Fixed Dose Combination -its Rationality and Safety

Fixed dose drug combination product is defined as combination of two or more active drugs in a single dosage form. Fixed dose combination product (FDCs) should be formulated in such a way that it should have an advantage over single formulation product in therapeutic effect, safety or compliance. With combination therapy, it is important to model how the drugs act in combination (synergistically, additively, or antagonistically) and how the differing population pharmacokinetics will affect the outcome. It helps to reduce the pill burden in patients with chronic diseases for e.g. in diabetes, hypertension and other cardiovascular disease. Fixed dose combination products are acceptable when the dosage of ingredients meet the requirements of a defined population group.