Analysis of granulation systems using idealistic modeling-principle of similarity for scaling up sustainable production lines

Abstract

Pharmaceutical industry produces safe, effective, affordable, and quality medicines used to guarantee a healthy life and promote the well-being of the entire population in a sustainable way. Currently, the solid dosage form is the preferred formulation for human use. However, the large scale production of these medicines it requires well-tested formulation and appropriate equipment because any substantial variation in the development of the pharmaceutical product can alter the final quality of the product, causing the entire manufactured batch to be discarded. For this reason, this research aimed to analyze and understand the behavior of the variables involved in the wet granulation process while scaling from a laboratory system and a production line unit to transfer the results obtained to a large-scale production unit of solid dosage forms to meet the health needs of the world population. This study was carried out under a mixed approach applying quantitative and qualitative technologies to explain and predict the behavior of the involved variables while scaling from a laboratory system to a production line unit. It was found that there are some regularities and causal relationships between geometric, kinematic, and dynamic similarities.