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Cutting-edge Formulation is Needed to Enable the Next Generation of Oral Biologics

An Introduction to Oral Solid Dose Traditionally, the pharmaceutical market has been dominated by oral drug delivery – whether oral solid dose (OSD) or liquid suspensions and solutions.

Oral drugs ease access by enabling patients to take medication at home with little discomfort or complexity. This differs from other dosage forms, such as parenteral, which often rely on healthcare professionals for their delivery. Additional OSD advantages include extended shelf-life, which eases transport and long-term storage.

Despite OSD popularity, certain active pharmaceutical ingredients (APIs) are incompatible with traditional OSD formulation techniques, as is the case for biologics. This is due to a myriad of reasons that stem from biologic physicochemical properties, stability, absorption, and immunogenicity.

Many pharmaceutical industry research programmes are exploring new strategies and technologies to propel OSD biologic formulations. These novel approaches aim to overcome associated obstacles and include the use of prodrugs, nanoparticle-based delivery systems, and innovative methods to optimise absorption and stability.

In this article, Dr. Uwe Hanenberg, Head of Product Development in Oral Solid Dose at Recipharm, explores recent advances in formulation technologies for both OSD and oral liquid dosage forms designed to enable the creation of oral biologics.

The Driving Force for Solid Dose Biologics

By the end of 2022, biologic approvals had narrowly outpaced those of new small molecule entities for the first time, setting a new precedent.¹ The biologic market is predicted to continue experiencing rapid growth with a compound annual growth rate of 4.1% between 2023 and 2028, reaching an estimated value of $415 billion by 2026.²

This rise in biologic approvals could contribute to the burden on the healthcare system, as biologics are often limited to parenteral administration, requiring healthcare professionals’ (HCPs) involvement. The way the biopharma industry can help reduce the HCPs’ load is by working towards self-administered therapeutics. Oral dosage forms seem an obvious alternative, but to make this delivery system viable, innovation is needed to improve biologic solubility, absorption, and stability. Patient centricity is also a priority for many pharmaceutical companies, and expanding the range of self-administered drugs increases patient access.

Many pharmaceutical companies are investing in OSD formulation research to find innovative solutions to current problems hindering oral biologic development. Overcoming these challenges requires a strong understanding of the issues that may arise during OSD biologic formulation.