Quality by Design (QbD) Concept for Formulation of Oral Formulations for Tablets

Pharmaceutical scientists use the Quality by Design (QbD) approach to develop robust oral dosage forms, such as tablets and pellets, by considering critical quality attributes and critical material attributes. The critical material attributes (CMAs) of raw materials are crucial for determining the critical quality attributes (CQAs) of a tablet. It is essential to identify and control the properties of active pharmaceutical ingredients (APIs), excipients, lubricants, and other materials to ensure optimal tablet quality and performance. The Risk Priority Number (RPN) method is used to conduct risk assessments of critical process parameters (CPPs) and critical material attributes (CMAs) in oral dosage forms. The RPN method ranks risks based on severity, occurrence, and detectability, and provides a numerical value that evaluates the risk of physical and chemical attributes affecting CQAs in oral dosage forms. To establish the design space, an in-depth understanding of the manufacturing process is crucial, including the effects of raw material properties, process parameters, and intermediate properties. Accomplishing this requires experimental investigations, data analysis, and a comprehensive understanding of the scientific and engineering principles. Multivariate modelling techniques, such as partial least squares (PLS) and response surface methodology (RSM), are utilised to establish connections between the input formulation parameters, process parameters, and tablet attributes. These models help comprehend the impact of variables on tablet properties and aid in the optimisation process. Additionally, Design of Experiments (DoE) is a systematic method employed to study the impact of multiple variables simultaneously and determine critical process parameters. It allows for the examination of a wide range of formulation and process variables to optimise the tablet formulation.