WO2000056263A1

WO2000056263A1 - Suppository package and production method therefor

Info

Publication number: WO2000056263A1
Application number: PCT/JP2000/001761
Authority: WO
Inventors: Ikuo Koyama
Original assignee: Taisho Pharmaceutical Co., Ltd.
Priority date: 1999-03-23
Filing date: 2000-03-23
Publication date: 2000-09-28
Also published as: JP2000271189A; AU3325600A

Abstract

A novel suppository package free from a collapsed suppository shape even when preserved or distributed in a comparatively high-temperature environment, and a production method therefor. A suppository package (5) comprising a suppository (1) and a container (2) enclosing the suppository (1) therein, characterized in that a filler (4) is filled in the entire space between the suppository (1) and the container (2), the filler (4) preferably being fixed to the container (2).

Description

Description Suppository package and manufacturing method thereof

TECHNICAL FIELD The present invention relates to a suppository package and a method for producing the suppository package in which the suppository body is contained or stored in a container, and particularly to a suppository package suitable for storage and distribution at a high temperature. It relates to the manufacturing method. Background art

Suppositories remain in a solid state at room temperature, but melt in the rectum due to body temperature to release the drug. Therefore, suppositories are widely used for administration of drugs that are preferably absorbed through the rectal mucosa.

In general, suppositories are manufactured by adding a drug or the like to an oily base, and are usually stored or passed through a suppository package packed in a plastic suppository container. I have. Since the melting point of suppositories is usually set at about 30 to 37 ° C, suppository packages should usually be cooled and solidified after the suppository is poured into the suppository container in a molten state. It is manufactured by.

By the way, in the storage and / or distribution process of suppositories, it is essential to keep cool and to prohibit rollover or upside down. This is because storing or distributing suppositories in a temperature environment equal to or higher than body temperature may cause the suppositories to melt in the suppository container, resulting in deformation. In particular, when the suppository melts due to an increase in ambient temperature while the suppository container is turned over or upside down, the suppository moves in the container and the suppository shape is greatly deformed. If the temperature drops in this state, the suppository will solidify as it is deformed, not only reducing the commercial value but also making it difficult to insert it into the rectum and making it unusable.

However, until now, it was impossible to completely prevent deformation of the suppository due to the negligence or force majeure of the handler, no matter how cold-keeping and prohibition of rollover or upside-down. By the way, Japanese Patent Publication No. 58-82869 proposes that a small piece of solid foamed plastic is inserted into a space in a suppository container and sealed. However, even with this method, deformation of the suppository body could not be completely prevented. However, the production of small pieces of foamed plastic that fits into a relatively small space in a suppository container requires many additional steps, and the insertion of the small pieces into the container requires Since special jigs were required, there were also problems in terms of manufacturing equipment, time and cost. Furthermore, in this method, the small pieces of foamed plastic are simply enclosed in the container together with the suppository, so that when the container is opened, the small pieces fall off the container. This not only caused anxiety to the user, but also required extra work to dispose of the small pieces. Disclosure of the invention

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

The suppository package of the present invention is a suppository package comprising a suppository and a container containing the suppository, wherein the entire space between the suppository and the container is sealed with a filler. It is characterized by having. The space may exist adjacent only to the end of the suppository. Here, the “end” refers to the end in the direction along the long axis of the suppository, and it is sufficient that there is a space to be filled adjacent to at least one end of the suppository body.

The filler used in the present invention preferably has a flow start temperature of 50 ° C. or higher. Here, the “flow start temperature” is a temperature at which the filler starts melting and softening to start fluidization. The specific value of the flow start temperature depends on the material of the filler and the measuring method. For example, when the filler is a low molecular compound or a crystalline polymer, the flow onset temperature is synonymous with the melting point (including the crystal melting point), and can be measured according to JISK7121. Further, for example, when the filler is an amorphous polymer, the flow start temperature has the same meaning as the softening temperature, and can be measured, for example, according to JISK720. Preferably, the filler is fixed to the container. In particular, when the container has a seal portion, the filler is more preferably integrated with the seal portion.

