MONITORING OF CRITICAL PROCESS VARIABLES FOR PILOT PLANT SCALE-UP STUDIES OF PARACETAMOL TABLETS

The objective of the study was to undertake pilot plant scale-up batches of paracetamol immediate release tablets by designing, optimizing and validating the tablet manufacturing process. A process design was developed to define the critical process variables and monitor it throughout the manufacturing process. Critical processes such as blending of intragranular ingredients, drying of the granules, lubrication and tablet compression were optimized. The process optimization was carried out based on the critical quality attributes of the formulation and their predetermined limits. Process validation was carried out to assure reproducibility in the quality of the product. The scale-up process produced batches showing good reproducibility with a relative standard deviation of less than 2%.