JP2015218143A - Tablet confectionery, granule, or compression powder for tablet using isomalt, manufacturing method of compression powder for tablet, and manufacturing method of tablet confectionery, granules or tablet - Google Patents

Abstract

PROBLEM TO BE SOLVED: To solve the problems in which: when isomalt is used as an excipient for a conventional tablet (tablet confectionery) and tablets such as a granular food and a medicine, the following steps are generally required, which are a pulverization step of pulverizing the isomalt, a pelletization step of pelletizing the pulverized isomalt, and a compression step of compressing the pelletized isomalt, causing the production cost of the tablet confectionery and the tablet to become comparatively high; and generally, flowability of the isomalt powder is not good, therefore, it has not been possible to directly compress the isomalt powder into the tablet confectionery, the tablet and the like.SOLUTION: A tablet confectionery, granule, or compression powder for a tablet using isomalt comprises: 99%-85% of the isomalt powder excellent in fluidity in which central particle size of the isomalt powder is 130-290 μm; and 1%-15% of the isomalt powder inferior in fluidity in which central particle size of the isomalt powder is 63-90 μm.

Description

  The present invention relates to a tablet (tablet) having strong irritation and refreshing feeling, a granule food having fruit and mint flavors, etc., or a tablet for tableting using isomalt as an excipient for tablets such as pharmaceuticals and the tablet The present invention relates to a method for producing a powder and a method for producing tablet confectionery, granules or tablets.

Conventionally, as a method for producing tablet confectionery, in paragraph 0027 of Patent Document 1, “Example 1 Agitating granulator FM-VG-5 (manufactured by POWREC), sorbitol (manufactured by Merck, bulk) Density: 0.3-0.6 g / ml, specific surface area: 0.7-1.5 m ² / g), mint white oil (Nagaoka Jitsugyo) while stirring at 300 rpm blade rotation speed and 3000 rpm chopper rotation speed (Manufactured by Kogyo Kogyo Co., Ltd.) and mixed for 3 minutes and 30 seconds, then finely divided silicon dioxide (manufactured by DSL. Japan, trade name “Carplex CS-500”) and sucrose fatty acid ester (manufactured by Daiichi Kogyo Seiyaku Co., Ltd.) Trade name “DK ESTER F-20W”) was added and mixed for 30 seconds at a blade rotation speed of 300 rpm and a chopper rotation speed of 3000 rpm. The mixing ratio of each component is as shown in Table 1. The powder mixture thus obtained was taken out from the stirring granulator. Is described. Further, in paragraph 0028 of Patent Document 1, “The above powder mixture was subjected to a main pressure using a Burgo small rotary tablet machine (manufactured by Kikusui Seisakusho Co., Ltd.) equipped with a ridge having a diameter of 8 mm and a radius of curvature of the tip surface of 6.5 mm. Tableting was performed with a tableting pressure of 900 kg and a preload of 300 kg. Thus, a tablet confection having a thickness of 4.0 to 4.2 mm and a weight of 200 mg / tablet was obtained.

Japanese Patent No. 4955974 JP 2008-37853 A

In Example 1 of the invention of the above-mentioned Patent Document 1, paragraphs 0027 and 0028 of the specification describe a method for producing tablet confectionery. The production process can be summarized as follows: sorbitol (bulk density: 0.3 to 0.6 g / ml, specific surface area: 0.7 to 1.5 m ² / g) produced by a spray drying method is charged into a stirring granulator. Then, while stirring at a blade rotation speed of 300 rpm and a chopper rotation speed of 3000 rpm, mint white oil was sprayed and mixed for 3 minutes 30 seconds.
Next, a second step in which fine silicon dioxide and sucrose fatty acid ester are added and mixed for 30 seconds at a blade rotation speed of 300 rpm and a chopper rotation speed of 3000 rpm.
Finally, the obtained powder mixture was compressed into a tablet with a main pressure of 900 kg and a preload of 300 kg using a Burgo small rotary tablet machine (manufactured by Kikusui Seisakusho Co., Ltd.) equipped with a punch having a diameter of 8 mm and a curvature radius of 6.5 mm at the tip. It describes a process of tableting with pressure to obtain a tablet confection having a thickness of 4.0 to 4.2 mm and a weight of 200 mg / tablet.

  The tablet confection obtained by the invention of Patent Document 1 uses sorbitol as an excipient. However, since sorbitol has high hygroscopicity, there is a problem in the storage stability of tablet confectionery and tablets. In the invention of Patent Document 1, in the tablet confection manufacturing process, a granulation step of taking out the powder mixture from the stirring granulator is essential.

