JP2009280263A - Unit-dose drug product accommodating container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a container capable of packaging unit-dose drug product individually, while allowing easy extraction of the drug product. <P>SOLUTION: A unit-dose drug product accommodating container includes a resin part 20 formed of a resin having a translucency and formed by a plurality of hollow accommodating parts 22, each opened to accommodate a unit-dose drug product 10, being arranged in a grid, and a sheet part 30 for closing the opening parts of the accommodating parts 22 of the resin part 20. The unit-dose drug product 10 accommodated in the accommodating part 22 has an asymmetrical outline shape, and the unit-dose drug product accommodating container also includes an extracting direction instructing means 40 for indicating an appropriate extracting direction according to the outline shape. Thereby, even if the unit-dose drug product 10 has the asymmetrical outline shape and its extracting direction is defined, it can guide a user in the correct extracting direction by the extracting direction instructing means 40 to achieve a smooth extraction of the drug product. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a container for storing a unit dose type preparation filled with pharmaceuticals, cosmetic ingredients and the like.

  Unlike liquid tablets, gels, ointments, creams, lotions, and the like found in pharmaceuticals and cosmetics, etc., since they do not have a certain form, it is not easy to limit the amount used once. Therefore, in order to limit the amount of use in these forms, various products have been developed, such as a dripping type container, a container with a metering pump, or a container type that is collected with a dropper or syringe. However, these containers have a problem that once they are opened, the opening and the injection port are contaminated. For this reason, it is indispensable to add a preservative, an antioxidant or the like in order to guarantee hygiene and quality.

  On the other hand, single-dose, so-called unit dose type products that contain a single dose of the preparation so that the preparation can be used up once are superior in terms of hygiene and quality. In fact, polypropylene (PP Injectables, eye drops, or liquids for internal use have been commercialized as integral molded products using chemical resins.

  However, such an integrally molded product is a robust container excellent in chemical resistance, but is bulky and has poor portability and has a problem of disposal as a non-combustible material. In addition, in the case of accidental ingestion, since it is not a biocompatible material, there has been a serious health problem.

  On the other hand, so-called self-cut soft capsules using water-soluble polymer materials such as gelatin, agar, starch, and cellulose have been developed. The self-cut capsule is opened by twisting and tearing the mouth portion from which the preparation is taken out. This type is small and excellent in portability although it is inferior to a chemical product in terms of robustness and durability as a container, except that there is a limitation in use that it cannot be filled with an aqueous solution. In addition, the above limitation on use is also advantageous in that it is excellent in discardability because it is soluble in water.

  However, this excellent feature also causes a problem of hygroscopicity. For this reason, it is necessary to store in a container that can block humidity, and the present situation is that a large number of capsules are packaged in a resin container such as an aluminum bag, a glass container, or PP. In addition, there is a problem that the capsule deteriorates due to moisture absorption, and the tearability of the twist-off opening is lowered.

  In addition to the portability problem, such packaging has a hygiene problem because once opened, all capsules are exposed each time a capsule is taken out. In addition, moisture absorption due to frequent opening cannot be avoided, thereby causing a problem that the tearability of the twist-off mouth portion is deteriorated.

  Therefore, it is conceivable to individually wrap each preparation by PTP (Press Through Pack) packaging or easy peel blister packaging (see Patent Document 1). Conventionally, many preparations stored in PTP or blister type containers have a symmetrical outer shape such as a capsule or a tablet, and the preparation can be taken out without any particular problem by pushing the back sheet. For this reason, when storing a formulation in a container, directionality did not become a problem.

However, when the unit dose type preparation is formed into a soft capsule shape having a twist-off mouth, the shape is inevitably asymmetric. In the case of storing an asymmetric preparation capsule in the PTP, the preparation can be easily taken out from the medicine storage section by pushing out the side of the capsule main portion which is the medicine storage section. However, even if the side of the neck part, which is a threaded part, is pushed, the space between the drug storage part and the neck part is large, so that the drug product can be taken out by pushing out the vinyl chloride drug storage part quite strongly and not greatly deforming it. There was a problem that it was difficult to take out. Since the preparation is used by various users (users), it is difficult for the normal person to understand that it is difficult to take out the preparation depending on the position of extrusion, particularly for elderly people, elderly people, and low vision people. It was. Further, if an attempt is made to push out the medicine from the neck portion side, an excessive pressure is applied to the neck portion, and as a result, the medicine may be damaged at the time of removal. In particular, the neck part is formed to be weaker than other parts so that it can be opened by threading. Therefore, it is easy to break, and if excessive pressure is applied to this part, the medicine may leak inside the medicine container. .
JP 2000-281130 A

  The present invention has been made to solve such conventional problems. A main object of the present invention is to provide a unit dose-type preparation storage container that can be easily taken out and used by an elderly person while making the unit dose-type preparation into a container that can be individually packaged.

Means for Solving the Problems and Effects of the Invention

  In order to solve the above-mentioned problem, a unit dose-type preparation storage container according to the first invention includes a plurality of hollow storage portions formed of a light-transmitting resin and opened to store a unit dose-type preparation. A unit dose-type preparation storage container comprising: a resin portion arranged in a grid pattern; and a sheet portion that closes an opening portion of the storage portion of the resin portion, and further a formulation stored in the storage portion. The outer shape is asymmetrical, and it is possible to provide take-out direction indicating means for indicating an appropriate take-out direction according to the external shape. Thereby, even if it is a formulation in which the outer shape is asymmetric and the extraction direction is defined, the correct extraction direction can be guided to the user by the extraction direction instructing means, and smooth drug extraction can be realized. In particular, since the conventional preparation has a symmetrical shape, it can be taken out from any direction and is stored without using the top and bottom, but the unit dose type preparation having an asymmetrical outer shape has directionality. Accordingly, by guiding the take-out direction instructing means so that the take-out can be surely taken out from a certain direction, smooth take-out can be achieved, and a preparation container particularly suitable for the elderly and low-sighted persons can be realized.

  In addition, the unit dose-type preparation storage container according to the second aspect of the present invention can have an array structure in which the take-out direction instructing means arranges the unit dose-type preparations stored in the storage units so as to have the same posture. Thereby, since the unit dose type | mold preparation is located in a line with the same attitude | position, the user can recognize easily the taking-out direction as a fixed direction.

  Furthermore, in the unit dose type drug product storage container according to the third aspect of the invention, the take-out direction indicating means can be an extrusion protrusion formed on the surface of each storage part and indicating a position for extruding the drug product. Thereby, since the user can confirm an extrusion protrusion with a finger | toe, anyone including a low vision person can grasp | ascertain an extraction position easily.

  Furthermore, in the unit dose type drug product storage container according to the fourth aspect of the present invention, the take-out direction instructing means can be an uneven surface that is formed on the surface of each storage part and indicates the position to push out the unit dose type drug product. Thereby, since the user can confirm an uneven surface with a finger, anyone including a weak eyesight can easily grasp the take-out position.

  Furthermore, the unit dose type preparation container according to the fifth aspect of the present invention can be an extrusion display indicating the position at which the take-out direction instruction means pushes out the unit dose type preparation displayed on the surface of each storage unit. Thereby, since the user can confirm the pushing position and direction with his / her eyes, even a person who has difficulty with fingers can easily grasp the picking position.

  Furthermore, in the unit dose type drug product storage container according to the sixth aspect of the invention, the take-out direction instructing means has a difference in height between the portion where the sheet portion closes the opening portion of the storage portion and the periphery of the opening portion of the storage portion, It can be adjusted to a range of 0.1 mm to 2 mm. Thereby, since the play width is provided in the seat portion, the user can confirm the directionality of the unit dose-type preparation stored inside by tracing the finger from the outer surface of the seat portion with a finger. Can easily grasp the take-out position with a finger without checking the appearance.

  Furthermore, the unit dose-type preparation container according to the seventh invention is a hollow capsule main portion in which the unit dose-type preparation stored in each storage portion stores a liquid or gel unit dose drug component inside, A neck portion that forms a tubular portion that is connected to the capsule main portion and has an outer diameter smaller than that of the capsule main portion, and the capsule main portion is opened by threading the neck portion. The unit dose medicine component is configured to be removable, and the unit dose type medicine stored in the storage part can be instructed by the take-out direction instruction means to take out from the capsule main part side. Thereby, the unit dose type preparation having an asymmetric shape between the capsule main part and the neck part can be guided by the take-out direction indicating means so that it can be taken out correctly.

