JP2017510654A - 一部がコーティングされた放出制御固形製剤 - Google Patents
一部がコーティングされた放出制御固形製剤 Download PDFInfo
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Abstract
Description
出願番号:201410139563.9
出願日:2014−04−08
発明の名称:新型放出制御錠
1)錠芯を調製するための各組成成分を混合し、I番パンチで一回目のプレスを行って、錠芯を得る工程と、
2)II番パンチに交換し、コーティング層を調製するための各組成成分を混合した後、中金型に充填する工程と、
3)工程1)でプレスした錠芯を中金型の中央に充填し、二回目のプレスを行って、固形製剤を得る工程と
を含み、
前記I番パンチの直径がII番パンチの直径より小さい。
製剤は、1層の徐放層のみを有する単層錠である錠芯と、錠芯外に被覆されたコーティングとを含む。図1に示すように、コアの頂面の一部が、コーティングで被覆されずに固形製剤の表面に露出している。
1、錠芯の原料と添加剤を処方に準じて秤量して、十分に混合した後使用に備え、そして、I番パンチの直径がII番より小さい二種類の規格のパンチを選択する;
製剤は、2層の錠である錠芯と、錠芯外に被覆されたコーティングを含む。図2に示すように、コアの頂面の一部がコーティングで被覆されずに固形製剤の表面に露出している。
1、錠芯の徐放層、錠芯の速放層の原料と添加剤を処方に準じて秤量し、それぞれ十分に混合した後使用に備え、そして、I番パンチの直径がII番より小さい二種類の規格のパンチを選択する;
製剤は、1層の徐放層のみを有する単層錠である錠芯と、錠芯外に被覆されたコーティングとを含む。図1に示すように、コアの頂面の一部がコーティングで被覆されずに固形製剤の表面に露出している。
1、錠芯の原料と添加剤を処方に準じて秤量し、十分に混合した後使用に備え、そして、I番パンチの直径がII番より小さい二種類の規格のパンチを選択する;
製剤は、第1徐放層と第2徐放層からなる2層の錠である錠芯と、錠芯外に被覆されたコーティングとを含む。図3に示すように、コアの頂面の一部がコーティングで被覆されずに固形製剤の表面に露出している。
1、錠芯の第1徐放層、錠芯の第2徐放層の原料と添加剤を処方に準じて秤量して、それぞれ十分に混合した後使用に備え、そして、I番パンチの直径がII番より小さい二種類の規格のパンチを選択する;
実施例5〜10の製剤は、実施例1と同様に、コアが単層である(1層の徐放層のみを有する)放出制御製剤である。
本実施例における放出制御製剤のコアが3層(いずれの層も活性成分を含む)であり、不完全なコーティング層にも活性物質が含まれ、最外層のフィルムコーティングにも活性物質が含まれる。図10に示すように、コアの上層薬物含有層の一部がコーティングで被覆されずに固形製剤の表面に露出している。
1、錠芯の上層、中間層、下層の原料と添加剤を処方に準じて秤量し、それぞれ十分に混合した後使用に備え、そして、I番パンチの直径がII番より小さい二種類の規格のパンチを選択する;
Claims (10)
- 活性薬物と添加剤を含むコアと、徐放・放出制御素材を含み、活性成分を含むか、または含まないコーティング層とからなる放出制御固形製剤において、前記コアの表面がコーティング層で完全に被覆されず、一部が固形製剤の表面に露出していることを特徴とする、放出制御固形製剤。
- 前記コアが1層または複数層であり、前記層が徐放層であり、あるいは速放層と徐放層を共に含み、コアが2層以上である場合、最外層の成分が最初に放出され、第二外層の成分が次に放出され、コアの最内層の成分が最後に放出されるようにそれぞれの層の成分が順次放出される、請求項1に記載の固形製剤。
- 前記コーティング層が圧縮コーティング法で調製されてなる、請求項1に記載の固形製剤。
- 前記コーティング層の素材が水可溶性または水不溶性であり、前記水可溶性のコーティング素材が、ヒドロキシプロピルメチルセルロース、ヒドロキシプロピルセルロースから選ばれる1種または2種であり、前記水不溶性のコーティング素材が、エチルセルロース、セルロースアセテートポリマー、アクリル樹脂から選ばれる1種または複数種であることを特徴とする、請求項4に記載の固形製剤。
- 前記コーティング層の素材が、ポリビニルピロリドン、ラクトース、塩化ナトリウムから選ばれる1種または複数種である水溶性ポロゲンをさらに含むことを特徴とする、請求項1に記載の固形製剤。
- 前記コーティング層の外面に、活性成分を含むか、または含まない、もう1層のコーティングを有する、請求項1〜5のいずれか一項に記載の固形製剤。
- 錠剤である請求項1に記載の固形製剤。
- コアは、1層以上の錠状物からなる錠芯である、請求項7に記載の固形製剤。
- 請求項7または請求項8に記載の固形製剤の調製方法であって、
打錠機でタブレットのプレスを行い、
1)錠芯を調製するための各組成成分を混合し、I番パンチで一回目のプレスを行って、錠芯を得る工程と、
2)II番パンチに交換し、コーティング層を調製するための各組成成分を混合した後、中金型に充填する工程と、
3)工程1)でプレスした錠芯を中金型の中央に充填し、二回目のプレスを行って、固形製剤を得る工程と
を含み、
前記I番パンチの直径がII番パンチの直径より小さい、固形製剤の調製方法。 - 前記工程2)と3)を、
II番パンチに交換した後、工程1)でプレスした錠芯を中金型の中央に充填し、その後、中金型の中で錠芯の周囲に、均一に混合されたコーティング層の組成成分を充填して、二回目のプレスを行うことへ変更する、請求項9に記載の調製方法。
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