Patent ID: 8579855

Claim:
An improved process for the preparation of a container closure assembly containing a lyophilized pharmaceutical powder product comprising: loading an empty product container into a industry standard vial manufacturing filling line; filling said product container with a liquid formulation containing a pharmaceutical product; dropping a plunger into the product container to create a container closure assembly; placing said container closure assembly into a lyophilizer apparatus; subjecting said container closure assembly to a lyophilization process; applying vertical pressure to the plunger to compress the lyophilized pharmaceutical product, and leaving the plunger in place at the compressed product; sealing said plunger into said product container to create a sealed container closure assembly containing lyophilized pharmaceutical powder product with minimal head space; bonding said sealed container closure assembly and whereby reconstitution and delivery occur in the same step such that the reconstituted product has a gradient delivery such that a higher concentration is delivered during the initial portion of the injection and a separate reconstitution step is not necessary.