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1. 发明申请

US20070196497A1 Pharmaceutical formulations for the prolonged release of active principle(s) and their applications 有权
标题翻译：用于延长释放活性成分及其应用的药物制剂
公开(公告)号：US20070196497A1
公开(公告)日：2007-08-23
申请号：US10580023
申请日：2004-11-19
申请人： Gauthier Pouliquen , Olivier Soula , Remi Meyrueix , Florence Nicolas
发明人： Gauthier Pouliquen , Olivier Soula , Remi Meyrueix , Florence Nicolas
IPC分类号： A61K9/14
CPC分类号： A61K9/0024 , A61K38/2013 , A61K38/212 , A61K47/42 , A61K47/645 , A61K51/1217
摘要： The present invention relates to novel pharmaceutical formulations based on stable, fluid aqueous colloidal suspensions for the prolonged release of active principle(s), particularly protein active principle(s), and to the applications, especially therapeutic applications, of these formulations. The object of the invention is to propose a fluid pharmaceutical formulation for the prolonged release of active principle(s) that makes it possible, after parenteral injection, to increase significantly the in vivo release time of a therapeutic protein while at the same time reducing the plasma concentration peak of the active protein, said formulation furthermore being stable on storage and also being biocompatible, biodegradable, non-toxic and non-immunogenic and having a good local tolerance. The formulation according to the invention is an aqueous colloidal suspension of low viscosity based on submicronic particles of water-soluble biodegradable polymer PO carrying hydrophobic groups (HG), said particles being non-covalently associated with at least one active principle (AP) and forming a gelled deposit at the injection site, this gelling being caused by a protein present in the physiological medium.
摘要翻译：本发明涉及基于用于延长释放活性成分（特别是蛋白质活性成分）的稳定的流体水性胶体悬浮液以及这些制剂的应用，特别是治疗应用的新型药物制剂。本发明的目的是提出用于延长释放活性成分的流体药物制剂，其使得在胃肠外注射后可以显着增加治疗性蛋白质的体内释放时间，同时减少活性蛋白质的血浆浓度峰值，所述制剂还在储存时稳定，并且还具有生物相容性，可生物降解，无毒和非免疫原性并且具有良好的局部耐受性。根据本发明的制剂是基于具有疏水基团（HG）的水溶性生物可降解聚合物PO的亚微米颗粒的低粘度水性胶体悬浮液，所述颗粒与至少一种活性成分（AP）非共价缔合并形成在注射部位的凝胶沉积物，这种胶凝是由存在于生理介质中的蛋白质引起的。

2. 发明授权

US08084045B2 Pharmaceutical formulations for the prolonged release of active principle(s) and their applications 有权
标题翻译：用于延长释放活性成分及其应用的药物制剂
公开(公告)号：US08084045B2
公开(公告)日：2011-12-27
申请号：US10580023
申请日：2004-11-19
申请人： Gauthier Pouliquen , Olivier Soula , Rémi Meyrueix , Florence Nicolas
发明人： Gauthier Pouliquen , Olivier Soula , Rémi Meyrueix , Florence Nicolas
IPC分类号： A61K9/32 , A61K9/52 , A61K9/54 , A61K9/64 , A61K38/00
CPC分类号： A61K9/0024 , A61K38/2013 , A61K38/212 , A61K47/42 , A61K47/645 , A61K51/1217
摘要： The present invention relates to novel pharmaceutical formulations based on stable, fluid aqueous colloidal suspensions for the prolonged release of active principle(s), particularly protein active principle(s), and to the applications, especially therapeutic applications, of these formulations.The object of the invention is to propose a fluid pharmaceutical formulation for the prolonged release of active principle(s) that makes it possible, after parenteral injection, to increase significantly the in vivo release time of a therapeutic protein while at the same time reducing the plasma concentration peak of the active protein, said formulation furthermore being stable on storage and also being biocompatible, biodegradable, non-toxic and non-immunogenic and having a good local tolerance.The formulation according to the invention is an aqueous colloidal suspension of low viscosity based on submicronic particles of water-soluble biodegradable polymer PO carrying hydrophobic groups (HG), said particles being non-covalently associated with at least one active principle (AP) and forming a gelled deposit at the injection site, this gelling being caused by a protein present in the physiological medium.
摘要翻译：本发明涉及基于用于延长释放活性成分（特别是蛋白质活性成分）的稳定的流体水性胶体悬浮液以及这些制剂的应用，特别是治疗应用的新型药物制剂。本发明的目的是提出用于延长释放活性成分的流体药物制剂，其使得在胃肠外注射后可以显着增加治疗性蛋白质的体内释放时间，同时减少活性蛋白质的血浆浓度峰值，所述制剂还在储存时稳定，并且还具有生物相容性，可生物降解，无毒和非免疫原性并且具有良好的局部耐受性。根据本发明的制剂是基于具有疏水基团（HG）的水溶性生物可降解聚合物PO的亚微米颗粒的低粘度水性胶体悬浮液，所述颗粒与至少一种活性成分（AP）非共价缔合并形成在注射部位的凝胶沉积物，这种胶凝是由存在于生理介质中的蛋白质引起的。

