JP2015048352A - セルロース系核粒子及びその製造方法 - Google Patents
セルロース系核粒子及びその製造方法 Download PDFInfo
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- JP2015048352A JP2015048352A JP2014001945A JP2014001945A JP2015048352A JP 2015048352 A JP2015048352 A JP 2015048352A JP 2014001945 A JP2014001945 A JP 2014001945A JP 2014001945 A JP2014001945 A JP 2014001945A JP 2015048352 A JP2015048352 A JP 2015048352A
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Abstract
Description
(1) セルロース10質量%以上と賦形剤90質量%以下とを含有し、見かけ嵩密度が0.20g/ml以上0.60g/ml未満、安息角が38〜50°、打圧3kN時の錠剤硬度が50N以上、目開き75μmの篩を通過し、目開き20μmの篩上に残留する粒子の割合が50質量%以上であるセルロース及び賦形剤を含有するセルロース系核粒子。
(2) 上記賦形剤が、含水二酸化ケイ素、軽質無水ケイ酸、合成ケイ酸アルミニウム、水酸化アルミナマグネシウム、メタケイ酸アルミン酸マグネシウム、ケイ酸アルミン酸マグネシウム、ケイ酸カルシウム、含水無水晶形酸化ケイ素、ケイ酸マグネシウム、及び含水ケイ酸マグネシウムからなる群から選ばれる少なくとも1種以上の化合物である、上記(1)のセルロース系核粒子。
(3) 上記賦形剤がケイ酸カルシウム、または軽質無水ケイ酸である、上記(1)のセルロース系核粒子。
(4)吸水能が0.3ml/g以上1.5ml/g未満である、上記(1)〜(3)のいずれかのセルロース系核粒子。
(5) 上記(1)〜(4)のいずれかのセルロース系核粒子と、該核粒子を被覆する薬物層を有する粒子。
(6) 上記(5)の粒子と、該粒子を被覆するフィルムコーティング層を有するフィルムコーティング粒子。
(7) 上記(5)の粒子、又は上記(6)のフィルムコーティング粒子を含有する錠剤。
(8) 上記(5)記載の粒子、又は上記(6)のフィルムコーティング粒子を3〜90質量%含有する、上記(7)の錠剤。
(9) 第16改正日本薬局方の崩壊試験法に準じて測定された崩壊時間が60秒未満である、上記(7)の錠剤。
(10) セルロースと結合液とを混合撹拌して造粒する造粒工程と、前記造粒工程で得られた造粒物を乾燥する乾燥工程と、前記乾燥工程で得られた造粒物を粉砕する粉砕工程とを含むセルロース系核粒子の製造方法。
(11) セルロース10質量%以上と賦形剤90質量%以上とを含有し、荷重ピーク値が200〜1000mNである造粒物を粉砕する工程を含む、上記(1)〜(4)のいずれかのセルロース系核粒子の製造方法。
本実施形態のセルロース系核粒子は、セルロース10質量%以上と賦形剤90質量%以下を含有し、見かけ嵩密度が0.20g/ml以上0.60g/ml未満、安息角が38〜50°、打圧3kN時の錠剤硬度が50N以上、目開き75μmの篩を通過し、目開き20μmの篩上に残留する粒子の割合が50質量%以上である。
本実施形態のセルロース系核粒子を薬物層で被覆し、更に場合によりフィルムコーティングすることで医薬品に配合可能な粒子を得ることができる。本実施形態のセルロース系核粒子を被覆する薬物層及びセルロース系核粒子を含有する粒子を含む医薬品、典型的には錠剤に使用される有効成分とは、人及び動物の疾病の治療、予防、診断に使用されるものであって、器具・機械ではなく、第十六改正日本薬局方に収載されている繁用な医薬品の有効成分である。
<核粒子、粒子の平均粒子径[μm]>
ロータップ式篩振盪機(平工製作所製、シーブシェーカーA型)によりJIS標準篩を用いて試料20gを10分間篩分することにより粒度分布を測定し、目開き75μmの篩を通過し、目開き20μmの篩上に残留する粒子の割合(質量%)を求めた。また、篩下積算分布における積算50質量%粒子径を平均粒子径とした。
