Comprehensive solid state research services for pharmaceutical development
We offer crystallography services for pharmaceutical solids analysis. Our X-ray diffraction method helps determine the crystal structure and intermolecular interactions. We can also solve crystal structures from X-ray powder diffraction and offer ambient or variable temperature/humidity measurements.
The selection of a suitable solid form is a vital step in drug substance development. Solid forms determine bioavailability, solubility, dissolution rate, stability and manufacturability.
Solid form screening is an important process in pharmaceutical development, which includes salt, polymorph, co-crystal, diastereomeric salt, conglomerate and amorphous solid dispersions. As the size and complexity of molecules increase, companies face a larger number of compounds that are either poorly soluble, difficult to crystallize or problematic with respect to desired physical-chemical properties.
Our solid-state research team specializes in identifying new crystal forms and solving problems related to polymorphism and crystallization, providing expertise in the field.
Salt formation can significantly alter the physicochemical properties of drug substances, including solubility, dissolution rate, and physicochemical stability. This, in turn, can have a radical impact on the bioavailability and shelf life of the drug product.
To facilitate high-throughput salt screening studies using minimal amounts of drug substance, our crystallization platform is well-equipped. Salt screening is essential for both early-phase salt selection studies and broad patent protection.
The ability of a drug substance to form a co-crystal depends on various factors, but the most significant ones are the number of hydrogen bonding donors or acceptors and its steric properties.
By carefully examining the combination of these relevant variables, we can increase the likelihood of discovering a co-crystal with the desired properties. Our expertise in crystallization, rational design of experiments, and proprietary high-throughput technologies, we can successfully identify and characterize co-crystals.
Regulatory bodies require pharmaceutical companies to fully characterize the different polymorphic forms that their drug substances can take. They also need to ensure that there are no polymorph interconversions that could affect the therapeutic performance of the drug.
Due to the unpredictable behaviour of polymorphs and their unique physicochemical properties, companies also need to demonstrate consistency in manufacturing between batches of the same product. Our company offers a unique polymorph screening methodology that enhances the understanding of polymorphic behaviour in drug candidates.
Using the amorphous form of a drug substance has advantages in terms of dissolution rate and solubility. However, it has major drawbacks like reduced chemical stability, increased hygroscopicity and physical instability.
To stabilize the amorphous phase of the drug substance, it needs to be mixed with a polymer matrix to form an amorphous solid dispersion (ASD). Several factors contribute to the formation of a suitable ASD, including the polymer's nature, drug-polymer ratio, impact of surfactants, and the solvent used.
To find the optimal combination of these factors, we have developed high-throughput solid dispersion screening technology.
Optimize drug properties for better bioavailability and stability.
Identify new polymorphic forms for intellectual property protection.
Ensure consistent product quality and manufacturability.
Contact our solid state research team to discuss your crystallization and polymorph screening needs.