3. 发明申请

US20090110742A1 Long-acting colloidal insulin formulation and its preparation 失效
标题翻译：长效胶体胰岛素制剂及其制备
公开(公告)号：US20090110742A1
公开(公告)日：2009-04-30
申请号：US11632992
申请日：2005-06-09
申请人： Alain Constancis , Florence Nicolas , Remi Meyrueix , Olivier Soula
发明人： Alain Constancis , Florence Nicolas , Remi Meyrueix , Olivier Soula
IPC分类号： A61K9/14 , A61K38/28 , A61P3/10
CPC分类号： A61K38/28 , A61K9/1075 , A61K9/5138 , A61K9/5146 , A61K9/5192 , Y10S977/773 , Y10S977/906
摘要： The invention relates to injectable long-acting insulin formulations for the treatment of types I and II diabetes in humans and animals.The essential object of the invention is to provide an injectable long-acting insulin formulation in the form of a colloidal suspension which is stable, which has a good local tolerance and toxicity compatible with the chronic treatment of diabetics, and which maintains a substantial hypoglycemic effect extending over at least 24 hours after a single administration, e.g. by the subcutaneous route.To achieve this object, the invention relates to a stable aqueous colloidal formulation of insulin-laden nanoparticles of at least one poly(Leu-block-Glu) in which the pH is between 5.8 and 7.0, the osmolarity O (in mOsmol) . . . : 270≦O≦800, and the viscosity v (in mPa.s) is low, namely v≦40. The nanoparticles of poly(Leu-block-Glu) have a mean hydrodynamic diameter Dh such that: 15≦Dh≦40.The invention relates to an antidiabetic drug based on this long-acting insulin formulation and injectable using needles of gauge 29G, 30G or 31G.
摘要翻译：本发明涉及用于治疗人和动物中I型和II型糖尿病的可注射长效胰岛素制剂。本发明的基本目的是提供一种稳定的胶体悬浮液形式的可注射的长效胰岛素制剂，其具有与糖尿病患者的慢性治疗相适应的良好的局部耐受性和毒性，并且其保持显着的降血糖效应在单次给药后延长至少24小时，例如通过皮下途径。为了实现这个目的，本发明涉及至少一种pH（在5.8至7.0之间），渗透压浓度O（以mOsmol计）的至少一种聚（Leu-block-Glu）的含胰岛素的纳米颗粒的稳定水性胶体制剂。。。：270 <= 0 <= 800，粘度v（mPa.s）低，即v <= 40。聚（Leu-block-Glu）的纳米颗粒具有平均流体动力学直径Dh，使得：15 <= Dh <= 40。本发明涉及基于该长效胰岛素制剂的抗糖尿病药物，并使用量规29G，30G或31G的针头进行注射。

