JP2000271189A - Suppository packing body and manufacture therefor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prevent deformation of a suppository by heat even if the suppository is placed in a preserving or flowing process in a temperature environment not less than a body temperature by sealing a filler in a space between the suppository and a container in a suppository packing body composed of the suppository and the container including the suppository. SOLUTION: When manufacturing a suppository packing body 5, first of all, a suppository 1 of a melting state is introduced to a space in a suppository container 2 via a nozzle in a state of opening an inlet 2a of the suppository container 2 vertically upward. At this time, the suppository 1 is not completely filled in the space in the suppository container 2, and is filled up to a height of a certain degree from the bottom part. Afterwards, the suppository 1 is cooled at a room temperature to be solidified. Next, a filler 4 is densely filled in a space remaining in the suppository container 2 via a supply means. Thus, since a recessed sunk-in part of an end part surface generated when solidifying the suppository 1 is also completely filled by the filler 4, a void does not remain in the suppository container 2.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a suppository package in which a suppository is stored or distributed in a state in which the suppository is contained in a container, and a method for producing the same, and more particularly to a suppository suitable for storage and distribution at high temperatures. The present invention relates to an agent package and a method for manufacturing the same.

[0002]

2. Description of the Related Art In general, suppositories are prepared by adding a drug or the like to an oily base, and are stored or distributed in a state of being packed in a plastic suppository container. The suppository usually has a melting point of about 30 to 37 ° C., and the suppository maintains a solid state at room temperature, but melts in the rectum due to body temperature to release the drug. Widely used for the administration of

[0003]

By the way, in the process of storing and distributing suppositories, it is essential to keep cool and to prohibit rollover or upside down. This is because if the suppository is stored or distributed under a temperature environment equal to or higher than the body temperature, the suppository may be melted and deformed in the suppository container. In particular, when the suppository is melted in a state where the suppository container is turned upside down or upside down, the suppository moves in the container and the suppository shape is largely deformed. If the temperature drops in this state, the suppository solidifies while being deformed, which not only reduces the commercial value, but also makes it difficult to insert it into the rectum, making it unusable.

[0004] However, no matter how far the cooling and the prohibition of rollover or upside-down rotation have been attempted,
It was impossible to completely prevent deformation of the suppository due to negligence or force majeure of the handler.

An object of the present invention is to solve the above-mentioned problems at the stage of storing or distributing suppositories. That is, an object of the present invention is to provide a novel suppository package in which a suppository is not deformed by heat, even when stored or distributed in a temperature environment equal to or higher than body temperature, and to provide a method for producing the same. It is in.

[0006]

SUMMARY OF THE INVENTION The suppository package of the present invention comprises:
A suppository package comprising a suppository and a container containing the suppository, wherein a filler is sealed in a space between the suppository and the container. The filler is preferably joined to the container, and more preferably, the container is provided with a seal, and more preferably, the filler is integrated with the seal.

In the suppository package of the present invention, it is preferable that the filler does not contain an eluted component, and it is particularly preferable that the filler is a hot-melt adhesive. The “eluting component” refers to any substance that elutes from the filler to the outside of the filler under any action or condition.

The method for producing a suppository package of the present invention comprises the steps of: injecting a liquid suppository into a container from a container entrance to solidify; and filling the space between the suppository and the container with the suppository. The method includes the steps of: filling a filler through a container entrance; and sealing the container entrance. Preferably, the container inlet is sealed together with the filler.

[0009]

DETAILED DESCRIPTION OF THE INVENTION The present inventors have studied in detail the mechanism by which a suppository deforms when exposed to a high temperature above body temperature during the storage or distribution process. It was ascertained that this was due to the presence of a gap between the suppository container and the suppository container. That is,
When the suppository is melted in a container having a void therein and the container is turned over or turned upside down, the suppository moves into the void and the shape of the original suppository is deformed. When the temperature drops, the suppository hardens while still deformed.

