swelling and gel formation of the water-swellable gel-forming agent.

The water-swellable gel forming layers 11 and 21 may be used by laminating a plurality of layers such as two layers or three layers. An adhesive layer may be provided on the surface to be bonded to the other water-swellable gel-forming layers 11 and 21, and an adhesion preventing layer may be provided on the opposite surface.
The adhesion preventing layer is provided as a surface layer located on the outer surface of the water-swellable gel forming layers 11 and 21.
In addition, the adhesion preventing layer has a function of quickly dissolving with moisture such as saliva in the oral cavity and preventing the oral administration agent 1 (water-swellable gel-forming layers 11 and 21) from adhering to the inner wall of the oral cavity. ing.
By providing such an adhesion preventing layer, when the orally administered agent 1 is administered into the oral cavity, the surface portion of the adhesion preventing layer quickly dissolves in saliva, so that the adhesion preventing layer and the inner wall of the oral cavity are In the meantime, a liquid film is rapidly formed, and the oral administration agent 1 becomes slippery with respect to the inner wall. For this reason, the oral administration agent 1 is prevented from coming into contact with the inner wall, and is difficult to adhere to the inner wall of the oral cavity. Even if a part of the orally administered agent 1 adheres to the inner wall, the orally administered agent 1 is easily peeled off from the inner wall. As a result, it is possible to prevent the oral administration agent 1 from adhering to the inner wall and causing discomfort, and it is easy to swallow the oral administration agent 1. In addition, the drug can be reliably transported to the target site in the body. Moreover, it becomes possible to apply the medicine which exhibits an unpleasant taste (for example, a bitter taste, astringency, a feeling of numbness), an odor, etc. to the oral administration agent 1.

The material constituting the adhesion preventing layer (adhesion preventing agent) is not particularly limited, and examples thereof include hydroxyalkyl cellulose, polyethylene glycol, polypropylene glycol, polyvinyl alcohol, polyoxyl stearate, polyoxyethylene polyoxypropylene glycol, and polyoxyethylene. Water-soluble polymer materials such as hydrogenated castor oil, gum arabic and gelatin, erythritol, sorbitol, xylitol, mannitol, inositol, maltitol, lactitol, glucose, xylose, mannose, fructose, galactose, sucrose, fructose, sucrose, etc. Propylene glycol, glycerin and the like can be mentioned, and one or more of these can be used in combination. Examples of the hydroxyalkyl cellulose include hydroxypropyl cellulose, hydroxypropyl methylcellulose, methylcellulose and the like.
Among the above, the adhesion preventing layer preferably contains a water-soluble polymer material as an adhesion preventing agent. The water-soluble polymer material can be suitably dissolved in moisture and has a molecular chain with an appropriate length. For this reason, the water-soluble polymer material can appropriately intertwine the molecular chains of a plurality of water-soluble polymers constituting the aqueous solution, and more reliably the aqueous solution around the oral administration agent 1 when eluted from the adhesion preventing layer. Can be unevenly distributed. For this reason, it is prevented that the oral administration agent 1 adheres to the inner wall of an oral cavity reliably over a longer period. In addition, the water-soluble polymer material as described above can also function as a base for the adhesion preventing layer, can facilitate the production of the water-swellable gel-forming layers 11 and 21, and has been produced. The durability of the water-swellable gel-forming layers 11 and 21 during storage can be made particularly excellent. In particular, among the above-mentioned water-soluble polymer materials, when at least one selected from hydroxypropylmethylcellulose, polyethylene glycol and polyvinyl alcohol is used, the above-described effects can be obtained more remarkably.
Further, the adhesion preventing layer may contain components other than those described above. For example, the adhesion preventing layer may include the above-described plasticizer, masking agent, preservative, colorant and the like.

The adhesive layer is a layer having a function of adhering the peripheral portions of the pair of water-swellable gel-forming layers 11 and 21, and is provided on the concave portions 110 and 120 side. The material constituting the adhesive layer is not particularly limited, but is preferably composed of at least one material selected from the group consisting of polyvinyl pyrrolidone, polyvinyl acetate, and vinyl acetate / vinyl pyrrolidone copolymer. Thereby, it becomes possible to join the water-swellable gel-forming layers 11 and 21 easily by heat.
Further, the adhesive layer may contain components other than those described above. For example, it may contain the aforementioned plasticizer, masking agent, preservative, colorant and the like.
In addition, at least one of the water-swellable gel-forming layer 11 and the water-swellable gel-forming layer 21 may be a layer having an adhesive function.