  In addition, the invention of Patent Document 2 discloses an invention of a rapidly disintegrating pharmaceutical solid preparation containing isomalt. In the paragraph 0013 of the specification of Patent Document 2, “The present invention will be described specifically by way of examples. Ingredients used for producing tablets for Example 1 are shown in Table 1.

  Further, in paragraph 0014 of Patent Document 2, “In Example 1-1, in addition to isomalt for direct hitting (trade name: galen IQ721, manufactured by Palatinit), croscarmellose sodium (trade name: Cross) Carmeldon, manufactured by Mingtai Chemical Co., Ltd.) and crystalline cellulose (trade name: Seldon, manufactured by Mingtai Chemical Co., Ltd.) were added to form a fast disintegrating tablet formulation.

Isomalt for direct hitting described in paragraph 0014 of the specification of Patent Document 2 (trade name: galen IQ721, manufactured by Palatinit)
The company guide dealing with the trade name shows that isomalt is granular.

Thus, when using isomalt as an excipient for conventional tablets (tablets), granular foods or pharmaceutical tablets, usually isomalt grinding step, granulating the ground isomalt and granulation The process of tableting isomalt has to be carried out, and the manufacturing cost of tablet confectionery and tablets is expensive.
Usually, isomalt powder has poor fluidity, and it is impossible to directly compress isomalt powder into tablet confectionery or tablets.

  The present invention has been made in order to solve the above-mentioned problems, and when producing tablets such as tablet confectionery, granular food or medicine, isomalt powder belonging to a range of particle size with poor fluidity and granules with good fluidity. By specifying each particle size range of the isomalt powder belonging to the diameter range and specifying the blending ratio thereof, tablets such as tablet confectionery, granular foods or medicines can be obtained without going through the granulation process from the state of isomalt powder. An object of the present invention is to provide a tableting powder using isomalt that can be directly compressed, a method for producing the powder, and a method for producing tablet confectionery, granule material, or tablet.

  Tablets for confectionery, granules or tablets using the isomalt according to the present invention, the center particle size of the isomalt powder is 99 μm to 290 μm, and the center of the isomalt powder is 99% to 85%. It is characterized by having a particle size of 1% to 15% of isomalt powder having poor fluidity and a blending ratio in which the particle size is in the range of 63 μm to 90 μm.

  The tableting powder, granule or tableting powder using the isomalt according to the present invention is composed of 99% to 90% isomalt powder having a center particle size of 140 to 250 μm and a center of the isomalt powder. Isomalt powder with poor fluidity having a particle size in the range of 63 μm to 90 μm is 1% to 10%.

  The isomalt raw material is administered to an airflow type pulverizer that rotates horizontally and at high speed, and the isomalt powder obtained by high-speed pulverization under the powder particle size set in advance by the airflow type pulverizer is sieved and the center particle size of the isomalt powder is 130 μm to A process for producing a tableting powder using isomalt, comprising 99% to 85% isomalt powder of 290 μm and 1 to 15% of isomalt powder having a center particle size in the range of 63 μm to 90 μm. .

  Isomalt powder having a center particle size of 140 μm to 250 μm with good fluidity 99% to 90%, and isomalt powder having a center particle size of 63 μm to 90 μm with poor fluidity is composed of 1% to 10%. Tablet confectionery and granule comprising a step of mixing isomalt powder, a tablet confectionery component excluding the isomalt component, a granular food component or a pharmaceutical tablet component, and a step of directly tableting without passing through the granulation step of the mixture Or the manufacturing method of a tablet.

  When manufacturing tablets such as tablet confectionery, granular foods or medicines, isomalt used as an excipient is isomalt powder belonging to the range of particle size with poor fluidity and isomalt belonging to the range of particle size with good fluidity By specifying each particle size range of powders and specifying their blending ratio, tablets such as tablet confectionery, granular foods or medicines can be directly compressed from the state of isomalt powder without going through the granulation process. As a result, the obtained tablet confectionery, granular food, tablet, etc. have low hygroscopicity, excellent moldability, and excellent storage stability. In the present invention, the composition of the isomalt powder with the center particle diameter of the isomalt powder 130 to 290 μm is 99% to 85%, and the composition of the isomalt powder with the center particle diameter of the isomalt powder 63 to 90 μm is 1% to 15%. The reason is that if the fine particles increase from the above range, the fluidity deteriorates, and the coarse particles increase and the tableting property deteriorates. Therefore, in order to eliminate this, the above range is specified. . That is, if it is the range of Claim 1, the fluidity | liquidity at the time of tableting is good, and a moldability is also good. In Claim 2, it turned out that the fluidity | liquidity at the time of tableting and a moldability improve further.

  Conventionally, isomalt powder has poor fluidity, and it has been impossible to tablet tablets such as tablet confectionery, granular foods or medicines in the state of powder, but the present invention improves the fluidity of isomalt powder. Thus, direct tableting can be performed without going through the granulation process.

