JPWO2016024493A1 - 微小セルロース粉末 - Google Patents
微小セルロース粉末 Download PDFInfo
- Publication number
- JPWO2016024493A1 JPWO2016024493A1 JP2016542538A JP2016542538A JPWO2016024493A1 JP WO2016024493 A1 JPWO2016024493 A1 JP WO2016024493A1 JP 2016542538 A JP2016542538 A JP 2016542538A JP 2016542538 A JP2016542538 A JP 2016542538A JP WO2016024493 A1 JPWO2016024493 A1 JP WO2016024493A1
- Authority
- JP
- Japan
- Prior art keywords
- cellulose powder
- tablet
- powder
- cellulose
- active ingredient
- 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.)
- Granted
Links
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Abstract
Description
本発明のセルロース粉末の平均重合度は、150〜450が好ましい。平均重合度が150以上であると圧縮成形性が高くなるので好ましく、また450以下であるとセルロースの加水分解が十分であり、セルロースの非晶質部分を多く含まず、繊維性が強く現れ弾性回復し易くなることがなく、成形性に優れる傾向にある。
以下に本発明のセルロース粉末の製造方法について記述する。
乾燥工程後のセルロース粉末の一次粒子率が50%未満である場合や、平均粒子径が100μmより大きい場合は、噴霧乾燥後に粉砕することが好ましい。当該粉砕は、超遠心粉砕機(ZM−200、Retsch製)、ジェットミル(STJ−200、セイシン企業製)やハンマミル(H−12、ホソカワミクロン製)、バンタムミル(AP−B、ホソカワミクロン製)ピンミル(160Z、パウレック製)フェザミル(FM、ホソカワミクロン)、ハンマーミル(HM−600、奈良機械製作所)、フラッシュミル(FL−250N、ダルトン)、ボールミル(Emax、Retsch)、振動ボールミル(2C、TRU)、スクリーンを通過させるスクリーンミル(U30、パウレック)などの粉砕機で粉砕することにより実施できる。特に、ジェットミル粉砕機(STJ−200、セイシン企業製)は、高い空気圧で粒子同士を衝突させながら粉砕する気流式粉砕機であり、二次粒子が破砕され一次粒子化しやすい為、好ましい。
本発明でいう口腔内崩壊錠は、1種以上の薬物または有効成分(以下、「活性成分」ともいう。)と本発明のセルロース粉末を含有している。該口腔内崩壊錠を製造する方法としては、各成分の混合、撹拌、造粒、整粒、打錠等の公知の方法で実施できる。
本発明の口腔内崩壊錠は、本発明のセルロース粉末と、1種以上の活性成分と必要に応じて他の添加剤を含んだ組成物であって、圧縮成形により得られる錠剤をいう。本発明の口腔内崩壊錠の製造方法は、本発明のセルロース粉末と、1種以上の活性成分と、必要に応じて他の添加物とを混合し、得られる混合物を圧縮成形するものが好ましく、より具体的には、本発明のセルロース粉末3〜99質量%と、薬物又は有効成分、賦形剤、結合剤、崩壊剤、及び滑沢剤のうち少なくとも薬物又は有効成分を含む1種以上の成分1〜97質量%とを混合し、圧縮成形するものがより好ましい。
i)本発明のセルロース粉末と活性成分単体を混合し圧縮成形する製造方法、
ii)活性成分を予め水に溶解または分散させたものと本発明のセルロース粉末を混合し圧縮成形する製造方法、
iii)活性成分を予め少量の有機溶剤に溶解させた後に水に分散させたものと本発明のセルロース粉末を混合し圧縮成形する製造方法、
iv)活性成分を予め水溶性高分子又は水溶性高分子水溶液に溶解または分散させたものを本発明のセルロース粉末と混合し圧縮成形する製造方法、
v)活性成分を予め油脂に溶解または分散させたものを本発明のセルロース粉末と混合し圧縮成形する製造方法
第16改正日本薬局方、結晶セルロースの確認試験(3)に記載された銅エチレンジアミン溶液粘度法により測定した値とした。
レーザー回折散乱粒度分布計(堀場製作所(株)製、LA−910)を用い測定した。平均粒子径は体積頻度の数平均として算出した。
