Issue link: https://www.e-digitaleditions.com/i/1509086
6 Pharmaceutical Technology ® Trends in Formulation 2023 eBook PharmTech.com Formul ation Self-service digital platforms, such as HyperStart C2C by Colorcon, are designed to address the com- plexity of developing a new drug product, through automating formulation and process recommenda- tions, and are gaining momentum as around 75% of business-to-business (B2B) customers prefer en- gagement with digital platforms over in-person in- teractions (4). Intuitive digital platforms empower R&D to make the right decisions at the start of the process and reduce formulation iterations. Having a digital platform at their fingertips enables formu- lation scientists to reduce costs and improve speed to market and this can mean the difference between failure and success. Right first time Although companies are aware of the benef its of investing in early formulation and developing an optimized formulation strategy, they may resort to the same tried and tested approach that they have used for previous products. This can result in lengthy iterations, delays, added costs, and, in the worst-case scenario, project termination. A well-designed digital formulation platform en- ables early phase formulation and proof-of-concept by including an API research tool, wide excipient databases, and integrated regulator y support. Im- portant aspects that should be considered during development include: • Physicochemical properties of the API • Excipient functionality and compatibility with the API • Coating for protection, branding, and dose dif- ferentiation • Design and shape of the dosage form • Manufacturing process • Regulatory requirements. T he d ig it a l pl at f or m shou ld prov ide s te p -by- step g uida nce, enabling users to a r r ive at a suit- able formulation for their solid oral dosage form and move through the downstream process with confidence (Figure 1). The recommended formulation can be evaluated and f ine-t uned as needed to ach ieve t he desired proper ties, dr ug release profile, and final appear- ance. Ease of administration and patient compli- ance must not be overlooked, and formulators should consider the size and shape of tablets or capsules to facilitate swallowing. Once the dosage is optimized, patient-friendly packaging and labelling may be in- cluded to improve patient experience and adherence. Digital evolution of drug formulation: bridging science and technology To be effective, formulation development platforms must be built on extensive datasets to power the al- gorithms that enable interactive selection. These platforms should also leverage the specialist expe- rience of technical experts to provide recommenda- tions, help with troubleshooting, and streamline the submission process. The most advanced platforms (e.g., Hy perStar t C2C, Colorcon) should offer interactive step-by-step formulation recommendations from core to coating. This user-driven process allows individuals to input their own project requirements, enabling them to view tailored core starting formulations suggested by the platform. Moreover, users have the freedom to customize their formulation by accessing a com- prehensive database of excipients, including an ex- tensive range of fillers, binders, disintegrants, poly- mers, solubility enhancers, surfactants, and other relevant components. The user can filter through these options, compare properties of the excipients, and make an informed decision on the type and the quantity of the excipient(s) to include. One such platform (HyperStart C2C, Colorcon) is powered by exper t systems to provide on line for- mulation advice as well as regulatory insights that instantly guide the user in their decision-making process. On completion of the core formulation, the platform can assist with dosage design (shape and size) through selection of the right tablet tooling, followed by detailed manufacturing process guid- a nce, wh i le addressing diverse requirements for specific applications. Following core formulation, the next step is to select the coating to be applied to the product. The coating process involves applying a thin, even, and continuous layer of coating around the surface of a tablet to create a n elega nt f in ish, protect f rom environmental factors (moisture, oxygen) and en- hance product stability, mask unpleasant odor and taste, and provide ease of swallowing. It can also enable t he required dr ug release prof i le and sup- port simpler product identification, branding, and trademark oppor tunities. The digital platform is designed to guide the user through the selection of suitable coatings, allowing them to choose the de- sired color and functionality, while providing prepa- ration methods and coating process parameters. Every stage of the development process should be carefully designed and backed by dedicated techni- cal and regulatory expertise. Ideally, users should be able to easily request samples of the recommended excipients and coating products of the desired color to prepare formulations in the lab. Platforms should offer live chats with technical experts around the clock and include built-in regu- lator y assistance specifically tailored to the user's target market for t he f ina l product. For example, due to constraints on the use of titanium dioxide