JP6068142B2 - 浮遊微粒剤 - Google Patents
浮遊微粒剤 Download PDFInfo
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- JP6068142B2 JP6068142B2 JP2012524262A JP2012524262A JP6068142B2 JP 6068142 B2 JP6068142 B2 JP 6068142B2 JP 2012524262 A JP2012524262 A JP 2012524262A JP 2012524262 A JP2012524262 A JP 2012524262A JP 6068142 B2 JP6068142 B2 JP 6068142B2
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Classifications
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- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
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Landscapes
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Glanulating (AREA)
- Manufacture Of Metal Powder And Suspensions Thereof (AREA)
Description
Claims (12)
- 胃液中で浮遊させるための浮遊顆粒剤であって、該浮遊顆粒剤は、コア/シェル型の構造及び3mm未満の直径を有し、かつ
(i)コアである不溶性支持体、並びに(ii)活性成分及び気体の放出を生じることが可能なアルカリ性剤を含む層
を含み
気体の放出を生じることが可能な酸性剤を含まず、
該活性成分が、チアプリド、アルフゾシン、カプトプリル、GHB、メトホルミン、ニフェジピン、ブプレノルフィン、モダフィニル、メタドン、ナルブフィン及びテトラヒドロカンナビノールからなる群から選択される、該浮遊顆粒剤。 - 前記アルカリ性剤が、炭酸塩及び重炭酸塩からなる群から選択されることを特徴とする、請求項1に記載の浮遊顆粒剤。
- 前記アルカリ性剤が、重炭酸ナトリウム、炭酸ナトリウム、グリシン炭酸ナトリウム、重炭酸カリウム、炭酸マグネシウム及び炭酸カルシウムからなる群から選択されることを特徴とする、請求項2に記載の浮遊顆粒剤。
- 前記不溶性支持体が、ポリオール、ガム、アルカリシリケート、タルク、ベントナイト、カオリン、リン酸二カルシウム、リン酸三カルシウム、サッカロース、単結晶セルロース、エチルセルロース、ヒドロキシプロピルメチルセルロース、デンプン、グルコネート、シリケート、糖結晶並びにそれらの混合物からなる群から選択されることを特徴とする、請求項1に記載の浮遊顆粒剤。
- 結合剤を含むことを特徴とする、請求項1〜4のいずれか一項に記載の浮遊顆粒剤。
- 前記結合剤が、マルトデキストリン、デンプン、サッカロース、アラビアゴム、ポリビニルピロリドン、ヒドロキシプロピルメチルセルロース、シェラック、ヒドロキシプロピルセルロース、セルロース、ポリオール又はそれらの混合物からなる群から選択される、請求項5に記載の浮遊顆粒剤。
- コーティングされることを特徴とする、請求項1〜6のいずれか一項に記載の浮遊顆粒剤。
- シェラック、ポリビニルピロリドン、ポリエチレングリコール、HPMC、HPC、サッカロース、脂肪酸グリセリド及びそれらの混合物からなる群から選択されるコーティング剤によってコーティングされる、請求項7に記載の浮遊顆粒剤。
- 前記顆粒剤の全重量に対して0.5重量%〜60重量%の活性成分を含む、請求項1〜8のいずれか一項に記載の浮遊顆粒剤。
- 前記顆粒剤の全重量に対して15重量%〜70重量%のアルカリ性剤を含む、請求項1〜9のいずれか一項に記載の浮遊顆粒剤。
- 前記不溶性支持体が前記顆粒剤の全重量に対して20重量%〜80重量%を占める、請求項1〜10のいずれか一項に記載の浮遊顆粒剤。
- 前記活性成分を前記不溶性支持体に粉末塗布することによって塗布する工程と、前記アルカリ性剤を添加する工程とを含むことを特徴とする、請求項1〜11のいずれか一項に記載の浮遊顆粒剤を調製する方法。
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