ABSTRACT
The first and the most 111 a lyolphjli2~ation is to characterize the formulation. This cannot be overemphasized
because the formulation will allow us to develop a Iyophylization cycle with a scientiflc instead of using trial and error [I]. Characterization of a formulation is new. In 1 the use of DTA and a to investigate tre:ezlIDg process of products [2]. In 1964, MacKenzie reported that the first model of a microscope that was constructed by R. J. Williams in 1962 enabled him to develop the model 2 as an Imp[(JV(~mlc:nt
In 1 MacKenzie discussed how the process could be affected different formulations by melting temperature (Tm ), eutectic (Tg), and transition temperature of a and collapse ternperaLtures of NaCI/sucrose system due to numerous publJ,::atlOIls about the transItion and the wide use of freeze-
in the biopharmaceutical industry, the of a lyo:phltl2:ec1 formulation became well Pikal that because eutectic and temperatures vary over an enormous range, r!pl!/'rmilninlP" the maximum allowable is and is the first in formulation and process development Franks pomled out that an of a formulation can remove most of the from the freeze-drying cycle development [1,8].
