BU-NOT-SET
Oral solid dosage (OSD) forms remain the foundation of drug delivery, but with innovation, the demands placed on them are evolving. As pipelines shift towards complex but poorly soluble molecules, formulation strategies are becoming increasingly sophisticated.
Overcoming bioavailability challenges
Many new active pharmaceutical ingredients have solubility and permeability limitations that can restrict absorption in the gastrointestinal tract. This issue has driven drug developers and manufacturers to further adopt technologies such as spray drying and hot-melt extrusion, which can convert crystalline drugs into amorphous solid dispersions (ASDs), thereby improving dissolution and raising bioavailability.
New stabilisation strategies, from mesoporous carriers and in situ nanoparticle formation to microenvironmental pH modification, are also gaining traction, offering alternative ways to strengthen amorphous forms and optimise drug loading.
Digital tools are beginning to influence early-stage development as well, with AI-driven models supporting faster excipient screening and formulation design.
Navigating regulatory and technical complexity
While these technologies offer clear benefits, they also introduce new challenges when it comes to regulation.
To gain approval of their therapeutic, developers must demonstrate a clear understanding of their ASD’s quality attributes, in vivo performance and lifecycle controls. This understanding may require extensive data on a drug’s physical stability and reproducible performance, as well as the complexity of any novel excipients used.
This growing data burden is compounded by differences in global regulatory requirements, further reinforcing the need for a strategic approach that considers lifecycle management from the outset.
A more complex future for OSDs
Looking ahead, the OSD market is expected to become increasingly segmented. Demand for conventional, high-volume products will continue, but growth is likely to be driven by more complex formulations, including modified-release systems and high-potency drugs.
As a result, drug developers will continue to seek out the specialised capabilities of experienced contract development and manufacturing organisations (CDMOs).
Want to learn more about OSD formulation?
Dr. Uwe Hanenberg, Head of OSD Product Development at Recipharm, explains how drug developers can prepare for the regulatory and scientific challenges of adopting innovative enabling technologies.
Read the interview in Tablets and Capsules here.