Drug formulation is a complicated process. Apart from APIs—active pharmaceutical ingredients—inactive excipients play a key role in a drug’s development. In comparison to the primary components of APIs, pharmaceutical excipients are secondary components.
Understanding what are excipients in pharmaceuticals is key to explaining the formulation process. Originating from the Latin word of excipere, which translates to “receive,” an excipient is a substance or additive that directly receives the active ingredient. As an inactive excipient is any component aside from the active substance, scientists define an excipient exclusively by its dosage form. Let’s examine their contribution to the drug delivery system more closely.
How Pharmaceutical Excipients Are Classified
Pharmaceutical excipients are classified distinctly by their performance function. This classification occurs within a dosage form. Because excipients have no pharmacological effect, their forms are listed on a drug’s label by function.
The most common principal excipient functions—also known as classifications—are as follows: disintegrants, fillers, binders, lubricants, compression aids, sweeteners, flavors, glidants, colors, preservatives, film coatings, dispersing agents, and printing inks. Within these classifications, excipients are used in medicinal products via capsules, tablets, injections, inhalers, and oral liquids.
Drug Development: Selecting an Appropriate Excipient
To further explain what excipients are in pharmaceuticals, one must consider the essential criteria that identify an inactive additive as an excipient. Excipients must be physiologically inactive, chemically stable, and conform to regulatory agencies. These substances must also be free from microbial organisms and have no interference with bioavailability.
Excipients with the above criteria play a critical part in the manufacturing process via their function as a carrier of the active ingredient. Typically, more than one excipient is utilized within the development of a medical product. Due to their basis as a carrier, an incorrect excipient choice for drug formulation can lead to serious toxication. An appropriate excipient will contain ideal pharmacokinetic properties for the anticipated application.
The Connection Between APIs and Excipients
Chosen excipients facilitate absorption, provide stability, and comprise a medicinal product’s delivery system. As stated, excipients are inactive vehicles, and they transport the active drug ingredients (APIs) to the intended site in the body where the drug will exert its action. Excipients’ direct relationship with APIs contributes to a product’s attributes that deem a drug acceptable for consumer use.
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