JP5733930B2 - 固形製剤 - Google Patents
固形製剤 Download PDFInfo
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- JP5733930B2 JP5733930B2 JP2010201199A JP2010201199A JP5733930B2 JP 5733930 B2 JP5733930 B2 JP 5733930B2 JP 2010201199 A JP2010201199 A JP 2010201199A JP 2010201199 A JP2010201199 A JP 2010201199A JP 5733930 B2 JP5733930 B2 JP 5733930B2
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Description
本発明の固形製剤は、(A)成形性の劣る活性成分(以下、単に第1の活性成分という場合がある)と(B)アルファー化デンプンとを含む。
本発明は、圧縮成形による結合力(自己結合能)が小さな第1の活性成分に適用され、この第1の活性成分は、単独で(又はこの第1の活性成分だけを)圧縮成形(又は打錠)したとき、低い硬度を示す。例えば、第1の活性成分を10kNの圧力(又は打錠圧)で圧縮成形し、質量330mg、9mmφの錠剤としたとき、錠剤の硬度は、25N以下(例えば、2〜25N程度)、好ましくは20N以下(例えば、3〜20N程度)、さらに好ましくは18N以下(例えば、5〜18N程度)であってもよい。例えば、第1の活性成分がL−カルボシステインであるとき、錠剤の硬度は10〜18N程度である。
アルファー化デンプンは、固形製剤の膨張(又は膨潤)を抑制する機能と、固形製剤を崩壊させる機能とを兼ね備えている。アルファー化デンプンは変性デンプン(又は加工デンプン)であってもよく、例えば、化学的及び/又は物理的に改質されたデンプンであってもよい。化学的改質方法は、例えば、反応成分との反応による化学的修飾方法であってもよい。一方、物理的改質方法は、例えば、デンプンを加熱(例えば、水の存在下での加熱)して乾燥させる方法であってもよい。好適なアルファー化デンプンは物理的改質方法で改質されている。
本発明の固形製剤は慣用の方法で製造できる。すなわち、第1の活性成分とアルファー化デンプンと担体成分とを混合し、必要により造粒、整粒、圧縮成形(打錠)又はカプセルに充填することにより製造できる。特に、本発明では、固形製剤の形態保持性及び崩壊性を両立できる点から、(a)第1の活性成分と担体成分と必要により第2の活性成分とを混合して粉体混合物を調製し、(b)前記粉体混合物を造粒して造粒物を調製し、必要により造粒物を整粒して粒剤(細粒剤又は顆粒剤)を調製し、(c)前記造粒物又は粒剤とアルファー化デンプンと必要により担体成分(賦形剤など)との混合物を打錠することにより裸錠(素錠)を調製してもよい。
表1に示す処方により、流動層造粒機(パウレック(株)、FD−3SN)を用いて結合剤としてのヒドロキシプロピルセルロース(HPC−L)水溶液を噴霧し、常法により造粒、整粒し、整粒末Aを得た。整粒末A16.3gにアルファー化デンプン(旭化成ケミカルズ(株)、swelstarPD−1)を0.36g、賦形剤としての結晶セルロース(旭化成ケミカルズ(株)、セオラスKG802)を1.232g、滑沢剤としてのステアリン酸マグネシウムを0.108g添加し、混合し、オートグラフにて打錠圧10kNで200mg/錠、9mmφの素錠を製造した。
実施例1の整粒末A16.3gにアルファー化デンプン(swelstarPD−1)の代わりに一般的な崩壊剤であるクロスカルメロースナトリウム(明台化工(株)製)を0.36g、賦形剤としての結晶セルロース(旭化成ケミカルズ(株)、セオラスKG802)を1.232g、滑沢剤としてのステアリン酸マグネシウムを0.108g添加し、混合し、オートグラフにて打錠圧10kNで200mg/錠、9mmφの素錠を製造した。
