JP2002363067A - Method for producing tablet preparation - Google Patents
Method for producing tablet preparationInfo
- Publication number
- JP2002363067A JP2002363067A JP2001170566A JP2001170566A JP2002363067A JP 2002363067 A JP2002363067 A JP 2002363067A JP 2001170566 A JP2001170566 A JP 2001170566A JP 2001170566 A JP2001170566 A JP 2001170566A JP 2002363067 A JP2002363067 A JP 2002363067A
- Authority
- JP
- Japan
- Prior art keywords
- disintegrant
- tablet
- granulation
- powder
- producing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 11
- 238000002360 preparation method Methods 0.000 title abstract description 8
- 239000007884 disintegrant Substances 0.000 claims description 27
- 238000001035 drying Methods 0.000 claims description 6
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 6
- 238000005550 wet granulation Methods 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 5
- 239000011230 binding agent Substances 0.000 claims description 4
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 abstract description 12
- 239000003814 drug Substances 0.000 abstract description 4
- 239000001863 hydroxypropyl cellulose Substances 0.000 abstract description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 abstract description 2
- 238000006467 substitution reaction Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 description 25
- 239000008187 granular material Substances 0.000 description 17
- 238000005469 granulation Methods 0.000 description 13
- 230000003179 granulation Effects 0.000 description 13
- 239000000843 powder Substances 0.000 description 13
- 238000007906 compression Methods 0.000 description 11
- 230000006835 compression Effects 0.000 description 11
- 239000004480 active ingredient Substances 0.000 description 7
- 230000000694 effects Effects 0.000 description 6
- 239000002245 particle Substances 0.000 description 6
- 238000007907 direct compression Methods 0.000 description 5
- 239000000314 lubricant Substances 0.000 description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
- 239000002994 raw material Substances 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 229940079593 drug Drugs 0.000 description 3
- -1 hydroxypropoxyl group Chemical group 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 description 2
- 229920002785 Croscarmellose sodium Polymers 0.000 description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 2
- FPIPGXGPPPQFEQ-BOOMUCAASA-N Vitamin A Natural products OC/C=C(/C)\C=C\C=C(\C)/C=C/C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-BOOMUCAASA-N 0.000 description 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 2
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 description 2
- 229960001681 croscarmellose sodium Drugs 0.000 description 2
- 229960000913 crospovidone Drugs 0.000 description 2
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 238000009775 high-speed stirring Methods 0.000 description 2
- 235000019359 magnesium stearate Nutrition 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 235000019155 vitamin A Nutrition 0.000 description 2
- 239000011719 vitamin A Substances 0.000 description 2
- 229940045997 vitamin a Drugs 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- 229920000881 Modified starch Polymers 0.000 description 1
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 description 1
- 238000005054 agglomeration Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 229950008138 carmellose Drugs 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 238000000748 compression moulding Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 238000007429 general method Methods 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000000449 pharmaceutical disintegrant Substances 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 238000004513 sizing Methods 0.000 description 1
- 239000008109 sodium starch glycolate Substances 0.000 description 1
- 229920003109 sodium starch glycolate Polymers 0.000 description 1
- 229940079832 sodium starch glycolate Drugs 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 239000007885 tablet disintegrant Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
Landscapes
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
【0001】[0001]
【発明の属する技術分野】本発明は、主に医薬用の固形
製剤に用いるため錠剤の製造方法に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for producing a tablet for use in a pharmaceutical solid preparation.
