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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
Review

Abstract

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.

Keywords

Excipients Excipient function Pharmaceutical formulation Physicochemical properties Risk assessment 

Abbreviations

ADI

Acceptable daily intake

API

Active pharmaceutical ingredient

CIR

Cosmetic Ingredient Review

CQAs

Critical quality attributes

DEG

Diethylene glycol

EU GMP

European Union’s Good Manufacturing Practice of Medicinal Products

FDA

Food and Drug Administration

FRCs

Functionality related characteristics

HPC

Hydroxypropylcellulose

IID

Inactive Ingredient Database

JECFA

Joint FAO/WHO Expert Committee on Food Additives

MCC

Microcrystalline cellulose

MDD

Maximum daily dose

NOAEL

No-observed-adverse-effect-level

Ph.Eur.

European Pharmacopoeia

SPhU

State Pharmacopoeia of Ukraine

TDI

Tolerable daily intake

USP

United States Pharmacopoeia

Notes

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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