<見かけ嵩密度[g/ml]>
100mlのメスシリンダーに粒子30gを疎充填(メスシリンダーの開口部にロートを差し込み、5秒から10秒程度かけてゆっくり核粒子を注ぎ込み、そのまま静置)させた粒子層の容積を読み取り、30gを該容積(ml)で除した値を算出した。繰り返し数は3で、その平均値をとった。
<荷重ピーク値>
顆粒強度測定装置(グラノ、岡田精工(株)製)を使用し、測定速度250μm/秒で測定し、変位をX軸とし荷重をY軸とした時に得られる出力信号波形における傾きの変曲点を荷重ピーク値とする。測定粒子の粒子径の50%以下の変位において、顆粒強度測定装置の先端チップの最小移動ステップ(1μm)の2倍以上の変位幅に渡って、荷重が変化しない又は下がった最初の点を変曲点とする。変曲点が検出できた100個の粒子の平均値をとった。
<安息角[°]>
パウダーテスター(PR−T型、ホソカワミクロン製)を使用して測定する。繰り返し数は3で、その平均値をとった。
<真球度><形状係数>
デジタルマイクロスコープ(VH−7000型、キーエンス製、VH−501レンズ使用)を用いて撮影した画像を1360×1024ピクセル、TIFFファイル形式で保存し、画像処理解析ソフト(Image HyperII、デジモ製)を使用して、100個の粒子の短径と長径の平均値をとって、短径の平均値/長径の平均値により真球度を算出した。また、該画像の100個の粒子の輪郭の長さを該粒子の投影面積と同じ面積を有する円の周長で除した値の平均値により形状係数を算出した。
<吸水能>
JIS K5101に記載の吸油量の測定に準じ、油の代わりに純水を用いて、セルロース系核粒子10gに純水30mlを加え、1時間室温で放置後、ろ取し、粒子表面の付着水をろ紙などで軽く拭き取った後、重量を測定し、重量の増加分から含水量を算出後、10gで除した。
<錠剤の硬度>
一般的に使用される錠剤硬度測定器(Tablet Tester 8M/DR.SCHLEUNIGER製)にて、錠剤の硬度を測定した。1錠ずつ錠剤硬度を測定し、20錠分の錠剤硬度の平均値を算出した。
<錠剤の崩壊試験>
第16改正日本薬局方、一般試験法「崩壊試験法」に従って実施した。試験液は水を用いた。
<錠剤の口腔内崩壊試験>
健康な成人男子3人を被験者として、口腔内の唾液で錠剤が完全に崩壊する時間を測定した。各人2回測定し、3人の平均値を算出した。
<服用感>
健康な成人男子3人を被験者として、口腔内の錠剤の服用感を官能的に評価した。錠剤の味や食感に問題がない場合を「良好」とし、粉っぽさを感じる場合は、「もさつき感あり」、粒子などのザラツキを感じた場合は、「違和感あり」として判定した。各人2回測定し、2回とも「良好」である場合のみ、その被験者の服用感の評価を「良好」と判定した。そして、例えば、もさつき感について、被験者が1回目に何も感じず、2回目にもさつき感を感じた場合は、その被験者の評価は「もさつき感あり」とし、同様に、1回でも粒子などのザラツキを感じた場合は、「違和感あり」として判定した。
結晶セルロース(製品名:セオラス(登録商標)UF−711、平均重合度250、旭化成ケミカルズ製)1.2kgとケイ酸カルシウム(製品名:フローライト、トクヤマ製)0.3kgを高速攪拌造粒機(VG−01、パウレック製)に仕込み、純水1000gを加え、30分間造粒した。この粒子2.5kgを転動流動層型造粒コーティング装置(MP−01、パウレック製)に仕込み、純水を10g/minの速度で550gを供給しながら、給気温度25℃で60分間転動させた。その後、給気温度を100℃に上げて乾燥させた粒子をジェットミル粉砕機(STJ−400A、セイシン製)で全量粉砕し、目開き63μmの篩と20μmの篩でふるい、20〜63μmの核粒子(C)を得た。得られた核粒子(C)の20〜75μmの割合は96質量%であった。物性を表1に示す。
結晶セルロース(製品名:セオラス(登録商標)UF−711、平均重合度250、旭化成ケミカルズ製)1.2kgとケイ酸カルシウム(製品名:フローライト、トクヤマ製)0.3kgを高速攪拌造粒機(VG−01、パウレック製)に仕込み、純水1000gを加え、30分間造粒した。この粒子2.5kgを転動流動層型造粒コーティング装置(MP−01、パウレック製)に仕込み、純水を10g/minの速度で550gを供給しながら、給気温度25℃で60分間転動させた。その後、給気温度を100℃に上げて乾燥させた粒子をバンタムミル粉砕機(AP−B、ホソカワミクロン製)で全量粉砕し、目開き63μmの篩と20μmの篩でふるい、20〜63μmの核粒子(D)を得た。核粒子(D)の20〜75μmの割合は96質量%であった。物性を表1に示す。
