Abstract
Excipients are ingredients in pharmaceutical products other than the active ingredient, added to facilitate manufacturing, enhance stability or modulate release and bioavailability. Vitamins are diverse molecules essential for human nutrition that also can fulfil excipient functions. This review focuses on vitamins used as excipients and provides an overview of the functions of vitamins in various pharmaceutical formulations. A thorough search was conducted to understand the current use of vitamins in marketed drug products, concluding that many vitamins are already used as functional excipients. Vitamins are used widely in different dosage forms, including oral, parenteral, and topical formulations, and alongside a broad range of active pharmaceutical ingredients, biologics, and small molecules from different biopharmaceutical classification system classes. Many examples of the use of vitamins to improve the performance of the pharmaceutical formulation in which they are included are presented and the mode of action of vitamins as excipients in the product is reviewed. Furthermore, the potential for future uses of vitamins in pharmaceutical products is highlighted. Lastly, considerations for the use of vitamins as excipients in drug products as well as the regulatory framework are discussed.
Published Version
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