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Applied Clinical Research, Clinical Trials and Regulatory Affairs


ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Review Article

Safety of Pharmaceutical Excipients and Regulatory Issues

Author(s): Kanteti V.R.N.S. Ramesh*, Hemant Yadav and Omar Sarheed

Volume 6, Issue 2, 2019

Page: [86 - 98] Pages: 13

DOI: 10.2174/2213476X05666181105123750


Background: Pharmaceutical excipients are critical in the formulation of any dosage form. Not many additives employed in the drug product manufacture have properties, which meet the desired qualities that the finished product must have. Therefore, it is mandatory to mix the drug substance with other substances to overcome the deficiencies. As a result, almost all pharmaceutical products are mixtures of active pharmaceutical ingredient and additives. So, there is a compelling need of these substances and normally they occupy the major part of any drug product. Excipients are of different chemical categories that have varying physicochemical properties like solubility, miscibility and the nature and source of these materials vary. With growing number of pharmaceutical excipients and polymers, the question of evaluating their toxicity is becoming a complex issue. Many polymers and novel excipients are now available in the market and with their diverse chemical nature and different sources and presence of impurities and their adverse effects will further complicate the safety profiling of these excipients.

Conclusion: This review article will discuss the unwanted biological activities of some commonly used excipients and issues of the supply of the pharmaceutical excipients that need to be highly regulated and monitored to ensure availability of quality and pure excipient compounds.

Keywords: Excipients, pharmaceutical product, safety, efficacy, biological effects, regulation, stability.

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