Here, generation of voids in the suppository container will be described with reference to the drawings. FIG. 1 is a longitudinal sectional view showing a conventional type suppository package and a manufacturing process thereof. FIG. 1 (a) shows a suppository container 2 before sealing, in which a suppository 1 is filled by a predetermined amount. . On the other hand, FIG. 1B shows a state where the entrance 2a of the suppository container 2 is sealed along the line XX in FIG. 1A.

In a conventional type of suppository package, as shown in FIG. 1, a high-temperature molten suppository 1 is introduced into a suppository container 2, and then cooled at room temperature to solidify the suppository 1. Then, it is manufactured by sealing the entrance 2a of the suppository container 2. Therefore, as is apparent from FIG. 1, when the entrance 2a is sealed in a state where the suppository 1 is not completely filled in the space in the suppository container 2, the space 3 is necessarily formed in the suppository container 2. Is done. Therefore, in order to avoid the generation of the voids 3, it is conceivable that the suppository 1 is densely filled in the suppository container 2 in manufacturing the suppository package.

However, in FIG. 1, when the suppository 1 is densely filled in the suppository container 2, the suppository 1 is sandwiched between the suppository 1 and the entrance 2a when the entrance 2a is sealed to obtain a product.
Is sealed, and the problem of incomplete sealing of the suppository container 2 occurs. On the other hand, in FIG.
-When the entrance 2a of the suppository container 2 is sealed along the line Y, the volume of the space 3 is certainly reduced, but the entrance 2a also sandwiches a part of the suppository 1
Seal is incomplete. Even if the suppository container 2 can be sealed along the line Y-Y without the suppository 1 being pinched, the end surface of the suppository 1 in a molten state is depressed into a concave shape when the suppository 1 in the molten state is solidified. It is inevitable that
A void remains in a part of the suppository container 2.

That is, in the case of manufacturing a conventional type suppository package, if the suppository 1 is prevented from being pinched and the seal at the entrance 2a of the suppository container 2 is completely sealed,
The space 3 in the suppository container 2 is preferably as large as possible. Therefore, in manufacturing a conventional type suppository package, it is not possible to densely fill the suppository container 2 with the suppository 1 in view of the sealing property of the suppository container 2.

[0014] The inventor of the present invention has intensively studied a new suppository package and a method for producing the same, which can completely seal the suppository container without generating a void in the suppository container. As a result, it has been found that a method of sealing the entrance of the suppository with the filler filled in the space between the suppository and the inner surface of the suppository container is useful.

FIG. 2 is a longitudinal sectional view showing one embodiment of the suppository package 5 and the method for producing the same according to the present invention.
(a) shows a state before the entrance 2a of the suppository container 2 is sealed. On the other hand, FIG. 2 (b) shows a suppository package in which the entrance 2a of the suppository container 2 is sealed together with the filler 4 along the line XX in FIG. Figure 5 shows the body 5.

In the embodiment shown in FIG. 2, the suppository container 2 is composed of two sheets having a concave portion having the same shape and bonded together with the concave portions facing each other.
The suppository 1 is held in the space formed by the recess. However, a part of the sheets is not bonded to each other and forms an entrance 2a to the space. The shape of the space is not particularly limited, but is preferably substantially spindle-shaped to facilitate use of the suppository 1.

The material of the suppository container 2 is not particularly limited. For example, polyethylene, polypropylene,
Although general-purpose synthetic resin materials such as polyvinyl chloride, polystyrene, and polyester can be used, polyolefin-based synthetic resin materials such as polyethylene and polypropylene are preferable from the viewpoint of heat sealing. Further, the sheets constituting the suppository container 2 may be a laminate of sheets made of a plurality of different materials.

In the present invention, the base of the suppository 1 held in the suppository container 2 and the kind of the drug mixed therein are not particularly limited. Examples of the base include caprylic acid, capric acid, pelagonic acid, undecylic acid, tridecylic acid, lauric acid, myristic acid, palmitic acid, pentadecylic acid, heptadecylic acid, stearic acid, oleic acid, elaidic acid, linoleic acid, and linoleic acid. Examples include unsaturated fatty acids such as acids and unsaturated fatty acid glycerin esters. These can be used alone or in admixture of two or more, if necessary. Usually, a mixture of mono-, di- and triesters of unsaturated or saturated fatty acid and glycerin is preferable.

