Fixed Dose Combination (FDC) Products: Introduction, Development and Regulations

A fixed dose combination (FDC) is a formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Combination therapy with two or more agents having complementary mechanisms of action represents a type of incremental innovation that has extended the range of therapeutic options in the treatment of almost every human disease. Combining two or more active pharmaceutical ingredients in a single-dosage form can increase a drug's efficacy and improve patient compliance. Several difficulties arise during formulation development, manufacturing and regulations of FDC products. Two or more active ingredients in the FDCs must be physically and chemically compatible along with their excipients. In this review article authors provided the brief information regarding advantages, formulation development and regulations of FDC products.