INDEPENDENT PROTOCOL DEVELOPMENT OF LYOPHILIZATION FOR DIFFERENT COMPOUNDS

Abstract

A multidimensional space that encompasses combinations of machine design and processing variables that provides assurance of suitable product performance. This review article mainly focuses on design space in the concern of developing and scaling up all the process variables with reference of one particular material for the development of individual product protocol. The design space should be developed as an envelope for every product specifying its sublimation rate, shelf temperature, and chamber pressure, one boundary of the design space is established by failure of the formulation under aggressive cycle conditions. Other boundaries of the design space are determined by equipment performance including refrigeration capacity, condenser capability, heating capacity or limitations of the dynamics of water vapor flow within the system. The characterization of this design space assures a thorough understanding of both the product and the process. It minimizes the probability of unpleasant surprises in the technology transfer process. Hence we can develop a collection of protocols regarding the individual product lyophilization in a very similar manner like I.P., B.P., U.S.P. etc. This will result in restriction from process variation and thus different troubles can be resolved.