Semi-solid characterisation

IVRT

The in vitro release test (IVRT) is used to evaluate the release rate of a drug from its dosage form Nuvisan’s highly experienced scientists support your formulation characterisation and formulation comparison with in vitro release testing (IVRT) under a GMP environment. In vitro release testing (IVRT) is an FDA - and EMA- approved test to support manufacturing changes (site, excipients, etc.) and demonstrate your formulation equivalence in compliance with SUPAC-SS requirements. 

Method development and validation: Nuvisan tailors IVRT methods to the specific formulation being tested, optimising conditions, developing HPLC assays, validating methods per ICH guidelines, and conducting GMP comparative studies. This helps ensure the release profile reflects in vivo behavior. 

Formulation optimisation: Through IVRT, Nuvisan can help optimise drug formulations by assessing how changes in the formulation impact drug release. This is essential in refining the dosage form to ensure consistent and reliable drug release over time. 

In-use stability studies: As part of our in-use stability expertise, Nuvisan may also use IVRT to assess how the stability of the formulation changes over time or under different storage conditions, which can influence the release characteristics. 

Nuvisan's expertise in IVRT is a critical part of our broader capabilities in drug development, helping ensure that new drug products are both effective and safe for patient use. 

 

Viscosity and Rheology

Nuvisan offers comprehensive viscosity and rheology testing services to analyse material flow and deformation, which are crucial for pharmaceuticals and cosmetics. Viscosity testing encompasses single-point measurements, rotational viscometry for steady-state flow analysis and capillary viscometry for low-viscosity fluids.

Rheology testing evaluates shear behavior, viscoelastic properties, thermal stability, yield stress and thixotropic behavior. These analyses help ensure product performance and stability across a broad spectrum of applications, including injectable drug products, creams and industrial formulations.