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” mentioned above 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 includes: an introduction step of introducing a suppository from the container entrance into the interior of the container; and a filling step of filling a space between the suppository and the container with a fluid filler. And a sealing step of sealing the container entrance. The introduction step may include a step of injecting a fluid suppository into the container and a step of solidifying the suppository. The filling in the filling step is preferably performed via the container inlet, and the container inlet is preferably sealed together with the filler.

Also in the production method of the present invention, the flow start temperature of the filler is preferably 50 ° C. or higher. Further, it is preferable that the filler does not contain an eluted component, and in particular, it is preferable that the filler is a hot-melt adhesive. The present invention also includes a suppository package produced by the above-mentioned production methods.

Another aspect of the present invention relates to a suppository package comprising a suppository and a container containing the suppository, wherein the suppository is deformed by filling a space in the container with a fluid filler. Is the way. Also in this embodiment, the flow start temperature of the filler is preferably 50 ° C. or higher. BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a longitudinal sectional view showing a conventional 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 the opened state of the suppository package of the present invention. 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 of body temperature or higher during the storage or distribution process, and found that the suppository is deformed by a suppository and a suppository including the suppository. It was found that this was caused by the existence of a gap between the agent container. In other words, if the suppository melts in a container with a void inside and the container rolls over or reverses, the suppository moves into the void and the original suppository deforms. However, if the temperature drops in this state, the suppository will harden in the deformed state.

Here, the generation of voids in the suppository container and the deformation mechanism of the suppository based on the presence of the voids will be described in detail with reference to the drawings. FIG. 1 is a longitudinal sectional view showing a conventional type of suppository package and its manufacturing process, and FIG. 1 (a) shows a suppository container 2 before sealing, filled with a predetermined amount of a suppository 1. . On the other hand, FIG. 1 (b) shows a state where the entrance 2a of the suppository container 2 is sealed along the line X-X in FIG. 1 (a).

As shown in Fig. 1, a conventional type of suppository package is to introduce a high-temperature molten suppository 1 into a suppository container 2 and then cool it at room temperature to solidify the suppository 1, followed by It is manufactured by sealing the entrance 2a of the suppository container 2. The suppository 1 in the suppository container 2 shrinks when it solidifies, so that the suppository 1 generally has a shape in which the center of the surface is depressed.

As is evident from FIG. 1, when the space inside the suppository container 2 is not completely filled with the suppository 1 and the inlet 2a is sealed, a space 3 is inevitably formed in the suppository container 2. You. Since the suppository 1 does not fluidize in the cooled state, the presence of the void 3 does not cause any particular problem. However, in a high temperature environment, the suppository 1 in the container melts and becomes fluid. Therefore, if the container 2 rolls over or turns upside down in this state, the suppository 1 moves to the gap 3. When the temperature of the surroundings is reduced while the container 2 is still turned over or turned upside down, the suppository 1 is hardened as it is, and its shape changes.

As described above, since the suppository is deformed due to the existence of free space in the container, it is preferable to avoid the space in the container in order to prevent the suppository from being deformed. Therefore, for example, in the example of FIG. In order to avoid this, it is conceivable that all the spaces in the suppository container 2 are densely filled with the suppository 1 in the manufacture of the suppository package.

However, in FIG. 1, when the suppository 1 is densely filled in the suppository container 2, the entrance 2a is sealed with the suppository 1 sandwiched when the entrance 2a is sealed to form a product. This causes a new problem that the seal of the suppository container 2 is incomplete.On the other hand, the suppository container is not filled tightly with the suppository 1 but along the line Y--Y in FIG. 1 (a). Even if the inlet 2a of 2 is sealed, the volume of the cavity 3 will certainly decrease, but again the inlet 2a may sandwich a part of the suppository 1 and the sealing of the suppository container 2 may be incomplete. is there. Even if the suppository container 2 could be sealed along the line Y--Y without the suppository 1 being pinched, the end surface of the suppository 1 would be concave when the molten suppository 1 solidified. Since it is inevitable to collapse, it is inevitable that voids remain in a part of the suppository container 2.

