Assessing flow and deformation
The highly flexible and robust Kinexus Ultra + instrument can be deployed for the development and validation of QC methods for critical properties such as viscosity, yield stress or viscoelasticity.
Additionally, Concept Life Sciences are set up to conduct in-depth investigative projects to understand the rheological behavior of products relevant to processing, storage and use.
- Viscosity profiling (pseudo-plasticity/dilatancy)
- Yield stress determination
- Viscoelastic behavior determination (G’, G’’, phase angle)
- Thixotropy assessments
- Monitoring of curing processes
- Axial testing
- Dynamic Mechanical Analysis (DMA) of solid samples
Demonstrating equivalence in generics
The development of generic formulations for release as drug products requires the demonstration of equivalence with the Reference Listed Drug (RLD). This can be challenging for complex formulations because data from pharmacokinetic studies may not fully represent bioavailability.
Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are now requiring that equivalence is demonstrated in vitro with suitable techniques, including rheological characterization to assess Q3/microstructural sameness.
Concept Life Sciences can support Q3 equivalence testing for regulatory submissions of generic formulations through evaluation of viscosity, yield stress and viscoelasticity with fully validated methods on our GXP compliant instrumentation. Our expert analytical scientists have a wealth of knowledge and experience with characterization of various formulation types, including:
- Topical ointments and gels
- Nasal sprays
- Ophthalmic emulsions