Dr. Sandeep Kumar, Formulation Development manager, Colorcon, sheds light on how selecting an excipient in early formulation development is critical to developing a robust scalable SOD formulation and can help the transition from capsule to tablet formulations.
Solid oral dosage forms still represent 50% of all new drug applications over the last three-year period, with 49% of applications submitted in a tablet format, of which 84% were coated, and 24% as capsules. While new dosage form technologies are coming to the market, such as 3D printing or “gummies”, the majority of most drug product manufacturers and patients consider tablets to be the preferred dosage format. However, for early safety and dose ranging studies, dose flexibility in the formulation is key and therefore capsule drug product formulations are considered the most convenient.