An excipient is an ingredient intentionally added to the formulation of a dosage form other than the active substance or active pharmaceutical ingredient (API). Although excipients are not necessarily inert, the term is often synonymous with inactive ingredient.
 
An inactive substance serves as the vehicle for a drug or other active substance and can include coloring agents, preservatives, and fillers.
 
Excipients can also be used in the manufacturing process to support the delivery of the active substance by aiding in vitro stability to support expected shelf life.
 
An excipient formulated with the active ingredient of a medication can be used for long-term stabilization, bulking up solid formulations that contain small amounts of potent active ingredients, or to enhance the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility.
 
Leveraging appropriate excipients also depends on drug delivery and the dosage form, as well as the active ingredient among other factors.
 
Excipients were once inactive ingredients, but now can be a key determinant of dosage form based on pharmacodynamics (PD) and pharmacokinetics (PK).

According a recently published report from Coherent Market Insights, the global pharmaceutical excipients market was valued at $6,557.6 million in 2018, and is expected to exhibit a CAGR of 6.9% over the forecast period (2019–2027). The market is set to surpass $11,944.6 million by 2027 the firm says.

With respect to compliance, the International Pharmaceutical Excipient Councils (IPE) governs the global pharmaceutical excipients manufacturing by providing harmonized excipient guidelines to manufacturers. IPE provide general guideline such as Good Manufacturing Practices implementation for excipient, guideline for manufacturing site selection, safety manufacturing and others.

Read More: Pharmaceutical Excipients Market Poised for Growth