(manufacturing device)
Next, an apparatus for producing an oral administration agent according to this embodiment will be described.
FIG. 2 shows a schematic diagram of an apparatus 5 for producing an oral administration agent according to this embodiment. The manufacturing apparatus 5 uses the first laminate 10 as the first web having the first water-swellable gel-forming layer 11 and the second laminate 20 as the second web having the second water-swellable gel-forming layer 21. Thus, the oral administration agent 1 shown in FIG. 1 is produced.

FIG. 2 shows a schematic cross-sectional view of the first laminated body 10 and the second laminated body 20 supplied to the manufacturing apparatus 5 during conveyance. The first laminated body 10 includes an elongated support base 12, a first water-swellable gel-forming layer 11 laminated on the support base 12, and a protection laminated on the first water-swellable gel-forming layer 11. A base 13. The second laminated body 20 includes a long support base 22, a second water-swellable gel-forming layer 21 laminated on the support base 22, and a protection laminated on the second water-swellable gel-forming layer 21. A base 23.
The supporting bases 12 and 22 to be used are not particularly limited as long as the water-swellable gel forming layers 11 and 21 can be formed on the surfaces thereof. Examples include resin films such as polyethylene terephthalate film, polybutylene terephthalate film, polypropylene film, polyethylene film, polyacetate film, and polyvinyl chloride film, and paper such as laminated paper such as glassine paper, clay coated paper, and polyethylene laminated paper. It is done. The surfaces of these support bases 12 and 22 may be subjected to a release treatment with a silicone release agent or the like, if necessary. Further, as the protective bases 13 and 23, the same materials as those described for the support bases 12 and 22 can be used, and further, a peeling process may be performed if necessary.

  The manufacturing apparatus 5 includes a first supply device 51 that feeds out the first laminate 10, a first press device 52 as a recess forming device that forms the recess 110 in the first laminate 10, and a conveyance direction of the first laminate 10. A first notch forming device 53 that forms a cut 130 in a direction intersecting with the second laminated body 20, a second supply device 54 that feeds out the second laminated body 20, and a first concave portion forming apparatus that forms the concave portion 210 in the second laminated body 20. A two-press device 55, a drug containing device 56 for containing the tablet-like drug 3 in the recess 210, a first laminate 10A from which the protective substrate 13 has been peeled off, and a second laminate 20A from which the protective substrate 23 has been peeled off are attached. A bonding device 57 to be combined, a heat seal device 58 that heat-seals the periphery of the site in which the drug 3 is stored, a second incision forming device 59 that forms an incision in the first laminate 10A along the transport direction, and a drug There and a punching device 60 to punch the periphery of the site housed.

First, the apparatus until the 1st laminated body 10 drawn | fed out from the 1st supply apparatus 51 turns into the 1st laminated body 10A, and is bonded with the 2nd laminated body 20A with the bonding apparatus 57 is demonstrated.
The first supply device 51 includes a support roller 512 that is rotatably provided by a rotation motor 511 as a drive device. The support roller 512 supports the long first laminated body 10 wound in a roll shape. The first laminated body 10 fed out from the support roller 512 is supplied to the first press device 52 while being guided in the conveyance direction by a guide roller.

The first pressing device 52 forms the concave portion 110 in the first laminate 10 as described above, and positioning holes 120 for positioning when the first laminate 10A and the second laminate 20A are bonded together (FIG. 3). Reference).
FIG. 3 shows a plan view of the first laminated body 10 </ b> A as viewed from the support base 12 side, and shows the positions where the concave portions 110 and the positioning holes 120 formed by the first press device 52 are formed. Note that FIG. 3 also shows the formation position of the notch 130 formed by a first notch forming device 53 described later.
The first press device 52 includes two molds, that is, a convex mold 521 and a concave mold 522. The convex mold 521 and the concave mold 522 can be brought close to and separated from each other by a linear motor as a driving device, and the conveyed first laminated body 10 is sandwiched between and pressed. In the present embodiment, the convex mold 521 presses the first laminated body 10 from the protective base 13 side to thereby swell the concave part 110 that bulges to the support base 12 side, and the positioning hole that penetrates the front and back of the first laminated body 10. 120 are formed simultaneously.
It is preferable to form the concave portion 110 by applying heat to the two molds (the convex mold 521 and the concave mold 522) during the pressing. The mold 110 is heated by using a heating device having a heat source using a heating wire or the like, the first laminated body 10 that is in contact is softened to follow the shape of the mold, and the concave portion 110 that reproduces the mold shape more. Can be formed. The surface temperature of the mold at this time is preferably 60 ° C. or higher and 250 ° C. or lower, and more preferably 75 ° C. or higher and 150 ° C. or lower. If the temperature is less than 60 ° C, the reproducibility of the mold shape may not be sufficient. If the temperature exceeds 250 ° C, the first laminate 10 may be melted, and the first laminate 10 may be broken.
Furthermore, it is preferable to provide a mechanism for providing innumerable minute holes in the concave mold 522 of the mold and sucking through the holes. By performing the suction process with the concave mold 522 provided with the suction mechanism, the shape of the mold can be formed with higher reproducibility even if the shape of the concave portion 110 is complicated.
When the pressing process is performed once by the first press device 52, the recess 110 is formed in a total of four locations of 2 × 2 in the width direction and the longitudinal direction of the first laminate 10, and the positioning holes 120 are formed in the first laminate. A total of two locations are formed, one on the outside of the recess 110 in the width direction of the body 10.

