OSD
In recent years, there have been several important factors and trends driving innovation in drug dosage forms. From the rise in demand for fixed-dose combination products to the promising realm of oral solid biologics, the industry is at an exciting precipice of patient-centric innovation.
Among these trends, some key advancements taking place include:
- Increasing focus on OSD biologics: While the sensitive nature of the active ingredients in biologics has traditionally necessitated parenteral administration, recent advancements have allowed for some molecules, such as insulin, to be formulated for oral delivery.
This innovation is set to further enhance patient centricity by offering a more convenient administration method. However, formulating biologics for oral delivery does pose challenges. These include issues with drug stability, physicochemical properties, absorption issues, and immune response.
To overcome these hurdles and bring improved ease of administration to patients, we can expect more developers to turn their attention to these formulations in the very near future. - Improving efficiencies and reducing costs with continuous manufacturing: By carrying out each element of the manufacturing process across a continuous production line, companies can significantly accelerate their production and efficiency. Once successfully implemented, continuous manufacturing can make the manufacturing process more reliable and flexible, while also reducing costs.
- Harnessing data analytics to enhance decision-making: By leveraging data science, digital tools, and statistical models, companies can make more informed decisions and gain a comprehensive understanding of how critical quality attributes (CQAs) and critical process parameters (CPPs) influence the final product's quality and performance.
These technologies also help streamline development timelines and optimise the quantity of active pharmaceutical ingredients (APIs) required for efficient and effective drug development.
In a recent Q&A piece with Pharm Tech, Dr Uwe Hanenberg, Head of Product Development, Oral Solid Dose shares more on the current trends and challenges in oral solid dosage development and innovation across the industry. He also discusses key topics such as the shift to meet global sustainability goals and the regulatory changes set to come into force in the near future.