  Furthermore, the unit dose-type preparation container according to the eighth aspect of the present invention is an array of a plurality of hollow storage portions formed of a light-transmitting resin and opened to store the unit dose-type preparation. A storage container containing a unit dose-type preparation comprising: a resin part; a sheet part that closes an opening of the storage part of the resin part; and a unit dose-type preparation stored in each storage part, The unit dose-type preparation has a hollow capsule main portion containing a liquid or gel unit dose drug component therein, and a tubular portion connected to the capsule main portion and having a smaller outer diameter than the capsule main portion. A neck portion that forms a unit dose drug component by opening the capsule main portion by threading the neck portion. Dose type formulation, so that the medicine container portion and the threaded portion are aligned in the same direction, it can be stored in each storage unit in the same posture. Thereby, since the unit dose type | mold formulation which has an asymmetrical shape by the capsule main part and a neck part is located in a line with the same attitude | position, a formulation extraction from each accommodating part can be performed easily.

  Furthermore, in the unit dose-type preparation container according to the ninth aspect of the present invention, the capsule main part of the unit dose-type preparation that is allowed to stand in a state where the unit dose-type preparation is stored in the storage part is the inner surface of the storage part. And the closest distance can be adjusted to a range of 0.1 mm to 2 mm. Thereby, the user can confirm the direction of the unit dose type preparation stored inside by tracing the storage part with the finger from the resin part, and the user including the low vision person can easily check with the finger without checking the appearance one by one. You can grasp the take-out position.

  Furthermore, in the unit dose-type preparation container according to the tenth aspect of the present invention, the storage portion can be formed in an asymmetric outer shape along the outer shape of the unit dose-type preparation. Thereby, since the user can grasp | ascertain the attitude | position of a unit dose type formulation by touching a storage part with a hand, the advantage which can discriminate | determine an extrusion position exactly along this attitude | position is acquired.

  Furthermore, in the unit dose-type preparation container according to the eleventh aspect of the invention, the storage container can be a blister pack packaging container for blister-packing the unit dose-type preparation.

  Furthermore, in the unit dose type drug product storage container according to the twelfth aspect of the invention, the blister pack packaging container can be PTP packaging.

  Furthermore, in the unit dose type drug product storage container according to the thirteenth aspect of the invention, the blister pack packaging container can be an easy peel packaging.

  Furthermore, in the unit dose-type preparation container according to the fourteenth aspect of the invention, the unit dose-type preparation can be made into a water-soluble self-cut soft capsule.

  Furthermore, in the unit dose-type preparation container according to the fifteenth aspect of the present invention, the self-cut soft capsule can be composed of at least one of animal protein including fish, starch, and water-soluble polymer.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. However, the embodiment shown below exemplifies a unit dose type drug container for embodying the technical idea of the present invention, and the present invention is a unit dose type drug product container. Not specified. In addition, the member shown by the claim is not what specifies the member of embodiment. In particular, the dimensions, materials, shapes, relative arrangements, and the like of the constituent members described in the embodiments are not intended to limit the scope of the present invention only to the description unless otherwise specified. It is just an example. Note that the size, positional relationship, and the like of the members shown in each drawing may be exaggerated for clarity of explanation. Furthermore, in the following description, the same name and symbol indicate the same or the same members, and detailed description thereof will be omitted as appropriate. Furthermore, each element constituting the present invention may be configured such that a plurality of elements are constituted by the same member and the plurality of elements are shared by one member, and conversely, the function of one member is constituted by a plurality of members. It can also be realized by sharing. In addition, the contents described in some examples and embodiments may be used in other examples and embodiments.

FIG. 1 shows an external view of a unit dose-type preparation, FIG. 2 shows a state in which the unit dose-type preparation is stored in a storage container, and FIG. 3 shows a schematic diagram showing how a unit dose-type preparation is taken out from the storage container.
(Unit dose type)

  A unit dose type preparation 10 shown in the plan view of FIG. 1A and the side view of FIG. 1B is a self-cut type soft capsule. This unit dose type preparation 10 has a capsule main part 1 constituting a medicine storage part and a twist mouth part 2 constituting a threading (twist-off) part. The twist opening 2 further includes a neck 3 and a head 4. By picking and twisting the head 4 of the twist mouth part 2 with a finger, the neck part 3 is threaded, the capsule main part 1 is opened, and the unit dose drug component stored inside can be taken out.

  The capsule connects the capsule main part 1 and the head part 4 with a neck part 3. The capsule main portion 1 and the twist mouth portion 2 can be integrally formed. As described above, the capsule includes not only a configuration in which the capsule is necessarily closed by a plurality of members but also an integral bag shape.

  The twist opening 2 has a neck portion 3 in a tubular shape, and the neck portion 3 is easily broken by forming the outer shape of the neck portion 3 smaller than the capsule main portion 1 and the head portion 4. Further, by narrowing down the neck portion 3, it is possible to obtain an effect of preventing the unit dose medicine component in the capsule main portion 1 from overflowing at a time when the twist-off is performed.

  On the other hand, the head 4 on the distal end side of the twist opening 2 is formed larger than the neck 3 so that it can be easily picked with a finger. As a result, the head 4 can be securely picked and twisted with a finger, while the neck portion 3 is narrowed to reduce the area to be broken and can be easily opened even with a weak force.

  In order to realize such a configuration, the outer shape of the capsule is a bowl shape that is confined by the neck portion 3. In addition, the capsule main part 1 is enlarged to secure an internal space for housing the unit dose-type preparation 10, while the head 4 is made small as long as it is sufficient to secure a knob for twist-off. Therefore, as shown in the plan view of FIG. 1A, the outer shape of the capsule has an asymmetrical shape in which the capsule main portion 1 is large and the head portion 4 is small. The ratio of the capsule main part 1 and the head 4 is, for example, about 100: 3 to 100: 50 in plan view. As for the thickness, as shown in the side view of FIG. 1 (b), the capsule main portion 1 is thick to secure the internal space, while the head 4 is formed thin so that it can be easily picked up with fingers. preferable. As described above, the head 4 is preferably flat and can be easily picked and twisted with two fingers such as a thumb and an index finger. However, the shape of the capsule is not limited to the above, and any shape can be used as long as it can be opened while securing a space in which the unit dose-type preparation 10 can be stored.

  The capsule is preferably a water-soluble soft capsule. Thereby, discard of the capsule after use can be facilitated. The capsule main part 1 is hollow and holds the unit dose drug component inside. The unit dose is a single dose or dose, and an accurate dose can be administered by setting the dose in advance so that it can be used up.

  The unit dose drug component can be liquid or gel. As such pharmaceutical ingredients, drugs, cosmetic ingredients, and their additives are dispersed in oils (fat-soluble) that can be used in pharmaceuticals and cosmetics such as vegetable oils and synthetic oils, or emulsions or water-soluble dispersion media. It is a liquid, gel-like substance. Thus, in the present specification, the unit dose type preparation is used in the sense of including health supplements, cosmetics and the like in addition to drugs such as pharmaceuticals.

  Hydrophobic drugs and cosmetic ingredients are dissolved as they are, and hydrophilic drugs and cosmetic ingredients are finely dispersed as they are, or the physical properties are changed to hydrophobic by a solid-in-oil (hereinafter referred to as “S / O”) method. Prepare by dispersing. The S / O is prepared by mixing a solution a in which a hydrophilic drug or a cosmetic ingredient (hereinafter referred to as “drug”) is dissolved in purified water and a solution b in which a hydrophobic surfactant is dissolved in a hydrophobic solvent. Then, after emulsification, solvent removal and dehydration are performed by drying under reduced pressure or freeze-drying to prepare a drug-surfactant complex (hereinafter referred to as “S”) to achieve fat solubilization (hereinafter referred to as “LipoS”). It is dispersed in a fat-soluble dispersion medium.

