Solid state services that streamline your program for success.
Poor bioavailability or instability of a drug substance can often be solved/improved by screening different salt forms. The selection of the most appropriate salt can not only improve the physicochemical properties but also identify all developable salts that can strengthen the intellectual property of the drug substance. The choice of counterions is typically based on the pKa of the drug substance, the relevance of the expected dosage form, and the know-how of our experts.
To meet regulatory requirements, the polymorphic behavior of a drug substance needs to be assessed and the polymorph chosen for development needs to be fully identified/characterized. Identifying the polymorph landscape can also strengthen intellectual property.
Amorphous forms can have increased solubility and bioavailability in comparison with their crystalline form. However, crystalline materials tend to be more stable, and amorphous material can recrystallize over time but can be stabilized as an amorphous solid dispersion. Whether it's spray-dried dispersions (SDDs) or hot melt extrusion (HME), our team of experts can support the enhancement needs of your molecule.
Supporting the drug substance development team, purification steps can be improved and drug substance manufacturing yield, throughput, and purity can be increased by integrating a solid-state approach to recrystallization processes.
We offer a wide range of analytical techniques to fully characterize solid-state forms, including dissolution/disintegration testing and X-ray powder diffraction (XRPD) as well as:
- Thermal analysis: differential scanning calorimetry (DSC), thermogravimetric analysis (TGA)
- Hygroscopy: dynamic vapor sorption (DVS)
- Hot-stage microscopy
- Particle size distribution and particle enumeration
- Surface area
- Solution and solid-state nuclear magnetic resonance (NMR) spectroscopy
- Fourier-transform infrared spectroscopy (FT-IR)
Our experienced material scientists can support your pre-formulation screening to allow selection of your drug candidate for pre-clinical evaluation and identification of your drug product in early clinical evaluation.