JP4799720B2 - Tableting punch with coating treatment - Google Patents

Description

【００３２】
次に上記の杵の離型性を打錠時に発生する杵の表面に打錠末が付着して錠剤表面に明瞭な刻印を形成しない錠剤(以下刻印不良)の発生状況にて評価した。上記の塩酸ピオグリタゾン２７．５５%含有する打錠末を用いて上記と同様の杵を対照に比較した。結果は表２に示す通りとなり、クロムメッキ杵、TiNコーティング杵およびCrNコーティング杵は打錠初期から刻印不良が発生し、打錠不可となったのに対し、実施例杵、SKS２杵およびアロイ杵は打錠初期及び終期においても刻印不良の発生は認められなかった。
【００３３】
【表２】

【００３４】
表１、２より耐腐食性、離型性ともに満足するものはクロームドッペ−Ｎコーティング杵（実施例杵）とアロイ杵であることがわかった。ただし、アロイ杵については、長時間打錠した際に杵先に亀裂が入り強度面で杵への適用は困難であった。
なお、ダイアモンドライクカーボン（ＤＬＣ）、ニウロイ９６処理等の他の表面処理もＳＫＳ２杵に試みたが満足な結果を得ることができなった。
【００３５】
〔実施例２〕
従来の合金工具からなる杵（以下ＳＫＳ２）に上記の自体公知の手段（型技術第８巻第５号（１９９３年４月号）第７０〜７８頁参照）に従ってクロームドッペ−Ｎコーティングを施して杵（以下単に実施例杵ともいう）を得た。上記実施例杵の離型性をＳＫＳ２で製造した杵、ＳＵＳ４４０Ｃで製造した杵およびＳＫＳ２にダイヤモンド・ライク・カーボン（ＤＬＣ）コーティングを施した杵とを比較した。杵の離型性を、打錠時に発生する杵の表面に打錠末が付着して錠剤表面に明瞭な刻印を形成しない錠剤（以下刻印不良）の発生状況および杵表面への打錠末の付着（以下杵付着不良）発生状況にて評価した。なお、この打錠の実施においてＤ−マンニトールを含有する下記の処方の打錠末を用いた。
【００３６】

【００３７】
結果は表３に示す通りとなり、ＳＫＳ２杵、ＳＵＳ４４０Ｃ杵およびＤＬＣコーティング杵は打錠初期から刻印不良が発生し、打錠不可となったのに対し、実施例杵は打錠初期及び終期においても刻印不良の発生は認められず、杵表面への打錠末の付着発生も認められなかった。
【００３８】
【表３】

【００３９】
〔実施例３〕
ランソプラゾール３０重量部を含有するランソプラゾール細粒（日本特許出願特願平１１−１３５１７７に記載の方法により製造した） ２７０重量部、Ｄ−マンニトール ２０４重量部、Ｌ−ＨＰＣ−３３ ３０重量部、セオラスＫＧ−８０１ ３０重量部、クロスポビドン １５重量部、無水クエン酸 ３重量部、アスパルテーム ９重量部、ストロベリ−Ｄ ３重量部およびステアリン酸マグネシウム ６重量部を混合して得られる打錠末を図１で示される打錠機で打錠した。杵材質および杵の表面処理は実施例１と同一である。打錠条件は打錠外径７ｍｍφ、重量１８０ｍｇ／錠、打圧０．５７ｔｏｎであった。杵材質・表面処理、２００００錠／杵打錠時の結果は下記表４のとおりであった。
【００４０】
【表４】