The first insert forming device 53 includes a fixing jig 531 to which a plurality of cutting blades 53a are fixed, and a receiving jig 532 (see FIG. 2) for receiving the cutting blades 53a. When the first laminated body 10 is transported between the fixing jig 531 and the receiving jig 532, the fixing jig 531 is brought close to the receiving jig 532 side by a driving device (not shown) and is attached to the first laminated body 10. The cutting blade 53a is inserted to form the cutting 130.
FIG. 4 shows the positional relationship between the first laminate 10 and the first notch forming device 53 when the notch 130 is formed. The position where the cutting blade 53a is inserted is a position that avoids the positions of the recess 110 and the positioning hole 120 as shown in FIG. After the cut 130 is formed, the fixing jig 531 is separated from the receiving jig 532 by the driving device.

The fixing jig 531 has a plurality of mountain-shaped cut portions 53b, and has a plurality of blade fixing surfaces 53c that are inclined with respect to the transport direction of the first laminate 10 indicated by arrows in FIG. The blade fixing surfaces 53c are formed in parallel to each other. A cutting blade 53a is detachably attached to the blade fixing surface 53c.
In this embodiment, as shown in FIG. 4, the cutting blades 53 a are attached one by one on both ends in the width direction of the fixing jig 531, but on the inner side in the width direction, the cutting blade 53 a is attached. Two pieces are attached in piles. By attaching the cutting blades 53a in this way, the cuts 130 are formed in two stages in parallel with each other, and since there is no other cut 130 in the extending direction of the cut 130, it becomes difficult to tear. Also, since there are two cuts 130 in the web (first laminated body 10) conveyance direction, the stretch ratio is further improved when tension is applied in the web conveyance direction.
In addition, as shown in FIG. 4, there exists a site | part which does not attach the cutting blade 53a in the blade fixing surface 53c. This is to prevent the cuts 130 from being formed on the rows of the concave portions 110 aligned along the transport direction of the first stacked body 10.

In the present embodiment, the first cut forming device 53 forms a plurality of cuts 130 in a direction intersecting with the transport direction of the first stacked body 10 indicated by an arrow in FIG. In the present embodiment, among the plurality of cuts 130, the direction in which one cut 130 extends and the direction in which the other cut 130 extends are not formed on the same straight line.
In addition, it is preferable that the direction in which the cut 130 extends also intersects the direction orthogonal to the conveyance direction (the width direction of the first stacked body 10). Specifically, the angle θ (see FIG. 3) formed by the transport direction and the cutting direction is preferably 10 degrees to 85 degrees, and more preferably 20 degrees to 70 degrees. This is because if the cut is formed in such an angle range, the first laminate is more difficult to tear.
Further, when the cutting blade 53 a is inserted by the fixing jig 531, the cut 130 is formed along the width direction of the first stacked body 10 on the inner side of the end portion in the width direction of the first stacked body 10. In the present embodiment, as shown in FIG. 3, the plurality of cuts 130 are formed by being divided into three cut regions, and specifically, both end sides in the width direction of the first stacked body 10. And the central part side. A region where the cut 130 is not formed is provided between the cut regions in the width direction of the first stacked body 10.

A winding device 61 is provided on the downstream side in the transport direction from the first insertion forming device 53. The winding device 61 peels the protective substrate 13 from the first laminate 10 and winds it in a roll shape.
As shown in FIG. 2, the first laminated body 10 </ b> A from which the protective substrate 13 has been peeled is conveyed to the laminating device 57 with the first water-swellable gel-forming layer 11 exposed.

Next, the apparatus until the 2nd laminated body 20 drawn | fed out from the 2nd supply apparatus 54 becomes the 2nd laminated body 20A, and is bonded with 10 A of 1st laminated bodies with the bonding apparatus 57 is demonstrated.
Similarly to the first supply device 51, the second supply device 54 includes a support roller 542 that is rotatably provided by a rotation motor 541 as a drive device. The support roller 542 supports the long second laminated body 20 wound in a roll shape. The second laminated body 20 fed out from the support roller 542 is supplied to the second press device 55 while being guided in the transport direction by the guide roller.

