Lyophilization of unit dose pharmaceutical dosage forms.

摘要

A lyophilization process for a pharmaceutical unit dosage form was developed which comprised a container closed with an impermeable membrane pierced with one or more holes through which the material in the container can be lyophilized. The hole or holes in the membrane have to be sufficiently large to allow water vapor to escape but small to ensure that the material is kept within the container. Lyophilization from sealed, perforated, unit-dose package has shown to be feasible. The technique offers a novel convenient means of lyophilizing nonsterile products in their primary pack and increases the potential for the development of lyophilized formulations for nonparenteral applications.