Experimental Analysis of Tablet Properties for Discrete Element Modeling of an Active Coating Process

• Published in: AAPS PharmSciTech Vol. 14; no. 1; pp. 402 - 411
• Main Authors: Just, Sarah, Toschkoff, Gregor, Funke, Adrian, Djuric, Dejan, Scharrer, Georg, Khinast, Johannes, Knop, Klaus, Kleinebudde, Peter
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.03.2013
• Subjects: Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Chemistry, Pharmaceutical; Coatings; Dosage Forms; Gastrointestinal Tract - drug effects; Materials Testing; Pharmacology/Toxicology; Pharmacy; Research Article; Tablets; tablet mechanical properties; tablet coating; DEM simulation; active film coating; dynamic angle of repose
• ISSN: 1530-9932; 1530-9932
• DOI: 10.1208/s12249-013-9925-5

Coating of solid dosage forms is an important unit operation in the pharmaceutical industry. In recent years, numerical simulations of drug manufacturing processes have been gaining interest as process analytical technology tools. The discrete element method (DEM) in particular is suitable to model tablet-coating processes. For the development of accurate simulations, information on the material properties of the tablets is required. In this study, the mechanical parameters Young’s modulus, coefficient of restitution (CoR), and coefficients of friction (CoF) of gastrointestinal therapeutic systems (GITS) and of active-coated GITS were measured experimentally. The dynamic angle of repose of these tablets in a drum coater was investigated to revise the CoF. The resulting values were used as input data in DEM simulations to compare simulation and experiment. A mean value of Young’s modulus of 31.9 MPa was determined by the uniaxial compression test. The CoR was found to be 0.78. For both tablet–steel and tablet–tablet friction, active-coated GITS showed a higher CoF compared with GITS. According to the values of the dynamic angle of repose, the CoF was adjusted to obtain consistent tablet motion in the simulation and in the experiment. On the basis of this experimental characterization, mechanical parameters are integrated into DEM simulation programs to perform numerical analysis of coating processes.