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公开(公告)号：US07959600B2
公开(公告)日：2011-06-14
申请号：US11716223
申请日：2007-03-09
IPC分类号： A61M37/00
CPC分类号： A61M5/31 , A61J1/2096 , A61M5/2448 , A61M5/31596 , A61M5/3294 , A61M5/34 , A61M5/345 , A61M2005/312 , A61M2005/3128 , A61M2005/3132 , A61M2005/31598
摘要： A container closure delivery system that is suitable for lyophilized pharmaceutical injectable powder products is disclosed. The system comprises storage stable powder formulations and a container closure assembly design wherein the formulation can be filled and lyophilized with a standard fill finish equipment, and the formulations and lyophilization processes are optimized to produce a powder that readily dissolves upon contact with a diluent, thereby facilitating the direct injection of the lyophilized product without the need for a separate reconstitution/mixing/priming step.
摘要翻译： 公开了适用于冻干药物可注射粉末产品的容器封闭递送系统。 该系统包括储存稳定的粉末制剂和容器封闭组件设计，其中可以用标准填充装置填充和冻干制剂，并优化制剂和冻干方法以产生在与稀释剂接触时容易溶解的粉末，从而 促进直接注射冻干产品，而不需要单独的重建/混合/起动步骤。
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公开(公告)号：US20110288531A1
公开(公告)日：2011-11-24
申请号：US13159346
申请日：2011-06-13
CPC分类号： A61M5/31 , A61J1/2096 , A61M5/2448 , A61M5/31596 , A61M5/3294 , A61M5/34 , A61M5/345 , A61M2005/312 , A61M2005/3128 , A61M2005/3132 , A61M2005/31598
摘要： A method of storing and delivery a drug, such as by lyophilizing and reconstituting, comprises performing both storing and delivering with the same container closure assembly. The container closure is assembled in a preparation configuration during which lyophilization occurs. After lyophilizing, the powdered drug is forced into a spiral channel in the container closure assembly by a plunger. The plunger leaves substantially no head space for the powdered drug, and the assembly is sealed thereby now being in the storage configuration. For delivery of the stored powdered drug, a syringe of diluent is introduced to the container assembly thereby changing the assembly to the delivery configuration. The spiral channel is continuous between an input end and a delivery end with the delivery end being in fluid communication with a delivery outlet of the assembly. The assembly includes a diluent flow path that forces the diluent into a spiral channel at only the input end. As the diluent is forced to flow through the spiral channel from the input end to the delivery end, it reconstitutes the powdered drug, thereby reconstituting and delivering in the same step. No separate reconstituting and priming steps are needed.
摘要翻译： 存储和递送药物的方法，例如通过冻干和重构，包括使用相同的容器封闭组件进行存储和递送。 容器封闭件以制备结构组装，在此期间发生冻干。 冻干后，粉末状药物通过柱塞被迫进入容器封闭组件中的螺旋通道。 柱塞基本上没有用于粉末状药物的顶部空间，并且组件被密封，从而现在处于储存结构。 为了输送储存的粉末药物，将稀释剂的注射器引入容器组件，从而将组件改变为输送构型。 螺旋通道在输入端和输送端之间是连续的，其中输送端与组件的输送出口流体连通。 组件包括稀释剂流动路径，其仅在输入端将迫使稀释剂进入螺旋通道。 当稀释剂被迫从输入端流到输送端时，它重新构成粉末药物，从而在相同的步骤中重构和输送。 不需要单独的重组和启动步骤。
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公开(公告)号：US08579855B2
公开(公告)日：2013-11-12
申请号：US13159346
申请日：2011-06-13
CPC分类号： A61M5/31 , A61J1/2096 , A61M5/2448 , A61M5/31596 , A61M5/3294 , A61M5/34 , A61M5/345 , A61M2005/312 , A61M2005/3128 , A61M2005/3132 , A61M2005/31598
摘要： A method of storing and delivery a drug, such as by lyophilizing and reconstituting, comprises performing both storing and delivering with the same container closure assembly. The container closure is assembled in a preparation configuration during which lyophilization occurs. After lyophilizing, the powdered drug is forced into a spiral channel in the container closure assembly by a plunger. The plunger leaves substantially no head space for the powdered drug, and the assembly is sealed thereby now being in the storage configuration. For delivery of the stored powdered drug, a syringe of diluent is introduced to the container assembly thereby changing the assembly to the delivery configuration. The spiral channel is continuous between an input end and a delivery end with the delivery end being in fluid communication with a delivery outlet of the assembly. The assembly includes a diluent flow path that forces the diluent into a spiral channel at only the input end. As the diluent is forced to flow through the spiral channel from the input end to the delivery end, it reconstitutes the powdered drug, thereby reconstituting and delivering in the same step. No separate reconstituting and priming steps are needed.
