Journal of Pharmaceutical Investigation

, Volume 48, Issue 4, pp 421–429 | Cite as

Excipient risk assessment: possible approaches to assessing the risk associated with excipient function

  • Olena Ruban
  • Yurii Pidpruzhnykov
  • Tetiana KolisnykEmail author


Excipients are an integral part of practically all medicines. Historically, excipients have been regarded as pharmacologically and chemically indifferent within the formulation. However, nowadays excipients along with active pharmaceutical ingredients are the subject of strict monitoring and quality control in pharmaceutical manufacture. According to the current rules of European Union’s Good Manufacturing Practice of Medicinal Products excipients should be subjected to a thorough assessment of the risks associated with their quality, safety and function and classified e.g. as low risk, medium risk or high risk. Thus, in the present article available data on excipient function and functionality is considered, on the basis of which possible approaches for the risk assessment related to the excipient function are proposed. These approaches are presented in the form of schematic algorithms and concern such aspects as dosage form and use of the medicinal product containing the excipient, functional purpose, daily patient intake and functional variability of the excipient.


Excipients Excipient function Pharmaceutical formulation Physicochemical properties Risk assessment 



Acceptable daily intake


Active pharmaceutical ingredient


Cosmetic Ingredient Review


Critical quality attributes


Diethylene glycol


European Union’s Good Manufacturing Practice of Medicinal Products


Food and Drug Administration


Functionality related characteristics




Inactive Ingredient Database


Joint FAO/WHO Expert Committee on Food Additives


Microcrystalline cellulose


Maximum daily dose




European Pharmacopoeia


State Pharmacopoeia of Ukraine


Tolerable daily intake


United States Pharmacopoeia


Compliance with ethical standards

Conflict of interest

All authors declare that they have no conflict of interest.

Ethical approval

This article does not contain any studies with human or animal subjects performed by any of the authors.


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Copyright information

© The Korean Society of Pharmaceutical Sciences and Technology 2017

Authors and Affiliations

  1. 1.Department of Industrial Technology of DrugsNational University of PharmacyKharkivUkraine
  2. 2.Department of Quality ManagementNational University of PharmacyKharkivUkraine

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