Document Detail

Determination of figures of merit for near-infrared and Raman spectrometry by net analyte signal analysis for a 4-component solid dosage system.
MedLine Citation:
PMID:  18181556     Owner:  NLM     Status:  MEDLINE    
Process analytical technology has elevated the role of sensors in pharmaceutical manufacturing. Often the ideal technology must be selected from many suitable candidates based on limited data. Net analyte signal (NAS) theory provides an effective platform for method characterization based on multivariate figures of merit (FOM). The objective of this work was to demonstrate that these tools can be used to characterize the performance of 2 dissimilar analyzers based on different underlying spectroscopic principles for the analysis of pharmaceutical compacts. A fully balanced, 4-constituent mixture design composed of anhydrous theophylline, lactose monohydrate, microcrystalline cellulose, and starch was generated; it consisted of 29 design points. Six 13-mm tablets were produced from each mixture at 5 compaction levels and were analyzed by near-infrared and Raman spectroscopy. Partial least squares regression and NAS analyses were performed for each component, which allowed for the computation of FOM. Based on the calibration error statistics, both instruments were capable of accurately modeling all constituents. The results of this work indicate that these statistical tools are a suitable platform for comparing dissimilar analyzers and illustrate the complexity of technology selection.
Steven M Short; Robert P Cogdill; Carl A Anderson
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Publication Detail:
Type:  Comparative Study; Journal Article     Date:  2007-11-09
Journal Detail:
Title:  AAPS PharmSciTech     Volume:  8     ISSN:  1530-9932     ISO Abbreviation:  AAPS PharmSciTech     Publication Date:  2007  
Date Detail:
Created Date:  2008-01-09     Completed Date:  2008-01-24     Revised Date:  2013-06-06    
Medline Journal Info:
Nlm Unique ID:  100960111     Medline TA:  AAPS PharmSciTech     Country:  United States    
Other Details:
Languages:  eng     Pagination:  E96     Citation Subset:  IM    
Duquesne University Center for Pharmaceutical Technology, 410A Mellon Hall, 600 Forbes Avenue, Pittsburgh, PA 15282, USA.
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MeSH Terms
Cellulose / chemistry
Chemistry, Pharmaceutical
Drug Compounding
Excipients / chemistry*
Lactose / chemistry
Least-Squares Analysis
Models, Statistical
Reproducibility of Results
Research Design
Signal Processing, Computer-Assisted*
Spectroscopy, Near-Infrared* / instrumentation,  standards
Spectrum Analysis, Raman* / instrumentation,  standards
Starch / chemistry
Technology, Pharmaceutical / instrumentation,  methods*,  standards
Theophylline / chemistry*
Reg. No./Substance:
0/Excipients; 0/Tablets; 0/microcrystalline cellulose; 58-55-9/Theophylline; 63-42-3/Lactose; 9004-34-6/Cellulose; 9005-25-8/Starch

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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