JP2005255595A - Tablet formulated with dioctyl sodium sulfosuccinate - Google Patents
Tablet formulated with dioctyl sodium sulfosuccinate Download PDFInfo
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- JP2005255595A JP2005255595A JP2004067876A JP2004067876A JP2005255595A JP 2005255595 A JP2005255595 A JP 2005255595A JP 2004067876 A JP2004067876 A JP 2004067876A JP 2004067876 A JP2004067876 A JP 2004067876A JP 2005255595 A JP2005255595 A JP 2005255595A
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- tablet
- silicic acid
- anhydrous silicic
- light anhydrous
- sulfosuccinate
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- CDOUZKKFHVEKRI-UHFFFAOYSA-N 3-bromo-n-[(prop-2-enoylamino)methyl]propanamide Chemical compound BrCCC(=O)NCNC(=O)C=C CDOUZKKFHVEKRI-UHFFFAOYSA-N 0.000 title claims abstract description 38
- 235000019329 dioctyl sodium sulphosuccinate Nutrition 0.000 title claims abstract description 38
- 239000008187 granular material Substances 0.000 claims abstract description 22
- 238000004519 manufacturing process Methods 0.000 claims abstract description 12
- 239000000843 powder Substances 0.000 claims abstract description 10
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 claims description 25
- 235000012239 silicon dioxide Nutrition 0.000 claims description 25
- 238000000034 method Methods 0.000 claims description 13
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 12
- 238000002156 mixing Methods 0.000 claims description 10
- 239000000314 lubricant Substances 0.000 claims description 8
- 235000019359 magnesium stearate Nutrition 0.000 claims description 6
- 238000002360 preparation method Methods 0.000 abstract description 5
- 239000007787 solid Substances 0.000 abstract description 5
- 150000008065 acid anhydrides Chemical class 0.000 abstract 2
- 239000000203 mixture Substances 0.000 description 15
- 238000005469 granulation Methods 0.000 description 10
- 230000003179 granulation Effects 0.000 description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 8
- 239000004480 active ingredient Substances 0.000 description 8
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 6
- 230000000052 comparative effect Effects 0.000 description 6
- 238000011156 evaluation Methods 0.000 description 6
- 239000008101 lactose Substances 0.000 description 6
- 238000009472 formulation Methods 0.000 description 5
- KHOITXIGCFIULA-UHFFFAOYSA-N Alophen Chemical compound C1=CC(OC(=O)C)=CC=C1C(C=1N=CC=CC=1)C1=CC=C(OC(C)=O)C=C1 KHOITXIGCFIULA-UHFFFAOYSA-N 0.000 description 4
- 229960000503 bisacodyl Drugs 0.000 description 4
- 239000004570 mortar (masonry) Substances 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 3
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 3
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 3
- 239000008213 purified water Substances 0.000 description 3
- 238000005507 spraying Methods 0.000 description 3
- 238000013019 agitation Methods 0.000 description 2
- 239000011230 binding agent Substances 0.000 description 2
- 238000013329 compounding Methods 0.000 description 2
- 210000000744 eyelid Anatomy 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 230000002475 laxative effect Effects 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000009495 sugar coating Methods 0.000 description 2
- 206010010774 Constipation Diseases 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 238000003723 Smelting Methods 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 239000003463 adsorbent Substances 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000010924 continuous production Methods 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 238000004898 kneading Methods 0.000 description 1
- 239000008141 laxative Substances 0.000 description 1
- 230000007721 medicinal effect Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
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- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
本発明はジオクチルソジウムスルホサクシネートを配合した錠剤に関し、さらに詳しくは錠剤製造時の打錠障害を防止し、大量生産が可能な錠剤に関する。 The present invention relates to a tablet containing dioctyl sodium sulfosuccinate, and more particularly to a tablet capable of preventing mass production during tablet production and capable of mass production.
ジオクチルソジウムスルホサクシネートは瀉下薬として知られ、広く利用されている。しかしながらその性状は、ロウのような半固形物質であるので、固形製剤に配合する場合にはそのままでの配合は困難である。 Dioctylsodium sulfosuccinate is known as a laxative and is widely used. However, since its properties are a semi-solid substance such as wax, it is difficult to mix as it is when blended into a solid preparation.
