Evaluation of the suitability of various lubricants for direct compaction of sorbitol tablet formulations

• Main Authors: Saniocki Ines, Sakmann Albrecht Leopold, Claudia S
• Format: Article
• Language: English
• Published: International Pharmaceutical Excipients Council
• Series: Journal of Excipients and Food Chemicals
• Online Access: http://jefc.scholasticahq.com/article/1011-evaluation-of-the-suitability-of-various-lubricants-for-direct-compaction-of-sorbitol-tablet-formulations.pdf

There is an increasing interest in using polyols, such as sorbitol, in pharmaceutical tablet formulations due to their sweet taste and reduced calorie content and noncariogenic characteristics. Sorbitol is a common tableting excipient and plays a major role in the manufacture of chewable and sublingual tablets. One limitation of sorbitol as a tableting excipient is that its hygroscopic nature may cause pronounced friction, as well as, sticking to the punch surfaces. Therefore, the aim of the present study was to evaluate the suitability of various lubricants for reducing friction and preventing sticking during the compaction of sorbitol-containing tablets. The efficiency of the most commonly used lubricant, magnesium stearate, was compared to that of sodium stearyl fumarate (Pruv®), microprilled poloxamer 407 (Lutrol® micro 127) and PEG 4000. Compaction studies were performed using both an eccentric tablet press and a rotary tablet press. In addition to their compaction properties, the effect of the investigated lubricants on the tablet properties was evaluated. Considering both the lubricant efficiency and the influence on tablet properties of the investigated lubricants, Pruv® was found to be most suitable for compaction of the investigated sorbitol tablet formulations. However, the best overall lubricant performance, accompanied by excellent tablet properties, was observed with a mixture (1:1) of magnesium stearate and Pruv®, indicating synergism between these lubricants.