公开(公告)号：US20110033464A1

公开(公告)日：2011-02-10

申请号：US12910146

申请日：2010-10-22

Applicant: Anthony BARRY ,  Thomas Crowley ,  Daniel Dixon ,  Jennifer Juneau ,  Ajay Kumar ,  Li Li ,  Nicholas Luksha ,  Michael Shamashkin ,  Erin Soley ,  Nicholas Warne ,  Chandra Webb

Inventor： Anthony BARRY ,  Thomas Crowley ,  Daniel Dixon ,  Jennifer Juneau ,  Ajay Kumar ,  Li Li ,  Nicholas Luksha ,  Michael Shamashkin ,  Erin Soley ,  Nicholas Warne ,  Chandra Webb

IPC: A61K39/395

CPC classification number: C07K14/7155 ,  A61K38/1774 ,  C07K14/705 ,  C07K2319/30 ,  C07K2319/31

Abstract: The present invention provides compositions of Ig fusion proteins, especially compositions including an Ig fusion protein, a bulking agent, a disaccharide, a surfactant, and a buffer. In one aspect, these compositions are stable under long-term storage or at least one freeze/thaw cycle. The invention also provides methods of preparation of the Ig fusion protein compositions. In one aspect, compositions of the invention are lyophilized. In a further aspect, the compositions are lyophilized by a process that includes an annealing step.

Abstract translation: 本发明提供Ig融合蛋白的组合物，特别是包含Ig融合蛋白，填充剂，二糖，表面活性剂和缓冲液的组合物。 在一个方面，这些组合物在长期储存或至少一个冷冻/融化循环下是稳定的。 本发明还提供了Ig融合蛋白组合物的制备方法。 在一个方面，本发明的组合物被冻干。 在另一方面，组合物通过包括退火步骤的方法冻干。

公开(公告)号：US20070237758A1

公开(公告)日：2007-10-11

申请号：US11562299

申请日：2006-11-21

Applicant: Anthony Barry ,  Thomas Crowley ,  Daniel Dixon ,  Jennifer Juneau ,  Ajay Kumar ,  Li Li ,  Nicholas Luksha ,  Michael Shamashkin ,  Erin Soley ,  Nicholas Warne ,  Chandra Webb

Inventor： Anthony Barry ,  Thomas Crowley ,  Daniel Dixon ,  Jennifer Juneau ,  Ajay Kumar ,  Li Li ,  Nicholas Luksha ,  Michael Shamashkin ,  Erin Soley ,  Nicholas Warne ,  Chandra Webb

IPC: A61K39/395

CPC classification number: C07K14/7155 ,  A61K38/1774 ,  C07K14/705 ,  C07K2319/30 ,  C07K2319/31

Abstract: The present invention provides compositions of Ig fusion proteins, especially compositions including an Ig fusion protein, a bulking agent, a disaccharide, a surfactant, and a buffer. In one aspect, these compositions are stable under long-term storage or at least one freeze/thaw cycle. The invention also provides methods of preparation of the Ig fusion protein compositions. In one aspect, compositions of the invention are lyophilized. In a further aspect, the compositions are lyophilized by a process that includes an annealing step.

Abstract translation: 本发明提供Ig融合蛋白的组合物，特别是包含Ig融合蛋白，填充剂，二糖，表面活性剂和缓冲液的组合物。 在一个方面，这些组合物在长期储存或至少一个冷冻/融化循环下是稳定的。 本发明还提供了Ig融合蛋白组合物的制备方法。 在一个方面，本发明的组合物被冻干。 在另一方面，组合物通过包括退火步骤的方法冻干。

公开(公告)号：US20050008580A1

公开(公告)日：2005-01-13

申请号：US10820656

申请日：2004-04-08

Applicant: David Gong ,  Jayne Hastedt ,  Robert Schaub ,  Nicholas Warne ,  Andrew Dorner ,  Chandra Webb ,  James Keith

Inventor： David Gong ,  Jayne Hastedt ,  Robert Schaub ,  Nicholas Warne ,  Andrew Dorner ,  Chandra Webb ,  James Keith

IPC: A61J3/02 ,  A61K20060101 ,  A61K9/00 ,  A61K9/12 ,  A61K9/16 ,  A61K38/00 ,  A61K38/37 ,  A61K38/48 ,  A61L9/04 ,  A61M11/02 ,  A61M15/00

CPC classification number: A61M15/0028 ,  A61K9/0075 ,  A61K9/1611 ,  A61K9/1617 ,  A61K9/1623 ,  A61K38/4846 ,  A61M11/02 ,  A61M2202/064

Abstract: Hemophilia treatment by the inhalation of coagulation factors. Dry powder Factor IX is aerosolized to a mass median aerodynamic diameter of 4 μm or less, with at least 90% monomer content, at least 80% activity level, and 10% water or less. The aerosol is slowly, and deeply inhaled into the lung, and followed by a maximal exhale.