  When these drugs are hydrophilic drugs, hydrophobic surfactants used for S / O conversion include sucrose stearate ester, sucrose palmitate ester, sucrose oleate ester, sucrose laurate ester, Sucrose fatty acid esters such as sucrose behenic acid ester and sucrose erucic acid ester, sorbitan fatty acid esters such as sorbitan monostearate, sorbitan tristearate, sorbitan monooleate, sorbitan trioleate, sorbitan sesquiolate, glycerol monostearate Glycerol fatty acid esters such as glycerol monooleate, polyglycerin fatty acid esters such as diglyceryl tetraisostearate, diglyceryl diisostearate, and diglyceryl monoisostearate But it may be two or more types.

  Furthermore, the organic solvent used in the present embodiment is not particularly limited as long as it is an oil component or organic solvent that can be used for pharmaceuticals, foods, and cosmetics. For example, vegetable oils, animal oils, neutral lipids (mono-substituted, di-substituted) Or tri-substituted glycerides), synthetic fats and / or sterol derivatives. Specifically, soybean oil, cottonseed oil, rapeseed oil, sesame oil, corn oil, peanut oil, safflower oil, sunflower oil, olive oil, perilla oil, etc. as animal oil, beef tallow, pork oil, fish oil, etc. Triolein, trilinolein, tripalmitin, tristearin, trimyristin, or triarachidonin, etc. as neutral lipids, azone etc. as synthetic lipids, cholesteryl oleate, cholesteryl linoleate, cholesteryl myristate, cholesteryl as sterol derivatives Examples include palmitate or cholesrelyl arachidate. Two or more of these may be used.

  Moreover, as a preferable oil component, triglyceride and vegetable oil and animal oil which have this as a main component can be mentioned. Practically, soybean oil, sesame oil, squalane and squalene are preferable, and olive oil purified to a high purity is particularly preferable.

  Examples of the pharmaceuticals include internal preparations, external preparations, eye drops, nasal drops, and dental preparations, but liquid preparations, internal preparations such as jelly preparations, ointments, cream preparations, gel preparations, lotions, liquid preparations, etc. External preparations, nasal drops, dental agents and the like can also be used. A known method can be used for the production of these dosage forms. Examples of cosmetics include creams, milky lotions, cosmetic liquids, cosmetic liquids, and cleansings.

  Furthermore, gelatin capsules made of gelatin or non-gelatin capsules that do not use gelatin can be used as the outer shape of the unit dose-type preparation 10 containing the unit dose drug component. Gelatin capsules are manufactured by adding glycerol or purified water to hydroxypropylated starch or tapioca starch, etc., to a combination of one or more types of gelatin such as bovine and porcine animals or fish. After mixing and slurrying, it is manufactured using a rotary die encapsulator. For example, a gelatin capsule raw material in which 24% by weight of purified water is added to 30% by weight of fish gelatin, 34% by weight of glycerin and 12% by weight of modified starch is dissolved while being heated to 55 ° C. Then, while degassing with a vacuum pump, stir well until the liquid becomes transparent, and transfer to a container with a heat insulation jacket. And while maintaining the temperature of the product at 50 to 55 ° C., using a blender, the pearl dye was added and kneaded, while the spreader box was maintained at 38 to 45 ° C., and the casting drum was 8 to While cooling to 12 ° C, the injection wedge is maintained at a temperature of 28 ° C to 35 ° C to produce a gelatin mass. Further, the capsule is filled with a rotary die encapsulating machine and dried with a rotary dryer to obtain a gelatin capsule with a twist-off mouth.

  On the other hand, as an example of a method for producing a non-gelatin capsule, a hydrophilic colloid substance (hereinafter referred to as “hydrocolloid”) that can easily absorb water is a plant extract, a seaweed extract, a plant seed gum or sticky substance, a grain Gum, modified cellulose and modified starch, preferably consisting of one or more from the group consisting of carrageenan, alginate, agar, guar, pectin, locust bean gum, xanthan gum, raw starch, modified starch, gellan gum, A mixture of one or more plasticizers consisting of sorbitol, maltitol and glycerol is made into a slurry and then made into non-gelatin capsules produced using a rotary die encapsulator.

For example, according to the method disclosed in Japanese Patent Application Laid-Open No. 2005-112849, a non-gelatin capsule raw material to which purified water to which glycerin and starch and a small amount of pearl pigment are added is added is degassed with a vacuum pump while the liquid becomes transparent. Stir well until it reaches, transfer to a container with a heat insulation jacket, and fill using a rotary die encapsulator. This manufacturing method is almost the same as that of the gelatin capsule described above except that the raw materials and dissolution conditions are different. The capsule thus formed is dried with a rotary dryer to obtain a non-gelatin self-cut capsule with a twist-off mouth. It is also possible to add a part of the above-mentioned animal or fish gelatin to the base of these non-gelatin capsules.
(Unit dose type drug container)

  The capsule of the unit dose-type preparation 10 having an asymmetric outer shape as described above is stored in a dedicated unit dose-type preparation storage container. FIG. 2 shows a unit dose type drug product storage container according to the first embodiment. The unit dose-type preparation storage container 100 includes a resin part 20 in which a plurality of storage parts 22 that individually store the unit dose-type preparations 10 are arranged, and a sheet part 30 that is attached to one surface of the resin part 20 and closes the storage part 22. It consists of.

In this example, the unit dose type preparation container 100 is a blister pack packaging container for blister packaging the unit dose type preparation 10. Further, when the unit dose type preparation 10 is taken out, the storage unit 22 is crushed with a finger so that the sheet part 30 on the back surface is broken and the unit dose type preparation 10 is pushed out so-called PTP type packaging. PTP packaging is also called extrusion blister packaging.
(Resin part 20)

The resin part 20 is formed of a resin having translucency so that the unit dose-type preparation 10 stored in the storage part 22 can be visually recognized from the outside. The resin part 20 has a strength capable of being deformed by pushing with a finger when taking out, while sufficiently protecting the unit dose-type preparation 10 from external force. Moreover, in order to protect the internal unit dose type preparation 10 from humidity and drying, it is preferable to provide a barrier function while suppressing air permeability. As such a material, resins such as polyester and polyethylene, specifically, polypropylene (PP) and polyvinyl chloride (PVC) can be used. Moreover, it colors, maintaining translucency as needed, and can protect the internal unit dose type formulation 10 from an ultraviolet-ray etc.
(Storage unit 22)

The storage unit 22 is a pocket-shaped capsule storage chamber that stores the unit dose-type preparation 10. A plurality of storage units 22 are arranged on the resin unit 20 in a grid pattern at substantially regular intervals. Each storage part 22 is formed in a size that can store one unit dose-type preparation 10. Generally, it is designed to be one size larger than the unit dose type preparation 10. Specifically, the margin is designed so that the unit dose-type preparation 10 can be pushed out by crushing the storage portion 22 while avoiding the influence of heat when the sheet portion 30 is welded. . Such a storage part 22 can be easily formed by pressing a resin sheet. The grid pattern is used to include a so-called staggered arrangement in which adjacent storage portions 22 are arranged in an offset shape.
(Sheet part 30)

  On the back side of the resin part 20, the sheet part 30 is affixed on almost the entire surface. Thereby, the opening of each storage part 22 is closed. Similar to the resin part 20, the sheet part 30 is required to have strength and barrier properties for protection from the outside. On the other hand, moderate breakability is also required so that the unit dose type preparation 10 that is pushed out by crushing the storage portion 22 can be broken. As a material of the sheet portion 30 having such characteristics, aluminum foil or polyvinyl chloride can be preferably used. The sheet portion 30 can have a multilayer structure, for example, an overcoat / ink / aluminum foil / ink / heat seal material coat layer is laminated in order from the outside. For joining the sheet portion 30 and the resin portion 20, heat welding or an adhesive can be used. Thereby, the sheet part 30 and the resin part 20 are joined airtightly. Thus, after the sheet | seat part 30 and the resin part 20 are joined, a tear line is formed as needed.

  The PTP packaging can be a container that stores only one unit dose-type preparation 10, but in many cases, it is in the form of a sheet including a large number of storage portions 22. For example, a PTP container with 10 sheets per sheet consisting of 2 vertical x 5 horizontal or 21 PTP containers consisting of 3 vertical x 7 horizontal. The packaging quantity in one sheet is set according to the use and purpose.

