ABSTRACT

It is perhaps fitting that the second chapter is by far the most important chapter in the entire book. The importance of this chapter lies not in its content, but in the topic itself. For the nature of the formulation is the pivot upon which the rest of the lyophilization and its associated equipment and instrumentation revolves. The formulation may be equated to the sun of our solar system but, from my experience, it appears to be more analogous to a black hole (i.e., the composition does not shed light on the anticipated lyophilization process). Since each formulation is a unique system, I can only guide the reader in recognizing those areas of formulation preparation that need to be addressed to produce a stable product.