従来、ジオクチルソジウムスルホサクシネートを固形製剤に配合する場合、軽質無水ケイ酸などの吸着剤に分散処理などを行うことにより粉状にして扱いやすくしていた。しかし、その様に粉状にしたものを錠剤の形に圧縮成形すると、打錠時にジオクチルソジウムスルホサクシネート由来の顆粒が打錠機回転盤や杵、臼へ付着してしまい、連続して大量に生産する場合に打錠障害が発生することがあった。特に杵や臼への付着が発生すると、錠剤質量にばらつきが生じたり、杵と臼のきしみなどの問題点が生じていた。 Conventionally, when dioctylsodium sulfosuccinate is blended in a solid preparation, it has been made powdery and easy to handle by dispersing the adsorbent such as light silicic anhydride. However, when the powdered product is compressed into a tablet, the granules derived from dioctylsodium sulfosuccinate adhere to the tableting machine rotary plate, punch, and die during tableting. In the case of mass production, tableting troubles may occur. In particular, when adhesion to the pestle or mortar occurred, the tablet mass varied, and problems such as crease and crease crease occurred.
このような打錠障害を防止するためには、打錠時にタルク、ステアリン酸マグネシウムなどの滑沢剤を配合するのが一般的である。しかし、滑沢剤を多く配合すると錠剤硬度の低下や崩壊遅延といった問題が生じやすく、特にジオクチルソジウムスルホサクシネートを核としたコーティング錠の場合、その影響が大きい。そのため、ジオクチルソジウムスルホサクシネートを配合した錠剤は限られたものだけであった。 In order to prevent such tableting troubles, it is common to blend lubricants such as talc and magnesium stearate during tableting. However, when a large amount of lubricant is blended, problems such as tablet hardness reduction and disintegration delay are likely to occur, and in particular, in the case of a coated tablet having dioctylsodium sulfosuccinate as the core, the effect is great. Therefore, only a limited number of tablets were blended with dioctyl sodium sulfosuccinate.
従来ジオクチルソジウムスルホサクシネートを配合した製剤の打錠障害を改善する技術として、ジオクチルソジウムスルホサクシネートおよび微粉末を特殊な条件で粉末化する技術（特許文献１）などが知られている。 Conventionally, as a technique for improving the tableting trouble of a preparation containing dioctylsodium sulfosuccinate, a technique for making dioctylsodium sulfosuccinate and fine powder under special conditions (Patent Document 1) is known. .
本発明は、ジオクチルソジウムスルホサクシネートを配合した処方で、打錠障害を発生せずに錠剤を大量かつ連続的に製造できる固形製剤を提供することを目的とする。 An object of this invention is to provide the solid formulation which can manufacture a tablet in large quantities continuously without generating a tableting trouble with the prescription which mix | blended dioctyl sodium sulfosuccinate.
本発明者らは上記課題を解決するために鋭意研究を重ねた結果、軽質無水ケイ酸を含む粉体に、ジオクチルソジウムスルホサクシネートを配合した溶液を用いて造粒を行い、その後さらに後末添加で軽質無水ケイ酸を配合して、打錠すると、大量に打錠しても打錠障害を発生せずに錠剤を連続して製造できることを見出し、本発明を完成した。 As a result of intensive studies to solve the above-mentioned problems, the present inventors performed granulation using a solution containing light anhydrous silicic acid and a solution containing dioctyl sodium sulfosuccinate, and then later It was found that when light anhydrous silicic acid was blended with powdered addition and tableted, tablets could be continuously produced without causing any tableting troubles even when tableted in large quantities, and the present invention was completed.
すなわち本発明は、
１．ジオクチルソジウムスルホサクシネートおよび軽質無水ケイ酸を含有する顆粒に後末でさらに軽質無水ケイ酸を添加し、打錠してなる錠剤。
２．ジオクチルソジウムスルホサクシネート１質量部に対する粉体中の軽質無水ケイ酸の配合量が０．５〜１．５質量部である請求項１に記載の錠剤。
３．ジオクチルソジウムスルホサクシネートが錠剤全体の１０質量％以上含有する請求項１に記載の錠剤。
４．ジオクチルソジウムスルホサクシネートを配合した溶液を用いて、軽質無水ケイ酸を含有する粉体を造粒し、得られた顆粒に後末でさらに軽質無水ケイ酸および滑沢剤を添加し、打錠してなる錠剤。
５．滑沢剤がステアリン酸マグネシウムである請求項４記載の錠剤。
６．後末で添加する軽質無水ケイ酸の配合量が錠剤全体の０．１〜５質量％である請求項１〜５のいずれかに記載の錠剤。
７．以下の工程
（１）ジオクチルソジウムスルホサクシネートを配合した溶液を用いて、軽質無水ケイ酸を含有する粉体を造粒し、顆粒を得る工程、
（２）得られた顆粒に後末でさらに軽質無水ケイ酸を添加する工程、
（３）打錠する工程、
からなるジオクチルソジウムスルホサクシネート含有錠剤の製造方法。
である。
That is, the present invention
1. A tablet obtained by further adding light anhydrous silicic acid to a granule containing dioctylsodium sulfosuccinate and light anhydrous silicic acid at the end and compressing it.
