TY - JOUR
T1 - Near-infrared spectroscopy for the detection and quantification of bacterial contaminations in pharmaceutical products
AU - Quintelas, Cristina
AU - Mesquita, Daniela P.
AU - Lopes, João A.
AU - Ferreira, Eugénio C.
AU - Sousa, Clara
N1 - Funding Information:
This work was funded by Fundação para a Ciência e a Tecnologia (FCT) under the project UID/QUI/50006/2013. The authors also thank the FCT Strategic Project of UID/BIO/04469/2013 unit, the project RECI/BBB-EBI/0179/2012 (FCOMP-01-0124-FEDER-027462) and the project “BioInd—Biotechnology and Bioengineering for improved Industrial and Agro-Food processes”, REF. NORTE-07-0124-FEDER-000028 co-funded by the Programa Operacional Regional do Norte (ON.2—O Novo Norte), QREN, FEDER. Daniela Mesquita (SFRH/BPD/82558/2011) and Cristina Quintelas were funded by post-doctoral grants from FCT and ON.2. Clara Sousa was funded by a CIENCIA2008 contract from FCT.
Publisher Copyright:
© 2015 Elsevier B.V. All rights reserved.
PY - 2015/7/27
Y1 - 2015/7/27
N2 - Accurate detection and quantification of microbiological contaminations remains an issue mainly due the lack of rapid and precise analytical techniques. Standard methods are expensive and time-consuming being associated to high economic losses and public health threats. In the context of pharmaceutical industry, the development of fast analytical techniques able to overcome these limitations is crucial and spectroscopic techniques might constitute a reliable alternative. In this work we proved the ability of Fourier transform near infrared spectroscopy (FT-NIRS) to detect and quantify bacteria (Bacillus subtilis, Escherichia coli, Pseudomonas fluorescens, Salmonella enterica, Staphylococcus epidermidis) from 10 to 108 CFUs/mL in sterile saline solutions (NaCl 0.9%). Partial least squares discriminant analysis (PLSDA) models showed that FT-NIRS was able to discriminate between sterile and contaminated solutions for all bacteria as well as to identify the contaminant bacteria. Partial least squares (PLS) models allowed bacterial quantification with limits of detection ranging from 5.1 to 9 CFU/mL for E. coli and B. subtilis, respectively. This methodology was successfully validated in three pharmaceutical preparations (contact lens solution, cough syrup and topic anti-inflammatory solution) proving that this technique possess a high potential to be routinely used for the detection and quantification of bacterial contaminations.
AB - Accurate detection and quantification of microbiological contaminations remains an issue mainly due the lack of rapid and precise analytical techniques. Standard methods are expensive and time-consuming being associated to high economic losses and public health threats. In the context of pharmaceutical industry, the development of fast analytical techniques able to overcome these limitations is crucial and spectroscopic techniques might constitute a reliable alternative. In this work we proved the ability of Fourier transform near infrared spectroscopy (FT-NIRS) to detect and quantify bacteria (Bacillus subtilis, Escherichia coli, Pseudomonas fluorescens, Salmonella enterica, Staphylococcus epidermidis) from 10 to 108 CFUs/mL in sterile saline solutions (NaCl 0.9%). Partial least squares discriminant analysis (PLSDA) models showed that FT-NIRS was able to discriminate between sterile and contaminated solutions for all bacteria as well as to identify the contaminant bacteria. Partial least squares (PLS) models allowed bacterial quantification with limits of detection ranging from 5.1 to 9 CFU/mL for E. coli and B. subtilis, respectively. This methodology was successfully validated in three pharmaceutical preparations (contact lens solution, cough syrup and topic anti-inflammatory solution) proving that this technique possess a high potential to be routinely used for the detection and quantification of bacterial contaminations.
KW - Bacterial contaminations
KW - Chemometrics
KW - FT-NIRS
KW - Pharmaceutical products
KW - Process analytical technology
UR - http://www.scopus.com/inward/record.url?scp=84937775051&partnerID=8YFLogxK
U2 - 10.1016/j.ijpharm.2015.07.005
DO - 10.1016/j.ijpharm.2015.07.005
M3 - Article
C2 - 26151105
AN - SCOPUS:84937775051
SN - 0378-5173
VL - 492
SP - 199
EP - 206
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
IS - 1-2
ER -