結晶セルロース(製品名:セオラス(登録商標)PH−101、平均重合度300、旭化成ケミカルズ製)1.2kgとケイ酸カルシウム(製品名:フローライト、トクヤマ製)0.3kgを高速攪拌造粒機(VG−01、パウレック製)に仕込み、純水950gを加え、30分間造粒した。この粒子2.45kgを転動流動層型造粒コーティング装置(MP−01、パウレック製)に仕込み、純水を10g/minの速度で500gを供給しながら、給気温度25℃で60分間転動させた。その後、給気温度を100℃に上げて乾燥させた粒子をバンタムミル粉砕機(AP−B、ホソカワミクロン製)で全量粉砕し、目開き63μmの篩と20μmの篩でふるい、20〜63μmの核粒子(E)を得た。核粒子(E)の20〜75μmの割合は97質量%であった。物性を表1に示す。
結晶セルロース(製品名:セオラス(登録商標)UF−711、平均重合度250、旭化成ケミカルズ製)0.75kgとケイ酸カルシウム(製品名:フローライト、トクヤマ製)0.75kgを高速攪拌造粒機(VG−01、パウレック製)に仕込み、純水1100gを加え、30分間造粒した。この粒子2.6kgを転動流動層型造粒コーティング装置(MP−01、パウレック製)に仕込み、純水を10g/minの速度で700gを供給しながら、給気温度25℃で60分間転動させた。その後、給気温度を100℃に上げて乾燥させた粒子をバンタムミル粉砕機(AP−B、ホソカワミクロン製)で全量粉砕し、目開き63μmの篩と20μmの篩でふるい、20〜63μmの核粒子(F)の核粒子(F)を得た。得られた核粒子(F)の20〜75μmの割合は97質量%であった。物性を表1に示す。
結晶セルロース(製品名:セオラス(登録商標)UF−711、平均重合度250、旭化成ケミカルズ製)0.30kgとケイ酸カルシウム(製品名:フローライト、トクヤマ製)1.20kgを高速攪拌造粒機(VG−01、パウレック製)に仕込み、純水1200gを加え、30分間造粒した。この粒子2.7kgを転動流動層型造粒コーティング装置(MP−01、パウレック製)に仕込み、純水を10g/minの速度で700gを供給しながら、給気温度25℃で60分間転動させた。その後、給気温度を100℃に上げて乾燥させた粒子をバンタムミル粉砕機(AP−B、ホソカワミクロン製)で全量粉砕し、目開き63μmの篩と20μmの篩でふるい、20〜63μmの核粒子(G)を得た。得られた核粒子(G)の20〜75μmの割合は98質量%であった。物性を表1に示す。
結晶セルロース(製品名:セオラス(登録商標)UF−711、平均重合度250、旭化成ケミカルズ製)0.15kgとケイ酸カルシウム(製品名:フローライト、トクヤマ製)1.35kgを高速攪拌造粒機(VG−01、パウレック製)に仕込み、純水1300gを加え、30分間造粒した。この粒子2.8kgを転動流動層型造粒コーティング装置(MP−01、パウレック製)に仕込み、純水を10g/minの速度で700gを供給しながら、給気温度25℃で60分間転動させた。その後、給気温度を100℃に上げて乾燥させた粒子をバンタムミル粉砕機(AP−B、ホソカワミクロン製)で全量粉砕し、目開き63μmの篩と20μmの篩でふるい、20〜63μmの核粒子(H)を得た。得られた核粒子(H)の20〜75μmの割合は98質量%であった。物性を表1に示す。
結晶セルロース(製品名:セオラス(登録商標)PH−101、平均重合度300、旭化成ケミカルズ製)1.2kgと軽質無水ケイ酸(製品名:アエロジル、日本アエロジル製)0.3kgを高速攪拌造粒機(VG−01、パウレック製)に仕込み、純水950gを加え、30分間造粒した。この粒子2.45kgを転動流動層型造粒コーティング装置(MP−01、パウレック製)に仕込み、純水を10g/minの速度で500gを供給しながら、給気温度25℃で60分間転動させた。その後、給気温度を100℃に上げて乾燥させた粒子をバンタムミル粉砕機(AP−B、ホソカワミクロン製)で全量粉砕し、目開き106μmの篩と20μmの篩でふるい、20〜106μmの核粒子(I)を得た。得られた核粒子(I)の20〜75μmの割合は55質量%であった。物性を表1に示す。
