Process Analytical Technology, continuous manufacturing, and the development of a surrogate model for dissolution: a pharmaceutical manufacturing statistical engineering case study

Abstract

Abstract Statistical engineering is a recent movement that seeks to promote a systematic application of statistical tools combined with a comprehensive view of project management to solve important commercial problems. We discuss how statistical engineering principles were applied in the development of a surrogate model for dissolution (also referred to as in vitro release), an important physical property of solid dose pharmaceutical products required for marketing. The approach relies on spectroscopic analytical methods, referred to more generally as Process Analytic Technology, to enable monitoring of a batch of pharmaceutical product in real time. Real time release (RTR) is the release to the market of a batch of final product, nearly immediately after its production, rather than the weeks to months currently needed using conventional wet chemistry analytical methods. The development of a surrogate model advances the goal of RTR of a batch of pharmaceutical product, and the application of statistical engineering tools enhances a coherent development process as illustrated in a case study.