【0002】[0002]
【従来の技術】一般に錠剤は、粉末を直接圧縮する直接
打錠法や、造粒工程を経て流動性のよい顆粒を調製しこ
れを打錠する顆粒圧縮法によって得られる。直接打錠法
も、顆粒圧縮法も、有効成分を速やかに放出させるため
崩壊剤が含有される場合が多い。例えば、クロスカルメ
ロースナトリウム、カルメロースカルシウム、部分アル
ファ化デンプン、デンプングリコール酸ナトリウム、ク
ロスポビドン、低置換度ヒドロキシプロピルセルロース
などが医薬用崩壊剤として上市され使用されている。こ
れらの崩壊剤は、直接打錠法の場合はそのまま他の成分
と混合されて使用され、また、顆粒圧縮法の場合は造粒
工程で顆粒に含有させるか、あるいは顆粒を調製した後
で崩壊剤を加え、必要に応じステアリン酸マグネシウム
などの滑沢剤を加えて打錠する方法(後末添加)が採ら
れる。顆粒圧縮法の場合は一般に後末添加の方が顆粒内
部に含有させる場合よりも速く崩壊することが知られて
いる。2. Description of the Related Art In general, tablets are obtained by a direct compression method of directly compressing powder or a granule compression method of preparing granules having good fluidity through a granulation step and compressing them. Both the direct compression method and the granule compression method often contain a disintegrant in order to rapidly release the active ingredient. For example, croscarmellose sodium, carmellose calcium, partially pregelatinized starch, sodium starch glycolate, crospovidone, low-substituted hydroxypropylcellulose and the like are marketed and used as pharmaceutical disintegrants. In the case of the direct compression method, these disintegrants are used as they are mixed with other components, and in the case of the granule compression method, they are contained in the granules in the granulation step, or disintegrated after preparing the granules. And adding a lubricant such as magnesium stearate, if necessary, and tableting (addition of powder). In the case of the granule compression method, it is generally known that the latter addition disintegrates faster than the case where it is contained inside the granules.
【0003】有効成分によっては崩壊性の極めて悪いも
のがあり、このような場合、崩壊剤の添加が十分でない
場合が多い。崩壊性を高めようとして崩壊剤の量を増や
しても効果がなかったり、あるいは効果がある程度認め
られても安定性に問題が生じたり、また崩壊剤自体の圧
縮成型性がよくないために錠剤の硬度が満足行かない場
合があった。上記の崩壊剤のうち、低置換度ヒドロキシ
プロピルセルロースは、非イオン性であり薬物との相互
作用が少ないこと、圧縮成型性がよく結合剤としての効
果も有することから錠剤の崩壊剤として好んで使用され
てきているが、崩壊力そのものがやや不足する欠点があ
った。[0003] Some active ingredients have extremely poor disintegration properties. In such cases, the addition of disintegrants is often insufficient. The effect of increasing the amount of disintegrant in an attempt to enhance disintegration is ineffective, or even if the effect is recognized to some extent, there is a problem in stability, and the compression molding properties of the disintegrant itself are not good, so the tablet In some cases, the hardness was not satisfactory. Among the above disintegrants, low-substituted hydroxypropylcellulose is preferred as a tablet disintegrant because it is nonionic, has little interaction with the drug, has good compression moldability and also has an effect as a binder. Although it has been used, it has a drawback that the collapse force itself is slightly insufficient.
【0004】[0004]
【発明が解決しようとする課題】本発明は、崩壊性の悪
い薬物についても従来のものよりも良好な崩壊性を持つ
錠剤の製造方法に関するものである。SUMMARY OF THE INVENTION The present invention relates to a method for producing a tablet having a better disintegration property than a conventional drug even for a drug having poor disintegration property.
【0005】[0005]
【課題を解決するための手段】本発明者は、低置換度ヒ
ドロキシプロピルセルロースにある処理を施すことによ
り崩壊機能を高まることを見いだし本発明を完成させ
た。すなわち、本発明は、崩壊剤を含む錠剤の製造方法
において、該崩壊剤が湿式造粒処理を施した低置換度ヒ
ドロキシプロピルセルロースであることを特徴とする錠
剤の製造方法に関する。Means for Solving the Problems The present inventor has found that by applying a certain treatment to low-substituted hydroxypropylcellulose, the disintegration function can be enhanced, and the present invention has been completed. That is, the present invention relates to a method for producing a tablet comprising a disintegrant, wherein the disintegrant is low-substituted hydroxypropylcellulose subjected to wet granulation.
【0006】[0006]
【発明の実施の形態】低置換度ヒドロキシプロピルセル
ロース(以下、L−HPC)は日本薬局方に収載されて
おり、ヒドロキシプロポキシル基含量が5〜14重量%
のセルロース誘導体である。同じ日本薬局方に収載され
ているヒドロキシプロピルセルロース(ヒドロキシプロ
ポキシル含量53.4〜77.2%)とは性質を異にす
る。DESCRIPTION OF THE PREFERRED EMBODIMENTS Low-substituted hydroxypropylcellulose (hereinafter referred to as L-HPC) is listed in the Japanese Pharmacopoeia and has a hydroxypropoxyl group content of 5 to 14% by weight.
Of cellulose derivatives. It differs from hydroxypropyl cellulose (hydroxypropoxyl content 53.4-77.2%) listed in the same Japanese Pharmacopoeia.