次に実施例1〜7で得られた核粒子を、各々500mg計りとり、11mmφの臼杵で打錠圧3kNの力で10秒間静圧プレス(1011CREEP、AIKOH ENGINEERING製)し、錠剤を作製した。各々の錠剤硬度は表2に示す。
実施例同様に、結晶セルロース(製品名:セオラス(登録商標)UF−711、平均重合度250、旭化成ケミカルズ製)0.075kgとケイ酸カルシウム(製品名:フローライト、トクヤマ製)1.425kgを高速攪拌造粒機(VG−01、パウレック製)に仕込み、純水1350gを加え、30分間造粒した。この粒子2.85kgを転動流動層型造粒コーティング装置(MP−01、パウレック製)に仕込み、純水を10g/minの速度で700gを供給しながら、給気温度25℃で60分間転動させた。その後、給気温度を100℃に上げて乾燥させた粒子をバンタムミル粉砕機(AP−B、ホソカワミクロン製)で全量粉砕し、目開き106μmの篩と20μmの篩でふるい、20〜106μmの核粒子(a)を得た。得られた核粒子(a)の20〜75μmの割合は98質量%であった。物性を表3に示す。
結晶セルロース(製品名:セオラス(登録商標)UF−711、平均重合度250、旭化成ケミカルズ製)0.75kgとケイ酸カルシウム(製品名:フローライト、トクヤマ製)0.75kgを高速攪拌造粒機(VG−01、パウレック製)に仕込み、純水1100gを加え、30分間造粒した。この粒子2.6kgを転動流動層型造粒コーティング装置(MP−01、パウレック製)に仕込み、純水を10g/minの速度で700gを供給しながら、給気温度25℃で60分間転動させた。その後、給気温度を100℃に上げて乾燥させ核粒子(d)を得た。得られた核粒子(d)の物性を表3に示す。
次に比較例1〜2で得られた核粒子を、各々500mg計りとり、11mmφの臼杵で打錠圧3kNの力で10秒間静圧プレス(1011CREEP、AIKOH ENGINEERING製)し、錠剤を作製した。各々の錠剤硬度は表4に示す。
[実施例9]
実施例1の核粒子800gをワースター型流動層造粒コーティング装置(MP−01型、パウレック製)に入れ、スプレーエアー圧:0.16MPa、スプレーエアー流量:40L/min、保護エア圧:0.2MPa、給気温度:75℃、排気温度:35℃、風量:30〜50m3/hの条件で、リボフラビン10質量部、ヒドロキシプロピルセルロース(HPC−L、日本曹達製)2質量部、水88質量部の懸濁液を、10g/minの供給速度で噴霧し、実施例1の核粒子100質量部に対してリボフラビンが2質量部となるまでリボフラビン含有被覆層(薬物層)を被覆した。実施例1の核粒子にリボフラビンを被覆した粒子を212μmの篩で篩分し、凝集粒子を取り除き、レイヤリング顆粒(核粒子を被覆する薬物層を有する粒子)を得た。
比較例1の核粒子800gをワースター型流動層造粒コーティング装置(MP−01型、パウレック製)に入れ、スプレーエアー圧:0.16MPa、スプレーエアー流量:40L/min、保護エア圧:0.2MPa、給気温度:75℃、排気温度:35℃、風量:30〜50m3/hの条件で、リボフラビン10質量部、ヒドロキシプロピルセルロース(HPC−L、日本曹達製)2質量部、水88質量部の懸濁液を、10g/minの供給速度で噴霧し、比較例1の核粒子100質量部に対してリボフラビンが2質量部となるまでリボフラビン含有被覆層を被覆した。比較例1の核粒子にリボフラビンを被覆した粒子を212μmの篩で篩分し、凝集粒子を取り除き、レイヤリング顆粒を得た。
[製造例1]
結晶セルロースのセオラス(登録商標)KG−1000(旭化成ケミカルズ製)300gとエリスリトール(三菱化学フーズ製)700gをバーチカルグラニュレーター造粒装置に仕込み、水を摘下させながら撹拌造粒を行い、造粒顆粒を得た。さらに、この造粒顆粒を、流動層乾燥機に移して造粒顆粒の乾燥を行った後、600μmの篩で篩分し、結晶セルロースとエリスリトールを含有する平均粒子径が150〜200μmの造粒顆粒を得た。
(1)使用装置 :バーチカルグラニュレーター(商品名)FM−VG−10(パウレック製)
(2)加水量 :200g
(3)ブレード回転数 :280rpm
(4)チョッパー回転数:3000rpm