表2に示す処方により、流動層造粒機(パウレック(株)、FD−3SN)を用いて結合剤としてのヒドロキシプロピルセルロース(HPC−L)水溶液を噴霧し、常法により造粒、整粒し、整粒末Bを得た。整粒末B15.76gにアルファー化デンプン(旭化成ケミカルズ(株)、swelstarPD−1)を0.9g、賦形剤としての結晶セルロース(旭化成ケミカルズ(株)、セオラスKG802)を1.232g、滑沢剤としてのステアリン酸マグネシウムを0.108g添加し、混合し、オートグラフにて打錠圧10kNで200mg/錠、9mmφの素錠を製造した。
実施例2と同様にして整粒末Bを得た。この整粒末B1576mgにアルファー化デンプン(旭化成ケミカルズ(株)、swelstarPD−1)を90mg、賦形剤としての結晶セルロース(旭化成ケミカルズ(株)、セオラスKG802)を123.2mg、滑沢剤としてのステアリン酸マグネシウムを10.8mg添加し、混合し、混合末Bを得た。
(膨張率)
実施例1および比較例1の素錠を秤量瓶に入れ、25℃、75%又は83%RHの条件下、3日又は10日間保存した。保存前後の錠剤の厚みを測定し、膨潤の程度を比較した。結果を表5に示す。
(崩壊時間)
崩壊時間は、日本薬局方第14改正に記載されている崩壊試験法により測定した。クロスカルメロースナトリウムを配合した比較例1の素錠の崩壊時間は7.5〜9.9分であったのに対し、アルファー化デンプンを配合した実施例1の素錠の崩壊時間は、10.2〜11.4分であった。すなわち、実施例及び比較例の素錠における崩壊性に大きな差は見られなかった。なお、崩壊剤を配合していない素錠の崩壊時間は13.0〜15.2分であった。
(外観)
アルファー化デンプンを配合した実施例1の素錠は、高水分下に保存しても膨張(膨潤)の程度が低く、素錠の表面や形状にも目立った変化は無かった。しかし、クロスカルメロースナトリウムを用いた比較例1の素錠は、大きく膨張しており、素錠自体も脆くなっていた。
Claims (11)
- (A)成形性の劣る活性成分と(B)アルファー化デンプンとを含む錠剤であって、固形製剤100重量部に対して、(A)成形性の劣る活性成分としてのL−カルボシステインを20〜60重量部の割合で含む、錠剤。
- (B)アルファー化デンプンが、バレイショ、コムギ、トウモロコシ、コメ、タピオカ、及びカンショから選択された少なくとも一種のデンプンのアルファー化物である請求項1記載の錠剤。
- (B)アルファー化デンプンの平均アルファー化度が55〜95%である請求項1又は2記載の錠剤。
- (B)アルファー化デンプンが、(a)膨潤体積8〜20mL/g及び(b)水溶性成分の含有量2〜10%のうち少なくとも1つの特性を有する請求項1〜3のいずれかに記載の錠剤。
- (A)成形性の劣る活性成分が、10kNの打錠圧で、質量330mg及び直径9mmの錠剤としたとき、硬度が25N以下となる成分である請求項1〜4のいずれかに記載の錠剤。
- (B)アルファー化デンプンがアルファー化されたバレイショデンプンである請求項1〜5のいずれかに記載の錠剤。
- 錠剤100重量部に対して、(A)成形性の劣る活性成分を25〜60重量部、(B)アルファー化デンプンを1〜20重量部の割合で含む請求項1〜6のいずれかに記載の錠剤。
- (A)成形性の劣る活性成分100重量部に対して、(B)アルファー化デンプンを0.5〜20重量部の割合で含む請求項1〜7のいずれかに記載の錠剤。
- 錠剤100重量部に対して、(A)成形性の劣る活性成分を35〜55重量部、(B)アルファー化デンプンを0.5〜10重量部の割合で含み、(A)成形性の劣る活性成分100重量部に対して、(B)アルファー化デンプンの割合が2〜16重量部である請求項1〜8のいずれかに記載の錠剤。
- (A)成形性の劣る活性成分と、(B)アルファー化デンプンとを含む混合物を打錠して、錠剤を製造する方法であって、錠剤100重量部に対して、(A)成形性の劣る活性成分としてのL−カルボシステインを20〜60重量部の割合で含む混合物を打錠して、錠剤を製造する方法。
- (A)成形性の劣る活性成分を含む錠剤に(B)アルファー化デンプンを配合することにより、錠剤の膨潤を抑制する方法であって、錠剤100重量部に対して、(A)成形性の劣る活性成分としてのL−カルボシステインを20〜60重量部の割合で配合し、錠剤の膨潤を抑制する方法。
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