2. The tablet according to claim 1, wherein the blending amount of light anhydrous silicic acid in the powder with respect to 1 part by mass of dioctylsodium sulfosuccinate is 0.5 to 1.5 parts by mass.
3. The tablet according to claim 1, wherein dioctyl sodium sulfosuccinate is contained in an amount of 10% by mass or more of the whole tablet.
4). Using a solution containing dioctylsodium sulfosuccinate, a powder containing light anhydrous silicic acid is granulated, and further light anhydrous silicic acid and lubricant are added to the resulting granule at the end. Tablets made from tablets.
5). The tablet according to claim 4, wherein the lubricant is magnesium stearate.
6). The tablet according to any one of claims 1 to 5, wherein the amount of light silicic acid added at the end is 0.1 to 5% by mass of the whole tablet.
7). The following step (1) a step of granulating a powder containing light anhydrous silicic acid using a solution in which dioctylsodium sulfosuccinate is blended to obtain granules,
(2) A step of further adding light anhydrous silicic acid to the obtained granules at a later stage,
(3) Tableting process,
The manufacturing method of the dioctyl sodium sulfosuccinate containing tablet which consists of these.
It is.
本発明でジオクチルソジウムスルホサクシネートの配合量は１日量で２４〜２００ｍｇが好ましい。そのためジオクチルソジウムスルホサクシネートの配合量が少ないと薬効を発現するためには大量の製剤を投与する必要があり、配合量が多すぎると、錠剤径を大きくせねばならず、服用性の点で問題になることから１錠あたりの配合量は限られたものになる。 In the present invention, the blending amount of dioctyl sodium sulfosuccinate is preferably 24 to 200 mg per day. Therefore, if the blending amount of dioctylsodium sulfosuccinate is small, it is necessary to administer a large amount of the drug in order to develop the medicinal effect, and if the blending amount is too large, the tablet diameter must be increased, and the ingestion point Therefore, the blending amount per tablet is limited.
また、本発明ではジオクチルソジウムスルホサクシネートが製剤全体の１０質量％以上という高濃度であっても打錠障害を発生しないという特徴がある。通常、ジオクチルソジウムスルホサクシネートの配合量が１０質量％以上にも達すると、ジオクチルソジウムスルホサクシネートの性状の影響から打錠することが困難になってしまうが、本発明では錠剤を得ることができる。これにより、本発明により得られる錠剤はより小型のものにすることができる。 Further, the present invention is characterized in that no tableting trouble occurs even if the dioctylsodium sulfosuccinate is at a high concentration of 10% by mass or more of the whole preparation. Usually, when the blending amount of dioctylsodium sulfosuccinate reaches 10% by mass or more, it becomes difficult to tablet due to the influence of the properties of dioctylsodium sulfosuccinate. In the present invention, tablets are obtained. be able to. Thereby, the tablet obtained by this invention can be made smaller.
一般に杵付着などの打錠障害を抑止するために行われる方法として、錠剤を製造する際に滑沢剤を高濃度で配合する方法がある。しかしその様にして得られた錠剤は錠剤硬度の低下や崩壊の遅延といった問題を生じるが、本発明では圧力伝達を改善するための通常の滑沢剤量を添加するだけで良いので、硬度の低下や崩壊遅延といった問題が起こりにくい。 As a method generally performed in order to suppress tableting troubles such as sticking, there is a method of blending a lubricant at a high concentration when producing tablets. However, the tablets obtained in this way cause problems such as a decrease in tablet hardness and a delay in disintegration. However, in the present invention, it is only necessary to add a normal amount of lubricant for improving pressure transmission. Problems such as degradation and decay delay are unlikely to occur.
本発明において、顆粒製造のときに配合される軽質無水ケイ酸はジオクチルソジウムスルホサクシネート１質量部に対して０．５〜１．５質量部の配合が好ましく、０.６〜１.３質量部の配合がさらに好ましい。 In the present invention, the light silicic acid compounded at the time of granule production is preferably 0.5 to 1.5 parts by mass with respect to 1 part by mass of dioctylsodium sulfosuccinate, and 0.6 to 1.3. The blending of parts by mass is more preferable.
