Utilisation of the Post Granulation Process to Improve the Compression Process of Tableting.

Abstract

Wet granulation is the most commonly used type of granulation in the tableting process.The wet granules, formed from a mixture of non-volatile liquids and APIs with excipients, undergo different unit operations and processes like drying of the wet granules in a fluidized bed dryer,blending with other APIs, lubrication of the granules and sizing and their storage in MIPC.The post granulation processes are vital in determining thequality and yield of the granules and hence the quality of the tablets.This study focused on the fluidized bed drying and storage of the wet granules. It was found that most formulation related problems of compression process originate from the effects of the post wet granulation process. This formed the basis of the study and the objectives included determining the minimum fluidization velocity required for the drying of the wet granules, the effect of storage on quality of the dried granules and the investigating the relationship between inlet air temperature and the residence time for drying of the wet granules.The findings of this study will help us to know how best we can utilize the inlet air temperature and residence time relationship: the velocity of air above which fluidization process occurs in order to avoid under-and over-granulated batches, a major problem in granulation.This will help us mitigate formulation-related problems. Intersection method was employed to obtain the minimum fluidization velocity as 2.6m/s. On comparison of the expected optimal value and the experimental optimal values, there was a small difference.The inlet air and residence time were obtained for different batches of Lumartem production.A graphical representation of the obtained data was obtained and the resultant relationship obtained. It was found that the two properties were inversely related and therefore an increase in the inlet air temperature is needed to shorten the residence time of the wet granules in the fluidized bed dryer. However, the limits of the inlet air temperature were not considered and therefore should be given due consideration. This is because beyond a certain temperature, decomposition of the granules may occur. Necessary adjustments being made in the optimum values of air velocity and reasonable increase in the inlet air temperature may see realistic improvement in the tableting process and hence the quality of tablets delivered to the final consumer