Green preformulation

Green preformulation is a relatively new kind of approach, which is related to green chemistry and sustainability, and is directed at the preformulation stage of pharmaceutical research, where the first definitions of the physicochemical characteristics of the active pharmaceutical ingredient and its interactions are carried out. Specifically, it seeks to apply concepts of “benign by design” and the GREENER pharmaceuticals series to preformulation with the objective of minimizing the use of hazardous solvent systems, while favouring the use of renewable and biodegradable excipients and the inclusion of life cycle thinking. There is a summation of traditional parameters for preformulation (solubility, pKa, polymorphism, stability, and compatibility), and it is also highlighted how these can be assessed using low solvent, high throughput, and in silico approaches, 0p-in conjunction with solid state methods that produce lower quantities. The integration of green pre-formulation within Quality by Design (QbD) as part of the Common Technical Document’s (CTD) development part, as well as new developments within environmental assessment methods, is also discussed to demonstrate the role of initial “green” options to eventually generate minimized life cycle effects for better sustainable healthcare.