When drug substance properties are well understood, problems in later stages of drug development are minimized, drug development costs are reduced and the time from development to market is decreased. An understanding of the physical properties and chemical stability of drug substance results in well-informed decision making when selecting the drug substance form and the optimal delivery system. The experienced scientists of Cirrus' utilize state of the art instrumentation and work closely with clients in designing and conducting physical and chemical characterization studies. Cirrus scientists have expertise in method development and offer a wide range of approaches for the physical and chemical characterization of small molecules, peptides and proteins to meet the clients' needs.

To determine particle size, shape and distribution, Cirrus has a complete Sympatec® laser diffraction system and has access to scanning electron microscopy. Additionally, Cirrus has a Malvern Zetasizer that is used for sub-micron particle sizing, (e.g., nanotechology projects). Our scientists can evaluate thermal decomposition profile (TGA) surface area, crystalinity vs. amorphous content, polymorphism, melting point, glass transition temperature, hygroscopicity, hydrates/solvates, FTIR spectra, density, and flowability.

The partition coefficient (log P) and dissociation constant(s) (pKa) can be determined at Cirrus. Our scientists have years of experience solubilizing poorly soluble molecules. Solubility studies can be conducted and can include a pH-solubility profile. Once a molecule is in solution, the surface properties of the solution (e.g., micellar solution, cyclodextrin solution, emulsion, cosolvent mixture) can be studied via surface tension measurements. Viscosity/rheological properties and colligative properties can also be determined at Cirrus.

Cirrus scientists have the expertise to study degradation kinetics and pathways, to identify mechanisms of degradation and to conduct studies to provide pH-rate profiles. Studies to evaluate excipient compatibility and packaging material compatibility are routinely conducted at Cirrus.