【００４１】
【発明の効果】
本発明の合金工具鋼にクロームドッペ−Ｎコーティングを施した杵は、酸性物質を含有する製剤の打錠において優れた耐腐食性と離型性を示し、付着性物質を含有する製剤の打錠において、離型性に優れ、安定した工業的生産に適した打錠を提供する。
【００４２】
【図面の簡単な説明】
【図１】本発明の実施形態の杵を用いた、回転式打錠機の概略断面図である。
[符号の説明]
１………………回転式打錠機、
２………………回転盤、
３………………臼、
３ａ……………臼孔、
４………………上杵、
５………………上杵保持盤、
６………………下杵、
７………………下杵保持盤、
８………………上杵ガイドレール、
９………………下杵ガイドレール、
１０……………打錠末[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a tablet punch for use in the production of tablets containing acidic substances such as acidic pharmacologically active substances and acidic excipients and having excellent corrosion resistance and releasability. In addition, the present invention is used for the production of tablets containing adhesive substances such as adhesive pharmacological substances and adhesive excipients (for example, sugar alcohols), and has a suitable release property. It relates to a lock bag.
Furthermore, the present invention relates to a tableting machine having such a tableting punch, a tablet manufacturing method using the tableting machine, and a tablet manufactured by the manufacturing method.
[0002]
[Prior art]
A general tablet is tableted by compressing and molding a tableting powder using a punch and a mortar provided in a tableting machine. That is, a mortar hole is formed in a mortar attached to the rotating disk, and the position of the lower punch placed under the mortar hole is adjusted to set the space in the mortar hole to a predetermined volume. After storing the tableting powder such as a medicine, it is compressed with an upper punch to form a tablet, and then pushed up with a lower punch to take out the tablet from the mortar.
The above-mentioned flaws must not be easily deformed by the above-described repeated compression operation, so high mechanical strength is required. Conventionally, they have been formed using super steel alloy or alloy tool steel, and are also used as a countermeasure against corrosion. As an example, a chrome-plated surface is used.
[0003]
[Problems to be solved by the invention]
The conventional scissors using the above-mentioned alloy tool steel have the property that the metal material is basically corroded, especially when the powder for tableting contains an acidic substance such as an acidic drug. When doing so, the corrosion of the metal material is more likely to proceed, and there is a possibility that the corrosion starts during tableting.
When these corrosions occur in the wrinkles, the surface slipperiness and releasability from the tableting powder are lowered, and it is difficult to take out the tablets from the mortar, and foreign substances generated by the corrosion may be mixed into the tablets. .
[0004]
In addition, when the release properties of the tableting powder and the surface of the punch are poor, the tableting powder adheres to the surface of the tablet and the tablet surface becomes rough, or a clear marking is formed on the tablet surface. Problems such as being unable to do so occur.
The present invention solves the above-mentioned problems, and particularly has excellent corrosion resistance and release properties suitable for a tableting machine for molding tablets for preparations containing acidic substances such as acidic drugs. It is a technical challenge to provide a vase.
[0005]
Furthermore, the conventional case using the above-mentioned alloy tool steel has the property that the metal material basically has a tableting powder adhering to the surface. When an adhesive substance such as an active substance or an adhesive excipient (for example, sugar alcohol) is included, adhesion to the metal material is more likely to proceed when tableting. When such adhesion occurs in the wrinkle, the release properties of the tableting powder and the surface of the wrinkle are deteriorated, and the tableted tablet surface becomes rough, or a clear inscription cannot be formed on the tablet surface. Problems arise.
The present invention solves the above-mentioned problems, and in particular, for molding a tablet for a preparation containing an adhesive substance such as an adhesive pharmacological agent and an adhesive excipient (for example, sugar alcohol). A technical problem is to provide a tableting punch suitable for a tableting machine and having excellent releasability.
[0006]
[Means for Solving the Problems]
As a result of intensive studies to solve the above-mentioned problems, the present inventors have found that the base metal (for example, alloy tool steel) is Chrome Dope-N (Cr-Dope'-N , registered trademark, the same shall apply hereinafter ) . The unexpected new knowledge that the coated soot has excellent corrosion resistance and mold release properties has been obtained, and further studies have been made to complete the present invention.
[0007]
That is, the present invention
(1) A tableting punch coated with a surface coated with Chrome Doppe-N, which is used in the manufacture of tablets that are any of pharmaceuticals, agricultural chemicals, fertilizers and foods,
(2) A tableting punch whose surface is anti-corrosion-treated with a Chrome Dope-N coating, which is used for manufacturing tablets that are any of pharmaceuticals, agricultural chemicals, fertilizers and foods,
(3) A tableting punch having a surface release-treated with a chrome dope-N coating, which is used for manufacturing tablets that are any of pharmaceuticals, agricultural chemicals, fertilizers and foods,
(4) A tableting punch whose surface is treated to prevent adhesion with a chrome doppe-N coating, which is used in the manufacture of tablets that are any of pharmaceuticals, agricultural chemicals, fertilizers and foods,
(5) The tableting punch of the above (1) applied to the punch (4, 6) used in the tableting machine (1) for forming a tablet containing an acidic substance or an adherent biomaterial,
(6) The tableting punch of the above (5), wherein the acidic substance is pioglitazone hydrochloride,
(7) The tableting punch of (5), wherein the adhesive substance is a sugar alcohol;
(8) The tableting punch according to (7), wherein the sugar alcohol is D-mannitol,
(9) A tableting machine used for the manufacture of tablets that are any one of pharmaceuticals, agricultural chemicals, fertilizers and foods, characterized by using a punch coated with Chrome Doppe-N,
(10) A tablet production method using the tableting machine of (9),
(11) The production method of the above (10), wherein the tablet contains an acidic substance or an adhesive substance,
(12) The production method of the above (11), wherein the acidic substance is pioglitazone hydrochloride,
