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Fixed Dose Combination Advantages And Disadvantages

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1. INTRODUCTION A fixed-dose combination (FDC) is a formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses1. WHO defines FDCs as a combination of two or more actives in a fixed ratio of doses. This term is used generically to mean a particular combination of actives irrespective of the formulation or brand. It may be administered as a single entity product given concurrently or as a finished pharmaceutical product.2 The USA Food and Drug Administration, defines a combination product as “a product composed of any combination of; -a drug and a device, or -a biological product and a device, or -a drug and a biological product, or -a drug, device, and a biological product. Fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement of a defined population group and when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance3. …show more content…

It never means a concomitant drug therapy, wherein two drugs are given separately for treatment of a disease4 Fixed dose combination drug products may improve medication compliance by reducing the pill burden of patients. Typically fixed-dose combination drug products are developed to target a single disease (such as with antiretroviral FDCs used against AIDS). However, FDCs may also target multiple diseases, such as atorvastatin to treat hypercholesterolemia and amlodipine to treat hypertension1 FDCs are highly popular in the Indian pharmaceutical market and have been particularly flourishing in the last few years3. 1.1: WHY FDCs ARE IN

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