Abstract translation: 血友病治疗吸入凝血因子。 干燥粉末因子IX被雾化至质量中值空气动力学直径为4μm或更小，具有至少90％的单体含量，至少80％的活性水平和10％的水或更少的水分。 气溶胶缓慢吸入肺部，最后呼气。

公开(公告)号：US5770700A

公开(公告)日：1998-06-23

申请号：US591332

申请日：1996-01-25

Applicant: Chandra Webb ,  Lawrence Bush

Inventor： Chandra Webb ,  Lawrence Bush

IPC: A61K47/00 ,  A61K38/43 ,  A61K38/48 ,  A61K38/36 ,  A61K47/26

CPC classification number: A61K38/4846 ,  A61K47/12 ,  A61K47/183 ,  A61K47/26 ,  A61K9/0019 ,  C12Y304/21022

Abstract: Provided by the present invention are novel compositions and methods for obtaining concentrated preparations of factor IX and liquid formulations of factor IX suitable for storage and administration.

Abstract translation: 本发明提供了新的组合物和方法，用于获得因子IX的浓缩制剂和适用于储存和给药的因子IX的液体制剂。

公开(公告)号：US20070135343A1

公开(公告)日：2007-06-14

申请号：US11589002

申请日：2006-10-27

Applicant: Chandra Webb ,  Julie Zerfas

Inventor： Chandra Webb ,  Julie Zerfas

IPC: A61K38/36

CPC classification number: A61K47/02 ,  A61K9/0019 ,  A61K9/08 ,  A61K9/19 ,  A61K38/4846 ,  A61K47/183 ,  A61K47/22 ,  A61K47/26

Abstract: The invention provides methods for preparing pharmaceutical formulations for injection such that upon injection the formulation does not cause erythrocyte agglutination, hemolysis, and/or cell shrinkage. To prevent agglutination, a pharmaceutical formulation ready for injection needs to have a sufficient ionic strength. To prevent hemolysis or cell shrinkage, a pharmaceutical formulation ready for injection needs to be about isotonic with respect to plasma. The invention provides methods that prepare pharmaceutical formulations for injection that have both the sufficient ionic strength to prevent agglutination and the requisite tonicity to prevent significant hemolysis or cell dehydration or shrinkage. The present methods involve the use of sodium chloride solutions that are about 25 mM to about 150 mM for reconstituting lyophilized cakes (or other non-liquid pharmaceutical formulations) into solution or for diluting pharmaceutical formulation solutions.

Abstract translation: 本发明提供制备用于注射的药物制剂的方法，使得在注射时制剂不引起红细胞凝集，溶血和/或细胞收缩。 为了防止凝集，准备注射的药物制剂需要具有足够的离子强度。 为了防止溶血或细胞收缩，准备注射的药物制剂关于等离子体需要约等渗。 本发明提供了制备具有足够的离子强度以防止凝集和必需的张力以防止显着溶血或细胞脱水或收缩的注射用药物制剂的方法。 本方法包括使用约25mM至约150mM的氯化钠溶液，用于将冻干的蛋糕（或其它非液体药物制剂）重构成溶液或稀释药物制剂溶液。

公开(公告)号：US06372716B1

公开(公告)日：2002-04-16

申请号：US08233663

申请日：1994-04-26

Applicant: Lawrence Bush ,  Chandra Webb

Inventor： Lawrence Bush ,  Chandra Webb

IPC: A61K3836

CPC classification number: A61K47/26 ,  A61K9/0019 ,  A61K38/4846 ,  A61K47/183

Abstract: Provided by the present invention are novel compositions and methods for obtaining concentrated preparations of factor IX and formulations of factor IX suitable for storage and administration.

Abstract translation: 本发明提供了用于获得因子IX的浓缩制剂和适用于储存和给药的因子IX制剂的新型组合物和方法。