The second pressing device 55 forms the recess 210 in the second laminate 20 supplied from the second supply device 54 as described above, and also applies the first laminate 10 and the second laminate 20 to each other. A positioning hole 220 for positioning (see FIG. 5) is formed.
FIG. 5 shows a plan view of the second laminate 20A as viewed from the second water-swellable gel-forming layer 21 side, and shows the positions where the recesses 210 and the positioning holes 220 formed by the second press device 55 are formed. Has been.
Similarly to the first press device 52, the second press device 55 includes two molds, that is, a convex die 551 and a concave die 552, which can be moved close to and away from each other by a direct acting motor as a driving device. The second laminate 20 is sandwiched and pressed. In this embodiment, the convex mold 551 presses the second laminated body 20 from the protective base 23 side to thereby swell the concave part 210 bulging to the support base 22 side, and the positioning hole penetrating the front and back of the second laminated body 20. 220 are formed simultaneously. The pressing condition can be carried out in the same manner as in the first press device 52. Further, the concave mold 552 may be provided with a heating device and a suction mechanism in the same manner as the first press device 52.
Further, in the present embodiment, as shown in FIG. 5, as in the case of the first laminated body 10, when the pressing process is performed once by the second press device 55, the concave portion 210 becomes the width of the second laminated body 20. A total of four locations of 2 × 2 locations are formed in the direction and the longitudinal direction, and the positioning holes 220 are formed in two locations, one location outside the recess 210 in the width direction of the second laminate 20.

A winding device 62 is provided on the downstream side in the transport direction from the second press device 55. The winding device 62 peels the protective substrate 23 from the second laminate 20 and winds it in a roll shape.
As shown in FIG. 5, the second laminated body 20 </ b> A from which the protective base 23 has been peeled is conveyed to the drug container 56 with the second water-swellable gel-forming layer 21 exposed.

  The drug storage device 56 is provided on the downstream side in the transport direction from the second press device 55, and stores the drug 3 in the recess 210 of the second water-swellable gel-forming layer 21. The drug container 56 includes a supply nozzle 561 for supplying the drug 3, and the supply port of the supply nozzle 561 is formed toward the recess 210. 20 A of 2nd laminated bodies in which the medicine 3 was accommodated are conveyed to the bonding apparatus 57. FIG.

The bonding apparatus 57 bonds the first laminated body 10A and the second laminated body 20A with the first water-swellable gel-forming layer 11 and the second water-swellable gel-forming layer 21 facing each other. .
As illustrated in FIG. 2, the bonding apparatus 57 is configured such that the first laminated body 10 </ b> A is wound around, and the bonding roll 571 guides the conveying direction of the first laminated body 10 </ b> A to match the conveying direction of the second laminated body 20 </ b> A. A conveyor 572 (see FIG. 6) that conveys the first laminate 10A and the second laminate 20A to the downstream side, and a pressing device 573 that presses the first laminate 10A toward the second laminate 20A. Prepare.

FIG. 6 is a schematic cross-sectional view illustrating a state in which the first stacked body 10 </ b> A and the second stacked body 20 </ b> A are bonded and transported by the transport conveyor 572.
A plurality of positioning pins 574 standing in a truncated cone shape at predetermined intervals are provided on the conveyor 572, and the second laminated body 20A has the bonding device 57 in a state where the positioning pins 574 are inserted into the positioning holes 220. It is conveyed from the upstream side. The positioning pins 574 are respectively formed in the width direction of the transport conveyor 572 so as to correspond to the positions of the positioning holes 220 respectively formed on the width direction end portion side of the second stacked body 20.

  The first laminate 10A is wound around the bonding roll 571 with the support base 12 inside, and the first water-swellable gel-forming layer 11 is the second laminate 20A in the bonding roll 571. Guide while rotating to face the water-swellable gel-forming layer 21. Then, 10 A of 1st laminated bodies are guided to the same conveyance direction as 20 A of 2nd laminated bodies by the bonding roll 571, and the positioning pin 574 is penetrated by the positioning hole 120. FIG.

