Development of an experimental methodology at the tablet compression stage based on Quality by Design principles

In a Quality by Design (QbD) way of working the product is designed to meet patient requirements and the process is also designed to consistently meet product critical quality attributes. This research develops and applies a methodology using design of experiments under a QbD platform that could be used to evaluate the process parameters at the compression stage with significant impact to critical quality attributes (CQA) during the manufacture of tablets. The design space (this is multivariate by definition) established for the critical process parameters (CPP's), provide process data that will mediate scale-up efficiency and will be able to support QbD regulatory submission. The variability form the CPP's was identified and understood during the development process. A control strategy to measure and control the CPP's was recommended to the compression stage to measure and controlled in real time the manufacturing process assuring a drug product in compliance with the CQA.