公开(公告)号：US20060069029A1

公开(公告)日：2006-03-30

申请号：US11272488

申请日：2005-11-10

申请人： Orville Kolterman ,  Andrew Young ,  James L'Italien

发明人： Orville Kolterman ,  Andrew Young ,  James L'Italien

IPC分类号： A61K38/22

CPC分类号： C07K14/605 ,  A61K38/00 ,  A61K38/16 ,  A61K38/26 ,  A61K47/48215 ,  A61K47/60 ,  C07K14/57563

摘要： Novel formulations containing exendins, exendin agonists and/or exendin analogs are provided.

摘要翻译： 提供了含有毒蜥外泌肽，毒蜥外泌肽激动剂和/或毒蜥外泌肽类似物的新型制剂。

公开(公告)号：US6136784A

公开(公告)日：2000-10-24

申请号：US005240

申请日：1998-01-09

申请人： James L'Italien ,  Shankar Musunuri ,  Kale Ruby ,  Orville Kolterman

发明人： James L'Italien ,  Shankar Musunuri ,  Kale Ruby ,  Orville Kolterman

IPC分类号： A61K38/22 ,  A61K38/28 ,  A61K38/00

CPC分类号： A61K38/22 ,  A61K38/28 ,  Y10S514/866

摘要： The present invention is concerned with a pharmaceutical formulation in a container, for example, a vial, prefilled cartridge, prefilled syringe or disposable pen, comprising approximately 0.01 to about 0.5% (w/v) amylin agonist, preferably pramlintide, in an aqueous system along with approximately 0.02 to about 0.5% (w/v) of an acetate, phosphate, citrate, or glutamate buffer to a pH of the final composition of approximately 3.0 to about 6.0 as well as approximately 1.0 to 10% (w/v) of a carbohydrate or polyhydric alcohol tonicifier; and, optionally, approximately 0.005 to 1.0% (w/v) of a preservative selected from the group consisting of m-cresol, benzyl alcohol, parabens and phenol. These formulations maintain stability upon storage under refrigerated or room temperature conditions. Such formulations can be further combined with insulin in the same syringe for administration to a patient.

摘要翻译： 本发明涉及容器中的药物制剂，例如小瓶，预填充的药筒，预充式注射器或一次性笔，其包含在水系统中约0.01至约0.5％（w / v）的胰岛淀​​粉样多肽激动剂，优选普兰林肽 以及约0.02至约0.5％（w / v）的乙酸盐，磷酸盐，柠檬酸盐或谷氨酸盐缓冲液至最终组合物的pH为约3.0至约6.0，以及约1.0至10％（w / v） 的碳水化合物或多元醇增稠剂; 和任选的约0.005至1.0％（w / v）的选自间甲酚，苯甲醇，对羟基苯甲酸酯和苯酚的防腐剂。 这些制剂在冷冻或室温条件下保存时保持稳定性。 这样的制剂可以在相同的注射器中进一步与胰岛素组合以给予患者。

公开(公告)号：US07312196B2

公开(公告)日：2007-12-25

申请号：US10159779

申请日：2002-05-31

申请人： James L'Italien ,  Gregg Stetsko

发明人： James L'Italien ,  Gregg Stetsko

IPC分类号： A61K38/00 ,  A61K47/00

CPC分类号： A61K9/0024 ,  A61K9/0014 ,  A61K9/0019 ,  A61K9/1647 ,  A61K9/19 ,  A61K38/22 ,  A61K38/28 ,  A61K47/02 ,  A61K47/10 ,  A61K47/12 ,  A61K47/26 ,  Y10S514/864 ,  Y10S514/866 ,  A61K2300/00

摘要： The present invention is concerned with a pharmaceutical formulation comprising an amylin agonist and optionally a buffer, a tonicifier or stabilizer, and a preservative in a container, for example, a vial, prefilled cartridge, prefilled syringe or disposable pen. This formulation may be in liquid, gel, solid or powdered form for delivery, for example, via nasal, pulmonary, oral, sublingual, buccal, transdermal, or parenteral routes. Formulation with biocompatible polymers and release modifiers, such as sugars, can facilitate controlled release after injection, minimizing the number of administrations to a patient. These formulations maintain stability upon storage under refrigerated or room temperature conditions. Such formulations can be further combined with insulin for administration to a patient.

摘要翻译： 本发明涉及包含胰岛淀粉样多肽激动剂和任选的缓冲剂，增稠剂或稳定剂以及容器中的防腐剂，例如小瓶，预充式药筒，预充式注射器或一次性笔的药物制剂。 该制剂可以是液体，凝胶，固体或粉末形式用于递送，例如通过鼻，肺，口服，舌下，口腔，经皮或肠胃外途径。 使用生物相容性聚合物和释放改性剂（例如糖）的制剂可以促进注射后的受控释放，从而最小化对患者的施用次数。 这些制剂在冷冻或室温条件下保存时保持稳定性。 这样的制剂可以进一步与胰岛素组合以给予患者。

公开(公告)号：US06410511B1

公开(公告)日：2002-06-25

申请号：US09005262

申请日：1998-01-09

申请人： James L'Italien ,  Shankar Musunuri ,  Kale Ruby

发明人： James L'Italien ,  Shankar Musunuri ,  Kale Ruby

IPC分类号： A61K3800

摘要： The present invention is concerned with a pharmaceutical formulation in a container, for example, a vial, prefilled cartridge, prefilled syringe or disposable pen, comprising approximately 0.01 to about 0.5% (w/v) amylin agonist, preferably pramlintide, in an aqueous system along with approximately 0.02 to about 0.5% (w/v) of an acetate, phosphate, citrate, or glutamate buffer to a pH of the final composition of approximately 3.0 to about 6.0 as well as approximately 1.0 to 10% (w/v) of a carbohydrate or polyhydric alcohol tonicifier; and, optionally, approximately 0.005 to 1.0% (w/v) of a preservative selected from the group consisting of m-cresol, benzyl alcohol, parabens and phenol. These formulations maintain stability upon storage under refrigerated or room temperature conditions. Such formulations can be further combined with insulin in the same syringe for administration to a patient.