In other words, when a suppository package as shown in FIG. 1 is manufactured by a conventional method, the gap 3 in the container 2 is such that the suppository 1 is prevented from being pinched and the seal of the inlet 2 a of the container 2 is completed. It is essential, and it is preferable that the volume is as large as possible. Therefore, in order to prevent deformation of the suppository 1 in the container 2, the void 3 in the container 2 should be eliminated in order to prevent the deformation of the suppository 1 in the container 2. It is not feasible to densely fill the container 2 in view of the sealing property of the container 2. -Accordingly, the present inventor has conducted intensive studies on a novel suppository package and a method for producing the suppository package which can completely seal the container without generating a void in the suppository container. It has been found that a method of sealing the entrance of the container with the fluid filler filled in the space between the suppository and the inner surface of the suppository container has been found to be useful.

FIG. 2 is a longitudinal sectional view showing an embodiment of a suppository package 5 and a method for producing the suppository package according to the present invention, and FIG. 2 (a) shows a state before an entrance 2a of a suppository container 2 is sealed. Indicates the status. On the other hand, in FIG. 2 (b), the entrance 2a of the suppository container 2 is sealed together with the filler 4 as described later along the line X--X in FIG. 2 (a) to form a seal portion 2a '. The present invention o

5 shows a suppository package 5 of the present invention.

In the embodiment shown in FIG. 2, the suppository container 2 is formed by bonding two sheets having the same shape of a concave portion with the concave portion facing each other, and a space formed by the concave portion. Suppository 1 is held in it. 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 formed by the container 2 is not particularly limited, but in order to facilitate the use of the suppository 1, the space must be substantially spindle-shaped with a long axis Z as shown in the figure. Is preferred.

The material of the suppository container 2 is not particularly limited, and for example, a general-purpose synthetic resin material such as polyethylene, polypropylene, polyvinyl chloride, polystyrene, or polyester can be used. In this respect, polyolefin-based synthetic resin materials such as polyethylene and polypropylene are preferable. 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 type of the base of the suppository 1 held in the suppository container 2 and the type of the drug to be mixed therewith are not particularly limited. Examples of the base include caprylic acid, capric acid, pelagonic acid, pendecylic acid, tridecylic acid, lauric acid, myristic acid, noremitic acid, penicillic acid, heptamine decylic acid, stearic acid, and oleic acid. And unsaturated fatty acids such as elaidic acid, linoleic acid and linoleic acid, 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.

One or more of a nonionic surfactant, a cationic surfactant and an anionic surfactant can be added to the base, but the dispersion of the melt of the suppository 1 is stable. In terms of properties, etc., 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 It is preferable to use a nonionic surfactant such as alkyl phenyl ether and polyoxyethylene castor oil. In order to improve the hardness or feeling of use of the suppository 1 and the release and stability of the drug from the suppository 1, it is preferable to add an oil component to the base. The oleaginous components include sesame oil, olive oil, camellia oil, soybean oil, rapeseed oil, cottonseed oil, linseed oil, castor oil, nuka oil, corn oil, peanut oil, coconut oil, fragrant oil, avogard oil, Palm oil, palm kernel oil, cocoa oil, royal hook oil, kuromoji oil, sazanka oil, charcoal oil, eno oil, cocoa butter, 20 cay fat, laurin fat, beef fat, lard, wool fat, turtle oil , Squalene, etc., and modified fats and oils obtained by chemically changing these animal and vegetable fats and oils by hydrogenation, fatty acid conversion, acetylation, fractional extraction, etc., cerin, white cerin, liquid paraffin, paraffin, Mineral oils such as dehydrated lanolin, silicone bars, silicone grease, isopropylvir myristate, normal butylmilystate, isopropylylinolate Higher fatty alcohols such as stearyl linoleate, getylse bucket, diisopropyl adipate, cetyl alcohol, stearyl alcohol, salami beeswax, gay wax, mocrowe, higher fatty acid esters, waxes, stearic acid, oleic acid And higher fatty acids such as palmitic acid. These may be used alone or as a mixture of two or more as necessary.

