Environment, Development and Sustainability

, Volume 15, Issue 1, pp 1–21

A system view of solvent selection in the pharmaceutical industry: towards a sustainable choice

  • S. Perez-Vega
  • E. Ortega-Rivas
  • I. Salmeron-Ochoa
  • P. N. Sharratt
Review

DOI: 10.1007/s10668-012-9365-5

Cite this article as:
Perez-Vega, S., Ortega-Rivas, E., Salmeron-Ochoa, I. et al. Environ Dev Sustain (2013) 15: 1. doi:10.1007/s10668-012-9365-5

Abstract

This paper presents a review of approaches that may be useful for the selection of solvents in the early stages of process development for the synthesis of active pharmaceutical ingredients. Characteristics of the methodologies and their applicability in early stages are explored. Early stages of development are recognised as ideal for detecting benefits and issues regarding the use of solvents. The “system” concept is introduced for the evaluation and selection of solvents in pharmaceutical processes; this concept does not yet seem to be widely utilised within the fine chemicals and pharmaceutical industries. System analysis is considered an important tool for viewing solvent selection from a holistic perspective. Hence, approaches suitable for the early stages of development and considering a holistic perspective might deliver more sustainable processes. The evolution of the synthesis of Ibuprofen API is used to illustrate this concept.

Keywords

APIHSESolvent selectionSystemEarly stageProcess developmentKey factors

Abbreviations

API

Active pharmaceutical ingredient

BRITEST

Best route innovative technology evaluation and selection techniques

CAMD

Computer-aided molecular design

EFRAT

Environmental fate and risk assessment

eNRTL-SAC

Ionic non-random two liquid segment activity coefficient thermodynamic model

FDA

Food and drug administration

FPP

Finished pharmaceutical product

GMP

Good manufacturing practice

HAP

Hazardous air pollutants

HF

Anhydrous hydrogen fluoride

HSE

Health safety and environment

LCA

Lifecycle assessment

MACT

Maximum available control technology

MEIM

Methodology for environmental impact minimisation

MHRA

Medicine and healthcare products regulation agency

NRTL

Non-random two liquid thermodynamic model

NRTL-SAC

Non-random two liquid segment activity coefficient thermodynamic model

RSMs

Regulatory starting materials

UNIFAC

Universal Functional Activity coefficient

USEPA

United States environmental protection agency

VOCs

Volatile organic compounds

VOE

Volatile organic emissions

WAR

Waste reduction algorithm

Copyright information

© Springer Science+Business Media B.V. 2012

Authors and Affiliations

  • S. Perez-Vega
    • 1
  • E. Ortega-Rivas
    • 1
  • I. Salmeron-Ochoa
    • 1
  • P. N. Sharratt
    • 2
  1. 1.School of Chemical ScienceAutonomous University of ChihuahuaChihuahuaMexico
  2. 2.Institute of Chemical and Engineering SciencesJurong IslandSingapore