MedPharm, specialist in formulation and in vitro performance testing of topical medicines, has launched two automated testing services, MedStat-HT and MedFlux-HT to de-risk client’s development programmes and shorten development timelines.
Both pieces of equipment incorporated design features, which provide significant improvements over commercially available systems.
MedFlux-HT is an automated system of 32 flow-through diffusion cells for measuring the in vitro permeation and penetration of drugs into and through human skin (IVPT).
It can also be set up with other tissues determined by the medicine’s target site (eg mucosal, buccal, etc). The system has been uniquely designed to provide local clearance of the tissue to mimic the clinical setting and to maximise sink conditions without the addition of solvents required when studying lipophilic compounds in static cells.
Another key design improvement is the use of a high-throughput collection enabling reduction in sample collection, set-up time and processing, which can be further coupled with liquid handlers and automated sample managers.
MedPharm use MedFlux-HT as a key tool in topical formulation development and optimisation.
Significant benefits of this new system include reduction in sample variation, system artefacts and experimental time to further de-risk topical formulation development prior to clinical trials. The use of MedFlux-HT has been important in the support of patent claims, substantiation of marketing claims for OTC products, new chemical entity development and development of generic products.
MedStat-HT TM is an automated system of 24 vertical diffusion cells (VDC) more commonly known as ‘Franz’ or ‘static’ cells for measuring the in vitro release of drug from topical medicines across synthetic membranes (IVRT).
Unique design features along with automated collection provide significant reduction in variation associated with sampling and fluidics compared to manually operated VDC systems.
The key benefits of the new system are its ability to better characterise formulation drug release properties for potential patent claim support, formulation optimisation, comparison, potential product quality and stability specifications with a reduction in experimental time and less variability.
“MedPharm is continuing to develop innovative solutions to help our clients further de-risk their topical development programmes and reduce development timelines,” said Jon Lenn, MedPharm’s VP of US Operations.
“MedStat-HT TM and MedFlux-HT greatly improve the efficiency of data collection and decrease variations seen with conventional systems for IVRT and IVPT, so clients and their investors gain confidence in the data generated and ultimately get to the market sooner.”
