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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.

The route of application and the intended daily dose play an important role within solid form selection. For ​example, the solid-state property requirements depend on whether an oral, parenteral, transdermal or inhalation ​route is the desired method of administration.

Solid form screening

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 screening

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.

Co-crystal screening

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.

Polymorph screening

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. Our services cater to a wide range of studies, from small screens for initial indication ​of polymorphism to large screens for intellectual property use.

Amorphous solid dispersion screening

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.

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