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1. 发明授权

US08236353B2 Self-precipitating pharmaceutical formulations for the modified release of an active principle 失效
标题翻译：用于改性释放活性成分的自沉淀药物制剂
公开(公告)号：US08236353B2
公开(公告)日：2012-08-07
申请号：US12149541
申请日：2008-05-05
申请人： Frédéric Checot , Cecile Bonnet-Gonnet , You-Ping Chan , Olivier Breyne , Remi Meyrueix
发明人： Frédéric Checot , Cecile Bonnet-Gonnet , You-Ping Chan , Olivier Breyne , Remi Meyrueix
IPC分类号： A61K9/14 , A61K9/64 , A61K9/58 , A61K38/00 , A61K9/52
CPC分类号： A61K9/0019 , A61K9/10 , A61K9/1641 , A61K38/02 , A61K47/645 , A61K48/00
摘要： The present invention relates to pharmaceutical formulations for the release of an active principle (AP) over a sustained period of time. The invention relates to a liquid formulation comprising at least one active principle (AP) and an aqueous suspension based on colloidal particles of a polymer (PO), wherein said formulation satisfies the following four conditions: (a) the PO is a polyamino acid comprising glutamic residues, wherein some glutamic residues each carry a pendant cationic group (CG), said CG being identical or different from one another, and other glutamic residues each carry a pendent hydrophobic group (GH), said GH being identical or different from one another, (b) the pHf value of the pH of said formulation is between 3.0 and 6.5; (c) at the pHf value, the PO forms a colloidal solution which associates spontaneously and noncovalently with the AP; (d) 1 ml of said formulation precipitates during mixing with a volume of 1 ml of a test buffer solution Tp.
摘要翻译：本发明涉及用于在持续时间内释放活性成分（AP）的药物制剂。本发明涉及包含至少一种活性成分（AP）和基于聚合物（PO）的胶体颗粒的水性悬浮液的液体制剂，其中所述制剂满足以下四个条件：（a）PO是聚氨基酸，其包含谷氨酸残基，其中一些谷氨酸残基各自携带阳离子基团（CG），所述CG彼此相同或不同，其他谷氨酸残基各自携带悬垂疏水基团（GH），所述GH彼此相同或不同，（b）所述制剂的pH值的pHf值为3.0至6.5; （c）在pHf值下，PO形成胶体溶液，其与AP自发地和非共价结合; （d）1ml所述制剂在与1ml测试缓冲溶液Tp的体积混合期间沉淀。

2. 发明授权

US08481019B2 Modified-release particles of polyelectrolytes and pharmaceutical formulations thereof 失效
公开(公告)号：US08481019B2
公开(公告)日：2013-07-09
申请号：US12149552
申请日：2008-05-05
申请人： Cecile Bonnet-Gonnet , Frédéric Checot , You-Ping Chan , Olivier Breyne
发明人： Cecile Bonnet-Gonnet , Frédéric Checot , You-Ping Chan , Olivier Breyne
IPC分类号： A61K31/74
CPC分类号： A61K9/5146 , A61K9/1641
摘要： The present invention relates to novel particles comprising polyelectrolyte polymers which are transporters of active principle (AP), in particular protein and peptide active principle, and to novel modified-release pharmaceutical formulations comprising said AP microparticles.These novel particles loaded with AP release the AP over a prolonged period of time of several days, or even several weeks.The invention relates, in a first aspect, to particles comprising: a) a first polyelectrolyte polymer (PE1) in a charged state, carrying side hydrophobic groups (GH), wherein said first polyelectrolyte polymer (PE1) can spontaneously form, in water, a colloidal solution of particles at least one pHm value of the pH of between 3 and 8; b) a second polyelectrolyte polymer (PE2) of opposite polarity to the first polyelectrolyte polymer (PE1), wherein said second polyelectrolyte polymer (PE2) forms, in water, a solution or a colloidal solution at said pHm value of the pH; and c) at least one active principle (AP) associated noncovalently with the particles of the colloidal solution of the first polyelectrolyte polymer (PE1); wherein said particles are obtained by mixing, at a pH equal to pHm, the first polyelectrolyte polymer (PE1), in the form of a colloidal solution of particles associated with the active principle (AP), with the second polyelectrolyte polymer (PE2), in the form of a solution or colloidal solution. The invention also relates to the process for the preparation of these particles, to a pharmaceutical formulation comprising such particles and to a process for the preparation of medicaments.

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