At Sirius Analytical we design and manufacture highly automated instruments to measure physicochemical parameters - pKa, logP & logD, solubility and dissolution. We also operate as a CRO providing a wide range of physical chemistry analytical services.
Dissolution testing plays an increasingly important role in the formulation, development and regulatory approval of pharmaceutical products.
For many drug molecules, dissolution testing shows good in vivo–in vitro correlation and dissolution data are often accepted by regulatory bodies in lieu of clinical studies.
This can greatly reduce the time-to-market for new drug products. Dissolution testing is also used to assess the product stability and batch-to-batch reproducibility, making it a valuable tool for the product development and quality control. Continual development of dissolution testing is needed as scientific and regulatory requirements change. The solubility and dissolution behaviour of ionizable compounds are strongly dependent on the pH environment. Many APIs have ionization constants which lie within the pH range of the GIT (gastrointestinal tract).
This can result in complex dissolution and precipitation behaviour as the API moves through the GIT, which is not adequately modelled by experiments at fixed pH. Some weakly basic drugs, for example dipyridamole, are soluble at gastric pH and have the ability to remain in supersaturated solution at intestinal pH, where they are otherwise highly insoluble, for some time before precipitating. This illustrates the need for dynamic pH control. It is also essential to be able to perform experiments in the presence of excipients and biorelevant media, which can both have a significant impact on the supersaturation behaviour.
Sirius GI Dissolution assay on SiriusT3 can provide all this information using minimal amounts of drug material. The assay is also available through our analytical services.
