Effect of Manufacturing Process on Stress Relaxation in Production of Cefuroxime Axetil Tablets

The main objective of this study was to investigate the effects of compression forces applied during slugging on the dissolution rates of cefuroxime axetil, since the cefuroxime axetil is not stable during wet granulation and that aging affects the dissolution of core and film coated tablets where slugging was the method of choice in this study. Dissolution was found to be dramatically affected by the compression force on tablets. It has also been shown that interparticle bonding affects relaxation times, and that relaxation increases with decreased bonding. The results obtained in this study confirmed that controlling both the compression force during slugging and film coating process of the core tablets will result in dissolution profiles within the acceptable USP limits. Furthermore, it has been demonstrated that any increase in compression force during slugging leads to dissolution rates outside the Pharmacopoeia limits, and therefore the undesired consequences of longer relaxation times