The method of manufacturing a tablet of the (13) with wear material is a sugar alcohol (11), and (14) producing how the sugar alcohol is D- mannitol (13),
About.
[0008]
The base material used as a raw material for the tableting punch of the present invention may be any material used as a tableting punch in the prior art, specifically, for example, cemented carbide, alloy tool steel, Any material may be used as long as it has a high mechanical altitude and is not easily deformed by a frequently repeated compression operation such as a gold bond, and more specifically, SKS2, SKD, NH alloy, SUS440C, etc. However, SKS2 is most preferable.
[0009]
More specifically, 95% iron, 1% chromium, 1.5% tungsten, 1% carbon, 0.35% silicon, 0.8% manganese, 0.03% phosphorus, 0% sulfur. SKS2 and cobalt manufactured with alloy tool steel containing 0.03% (% is weight ratio, the same applies below) 36 to 53% of cobalt, 27 to 35% of chromium, 10 to 20% of tungsten, 2 to 2 of carbon Add 0.2-5% of at least one of tantalum and niobium to the component containing 3%, further add 1-5% of iron and 1-3% of silicon as required, and if necessary, further add 5% or less of nickel A spear bond gold or the like characterized by adding
[0010]
Coating of the base material with chrome doppe-N can be performed by a method known per se, for example, a sputtering method which is a kind of physical vapor deposition technology. More specifically, for example, die technology Vol. 8 No. 5 (April 1993). No.) It is easily carried out by the method described on pages 70-78.
[0011]
The tablets in the present invention are not limited to pharmaceuticals, but include agricultural chemicals, fertilizers, foods, plastics, ceramics, metals, and the like. These tablets often contain physiologically active ingredients such as pharmacologically active ingredients in medicine, and any pharmacologically active ingredient may be used. The pharmacologically active ingredient is not particularly limited. Specific examples of acidic substances for pharmaceutical use, such as acidic drugs, include pioglitazone hydrochloride, manidipine hydrochloride, delapril hydrochloride, fursultiamine hydrochloride, cefotium hexetyl hydrochloride, thiamine hydrochloride, and hydroxyzine hydrochloride. These acidic drugs are easily produced according to a method known per se.
[0012]
Furthermore, the acidic drug in the present invention may be, for example, a mixture of an acidic drug and a neutral drug. In short, the acidic drug in the present invention may be any solid substance that exhibits acidity.
[0013]
The tableting powder used in the present invention contains an adhesive substance. Examples of such an adhesive substance include an adhesive pharmacologically active ingredient and an adhesive excipient (for example, sugar alcohol). For example, 3- [1- (phenylmethyl) piperidin-4-yl] -1- (2,3,4,5-tetrahydro-1H-1-benzazepin-8-yl) -1- Examples include propanone fumarate, risedronate, and pioglitazone hydrochloride. Further, when the tableting powder contains an adhesive excipient, the pharmacologically active ingredient may not be adhesive. Examples of the pharmacologically active ingredient that may be used in the present invention without adhesion are lansoprazole, manidipine hydrochloride, delapril hydrochloride, candesartan cilexetil, vinpocetine, seratrodast and the like.
Therefore, when manufacturing a tablet, in addition to the above-mentioned pharmacologically active ingredients, for example, a sugar alcohol having an adhesive property to a bag as an excipient or a binder is used as a raw material for tableting.
[0014]
Sugar alcohols include sugar alcohols used in the fields of agricultural chemicals, fertilizers, foods, plastics, ceramics and metals as well as pharmaceutical applications. Specific examples of sugar alcohols for pharmaceutical use include erythritol, D-mannitol, D-sorbitol, xylitol, maltitol, anhydrous maltose, hydrous maltose, anhydrous lactitol, anhydrous maltose, hydrous maltose, anhydrous lactitol, hydrous lactitol, Reduced maltose water candy is mentioned.
Also, a plurality of sugar alcohols can be used in combination.
As is clear from the above examples (for example, pioglitazone hydrochloride), a substance that is both an acidic substance and an adhesive substance is also used in the present invention for convenience.
[0015]
It is needless to say that the tablet may be anything having a so-called tablet shape, and may be a tablet including fine granules, pellets and the like containing the drug.
When producing such tablets, the above-mentioned pharmacologically active ingredients (drugs) are usually mixed with excipients, lubricants, disintegrants, etc. to form a tableting powder, which is compressed with a pestle and a mortar to produce tablets. The In the present invention, for example, a sugar alcohol or an adhesive drug is usually contained in the tableting powder. The tablet thus obtained may be further surface-coated according to a conventional method to obtain a product. In addition, prescription additives such as preservatives, antioxidants, coloring agents, sweeteners, fragrances, flavors and the like can be added to the tablet as needed.
[0016]
Suitable examples of excipients include sugars such as lactose and sucrose, sugar alcohols such as D-mannitol and D-sorbitol, starch (eg corn starch, potato starch, wheat starch etc.), pregelatinized starch, dextrin, Examples thereof include crystalline cellulose, low-substituted hydroxypropylcellulose, sodium carboxymethylcellulose, gum arabic, dextrin, pullulan, light anhydrous silicic acid, synthetic aluminum silicate, calcium carboxymethylcellulose, and magnesium aluminate metasilicate.
[0017]
Preferable examples of the lubricant include magnesium stearate, calcium stearate, talc, colloidal silica and the like.
[0018]
Preferable examples of the binder include starch, pregelatinized starch, sucrose, gelatin, gum arabic, methylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, crystalline cellulose, sucrose, D-mannitol, trehalose, dextrin, pullulan, hydroxypropyl. Examples thereof include cellulose, hydroxypropylmethylcellulose, and polyvinylpyrrolidone.
[0019]
Preferable examples of the disintegrant include starch, pregelatinized starch, carboxymethyl cellulose, carboxymethyl cellulose calcium, croscarmellose sodium, carboxymethyl starch sodium, crospovidone, light anhydrous silicic acid, low-substituted hydroxypropyl cellulose and the like. It is done.
[0020]