100mlのメスシリンダーに粒子30gを疎充填させた粒子層の容積を読み取り、30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。
セルロース粉末2.0gをガラス盤上において、ビューレットからポリエチレングリコール(三洋化成(株)製、マクロゴール400)を滴下しながら、その都度スパチラで混練し、粉体表面にマクロゴールが浸みだす点を終点として、ポリエチレングリコール重量g×100/セルロース粉末量(2.0g)にて飽和保持率を算出した。
乾式画像解析装置(マルバーン Morphorogi G3S)を使用し、約1万個程度の粒子を撮影、画像解析を行い、各粒子の面積円相当の粒子径とアスペクト比を求めた。その結果より、面積円相当の粒子径の平均値±5μmの範囲とアスペクト比の平均値±0.1の範囲に入る粒子の中から任意に粒子画像を1000個抜き取った。なお、上記範囲に入る粒子が1000個に満たない場合は、全粒子画像を使用するものとする。
抜き取った一つ一つの粒子画像における粒子形状を目視確認し、粒子単体を一次粒子、粒子が凝集しているものを2次粒子と判定し、1000個中の一次粒子数の割合を一次粒子率として算出した。
簡易的な方法としては、各々の抜き取った粒子画像の輝度分散値を1〜Xで範囲を選択したものを一次粒子、X〜100で範囲を選択したものを二次粒子とし、一次粒子数/全体の粒子数×100により、一次粒子率(%)を算出することもできる。この方法は、上記目視方法によって測定される一次粒子率と最もよく一致するように実験的にXを1〜100の範囲内で定めるものであり、本実施例においてはX=30を採用した。
ここで、「面積円相当の粒子径」とは、3次元処理された粒子画像を2次元へ変換し、その面積と同じ円面積になる円を出し、円の直径を粒子径とする方法である。「アスペクト比」とは、粒子の短径/粒子の長径で求められる比である。
「輝度分散値」とは、0〜255のグレースケールレベルで表された画素の輝度の標準偏差を意味し、数1に示される式で表される。値が大きいほど粒子内の白〜黒のコントラストが強く、小さいほど、コントラストが低い粒子となる。二次粒子になると粒子同士が重なり合うため、粒子のコントラストが強くなり、輝度分散値が大きくなる。
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を測定してL/Dの比を算出し、粒子100個のL/Dの平均値をとった。
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。
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。
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。
シャーレ上に錠剤を置き、錠剤の重量を測定し、錠剤底部側にスポイトで、水をゆっくり滴下していき、錠剤が吸水しなくなった時点の重量を測定し、(錠剤重量+吸水された水重量)/錠剤重量×100で錠剤の吸水能を算出した。
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。
健康な成人男子3人をパネラーとして、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」、顆粒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、パネラーが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、そのパネラーの評価は「もさつき感あり」とし、同様に、1回でも顆粒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。
市販のパルプ(重合度790)を細断したもの2kgと、4Nの塩酸水溶液30Lを低速型攪拌機(池袋琺瑯工業(株)製、30LGL反応器、翼径約30cm)に入れ、攪拌速度5rpmで攪拌しながら、40℃、24時間加水分解し、平均重合度310の酸不溶解性残渣を得た。得られた酸不溶解性残渣は、ヌッチェを使用し、固形分40質量%となるよう濾過し、濾過残渣をさらに純水で洗浄し、アンモニア水で中和後、90Lのポリバケツに入れ、純水を加えて、スリーワンモーター(HEIDON製、タイプ1200G、8M/M、攪拌翼径5cm)で、攪拌速度5rpmで攪拌することにより、固形分濃度10質量%のセルロース分散液とした。これを噴霧乾燥(分散液供給速度6L/hr、入口温度180〜220℃、出口温度50〜70℃)して、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.4MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Aを得た。セルロース粉末Aの粉体物性を表1に示す。