  In addition, since there is no granulation process in the manufacturing process of tablets such as tablet confectionery, granular foods or pharmaceuticals, it is possible to reduce product costs by reducing manufacturing processes and reducing labor savings such as energy and power. .

It is a figure which shows the particle size distribution of the isomalt powder for direct striking.

  An embodiment of the present invention will be described below.

  The isomalt used in the present invention is a 100% isomalt raw material purchased from Cargill. A raw material of 100% isomalt is subjected to a microbial test and a water test for general live bacteria and coliforms. Next, the pulverization / classification process starts. This pulverization / classification step is performed using an airflow pulverizer (manufactured by Micro Foods Japan). This airflow type pulverizer is provided with struts spaced in the circumferential direction near the center between a lower disk and an upper disk that rotate horizontally at high speed around a central axis in a lathe circuit casing installed horizontally. The blades provided near the outer periphery of the lower disk and the upper disk are installed at positions shifted from each other when viewed from the radial direction, and the support columns and the blades are provided at intervals in the circumferential direction. 100% isomalt raw material is charged from a charging pipe installed vertically toward a hole provided in the center of the upper disk. The isomalt raw material 100% charged from the charging pipe collides with each of the columns and the blades by the centrifugal force of the disk rotating at high speed, and is pulverized. By sieving, the pulverized isomalt powder has a powder having a center particle size of 130 μm to 290 μm in a range of 99% to 85% of the whole, and a powder having a particle size of 63 μm to 90 μm is 1% to 15%. As a result, an isomalt powder having good fluidity and tableting property was obtained. Metal impurities are removed from the classified isomalt powder by a 12,000 gauss magnet. Microbiological tests such as general live bacteria and Escherichia coli and moisture test are performed.

The particle size of isomalt in Example 1 was measured by Laser Micron Sizer (LMS-2000e).
FIG. 1 is a graph showing the particle size distribution of a direct hitting isomalt powder, wherein the horizontal axis represents the particle diameter (μm) and the vertical axis represents the volume (%).

  By making the particle size and blending of the isomalt of Example 1 in the following ranges, an isomalt powder having better fluidity and tableting properties was obtained. That is, the center particle diameter of the isomalt powder is in the range of 140 μm to 250 μm in the range of 99% to 90% of the total, and the powder of 63 μm to 90 μm in the range of 1% to 10% of the total.

  A tableting test was conducted with 97% isomalt powder and 3% sucrose fatty acid ester of Example 1 having different particle size ranges. A hardness of 100 N or more was stably obtained at a diameter of 8 mm, a weight of 250 mg, a tableting pressure of 10 KN, and a turntable rotation speed of 20 rpm. The machine used is a rotary tableting machine (PICCOLA).

The present invention relates to a powder for tableting using isomalt, which can directly tablet tablets such as tablet confectionery, granular foods or medicines without undergoing a granulation step from the state of isomalt powder, a method for producing the same, and tablet confectionery. It is an invention of a method for producing granules or tablets, and is an invention widely used in a wide range of fields such as the food industry and the pharmaceutical production industry.

Claims (4)

Isomalt powder having a center particle size of 130 μm to 290 μm and good fluidity isomalt powder 99% to 85%, and isomalt powder having a center particle size of 63 μm to 90 μm and poor fluidity isomalt powder 1% to 15% Tableting powder for tablets and granules or tablets using isomalt characterized by comprising a blending ratio.   Tablets, granules, or tableting powders for tablets using isomalt have 99% to 90% isomalt powder with a fluidity of isomalt powder having a center particle size of 140 to 250 μm and a center particle size of isomalt powder of 63 μm. The tableting powder for tablets or granules or tablets using isomalt according to claim 1, wherein the isomalt powder having poor fluidity in the range of -90 µm is 1% to 10%.   The isomalt raw material is administered to an airflow type pulverizer that rotates horizontally and at high speed, and the isomalt powder obtained by high-speed pulverization under the powder particle size set in advance by the airflow type pulverizer is sieved and the center particle size of the isomalt powder is 130 μm to A process for producing a tableting powder using isomalt, comprising 99% to 85% isomalt powder of 290 μm and 1 to 15% of isomalt powder having a center particle size in the range of 63 μm to 90 μm. . Isomalt powder having a center particle size of 140 μm to 250 μm with good fluidity 99% to 90%, and isomalt powder having a center particle size of 63 μm to 90 μm with poor fluidity is composed of 1% to 10%. Production of tablet confectionery, granule or tablet comprising isomalt powder, step of mixing tablet confectionery component, granule component or tablet component excluding the isomalt component, and step of directly tableting without going through granulation step of the mixture Method.

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