The drug to be incorporated in suppository 1 is appropriately selected depending on the target of treatment and the like. For example, diclofenac sodium, piroxicam, acetaminophen, indomethacin, ketoprofen, buprenorphine hydrochloride, ibuprofen, aspirin Antipyretic analgesics and anti-inflammatory drugs, such as diflucortron valerate, hydrocortidone acetate, betamethasone, etc., corticosteroids such as morphine hydrochloride, alkaloid drugs such as morphine hydrochloride, drugs for digestive organs such as domperisone, tegafur, fluorouracil Antimetabolites such as gemprost; sedatives such as diazepam and phenobarbital; sedatives such as anxiolytics and visacodyl; enemas; sulphas such as salazosulfaviridine; ceftidixim sodium; Bronchodilation of antibiotics, aminophylline, etc. Agents, tribenoside, protosedil, killed bacteria of Escherichia coli, sicon extract, rotoex, and the like. Suppository 1 may further contain a drug such as a local anesthetic, an anti-histamine, a bactericide, a vitamin, an amino acid, or a bile acid, if necessary. Further, other auxiliary ingredients can be added to the suppository 1 as needed. o

Examples of the auxiliary component include water, a stabilizer, a preservative, a coloring agent, a fragrance, a dispersant, a thickener, a pH regulator, a wetting agent, an antioxidant, a preservative, and an excipient. 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 in the suppository container 2 but is filled to a certain height from the bottom. Thereafter, the suppository 1 is cooled and solidified at room temperature. In addition, a solid suppository 1 having a surface shape matching the shape of the container 2 is prepared in advance in a separate process, inserted into the container 2, and the suppository 1 is introduced into the container 2. Is also good.

Next, the space remaining in the suppository container 2 is densely filled with the fluid filler 4 via a supply means (not shown). The filling path of the filler 4 into the space is not particularly limited, but it is preferable that the filler 4 is filled from the inlet 2a in terms of working efficiency.

In order to avoid that the entire surface of the suppository 1 is surrounded by the filler 4 and that it becomes difficult to use the suppository 1, the space in the container 2 to be filled with the filler 4 is the length of the suppository 1. It is preferably present only adjacent to the end along the axis Z. In addition, in terms of ease of filling with the filling material 4, the space to be filled with the filling material 4 is adjacent to the end of the suppository 1 near the entrance 2a of the container 2, as shown in FIG. It is preferable that they exist.

When the suppository 1 in the container 2 solidifies, the surface of the suppository 1 sinks into various shapes for each container, so the inside of the container 2 as described in JP-A-58-82869 is disclosed. Although it is inevitable that voids causing deformation of the suppository 1 remain in the container 2 by the method of inserting solid plastic pieces of a certain shape into the space of the present embodiment, in the present embodiment, the fluid filler Since the suppository 1 is used, the space in the container 2 is completely filled with the filler 4 irrespective of the shape of the concave depression on the end surface generated when the suppository 1 solidifies. Therefore, no void remains in the suppository container 2. The material of the filler 4 is not particularly limited, but it must be a substance that maintains a solid shape even in a high-temperature environment that may occur in the storage and / or distribution process of the suppository package. Is preferred. Therefore, specifically, the flow start temperature of the filler 4 is preferably 50 ° C. or higher, more preferably 70 ° C. or higher, and most preferably 90 ° C. or higher. If the temperature is lower than 50 ° C, the filler 4 may be melted and integrated with the suppository 1 during the storage and / or distribution of the suppository package. On the other hand, if the flow start temperature of the filler 4 is too high, the filler 4 may cause thermal deterioration of the suppository 1 when introduced into the suppository container 2, so that the flow start temperature of the filler 4 The temperature is preferably 150 ° C. or lower, more preferably 130 ° C. or lower, and most preferably 110 ° C. or lower.

The physical properties of the filler 4 in a fluid state are not particularly limited as long as the space in the suppository container 2 is completely filled and the suppository 1 is prevented from moving. Or it may be in a paste form or the like. However, in view of the ease of introduction into the suppository container 2 and the ease of sealing the suppository container 2, it is preferable that the viscosity of the filler 4 can be controlled by means such as heating.