市販のパルプ(重合度840)を使用し、加水分解条件を5N塩酸水溶液、40℃、60時間とする以外は、実施例1と同様の操作を行い、平均重合度160の酸不溶解性残渣を得た。得られた酸不溶解性残渣は濾過せず、純水で洗浄した後中和し、攪拌を与えず、目開き38μmの篩を使用し、篩通過分を除去し、固形分濃度10質量%のセルロース分散液を得た。得られたセルロース分散液は、実施例1と同様の操作を行い噴霧乾燥し、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.4MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Bを得た。セルロース粉末Bの粉体物性を表1に示す。
市販のパルプ(重合度790)を使用し、加水分解条件を5N塩酸水溶液、40℃、4時間、攪拌速度30rpmとする以外は実施例1と同様の操作を行い、平均重合度440の酸不溶性残渣を得た。得られた酸不溶解性残渣は、実施例1と同様の操作を行い濾過、中和した後、攪拌速度500rpmで攪拌し、固形分濃度17質量%のセルロース分散液を得た。得られたセルロース分散液をドラム乾燥機(楠木製作所(株)製、KDD−1型、スチーム圧力0.35MPa、ドラム表面温度136℃、ドラム回転数2rpm、溜部分温度100℃)で乾燥後、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.4MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Cを得た。セルロース粉末Cの粉体物性を表1に示す。
市販の結晶セルロース(セオラスKG−1000:旭化成ケミカルズ製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.4MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Dを得た。セルロース粉末Dの粉体物性を表1に示す。
市販の結晶セルロース(セオラスPH−302:旭化成ケミカルズ製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.4MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Eを得た。セルロース粉末Eの粉体物性を表1に示す。
市販の結晶セルロース(セオラスKG−1000:旭化成ケミカルズ製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.6MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Fを得た。セルロース粉末Fの粉体物性を表1に示す。
市販の結晶セルロース(セオラスKG−1000:旭化成ケミカルズ製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.25MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Gを得た。セルロース粉末Gの粉体物性を表1に示す。
市販の結晶セルロース(セオラスPH−302:旭化成ケミカルズ製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.8MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Hを得た。セルロース粉末Hの粉体物性を表1に示す。
市販の結晶セルロース(セオラスPH−302:旭化成ケミカルズ製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.2MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Iを得た。セルロース粉末Iの粉体物性を表1に示す。