Examples of the coating agent include hydroxypropylmethylcellulose, ethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, polyoxyethylene glycol, Tween 80, Pluronic F68, castor oil, cellulose acetate phthalate, hydroxymethylcellulose acetate succinate, Eudrakit (Rohm, West Germany) Acrylic acid copolymer), carboxymethyl ethyl cellulose, porvinyl acetal diethylaminoacetate, waxes and pigments such as talc, titanium oxide, and bengara.
[0021]
Examples of the acidulant include citric acid (anhydrous citric acid), tartaric acid, malic acid and the like.
Examples of the artificial sweetener include saccharin sodium, glycyrrhizin dipotassium, aspartame, stevia, thaumatin and the like.
As a fragrance | flavor, any of a synthetic material and a natural product may be sufficient, for example, lemon, lime, orange, menthol, strawberry, etc. are mentioned.
Examples of the colorant include edible dyes such as edible yellow No. 5, edible red No. 2 and edible blue No. 2, edible lake dyes, bengara, talc, and tar dyes.
[0022]
The rate of use of acidic substances such as acidic drugs in tableting powders is unclear and varies widely. Specifically, it is about 0.001 to 99.5%, more preferably about 0.01 to 70%, and most preferably about 0.1 to 50%.
The tableting pressure is usually about 0.1 to 3.0 ton / 杵, preferably about 0.5 to 3.0 ton / 杵, and more preferably about 0.8 to 1.6 ton / 杵. is there.
The inner diameter of the mortar is usually about 3 to 20 mm, preferably about 3 to 13 mm, and more preferably about 5 to 9 mm. The shape of the mortar may be circular or may be irregular such as an oval or oblong.
[0023]
The proportion of sugar alcohol used in the tableting powder is unclear and varies widely. Specifically, it is about 0.001 to 99.5%, more preferably about 0.01 to 90%, and most preferably about 0.1 to 90%.
The tableting pressure is usually about 0.1 to 3.0 tons / 杵, preferably about 0.8 to 1.6 tons / 杵.
The inner diameter of the mortar is usually about 3 to 20 mm, preferably about 5 to 13 mm. The shape of the mortar may be circular or may be irregular such as an oval or oblong.
[0024]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a schematic cross-sectional view of a rotary tableting machine using a punch according to an embodiment of the present invention. As shown in FIG. 1, a plurality of mortars are arranged at predetermined intervals in the circumferential direction on the rotary disk (2) of the rotary tableting machine (1), and the mortars are placed in the mortar (3). A hole (3a) is formed.
[0025]
Above the mortar hole (3a), the upper ridge (4) is held on the upper ridge holding plate (5) so as to be movable up and down with respect to the mortar hole (3a). Also, below the mortar hole (3a), a lower punch (6) is held on the holding disc (7) so as to be movable up and down, and the tip of the lower punch (6) enters the mortar hole (3a) from below. I'm allowed.
[0026]
Above the upper rod (4), an upper rod guide rail (8) is arranged so as to come into contact with the head provided at the upper end of the upper rod (4), while below the lower rod (6). The lower heel guide rail (9) is arranged so as to contact the head provided at the lower end of the lower heel (6). The rotating plate (2), the upper rod holding plate (5) and the lower rod holding plate (7) are rotationally driven coaxially, and this rotation causes the upper rod (4) and the lower rod (6) to both guide rails. Guided by (8, 9), it is driven up and down at a predetermined position.
The upper iron (4) and the lower iron (6) are both coated with chrome doppe-N coating on alloy tool steel.
[0027]
In the rotary tableting machine, tablets are tableted by the following procedure.
First, the lower armpit (6) is positioned at a predetermined height by the lower armpit guide rail (9), and the space in the mortar hole (3a) is set to a predetermined volume, and in this mortar hole (3a) in the filling zone. The tableting powder (10) is filled. Next, in the compression zone, the upper punch (4) is guided by the upper guide rail (8), moved downward and guided to the compression roller, and the tableting powder (10) is compressed to be compressed.
[0028]
Thereafter, the upper guide (4) is guided by the upper guide rail (8), and the lower guide (6) is pushed up by the lower guide guide rail (9) in the take-out zone, and is compressed from the mortar hole (3a). The molded tablet is taken out.
Next, the corrosion resistance and releasability for the preparation containing the acidic drug of candy coated with Chrome Doppe-N and the release for the preparation containing sugar alcohol of the candy coated with N-chrome Doppe-N. The moldability will be described in comparison with the conventional alloy tool steel and the corrosion resistance and releasability of the heel coated with the alloy tool steel.
[0029]
【Example】
[Example 1]
A chrome doppe-N coating is applied to the conventional alloy tool steel (hereinafter referred to as SKS2) according to the above-mentioned means known per se (see Mold Technology Vol. 8 No. 5 (April 1993) pp. 70-78). To obtain cocoon (hereinafter also simply referred to as Example 杵).
The corrosivity of the cocoons coated with the above Chrome Doppe-N coating was compared with that of cocoons coated with SKS2, cocoon bonding gold (alloy) and SKS2. The results were as shown in Table 1. SKS2 杵 was corroded during storage (RH 75%, room temperature, 3 days), and tableted powder containing 27.55% pioglitazone hydrochloride (33.06 parts by weight pioglitazone hydrochloride, 76.34 parts by weight lactose, hydroxypropylcellulose 3 Corrosion was greatly accelerated by contact with 0.0 parts by weight, 7.2 parts by weight of carboxymethylcellulose calcium and 0.4 parts by weight of magnesium stearate). The titanium nitride (hereinafter, TiN) coated wrinkles were partially corroded by contact with the tableting powder. On the other hand, Example 杵, Alloy 杵, Chromium plating 杵 and Chromium nitride (hereinafter referred to as CrN) coating 杵 were not corroded at all.
[0030]
The followings were used for the comparison.
a) SKS2 杵: 95% iron, 1% chromium, 1.5% tungsten, 1% carbon, 0.35% silicon, 0.8% manganese, 0.03% phosphorus, sulfur Made of alloy tool steel containing 0.03%.
b) Alloy iron: manufactured with a gold bond gold excellent in corrosion resistance (Japanese Patent Application No. 09-323123).
c) Chrome-plated iron, TiN-coated iron and CrN-coated iron: manufactured by applying chrome-plated, TiN-coated and CrN-coated to SKS2 steel according to known methods, respectively.
[0031]
[Table 1]