Examples of the material of the filler 4 that satisfies the above preferable characteristics include synthetic and / or natural polymer materials. When the filler 4 is composed of a synthetic or natural polymer material, it is particularly preferable to use a hot-melt adhesive in view of adhesiveness to the container 2 and sealing of the inlet 2a. As the hot-melt adhesive in the present invention, a so-called reactive hot-melt adhesive may be used, in addition to one that melts by heating to exhibit adhesiveness and solidifies by cooling to maintain an adhesive state. it can. Examples of such hot melt type adhesives include, for example, polyethylene resin, polypropylene, and polyolefin resin-based adhesives, polybutylene polyamide, polyamide-based adhesives such as nylon-11, nylon-11, and the like. , Acryl resin adhesives, polyvinyl acetate adhesives, polyester adhesives, polyvinyl acetal adhesives such as polyvinyl butyral, ethylene-vinyl acetate copolymer adhesives, thermoplastic elastomer adhesives And urethane-based hot-melt adhesives, etc., but preferably do not contain elution components harmful to the human body. Filler 4 comes in contact with suppository 1, so the material of filler 4 should be water, organic solvent, polymerization initiator, cross-linking agent in order to prevent undesired components from migrating to suppository 1. It is preferred that various components such as unpolymerized monomers are not eluted, or at least very little. It is preferable that the filler 4 is fixed to the suppository container 2 from the viewpoints of the shape retention of the suppository 1 and the easiness of handling at the time of opening. Examples of a method of fixing the filler 4 to the suppository container 2 include a mode 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 formation, it is preferable that the filler 4 itself be made of a material having adhesiveness or adhesiveness to the suppository container 2. However, in this case, it is preferable that the material constituting the filler 4 does not adhere to or adhere to the suppository 1.

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, X—X in FIG. Along the line, the entrance 2a of the suppository container 2 is sealed. Various methods such as sealing with an adhesive, heat sealing by contact or pressing with a heating means, and closing with a fastening member can be adopted as the sealing method of the inlet 2a, but the ease of sealing operation is easy. It is preferable to use a heat seal in view of reliability and the like. 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 is made of a material which melts by heating to exhibit adhesiveness. Need to be. Finally, the inlet 2a of the suppository container 2 is sealed to form a seal portion 2a ', whereby the suppository package 5 according to the present invention is manufactured as shown in FIG. 2 (b). . In the present embodiment, 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 both are sealed. However, since the filler 4 itself has a function as a sealing material, the hermeticity inside the suppository package 5 is completely maintained during storage and / or distribution. That is, in the suppository package 5 thus manufactured, since the filler 4 is sealed in the suppository container 2 via the seal portion 2a, the filler 4 is used for the suppository. The suppository container 2 can be more securely sealed by being integrated with the seal portion 2a 'of the container 2. Therefore, in the present embodiment, the contact between the suppository and the outside world can be completely cut off, so that the suppository 1 contained in the suppository container 2 is kept in a safe and good state until use. can do.

As is clear from FIG. 2 (b), the suppository package 5 of the present embodiment Since there is no space in which the suppository 1 can move, even if the suppository 1 is melted when the suppository package 5 is kept at a temperature equal to or higher than the body temperature during the storage and / or distribution process, Suppository 1 does not move in container 2 for use. 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. Suppository 1 slightly increases in volume when melted, but this increase can be absorbed by the expansion of container 2.

In addition, as shown in FIG. 2 (b), in the suppository package 5, only the space around the end along the long axis Z direction of the suppository 1 is filled with the filler 4, Filler 4 does not cover the surface of suppository 1 extensively. Therefore, when container 2 is opened, suppository 1 can be easily taken out.