加水分解条件を3N塩酸水溶液、40℃、20時間、反応中の攪拌速度を20rpmとする以外は、実施例1と同様の操作により加水分解し、平均重合度440の酸不溶解性残渣を得た。得られた酸不溶解性残渣は、ヌッチェを使用し、固形分70質量%となるよう濾過した。得られた濾過残渣をさらに純水で洗浄し、アンモニア水で中和後、90Lのポリバケツに入れ、純水を加えて、実施例1と同様の操作で、攪拌速度100rpmで攪拌し、固形分濃度6質量%のセルロース分散液とした。得られたセルロース分散液を実施例1と同様の操作で噴霧乾燥し、セルロース粉末Jを得た。セルロース粉末Jの粉体物性を表1に示す。
加水分解条件を0.14N塩酸水溶液、121℃、1時間、反応中の攪拌速度を30rpmとする以外は、実施例1と同様の操作により加水分解し、平均重合度220の酸不溶解性残渣を得た。得られた酸不溶解性残渣は、ヌッチェを使用し、固形分70質量%となるよう濾過した。得られた濾過残渣をさらに純水で洗浄し、アンモニア水で中和後、90Lのポリバケツに入れ、純水を加えて、実施例1と同様の操作で、攪拌速度500rpmで攪拌し、固形分濃度17質量%のセルロース分散液とした。得られたセルロース分散液を実施例1と同様の操作で噴霧乾燥した後、目開き325メッシュの篩で粗大粒子を取り除き、セルロース粉末Kを得た。セルロース粉末Kの粉体物性を表1に示す。
市販の結晶セルロース(セオラスPH−101:旭化成ケミカルズ製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.4MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Lを得た。セルロース粉末Lの粉体物性を表1に示す。
市販の結晶セルロース(セオラスPH−102:旭化成ケミカルズ製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.4MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Mを得た。セルロース粉末Mの粉体物性を表1に示す。
市販のセルロース粉末(商品名:KCフロック、日本製紙ケミカル製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.4MPa、粉体供給速度10kg/hで粉砕し、セルロース粉末Nを得た。セルロース粉末Nの粉体物性を表1に示す。
市販のパルプ(重合度1030)を細断したもの2kgを使用する以外は実施例1と同様の操作を行い、セルロース粉末Oを得た。セルロース粉末Oの粉体物性を表1に示す。
市販のパルプ(重合度790)を細断したもの2kgと、0.14Nの塩酸水溶液30Lを低速型攪拌機(池袋琺瑯工業(株)製、30LGL反応器、翼径約30cm)に入れ、攪拌速度30rpmで攪拌しながら、121℃、1時間加水分解し、平均重合度220の酸不溶解性残渣を得た。得られた酸不溶解性残渣は、ヌッチェを使用し、固形分70質量%となるよう濾過し、濾過残渣をさらに純水で洗浄し、アンモニア水で中和後、90Lのポリバケツに入れ、純水を加えて、スリーワンモーター(HEIDON製、タイプ1200G、8M/M、攪拌翼径5cm)で、攪拌速度500rpmで攪拌することにより、固形分濃度17質量%のセルロース分散液とした。これを噴霧乾燥(分散液供給速度6L/hr、入口温度180〜220℃、出口温度50〜70℃)して、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.8MPa、粉体供給速度5kg/hで粉砕し、セルロース粉末Pを得た。セルロース粉末Pの粉体物性を表1に示す。
市販の結晶セルロース(セオラスKG−1000:旭化成ケミカルズ製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.8MPa、粉体供給速度5kg/hで粉砕し、セルロース粉末Qを得た。セルロース粉末Qの粉体物性を表1に示す。
市販の結晶セルロース(セオラスKG−1000:旭化成ケミカルズ製)を、気流式粉砕機((株)セイシン企業製、シングルトラックジェットミルSTJ−200型)を使用して粉砕圧力0.10MPa、粉体供給速度20kg/hで粉砕し、セルロース粉末Rを得た。セルロース粉末Rの粉体物性を表1に示す。
実施例1〜9で得た各々のセルロース粉末0.5gを使用し、臼(菊水製作所製、材質SUK2,3を使用)に入れ、直径1.13cmの円形平面杵(菊水製作所製、材質SUK2,3を使用)で打錠圧力2.0kNで圧縮した。その圧力を10秒間保持し錠剤を作製した(圧縮機はアイコーエンジニアリング製、PCM−1Aを使用)。得られた錠剤の硬度を表2に示す。
