The word excipient, derived from the Latin phrase excipere - to receive, to except, or take out, refers to any component other than the active pharmaceutical ingredient contained in solid dosage forms or used to manufacture a finished pharmaceutical product (FPP). Excipients play a significant role in the formulation and administration of dosage forms and the drug development process. They affect the aesthetics, processing capability, bioavailability, and performance of the drug substance and the compliance of patients using a specific dosage form.
Excipients can either act as carriers (basis or vehicles) or diluents, etc., of the active ingredients or components. They aid in the drug product manufacturing process and also enhance the bioavailability, stability, appearance, storage integrity, effectiveness, safety, and delivery of the drug product during use.
Excipients and active ingredients form the major components of drugs. However, excipients make up the bulk of drugs and medicines, making about 90% of each drug’s composition. These substances are mostly pharmacologically inactive or inert and serve specific purposes. However, as opposed to popular assumptions, excipients are not always inactive or inert and may result in side effects or adverse reactions if misused.
The wrong choice, quality, combination, or amounts of excipients used can have devastating effects on the patient’s health. Like every other drug component, these inactive ingredients need to be standardized, regulated, and validated to ensure the safety of the chemical decomposition products for consumption.
Pharmaceutical products contain not just active ingredients but also other components that largely influence the drug’s pharmacokinetics and pharmacodynamics
Role of excipients in drug formation
The traditional use of excipients has been modified by the development of novel drug delivery systems. Beyond increasing the bulk of formulation and simplifying the manufacturing process, excipients perform a variety of roles such as binding ingredients, boosting patient’s acceptance and compliance (by masking unpleasant odors or tastes), enhancing the stability of active ingredients, extending viability and acting as diluents (for example, microcrystalline cellulose, starch), etc.