Abstract

A REVIEW ON LYOPHILIZATION OF PHARMACEUTICAL DOSAGE FORMS

Harishanker Padakanti*, Dr. P. Satyanarayana Rao, Ponnam Ravi Kumar, M.Ataurrahman Ameen

ABSTRACT

Pharmaceutical products are designed to be manufactured in the lyophilized form due to their instability in solution form. In order to avoid the degradation and to extend the shelf life of thermo-labile and moisture sensitive actives, formulations need to be developed as lyophilized powder. Lyophilization is a complex process with critical processing steps. Control of manufacturing process will play a major role in the development of lyophilized formulations. The current review is focused on the principle behind lyophilization, steps involved in manufacturing, methods of freezing, and excipient selection for the development of lyophilized formulations.

Keywords: Lyophilization, Annealing, Sublimation, Desorption, Triple point.