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Assessment of diffuse transmission and reflection modes in near-infrared quantification, part 2: Diffuse reflection information depth
JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)
 
ID 531357
Author(s) Saeed, Muhanned; Probst, Leila; Betz, Gabriele
Author(s) at UniBasel Betz, Gabriele
Saeed, Muhanned
Year 2011
Title Assessment of diffuse transmission and reflection modes in near-infrared quantification, part 2: Diffuse reflection information depth
Journal Journal of pharmaceutical sciences
Volume 100
Number 3
Pages / Article-Number 1130-41
Keywords coating, diffuse reflection, information depth, near-infrared spectroscopy, solid dosage form, tableting
Abstract

Near-infrared spectroscopy offers tremendous advantages for pharmaceutical manufacturing as a fast and nondestructive method of quantitative and qualitative analysis. Content uniformity (end-product analytics) and process analytics are two important applications of the method. Diffuse reflection (DR) information depth (vertical sampling span) assessment is of equal importance in content prediction applications and to understand the effect of inhomogeneities in the sample. Three experiments were conducted: (a) 0.5 to 10.0 mm incremental thickness MCC tablets with constant porosity, (b) MCC/phenylbutazone (PBZ) double-layered (DL) tablets (PBZ layer 0%-100% in 0.5 mm steps), and (c) Comparison of placebo and 30% caffeine tablet cores with incremental film coating (film thickness of 0-0.35 mm). Incremental thickness and cluster analysis of DL tablets showed that DR information depth was <0.5 mm, whereas the data fitting from incremental coating showed that signal drop reached 50% at 0.05 to 0.07 mm, depending on the wavenumber and 90% signal drop (10% information content) can be seen between 0.20 and 0.25 mm without extrapolation. These results mean that DR mode for pharmaceutical tablets obtains spectral information from the very surface, and radiation is barely reflected back from beyond thin-film coatings, making it less useful than diffuse transmission mode for core content analysis, especially for thick-coated, multilayer, multicore, or highly inhomogeneous tablets. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:1130-1141, 2011.

Publisher American Pharmaceutical Association
ISSN/ISBN 0022-3549
edoc-URL http://edoc.unibas.ch/dok/A5843100
Full Text on edoc No
Digital Object Identifier DOI 10.1002/jps.22344
PubMed ID http://www.ncbi.nlm.nih.gov/pubmed/20862671
ISI-Number WOS:000287947100032
Document type (ISI) Article
 
   

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