Trends and Technologies in Oral Solid Dosage Formulation
The trends and challenges in oral solid dosage formulations contribute to greater stability for drugs used by patients worldwide.
| 3 min read | Interview
Oral solid dose (OSD) drug formulations make up the majority of drugs on the market thanks to their patient-friendly administration and reliable storage stability. New technologies and formulation approaches are now being developed to enable a larger number of molecules to be delivered orally, including peptides, proteins, oligonucleotides, enzymes, and monoclonal antibodies. Contract Development and Manufacturing Organizations (CDMOs) working in this space need to be prepared for OSD to continue on an upward trajectory, which means that investing in the appropriate facilities and infrastructure is vital.
Here, we speak with Anil Kane, Executive Director, Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific, about the company’s recent OSD expansions. A total of $22 million has been invested since 2021.
What are the big trends in OSD?
Increasing OSD projects across different types of molecules means that CDMO services are in high demand, including formulation, testing and analytical support, clinical supply chain management, and more. Pharma companies are also looking to pivot from trial-and-error approaches to find the most effective formulations early on using predictive modelling. With the rise of next-generation technologies, such as Artificial Intelligence (AI) and machine learning (ML), CDMOs have been investing in solutions that can help pharma companies adopt these tools and streamline decision processes. Predictive platforms evaluate technologies and excipients to enhance bioavailability and solubility with higher accuracy, enabling companies to make data-informed decisions and avoid the trial-and-error cycle while solving common drug development challenges.
How are OSD forms becoming more complex?
Over the past decade, we have supported 125 new drug approvals in OSD alone, and the pace of pipeline demand and development shows no sign of slowing down anytime soon. Many projects now target the oral delivery of large molecules, but we are also seeing increases in challenging small molecules and complex dosage forms.
Poor solubility and bioavailability remain significant challenges in small molecule development, often driving greater formulation complexity. As drug candidates transition from discovery to clinical studies, they require rapid and precise assessments to optimize their properties and enhance efficacy, including through targeted delivery. Balancing the need for speed with the demands for quality and efficacy adds to the complexity. Success depends on quickly understanding and addressing these molecular characteristics with the scientific precision needed to advance promising molecules to the next phase of development.
How are manufacturing processes and techniques continuing to advance?
Continuous manufacturing, although commercially established for over a decade, continues to gain momentum. Its demonstrated success in bringing molecules to market is prompting companies to revisit their development pipelines, increasingly integrating continuous manufacturing early in the process. With the ongoing shift toward Industry 4.0, opportunities for automation and software integration are expanding, driving significant advancements across manufacturing workflows.
Advances in AI and ML are also reshaping complex challenges in OSD formulation. Predictive modelling and AI/ML tools can accelerate development, reduce risks, and help formulators make data-driven decisions around excipients, solubility, and bioavailability.
Why did Thermo Fisher Scientific expand its OSD capabilities?
OSD is the most prescribed dosage form in the world. We produce around 4.2 billion tablets and capsules annually to support our customers! The new expansion bolsters our network to fulfil both large- and small-scale commercial projects. The investments in Bend, Oregon, and Cincinnati, Ohio, are part of our early development initiative to accelerate pre-clinical oral drug product development, with the goal of reducing timelines to Good Manufacturing Practice (GMP) production of clinical trial materials and providing greater flexibility to customers.
The expansions are part of our continued investment in small molecule OSD solutions, including development and manufacturing services in Puerto Rico, Canada, and France, and with continuous manufacturing in Greenville, NC in the US. As demand for OSD continues to grow, we want to ensure we can continue leveraging the insights learned at any given site in our network.
In Bend, the new facility is 29,000 square feet, doubling the site’s existing footprint. The expansion enables augmented site capabilities at the company’s Center of Excellence for early development and advanced drug delivery, which specializes in solubility and bioavailability enhancement solutions and OSD development – from collaborative workspaces to advanced safety features and sustainability efforts, such as energy-efficient fume hoods to reduce electrical burden. In addition, it brings new capabilities online, including eight formulation and process development suites and a 5,500-square-foot analytical development lab.
In Cincinnati, the investment adds a 3,200-square-foot research and development (R&D) non-GMP space with state-of-the art equipment and technologies to support early development of OSD formulations. The expansion includes a new, pilot-scale high-shear granulation and fluid bed processing suite, as well as the launch of two new major offerings designed to improve stability and simulation.