The base may contain one or more of a nonionic surfactant, a cationic surfactant and an anionic surfactant. Glycerin fatty acid ester, propylene glycol fatty acid ester, sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene fatty acid ester, polyoxyethylene fatty acid alcohol ether, polyoxyethylene alkyl phenyl ether, polyoxyethylene alkyl phenyl ether, It is preferred to use a non-ionic surfactant such as oxyethylene castor oil.

Hardness or feeling of use of suppository 1 and suppository 1
It is preferable to add an oil component to the base in order to improve the release property and stability of the drug from the base. As the oily component, sesame oil, olive oil, camellia oil, soybean oil, rapeseed oil, cottonseed oil, linseed oil, castor oil, bran oil,
Corn oil, peanut oil, coconut oil, almond oil, avoguard oil, palm oil, palm kernel oil, kaya oil, kahotsuku oil, kuromoji oil, sasanqua oil, cinnamon oil, eno oil, cocoa oil, nitsukei oil, laurin oil, tallow oil Animal and vegetable fats such as lard, wool fat, turtle oil and squalene, and modified fats and oils, vaseline, white obtained by chemically changing these animal and vegetable fats by hydrogenation, fatty acid conversion, acetylation, split extraction, etc. Vaseline, liquid paraffin, paraffin, dehydrated lanolin, isobar, mineral oils such as silicone oil, isopropyl myristate, normal butyl myristate, isopropyl linoleate, stearyl linoleate, diethyl sebacate, diisopropyl adipate, cetyl alcohol, stearyl alcohol, Salami beeswax, gay wax, mokuro etc. Higher aliphatic alcohols, higher fatty acid esters, waxes, stearic acid, oleic acid, higher fatty acids such as palmitic acid. These may be used alone or in combination of two or more as necessary.

The drug to be incorporated in the suppository 1 is appropriately selected according to the target of treatment or the like. For example, antipyretic analgesia such as diclofenac sodium, piroxicam, acetaminophen, indomethacin, ketoprofen, buprenorphine hydrochloride, ibuprofen, aspirin and the like Anti-inflammatory agents, diflucortron valerate, hydrocortidone acetate, betamethasone, etc., corticosteroids such as morphine hydrochloride, alkaloid narcotics such as morphine, drugs for digestive organs such as domperisone, antimetabolites such as tegafur, fluorouracil, gemeprost Hormones such as diazepam, phenobarbital, etc., hypnotics and anxiolytics such as diazepam, physicians and enemas such as bisacodyl, sulfa drugs such as salazosulfapyridine, antibiotics such as ceftizoxime sodium, and bronchodilation such as aminophylline Agent, bird Noshido, Purokutosediru, E. coli killed, Shikonekisu, hemorrhoid agents such as scopolia extract and the like. If necessary, the suppository 1 may further contain a drug such as a local anesthetic, an antihistamine, a bactericide, a vitamin, amino acids, and bile acids. Further, other auxiliary ingredients can be added to the suppository 1 as needed. Water, stabilizers, preservatives, coloring agents, fragrances, dispersants, thickeners, pH regulators, wetting agents, antioxidants,
Preservatives, excipients and the like can be mentioned.

The suppository package 5 in the present embodiment is manufactured as follows. First, with the inlet 2a of the suppository container 2 opened vertically upward, the suppository 1 in a molten state is introduced into the space in the suppository container 2 via a nozzle (not shown). The suppository 1 is not completely filled in the space inside the suppository container 2, but is filled to a certain height from the bottom. Thereafter, the suppository 1 is cooled at room temperature and solidified. Next, the filler 4 is densely filled in the space remaining in the suppository container 2 via a supply means (not shown). As described above, in the present embodiment, since the concave portion of the end surface generated when the suppository 1 is solidified is completely filled with the filler 4, a void remains in the suppository container 2. Nothing.