本発明において、後末で添加する軽質無水ケイ酸の配合量は、錠剤全体の０．１〜５質量％である。 In this invention, the compounding quantity of the light silicic acid added at the end is 0.1-5 mass% of the whole tablet.
本発明において粉体を造粒する際の造粒方法としては、高速撹拌造粒法、流動層造粒法、練合造粒法などの湿式造粒法があげられ、特に高速撹拌造粒法、錬合造粒法が好ましい。 Examples of the granulation method when granulating the powder in the present invention include wet granulation methods such as high-speed agitation granulation method, fluidized bed granulation method, kneading granulation method, and particularly high-speed agitation granulation method A smelting granulation method is preferred.
本発明の錠剤は以下のように製造される。 The tablet of the present invention is produced as follows.
ジオクチルソジウムスルホサクシネートおよび必要があれば結合剤を、水、エタノールなどの溶媒に溶解して溶液とする。その溶液を噴霧しながらもしくは一括に添加し、軽質無水ケイ酸および必要があれば賦形剤など他の配合成分を混合した粉体を造粒して顆粒を得る。 Dioctyl sodium sulfosuccinate and, if necessary, the binder are dissolved in a solvent such as water or ethanol to form a solution. The solution is sprayed or added all at once, and a granule is obtained by granulating powder mixed with light anhydrous silicic acid and, if necessary, other ingredients such as excipients.
得られた顆粒に、さらに軽質無水ケイ酸を添加し、必要があれば通常の医薬品製造に使用される他の薬効成分、添加剤などを加え、常法により打錠して、錠剤を得ることができる。得られた錠剤は素錠としてそのまま錠剤にすることもできるが、さらにコーティング、糖衣などを施し、フィルム錠、糖衣錠などの剤形とすることができる。 To the resulting granules, add light anhydrous silicic acid, and if necessary, add other medicinal ingredients and additives used in normal pharmaceutical production, and tablet in the usual way to obtain tablets Can do. The obtained tablets can be used as plain tablets as they are, but they can be further coated and coated with sugar coatings to form dosage forms such as film tablets and sugar coating tablets.
また、ジオクチルソジウムスルホサクシネートおよび結合剤を溶解するための溶媒は作業効率の点から可能な限り少量が好ましいが、通常、溶質の１．０〜３．０倍程度を用いる。 The solvent for dissolving dioctylsodium sulfosuccinate and the binder is preferably as small as possible from the viewpoint of work efficiency, but usually about 1.0 to 3.0 times the solute is used.
本発明では、特にジオクチルソジウムスルホサクシネートと他の瀉下作用のある活性成分を同顆粒中、もしくは別顆粒とし、これを混合して打錠すると瀉下作用の向上が期待できるので好ましい。ここで他の瀉下作用のある活性成分としてはビサコジルが好ましく、その配合量は１日投与量で３〜２０mgが好ましい。 In the present invention, it is particularly preferable to dioctylsodium sulfosuccinate and other active ingredients having an axillary action in the same granule or in a separate granule, and mixing them for tableting can be expected to improve the axillary action. Here, bisacodyl is preferable as another active ingredient having a laxative action, and the compounding amount thereof is preferably 3 to 20 mg as a daily dose.
本発明により得られた製剤組成物は、大量に連続的に打錠を行っても、杵や臼に付着が発生せず、打錠障害が発生しにくい。 The pharmaceutical composition obtained according to the present invention does not cause sticking to the pestle or mortar, and does not easily cause tableting troubles, even if tableting is carried out continuously in large quantities.
本発明により、打錠時に起こるジオクチルソジウムスルホサクシネート由来の付着を防止し、連続生産可能な錠剤組成物を提供することが可能となった。 According to the present invention, it is possible to provide a tablet composition capable of preventing continuous adhesion from dioctyl sodium sulfosuccinate that occurs during tableting and capable of continuous production.
以下に実施例及び試験例をあげて本発明をさらに詳細に説明する。 Hereinafter, the present invention will be described in more detail with reference to examples and test examples.
