Fixed-dose combination

Fixed-dose combination (FDC) refers to a medication that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form. The purpose of FDCs is to improve patient compliance by reducing the number of pills a patient must take daily. FDCs are commonly used in the treatment of a variety of conditions, including HIV/AIDS, tuberculosis, and cardiovascular disease.

History

The concept of FDCs has been around for many years, but it gained significant attention in the 1990s with the advent of combination therapies for HIV/AIDS. The World Health Organization (WHO) has since endorsed the use of FDCs for the treatment of a variety of diseases, including tuberculosis and malaria.

Advantages

FDCs offer several advantages over separate dosage forms. They can improve patient compliance, reduce the risk of medication errors, and simplify complex medication regimens. In addition, FDCs can potentially reduce the development of drug resistance, particularly in the treatment of infectious diseases like HIV/AIDS and tuberculosis.

Disadvantages

Despite their advantages, FDCs also have potential disadvantages. These include the risk of drug interactions, the inability to adjust the dose of individual components, and the potential for increased side effects. In addition, the development and manufacturing of FDCs can be more complex and costly than for single-ingredient drugs.

Regulatory considerations

Regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have specific guidelines for the development and approval of FDCs. These guidelines address issues such as the rationale for the combination, the evidence of efficacy and safety for the combination, and the quality control measures for manufacturing.

Examples

Examples of FDCs include Atripla, a combination of three antiretroviral drugs for the treatment of HIV/AIDS, and Isoniazid/Rifampin, a combination therapy for tuberculosis.

See also

• Pharmacology
• Drug development
• Drug resistance