OSD
To develop any dosage form, developers must understand the molecules’ physical attributes, such as particle shape, size and other parameters. These characteristics dictate the feasibility of various formulation technologies.
Oral solid dose (OSD) formulations are no exception, posing intricate challenges for developers and manufacturers, with drug discovery also playing an essential role in their development. Ultimately, the effectiveness of an OSD form relies on the compound’s behaviour within the body.
If the physical properties prevent the formulation from achieving the right concentration at the right place and time, it will face certain challenges. Tailoring formulations to specific patient needs adds another layer of complexity. Considering factors such as taste, swallowability and suitability for different patient demographics, such as children and the elderly population, is crucial for achieving compliance and effectiveness.
Addressing solubility challenges for water-soluble drugs remains a significant hurdle. Identifying enabling technologies to overcome poor solubility is crucial. Amorphous systems offer potential solutions by enhancing solubility kinetics. However, assessing the stability of the active pharmaceutical ingredient (API) within these systems and its continued absorbability in the body is also essential.
Emerging OSD formulation technologies are revolutionising biologics’ drug delivery. Shifting from injections to oral delivery for biologics reduces manufacturing complexities, transportation issues and patient discomfort.
Additionally, the integration of data science is transforming the OSD landscape. Leveraging big data for meaningful insights and applying machine learning for statistical evaluations allows for standardised data usage and informed decision-making throughout the formulation process.
In a recent interview recorded at CPHI Barcelona, our Head of OSD Product Development Dr Uwe Hanenberg highlighted that the future of OSD formulation lies in a comprehensive understanding of molecular properties, addressing solubility challenges, tailoring formulations to patient needs and leveraging cutting-edge technologies enabling oral delivery of biologics and using data science to drive innovation. Balancing economic feasibility and environmental impact further enriches this landscape, ensuring robust, patient-centric solutions.