FIG. 3 shows how the unit dose-type preparation 10 is taken out from such PTP packaging. As shown in this figure, the storage unit 22 is crushed with a finger from the resin unit 20 side to push out the internal unit dose type preparation 10. At this time, since the unit dose-type preparation 10 has an asymmetric shape, the unit dose-type preparation 10 can be easily pushed out by easily squeezing the larger capsule main part side so that an external force can be easily transmitted to the unit dose-type preparation 10. . On the other hand, if the head side is crushed, the head 4 is thin, so that the gap with the wall surface of the storage part 22 is considerably large, and the deformation of the resin part 20 becomes difficult to be transmitted to the unit dose-type preparation 10 and pushed considerably deeply. If it is not crushed, the unit dose-type preparation 10 cannot be extruded. This work becomes difficult especially for elderly people. Therefore, in such an asymmetric unit dose type preparation 10, it is necessary to define the push-out position of the storage part 22 on the capsule main part side. For this reason, the unit dose-type preparation storage container 100 is provided with an extraction direction indicating means 40 that indicates an appropriate extraction direction of the unit dose-type preparation 10 to be stored.
(Extraction direction instruction means 40)

  The take-out direction instruction means 40 designates the push-out position or direction of the storage container to the user. That is, in addition to designating a specific position with a pinpoint, as shown in FIG. 3, it is possible to sufficiently facilitate taking out only by indicating which side is pressed from the center in the longitudinal direction of the storage portion 22. As such a take-out direction instruction means 40, in the example of FIG. 4, an extrusion protrusion 41 indicating the position for pushing out the unit dose type preparation 10 is formed on the surface of each storage portion 22. As a result, the optimal pushing position can be shown to the user, and the user can check the position of the push-out protrusion 41 not only by visual recognition but also by touching the storage portion 22 with a finger. The take-out position can be easily grasped. Such an extrusion protrusion 41 can be easily formed simultaneously with the forming of the storage portion 22 by press working. Further, the extrusion protrusion 41 may be a separate member from the resin portion 20. For example, a sticking direction instruction means can be added to an existing PTP sheet by sticking a seal-like protrusion on the surface of the storage portion 22. In addition, with this method, as shown in FIG. 2, the unit dose type preparation 10 is not limited to the case where the postures in which the unit dose-type preparations 10 are stored in the respective storage units 22 are aligned in a certain direction. 41 can be added to instruct the user of the pushing position, and there is an advantage that it can be easily added to an existing PTP sheet.

  The take-out direction instructing means 40 may be an extrusion display 42 that displays a position for pushing out the unit dose type preparation 10. Such an example is shown in FIG. Here, the position where the unit dose-type preparation 10 is pushed out is indicated by an arrow on the surface of each storage unit 22. Thereby, the user can visually recognize which side the push-out direction is on and can easily grasp it. An arrow can also be provided to indicate the push-out position more accurately. For example, if the position of the arrowhead is defined as the extrusion position, not only the direction but also the accurate extrusion position can be notified. Further, the push position or direction can be instructed by a symbol such as ◯ or Δ, a character, a pattern, etc. without being limited to the arrow.

  Furthermore, by providing these displays by engraving, it is possible to grasp not only visually but also by tactile sensation, as in FIG. In addition, although the extrusion display 42 is provided on the storage unit 22 side in the example of FIG. 5, it may be provided on the sheet unit 30 side, or may be provided on both the storage unit side and the sheet unit side. When the extrusion display is provided on the sheet portion side, it can be easily realized by printing. Further, by adjusting the position of the existing print character so as to be the extrusion position, it is possible to realize the extraction direction instruction means with the existing configuration. For example, the printing interval and position are adjusted so that the name of the medicine stored in the container, the name of the manufacturer, the “plastic” indicating the material, the recycling mark, and the like are located at the extrusion position. Thereby, the character information and the symbol information can be used as an index indicating the extrusion position.

  Alternatively, as another example of the take-out direction instructing unit 40, the push-out position or direction may be processed so as to be distinguished from other parts. For example, as shown in FIG. 6, by applying a satin finish to the resin surface of the storage portion 22 on the side of the extrusion position as the uneven surface 43, the transparency in appearance changes, and the direction can be visually notified to the user. . In addition, even if the user touches the storage unit 22 with his / her hand, the indication area can be grasped by the change in texture of the satin texture, so that the same effect as described above can be obtained. Such processing is not limited to satin processing, for example, coloring the resin part with a light-transmitting paint, applying a seal with different transparency, applying a pattern such as shading, diagonal lines, hatching, etc. Any means that can express an appearance and / or feel different from the part can be used.

  Furthermore, it goes without saying that the same processing can be provided not only on the storage portion side but also on the seat portion side. For example, as shown in the sectional view of FIG. 7A and the bottom view of FIG. 7B, an uneven surface 44 is provided on the side indicating the take-out position of the sheet portion 30. Thus, as described above, the user can grasp the take-out position or direction by touch or vision. Furthermore, such a concavo-convex surface can be provided not only in the region of the seat portion 30 that closes the storage portion and its opening, but also in the periphery thereof. For example, a concavo-convex pattern is provided as the extraction direction instruction means 40 in the region of the flat plate portion 24 adjacent to the extrusion position of the sheet portion or the resin portion. In the modification shown in FIG. 8, a semicircular uneven pattern 44 </ b> B is provided as the take-out direction instruction means 40 on the flat plate portion 24 outside the opening edge of the storage portion 22. In this example, the concavo-convex pattern 44B is provided on the sheet portion side of the back surface, but the concavo-convex pattern 44B can also be provided on the resin portion side of the front surface. Thus, the user can push out the unit dose type preparation by tracing the uneven pattern with a finger or by visually locating the uneven pattern and pressing the finger along the uneven pattern. In addition, when the take-out direction indicating means is provided at the breakage portion of the sheet portion or the push-out portion of the storage portion, it is difficult to confirm the direction after use due to breakage or deformation. In particular, in recent years, there is a tendency to avoid individual separation of PTP sheets in units of drugs in order to prevent accidental ingestion of PTP sheets. If the direction of push-out can be confirmed by the take-out direction indicating means provided around the storage section after use, the take-out direction can be grasped more conveniently and reliably.

  Further, if only the direction is notified instead of the accurate extrusion position, a tear line provided on the PTP sheet can be used as a simpler method. For example, as shown in FIG. 9, if each punching shape constituting the cut line 45 is made asymmetrical so that the direction can be distinguished, the user can see the touch line 45 or touch the cut line 45 to confirm the take-out direction. As shown in FIG. 10, the direction can be similarly distinguished by changing the punching shape of the cut line 46 according to the position.

  Further, the pushing direction can be indicated by the shape of the storage portion itself. As shown in FIG. 11, the user can easily confirm the pushing direction by making the shape of the storage portion 22B asymmetrical. In particular, since the unit dose-type preparation 10 stored in the pocket of the storage unit 22B is asymmetric, it is preferable that the shape of the storage unit 22B is also asymmetric in terms of space efficiency and external shape protection. By using such a change in the external shape in combination with the direction of the extrusion or the position, further utilization promotion of the unit dose type preparation 10 can be expected.

  Furthermore, as another example of the take-out direction instructing means 40, the posture of the unit dose-type preparation 10 can also be grasped by providing a play width d in a portion where the opening of the storage portion 22 is closed by the seat portion 30. That is, as shown in FIG. 12, the back surface of the sheet part 30 is adjusted as shown in FIG. Therefore, the user can search for the unit dose-type preparation 10 with a finger. As a result, the orientation of the unit dose-type preparation 10 can be determined by hand in which direction the longitudinal direction of the storage unit 22 is arranged, in other words, where the head 4 is located, and this part is reliably pushed out. be able to. For example, the height difference between the portion where the seat portion 30 closes the opening portion of the storage portion 22 and the periphery of the opening portion of the storage portion 22, that is, the flat plate portion 24, is in the range of 0.1 mm to 2 mm, more preferably 0.5. It adjusts to -1.0mm, More preferably, it is 0.6-0.8mm. By providing such a height difference, that is, by setting the play width d in the seat portion 30, the user uses the slack of the play width d to trace the surface of the unit dose-type preparation 10 in the storage portion 22 with a finger. It is possible to easily grasp the posture of the unit dose-type preparation 10. In particular, as shown in FIG. 15 which will be described later, if the unit dose type preparation 10 itself has a concavo-convex pattern as the take-out direction instruction means 47 and is stored in a posture in which this concavo-convex surface faces the sheet portion 30 side, the user can With this unevenness as a clue, the posture of the unit dose-type preparation 10 can be grasped more easily.