表１に示した処方で錠剤を製造した。すなわち、活性成分のビサコジルに乳糖、ヒドロキシプロピルセルロース、低置換度ヒドロキシプロピルセルロース、軽質無水ケイ酸を混合し合剤とした。活性成分ジオクチルソジウムスルホサクシネートをエタノールと精製水の混液に溶解させ、これを造粒溶液として合剤中に噴霧し造粒した。その後乾燥させ、得られた顆粒に後末で軽質無水ケイ酸、ステアリン酸マグネシウム、造粒乳糖を加え混合顆粒を１錠質量５０ｍｇでロータリー式打錠機を用いて連続で打錠して錠剤を得た。 Tablets were produced according to the formulation shown in Table 1. That is, lactose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and light anhydrous silicic acid were mixed with bisacodyl as an active ingredient to prepare a mixture. The active ingredient dioctylsodium sulfosuccinate was dissolved in a mixture of ethanol and purified water, and this was granulated by spraying it into the mixture as a granulation solution. After that, it was dried, and light anhydrous silicic acid, magnesium stearate and granulated lactose were added to the obtained granule at the end, and the mixed granule was tableted continuously with a rotary tableting machine at a mass of 50 mg. Obtained.
比較例１ 製造方法
表１に示した処方で比較用錠剤を製造した。活性成分のビサコジルに乳糖、ヒドロキシプロピルセルロース、低置換度ヒドロキシプロピルセルロース、軽質無水ケイ酸を混合し合剤とした。活性成分ジオクチルソジウムスルホサクシネートをエタノールと精製水の混液に溶解させ、これを造粒溶液として合剤中に噴霧し造粒した。その後乾燥させ、得られた顆粒に後末でステアリン酸マグネシウム、造粒乳糖を加え混合顆粒を１錠質量５０ｍｇでロータリー式打錠機を用いて連続で打錠して錠剤を得た。
Comparative Example 1 Production Method Comparative tablets were produced according to the formulation shown in Table 1. Lactose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and light anhydrous silicic acid were mixed with bisacodyl as an active ingredient to prepare a mixture. The active ingredient dioctylsodium sulfosuccinate was dissolved in a mixture of ethanol and purified water, and this was granulated by spraying it into the mixture as a granulation solution. Thereafter, it was dried, and magnesium stearate and granulated lactose were added to the resulting granule at the end, and the mixed granule was tableted continuously at a mass of 50 mg using a rotary tableting machine to obtain a tablet.
比較例２ 製造方法
表１に示した処方で比較用錠剤を製造した。活性成分のビサコジルに乳糖、ヒドロキシプロピルセルロース、低置換度ヒドロキシプロピルセルロースを混合し合剤とした。活性成分ジオクチルソジウムスルホサクシネートをエタノールと精製水の混液に溶解させ、これを造粒溶液として合剤中に噴霧し造粒した。その後乾燥させ、得られた顆粒に後末でステアリン酸マグネシウム、造粒乳糖を加え混合顆粒を１錠質量５０ｍｇでロータリー式打錠機を用いて連続で打錠して錠剤を得た。
Comparative Example 2 Production Method Comparative tablets were produced according to the formulation shown in Table 1. Lactose, hydroxypropylcellulose, and low-substituted hydroxypropylcellulose were mixed with bisacodyl as an active ingredient to prepare a mixture. The active ingredient dioctylsodium sulfosuccinate was dissolved in a mixture of ethanol and purified water, and this was granulated by spraying it into the mixture as a granulation solution. Thereafter, it was dried, and magnesium stearate and granulated lactose were added to the resulting granule at the end, and the mixed granule was tableted continuously at a mass of 50 mg using a rotary tableting machine to obtain a tablet.
試験例１ 打錠時の付着状態の評価
実施例１および比較例１、２で製造した顆粒を後に、上杵、下杵、臼、回転盤への付着状態を目視により観察した。評価基準は以下の基準に従った。
（評価基準）
付着本数・杵１０本中の付着発生本数
付着度・・・４段階評価
３；打錠障害に発展する著しい付着
２；付着あり
１；非常に軽微な付着
０；付着なし
杵、臼の付着状態の評価結果を表２に、回転盤の付着状態の評価結果を表３に示した。実施例１に示される処方で製造される錠剤は打錠時に発生する臼、杵への付着が比較例に比べ明らかに改善されることがわかった。また打錠機の回転盤への付着に関しても実施例で示す錠剤を製造する場合には大幅に付着が改善されることがわかった。
Test Example 1 Evaluation of Adhesion State at the Time of Tableting The granules produced in Example 1 and Comparative Examples 1 and 2 were later visually observed for the adhering state to the upper eyelid, lower eyelid, mortar and turntable. The evaluation criteria were as follows.
