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

[Display omitted] 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 practi...

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Bibliographic Details
Published in:International journal of pharmaceutics 2024-12, Vol.670, p.125070, Article 125070
Main Authors: Martínez-Jiménez, Jorge E., Sathisaran, Indumathi, Reyes Figueroa, Francheska, Reyes, Stephanie, López-Nieves, Marisol, Vlaar, Cornelis P., Monbaliu, Jean-Christophe M., Romañach, Rodolfo, Ruaño, Gualberto, Stelzer, Torsten, Duconge, Jorge
Format: Article
Language:English
Subjects:
Formulation
Personalized medicine
Pharmaceutical manufacturing
Precision medicine
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Summary:[Display omitted] 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.
ISSN:0378-5173
1873-3476
1873-3476
DOI:10.1016/j.ijpharm.2024.125070