The pressing device 573 is provided on the downstream side in the transport direction from the bonding roll 571, presses the first stacked body 10A toward the second stacked body 20A, and positioning holes 120 of the first stacked body 10A and the second stacked body 20A. , 220 is pushed deeper into the positioning pin 574. Then, the first stacked body 10 </ b> A and the second stacked body 20 </ b> A are overlapped closer to each other, and the drug 3 is stored in the storage space S formed by the recesses 110 and 210.
In addition, the positioning pin 574 formed in a truncated cone shape has a larger diameter as it goes downward. Therefore, the first laminated body 10A and the second laminated body 20A pushed by the pressing device 573 are pushed to a position where the diameter dimension of the positioning holes 120 and 220 and the diameter dimension of the positioning pin 574 are substantially coincident with each other. When pushed in this way, the first laminated body 10A and the second laminated body 20A have a tension T1 toward the downstream side in the conveying direction and a tension T2 toward the upstream side as shown in FIG. Is granted. That is, the tension applying mechanism in the present invention is configured by the positioning pins 574 of the transport conveyor 572 and the pressing device 573.

  The heat seal device 58 is provided on the downstream side in the transport direction with respect to the pressing device 573, and heat-seals the area around the part where the drug 3 is accommodated. The heat seal device 58 includes an annular seal disc 581 and an annular seal disc 582 having diameters larger than the diameters of the recesses 110 and 210, and are disposed to face each other. The annular seal discs 581 and 582 can be brought close to and separated from each other by a linear motion motor as a driving device, and sandwich and press the stacked bodies 10A and 20A which are conveyed in a superimposed manner. By performing heat sealing, the water-swellable gel-forming layers 11 and 21 are joined around the drug 3 and the drug 3 is sealed between them.

The second incision forming device 59 is provided on the downstream side in the transport direction from the heat seal device 58 and includes a incision blade 591. In the second cut forming device 59, a so-called half cut process is performed in which the cut 591a is cut only in the support base 12 of the first laminated body 10A along the transport direction. The mounting position of the cutting blade 591 is appropriately adjusted according to the thickness dimension of the support base 12.
FIG. 7 shows a plan view of the first laminate 10A and the second laminate 20A after the drug 3 is encapsulated as seen from the support base 12 side. As shown in FIG. 7, the cut 591 a is formed at a position that avoids the positions of the recesses 110 and 210 in which the drug 3 is enclosed, and does not overlap with the previously formed cut 130.

A winding device 63 and a winding device 64 are provided on the downstream side of the second cut forming device 59. The winding device 63 peels the support base 12 along the notch 591a so as to expose the part in which the drug 3 is enclosed along the transport direction, and winds the support base 12 in a roll shape.
Moreover, the winding device 64 peels the support substrate 22 entirely and winds it up in a roll shape. Therefore, the second water-swellable gel-forming layer 21 is conveyed in a state supported by the first laminate 10A.

  The punching device 60 is provided on the downstream side in the transport direction with respect to the heat seal device 58, and performs a process of punching out the periphery of the portion in which the drug 3 is accommodated. The punching device 60 includes a blade mold 601 having a punching blade and a receiving mold 602 that receives the cutting tool 601, and the blade mold 601 and the receiving mold 602 are arranged to face each other. The punching blade is formed in a shape along the peripheral edge of the recesses 110 and 210. The blade mold 601 and the receiving mold 602 can be brought close to and separated from each other by a linear motor as a driving device, and the first laminated body 10A conveyed and the second water-swellable gel-forming layer 21 supported by the first laminated body 10A. The laminated body 10B made of is sandwiched, and a punching blade is put around the site where the drug 3 is accommodated. Then, the drug 3 is separated into pieces while being sealed with the water-swellable gel-forming layers 11 and 21, and is taken out in the form of the above-mentioned oral administration agent 1.

  The manufacturing apparatus 5 of this embodiment conveys the laminated bodies 10 and 20 while being intermittently fed by the supply apparatuses 51 and 54. And the manufacturing apparatus 5 performs the above-mentioned press process, a cutting process, accommodation of a medicine, bonding, a heat seal, and a punching process in synchronization, while conveyance is stopped.

(Method for producing an orally administered agent)
Next, the manufacturing method using the manufacturing apparatus 5 of an oral administration agent is demonstrated.
The laminated bodies 10 and 20 used for manufacture of an orally administered agent are obtained as follows.
First, the water-swellable gel forming layers 11 and 21 are formed on the support bases 12 and 22. A composition for forming a water-swellable gel-forming layer is applied using a known coating apparatus such as a gravure coater, knife coater, roll coater, die coater, applicator, or sprayed using a known spray apparatus, and a supporting substrate A coating film of the composition for forming a water-swellable gel-forming layer is formed on 12 and 22. Next, the solvent is removed by drying to form the water-swellable gel-forming layers 11 and 21. Then, the laminated bodies 10 and 20 are obtained by bonding the protective bases 13 and 23 so as to cover the water-swellable gel-forming layers 11 and 21.