【0007】L−HPCを湿式造粒する方法は、一般に
顆粒剤や錠剤を製造するときの湿式造粒法を用いればよ
い。湿式造粒法としては、撹拌造粒法と流動層造粒法が
あり、いずれの方法をとっても同様な効果が得られる。
ただし、撹拌造粒法の方が重質な粒となるためL−HP
Cの場合は好都合なことが多い。As a method for wet granulation of L-HPC, generally, a wet granulation method for producing granules or tablets may be used. As the wet granulation method, there are a stirring granulation method and a fluidized bed granulation method, and the same effect can be obtained by either method.
However, since the agitation granulation method produces heavier particles, L-HP
In the case of C, it is often convenient.
【0008】撹拌造粒法は、一般に次のような方法で行
われる。すなわち、ヘンシェルミキサーやバーチカルグ
ラニュレーターのような造粒装置に原料粉末を入れ、結
合液を添加しながら高速撹拌してウェットマス(Wet
mass)とする。これを篩に通過させて整粒し、乾
燥し、必要に応じて再度篩過して顆粒を得る。[0008] The stirring granulation method is generally performed by the following method. That is, the raw material powder is placed in a granulating device such as a Henschel mixer or a vertical granulator, and is stirred at a high speed while adding a binding liquid, and wet mass (wet) is added.
mass). This is passed through a sieve, sized, dried, and, if necessary, sieved again to obtain granules.
【0009】原料粉末は、L−HPCの粉末であれば特
に限定しないが、好ましくは平均粒径10〜100μm
である。結合液の種類は、特に限定されないが、本発明
の場合、水が好ましい。結合液の量も特に限定されない
が、原料のL−HPCに対し50〜200重量%が好ま
しい。また、高速撹拌とは、高速撹拌装置を用いて粉体
と結合液を混合する工程であり、得られるウェットマス
とは、適度な水分を含んだ湿った粉体である。整粒は、
粒度分布をシャープにすることを目的とする工程であっ
て、具体的には篩を振動させてウェットマスを通過させ
る。篩の大きさは、特に限定されないが、一般には18
〜24メッシュ程度であればよい。乾燥は、例えば乾燥
機を用いて有効成分に影響を与えない温度で乾燥するも
のであり、乾燥機を用いずに自然乾燥であってもよい。
なお、乾燥後、粒子の塊が生じる等の場合には、必要に
応じて再度篩過を行う。The raw material powder is not particularly limited as long as it is an L-HPC powder, but preferably has an average particle size of 10 to 100 μm.
It is. The type of the binding solution is not particularly limited, but in the case of the present invention, water is preferred. Although the amount of the binding solution is not particularly limited, it is preferably 50 to 200% by weight based on the L-HPC of the raw material. The high-speed stirring is a step of mixing the powder and the binding liquid using a high-speed stirring device, and the obtained wet mass is a wet powder containing appropriate moisture. The sizing is
This is a step aimed at sharpening the particle size distribution, specifically, by vibrating a sieve to pass through a wet mass. The size of the sieve is not particularly limited, but is generally 18
What is necessary is just about 24 mesh. Drying is, for example, drying using a dryer at a temperature that does not affect the active ingredient, and may be natural drying without using a dryer.
In the case where agglomeration of particles occurs after drying, sieving is performed again as necessary.
【0010】一方、流動層造粒法とは、流動層造粒装置
を用いて粉体を流動させながら結合液をスプレーして粒
を成長させる方法である。On the other hand, the fluidized-bed granulation method is a method in which a binder is sprayed while powder is fluidized using a fluidized-bed granulator to grow particles.
【0011】このようにして得られた崩壊剤の平均粒子
径は、特に限定されないが、おおよそ0.5〜2mm、
好ましくは0.8〜1.5mmとなるように調製する。The average particle size of the disintegrant thus obtained is not particularly limited, but is approximately 0.5 to 2 mm,
Preferably, the thickness is adjusted to 0.8 to 1.5 mm.
