Microcrystalline cellulose, a direct compression binder in a quality by design environment—A review
Year: 2014
Type: review
Abstract: The ICH quality vision introduced the concept of quality by design (QbD), which requires a greater understanding of the raw material attributes, of process parameters, of their variability and their interactions. Microcrystalline cellulose (MCC) is one of the most important tableting excipients thanks to its outstanding dry binding properties, enabling the manufacture of tablets by direct compression (DC). DC remains the most economical technique to produce large batches of tablets, however its efficacy is directly impacted by the raw material attributes. Therefore excipients' variability and their impact on drug product performance need to be thoroughly understood. To help with this process, this review article gathers prior knowledge on MCC, focuses on its use in DC and lists some of its potential critical material attributes (CMAs).
Authors: Gregory Thoorens, Fabrice Krier, Bruno Leclercq, Brian Carlin, Brigitte Evrard
Institutions: University of Liège, FMC (United States)
Language: English
Subfield: Computational Mechanics
Field: Engineering
Domain: Physical Sciences
Open Access status: hybrid
Estimated APC paid: $4,650
OpenAlex ID: W2009242118