[0032]
Next, the releasability of the above-mentioned wrinkles was evaluated in terms of the occurrence of tablets (hereinafter referred to as imprinting defects) in which a tableting powder adhered to the surface of the wrinkles generated during tableting and no clear marking was formed on the tablet surface. Using the tableting powder containing 27.55% of the above pioglitazone hydrochloride, the same wrinkles as described above were compared with the control. The results are shown in Table 2. The chrome-plated iron, TiN-coated iron and CrN-coated iron had imprinting defects from the initial stage of tableting and were unable to be tableted. In the initial and final tableting, no imprinting was observed.
[0033]
[Table 2]

[0034]
From Tables 1 and 2, it was found that the ones satisfying both the corrosion resistance and the releasability were the Chrome Doppe-N coating cage (Example IV) and the alloy cage. However, with regard to alloy rivets, it was difficult to apply to the heel in terms of strength due to cracks at the heel when tableted for a long time.
Although other surface treatments such as diamond-like carbon (DLC) and Niuroy 96 treatment were also attempted on SKS2 杵, satisfactory results could not be obtained.
[0035]
[Example 2]
A chrome doppe-N coating is applied to a cage made of a conventional alloy tool (hereinafter referred to as SKS2) according to the above-mentioned means known per se (see Mold Technology Vol. 8 No. 5 (April 1993) pp. 70-78). A cocoon (hereinafter also simply referred to as Example 杵) was obtained. The releasability of the above-mentioned Example cocoon was compared with the cocoon produced with SKS2, the cocoon produced with SUS440C, and the cocoon with diamond-like carbon (DLC) coating on SKS2. The releasability of the cocoons is determined by the occurrence of tablets (hereinafter referred to as imprinting defects) where the tableting powder adheres to the surface of the candy that occurs during tableting and does not form a clear marking on the tablet surface, and the Evaluation was performed based on the occurrence of adhesion (hereinafter referred to as flaw adhesion). In the tableting, a tableting powder having the following formulation containing D-mannitol was used.
[0036]

