New instrument for automated biorelevant biphasic dissolution and solubility testing

Sirius Analytical Instruments Ltd, the leaders in instrumentation and services for the determination of physicochemical properties, today announces the launch of a new product, the Sirius InForm. The Sirius InForm is a fully automated instrument for biorelevant biphasic dissolution and solubility testing. This automated platform allows for precise supersaturation measurements, intestinal precipitation simulation, and quantifies the kinetics of solubility while accommodating multiple dosage forms and sample types. This versatile instrument comprises precise media control coupled with multiple measurement techniques to understand and develop the absorption performance of APIs in multiple dosage forms. Versatile assay options with flexible experimental design solutions will enable high-class analytical support for biorelevant formulation development.

John Comer, Chief Scientific Officer of Sirius Analytical explained: “Biphasic dissolution was first proposed as a way to provide sink conditions during dissolution of poorly soluble drugs by allowing dissolved drug to partition into a lipid phase so that more could dissolve in the aqueous phase without it becoming saturated. It’s also been recognised that biphasic dissolution experiments can mimic dissolution and absorption within the human gastrointestinal tract. The pH and composition of the aqueous phase can be adjusted to simulate gastro intestinal conditions, while the passage of drug into the lipid phase simulates the absorption into the gut wall. Biphasic dissolution experiments are quite complicated and involve many steps, and can be difficult to perform using conventional apparatus. The protocols in Sirius InForm take advantage of robotics and automation to ensure well-designed, reproducible and successful experiments.”

Brett Hughes, Chief Executive Officer of Sirius Analytical said: “The Sirius InForm is aimed at solubility and dissolution measurement for optimization of formulations during later stages of formulation development, and it serves this market well with its ability to handle biphasic dissolution with multiple pH sectors, automated introduction of lipids and simulated intestinal fluids, precise supersaturation and intestinal precipitation analysis, excipient screening, larger volumes and final drug product. We are proud to deliver a powerful new instrument for formulation development with the Sirius InForm.”