Solid Dispersion Preparation and Characterization Service

An amorphous solid dispersion is a formulation in which a poorly water-soluble crystalline drug is dispersed at the molecular level in an inert hydrophilic carrier (polymer or silica). This eliminates the crystal lattice, creating a high-energy amorphous state that significantly increases apparent solubility and dissolution rate.

We evaluate your API's physicochemical properties (melting point, solubility parameters, thermal stability) and screen candidate carriers from our library of cellulosic polymers, vinyl polymers, and mesoporous silicas. The selection is optimized through drug-to-carrier ratio screening and compatibility analysis.

We offer spray drying, hot-melt extrusion, and solvent evaporation. The method is chosen based on your API's thermal and chemical stability, as well as the desired scalability. Each method is documented with process parameters to support future technology transfer.

Standard characterization includes X-ray diffraction (XRD) to confirm amorphization, differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) for thermal behavior, scanning electron microscopy (SEM) for morphology, and Fourier-transform infrared spectroscopy (FT-IR) for molecular interactions. Additional techniques can be added as scoped.

We conduct accelerated stability studies under elevated temperature and humidity (e.g., 40°C/ performance scoped per project RH) and monitor for recrystallization using XRD. Long-term stability can also be evaluated if required. Storage recommendations are provided based on the data.

Yes. For heat-sensitive compounds we typically use solvent evaporation or spray drying with mild processing conditions. For moisture-sensitive APIs, we can recommend carriers with low hygroscopicity and advise on handling conditions during and after preparation.

We supply comprehensive characterization data and dissolution profiles that serve as a foundation for downstream formulation development. Upon request, we can also interpret results and recommend next steps during a project consultation.