比較例1〜9で得た各々のセルロース粉末0.5gを使用し、臼(菊水製作所製、材質SUK2,3を使用)に入れ、直径1.13cmの円形平面杵(菊水製作所製、材質SUK2,3を使用)で打錠圧力2kNで圧縮した。その圧力を10秒間保持し錠剤を作製した(圧縮機はアイコーエンジニアリング製、PCM−1Aを使用)。得られた錠剤の硬度を表2に示す。
実施例10同様に、実施例1〜9で得た各々のセルロース粉末0.5gを使用し、臼(菊水製作所製、材質SUK2,3を使用)に入れ、直径1.13cmの円形平面杵(菊水製作所製、材質SUK2,3を使用)で、打錠圧力を実施例10より下げて錠剤硬度60N付近の錠剤を作製した。得られた錠剤の吸水能を表3に示す。
比較例10同様に、比較例1〜9で得た各々のセルロース粉末0.5gを使用し、臼(菊水製作所製、材質SUK2,3を使用)に入れ、直径1.13cmの円形平面杵(菊水製作所製、材質SUK2,3を使用)で、打錠圧力を比較例6より下げて錠剤硬度60N付近の錠剤を作製した。得られた錠剤の吸水能を表3に示す。
エリスリトール(カーギルジャパン)1.12kgと実施例1〜9で得た各々のセルロース粉末0.48kgとN−アセチルグルコサミン(焼津水産)、1.60kgをタンブラー混合機(TM−50S型;ダルトン)に仕込み、20分間混合させた後、取り出し、高速攪拌造粒機(バーチカルグラニュレーターVG−10;パウレック)に投入し、造粒した。造粒条件は下記の通りであった。
(1)ブロード回転数 :500rpm
(2)チョッパー回転数:1500rpm
(3)造粒時間 :3分間
(4)水添加量 :0.24kg
造粒顆粒を取り出し、流動層乾燥機に仕込み、顆粒を乾燥させた。乾燥条件は下記の通りであった。
(A)使用装置 :マルチプレックス(商品名)、MP−01型、(株)パウレック、
(B)風量 :7m3/min
(C)給気温度 :70〜75℃
(D)停止排気温度:45℃
乾燥した顆粒を取り出し、篩目710μmで整粒後、顆粒の粒度分布を測定し、平均粒子径を得た。顆粒の平均粒子径を表4に示す。
この顆粒1200gにアルファー化でんぷん(商品名SWELSTAR FD−1:旭化成ケミカルズ)36g、アスコルビン酸(武田薬品工業)14gを加え、タンブラー混合機(TM−50S型;ダルトン)に仕込み20分間混合させた後、ステアリン酸カルシウム(太平化学工業)を12g加えて、さらに3分間混合し、取り出した。この混合粉体のセルロース粉末の重量比率は28.5%で、打錠機(リブラ2(商品名);菊水製作所)に仕込み、錠剤を作製した。打錠条件は下記の通りであった。全て打錠障害もなく打錠でき、口腔内での服用感は、ザラツキやもさつき感も無く、口腔内崩壊錠として十分な結果を得ることができた。得られた錠剤の物性及び評価結果は表5に示す。
(イ)錠剤重量 :280mg
(ロ)錠剤径 :8mmφ、12R
(ハ)ローター回転数 :45rpm
(ニ)フィーダー種類 :オープンフィーダー
(ホ)打錠圧 :5kN
(ヘ)打錠時間 :10分間
(ト)臼杵本数 :12本
エリスリトール(カーギルジャパン)0.42kgと実施例1〜9で得た各々のセルロース粉末0.18kgとN−アセチルグルコサミン(焼津水産)0.60kgとSWELSTAR FD−1(商品名)(旭化成ケミカルズ)36g、アスコルビン酸(武田薬品工業)14gを加え、タンブラー混合機(TM−50S型;ダルトン)に仕込み20分間混合させた後、ステアリン酸カルシウム(太平化学工業)を12g加えて、さらに3分間混合し、取り出した。この混合粉体のセルロース粉末の重量比率は14.3%で、打錠機(リブラ2(商品名);菊水製作所)に仕込み、錠剤を作製した。打錠条件は下記の通りであった。全て打錠障害もなく打錠でき、口腔内での服用感は、ザラツキやもさつき感も無く、口腔内崩壊錠として十分な結果を得ることができた。得られた錠剤の物性及び評価結果は表6に示す。
(イ)錠剤重量 :280mg
(ロ)錠剤径 :8mmφ、12R
(ハ)ローター回転数 :45rpm
(ニ)フィーダー種類 :オープンフィーダー
(ホ)打錠圧 :5kN
(ヘ)打錠時間 :10分間
(ト)臼杵本数 :12本
エリスリトール(カーギルジャパン)1.12kgと比較例1〜69で得た各々のセルロース粉末0.48kgとN−アセチルグルコサミン(焼津水産)1.60kgをタンブラー混合機(TM−50S型;ダルトン)に仕込み、20分間混合させた後、取り出し、高速攪拌造粒機(バーチカルグラニュレーターVG−10;パウレック)に投入し、造粒した。造粒条件は下記の通りであった。
(1)ブロード回転数 :500rpm
(2)チョッパー回転数:1500rpm
(3)造粒時間 :3分間
(4)水添加量 :0.24kg
