Critical factors in manufacturing multi-layer tablets--assessing material attributes, in-process controls, manufacturing process and product performance

International Journal of Pharmaceutics
Sivakumar R Vaithiyalingam, Vilayat A Sayeed

Abstract

Advancement in the fields of material science, analytical methodologies, instrumentation, automation, continuous monitoring, feed forward/feed back control and comprehensive data collection have led to continual improvement of pharmaceutical tablet manufacturing technology, notably the multi-layer tablets. This review highlights the material attributes, formulation design, process parameters that impact the performance, and manufacturability of the multi-layer tablets. It also highlights on critical-to-quality elements that needs to be addressed in the regulatory submission.

References

Sep 1, 1982·Journal of Pharmaceutical Sciences·H SchottS Feldman
Jul 30, 1999·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·T Sebhatu, G Alderborn
Apr 17, 2002·International Journal of Pharmaceutics·Calum R Park, Dale L Munday
Mar 24, 2005·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·L MaggiU Conte
May 16, 2006·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·V BusigniesP Tchoreloff
Apr 25, 2007·Journal of Pharmaceutical Sciences·Xiaorong HeGregory E Amidon
Aug 7, 2007·The American Journal of Medicine·Sripal BangaloreFranz H Messerli
Oct 31, 2007·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Srisagul SungthongjeenSatit Puttipipatkhachorn
Oct 2, 2008·Chemical & Pharmaceutical Bulletin·Jayabalan NirmalMuthuraja Nagarajan
Dec 9, 2008·International Journal of Pharmaceutics·Takahiro YamamuraKeiji Yamamoto
Dec 24, 2008·Acta Pharmaceutica : a Quarterly Journal of Croatian Pharmaceutical Society and Slovenian Pharmaceutical Society, Dealing with All Branches of Pharmacy and Allied Sciences·Sajjan Aryal, Natasa Skalko-Basnet

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Citations

May 18, 2013·International Journal of Pharmaceutics·Masahiro NiwaKatsuhide Terada
Dec 5, 2013·International Journal of Pharmaceutics·Masahiro Niwa, Yasuhiro Hiraishi
Dec 29, 2013·International Journal of Pharmaceutics·Admassu AbebeAlberto M Cuitiño
Mar 9, 2012·Drug Development and Industrial Pharmacy·M Y YangC S Gao
Nov 8, 2015·International Journal of Pharmaceutics·Kitti PapósTamás Sovány
Dec 19, 2015·Acta Pharmaceutica : a Quarterly Journal of Croatian Pharmaceutical Society and Slovenian Pharmaceutical Society, Dealing with All Branches of Pharmacy and Allied Sciences·Sandra Urek BlatnikStanko Srčič
Jul 11, 2012·International Journal of Pharmaceutics·Fridrun Podczeck
Feb 15, 2011·International Journal of Pharmaceutics·Fridrun Podczeck
Sep 24, 2013·International Journal of Pharmaceutics·Virginie BusigniesPierre Tchoreloff
Oct 11, 2013·Saudi Pharmaceutical Journal : SPJ : the Official Publication of the Saudi Pharmaceutical Society·K Mohana Raghava SrivalliJ Balasubramaniam
Oct 25, 2016·International Journal of Pharmaceutics·Luca CastratiPierre Tchoreloff
Nov 5, 2016·International Journal of Pharmaceutics·Hien Van NguyenBeom-Jin Lee
Feb 1, 2017·Journal of Pharmaceutical Sciences·Luca CastratiPierre Tchoreloff
Jun 21, 2021·Advanced Drug Delivery Reviews·Muhammad Sohail ArshadKendal Pitt

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