ABSTRACT

As discussed in previous chapters, preformulation scientists must determine whether the bulk drug substance will be developed as a salt form or not, they must decide which of the known polymorphs or solvatomorphs is the most desirable physical form, and then catalog all of the physical and chemical characteristics of this form. Once the profiling of the drug substance is complete, one can begin to design appropriate prototype formulations that will meet the needs set down by the pharmacologists regarding the particulars of drug availability. After considering the range of possible solid-solid reactions, the preformulation scientist is able to propose several trial formulations that hopefully will achieve the desired drug release profile.