(Evaluation criteria)
Number of adhesions and number of adhesion occurrences in 10 ridges · Degree of adhesion · · · 4-grade evaluation 3; Remarkable adhesion 2 that develops into tableting failure; 1 adhesion; very slight adhesion 0; no adhesion. Table 2 shows the evaluation results, and Table 3 shows the evaluation results of the adhesion state of the rotating disk. It was found that the tablets produced with the formulation shown in Example 1 clearly improved the adhesion to the mortar and crease generated during tableting compared to the comparative example. It was also found that the adhesion to the rotary disk of the tableting machine was greatly improved when the tablets shown in the examples were produced.
本発明は、便秘薬などの医薬品として利用可能である。
The present invention can be used as a medicine such as a constipation medicine.
Claims (7)
（２）得られた顆粒に後末でさらに軽質無水ケイ酸を添加する工程、
（３）打錠する工程、
からなるジオクチルソジウムスルホサクシネート含有錠剤の製造方法。 (1) A step of granulating a powder containing light anhydrous silicic acid using a solution containing dioctylsodium sulfosuccinate to obtain granules,
(2) A step of further adding light anhydrous silicic acid to the obtained granules at a later stage,
(3) Tableting process,
The manufacturing method of the dioctyl sodium sulfosuccinate containing tablet which consists of these.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| JP2004067876A JP2005255595A (en) | 2004-03-10 | 2004-03-10 | Tablet formulated with dioctyl sodium sulfosuccinate |
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| Application Number | Priority Date | Filing Date | Title |
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| JP2004067876A JP2005255595A (en) | 2004-03-10 | 2004-03-10 | Tablet formulated with dioctyl sodium sulfosuccinate |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007161706A (en) * | 2005-11-15 | 2007-06-28 | Taisho Pharmaceut Co Ltd | Antyusan-containing tablet |
| JP2015522652A (en) * | 2012-07-27 | 2015-08-06 | レッド ヒル バイオファーマ リミテッド | Formulation for use in promoting colonic drainage and method for producing the formulation |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5799521A (en) * | 1980-12-11 | 1982-06-21 | Eisai Co Ltd | Solid composition containing bisacodyl |
| JPH02255613A (en) * | 1989-03-27 | 1990-10-16 | Lion Corp | Pharmaceutical containing dioctyl sodium sulfosuccinate blended therein |
| JPH11130662A (en) * | 1997-08-29 | 1999-05-18 | Toyama Chem Co Ltd | Quickly disintegrable solid preparation |
| JP2000239185A (en) * | 1999-02-16 | 2000-09-05 | Taisho Pharmaceut Co Ltd | Medicinal composition |
| JP2004123731A (en) * | 2002-09-10 | 2004-04-22 | Taisho Pharmaceut Co Ltd | Tablet formulated with dioctyl sodium sulfosuccinate |
-
2004
- 2004-03-10 JP JP2004067876A patent/JP2005255595A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5799521A (en) * | 1980-12-11 | 1982-06-21 | Eisai Co Ltd | Solid composition containing bisacodyl |
| JPH02255613A (en) * | 1989-03-27 | 1990-10-16 | Lion Corp | Pharmaceutical containing dioctyl sodium sulfosuccinate blended therein |
| JPH11130662A (en) * | 1997-08-29 | 1999-05-18 | Toyama Chem Co Ltd | Quickly disintegrable solid preparation |
| JP2000239185A (en) * | 1999-02-16 | 2000-09-05 | Taisho Pharmaceut Co Ltd | Medicinal composition |
| JP2004123731A (en) * | 2002-09-10 | 2004-04-22 | Taisho Pharmaceut Co Ltd | Tablet formulated with dioctyl sodium sulfosuccinate |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007161706A (en) * | 2005-11-15 | 2007-06-28 | Taisho Pharmaceut Co Ltd | Antyusan-containing tablet |
| JP2015522652A (en) * | 2012-07-27 | 2015-08-06 | レッド ヒル バイオファーマ リミテッド | Formulation for use in promoting colonic drainage and method for producing the formulation |
| US10166219B2 (en) | 2012-07-27 | 2019-01-01 | Redhill Bipharma Ltd. | Formulations and methods of manufacturing formulations for use in colonic evacuation |
| US10493065B2 (en) | 2012-07-27 | 2019-12-03 | Redhill Biopharma Ltd. | Formulations and methods of manufacturing formulations for use in colonic evacuation |
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