The primary consideration in selecting appropriate excipients for any lipid-based formulation lies in identifying an excipient or excipient combination that will sol-ubilize the entire drug dose in a volume acceptable for unit oral administration. But equally, if not more important, the drug must be physically and chemically stable in the formulation and the drug release characteristics must remain constant as the formulation ages. This latter requirement is dependent on the physical and chemical stability of the excipients, which like the drug substance, must be carefully monitored during formulation development.
Excipient toxicity has assumed greater importance to regulatory agencies and guidelines are now available describing the safety evaluation of new pharmaceutical excipients (17). The United States Food and Drug Administration (FDA) has published a list of "generally recognized as safe" (GRAS) excipients, which are considered nontoxic to humans and animals and thus, do not require additional toxicity testing when used in formulations. In addition, the agency has published another list of acceptable inactive ingredients currently utilized in previously approved products that most likely will not require additional safety evaluations prior to clinical application (18). However, as formulations often consist of more than one excipient, the possibility of an additive toxicological effect should always be considered.
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