  Furthermore, if the amount of the gap between the storage unit 22 and the unit dose-type preparation 10 is adjusted, the directionality can be grasped by tracing the unit dose-type preparation 10 with a finger from the outside of the storage unit 22 as opposed to FIG. In the modified example shown in FIG. 13A, the capsule main part 1 of the unit dose-type preparation 10 is closest to the inner surface of the storage part 22 in a posture in which the unit-dose-type preparation 10 is stored in the storage part 22 and left standing. The distance d2 is adjusted such that the capsule 22 can be touched by deforming the storage portion 22 with a finger. Thereby, it can be discriminated by touching the main part 1 of the unit dose-type preparation 10 in the storage part 22 with, for example, the left or right side, and this part can be reliably pushed out.

  The distance d2, that is, the gap between the capsule main portion 1 and the inner surface of the storage portion 22, is preferably adjusted to a range of 0.1 mm to 2 mm. Thus, while providing a gap that can be separated to the extent that the unit dose-type preparation 10 stored in the storage unit 22 is not deformed by heat generated when the sheet unit 30 is bonded to the resin unit 20, the storage unit 22 is held with a finger. It is possible to maintain a state in which the unit dose-type preparation 10 is deformed and close enough to be traced.

  Furthermore, as shown in FIG. 14, the unit dose-type preparation 10 can be searched by picking with both fingers from both the storage part side and the sheet part side. This method is preferable because the posture of the unit dose-type preparation 10 can be more reliably grasped using the sense of touch of two fingers.

  The play width d is optimally adjusted according to the outer shape and size of the unit dose-type preparation 10 to be stored, the shape of the storage portion, and the like. That is, if the play width is too small, the internal unit dose-type preparation is easily subjected to stress from the bottom surface of the seat, and there is a possibility of physical damage. On the other hand, if the play width is too large, the unit dose type with fingers It becomes impossible to trace the external shape of the preparation. Therefore, the optimum play width is set in consideration of the balance between the protection of such unit dose type preparations and the ease of grasping by the user.

  In each of the above examples, the example in which the extraction direction instruction means is provided at the pushing position or direction is shown. However, even if the extraction direction instruction means is provided on the opposite side, such an instruction is provided to the user. It goes without saying that the same notification effect can be obtained. For example, in the example of FIG. 5, even if an arrow is displayed on the right side of the storage unit in the drawing, it is possible to display to the user that the left side on the opposite side is pushed out in the direction of the arrow. In the example of FIG. 6 as well, if the extruding surface is a smooth surface and the matte processing is performed on a region that is not the extruding surface, the user can easily recognize that a smooth or transparent region is extruded. In short, since it is sufficient if the user can be notified of the push-out position or direction, it does not depend on the position where the take-out direction instruction means is provided.

  Furthermore, the taking-out direction instruction means can be provided not on the container side but on the unit dose type preparation itself. For example, as shown in FIG. 15, by displaying or engraving an arrow as the extrusion display 47 on the capsule main part 1 of the unit dose-type preparation 10, the directionality or the extrusion position can be confirmed by visual recognition as in FIG. 5. With this method, there is an advantage that the conventional container can be used as it is.

  Furthermore, it is possible to instruct the take-out direction by the arrangement of the unit dose-type preparation 10 without providing a separate take-out direction instruction means. That is, as shown in FIG. 2, by unifying all the postures of the unit dose-type preparation 10 to be stored in a certain direction, the user can visually grasp the take-out direction with a glance at the PTP sheet. With this method, it is possible to instruct the user to take out the unit dose-type preparation easily and inexpensively without changing any existing container. In addition, this method has the advantage that the PTP sheet containing the unit dose type preparation is visually attractive. That is, in the conventional PTP container, since the capsule or tablet whose outer shape is the object is stored, the direction is not constant. For example, in the case of capsules that are separately painted in the center in two colors of red and white, the directions of the unit dose-type preparation 10 accommodated in the PTP sheet are scattered and not visually beautiful. On the other hand, by defining the arrangement in a fixed direction as shown in FIG. 2, in addition to being able to indicate the take-out direction, it is possible to obtain a design effect that the appearance can be improved.

  Furthermore, it goes without saying that the above-described examples of the take-out direction instruction means can be combined not only independently but also in combination. This makes it possible to notify the user of the pushing position or direction more reliably. For example, when making a notification with a cut line, it may be difficult to distinguish the direction once the PTP sheet has been cut, but if the arrow in FIG. 5 is used together, the direction can be confirmed even after separation.

In addition, by providing take-out direction instruction means individually in each storage section, it is possible to accurately grasp the take-out direction of each storage container even if the unit dose type preparation storage container is separated for each storage section by perforations, scissors, etc. Can greatly contribute to the promotion of the use of unit dose type preparations. Alternatively, as described above, from the viewpoint of preventing accidents in which a user accidentally swallows a PTP container in recent years, there is a tendency to make it impossible to separate individual PTP sheets by perforations. Even without providing the instruction means, it is possible to grasp the take-out direction by using the take-out direction instruction means provided in another storage section or collectively provided for a plurality of storage sections.
(Easy peel packaging)

  In the above example, PTP packaging has been described. However, the present invention is not limited to PTP packaging, and other packaging formats such as easy peel packaging can be used. FIG. 16 shows the appearance of a unit dose-type drug container 200 that employs easy-peel packaging as a second embodiment. In particular, in terms of the flexibility and strength of the capsule of the unit dose-type preparation 10, when the capsule is broken and the drug component is discharged when it is pushed out from the PTP package, it is more than the structure of pushing out and taking it out. As shown in FIG. 17, a configuration is preferable in which the sheet part 30 is peeled and opened for each storage part 22 and taken out individually. As shown in FIG. 17, the easy peel packaging is opened by peeling (peeling) the sheet portion 30 by hand from the back surface of the unit dose-type preparation container 200, and the unit dose-type preparation 10 in the storage portion 22 is taken out. . For this reason, the peeling part 32 which comprises the peel part which does not adhere | attach with the resin part 20 in a part of sheet | seat part 30 is comprised. Further, when the sheet portion 30 is peeled off by the tab 32, the perforated surface of the sheet portion 30 and the resin portion 20 is formed between the storage portions 22 so as not to peel off the sheet portions 30 of the adjacent storage portions 22. And half-cut cuts (cut lines) are formed. Thereby, only the tab 32 of the sheet | seat part 30 of the desired accommodating part 22 is peeled, and the capsule of the unit dose type preparation 10 can be taken out easily, without affecting the tab of an adjacent accommodating part. . The adhesive strength between the sheet portion 30 and the resin portion 20 is a peelable strength. Furthermore, although the sheet part 30 does not need to be broken, it is desirable to provide flexibility so that it can be easily peeled off.

  Even in such easy peel packaging, the take-out operation can be facilitated by defining the take-out direction with the take-out direction indicating means. However, in the case of easy peel packaging, it is preferable to take out from the head side opposite to PTP. This is because the head 4 is flat and easy to pick, and conversely, since the capsule main portion 1 is large, the gap with the storage portion 22 is small and difficult to pick. Therefore, it is preferable to provide a take-out direction indicating means so as to indicate the direction of the head 4 contrary to the PTP. For example, an arrow or an unevenness is provided as a take-out direction indicating means on the peeling tab on the head side.

  Moreover, it can also be set as the hybrid type which combined easy peel type packaging and PTP packaging. That is, it is possible to use either a method of crushing the surface of the storage unit 22 with a finger or a method of peeling the sheet unit 30 on the back surface. In this case, as the take-out direction instruction means 40, for example, the crushing position (capsule main part side) of the storage unit 22 is displayed on the front side, and the position (head side) of the separation tab 32 of the sheet part 30 is displayed on the back side. ) Is displayed.

