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公开(公告)号：EP3256106A1
公开(公告)日：2017-12-20
申请号：EP16709489.5
申请日：2016-02-09
发明人： DOUROUMIS, Dennis , MANIRUZZAMAN, Mohammed , BHATT, Saumil Kiritkumar , ALI, Anwar , JANGRA, Arun
CPC分类号： A61K9/2095 , A61J3/10 , A61K9/143 , A61K9/20 , A61K31/00 , A61K31/192 , A61K33/12 , A61K47/32 , B29B9/00 , B29B9/06 , B29C47/0014 , B29C47/004
摘要： The present invention relates to a method of producing a direct compression tablet composition comprising the step of processing ibuprofen, a hydrophilic polymer, and an inorganic excipient by an extrusion process to produce an extruded composition in which the ibuprofen forms a solid dispersion/solution within the hydrophilic polymer. The invention is particularly useful in preparing oral dissolvable tablets. Also provided are composition comprising an inorganic excipient and ibuprofen within a hydrophilic polymer.
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公开(公告)号：EP3256105A1
公开(公告)日：2017-12-20
申请号：EP16709488.7
申请日：2016-02-09
发明人： DOUROUMIS, Dennis , MANIRUZZAMAN, Mohammed , BHATT, Saumil Kiritkumar , ALI, Anwar , JANGRA, Arun
CPC分类号： A61K9/143 , A61K9/145 , A61K9/2009 , A61K9/2013 , A61K9/2018 , A61K9/2027 , A61K9/2054 , A61K9/2095 , A61K31/00 , A61K31/192 , B29B9/00 , B29B9/06
摘要： A method of producing an extruded, powdered/granulated composition comprising an active pharmaceutical ingredient (API), by the steps of providing an API and a porous inorganic excipient, and processing them by an extrusion process to directly produce an extruded, powdered/granulated composition wherein the API is at least partially absorbed within the pores of the inorganic excipient. In preferred embodiments, the API is melted, or solubilised in a solubilizer.
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公开(公告)号：EP3405176A1
公开(公告)日：2018-11-28
申请号：EP17700744.0
申请日：2017-01-16
IPC分类号： A61K9/16
CPC分类号： A61K9/1688 , A61K9/1694
摘要： The invention relates to a process of preparing a salt of an active pharmaceutical ingredient, the process comprising providing a blend of an active pharmaceutical ingredient (e.g. ibuprofen, phenytoin diclofenac) and a salt forming substance (i.e. a base, e.g. sodium/potassium hydroxide, sodium/potassium carbonate) mixing the blend, optionally in the presence of added water, to react the active pharmaceutical ingredient with the salt forming substance to provide the salt of the active pharmaceutical ingredient; wherein when the active pharmaceutical ingredient is acidic, the salt forming substance is a base and the pKa difference between the acidic active pharmaceutical ingredient and the base is greater than 3; or when the active pharmaceutical ingredient is basic, the salt forming substance is an acid and the pKa difference between the basic active pharmaceutical ingredient and the acid is greater than 3. Also the invention relates to the salts of active pharmaceutical ingredients obtainable from said process which may be directly compressed to form a tablet/capsule or further blended with a lubricant to form same.
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