Further, in the suppository package 5 of the present embodiment, since the filler 4 is integrated with the suppository container 2, even if the suppository container 2 is opened during use as shown in FIG. The filler 4 does not come off the suppository container 2. Therefore, when the user removes the suppository 1 from the suppository container 2, there is no danger that the filler 4 will be removed by mistake. Further, disposal of the suppository package after removing the suppository 1 is easy. In addition, since the filler 4 is fixed to the suppository container 2, the filler 4 does not move during storage or distribution, and does not affect the shape of the suppository 1. Example

The suppositories used in the examples were prepared by a conventional method. Table 1 shows the composition and properties. Next, 1.5 g of molten suppository was filled in a polypropylene suppository container having polyethylene laminated inside. After the suppository was solidified, 0.5 g of the melted polyvinyl acetate-based hot-melt adhesive was quickly filled thereon, and the suppository container inlet was immediately sealed with a heat sealer to seal the suppository package. I got Table 1 Composition and properties of suppositories in Examples Drugs / Content (per one) Diflucortron valerate 0.2 mg Base powder

Property White to pale yellow The 20 suppository packs obtained as described above were turned upside down 45. After storing in a C thermostat for 1 hour, it was left still in a room at 25 ° C for 1 day. As a result, no suppository leaked from the suppository container in any of the 20 samples subjected to the test. When the suppository was removed from the suppository container, no deformation was observed in the suppository. Industrial applicability

According to the suppository package of the present invention, even if the suppository package is stored and / or circulated under a temperature condition equal to or higher than the body temperature and is turned over or turned upside down, the suppository is held in the suppository container. Is not deformed. When the flow starting temperature of the suppository is 50 ° C or more, deformation of the suppository can be more reliably prevented.

Also, when the filler is filled only in the space adjacent to the end of the suppository, the suppository can be easily taken out of the container and the usability is improved.

If the filler in the suppository container is fixed to the suppository container, there is no danger that the filler will accidentally remove the filler when removing the suppository from the suppository container. Subsequent disposal can be easily performed. Furthermore, the filler does not move in the suppository container, so it does not affect the shape of the suppository. In particular, when the filler is integrated with the seal portion of the suppository container, in addition to the above-described effects, the sealing of the seal portion becomes more reliable, 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 prevent a chemical substance or the like that is not desirable for the human body from migrating to a suppository. When the filler is a hot-melt adhesive, integration with a suppository container and sealing can be easily performed.

According to the method 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. When a suppository and a filler are introduced into a container through the same container entrance, production of a suppository package becomes easier and work efficiency is improved. And In the case where the inlet of the antenna is sealed together with the filler, the sealing portion can be more reliably sealed.

Claims

The scope of the claims

1. Suppositories,

A suppository package comprising a container containing the suppository,

A suppository package, wherein the entire space between the suppository and the container is filled with a filler.

2. The suppository package according to claim 1, wherein the space exists only adjacent to an end of the suppository.

3. The suppository package according to claim 1, wherein a flow start temperature of the filler is 50 ° C. or higher.

4. The suppository package according to any one of claims 1 to 3, wherein the filler is fixed to the container.

5. The suppository package according to any one of claims 1 to 4, wherein the container has a seal portion, and the filler is integrated with the seal portion.

6. The suppository package according to any one of claims 1 to 5, wherein the filler does not contain an eluted component.

7. The suppository package according to any one of claims 1 to 6, wherein the filler is a hot melt adhesive.

8. Introducing the suppository into the container from the container entrance,

A filling step of filling a space between the suppository and the container with a fluid filler, and

A method for producing a suppository package, comprising a sealing step of sealing the container entrance.

9. The method according to claim 8, wherein the introducing step includes a step of injecting a fluid suppository into a container, and a step of solidifying the suppository.

10. The manufacturing method according to claim 8, wherein the filling in the filling step is performed through the container inlet.

11. The method according to claim 8, wherein the flow start temperature of the filler is 50 ° C. or higher.

12. The method according to any one of claims 8 to 11, wherein in the sealing step, the container inlet is sealed together with the filler.

13. The method according to any one of claims 8 to 12, wherein the filler does not contain an eluted component.

14. The method according to any one of claims 8 to 13, wherein the filler is a hot melt adhesive.

15. A suppository package obtained by the method according to any one of claims 8 to 14.

16. In a suppository package comprising a suppository and a container containing the suppository, a method for preventing deformation of the suppository, which comprises filling a space in the container with a fluid filler.

17. The method according to claim 16, wherein the flow start temperature of the filler is 50 ° C or higher.