Nanoformulation and Fixed Dose Combination

Nanoformulation refers to the design of drug delivery systems at the nanoscale to enhance solubility, stability, and bioavailability. According to the U.S. Food and Drug Administration (FDA), nanoformulation refers to the design and development of drug delivery systems with components in the nanoscale range (typically 1-100 nanometers), where the unique physiochemical properties at this scale are leveraged to enhance therapeutic efficacy, improve bioavailability, and enable targeted delivery1. FDC (Fixed-Dose Combination) combines two or more drugs in a single dosage form. As defined by the Central Drugs Standard Control Organization (CDSCO) of India, FDCs are pharmaceutical products containing two or more active pharmaceutical ingredients (APIs) in a fixed ratio of doses, formulated into a single dosage form2. Combining nanoformulation with FDC ensures improved therapeutic efficacy, reduced dosing frequency, and better patient adherence3. Nanoformulation and fixed-dose combinations (FDCs) are a revolutionary area of frontier therapeutics, providing new approaches toward overcoming age-old issues in drug delivery and compliance of patients.