The physical properties of the filler 4 are not particularly limited as long as they prevent the movement of the suppository 1 in the suppository container 2, and may be in the form of a liquid, a paste, or a solid. There may be. However, from the viewpoint of easy introduction into the suppository container 2 and easy sealing of the suppository container 2, a liquid or paste-like one is preferable. On the other hand, since the filler 4 comes into contact with the suppository 1, the material of the filler 4 is water, an organic solvent, a polymerization initiator, It is preferable that various components such as an agent and an unpolymerized monomer are not eluted, or at all very little.

From the viewpoint of the shape retention of the suppository 1 and the simplicity of handling at the time of opening, the filler 4 is used as the suppository container 2.
It is preferred to be joined to. Examples of a method of joining the filler 4 and the suppository container 2 include an embodiment in which at least a part of the filler 4 is adhered to the suppository container 2 using an adhesive, but the manufacturing process is simplified. From the viewpoint of conversion, the filler 4 itself is preferably made of a synthetic or natural polymer material having an adhesive property or an adhesive property to the suppository container 2. However, in this case, it is preferable that the polymer material constituting the filler 4 does not adhere to or adhere to the suppository 1.

When the filler 4 is made of a synthetic or natural polymer material, the melting point of the polymer material is 50 ° C. to 1 ° C.
Preferably it is in the range of 50 ° C. If the melting point is less than 50 ° C., the filler 4 may be melted and integrated with the suppository 1 during the storage or distribution of the suppository package. On the other hand, if the melting point exceeds 150 ° C., the suppository 1 may be thermally deteriorated when introduced into the suppository container 2. As the synthetic or natural polymer material, a hot-melt adhesive is particularly preferable in terms of adhesiveness to the suppository container 2, sealing property of the entrance 2a, and the like. As the hot-melt adhesive in the present invention, a so-called reactive hot-melt adhesive can be used, in addition to one that melts by heating to exhibit adhesiveness and solidifies by cooling to maintain an adhesive state. Examples of such hot melt adhesives include olefin resin adhesives such as polyethylene, polypropylene and polyisobutylene, polyamide adhesives such as polyisobutylene polyamide, nylon-11 and nylon-12, and acrylic resin adhesives. , Polyvinyl acetate adhesive, polyester adhesive, polyvinyl acetal adhesive such as polyvinyl butyral, ethylene-vinyl acetate copolymer adhesive, thermoplastic elastomer adhesive,
Examples thereof include urethane-based reactive hot melt adhesives and the like, and preferably do not contain elution components harmful to the human body.

In the present embodiment, as shown in FIG. 2 (a), when the filler 4 is completely filled in the space between the suppository 1 and the suppository container 2, The entrance 2a of the suppository container 2 is sealed along the line XX. Entrance 2
As the sealing method a, various methods such as sealing with an adhesive, heat sealing by contact or pressing with a heating means, closing with a fastening member, etc. can be adopted. In this respect, heat sealing is preferable. When the entrance 2a of the suppository container 2 is sealed by heat sealing, at least a portion of the entrance 2a of the suppository container 2 needs to be made of a material which is melted by heating to exhibit adhesiveness. There is.

Finally, the entrance 2 of the suppository container 2
As a is sealed to form the seal portion 2a ', the suppository package 5 according to the present invention is manufactured as shown in FIG. 2 (b). Since the space inside the suppository container 2 is densely filled with the filler 4, when the inlet 2a is sealed, a part of the filler 4 is sandwiched between the sealing portions and sealed together. Since the suppository package 5 itself has a function as a sealing material, the hermeticity of the suppository package 5 is completely maintained during the storage or distribution process.

In the suppository package 5 manufactured as described above, the filler 4 is sealed in the suppository container 2 via the seal portion 2a '. 2 and a seal part 2a 'of the suppository container 2 to make the seal more secure. Therefore, it is possible to completely cut off the contact between the suppository and the outside world,
The suppository 1 contained in the suppository container 2 can be held in a safe and good state until use.