  In the above example, an example in which a twist-off type unit dose type preparation is stored has been described. However, the present invention is not limited to the unit dose type preparation to be stored, and the shape is asymmetric and the take-out direction is defined. Needless to say, it can be suitably used for other solid medicines, for example, tablets and capsules for oral use.

  Examples of preparing various unit dose type preparations and storing them in unit dose type preparation containers will be described below as examples.

(Production of vitamin E-containing purified olive oil / gelatin capsule PTP packaging product)
Vitamin E-containing refined olive oil / self-cut gelatin capsule (capacity) at Fuji Capsule Co., Ltd. (Fujinomiya City, Shizuoka Prefecture) using fish gelatin with oily components dispersed in 999.5 g of refined olive oil in which 0.5 g of vitamin E is dissolved 250 mg) was produced. This capsule was subjected to PTP packaging using a blister packing machine PF-D1 type PTP packaging machine (manufactured by Maruho Hakko Kogyo Co., Ltd.) to prepare a unit dose type preparation according to Example 1.

  The overall configuration of the sheet portion 30 constituting the lid material of the PTP packaging and the resin portion 20 constituting the bottom material is as shown in FIG. In FIG. 2, the take-out direction instruction means is not shown. As the resin part 20, a polyvinyl chloride sheet (manufactured by Sumitomo Bakelite Co., Ltd., length 70 mm, width 140 mm) was used, and the concave storage part 22 was formed using a dedicated mold. Furthermore, a laminated film (manufactured by Shohoku Laminate Industrial Co., Ltd., length 70 mm, made of aluminum foil and polyethylene film (hereinafter referred to as “PE”) is formed on the sheet part 30 in which the storage part 22 and the surrounding flat plate part 24 are formed flat. Width 135 mm) was used. The sheet part 30 is heat-sealed with respect to the upper surface of the resin part 20. Here, the play width d was 0.7 mm. The packaged PTP package is prepared in a total of 10 capsules of 1 sheet in 2 columns x 5 rows. By packaging gelatin capsules with self-cut mouths in this PTP packaging, the gelatin capsules are sufficiently protected, and the take-out direction indicating means described above is provided to improve the take-out property.

(Manufacture of gelatin capsule PTP packaging product with self-cut mouth consisting of refined olive oil containing VC-LipoS and VE)
As Example 2, a self-cut gelatin capsule PTP package product made of purified olive oil containing VC-LipoS and VE was prepared. First, 8 g of sucrose fatty acid ester (ER-290) is completely dissolved in 75 g of hexane. Separately, 0.1 g of citric acid and 1 g of ascorbyl phosphate phosphate (VCPMg: hereinafter abbreviated as “VC”) are added to 50 g of purified water and completely dissolved. This aqueous solution is added to a hexane solution in which the sucrose fatty acid ester (ER-290) is dissolved, and emulsified with a homogenizer at 20000 rpm for 5 minutes. After emulsification, the hexane phase is removed with an evaporator. After removing the solvent, it was frozen at −45 ° C. and lyophilized, and the solvent was completely removed to prepare a VC-surfactant complex (VC-LipoS). This VC-LipoS was dispersed in 995 g of refined olive oil in which vitamin E was dissolved at Fuji Capsule Co., Ltd. (Fujinomiya City, Shizuoka Prefecture) to prepare a VC-LipoS-vitamin E / purified olive oil dispersion. Used, gelatin capsules with self-cut mouth using fish gelatin were filled at 250 mg / piece. This capsule is a blister packing machine PF-D1 type PTP packaging machine (manufactured by Maruho Hatsu Kogyo Co., Ltd.) and is a capsule consisting of 2 columns x 5 rows formed in a dedicated mold in the same manner as in Example 1. PTP packaged on 10 sheets. Similarly to Example 1, in Example 2, it was confirmed that the take-out property was improved by providing the above-described take-out direction instruction means in the PTP package.

(Production of VC-LipoS-VE-containing purified olive oil / non-gelatin capsule PTP packaging product)
Furthermore, as Example 3, the VC-LipoS-vitamin E / purified olive oil dispersion produced in Example 2 was commissioned to Fuji Capsule Co., Ltd. (Fujinomiya City, Shizuoka Prefecture), and the company developed a non-gelatin with a self-cut mouth. The capsule was filled with 360 mg / piece, and then PTP packaged according to Example 1. The refined olive oil filled in 360 mg of this capsule contains 0.05% VC and 0.05% VE. Similarly to Example 1 and the like in Example 3, it was confirmed that the take-out property was improved by providing the above-described take-out direction instruction means in the PTP package.

(Manufacturing of Easy-peelable Blister Packed Product of Purified Olive Oil / Non-gelatin Capsule Containing VC-LipoS-VE)
Furthermore, as Example 4, the capsule produced in Example 3 was blister-packed with a blister packing machine PF-D1 type PTP packaging machine (manufactured by Maruho Hakko Kogyo Co., Ltd.) using a dedicated mold for easy peel. Here, as shown in FIGS. 16A and 16B, a storage portion 22 is formed as a capsule storage chamber in a concave shape on a PVC sheet (manufactured by Sumitomo Bakelite Co., Ltd.). The sheet part 30 affixed to the circumference | surroundings and the plane part of the accommodating part 22 is a sheet | seat (Shohoku Laminate Industrial Co., Ltd. product, easy peel aluminum foil for PVC) which bonded together. The sheet portion 30 becomes a seal portion that is peeled off by an easy peel method, and seals the periphery of the storage portion 22 and the flat portion so that an easy peel is possible. In the easy peel blister package, as shown in FIGS. 16A and 16B, tabs 32 which are unsealed portions are formed for every two of the storage portions 22. The shape, size, and position of the tab 32 and the unsealed portion are appropriately set according to the shape, size, and the like of the unit dose-type preparation 10 to be stored. In Example 4, as in Example 1 and the like, it was confirmed that the take-out property was improved by providing the above-described take-out direction instruction means in the easy peel packaging container.

(Easy peel blister packaging of VE-containing purified olive oil / gelatin capsule)
Furthermore, as Example 5, the capsule prepared in Example 1 was packaged and manufactured in a blister packing machine PF-D1 type PTP packaging machine (manufactured by Maruho Hakko Kogyo Co., Ltd.) using an easy peel dedicated type. Similarly to Example 4 and the like in Example 5, it was confirmed that the take-out property was improved by providing the above-described take-out direction instruction means in the easy peel packaging container.

(Self-cut twist-off property of gelatin capsules and the effect of PTP packaging)
Next, as Example 6, a gelatin capsule with a self-cut mouth made of purified olive oil containing VC-LipoS and VE produced in Example 2 above (unit dose type preparation 10) and a product obtained by PTP wrapping the same were prepared at high temperature and high temperature. A comparative study was conducted on the twist-off property of self-cutting when left under humidity.

  Here, as shown in FIG. 18, a total of 10 dishes were prepared in which the gelatin capsule products were placed one by one in a glass petri dish SC (φ90 mm). On the other hand, a product (unit dose-type preparation storage container 100) in which the gelatin capsules were PTP-wrapped was put into the glass petri dish SC one by one, and a total of 10 dishes were prepared. Next, filter paper moistened with purified water is laid on the bottom of a square jar made of PP (13.5 × 19.7 × 9.5 [cm]). It was allowed to stand to be stacked and left at 30 ° C. for 1 week.

  On the other hand, as Comparative Example 1, five of these gelatin capsules were put in a dedicated glass container with an inner lid and high airtightness, sealed, and also put in a PP container and left at 30 ° C. for 1 week.

  One week later, the PP container was taken out of the thermostat, the capsules were collected from each petri dish SC or glass container, and the influence of humidity on the twist-off property was examined. The twist-off property was evaluated by how many times the twist opening of the twist mouth (one rotation at 360 degrees) was made by the same person and the opening. The results are shown in Table 1.

  From the above results, it was confirmed that the gelatin capsule easily absorbs moisture as it is. Gelatin capsules have poor twist-off properties due to moisture absorption, and take time for self-cutting. On the other hand, it has been proved that stable twist-off property and capsule deterioration can be prevented by PTP packaging.

