Multiparticulate Drug Delivery-Formulation, Processing and Manufacturing
Chapter 7: Multiparticulate Technologies for Fixed-Dose Combinations
W. Brett Caldwell and Aditya M. Kaushal
Multiparticulates (MPs) offer a high degree of capability and flexibility for attaining pharmacokinetic (PK), pharmacodynamic (PD), or target product profile goals. Reasons to use MPs in fixed-dose combinations (FDCs) include the ability to (1) mix and match release profiles for enhanced PK or PD effects; (2) isolate chemically incompatible active pharmaceutical ingredients (APIs); (3) lower costs or simplify handling and distribution of the FDC relative to two or more separate materials; and (4) maximize commercial opportunities by serving new indications or capturing market exclusivity through improved efficacy and compliance. The primary goals of this chapter are to (1) review the state of the art for MP usage in FDCs and (2) use case studies or hypothetical combinations to
describe formulation efficacy improvements enabled through MP usage in FDCs.