Process of lyophilizing and sealing injectable product in cartridge, set of cartridge to keep lyophilized drug and form disposable part of injector pen, process that reconstitutes lyophilized compound, apparatus to reconstitute lyophilized drug and device of injector pen and cartridge to administer drug

摘要

A cartridge assembly for holding a lyophilized product, forming a disposable portion of a pen injector includes a cylindrical glass cartridge adapted to receive the product, a closure cap, a cartridge case, and a plunger mechanism. The closure cap is adapted to retain an elastomeric disc seal during lyophilization and includes diametrically opposed ledges. The closure cap and seal are adapted to cover a neck portion of the ampule, the neck portion having on its end a radially extending circumferential flange. The ledges of the closure cap and the flange of the neck portion allow the closure cap to remain open during lyophilization, oxygen purge and nitrogen overlay. An oval-shaped indentation formed on the inside of the closure cap aids in snapping the closure cap about the flange without crimping to retain the closure cap underneath the flange. Reconstitution of the lyophilized drug is accomplished without foaming by use of an obliquely angled connector which causes the diluent to indirectly impinge on the drug. The injection pen and cartridge assembly cooperate such that the length of travel of the plunger rod during retraction is less than the axial length of a recess in the rod tip.