Welcome to pharma excipients

“The word excipient is derived from the Latin excipere, meaning ‘to except’, which is simply explained as ‘other than‘. Pharmaceutical excipients are basically everything other than the active pharmaceutical ingredient. Ideally, excipients should be inert, however, recent reports of adverse reactions have suggested otherwise.” (Australian Prescriber)

“Pharmaceutical excipients are substances other than the active pharmaceutical ingredient (API) that have been appropriately evaluated for safety and are intentionally included in a drug delivery system.”

Simply said the excipients enable the drug substance to be applied to the patient in the right form and supports the way and place of action without being active themselves.

Ideal Excipient Properties

Excipients  range from inert and simple to active and complex substances that can be difficult to characterize. Traditionally, excipients were often structurally simple, biologically inert, and of natural origin, such as corn, wheat, sugar, and minerals. Many more novel and increasingly complex excipients have been developed as novel drug formulation delivery systems emerge and evolve. The inert and innocuous nature of excipients is no longer a given feature in drug formulations. Many excipients are potential toxicants at high doses in animals, though safe in humans at therapeutic doses, including commonly used excipients such as cyclodextrins, dextran, and polyethylene glycol.

Roles of Excipients

Excipients have different roles in a formulation. Some of the major ones can be:

• Aid in the processing of the drug delivery system during its manufacture
• Protect, support, or enhance stability, bioavailability, or patient acceptability,
• Assist in product identification, and enhance any attribute of the overall safety
• Assist in the effectiveness and/or delivery of the drug in use
• Assist in maintaining the integrity of the drug product during storage

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