posted on 2023-06-09, 14:05authored byMohammed Maniruzzaman, Ali Nokhodchi, Robert O Williams III
In recent years, the pharmaceutical industry is going through a period of exceptional changes, where emerging market expansion and technology advances have increased sector growth. Many new drug candidates found in the drug discovery pipeline generally have poor physicochemical and biopharmaceutical properties, such as poor solubility or low chemical compatibility, which severely limits their oral bioavailability and thus therapeutic performance. The reduction in the numbers of new molecules coming to market along with the expiry of the existing patents is also forcing the pharmaceutical industry to invest in and embrace new technologies that can save both costs and time for manufacture. One timely solution to the growing need can be the exploitation of continuous manufacturing and process engineering with better controls and reproducibility and low labour and production cost. Recently, implementation of process analytical tools (PAT) under the Quality by Design (QbD) paradigm has attracted a strong interest by pharmaceutical scientists as well as the regulatory agencies across the globe. The ultimate aims of these QbD approaches are being the science-based design and development of formulation and manufacturing processes for the predefined product quality objects.