Next, the laminates 10 and 20 are wound into rolls and attached to the supply devices 51 and 54, respectively. And while feeding the 1st laminated body 10 with the 1st supply apparatus 51, the 2nd laminated body 20 is drawn out with the 2nd supply apparatus 54 (unfolding process of a laminated body).
Next, the first press unit 52 simultaneously molds the concave portion 110 and the positioning hole 120 with respect to the first laminate 10 fed from the first supply device 51, and the second laminate fed from the second supply device 54. The recessed part 210 and the positioning hole 220 are shape | molded with respect to the two laminated body 20 with the 2nd press apparatus 55 (recessed part formation process).
Next, a cut 130 is formed in the first laminated body 10 in which the recess 110 and the positioning hole 120 are formed by the first cut forming device 53 (cut forming process). In the present embodiment, the first laminated body 10 is conveyed downward in the vertical direction as shown in FIG. 2, and the cutting blade 53 a of the fixing jig 531 is inserted into the first laminated body 10 from the horizontal direction. .
After forming the cut 130, the protective substrate 13 is peeled off from the first laminated body 10, and wound into a roll by the winding device 61 (first protective substrate winding process). When the protective substrate 13 is peeled off, the first laminate 10A is conveyed with the first water-swellable gel-forming layer 11 exposed.
On the other hand, also about the 2nd laminated body 20, after forming the recessed part 210 and the positioning hole 220, the protection base | substrate 23 is peeled and it winds in roll shape with the winding device 62 (2nd protection base | substrate winding process). When the protective substrate 23 is peeled off, the second water-swellable gel-forming layer 21 is exposed, and the second laminate 20A is transported with the recess 210 facing upward. Then, the drug 3 is stored in the recess 210 by the drug storage device 56 (drug storage step).

Next, with the bonding apparatus 57, 10A of 1st laminated bodies and 20A of 2nd laminated bodies are bonded together. Positioning pins 574 of a conveyor 572 are inserted in advance in the positioning holes 220 of the second stacked body 20A, and the transport direction of the first stacked body 10A is changed to the transport direction of the second stacked body 20A by the bonding roll 571. While aligning, the positioning pin 574 is inserted into the positioning hole 120 of the first laminate 10A. Thereafter, the pressing device 573 presses the first laminated body 10 </ b> A toward the second laminated body 20 </ b> A, and pushes the positioning holes 120 and 220 to a deeper position of the positioning pins 574. By pressing in this way, the first stacked body 10A and the second stacked body 20A are overlapped and bonded together (bonding step). And the medicine 3 accommodated in the recessed part 210 of 20 A of 2nd laminated bodies is covered with the recessed part 110 of 10 A of 1st laminated bodies, and the state where the medicine 3 was accommodated in the accommodation space S formed by the recessed parts 110 and 210 become.
Further, by pressing with the pressing device 573, the first laminate 10A and the second laminate 20A are given a tension T1 toward the downstream side in the transport direction shown in FIG. Position adjustment in the conveyance direction of the one laminated body 10A and the second laminated body 20A is performed. At this time, by applying tension T1 and tension T2 to the first laminated body 10A, the portion where the cut 130 of the first laminated body 10A is formed is easily extended along the conveying direction, and the position in the conveying direction is set. It can be adjusted (conveyance direction position adjustment step).

Next, the heat sealing device 58 heat-seals the periphery of the site where the drug 3 is stored, and the drug 3 is placed between the first water-swellable gel-forming layer 11 and the second water-swellable gel-forming layer 21. Enclose (heat sealing process). After heat sealing, the second cut forming device 59 performs half-cut processing along the conveying direction to form a cut 591a (half-cut process).
After half-cutting, the support substrate 12 at the site where the drug 3 is encapsulated is peeled along the notch 591a, and the first water-swellable gel-forming layer 11 at the site where the drug 3 is encapsulated is exposed. The peeled support base 12 is wound up in a roll shape by the winding device 63.
Further, the support substrate 22 is entirely peeled from the second laminate 20 </ b> A, and the peeled support substrate 22 is wound up in a roll shape by the winding device 64.
In this way, a part of the support substrate 12 and the support substrate 22 are peeled off, and the thickness of the laminate 10B (the laminate comprising the first laminate 10A and the second water-swellable gel-forming layer 21 supported thereby). The portion in which the drug 3 is enclosed in the vertical direction is not sandwiched between the support bases 12 and 22 and the water-swellable gel-forming layers 11 and 21 are exposed, and then the laminate 10B is conveyed to the punching device 60. To do.
Then, the punching device 60 punches the periphery of the part in which the drug 3 is accommodated, and the drug 3 is separated into pieces in a state of being sealed with the water-swellable gel-forming layers 11 and 21 (individualization step). What is singulated in this way is the above-mentioned oral administration agent 1.