(Self-cut twist-off of non-gelatin capsules and the effect of PTP packaging)
Next, as Example 7, a self-cutting non-gelatin capsule PTP packaging product with a self-cut mouth made of purified olive oil containing VC-LipoS and VE produced in Example 3 was allowed to stand under high temperature and high humidity. The twist-off property was compared and examined.

  Here, as shown in FIG. 18, a total of 10 dishes were prepared in which the above non-gelatin capsule products were placed one by one in a glass petri dish SC (φ90 mm). On the other hand, filter paper moistened with purified water is laid on the bottom of a square jar made of PP (13.5 × 19.7 × 9.5 [cm]), and the above glass petri dish SC is placed on each of the above five dishes. It was allowed to stand to be stacked and left at 30 ° C. for 1 week.

  On the other hand, as Comparative Example 2, five of these gelatin capsules were put in a dedicated glass container with an inner lid and high airtightness, sealed, and also put in a PP container and left at 30 ° C. for 1 week.

  One week later, the PP container was taken out of the thermostat, the capsules were collected from each petri dish SC or glass container, and the influence of humidity on the twist-off property was examined. The twist-off property was evaluated by how many times the twist opening of the twist mouth (one rotation at 360 degrees) was made by the same person and the opening. The results are shown in Table 2.

  From the above results, the non-gelatin capsule is superior in twist-off property, but it is easy to absorb moisture in the same state as the gelatin capsule. Therefore, non-gelatin capsules are poor in twist-off properties due to moisture absorption and are troublesome for self-cutting. It was found that PTP packaging prevents stable twist-off and capsule deterioration.

(Effect of twist-off property of non-gelatin capsule self-cut and easy peel packaging)
Self-cutting of non-gelatin capsules with self-cut mouth made of refined olive oil containing VC-LipoS and VE produced in Example 4 when a blister pack package product using easy peel is left under high temperature and high humidity The twist-off property of each was compared and examined.

  Similarly to the above, as shown in FIG. 18, the non-gelatin capsule products were put one by one in a glass petri dish SC (φ90 mm) to prepare a total of 10 dishes. Next, filter paper moistened with purified water is laid on the bottom of a square jar made of PP (13.5 × 19.7 × 9.5 [cm]), and the above glass petri dish SC is stacked on each of the above five dishes. And left at 30 ° C. for 1 week.

  On the other hand, as Comparative Example 3, five of these non-gelatin capsules were put in a dedicated glass container with an inner lid and high airtightness, sealed, and also put in a PP container and left at 30 ° C. for 1 week.

  One week later, the PP container was taken out of the thermostat, the capsules were collected from each petri dish SC or glass container, and the influence of humidity on the twist-off property was examined. The twist-off property was evaluated by how many times the twist opening of the twist mouth (one rotation at 360 degrees) was made by the same person and the opening. The results are shown in Table 3.

  From the above results, as with the results of Example 2, the non-gelatin capsules easily absorb moisture in the same state as the gelatin capsules. Therefore, non-gelatin capsules are poor in twist-off properties due to moisture absorption and are troublesome for self-cutting. Even in blister pack packaging using easy peel, the perforation of the resin part 20 on the flat plate portion 24 does not affect humidity, and it is effective for maintaining the quality as in the case of PTP packaging. understood. It has been found that even in blister pack packaging using an easy peel, stable twist-off property and capsule deterioration can be prevented.

  Next, in Examples 9 to 12 and Comparative Example 1, it was verified whether or not the ease of taking out the medicine by the user was improved by providing the take-out direction instruction means. The results are shown in Table 4.

  First, the example which provided the convex part in the surface of the accommodating part is demonstrated as Example 9. FIG. On the surface of the vinyl chloride film forming the surface of the storage portion of the PTP-wrapped sheets (2 × 5 rows; 10 / sheet) in Example 1, as shown in FIG. 19, convex portions 41B as protrusions indicating the direction of the capsule main portion. Formed. Here, protrusions having a height of about 1 mm were formed using an epoxy adhesive and air-dried. One sheet with this protrusion and one sheet separated according to the cut line, and a total of 10 sheets are placed in a black bag, and the sheet is completely invisible, and then selected arbitrarily. Three females A, B, and C aged 26 to 30 years old put their left and right hands so as to hold the respective bags, and measured the time required to take out all the capsules from the sheet film.

  Further, an example in which a concave surface is formed at the position of the bottom (storage) surface will be described as Example 10. Here, on the surface of the polyvinyl chloride film that forms the bottom surface of the storage portion 22 of the sheets (2 × 5 rows; 10 sheets / sheet) PTP-wrapped in Example 1, a recess 41C is provided as a take-out direction indicating means indicating the direction of the capsule main portion. Provided. In the example of FIG. 20, a concave surface was formed by pressing a heated soldering iron tip with water and lowered in temperature, and immediately cooled to form a concave portion 41C.

  Each sheet made with this concave surface and cut one by one according to the cutting line, put the total of 10 sheets into a black bag, and make the sheet completely invisible, then choose arbitrarily Three females A, B, and C aged 26 to 30 years old put their left and right hands so as to hold the respective bags, and measured the time required to take out all the capsules from the sheet film.

  Furthermore, an example in which the direction of the main part is marked on the lid film will be described as Example 11. A mark 41D is provided on the surface of the lid film part of the storage part of the sheets (2 × 5 rows; 10 sheets / sheet) PTP-wrapped in Example 1 as take-out direction instruction means for specifying the directionality of the capsule main part. In the example shown in FIG. 21, an arrow-shaped display is drawn with an epoxy paint, air-dried, overwritten with the same paint, air-dried again, and further overlaid with an over-paint, thereby providing a touch with a thickness of about 1 mm. A possible mark 41D was marked. With this marking, it was confirmed that even when the sheet was turned upside down (with the lid face up), the extrusion position could be easily found visually from above.

  Each sheet that has been marked and cut out one by one according to the cut line, each of which has been made into a total of 10 sheets, put each in a black bag, the sheet is completely invisible, and then selected arbitrarily Three females A, B, and C aged 26 to 30 years old put their left and right hands so as to hold the respective bags, and measured the time required to take out all the capsules from the sheet film.

  Furthermore, an example in which the directionality is shown by providing unevenness on the main part side of the peripheral part of the lid film will be described as Example 12. Here, an uneven portion 41E is provided as a take-out direction instruction means on the periphery (flange portion) of the lid film of the storage portion of the sheet (2 × 5 rows; 10 sheets / sheet) PTP-wrapped in the first embodiment. In this example, as shown in FIG. 22, the side of the capsule main part packaged was sanded with No. 120 sandpaper, and lightly uneven portions 41E were provided so that the lid film was not peeled off. By this marking operation, one of the flanges (peripheral part) of the lid film can be touched with the fingertip, so that the directionality of the packaged capsule was well understood.

  Select one sheet that has been sanded and cut one by one according to the cut line, and put each sheet into a total of 10 sheets in a black bag so that the sheet is completely invisible from the outside. Three females A, B, and C aged 26 to 30 years old put their left and right hands so as to hold the respective bags, and measured the time required to take out all the capsules from the sheet film.

  Finally, as Comparative Example 4, one sheet manufactured by the same method as in Example 1 except that the take-out direction instruction means is not provided, and individual sheets obtained by separating the sheets into 10 pieces according to the cut line one by one Are placed in a black bag, and the sheet is completely invisible from the outside, so that women A, B, and C, who are arbitrarily selected from 26 to 30 years old, hold their bags. Both hands were put in and the time required for taking out all the capsules from the sheet film was measured.

  From the results of Examples 9 to 12 and Comparative Example 4, it was confirmed that in any case, the storage container provided with the extraction direction indicating means can extract the drug in a shorter time than the normal storage container. In addition, the drug was not damaged during removal. In particular, it was confirmed that the medicine could be taken out correctly even when the medicine was not visible. In this way, when storing a formulation whose unit dose type formulation has an asymmetric outer shape in a storage container, the height of the storage portion and the thickness of the main portion of the formulation are allowed to have a play width, and extrusion protrusions, irregularities, or display, etc. By providing the take-out direction instruction means, it is possible to improve the ease of taking out by the user even when a plurality of storage containers are connected and packaged in a blister package or separated into individual packages.