[0037]
The results are as shown in Table 3. SKS2 杵, SUS440C 杵 and DLC coated 杵 had imprinting defects from the beginning of tableting and became unable to be tableted, whereas Example 杵 was also in the initial and final stages of tableting. The occurrence of imprinting defects was not observed, and the occurrence of tableting powder adhering to the surface of the punch was not observed.
[0038]
[Table 3]

[0039]
Example 3
Lansoprazole fine granules containing 30 parts by weight of lansoprazole (manufactured by the method described in Japanese Patent Application No. 11-135177) 270 parts by weight, D-mannitol 204 parts by weight, L-HPC-33 30 parts by weight, Theolas KG FIG. 1 shows a tableting powder obtained by mixing 30 parts by weight of 801, 15 parts by weight of crospovidone, 3 parts by weight of anhydrous citric acid, 9 parts by weight of aspartame, 3 parts by weight of Strobery-D and 6 parts by weight of magnesium stearate. Tableting was performed with the indicated tableting machine. The soot material and the soot surface treatment are the same as those in Example 1. The tableting conditions were a tableting outer diameter of 7 mmφ, a weight of 180 mg / tablet, and a tableting pressure of 0.57 ton. Table 4 below shows the results of scissors material / surface treatment and 20000 tablets / compressed tablets.
[0040]
[Table 4]

