Early stage formulation strategy for a smooth drug product lifecycle

Michelle Gischewski-Silva, MSc. Head of Formulations; Kevin Rosenthal, Business Head; Eurofins CDMO (Alphora Research Inc.); Michelle.Gischewski-Silva@alphoraresearch. com; Kevin.Rosenthal@alphoraresearch.com

The drug product life cycle for oral dosage forms generally covers two major phases-early stage or phase appropriate formulation development and late stage commercialisation activities. At the early stage, formulation and drug product strategies tend to focus on speed to clinic and “drugability” (i.e. solubility enhancement and improvement of drug exposure at the site of action). At the late stage, efforts shift to process and manufacturability, with an eye on commercialisation. Oftentimes a programme’s success or advancement to late stage is driven by early clinical data to reach the next corporate milestone.

A phase appropriate formulation development programme must consider all aspects of the drug product life cycle as well as the physicochemical characteristics of the compound. The knowledge gained at the early stage helps favour the formulation and process strategies which target increased drug solubility and exposure at the site of action.

Eurofins CDMO has a formulation team focused on the challenges of early stage development, thus paving the way for a successful late stage programme. To address drug solubility and absorption, strategies such as amorphous solid dispersions, self-microemulsifying drug delivery systems, lipid-based systems, API complexation and API micronisation are often targeted. The formulation team works synergistically with the pre-formulation and solid state characterisation teams to develop phase-appropriate and advanceable formulations.

The formulation team is also highly skilled at addressing the challenges of the late stage drug product lifecycle, normally associated with manufacturability improvement and performance. The knowledge acquired from the early phases can be used to execute bridging studies that aim to further optimise the formulation in the later stages of drug development.

Eurofins CDMO provides phase appropriate solutions for all aspects of the drug product lifecycle from pre-clinical through to commercialisation.

For more information visit: www.eurofins.com/biopharma-services/cdmo/