Issue link: https://www.e-digitaleditions.com/i/1509086
4 Pharmaceutical Technology ® Trends in Formulation 2023 eBook PharmTech.com ALEKSANDR - STOCK.ADOBE.COM D evelopment of any new drug product from concept to commercialization requires de- tailed understanding of drug properties, ex- cipients, manufacturing processes, analyt- ical methods, and regulatory requirements in target markets. Solid oral dosage forms are the preferred delivery route, and it is vital to select the right core excipients early in the development process to ensure stability, performance quality attributes, patient ac- ceptance, and manufacturability. The pharmaceutical excipients market continues to grow due to the surge in generic drugs, an increas- ing development of novel drugs, and the development of new multifunctional excipients. As a consequence, the global pharmaceutical excipients market is fore- cast to grow from $9.1 billion in 2023 to $11.5 billion in 2027, a compound annual growth rate of over 6% (1). This is slightly below forecasts for biologics, which are predicted to grow at around 8% over the same period (2). Moreover, the costs of R&D for a new med- icine could range from $944 million to $2.83 billion (based on 2019 prices) with an anticipated increase over time (3). While these estimates are dynamic and dependent upon the sources and methodology used, they speak volumes about the challenges that the in- dustry continues to face. T he pa s t decade h a s seen sig n i f ica nt i n nova- tions in formulation and delivery methods for APIs, wh ic h mea n s t h at opt i m i z i ng t he dosage for m is now h igh ly complex. Key aspects i nclude A PI characteristics, the intended drug release profile (im mediate, modif ied, or ta rgeted release), dose size, target patient group, and the manufacturing process. For coatings, the tablet shape, color, sta- bilit y, ease of swallow, taste-masking, and brand ident i f icat ion a re i mpor t a nt con siderat ion s, i n add it ion to loca l reg u lator y i n for mat ion for t he finished dosage product. The New Digital Era for Formulation Development Shahrzad Missaghi, PhD, is senior manager—Product Development, and Jason Hansell is global technical excellence manager; both at Colorcon. A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.