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Assessing compressibility and compactibility of powder formulations with Near-Infrared Spectroscopy
JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)
 
ID 1183612
Author(s) Gentis, Nicolaos D; Vranic, Branko Z; Betz, Gabriele
Author(s) at UniBasel Betz, Gabriele
Vranic, Branko
Year 2013
Title Assessing compressibility and compactibility of powder formulations with Near-Infrared Spectroscopy
Journal Pharmaceutical development and technology
Volume 18
Number 1
Pages / Article-Number 156-71
Keywords Solid dosage form, powder compaction, tablet, quality, development, drug design
Abstract

Context: The compressibility and compatibility of a powder formulation is usually determined by compaction and following destructive tensile strength and relative density measurement of the final compact. Objective: In this study, a non-destructive method with Near-Infrared Spectroscopy (NIRS) was designed and evaluated for the measurement of powder compressibility and compactibility. Materials and Methods: 12 different formulations with a wide range of difference in properties were investigated by compaction and analysis of the resulting tablets. Two similar tablet batches were produced with every formulation. Relative density and tensile strength were measured with the traditional, destructive method on one tablet batch while a newly developed non-destructive chemometric NIRS method was applied for the second batch. The outcomes of the two approaches were compared to validate the developed method. All data sets were applied to three established mathematical equations to calculate equation factors, which are claimed to represent the formulation compressibility and compactibility. The study focus was set on the equation factor value comparison between the traditional and the newly designed method. Results & Discussion: The results showed a high similarity between the outcomes of the two methods. An essential difference was noticed for the outcomes of the equation factors after application to the Leuenberger equation. Conclusion: The approach with the NIRS is suggested as a promising tool for a reliable inline quality monitoring in the tablet manufacturing process.

Publisher Marcel Dekker
ISSN/ISBN 1083-7450
edoc-URL http://edoc.unibas.ch/dok/A6002771
Full Text on edoc No
Digital Object Identifier DOI 10.3109/10837450.2012.663388
PubMed ID http://www.ncbi.nlm.nih.gov/pubmed/22506493
ISI-Number WOS:000312008200018
Document type (ISI) Journal Article
Additional Information Note: Online publiziert am 16.4.2012
 
   

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