Firouz Asgarzadeh, Senior Vice President of Pharmaceutics at BioDuro-Sundia, explained that many new chemical entities (NCEs) are poorly soluble or have inadequate bioavailability. Amorphous solid dispersion and lipid-based systems are popular strategies for increasing the solubility and bioavailability of these drugs and are critical for formulation success. Asgarzadeh explained that scientists can use the DCS classification to guide their decision on whether to use lipid-based systems, ASD, or micronisation.
BioDuro-Sundia is a CRDMO that operates using a unique business model that integrates discovery, development, and manufacturing. This multidisciplinary approach allows for a rapid turnaround of 4 weeks from in silico studies to animal PK ones, in-house capabilities for screening, formulation, and scale-up, or global reach with a focus on oral solid dosage forms.
Asgarzadeh expressed the importance of bridging the gap between discovery and development. Efficient early-stage screening using predictive tools and nano-tablets can guarantee rapid assessment of drug candidates with limited material.
The multi-formulation screening and selection process aims to use several technologies to identify the optimal formulation for a poorly soluble drug. An existing client requested an in-depth screening using solution engine 2.0, spray drying, hot melt extrusion, and nano suspension. The process involved evaluating dissolution profiles using in vitro UV methods and picking the best-performing formulation for animal studies.
Asgarzadeh said: “The PK profiles showed that the SDD formulation and the simulated tube formulation have the same release profiles. Interestingly enough, the nano suspension and the PEC solution had better bioavailability, but a tablet is often more attractive.” Ultimately, this client opted for the tablet formulation. He also outlined another case study of a university spin-out that became a standalone company following the successful formulation and publication of results.
The concluding remarks emphasised that carefully choosing the right commercial partner with integrated capabilities can significantly reduce time-to-market. Finally, scientific rigour should never be underestimated – whether it is applied to predictive modelling or material science, it is critical for successful formulation outcomes.
