Are Excipients Inert? Phenytoin Pharmaceutical Investigations with New Incompatibility Insights
The U.S. Pharmacopeia defines excipients as substances other than the active pharmaceutic ingredient (API) that are added in a drug delivery system in order to aid in the manufacturing process and enhance stability, bioavailability, safety, effectiveness and delivery of the drug. These substances have been appropriately evaluated for
Although excipients are well characterized and evaluated for safety, they can interact with the API chemically or physically (2). An incompatibility can possibly affect the drug delivery performance and bioavailability, leading to loss of quality and potency, and compromising the safety and efficacy of the medication (3, 4). Thus, choosing the right excipients based on their function and compatibility with the API is of primary importance for a good quality drug product.
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