A multivariate data analysis approach to tablet sticking on an industrial scale: a qualitative case study of an ibuprofen-based formulation

被引:9
作者
Dembele, Mahamadou [1 ,2 ]
Hudon, Sophie [2 ]
Simard, Jean-Sebastien [2 ]
Abatzoglou, Nicolas [1 ]
Gosselin, Ryan [1 ]
机构
[1] Univ Sherbrooke, Dept Chem & Biotechnol Engn, Sherbrooke, PQ, Canada
[2] Pfizer Canada, Kirkland, PQ, Canada
基金
加拿大自然科学与工程研究理事会;
关键词
Tablet sticking; powder compaction; multivariate data analysis; principal component analysis; linear discriminant analysis; partial least squares-discriminant analysis; PUNCH STICKING; SURFACE-ROUGHNESS; COMPRESSION; COMPACTION; PROPENSITY; PRESSURE; FORCE;
D O I
10.1080/10837450.2022.2153866
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Objectives: Sticking is one of the most common and damaging issues that occur during tablet manufacturing. Sticking is the adhesion of powder onto tooling surfaces during compression. Because of the numerous factors involved in its occurrence, understanding tablet sticking requires the simultaneous investigation of these factors to clarify their possible interactions. However, conducting such a study experimentally can present a significant financial and technical burden. In this study, we aimed to leverage the large amount of data that is usually generated during industrial manufacturing to gain insights into sticking.Methods: This was achieved by collecting and analyzing a total of 71 historical batches that used an ibuprofen-based formulation. We associate each batch with a hundred parameters, including a qualitative descriptor of sticking, and employ a predefined methodology based primarily on multivariate data analysis.Results and Conclusions: Our results highlight the role of lubrication, water content, and the low melting point of ibuprofen in its sticking tendency. Based on these findings, we propose and discuss an industrial manufacturing data analysis approach to sticking and its associated systematic methodology, consisting of collection, exploration, and data modeling.
引用
收藏
页码:1093 / 1109
页数:17
相关论文
共 50 条
[1]  
Al-Karawi C., 2018, THESIS
[2]   A comparative study on the sticking tendency of ibuprofen and ibuprofen sodium dihydrate to differently coated tablet punches [J].
Al-Karawi, Claudia ;
Leopold, Claudia S. .
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, 2018, 128 :107-118
[3]   Novel aspects on the direct compaction of ibuprofen with special focus on sticking [J].
Al-Karawi, Claudia ;
Lukasova, Ivana ;
Sakmann, Albrecht ;
Leopold, Claudia S. .
POWDER TECHNOLOGY, 2017, 317 :370-380
[4]   Effect of tableting conditions on the sticking of tablet using ibuprofen [J].
Aoki, S ;
Danjo, K .
YAKUGAKU ZASSHI-JOURNAL OF THE PHARMACEUTICAL SOCIETY OF JAPAN, 1998, 118 (11) :511-518
[5]  
Boussaoud B., 2003, DIAGNOSIS PHARM ENG, V1
[6]   Characterising the surface adhesive behavior of tablet tooling components by atomic force microscopy [J].
Bunker, Matt ;
Zhang, Jianxin ;
Blanchard, Rob ;
Roberts, Clive J. .
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2011, 37 (08) :875-885
[7]   Sticking and Picking in Pharmaceutical Tablet Compression: An IQ Consortium Review [J].
Chattoraj, Sayantan ;
Daugherity, Patrick ;
McDermott, Todd ;
Olsofsky, Angela ;
Roth, Wyatt J. ;
Tobyn, Mike .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2018, 107 (09) :2267-2282
[8]   Solving a sticking related tablet problem by multivariate statistics and computational tomographic analysis [J].
Costa, Nuno F. ;
Paulo, Mario G. ;
Diogo, Herminio P. ;
Pinto, Joao F. .
POWDER TECHNOLOGY, 2020, 367 :456-463
[9]  
Danjo K, 1997, CHEM PHARM BULL, V45, P706
[10]   Collinearity: a review of methods to deal with it and a simulation study evaluating their performance [J].
Dormann, Carsten F. ;
Elith, Jane ;
Bacher, Sven ;
Buchmann, Carsten ;
Carl, Gudrun ;
Carre, Gabriel ;
Garcia Marquez, Jaime R. ;
Gruber, Bernd ;
Lafourcade, Bruno ;
Leitao, Pedro J. ;
Muenkemueller, Tamara ;
McClean, Colin ;
Osborne, Patrick E. ;
Reineking, Bjoern ;
Schroeder, Boris ;
Skidmore, Andrew K. ;
Zurell, Damaris ;
Lautenbach, Sven .
ECOGRAPHY, 2013, 36 (01) :27-46