![]() ![]() ![]() Among the granulation techniques, wet granulation method can be the most popular one. Main objectives of the process include: reduce dustiness, improve flowability, improve density of materials, minimize tablet weight variation, and improve dissolution rate. ![]() Granulation has long been considered as a pharmaceutical process of particle design where fine particles are changed to larger ones as granules or agglomerates. In overall, the combined experimental design and principal component analysis approach allowed to better understand the correlation between process variables and granules and tablet attributes. Moreover, multivariate data analysis demonstrated that impeller speed and massing time had strong correlation with the granule and tablet properties. ![]() The SEM image of granules showed that spherical and smooth granules produced at higher impeller speed, whereas rough and irregular shape granules at lower speed. Overall desirability was 0.84 suggesting that the response values were closer to the target one. The results also revealed that quality of granules and tablets could be optimized by adjusting specific process variables (impeller speed 1193 rpm, water spray rate 3.7 ml/min, and wet massing time 2.84 min). The experimental results showed that the impact of impeller speed was more dominant compared to wet massing time and water addition rate. Multiple linear regression models were built providing understanding of the impact of each variable on granule hardness, Carr's index, tablet tensile strength, surface mean diameter of granules, and compression behavior. Formulation compositions were kept constant to minimize their influence on granules properties. The variables were selected based on the risk assessment as impeller speed, liquid addition rate, and wet massing time. The knowledge gained was intended to be used for Quality-by-Design based process design and optimization. The current study was to understand how process variables of high shear wet granulations affect physical properties of granules and tablets. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |