JP2851073B2 - Suppository kit - Google Patents

Description

The present invention relates to a suppository kit useful in the field of pharmaceutical preparations.

2. Description of the Related Art Suppositories have recently attracted particular attention as an administration method that does not undergo hepatic metabolism of drugs such as analgesics, antipyretics, and antibiotics for the purpose of systemic treatment as well as treatment of anal disease.

However, the disadvantage of suppository administration is that the dosage can hardly be increased or decreased. Solutions to this problem include shortening the dosing interval, administering several suppositories at the same time, preparing suppositories with different drug contents individually as needed, or cutting suppositories Such a method is conceivable.
However, these methods may not be able to continuously increase or decrease the dosage or may be difficult to implement. Also, suppositories are often difficult to administer multiple drugs simultaneously. Attempts have been made to mix a plurality of drugs in one suppository with the same idea as multilayer tablets, but it is not possible to arbitrarily select a drug according to the disease.

These problems are compared with the case of oral administration,
Be clearer. For example, when a powder is orally administered, the dose can be continuously and freely changed, and other powders and tablets arbitrarily selected can be taken at the same time, and this is actually widely practiced. In contrast, increasing or decreasing the dose as well as simultaneous administration of any multiple drugs is not easy to achieve in suppositories.

Japanese Patent Application Laid-Open No. 50-157518 discloses a suppository in which a recess is provided in a part of a suppository, a heated solution of a suppository base containing a drug is injected into the recess, and the recess is filled with the heated suppository base. A finished suppository is disclosed. The suppository provides drug stabilization but is not intended to continuously increase or decrease the dosage or to administer any number of drugs simultaneously.

JP-A-59-65010 discloses a hollow suppository, in which a suppository is filled with a powdered drug in the hollow portion and the surface of a stopper made of a suppository base is melted to form an opening. It is used after sealing. Although it is disclosed only to prevent a bad interaction between the drug and the suppository base, it is thought that the suppository can be used to continuously increase or decrease the dose of the drug. However, filling the drug and sealing the opening takes time and is troublesome. In addition, in this hollow suppository, the person and the place (for example, a drug department in a hospital) who fill the powdered drug and seal the opening are different from the person (patient) who actually uses the place (for example, a hospital or home). It is unsanitary because naked suppositories pass from person to person. Also, the suppository itself is only produced in small quantities in hospitals for individual patients.

Therefore, the present inventors have conducted various studies to easily achieve simultaneous administration of a plurality of drugs as well as continuous administration of a plurality of drugs in a suppository, and have completed the present invention.

The present invention comprises a combination of a main body having a hollow portion or a concave portion, and a mandrel that can be inserted into the hollow portion or the concave portion of the main body and is formed into a suppository after insertion. Suppository kit.

Here, the main body takes, for example, a shell shape as shown in FIG. 1, a tubular shape as shown in FIG. 2, and a mortar shape as shown in FIG. 3 and FIG. 1 to 4, 1 denotes a main body, 2 denotes a hollow portion or a concave portion, 3 denotes a head or a head direction, and 4 denotes a tail. The size of each part of the main body 1 varies depending on its shape, type of drug, and thus the type of disease, or whether the patient is an adult or an infant, for example, the main body 1 is shown in FIG. If it is shell-shaped, its overall length (b) is about 10-
50 mm, usually 30 to 40 mm, the depth (a) of the hollow part or the concave part 2 is about 3 to 30 mm, usually 15 to 25 mm,
Its width (c) is about 3 to 12 mm, usually 5 to 8 mm, and the diameter (d) of the tail 4 is about 6 to 16 mm, usually 7 to
The thickness (e) of the side wall is about 1.5 mm or more, usually about 2 to 3 mm. The size of the main body 1 having the shape shown in FIGS. 2 to 4 conforms to the case of FIG. In any case, after assembling, the shell has the shape shown in FIG. 1 or a shape close thereto. A skirt may be provided around the tail part 4 of the main body 1 so as to form a rocket when assembled. The hollow portion or the concave portion 2 is preferably finished in a columnar or conical shape. The hollow portion or the concave portion may be finished in a prismatic shape, but there is no particular advantage.

