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34 Pharmaceutical Technology ® Trends in Formulation eBook September 2024 PharmTech.com JOHN - STOCK.ADOBE.COM Forging Ahead in Formulation Susan Haigney New and existing technologies, as well as a patient-centric focus, are pushing drug formulation into exciting directions. T here are a variety of factors pushing innovation in formulation of drug products forward. The desire to create new delivery methods for biologics, the need to increase patient adherence, and technol- ogies such as artificial intelligence (AI) are some of the trends drug developers in the industry are cultivating. According to Sibaji Biswas, executive director and chief financial officer at Syngene International, pa- tient-centric approaches have led to formulation strat- egies being reshaped, especially for biologics, with compounds for low solubility and oral bioavailability in small-molecule drugs continuing to see growth. "This has increased demand for solubility and bioavailabil- ity enhancement technologies, with CDMOs [contract development and manufacturing organizations] now needing more comprehensive capabilities so they can take a 'fit-for-purpose' approach to any challenge," says Biswas. "Solid dispersion technology and other solu- bility enhancement methods are gaining prominence, while AI and machine learning [ML] are helping trans- form pharmaceutical formulation by predicting prop- erties and behaviors." The use of ML and AI has been increasing in the bio/pharmaceutical industry. For formulation, they are being used to enhance modeling and predictive approaches, according to Shahrzad Missaghi, senior manager of Product Development, at Colorcon. ML and AI allow for rapid innovation, according to Asma Patel, VP, Integrated Development Services, Quotient Sciences, as long as members of the industry are open to using these technologies. "From a discov- ery perspective, this can continue to fuel complexity in small new chemical and new molecular entities (NCEs/NMEs). Regardless of AI/ML, NCEs/NMEs con- tinue to see an increase in average molecular weights and generation of new classes such as PROTACs [Pro- teolysis targeting chimeras], both creating solubility challenges for pharmaceutical formulation," says Patel. Vincent Levet, PhD, director, Formulation Devel- opment and Production, Ardena, agrees. "[AI] is showing great potential to revolutionize formulation development, from supporting excipient selection to predicting outcomes and optimizing processes."