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公开(公告)号：EP2906205A1
公开(公告)日：2015-08-19
申请号：EP13780276.5
申请日：2013-10-09
发明人： DAVE, Rajesh, N. , TO, Daniel , CAPECE, Maxx
CPC分类号： A61K9/5042 , A61K9/5063 , A61K9/5073 , A61K9/5089 , A61K35/00
摘要： The present invention is a solventless method of producing polymer coated active pharmaceutical ingredient that is taste-masked and may be released in relatively short time. It employs high energy vibrations or acoustic mixing of API particles, water soluble coating material particles and hydrophobic polymer particles, with or without use of other pharmaceutically relevant powders as media. Additionally the method is capable of producing individually coated drug particles without agglomeration or the long drying times associated with solvent based coating methods.
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2.发明公开PHARMACEUTICAL CORE-SHELL COMPOSITE POWDER AND PROCESSES FOR MAKING THE SAME 审中-公开药物的皮芯型复合粉体的方法及其制造
公开(公告)号：EP2916824A1
公开(公告)日：2015-09-16
申请号：EP13852722.1
申请日：2013-11-08
CPC分类号： A61K9/1676 , A61K9/14 , A61K9/141 , A61K9/145 , A61K9/1611 , A61K9/1623 , A61K9/1652 , A61K9/1682 , A61K9/1694 , A61K9/20 , A61K9/2077 , A61K9/501 , A61K9/5078 , A61K9/5089 , A61K31/216 , B05D1/22
摘要： A composite particle including a core with at least one carrier material; a fluidizing material layer on the surface of the core; and an outer layer comprising nanoparticles of an ingestible material distributed in at least one matrix-forming material. A process of making the composite particles includes the steps of dry coating carrier particles with a fluidizing material; preparing a suspension of nanoparticles of an ingestible material distributed in a matrix-forming material; and fluid bed coating the carrier particles with the suspension. The process and products provide quick dissolving composite particles which can be used for delivery of poorly water soluble ingestible materials in suitable dosage forms. The process of the invention reduces or prevents particle agglomeration during fabrication of the composite particles to enable delivery and quick redispersion of nanoparticles of the ingestible material from a dosage form.
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3.发明公开TASTE MASKED ACTIVE PHARMACEUTICAL POWDER COMPOSITIONS AND PROCESSES FOR MAKING THEM 审中-公开品味的活性粉末组合物和方法及其制造
公开(公告)号：EP2906204A1
公开(公告)日：2015-08-19
申请号：EP13779706.4
申请日：2013-10-09
发明人： TO, Daniel , DAVE, Rajesh, N.
IPC分类号： A61K9/50
CPC分类号： A61K9/501 , A61K9/5026 , A61K9/5042 , A61K9/5089
摘要： A taste masked particulate pharmaceutical formulation include a core that comprises an active pharmaceutical ingredient; at least a partial nanoparticle material layer on the core that comprises a nanoparticle material with a median particle size not greater than 100 nm; a first polymer layer that is at least partially water soluble and a second polymer layer that is water insoluble. The active pharmaceutical ingredient is completely released in 30 minutes in the USP Dissolution Test. A process of making the particulate pharmaceutical formulation using sequential fluidized bed coating steps under controlled conditions is also described.
摘要翻译： 掩味的药物微粒制剂包括核心确实包括向活性药物成分; 至少在铁心的局部纳米粒子材料层做包括具有的平均粒度不大于100纳米的纳米颗粒材料; 的第一聚合物层是至少做部分水溶性和第二聚合物层所做的是水不溶性的。 活性药物成分释放完全调用在USP溶出试验30分钟。 由此描述了使用在受控条件下连续流化床包衣步骤使微粒药物制剂的方法。
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公开(公告)号：EP2916824B1
公开(公告)日：2019-06-19
申请号：EP13852722.1
申请日：2013-11-08
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公开(公告)号：EP2906205B1
公开(公告)日：2018-06-13
申请号：EP13780276.5
申请日：2013-10-09
发明人： DAVE, Rajesh, N. , TO, Daniel , CAPECE, Maxx
CPC分类号： A61K9/5042 , A61K9/5063 , A61K9/5073 , A61K9/5089 , A61K35/00
摘要： The present invention is a solventless method of producing polymer coated active pharmaceutical ingredient that is taste-masked and may be released in relatively short time. It employs high energy vibrations or acoustic mixing of API particles, water soluble coating material particles and hydrophobic polymer particles, with or without use of other pharmaceutically relevant powders as media. Additionally the method is capable of producing individually coated drug particles without agglomeration or the long drying times associated with solvent based coating methods.
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