(Function and effect)
According to the manufacturing method of the above-mentioned oral administration agent 1, there exist the following effects.
In the manufacturing method of the oral administration agent 1 of this invention, the notch | incision 130 of several places is formed with respect to the 1st laminated body 10 in the direction which cross | intersects a conveyance direction. Further, the cuts 130 are formed at a plurality of locations along the width direction of the first stacked body 10 inside the widthwise end of the first stacked body 10.
Therefore, when the tension T1 toward the downstream side in the transport direction of the first stacked body 10A and the tension T2 toward the upstream side are applied, the first stacked body 10A easily extends toward the upstream side and the downstream side in the transport direction.
Therefore, according to the manufacturing method of the oral administration agent 1 of this invention, it is easy to adjust the conveyance direction position of 10 A of 1st laminated bodies. As a result, the accuracy of the bonding position between the first stacked body 10A and the second stacked body 20A can be improved.

  If no cut is formed, the first water-swellable gel-forming layer 11 and the support base 12 of the first laminate 10A are stretched by being elastically deformed or plastically deformed and extended toward the upstream side and the downstream side in the transport direction. It is difficult to stretch. If the first water-swellable gel-forming layer 11 is forcibly extended, the first water-swellable gel-forming layer 11 may be torn and the drug 3 may not be encapsulated. Further, if the support base 12 is also forced to extend, the shape of the recess 110 is deformed, and even if the support 3 is aligned with the recess 210 of the second laminate 20A, the drug 3 is formed from the accommodation space S formed by the recesses 110 and 210. May protrude. Further, if the positions of the concave portions 110 and 210 are not precisely matched and bonded, the concave portions 110 and 210 may be punched out in the individualizing process instead of the peripheral edge of the concave portions 110 and 210, or the concave portions 110 and 210 may be punched. There is a risk that the drug may protrude from the body. That is, there is a possibility that the production yield of the orally administered agent is lowered.

Moreover, in the manufacturing method of the oral administration agent 1 of this invention, it forms so that the direction where one notch 130 extends among the some notches 130 and the direction where the other notches 130 extend may not be on the same straight line. Yes. Further, each of the plurality of cuts 130 also intersects with a direction (width direction of the first stacked body 10) orthogonal to the transport direction of the first stacked body 10. That is, the angle formed by the transport direction and the direction in which the cut 130 extends is greater than 0 degrees and less than 90 degrees. Therefore, compared with the case where the direction in which the cut 130 extends is along the width direction of the first stacked body 10A, the first stacked body 10A is less likely to be torn when the tension T1 and the tension T2 are applied in the bonding process.
Moreover, since the notch 130 is formed inside the width direction edge part of 10 A of 1st laminated bodies, compared with the case where the cut is formed from the width direction edge part, 10 A of 1st laminated bodies are hard to tear. Become.

[Modification of Embodiment]
In addition, this invention is not limited to embodiment mentioned above, For example, the deformation | transformation as shown below is also included.
In the above embodiment, in order to make the first laminate 10 easily extend toward the upstream side and the downstream side in the transport direction, the cutting blade 53a is inserted linearly to form the cut 130. It is not limited to. In addition, the first laminated body 10 may be punched out with the same position dimensions as the cuts 130 to form narrow through holes.

The direction of the cut 130 is not limited to the form of being formed substantially parallel as in the above embodiment.
For example, a cut 130 as shown in FIGS. 8A to 8F may be formed in the web (first laminated body 10). Each incision 130 has at least a part of a portion extending in a direction intersecting with the web conveyance direction indicated by an arrow in FIG.

  In the embodiment described above, the two cutting blades 53a are attached to the blade fixing surface 53c in the width direction of the fixing jig 531 of the first insertion forming device 53, but the present invention is not limited to such a form. The cutting blades 53a may be attached to the blade fixing surface 53c of the fixing jig 531 one by one. Further, the cutting blade 53a may be attached in the direction intersecting with the cutting blade 53a to which the blade fixing surface 53c is attached, and the cutting may be formed in the direction intersecting with the cutting 130. In addition, the shape of the blade, the shape of the jig, and the attachment position of the blade can be appropriately changed according to the desired cutting shape.

