In vitro tests

Advanced In Vitro Testing

Nuvisan offers advanced in vitro testing capabilities to support R&D for topical product development. Using membranes or human skin explants obtained from elective surgeries, we provide customised study designs to evaluate and optimise penetration, absorption and delivery profiles. These tests inform formulation decisions, enabling the development of effective, safe and well-tolerated topical products tailored to specific indications and APIs.

Two Franz cells on a grey table

IVPT

The in vitro permeation test (IVPT) technique is used to evaluate the ability of a drug to permeate through biological membranes, typically simulating human skin or intestinal tissue. IVPT is crucial for assessing the absorption characteristics of topical and transdermal formulas and can support the assessment of bioavailability and therapeutic effectiveness.

Using in vitro permeation testing (IVPT) with human skin explants, we gather preliminary data on drug delivery into the skin and receptor fluid, aiding API candidate selection and formulation decisions.

In compliance with OECD Test Guideline 428 for dermal absorption, Nuvisan can:

Establish the penetration profile of your active compound
Assist in the selction of lead compound for development
Support decision making in formulation development
Test the appropriate regimen of your pharmaceutical, consumer or agrochemical compound for clinical studies.

Our services include study design, protocol development, execution of experiments, analytical method development and validation, and interpretation of results and reporting. For these studies, Nuvisan has a regular supply of fresh human skin samples via a local network of surgeons, and our experts have more than 25 years of experience in dermatology, cosmetic and aesthetic and corrective innovation.

IVRT

The in vitro release test (IVRT) is used to evaluate the release rate of a drug from its dosage form (e.g., tablets, capsules, suspensions) into a solution simulating bodily fluids. It plays a key role in understanding drug bioavailability and is crucial in oral drug product development and quality control. Nuvisan has extensive expertise in IVRT, offering services in:

Method development and validation: Nuvisan tailors IVRT methods to the specific formulation being tested, optimizing conditions, developing HPLC assays, validating methods per ICH guidelines, and conducting comparative GMP-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 composition can affect 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.