ABSTRACT
Pharmaceutical excipients are additives used in the formulation of pharmacologically active drugs and can be viewed as any ingredient of a medicinal product other than the active ingredient. Excipients include diluents, fillers and bulking agents, binders and adhesives, propellants, disintegrants, lubricants and glidants, colors, flavors, coating agents, polishing agents, fragrances, sweetening agents, polymers, and waxes. A new excipient is a compound that has not been used previously or permitted for use in a pharmaceutical preparation. The need to develop an excipient as a new chemical entity, leading to expense and potential time delay, has resulted in a reluctance in the pharmaceutical industry to introduce new materials. Essentially new excipients can be thought of as substances resulting from a structural modification of an ‘‘approved’’ excipient, a recognized food additive, a structurally modified food additive, or a constituent of an over-the-counter medicine.