摘要翻译： 存储和递送药物的方法，例如通过冻干和重构，包括使用相同的容器封闭组件进行存储和递送。 容器封闭件以制备结构组装，在此期间发生冻干。 冻干后，粉末状药物通过柱塞被迫进入容器封闭组件中的螺旋通道。 柱塞基本上没有用于粉末状药物的顶部空间，并且组件被密封，从而现在处于储存结构。 为了输送储存的粉末药物，将稀释剂的注射器引入容器组件，从而将组件改变为输送构型。 螺旋通道在输入端和输送端之间是连续的，其中输送端与组件的输送出口流体连通。 组件包括稀释剂流动路径，其仅在输入端将迫使稀释剂进入螺旋通道。 当稀释剂被迫从输入端流到输送端时，它重新构成粉末药物，从而在相同的步骤中重构和输送。 不需要单独的重组和启动步骤。
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公开(公告)号：US09174002B2
公开(公告)日：2015-11-03
申请号：US14033498
申请日：2013-09-22
申请人： Byeong Seon Chang
CPC分类号： A61M5/31 , A61J1/2096 , A61M5/2448 , A61M5/31596 , A61M5/3294 , A61M5/34 , A61M5/345 , A61M2005/312 , A61M2005/3128 , A61M2005/3132 , A61M2005/31598
摘要： A container closure delivery system that is suitable for lyophilized pharmaceutical injectable powder products is disclosed. The system comprises storage stable powder formulations and a container closure assembly design wherein the formulation can be filled and lyophilized with a standard fill finish equipment, and the formulations and lyophilization processes are optimized to produce a powder that readily dissolves upon contact with a diluent, thereby facilitating the direct injection of the lyophilized product without the need for a separate reconstitution/mixing/priming step.
摘要翻译： 公开了适用于冻干药物可注射粉末产品的容器封闭递送系统。 该系统包括储存稳定的粉末制剂和容器封闭组件设计，其中可以用标准填充装置填充和冻干制剂，并优化制剂和冻干方法以产生在与稀释剂接触时容易溶解的粉末，从而 促进直接注射冻干产品，而不需要单独的重建/混合/起动步骤。
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公开(公告)号：US20140025040A1
公开(公告)日：2014-01-23
申请号：US14033498
申请日：2013-09-22
申请人： Byeong Seon Chang
CPC分类号： A61M5/31 , A61J1/2096 , A61M5/2448 , A61M5/31596 , A61M5/3294 , A61M5/34 , A61M5/345 , A61M2005/312 , A61M2005/3128 , A61M2005/3132 , A61M2005/31598
摘要： A container closure delivery system that is suitable for lyophilized pharmaceutical injectable powder products is disclosed. The system comprises storage stable powder formulations and a container closure assembly design wherein the formulation can be filled and lyophilized with a standard fill finish equipment, and the formulations and lyophilization processes are optimized to produce a powder that readily dissolves upon contact with a diluent, thereby facilitating the direct injection of the lyophilized product without the need for a separate reconstitution/mixing/priming step.
摘要翻译： 公开了适用于冻干药物可注射粉末产品的容器封闭递送系统。 该系统包括储存稳定的粉末制剂和容器封闭组件设计，其中可以用标准填充装置填充和冻干制剂，并优化制剂和冻干方法以产生在与稀释剂接触时容易溶解的粉末，从而 促进直接注射冻干产品，而不需要单独的重建/混合/起动步骤。
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公开(公告)号：US20130261046A1
公开(公告)日：2013-10-03
申请号：US13902602
申请日：2013-05-24
申请人： Byeong Seon Chang
IPC分类号： A61J1/00
CPC分类号： A61J1/00 , A61M5/2448 , A61M5/31596 , A61M2005/312 , A61M2005/3128 , A61M2005/31598
摘要： The present invention relates to a container closure delivery system that is suitable for lyophilized pharmaceutical injectable powder products. The system comprises storage stable powder formulations and a container closure assembly design wherein the formulation can be filled and lyophilized with a standard fill finish equipment, and the formulations and lyophilization processes are optimized to produce a powder that readily dissolves upon contact with a diluent, thereby facilitating the direct injection of the lyophilized product without the need for a separate reconstitution/mixing/priming step.
摘要翻译： 本发明涉及适用于冻干药物可注射粉末产品的容器封闭递送系统。 该系统包括储存稳定的粉末制剂和容器封闭组件设计，其中可以用标准填充装置填充和冻干制剂，并优化制剂和冻干方法以产生在与稀释剂接触时容易溶解的粉末，从而 促进直接注射冻干产品，而不需要单独的重建/混合/起动步骤。
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