Abstract: 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.

Abstract: 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.

Abstract: 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.