A review of precision medicine in developing pharmaceutical products: Perspectives and opportunities.

Over the next decade, Precision Medicine (PM) is poised to become the standard of care in pharmaceutical therapy, necessitating a fundamental transformation in the design and development of innovative custom-made drug products. To date, a comprehensive review linking PM with practical personalized drug formulations is missing. This review attempts to provide an overview of state-of-the-art formulation approaches capable of translating PM evaluation and resulting recommendations (clinical research) into tailored drug products (non-clinical research) for real-world patients. Comprehensive literature searches in four scientific databases (Scopus, SciFinder, Web of Science, and PubMed) were performed. Current approaches to point-of-care PM formulations and needs-based locally distributed manufacturing presently under research & development (R&D) as alternatives to conventional large-scale manufacturing of one-size-fits-all drug products are discussed. The following methods were identified as the most promising PM formulation strategies: tablet splitting, liquid dispensing, compounding pharmacies, additive manufacturing, drug impregnation, drug extrusion, and orodispersible films (ODFs). The challenges and opportunities of current state-of-the-art formulation technologies that can enable making PM routinely accessible in practice settings will be discussed. Additionally, light will be shed on point-of-use manufacturing (Pharmacy on Demand) as an uncharted territory for PM and its pathway towards practical implementation.