The mandrel can be inserted into a hollow portion or a concave portion of the main body 1 of the mandrel, and is formed so as to form a suppository as a whole after the insertion. For example, the columnar mandrel 5 shown in FIG. 10 and FIG.
The conical mandrel 5 shown in the figure is inserted into the shell-shaped main body 1 shown in FIG. 1 and assembled into a suppository shown in FIGS. 5 and 6. Fig. 13 (mushroom shape) and Fig. 14
The mandrel 5 shown in the figure (acorn-like) is assembled into a suppository shown in FIG. 7 to FIG. When the mandrel takes the shape shown in FIGS. 13 and 14, ie, when a part of the mandrel forms the head of a suppository, the size of the head depends on the size of the main body 1. It is determined. 10 to 12, the length of the cylindrical or conical mandrel 5 shown in FIGS. 13 and 14, and the mandrel shown in FIGS. 13 and 14; The length (f ') of the portion to be inserted into the main body 1 is not particularly limited, but is approximately equal to or less than the depth (a) of the hollow portion or the concave portion of the main body 1, for example, 1/2 or 1/3 of (a). It is. Further, a protrusion or a band-like material 6 as shown in FIG. 10 can be provided on the surface of the mandrel 5, which is crushed when the mandrel 5 is inserted into the hollow portion or the concave portion 2 and is crushed. 5 is held in the hollow or concave portion 2. The mandrel 5 may be coated with a thin film of a wax-like material to facilitate insertion into the hollow or recess 2. The mandrel 5 may be formed so as to connect a plurality of mandrels as shown in FIGS. 11 and 12, and a cut line 7 may be provided.

The main body and the mandrel are packaged together or separately, made into a kit, and assembled at the time of use, that is, at the time of administration. The assembling is performed by inserting the mandrel 5 into the hollow portion or the concave portion 2 of the main body 1. The insertion can be easily performed by pushing the mandrel 5 from the hollow or the opening of the recess 2 with a finger.
In the case where a plurality of mandrel bodies are connected as shown in FIGS. 11 and 12, for example,
The mandrel body having the length (f) is cut off with a finger and then inserted, or inserted as it is, and cut off at the cutting line 7 by the leverage. As shown in FIGS. 5 and 8, a plurality of mandrels may be inserted into one main body. 5 to 9 show examples of the suppository thus assembled.

The drug incorporated in the main body 1 and the mandrel 5 may be any drug, and examples thereof include narcotics such as morphine hydrochloride and analgesics such as indomethacin, as well as antibiotics, anticancer drugs, and antipyretics.

These drugs are dispersed or dissolved in a suppository base which may contain auxiliary components, and formed into the main body 1 and the mandrel 5. The suppository base in the main body 1 and the mandrel 5 may be the same or different, but in any case, a suppository base which is solid at room temperature and melts at around 35 to 43 ° C is used. Can be Suppository bases include lipophilic bases such as cocoa butter, higher fatty acid triglyceride, higher fatty acid triglyceride-monoglyceride mixture (various Witepsol; Huls), polyethylene glycol (various carbowax; Dow Chemical), and the like. A hydrophilic base such as glycerogelatin is used. Auxiliary components other than the base include surfactants, coloring agents, antioxidants and the like.

The main body 1 can be manufactured by further adding a hollow portion or concave portion forming process such as a process using a rod with a heater for forming a hollow portion or a drilling process to the usual suppository manufacturing process. The mandrel 5 can be easily formed by a method such as a melting method or a punching method using a mold container or a mold.
The projection or band 6 shown in FIG. 10 is formed by a mold container, by scratching the surface of the mandrel 5, or by loosely pressing the mandrel 5 on a heating curved plate provided with small projections. be able to. Putting a coloring agent in the main body 1 and the mandrel 5, changing the color according to the type of the drug, and changing the color depth according to the drug content is useful in the management of drugs, especially narcotics.

Specific Example Next, the present invention will be described more specifically with reference to examples.

