Lubrication In Pharmaceutical Tablet Manufacturing

Abstract

Appropriate compaction properties are critical to ensure a successful and robust tablet manufacture. According to Materials Science Tetrahedron (MST) theory, the quality of the tablet product is determined by the properties of pharmaceutical materials and the process conditions during manufacture. Lubricant, as one of the most important tablet excipients, has great impacts on the flow and mechanical properties of formulation. This work is heavily focused on understanding of the effects of process parameters on the lubrication as well as development of new lubricants for tablet formulation. Magnesium stearate, the most commonly used tablet lubricant, though exhibits excellent lubrication efficiency, leads to deterioration in tablet strength and dissolution. Sodium lauryl sulfate (SLS), Poloxamer 188 and Poloxamer 407 were selected as MgSt-alternative lubricants to be tested in tablet formulations. We found that the lubrication efficiency of these three materials are comparable with MgSt. More importantly, no significant tablet strength reduction was observed. Given to the higher hydrophilicity, tablets containing either of SLS, P188 or P407 showed enhanced dissolution profiles compared with MgSt containing tablets. Furthermore, robustness of formulation was remarkably improved when P188 or P407 was used as lubricant.