Fixed dose combination, a model therapy optimization strategy: A review

Abstract

Therapy optimization involves a continuous improvement process of treatment interventions in the management of specific health challenges. Such optimization practices will not only help in achieving the desired treatment goals but will also improve the overall patients’ quality of life. One of the available therapy optimization strategy is the use of fixed dose combinations over monotherapies or poly-pharmacy. Fixed dose combination (FDC) is combination product that includes two or more active pharmaceutical ingredients (APIs) with similar or different pharmacological activity and different mechanisms of action combined in a single dosage form, which is manufactured and distributed in fixed doses. Many advantages have been attributed to FDCs as a therapy optimization option. This is particularly important in the treatment of chronic diseases. This paper was designed to highlight an overview of fixed dose combinations, their advantages and disadvantages, examples of approved FDCs commercially available and FDCs’ formulation options. Although several FDC products have been approved and are in use globally, there is still room for research and development of more FDCs with special emphasis on chronic comorbid disease conditions.