title: Evaluation of risk and benefit in thermal effusivity sensor for monitoring lubrication process in pharmaceutical product manufacturing.
abstract: In the process design of tablet manufacturing, understanding and control of the lubrication process is important from various viewpoints. A detailed analysis of thermal effusivity data in the lubrication process was conducted in this study. In addition, we evaluated the risk and benefit in the lubrication process by a detailed investigation. It was found that monitoring of thermal effusivity detected mainly the physical change of bulk density, which was changed by dispersal of the lubricant and the coating powder particle by the lubricant. The monitoring of thermal effusivity was almost the monitoring of bulk density, thermal effusivity could have a high correlation with tablet hardness. Moreover, as thermal effusivity sensor could detect not only the change of the conventional bulk density but also the fractional change of thermal conductivity and thermal capacity, two-phase progress of lubrication process could be revealed. However, each contribution of density, thermal conductivity, or heat capacity to thermal effusivity has the risk of fluctuation by formulation. After carefully considering the change factor with the risk to be changed by formulation, thermal effusivity sensor can be a useful tool for monitoring as process analytical technology, estimating tablet hardness and investigating the detailed mechanism of the lubrication process.
authors.affiliation: Manufacturing Department Kawashima Plant and.
authors.forename: Jumpei
authors.initials: J
authors.lastname: Uchiyama
authors.forename: Yoshiteru
authors.initials: Y
authors.lastname: Kato
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Uemoto
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D006244:Hardness; D054327:Lubricants / Q000737:chemistry; D008153:Lubrication / Q000379:methods*; D011208:Powders / Q000737:chemistry; D018570:Risk Assessment; D013607:Tablets / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D054327:Lubricants; D011208:Powders; D013607:Tablets
keywords: Magnesium stearate; mechanism of lubrication process; monitoring lubrication process; process analytical technology; tablet hardness; thermal effusivity