Formulation, Analytical, and Process Development

Over 90% of oral drug candidates face poor solubility and bioavailability—barriers that can halt development of even the most promising compounds. BioDuro-Sundia overcomes these obstacles with expertise in spray-dried dispersions and hot-melt extrusion, transforming poorly soluble molecules into bioavailable, patient-ready formulations and maximizing the potential of life-changing therapies to reach the market.

BioDuro-Sundia’s Solution Engine accelerates early-stage formulation development by screening solubility-enhancing technologies with minimal API required. Our expert scientists use amorphous solid dispersion (ASD) methods, combining in-vitro analysis with animal PK data to rapidly identify the optimal formulation for scale-up and stability studies. With Solution Engine, clients can reach the clinic faster by identifying the best formulation earlier in development. For even greater flexibility, we offer tailored alternatives such as lipid-based solutions, SMEDDS, nanosuspensions, and micronization to address specific client needs.

ASDs are created by breaking down the crystalline API structure and dispersing it at the molecular level within a polymer matrix. With just 100 mg of API, BioDuro-Sundia screens ASD polymers using a targeted, data-driven approach. Rather than trial-and-error, we leverage solubility parameters and potential polar, dipole, and ionic interactions between polymer and drug structures to identify the most compatible pairs. Our in-silico modeling uses the Flory-Huggins equation to pinpoint the optimal polymer-drug ratios, maximizing solubility potential.

Next, these promising polymer-drug combinations are tested in micro-evaporation tubes and quickly evaluated in rodents for pharmacokinetic (PK) profiles. Only the formulations with the best bioavailability are selected for scale-up and stability studies, allowing our clients to advance the most effective formulation faster and with greater confidence.

BioDuro-Sundia selects the highest-performing drug-polymer ASD candidates, based on PK data, for advanced spray-drying dispersion (SDD) and hot-melt extrusion (HME) techniques. Using the Buchi B290 for SDD and the Haake extruder for HME, we conduct small-batch trials (1–2 grams of API) to achieve optimal batch profiles. Each ASD undergoes a comprehensive suite of analyses, including amorphous content determination (XRPD), thermal profiling (mDSC and TGA), assay for related substances, and in-vitro non-sink dissolution testing. Stable formulations are fast-tracked for ICH accelerated stability chambers and subsequent PK studies, confirming the top-performing ASDs for scale-up and clinical trial material (CTM) manufacturing. BioDuro-Sundia’s SDD and HME solutions ensure clients get bioavailability-ready formulations for faster clinical advancement.

BioDuro-Sundia offers end-to-end SDD and HME process development and cGMP manufacturing, scaling from gram-level batches to hundreds of kilograms. Our advanced spray-drying capabilities scale up seamlessly, from initial development with Anhydro MS35 (500 g/h aqueous, 2 Kg/h solvent spray rates) to the MS150 (2 Kg/h aqueous, 10 Kg/h solvent spray rates). BioDuro-Sundia provides expert process development, CTM cGMP manufacturing, and streamlined packaging, labeling (open or blinded), and clinical site distribution—ensuring clients gain accelerated paths from API to clinical trials with optimized ASD tablets and capsules.