Further, as is clear from FIG. 2 (b), in the suppository package 5 of the present embodiment, there is no space in which the suppository 1 can move, so that the suppository can be stored or distributed in the course of storage or distribution. Even when the suppository 1 is melted when the package 5 is placed at a temperature equal to or higher than the body temperature, the suppository 1 does not move in the suppository container 2. Therefore, the original shape of the suppository 1 can be maintained even when the suppository package 5 is turned over or turned upside down at a high temperature.

Further, in the suppository package 5 of the present embodiment, since the filler 4 is integrated with the suppository container 2, the suppository container 2 is opened when used as shown in FIG. Even if it does, the filler 4 does not come off from the suppository container 2. Therefore, when the user takes out the suppository 1 from the suppository container 2, there is no possibility that the filler 4 will be taken out by mistake. Further, disposal of the suppository package after taking out the suppository 1 is also easy. In addition, since the filler 4 is fixed to the suppository container 2, the filler 4 does not move during the storage or distribution stage and does not affect the shape of the suppository 1.

[0031]

EXAMPLES The suppositories used in the examples were prepared by a conventional method.
The composition and properties are shown in Table 1. Next, a polypropylene suppository container having polyethylene laminated inside was filled with 1.5 g of molten suppository. After the suppository was solidified, 0.5 g of the molten polyvinyl acetate hot melt adhesive was quickly filled thereon, and the suppository container inlet was immediately sealed with a heat sealer to obtain a suppository package. Was.

[Table 1]

The suppository package 20 obtained as described above
The pieces were stored upside down in a 45 ° C. constant temperature bath for 1 hour, and then left standing in a room at 25 ° C. for 1 day. As a result, there was no leakage of the suppository from the suppository container in any of the 20 samples subjected to the test. When the suppository was taken out of the suppository container, no deformation was observed in the suppository.

[0033]

According to the suppository package of the present invention, even if the suppository package is stored or distributed under a temperature condition equal to or higher than the body temperature, and is turned over or turned upside down, it is held in the suppository container. Suppository does not deform.

When the filler in the suppository container is joined to the suppository container, there is no danger that the filler may be removed by mistake when the user removes the suppository from the suppository container. In addition, disposal after use can be easily performed. Further, since the filler does not move in the suppository container, the shape of the suppository is not affected.
In particular, in the case where the filler is integrated with the seal portion of the suppository container, in addition to the effects described above, the sealing of the seal portion becomes more secure, and the suppository is shielded from the outside world, thereby providing a more secure Can be held.

When the filler does not contain an eluting component, it is possible to avoid the transfer of a chemical substance or the like which is undesirable for the human body to a suppository. In addition, when the filler is a hot-melt adhesive, integration with the suppository container and sealing can be easily performed.

According to the method for producing a suppository package of the present invention,
It is possible to obtain a suppository package in which the shape of the suppository is not lost even if the suppository is stored or distributed under a temperature condition equal to or higher than the body temperature and turned over or upside down. In particular, when the container entrance is sealed with the filler, the sealing portion can be more reliably sealed.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view showing a conventional type suppository package and a manufacturing process thereof.

FIG. 2 is a longitudinal sectional view showing one embodiment of a suppository package and a method for producing the same according to the present invention.

FIG. 3 is a longitudinal sectional view showing an opened state of the suppository package of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Suppository 2 Suppository container 3 Void 4 Filler 5 Suppository package

Claims (7)

[Claims] 1. A suppository package comprising a suppository and a container containing the suppository, wherein a filler is sealed in a space between the suppository and the container. Suppository packaging. 2. The suppository package according to claim 1, wherein the filler is bonded to the container. 3. The container has a seal portion,
The suppository package according to claim 1 or 2, wherein the filler is integrated with the seal portion. 4. The suppository package according to claim 1, wherein the filler does not contain an eluted component. 5. The suppository package according to claim 1, wherein the filler is a hot-melt adhesive. 6. A step of injecting a liquid suppository into the container from a container inlet to solidify, and a step of filling a space between the suppository and the container with a filler through the container inlet. And a step of sealing the container entrance. 7. The method for producing a suppository package according to claim 6, wherein in the step of sealing the container entrance, the container entrance is sealed together with the filler.