(5)造粒時間 :3分間
乾燥の条件は下記の通りであった。
(1)使用装置 :マルチプレックス(商品名)MP−01型(パウレック製)
(2)風量 :50m3/時間
(3)給気温度 :70〜75℃
(4)排気温度 :45℃停止
次に、実施例8で得た実施例1のフィルムコーティング粒子を30.0質量%、製造例1で得た造粒顆粒を56.9質量%、無水リン酸水素カルシウム(フジカリン(商品名)富士化学製)を5.0質量%、結晶セルロース(セオラス(登録商標)KG−1000(商品名)、旭化成ケミカルズ製)を5.0質量%、崩壊剤としてアルファー化デンプン(SWELSTAR PD−1(商品名)、旭化成ケミカルズ製)を3.0質量%、ステアリン酸マグネシウム(太平化学工業)を0.1質量%混合し、ロータリー打錠機(リブラ2(商品名)、菊水製作所製)で、打錠した。打錠用の臼杵は、直径9.5mm、杵の凹曲面半径が13.5mmのものを使用し、ターンテーブル回転数40rpm、圧縮圧力7.0kNで打錠し、錠剤重量が380mgの錠剤を得た。実施例8で得た実施例2〜7のフィルムコーティング粒子に対しても同様の操作を行った。
実施例10同様に、比較例4で得た比較例1のフィルムコーティング粒子を30.0質量%、製造例1で得た造粒顆粒を56.9質量%、無水リン酸水素カルシウム(フジカリン(商品名)富士化学製)を5.0質量%、結晶セルロース(セオラス(登録商標)KG−1000(商品名)、旭化成ケミカルズ製)を5.0質量%、崩壊剤としてアルファー化デンプン(SWELSTAR PD−1(商品名)、旭化成ケミカルズ製)を3.0質量%、ステアリン酸マグネシウム(太平化学工業製)を0.1質量%混合し、ロータリー打錠機(リブラ2(商品名)、菊水製作所製)で打錠した。打錠用の臼杵は、直径9.5mm、杵の凹曲面半径が13.5mmのものを使用し、ターンテーブル回転数40rpm、圧縮圧力7.0kNで打錠し、錠剤重量が380mgの錠剤を得た。比較例4で得た比較例2のフィルムコーティング粒子に対しても同様の操作を行った。
2..薬物層
3..粒子
4..フィルムコーティング層
5..フィルムコーティング粒子
Claims (11)
- セルロース10質量%以上と賦形剤90質量%以下とを含有し、見かけ嵩密度が0.20g/ml以上0.60g/ml未満、安息角が38〜50°、打圧3kN時の錠剤硬度が50N以上、目開き75μmの篩を通過し、目開き20μmの篩上に残留する粒子の割合が50質量%以上であるセルロース及び賦形剤を含有するセルロース系核粒子。
- 上記賦形剤が、含水二酸化ケイ素、軽質無水ケイ酸、合成ケイ酸アルミニウム、水酸化アルミナマグネシウム、メタケイ酸アルミン酸マグネシウム、ケイ酸アルミン酸マグネシウム、ケイ酸カルシウム、含水無水晶形酸化ケイ素、ケイ酸マグネシウム、及び含水ケイ酸マグネシウムからなる群から選ばれる少なくとも1種以上の化合物である請求項1記載のセルロース系核粒子。
- 上記賦形剤がケイ酸カルシウム、または軽質無水ケイ酸である請求項1記載のセルロース系核粒子。
- 吸水能が0.3ml/g以上1.5ml/g未満である請求項1〜3のいずれかに記載のセルロース系核粒子。
- 請求項1〜4のいずれかに記載のセルロース系核粒子と、該核粒子を被覆する薬物層を有する粒子。
- 請求項5記載の粒子と、該粒子を被覆するフィルムコーティング層を有するフィルムコーティング粒子。
- 請求項5記載の粒子、又は請求項6記載のフィルムコーティング粒子を含有する錠剤。
- 請求項5記載の粒子、又は請求項6記載のフィルムコーティング粒子を3〜90質量%含有する請求項7記載の錠剤。
- 第16改正日本薬局方の崩壊試験法に準じて測定された崩壊時間が60秒未満である請求項7記載の錠剤。
- セルロースと賦形剤と結合液とを混合撹拌して造粒する造粒工程と、前記造粒工程で得られた造粒物を乾燥する乾燥工程と、前記乾燥工程で得られた造粒物を粉砕する粉砕工程とを含むセルロース系核粒子の製造方法。
- セルロース10質量%以上と、賦形剤90質量%以下とを含有し、荷重ピーク値が200〜1000mNである造粒物を粉砕する工程を含む請求項1〜4のいずれか一項に記載のセルロース系核粒子の製造方法。
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