公开(公告)号：US20130302281A1

公开(公告)日：2013-11-14

申请号：US13944569

申请日：2013-07-17

Applicant: BIOGEN IDEC MA INC.

Inventor： Mary D. DiBiase ,  Wen-Li Chung ,  Mark Staples ,  Eric Scharin

IPC: A61K38/21

CPC classification number: A61K38/215 ,  A61K9/0019 ,  A61K38/21 ,  A61K47/10 ,  A61K47/183 ,  C07K14/565

Abstract: Liquid interferon compositions having a pH between 4.0 and 7.2 are described. The compositions comprise interferon-beta and a stabilizing agent at between about 0.3% and 5% by weight which is an amino acid selected from the group consisting of acidic amino acids, arginine and glycine. If needed, salt is added to provide sufficient ionic strength. The liquid composition has not been previously lyophilized or previously cavitated. The liquid is preferably contained within a vessel having at least one surface in contract with the liquid that is coated with a material inert to adsorption of interferon-beta. A kit for parenteral administration of a liquid interferon formulation and a method for stabilizing liquid interferon compositions are also described.

公开(公告)号：US20150093359A1

公开(公告)日：2015-04-02

申请号：US14564637

申请日：2014-12-09

Applicant: Biogen Idec MA Inc.

Inventor： Mary D. DiBiase ,  Wen-Li Chung ,  Mark Staples ,  Eric Scharin

IPC: A61K38/21 ,  A61K47/10 ,  A61K47/18

CPC classification number: A61K38/215 ,  A61K9/0019 ,  A61K38/21 ,  A61K47/10 ,  A61K47/183 ,  C07K14/565

Abstract: Liquid interferon compositions having a pH between 4.0 and 7.2 are described. The compositions comprise interferon-beta and a stabilizing agent at between about 0.3% and 5% by weight which is an amino acid selected from the group consisting of acidic amino acids, arginine and glycine. If needed, salt is added to provide sufficient ionic strength. The liquid composition has not been previously lyophilized or previously cavitated. The liquid is preferably contained within a vessel having at least one surface in contract with the liquid that is coated with a material inert to adsorption of interferon-beta. A kit for parenteral administration of a liquid interferon formulation and a method for stabilizing liquid interferon compositions are also described.

Abstract translation: 描述pH在4.0和7.2之间的液体干扰素组合物。 所述组合物包含约0.3％至5％重量的干扰素-β和稳定剂，其为选自酸性氨基酸，精氨酸和甘氨酸的氨基酸。 如果需要，加入盐以提供足够的离子强度。 液体组合物以前没有冻干或先前被气蚀。 液体优选包含在具有至少一个与液体收缩的表面的容器中，该表面涂覆有对吸附干扰素-β无惰性的物质。 还描述了用于液体干扰素制剂的肠胃外给药的试剂盒和用于稳定液体干扰素组合物的方法。

公开(公告)号：US08932574B2

公开(公告)日：2015-01-13

申请号：US13944569

申请日：2013-07-17

Applicant: Biogen Idec MA Inc.

Inventor： Mary D. DiBiase ,  Wen-Li Chung ,  Mark Staples ,  Eric Scharin

IPC: A61K38/21 ,  A61K38/00 ,  C07K14/565 ,  A61K9/00 ,  A61K47/18

CPC classification number: A61K38/215 ,  A61K9/0019 ,  A61K38/21 ,  A61K47/10 ,  A61K47/183 ,  C07K14/565

Abstract: Liquid interferon compositions having a pH between 4.0 and 7.2 are described. The compositions comprise interferon-beta and a stabilizing agent at between about 0.3% and 5% by weight which is an amino acid selected from the group consisting of acidic amino acids, arginine and glycine. If needed, salt is added to provide sufficient ionic strength. The liquid composition has not been previously lyophilized or previously cavitated. The liquid is preferably contained within a vessel having at least one surface in contract with the liquid that is coated with a material inert to adsorption of interferon-beta. A kit for parenteral administration of a liquid interferon formulation and a method for stabilizing liquid interferon compositions are also described.

Abstract translation: 描述pH在4.0和7.2之间的液体干扰素组合物。 所述组合物包含约0.3％至5％重量的干扰素-β和稳定剂，其为选自酸性氨基酸，精氨酸和甘氨酸的氨基酸。 如果需要，加入盐以提供足够的离子强度。 液体组合物以前没有冻干或先前被气蚀。 液体优选包含在具有至少一个与液体收缩的表面的容器中，该表面涂覆有对吸附干扰素-β无惰性的物质。 还描述了用于液体干扰素制剂的肠胃外给药的试剂盒和用于稳定液体干扰素组合物的方法。