Topical Pharmaceutical Testing | IVRT & IVPT Testing

At MedPharm, performance testing is integral to any formulation development program. MedPharm utilizes in vitro and ex vivo testing strategically throughout the development process to mitigate development risks in early stages of product development or to help determine why products have underperformed in clinical phases.

It is well established that the performance of any topical or transdermal product is closely linked to the quantity and nature of excipients used to formulate the active ingredient. MedPharm’s industry-leading performance testing models provide our clients with the data needed to mitigate risk prior to reaching clinical trials.

These assays are consistently used to inform:

API selection
Formulation activity optimization
Posology and dose regime
Equivalence testing
Marketing claim support
Patent claims support
Toxicity assessment

Find out more about our topical and transdermal services or reach out to our expert team to discover how our performance testing services could benefit your project.

Learn how IVPT and IVRT models can be used to demonstrate bioequivalence of topical generic drug products in our poster ‘Meeting the Draft Guidance for Bioequivalence for Topical Products’.

In vitro Release Testing (IVRT)

IVRT measures the release of a drug from a topical formulation. Regulatory bodies are increasingly requiring its use as a quality tool in release and stability specifications. It is also used as a key tool for demonstrating generic equivalence.

In vitro Permeation Testing (IVPT)

MedPharm offers customers options for testing permeation and penetration using methods such as its unique MedFlux-HT® automated flow-through system or classic static cells. IVPT is increasingly accepted by regulatory authorities as part of the justification for generic biowaiver and can be used to justify patentable differences between formulations.

Disease Activity Models

MedPharm has helped many clients minimise risk in their development programs with bespoke disease/activity models. These proprietary models exist for many pathways in these major areas (e.g. psoriasis, atopic dermatitis, herpes, onychomycosis, etc).

Performance Testing