【0012】本発明の崩壊剤を固形製剤に配合するの
は、一般的な方法で行えばよいが、直接打錠法や、顆粒
圧縮法の後末添加で本発明の効果がよく発揮される。直
接打錠法は、有効成分を含んだ粉末を直接圧縮して錠剤
を得る方法であり、本発明の崩壊剤は、圧縮前に有効成
分等の粉末に添加され、混合される。顆粒圧縮法は、有
効成分及び賦形剤等からなる粉末から造粒工程を経て流
動性のよい顆粒を調製しこれを打錠して錠剤を得る方法
である。顆粒圧縮法では、造粒工程で顆粒調製中にに本
発明の崩壊剤を添加するか、または顆粒を調製した後で
崩壊剤を加え、必要に応じステアリン酸マグネシウムな
どの滑沢剤を加えて打錠する方法(後末添加)が採られ
る。造粒工程は、撹拌造粒、流動層造粒、打出造粒等で
ある。崩壊剤の添加量は処方中の1〜99重量%の範
囲、好ましくは3〜60重量%の範囲である。なお、打
錠時にスティッキング等の障害を起こす場合には、必要
に応じて滑沢剤を添加することも可能であり、その添加
量は、処方中0.1〜5重量%である。The disintegrant of the present invention may be incorporated into a solid preparation by a general method, but the effects of the present invention are sufficiently exhibited by direct compression or granule compression. . The direct compression method is a method of directly compressing a powder containing an active ingredient to obtain a tablet. The disintegrant of the present invention is added to a powder of the active ingredient and the like before compression and mixed. The granule compression method is a method of preparing granules having good fluidity from a powder comprising an active ingredient, an excipient, and the like through a granulation step, and compressing the granules to obtain tablets. In the granule compression method, the disintegrant of the present invention is added during the preparation of granules in the granulation step, or the disintegrant is added after preparing the granules, and a lubricant such as magnesium stearate is added as necessary. A tableting method (addition at the end) is employed. The granulation process includes stirring granulation, fluidized bed granulation, and punch granulation. The amount of the disintegrant added is in the range of 1 to 99% by weight, preferably 3 to 60% by weight in the formulation. In addition, when troubles such as sticking occur at the time of tableting, a lubricant can be added as needed, and the amount of addition is 0.1 to 5% by weight in the formulation.
【0013】本発明の崩壊剤を含有する錠剤は、有効成
分や滑沢剤の他に、賦形剤、結合剤、矯味剤等を含むこ
ともできる。The tablet containing the disintegrant of the present invention may contain excipients, binders, flavoring agents and the like in addition to the active ingredient and the lubricant.
【0014】[0014]
【実施例】以下に実施例を示すが、本発明は実施例のみ
に限定されるものではない。 実施例1 (崩壊剤の製造) 市販L−HPC(信越化学工業社製
L−HPCタイプLH−21)200gをバーチカルグ
ラニュレーター(パウレック社製VG−05型)に入
れ、ブレード回転数600rpm、チョッパー回転数1
000rpmで撹拌を開始し、精製水200gを添加し
て5分間撹拌してウェットマスを調製した。これを取り
出して18メッシュの篩で整粒し、これを60℃のオー
ブンで水分が約2重量%となるまで乾燥した。乾燥後、
再び18メッシュの篩を通して崩壊剤を得た。EXAMPLES Examples will be shown below, but the present invention is not limited only to the examples. Example 1 (Production of disintegrant) 200 g of commercially available L-HPC (L-HPC type LH-21 manufactured by Shin-Etsu Chemical Co., Ltd.) was placed in a vertical granulator (VG-05 manufactured by Powrex), and the blade rotation speed was 600 rpm, and the chopper was used. Rotation speed 1
Stirring was started at 000 rpm, 200 g of purified water was added, and the mixture was stirred for 5 minutes to prepare a wet mass. This was taken out, sized with an 18-mesh sieve, and dried in an oven at 60 ° C. until the water content became about 2% by weight. After drying,
The disintegrant was obtained again through an 18 mesh sieve.
【0015】(錠剤の調製と評価) ビタミンA吸着末
(三共社製、ドライビタミンA)と実施例1の崩壊剤を
7:3の重量比で混合した。これをタブレッティングテ
スター(三協パイオテック社製)で圧縮成型して錠剤を
得た。なお、圧縮圧は150MPaとして、この時の錠
剤の硬度が3kgfを下回るものは硬度不足と判断し、
それ以外のものは錠剤硬度を5±0.5kgfとなるよ
うに圧力を適宜調節した。硬度が5±0.5kgfの錠
剤について日本薬局方崩壊試験機を用いて崩壊時間を測
定した。試験液は水とし、ディスクは使用すると錠剤が
ディスク面に粘着するため使用しなかった。比較として
実施例1の崩壊剤の代わりに原料のL−HPCや他の崩
壊剤を用いて同様に行った。結果を表1に示す。(Preparation and Evaluation of Tablet) Vitamin A adsorption powder (manufactured by Sankyo Co., Ltd., dry vitamin A) and the disintegrant of Example 1 were mixed in a weight ratio of 7: 3. This was compression-molded with a tableting tester (manufactured by Sankyo Piotech) to obtain a tablet. The compression pressure was set to 150 MPa. If the tablet hardness at this time was lower than 3 kgf, it was determined that the hardness was insufficient.