In the said embodiment, although the example which formed the cut 130 in the 1st laminated body 10 side was shown, it is not limited to this aspect, You may form a cut also in the 2nd laminated body 20. FIG.
Moreover, in the said embodiment, although demonstrated taking the example of the method of bonding the 1st laminated body 10 and the 2nd laminated body 20, 3 or more sheets, such as bonding the 3rd laminated body as a 3rd web, are further bonded. The present invention can also be applied to the case where the webs are bonded together.

  In the said embodiment, although demonstrated taking the example of the apparatus and method which manufacture the oral administration agent 1 using the laminated bodies 10 and 20 as a web, it is not limited to this. For example, the present invention can also be applied when printing a plurality of times on a web. According to the present invention, it becomes easy to adjust the conveyance position of the web, and the alignment accuracy can be improved. As a result, printing misalignment can be prevented even when printing is performed at the same position, or when the first printing position and the second printing position are separated by a desired distance.

  The drug 3 encapsulated in the orally administered agent 1 is not limited to a tablet.

  INDUSTRIAL APPLICABILITY The present invention can be applied to a process for adjusting a position in the web conveyance direction and a process for adjusting a bonding position, in addition to a process for producing an orally-administered drug in which a drug is encapsulated between water-swellable gel-forming layers.

DESCRIPTION OF SYMBOLS 1 ... Oral administration agent 3 ... Drug 5 ... Manufacturing apparatus of oral administration agent 10 ... 1st laminated body (web)
110 ... concave 130 ... cut 20 ... second laminated body (web)
210: concave portion 52 ... first press device (concave forming device)
521 ... Convex type 522 ... Concave type 53 ... First cut forming device (cut forming device)
53a ... Cutting blade 55 ... Second press device (concave forming device)
551 ... Convex type 552 ... Concave type 56 ... Drug storage device 57 ... Bonding device 573 ... Pressing device 60 ... Punching device

Claims (5)

Forming at least one notch extending in the width direction of the web on the inside of the width direction end of the web, extending in a direction intersecting the web conveyance direction;
A tension is applied to the web in which the incision is formed toward at least one of an upstream side and a downstream side in the web conveyance direction with respect to the notch, and the position in the web conveyance direction is adjusted. Web position adjustment method. The web position adjusting method according to claim 1,
Forming the incisions at a plurality of locations along the width direction of the web;
The web position adjusting method, wherein a direction in which one of the plurality of cuts extends and a direction in which another cut extends are not on the same straight line. A web laminating method for laminating a first web and a second web,
Forming a cut in a direction intersecting with the conveyance direction of the first web at one or more locations along the width direction of the first web, inside the width direction end of the first web;
A tension is applied to the first web in which the incision is formed toward at least one of the upstream side and the downstream side in the transport direction of the first web from the notch, and the transport direction position of the first web is determined. Adjusting, and
A method for laminating a web, comprising the step of laminating the first web whose transport direction position is adjusted and the second web. A method for producing an oral administration agent, wherein a drug is contained in a recess formed in at least one of a first web and a second web, and an oral administration agent is produced by laminating both webs,
Forming a recess for accommodating the drug in at least one of the first web and the second web to be conveyed;
Forming a cut in a direction intersecting with the conveyance direction of the first web at one or more locations along the width direction of the first web, inside the width direction end of the first web;
Containing the drug in the recess;
A tension is applied to the first web in which the incision is formed toward at least one of the upstream side and the downstream side in the transport direction of the first web from the notch, and the transport direction position of the first web is determined. Adjusting, and
Bonding the first web and the second web, the position of which is adjusted in the conveying direction, and sealing the drug contained in the recess with the first web and the second web;
And a step of punching out a peripheral edge of the recess and separating the drug into a sealed state after pasting the first web and the second web. Manufacturing method. An apparatus for producing an orally administered agent that contains a drug in a recess formed in at least one of a first web and a second web, and produces an orally administered agent by bonding both webs,
A concave portion forming device having a convex shape and a concave shape, and forming a concave portion for accommodating the drug by pressing at least one of the first web and the second web;
It has a cutting blade attached along the direction crossing the conveyance direction of the first web, and is one or more along the width direction of the first web inside the width direction end of the first web. An incision forming device for inserting the incision blade into,
A drug storage device for storing the drug in the recess;
A tension applying mechanism that applies tension to at least one of an upstream side and a downstream side in the transport direction of the first web with respect to the first web in which the cut is formed; and the first web; A bonding device having a pressing device for pressing and bonding the second web;
A punching blade having a shape along the peripheral edge of the recess, and after the first web and the second web are bonded together, the peripheral edge of the recess is punched out and the drug is sealed in an individual state. An apparatus for producing an orally-administered agent, comprising: a punching device that divides into pieces.

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