A Critical Review on Pharmaceutical Manufacturing Sciences

Abstract

The entire pharmaceutical industry desperately needs both creative technical solutions and fundamental research work to allow highly engineered drug products to be manufactured. The development of complex drug delivery systems (DDSs) on a commercial scale using existing technologies is difficult. This analysis covers essential elements of manufacturing sciences, starting with methods for risk management and experiment design (DoE) techniques. Where appropriate, experimental methods should be accompanied by analytical approaches. In this respect, state-of-the-art methods of mechanistic process modelling are listed in detail. The implementation of material science instruments paves the way for the processing of future DDSs on a molecular basis. A snapshot is presented of some of the existing tools. In addition, general engineering concepts that include process measurement and process control solutions are discussed. The last part of the review addresses future production solutions, covering continuous processing and, specifically, technology based on hot-melt processing and printing. Finally, issues are addressed relating to the application of these innovations as part of future health care systems.