4. 发明授权

US08017156B2 Long-acting colloidal insulin formulation and its preparation 失效
标题翻译：长效胶体胰岛素制剂及其制备
公开(公告)号：US08017156B2
公开(公告)日：2011-09-13
申请号：US11632992
申请日：2005-06-09
申请人： Alain Constancis , Florence Nicolas , Rémi Meyrueix , Olivier Soula
发明人： Alain Constancis , Florence Nicolas , Rémi Meyrueix , Olivier Soula
IPC分类号： A61K9/14 , A61K38/28
CPC分类号： A61K38/28 , A61K9/1075 , A61K9/5138 , A61K9/5146 , A61K9/5192 , Y10S977/773 , Y10S977/906
摘要： The invention relates to injectable long-acting insulin formulations for the treatment of types I and II diabetes in humans and animals.The essential object of the invention is to provide an injectable long-acting insulin formulation in the form of a colloidal suspension which is stable, which has a good local tolerance and toxicity compatible with the chronic treatment of diabetics, and which maintains a substantial hypoglycemic effect extending over at least 24 hours after a single administration, e.g. by the subcutaneous route.To achieve this object, the invention relates to a stable aqueous colloidal formulation of insulin-laden nanoparticles of at least one poly(Leu-block-Glu) in which the pH is between 5.8 and 7.0, the osmolarity O (in mOsmol) . . . : 270≦O≦800, and the viscosity v (in mPa·s) is low, namely v≦40. The nanoparticles of poly(Leu-block-Glu) have a mean hydrodynamic diameter Dh such that: 15≦Dh≦40.The invention relates to an antidiabetic drug based on this long-acting insulin formulation and injectable using needles of gauge 29 G, 30 G or 31 G.
摘要翻译：本发明涉及用于治疗人和动物中I型和II型糖尿病的可注射长效胰岛素制剂。本发明的基本目的是提供一种稳定的胶体悬浮液形式的可注射的长效胰岛素制剂，其具有与糖尿病患者的慢性治疗相适应的良好的局部耐受性和毒性，并且其保持显着的降血糖效应在单次给药后延长至少24小时，例如通过皮下途径。为了实现这个目的，本发明涉及至少一种pH（在5.8至7.0之间），渗透压浓度O（以mOsmol计）的至少一种聚（Leu-block-Glu）的含胰岛素的纳米颗粒的稳定水性胶体制剂。。。：270＆nlE; O＆nlE; 800，粘度v（mPa·s）低，即v＆nlE; 40。聚（Leu-block-Glu）的纳米颗粒具有平均流体动力学直径Dh，使得：15＆nlE; Dh＆nlE; 40。本发明涉及一种基于该长效胰岛素制剂的抗糖尿病药物，并使用量规29 G，30 G或31 G的针头进行注射。

5. 发明授权

US06916909B1 Collagen peptides modified by grafting mercapto functions, method for the production thereof and uses thereof as biomaterials 失效
标题翻译：通过接枝巯基功能修饰的胶原肽，其制备方法及其用途作为生物材料
公开(公告)号：US06916909B1
公开(公告)日：2005-07-12
申请号：US09914426
申请日：2000-03-01
申请人： Florence Nicolas , Nathan Bryson
发明人： Florence Nicolas , Nathan Bryson
IPC分类号： A61L15/00 , A61L15/32 , A61L17/00 , A61L17/08 , A61L24/00 , A61L27/00 , A61L27/24 , A61L31/00 , A61L33/00 , C07K1/08 , C07K14/78 , C08H1/06 , C08L89/00 , A61K38/17 , A61F13/00 , C07K1/00
CPC分类号： A61L27/24 , A61L15/325 , A61L17/08 , C07K14/78
摘要： The invention relates to novel collagen peptides that are modified by grafting free or substitued thiol functions carried by mercaptoamine radicals. The aim of the invention is to provide thiol collagens that can be cross-linked in a sufficient and controlled manner by forming S—S bridges and which are biocompatible. This is achieved by means of the inventive thiol collagens which are characterized in that the mercaptoamine radicals are identical to or different from each other and are exclusively grafted on the aspartic and glutamic acids of the collagen chain by amide bonds. The invention also relates to a method for the production of said thiol and cross-linkable collagens. The novel modified cross-linkable and/or cross-linked collagens can be used as biomaterials.
摘要翻译：本发明涉及通过接枝由巯基胺自由基携带的游离或取代的硫醇官能团来修饰的新型胶原肽。本发明的目的是提供可以通过形成S-S桥并以生物相容性的方式以充分和受控的方式交联的硫醇胶原蛋白。这通过本发明的硫醇胶原实现，其特征在于巯基胺基彼此相同或不同，并且通过酰胺键独特地接枝在胶原链的天冬氨酸和谷氨酸上。本发明还涉及生产所述硫醇和可交联胶原蛋白的方法。可改性的可交联和/或交联的胶原蛋白可用作生物材料。