Manufacture of main body (without drug) First, a plastic container is prepared. Then 38 ° C
A predetermined amount of Witepsol H-15 melted in the above step is filled in a plastic container, and a rod with a heater for forming a hollow portion is inserted into the container. This is kept at 18 ° C for 30 minutes, then 25
Allow to cool at room temperature for 1 hour. Thereafter, the hollow portion forming rod-shaped body is gently heated and extracted, and a cylindrical hollow portion 2 is formed, followed by sealing. The obtained main body 1 had the shape shown in FIG. 1, and the size of each part was as follows.

Depth of hollow part (A); 24mm Overall length of main body (B); 33mm Width of hollow part (C); 7mm Diameter of tail part (D); 12mm Side wall thickness (E); 2.5mm Mandrel containing morphine hydrochloride Production Witepsol H-15 is melted at 38 ° C., mixed with morphine hydrochloride, and filled into a mandrel container.
After leaving to cool at 10 ° C. for 10 minutes and at 25 ° C. for 30 minutes, the container was opened and the solidified contents were taken out to obtain a mandrel having the shape shown in FIG. 10 (however, the protrusion 6 was not provided). The size of each part of the mandrel is as follows, and it is a size that occupies exactly 1/3 of the hollow body obtained above.

Overall length (f); 8 mm width (g); 6.9 mm kit The 10 main bodies produced above and 30 morphine-containing mandrels were formed into a kit. This kit can be used for removing cancer pain. Cancer disease progresses due to the proliferation of cancer cells, and eventually pain becomes intolerable. WHO from a humanitarian point of view
Recommends oral administration of morphine hydrochloride, but as the symptoms progress, oral administration becomes impossible. The administration of morphine hydrochloride in such terminal stage cancer using the suppository kit of the present invention and gradually increasing the dosage or simultaneously administering other drugs is simpler than injection administration instead of oral administration. Yes, it is also advantageous for drug management.

Thus, the suppository kit of the present invention can easily achieve almost continuous increase / decrease of the dose by suppositories and simultaneous administration of arbitrary multiple drugs, which have been considered difficult, and mass production. To facilitate and ensure drug management, especially drug management.

In addition, the suppository kit of the present invention enables simultaneous administration of a plurality of drugs, even if these drugs are mixed at the same time, causing a bad interaction.

The main body and mandrel are easily mass-produced and made into kits, and nurses, attendants, or patients themselves can easily assemble and use (administer) suppositories based on the instructions of a doctor. Can be. The suppository kit of the present invention, ie, the body 1 and the mandrel 5, are packaged together or separately, and the package is broken, assembled and administered just before use (administration). Therefore, in the suppository kit of the present invention, there is almost no time lag from when the packaging is broken until use (administration). Therefore, the assembled naked suppository can be used safely without any concern about contamination between humans and before use.

[Brief description of the drawings]

1 to 4 are sectional views of the main body, FIGS. 5 to 9 are assembled sectional views of a suppository kit, and FIGS. 10 to 14 are sectional views of a mandrel. In addition, each number in each figure means the following. 1; body 2; hollow or concave portion 3; head or head direction 4; tail 5; mandrel 6; protrusion or band 7; score line

Continuation of front page (58) Field surveyed (Int. Cl. ⁶ , DB name) A61K 9/00, 9/02

Claims (3)

(57) [Claims] 1. A tubular body having a hollow or concave portion,
A suppository kit comprising a combination with a mushroom-shaped mandrel that can be inserted into a hollow portion or a concave portion of a main body and formed into a suppository after insertion. 2. A main body having a hollow portion or a concave portion, and a cut line which can be inserted into the hollow portion or the concave portion of the main body, is formed into a suppository after the insertion, and can be cut when used. Suppository kit consisting of a combination with a given mandrel. 3. A combination of a main body having a hollow portion or a concave portion, and a mandrel that can be inserted into the hollow portion or the concave portion of the main body and is formed into a suppository after the insertion, A suppository kit in which one or both of a main body and a mandrel is mixed with a drug.