title: Critical factors in manufacturing multi-layer tablets--assessing material attributes, in-process controls, manufacturing process and product performance.
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.
authors.affiliation: Division of Chemistry III, OGD, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, MD, USA.
authors.forename: Sivakumar R
authors.initials: SR
authors.lastname: Vaithiyalingam
authors.forename: Vilayat A
authors.initials: VA
authors.lastname: Sayeed
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D019245:Compressive Strength; D006801:Humans; D011786:Quality Control; D013608:Tablets, Enteric-Coated / Q000737:chemistry / Q000592:standards*; D013678:Technology, Pharmaceutical / Q000379:methods*; D013718:Tensile Strength
chemical_list: D013608:Tablets, Enteric-Coated