REVIEW OF REGULATIONS FOR NOVEL PHARMACEUTICAL EXCIPIENTS

Excipients form a bulk of the finished dosage forms. They affect various properties in the finished products like patient acceptability, dissolution, bioavailability, rate of release of active ingredients etc. Now a day’s many new means of drug delivery systems are coming up which require new excipients to improve the characteristics of the dosage form. Further new excipients are being discovered which are replacing the older ones by having better desirable characteristics. The novel excipients are developed in such a way that they are more compatible with the active ingredients but there are several hurdles in their development. The establishment of safety of novel excipients is a major hindrance in their development. The evaluation of novel excipients requires huge investments of time and money. As a result, pharmaceutical manufacturers are not interested in evaluating novel excipients in terms of safety and efficacy because any discrepancies in their use may cause delays in the approval of the formulations causing a major loss to the manufacturers. Also there are no well defined laws for their evaluation in most of the countries. However, the regulatory agencies worldwide have been trying to draft guidelines for the safety evaluation of the novel excipients and establish a procedure to review the novel excipients. The article reviews the guidelines drafted by regulatory authorities of USFDA, EU and the IPEC for the safety evaluation of the novel excipients and lays emphasis to make these guidelines mandatory before any new excipient is used commercially. Further a uniform procedure of evaluation of these excipients should be followed throughout the world