ABSTRACT
What Is an Excipient? What is an excipient? For the purposes of this chapter, it will be taken to mean any component in a pharmaceutical formulation other than the active ingredient or a prodrug of the active ingredient. It will therefore include any solvent or diluent (liquid or solid) and any additive in the formulation that is intended to perform a particular function. It will include materials added to the formulation that act as stabilizer, thickener, surfactant, antifoaming agent, solubilizer, plastcizer, lubricant, buffer, pH adjustment agent, adsorbent, binding agent, suspending agent, coating agent, moisture-adjusting agent, filler, colouring matter, flavouring agent, fragrance, tonicity-adjusting agent, emulsifier, viscosity-adjusting agent, thickening agent, dispersing agent, propellant, disintegrating agent, antioxidant, antimicrobial preservative, permeation enhancer, constituents of the coating of tablets or the shell of capsules, adhesive components for transdermal delivery systems and compression aids, for example. It will also cover materials added to the formulation during manufacture but which are not present in the final dosage form supplied to the market (such as water in granulation processes or volatile solvents).
