European Journal of Biomedical and Pharmaceutical Sciences

A REVIEW: THE LYOPHILIZATION PROCESS FOR THE DEVELOPMENT OF UNSTABLE DRUG

Sunil Rautela*, Ashutosh Badola, Ritesh Verma, Shweta Baluni, Preeti Kothiyal

ABSTRACT

The lyophilization technique is most suitable process for the development of unstable drug for its betterment for use as parenteral formulation by intravenous administration. Lyophilization is used to improve the stability of a perishable product or make the product easier to store or transport. In the biotechnology and pharmaceutical industry, lyophilization is used as a final processing step for active pharmaceutical ingredients or drug products to stabilize the protein for long-term storage. Freeze-drying is a process that removes water by first freezing the material within a lyophilizer. The ambient pressure is then reduced and the temperature is slowly increased within the lyophilization chamber to allow frozen water to sublimate (i.e., move from the solid phase directly to gas). Many food products (coffee, fruits, vegetables, meats, and ice cream) can be freeze-dried and subsequently stored at room temperature. The resulting product generally retains its original shape and is much lighter and easier to carry. For example, hikers frequently pack freeze-dried food to reduce weight in their packs. The freeze-dried products are easily reconstituted with water. In the biotechnology industry, protein products, antibodies, oligonucleotides, and vaccines are lyophilized to increase the shelf life by reducing the risk of degradation during storage. Again, these products are much lighter and take up much less space, which make them easier to store and ship. The end user (i.e., doctor, patient, downstream manufacturer, etc.) simply reconstitutes the freeze-dried powder prior to injection or other use. This article discusses the process and the fundamental principles behind lyophilization and the stages of the lyophilization cycle.

Keywords: Lyophilization, Desiccation, Desorption, Stability.