Analytical approach for lubricant characterization of excipients using the surface replication method

Lubricants are indispensable pharmaceutical ingredients for preventing tableting failure due to powder adhesion the die wall. The impact of lubricants was evaluated with use Binding Identification Net Detriment (BIND) surface replication method. Raloxifene hydrochloride (RH) selected as a model chemical high adhesion, and four commercially available tablet – stearic acid, sodium stearyl fumarate, calcium stearate, magnesium stearate were used RH formulation. BIND applied wall analyze effect various on binding properties. preparations without showed poor properties evidenced by much 61.7% density. significantly altered properties, yielding densities 40.2% (stearic acid), 29.7% (stearyl fumarate), 23.0% (calcium stearate), 13.6% (magnesium stearate). Evaluation three grades resulted in two-fold difference between highest lowest Throughout work, conventional methods including visual observations measurement ejection force unable provide qualitative/quantitative evaluations. process depends both axial radial force; however, show only force. At same time, observation could release significant qualitative results. However, allowed quantitative analysis is promising assessment method analyzing impacts optimizing formulations.