6. 发明授权

US5763579A Collagen derivatives, process for producing them and their application to the preparation of biomaterials 失效
标题翻译：胶原衍生物，其制备方法及其在制备生物材料中的应用
公开(公告)号：US5763579A
公开(公告)日：1998-06-09
申请号：US454189
申请日：1995-06-16
申请人： Christian Gagnieu , Florence Nicolas , Gerard Soula
发明人： Christian Gagnieu , Florence Nicolas , Gerard Soula
IPC分类号： A61L15/00 , A61F2/00 , A61L15/32 , A61L27/00 , A61L27/24 , C08H1/00 , C08H1/06 , A61K38/17 , A61K9/70 , C07K13/00
CPC分类号： A61L15/325 , A61L27/24 , C08H1/06 , A61F2310/00365
摘要： The present invention relates to a modified collagen which is soluble in water and/or in aprotic polar organic solvents and which comprises free or substituted thiol functional groups carried by residues of cysteine or its derivatives, the residues being, at least partially, residues which are directly grafted onto the collagen chain, characterized in that it possesses a level of free or substituted thiol functional groups greater than 0.3, preferably 0.5 mM/g of collagen. The invention also relates to the production of these new collagen derivatives and to their application in the preparation of biomaterials, it being possible for the latter to be used especially in the manufacture of implants, prostheses or the like.
摘要翻译： PCT No.PCT / FR93 / 01258 Sec。 371日期：1995年6月16日 102（e）日期1995年6月16日PCT提交1993年12月16日PCT公布。第WO94 / 13731号公报日期：1994年6月23日本发明涉及可溶于水和/或非质子极性有机溶剂的改性胶原，其包含由半胱氨酸或其衍生物的残基携带的游离或取代的巯基官能团，所述残基至少部分地，直接接枝到胶原链上的残基，其特征在于其具有大于0.3，优选0.5mM / g胶原的游离或取代的硫醇官能团的水平。本发明还涉及这些新型胶原衍生物的生产及其在制备生物材料中的应用，后者可能特别用于植入物，假体等的制造中。

7. 发明授权

US06630171B1 Particles based on polyamino-acid(s) and methods for preparing same 失效
标题翻译：基于聚氨基酸的颗粒及其制备方法
公开(公告)号：US06630171B1
公开(公告)日：2003-10-07
申请号：US09856378
申请日：2001-07-06
申请人： Sylvain Huille , Florence Nicolas , Nathan Brison , Gérard Soula
发明人： Sylvain Huille , Florence Nicolas , Nathan Brison , Gérard Soula
IPC分类号： A61K914
CPC分类号： A61K9/5146 , A61K8/0241 , A61K8/88 , A61K9/1075 , A61K9/1641 , A61K2800/10 , A61K2800/412 , A61K2800/56 , A61Q19/00 , Y10S977/727 , Y10S977/728 , Y10S977/729 , Y10S977/775 , Y10S977/795 , Y10S977/896 , Y10S977/906 , Y10S977/915
摘要： The invention concerns delivery particles (DP's) for active principles (AP's) based on linear amphiphilic polyamino-acids (PAA's), with &agr;-peptide chains, capable of being spontaneously formed by contacting PAA's with a liquid medium, preferably with water, wherein the hydrophile part of the PAA's is solubilized more than the hydrophobic parts of said PAA's, such that the latter precipitate while being organised in discrete supra-molecular arrangements, of average size ranging between 0.01 and 20 &mgr;m, capable of combining with at least an AP and releasing the latter in vivo, in prolonged and controlled manner. The inventive suspension is characterised in that the recurrent amino acids (rAA's) constituting the main chain of PAA's are identical to or different from one another and are glutamic acid and/or aspartic acid and/or their salts; and some of said rAA's bear at least one hydrophobic group, said hydrophobic group, being identical to or different from one another. The invention is useful as carriers for active principles, in particular pharmaceutical, insulin or for therapeutic uses.
摘要翻译：本发明涉及基于具有α-肽链的线性两亲性多氨基酸（PAA）的活性成分（AP）的递送颗粒（DP），其能够通过使PAA与液体介质优选与水接触而自发形成，其中 PAA的亲水部分比所述PAA的疏水部分溶解得多，使得后者沉淀，同时以分散的分子结构组织，平均尺寸范围为0.01至20μm，能够与至少一种AP和以延长和受控的方式在体内释放后者。本发明的悬浮液的特征在于，构成PAA主链的复发氨基酸（rAA）彼此相同或不同，为谷氨酸和/或天冬氨酸和/或其盐; 并且一些所述rAA携带至少一个疏水基团，所述疏水基团彼此相同或不同。本发明可用作活性成分的载体，特别是药物，胰岛素或用于治疗用途。

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