造粒顆粒を取り出し、流動層乾燥機に仕込み、顆粒を乾燥させた。乾燥条件は下記の通りであった。
(A)使用装置 :マルチプレックス(商品名)、MP−01型、(株)パウレック、
(B)風量 :7m3/min
(C)給気温度 :70〜75℃
(D)停止排気温度:45℃
乾燥した顆粒を取り出し、篩目710μmで整粒後、顆粒の粒度分布を測定し、平均粒子径を得た。顆粒の平均粒子径を表7に示す。
この顆粒1200gにSWELSTAR FD−1(商品名)(旭化成ケミカルズ)36g、アスコルビン酸(武田薬品工業)14gを加え、タンブラー混合機(TM−50S型;ダルトン)に仕込み20分間混合させた後、ステアリン酸カルシウム(太平化学工業)を12g加えて、さらに3分間混合し、取り出した。この混合粉体のセルロース粉末の重量比率は28.5%で、打錠機(リブラ2(商品名);菊水製作所)に仕込み、錠剤を作製した。打錠条件は下記の通りであった。全て打錠障害もなく打錠できたが、口腔内での服用感は、ザラツキやもさつき感を感じ、口腔内崩壊錠として十分な結果を得ることができなかった。得られた錠剤の物性及び評価結果は表8に示す。
(イ)錠剤重量 :280mg
(ロ)錠剤径 :8mmφ、12R
(ハ)ローター回転数 :45rpm
(ニ)フィーダー種類 :オープンフィーダー
(ホ)打錠圧 :5kN
(ヘ)打錠時間 :10分間
(ト)臼杵本数 :12本
エリスリトール(カーギルジャパン)0.42kgと比較例1〜9で得た各々のセルロース粉末0.18kgとN−アセチルグルコサミン(焼津水産)0.60kgとSWELSTAR FD−1(商品名)(旭化成ケミカルズ)36g、アスコルビン酸(武田薬品工業)14gを加え、タンブラー混合機(TM−50S型;ダルトン)に仕込み20分間混合させた後、ステアリン酸カルシウム(太平化学工業)を12g加えて、さらに3分間混合し、取り出した。この混合粉体のセルロース粉末の重量比率は14.3%で、打錠機(リブラ2(商品名);菊水製作所)に仕込み、錠剤を作製した。打錠条件は下記の通りであった。全て打錠障害もなく打錠でき、口腔内での服用感は、ザラツキやもさつきを感じ口腔内崩壊錠として十分な結果を得ることができなかった。得られた錠剤の物性及び評価結果は表9に示す。
(イ)錠剤重量 :280mg
(ロ)錠剤径 :8mmφ、12R
(ハ)ローター回転数 :45rpm
(ニ)フィーダー種類 :オープンフィーダー
(ホ)打錠圧 :5kN
(ヘ)打錠時間 :10分間
(ト)臼杵本数 :12本
エリスリトール(カーギルジャパン)0.62kgと実施例1〜9で得た各々のセルロース粉末0.18kgとクルクミン末0.40kgとSWELSTAR FD−1(商品名)(旭化成ケミカルズ)36g、アスコルビン酸(武田薬品工業)14gを加え、タンブラー混合機(TM−50S型;ダルトン)に仕込み20分間混合させた後、ステアリン酸カルシウム(太平化学工業)を12g加えて、さらに3分間混合し、取り出した。この混合粉体のセルロース粉末の重量比率は14.3%で、打錠機(リブラ2(商品名);菊水製作所)に仕込み、錠剤を作製した。打錠条件は下記の通りであった。全て打錠障害もなく打錠できたが、実施例8および9のセルロース粉末の口腔内での服用感は、ザラツキやもさつきを感じ口腔内崩壊錠として十分な結果を得ることができなかった。得られた錠剤の物性及び評価結果は表10に示す。
(イ)錠剤重量 :280mg
(ロ)錠剤径 :8mmφ、12R
(ハ)ローター回転数 :45rpm
(ニ)フィーダー種類 :オープンフィーダー
(ホ)打錠圧 :5kN
(ヘ)打錠時間 :10分間
(ト)臼杵本数 :12本
Claims (5)
- 平均重合度が150〜450、平均粒子径が10μm以上100μm未満、一次粒子率が50%以上であるセルロース粉末。
- セルロース粉末粒子の長径/短径(L/D)の比が1.8〜2.8である、請求項1に記載のセルロース粉末。
- 平均分子量400のポリエチレングリコール保持率が190%未満、錠剤硬度60Nの錠剤吸水能が170%以下、2.0kN打圧の錠剤硬度が130N以上である請求項1又は2に記載のセルロース粉末。
- 請求項1〜3のいずれかに記載のセルロース粉末の口腔内崩壊錠用賦形剤としての使用。
- 請求項1〜3のいずれかに記載のセルロース粉末3〜99質量%と、薬物又は有効成分、賦形剤、結合剤、崩壊剤、及び滑沢剤のうち少なくとも薬物又は有効成分を含む1種以上の成分1〜97質量%とを混合し、圧縮成形することを特徴とする口腔内崩壊錠の製造方法。
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