In other cases, the pressure was appropriately adjusted so that the tablet hardness was 5 ± 0.5 kgf. The disintegration time of tablets having a hardness of 5 ± 0.5 kgf was measured using a disintegration tester of the Japanese Pharmacopoeia. The test liquid was water, and the disk was not used because the tablet adhered to the disk surface when used. For comparison, the same procedure was carried out using L-HPC as a raw material or another disintegrant instead of the disintegrant of Example 1. Table 1 shows the results.
【0016】[0016]
【表1】 [Table 1]
【0017】表1に示すように、クロスカルメロースナ
トリウムとクロスポビドンを使用した錠剤は、硬度が不
足であった。その他のものについては同程度の硬度で、
本発明の錠剤が最も崩壊時間が短かった。As shown in Table 1, the tablets using croscarmellose sodium and crospovidone were insufficient in hardness. Others have similar hardness,
The tablets of the present invention had the shortest disintegration time.
【0018】実施例2 (崩壊剤の製造) 市販L−HPCを低ヒドロキシプロ
ポキシルタイプのLH−22とした他は実施例1と同様
な方法で崩壊剤を調製した。 (錠剤の調製と評価) この崩壊剤と葛根湯エキス末
(アルプス薬品社製)を重量比で3:7の割合で混合
し、実験1と同様に錠剤を調製した。なお、錠剤硬度は
約11kgfになるように圧縮圧を調節した。錠剤の崩
壊時間を市販L−HPCを使用した場合、および崩壊剤
のない場合と比較した。結果を表2に示す。Example 2 (Production of disintegrant) A disintegrant was prepared in the same manner as in Example 1 except that commercially available L-HPC was changed to LH-22 of low hydroxypropoxyl type. (Preparation and evaluation of tablet) This disintegrant and Kakkonto extract powder (manufactured by Alps Pharmaceutical Co., Ltd.) were mixed at a weight ratio of 3: 7, and a tablet was prepared in the same manner as in Experiment 1. The compression pressure was adjusted so that the tablet hardness was about 11 kgf. The disintegration time of the tablets was compared with using a commercial L-HPC and without disintegrant. Table 2 shows the results.
【0019】[0019]
【表2】 [Table 2]
【0020】[0020]
【発明の効果】本発明の錠剤は、市販のL−HPCを使
用したものに比較して同一硬度で崩壊力が強いこと、ま
た他の崩壊剤を使用したものに対しても崩壊力が強いこ
とがわかる。EFFECTS OF THE INVENTION The tablet of the present invention has the same hardness and a higher disintegration power as compared with a tablet using a commercially available L-HPC, and also has a higher disintegration force with respect to those using other disintegrants. You can see that.
Claims (2)
該崩壊剤が湿式造粒処理をした低置換度ヒドロキシプロ
ピルセルロースであることを特徴とする錠剤の製造方
法。1. A method for producing a tablet comprising a disintegrant,
A method for producing a tablet, wherein the disintegrant is a low-substituted hydroxypropylcellulose subjected to a wet granulation treatment.