  The unit dose type pharmaceutical container of the present invention can be suitably applied to unit dose type products in which pharmaceuticals and cosmetics are filled in water-soluble self-cut soft capsules with a twist-off mouth and PTP packaging or easy peel blister packaging.

It is (a) top view and (b) side view which show the external appearance of a unit dose type formulation. It is the (a) top view, (b) side view, and (c) front view which show the unit dose type pharmaceutical container which concerns on Embodiment 1. FIG. It is a schematic sectional drawing which shows a mode that a unit dose type formulation is taken out from the storage container of FIG. It is a schematic sectional drawing which shows the extrusion protrusion which is one form of an extraction direction instruction | indication means. It is (a) schematic side view and (b) top view which show the extrusion display which is one form of a taking-out direction instruction | indication means. It is a schematic side view which shows the example which provided the uneven | corrugated surface which is one form of the extraction direction instruction | indication means in the resin part. It is (a) schematic sectional drawing and (b) bottom view which show the example which provided the uneven | corrugated surface which is one form of the extraction direction instruction | indication means in the sheet | seat part. It is a bottom view which concerns on the modification which provided the uneven | corrugated surface which is one form of an extraction direction instruction | indication means in the sheet | seat part. It is a top view which shows the cutoff line which is one form of an extraction direction instruction | indication means. It is a top view which shows the other pattern of the tear line which is one form of an extraction direction instruction | indication means. It is a schematic sectional drawing which shows the shape change of the accommodating part which is one form of an extraction direction instruction | indication means. It is (a) schematic sectional drawing which shows the play width in the accommodating part which is one form of taking-out direction instruction | indication means, (b) Bottom view, (c) Schematic sectional drawing which shows the mode of direction discrimination | determination with a finger. FIG. 6 is a schematic cross-sectional view showing a gap between the capsule main portion and the inner surface of the storage portion, and (b) a schematic cross-sectional view showing a state of direction determination by a finger, as a take-out direction instruction means according to a modified example. It is a schematic sectional drawing which shows the mode of direction discrimination | determination with two fingers using the extraction direction instruction | indication means which concerns on a modification. It is the (a) schematic side view and the (b) top view which show the example which provided the extrusion display which is one form of the extraction direction instruction | indication means in the unit dose type formulation. It is (a) top view, (b) side view, (c) front view which shows the unit dose type formulation storage container which concerns on Embodiment 2. FIG. It is the schematic which shows a mode that a unit dose type formulation is taken out from the storage container of FIG. It is a schematic cross section which shows the state which performs the twist-off property and the influence test of a packaging container in a humidified state. It is the (a) schematic side view and (b) top view which show the unit dose type formulation storage container which concerns on Example 9. FIG. It is the (a) schematic side view and (b) top view which show the unit dose type formulation storage container which concerns on Example 10. FIG. It is (a) schematic side view and (b) bottom view which show the unit dose type formulation storage container which concerns on Example 11. FIG. It is the (a) schematic side view and the (b) bottom view which show the unit dose type formulation storage container which concerns on Example 12. FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 100, 200 ... Unit dose type formulation storage container 1 ... Capsule main part; 2 ... Twist mouth part 3 ... Neck part; 4 ... Head 10 ... Unit dose type formulation 20 ... Resin part 22, 22B ... Storage part 24 ... Flat plate part 30 ... sheet portion 32 ... tab 40 ... extraction direction instruction means 41 ... extrusion protrusion; 41B ... convex portion; 41C ... concave portion; 41D ... mark; 41E ... concave portion 42 ... extrusion display 43 ... concave surface; 44 ... concave surface; 44B ... Uneven pattern 45 ... Cut line; 46 ... Cut line 47 ... Extrusion display d ... Play width; d2 ... Distance; SC ... Glass petri dish

Claims (15)

A plurality of hollow storage portions formed of a light-transmitting resin and opened to store unit dose-type preparations, a resin portion arranged in a grid pattern; and
A sheet portion for closing the opening portion of the storage portion of the resin portion;
A unit dose type drug product storage container comprising:
Furthermore, the unit dose-type preparation storage container is characterized in that the external shape of the unit dose-type preparation stored in the storage portion is asymmetrical, and is provided with an extraction direction indicating means that indicates an appropriate extraction direction according to the external shape. A unit dose type drug product storage container according to claim 1,
The take-out direction instruction means
A unit dose-type preparation storage container storing unit dose-type preparations, wherein the unit dose-type preparations stored in each storage section have an arrangement structure in which they are arranged in the same posture. A unit dose type drug product storage container according to claim 1,
The take-out direction instruction means
A unit dose-type preparation storage container storing a unit dose-type preparation, which is an extrusion protrusion formed on the surface of each storage portion and indicating a position for extruding the unit dose-type preparation. A unit dose type drug product storage container according to claim 1,
The take-out direction instruction means
A unit dose-type preparation storage container storing a unit dose-type preparation, characterized in that it is an uneven surface formed on the surface of each storage portion and showing a position for extruding a unit dose-type preparation. A unit dose type drug product storage container according to claim 1,
The take-out direction instruction means
A unit dose-type preparation storage container storing a unit dose-type preparation, characterized in that it is an extrusion display showing a position for extruding a unit dose-type preparation displayed on the surface of each storage section. A unit dose type drug product storage container according to claim 1,
The take-out direction instruction means
A unit dose type preparation characterized in that a height difference between a portion where the sheet portion closes the opening portion of the storage portion and a periphery of the opening portion of the storage portion is adjusted to a range of 0.1 mm to 2 mm. Stored unit dose type drug container. A unit dose type drug product storage container according to any one of claims 1 to 6,
Unit dose type preparations stored in each storage part
A hollow capsule main portion containing a liquid or gel unit dose drug component inside,
A neck portion that forms a tubular portion that is continuous with the capsule main portion and has a smaller outer diameter than the capsule main portion;
It is configured to be able to take out the unit dose drug component by opening the capsule main part by threading the neck part,
A unit dose-type preparation storage container characterized in that the unit-dose-type preparation stored in the storage part is instructed by the take-out direction instruction means so as to be taken out from the capsule main part side. A plurality of hollow storage portions formed of a light-transmitting resin and opened to store unit dose-type preparations, a resin portion arranged in a grid pattern; and
A sheet portion for closing the opening portion of the storage portion of the resin portion;
A unit dose type preparation stored in each storage section;
A storage container containing a unit dose-type preparation comprising:
The unit dose formulation is
A hollow capsule main portion containing a liquid or gel unit dose drug component inside,
A neck portion that forms a tubular portion that is continuous with the capsule main portion and has a smaller outer diameter than the capsule main portion;
It is configured to be able to take out the unit dose drug component by opening the capsule main part by threading the neck part,
Each unit dose-type preparation is stored in each storage section in the same posture so that the medicine storage section and the threaded section are aligned in the same direction. container. A unit dose type drug storage container according to claim 7 or 8,
In a state where the unit dose type preparation is stored in the storage unit, the distance of the capsule main part of the unit dose type formulation that is allowed to stand closest to the inner surface of the storage unit is in the range of 0.1 mm to 2 mm. A unit dose-type preparation storage container storing a unit dose-type preparation characterized by being adjusted. A unit dose-type drug product storage container according to any one of claims 1 to 9,
The unit dose type drug container is characterized in that the storage part is formed in an asymmetric outer shape along the outer shape of the unit dose type drug product. A unit dose-type preparation container according to any one of claims 1 to 10,
A unit dose-type preparation storage container, wherein the storage container is a blister pack packaging container for blister-packing a unit dose-type preparation. The unit dose type drug product storage container according to claim 11,
A unit dose-type preparation container, wherein the blister pack packaging container is PTP packaging. The unit dose type drug product storage container according to claim 11,
The unit dose type drug product storage container, wherein the blister pack packaging container is easy peel type packaging. A unit dose type drug product storage container according to any one of claims 1 to 13,
A unit dose-type preparation container, wherein the unit dose-type preparation is a water-soluble self-cut soft capsule. A unit dose-type preparation container according to any one of claims 1 to 14,
The unit-dose type drug storage container, wherein the self-cutting soft capsule is composed of at least one of animal protein including fish, starch, and water-soluble polymer.

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