[0041]
【The invention's effect】
The punch made of chrome doppe-N coating on the alloy tool steel of the present invention exhibits excellent corrosion resistance and mold release in tableting of a preparation containing an acidic substance, and tableting of a preparation containing an adhesive substance Provides a tableting which is excellent in releasability and suitable for stable industrial production.
[0042]
[Brief description of the drawings]
FIG. 1 is a schematic cross-sectional view of a rotary tableting machine using a punch according to an embodiment of the present invention.
[Explanation of symbols]
1 ……………… Rotary tablet press,
2 ……………… Turntable,
3 ……………… Mus,
3a …………… Mole hole,
4 ……………… Upper,
5 ……………… Upper holding board,
6 ……………… Shimojo,
7 ……………… The lower arm holding board,
8 ……………… Upper guide rail,
9 ……………… Shimojo guide rail,
10 ......... Tablet powder

Claims (14)

A tableting punch coated with a surface treated with Chrome Doppe-N (registered trademark), which is used for manufacturing tablets that are any of pharmaceuticals, agricultural chemicals, fertilizers and foods. A tableting punch whose surface is subjected to anticorrosion treatment with a Chrome Dope-N (registered trademark) coating, which is used for manufacturing tablets that are any of pharmaceuticals, agricultural chemicals, fertilizers and foods. A tableting punch whose surface is release-treated with a Chrome Dope-N (registered trademark) coating, which is used in the manufacture of tablets that are pharmaceuticals, agricultural chemicals, fertilizers and foods. A tableting punch whose surface is treated to prevent adhesion with a Chrome Dope-N (registered trademark) coating, which is used for manufacturing tablets that are any of pharmaceuticals, agricultural chemicals, fertilizers and foods.   The tableting punch according to claim 1, applied to a punch (4, 6) used in a tableting machine (1) for forming tablets containing an acidic substance or an adhesive substance.   The tableting punch according to claim 5, wherein the acidic substance is pioglitazone hydrochloride.   The tableting punch according to claim 5, wherein the adhesive substance is a sugar alcohol.   The tableting punch according to claim 7, wherein the sugar alcohol is D-mannitol. A tableting machine for use in the manufacture of tablets that are any one of pharmaceuticals, agricultural chemicals, fertilizers and foods, characterized in that it uses a candy coated with Chrome Doppe-N (registered trademark). .   A tablet production method using the tableting machine according to claim 9.   The manufacturing method of Claim 10 in which a tablet contains an acidic substance or an adhesive substance.   The process according to claim 11, wherein the acidic substance is pioglitazone hydrochloride. Method for producing a tablet of claim 11 with adhesive substance is a sugar alcohol. The process according to claim 13 , wherein the sugar alcohol is D-mannitol.

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