拌する工程と、篩を通過させて整粒する工程と、乾燥工
程とを含む請求項1に記載の錠剤の製造方法。2. The tablet manufacturing method according to claim 1, wherein the wet granulation treatment includes a step of adding a binder solution and stirring, a step of passing through a sieve to regulate the size, and a drying step.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2001170566A JP2002363067A (en) | 2001-06-06 | 2001-06-06 | Method for producing tablet preparation |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2001170566A JP2002363067A (en) | 2001-06-06 | 2001-06-06 | Method for producing tablet preparation |
Publications (1)
Publication Number | Publication Date |
---|---|
JP2002363067A true JP2002363067A (en) | 2002-12-18 |
Family
ID=19012464
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001170566A Pending JP2002363067A (en) | 2001-06-06 | 2001-06-06 | Method for producing tablet preparation |
Country Status (1)
Country | Link |
---|---|
JP (1) | JP2002363067A (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2007161706A (en) * | 2005-11-15 | 2007-06-28 | Taisho Pharmaceut Co Ltd | Annakasan-containing tablets |
WO2009151072A1 (en) * | 2008-06-13 | 2009-12-17 | 大日本住友製薬株式会社 | Tablet quickly disintegrating in the oral cavity and method for producing the same |
US8980316B2 (en) | 2005-05-18 | 2015-03-17 | Sumitomo Dainippon Pharma Co., Ltd. | Stable tablet containing droxidopa |
-
2001
- 2001-06-06 JP JP2001170566A patent/JP2002363067A/en active Pending
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8980316B2 (en) | 2005-05-18 | 2015-03-17 | Sumitomo Dainippon Pharma Co., Ltd. | Stable tablet containing droxidopa |
JP2007161706A (en) * | 2005-11-15 | 2007-06-28 | Taisho Pharmaceut Co Ltd | Annakasan-containing tablets |
WO2009151072A1 (en) * | 2008-06-13 | 2009-12-17 | 大日本住友製薬株式会社 | Tablet quickly disintegrating in the oral cavity and method for producing the same |
CN102119034B (en) * | 2008-06-13 | 2013-05-22 | 大日本住友制药株式会社 | Tablets that disintegrate rapidly in the oral cavity and methods of making the same |
JP5583012B2 (en) * | 2008-06-13 | 2014-09-03 | 大日本住友製薬株式会社 | Intraoral quick disintegrating tablet and method for producing the same |
US9119820B2 (en) | 2008-06-13 | 2015-09-01 | Sumitomo Dainippon Pharma Co., Ltd. | Tablet quickly disintegrating in the oral cavity and method for producing the same |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US5104648A (en) | High ibuprofen content granulations | |
NZ503766A (en) | Pharmaceutical preparation comprising clodronate as active ingredient and silicified microcrystalline cellulose as excipient | |
JPS62174013A (en) | Vitamin granule for direct tableting, production thereof and tablet prepared therefrom | |
JP2556623B2 (en) | Granules with high ibuprofen content | |
JPH0440331B2 (en) | ||
JPH023606A (en) | Granular medicine | |
AU784128B2 (en) | Ibuprofen containing active agent preparation | |
JPS6011414A (en) | Granular n-acetyl-p-aminophenol composition and manufacture | |
JPH0753663B2 (en) | Thiamine salt granules, their production and tablets | |
JP2005507896A (en) | Metformin-containing extended-release pharmaceutical composition | |
JP2002104956A (en) | Base for dry direct compressing hydroxypropylcellulose having low substitution degree | |
CN106999600A (en) | Include the disintegrating particles composition for crushing lactose or lactose of pelletizing | |
EP2603288A1 (en) | Pharmaceutical granulate comprising imatinib mesylate | |
TWI498130B (en) | Directly compressible high functionality granular microcrystalline cellulose based excipient, manufacturing process and use thereof | |
JP2010508270A (en) | Dry granulated pharmaceutical compositions and methods for their preparation | |
WO1997033571A1 (en) | Rapid-release microdispersible ecadotril preparation | |
JP2002363067A (en) | Method for producing tablet preparation | |
CA2450233C (en) | Compressible guaifenesin compositions, method for making same and method for making compressed guaifenesin dosage forms therefrom | |
JP4774739B2 (en) | Kampo extract-containing tablet composition and method for producing the same | |
EA015349B1 (en) | Solid unit oral pharmaceutical dosage form of saquinavir mesylate and a process for making thereof | |
KR101532810B1 (en) | Pharmaceutical compositions of entacapone co-micronized with sugar alcohols | |
JP2007332074A (en) | Tablet quickly disintegrable in oral cavity and method for producing the same | |
RU2536258C1 (en) | Method for preparing teriflunomide tablets | |
CA2924016A1 (en) | Pharmaceutical composition | |
JP7430937B1 (en) | Method for manufacturing premix particles |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
A977 | Report on retrieval |
Free format text: JAPANESE INTERMEDIATE CODE: A971007 Effective date: 20040407 |
|
A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20040413 |
|
A02 | Decision of refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A02 Effective date: 20040806 |