Study Purpose

from formulations across synthetic
membranes in Franz cells

Evaluate the dermal permeability and/or accumulation of test articles

Type of Model
Franz Cell
Time
2-4 weeks
Test System
Human Skin

Deliverables

  • Flux or apparent permeability of the test article and reference compounds
  • Percent recovery of the test article
  • Comparison of the absorption potential of test article to that of reference compounds
  • Comparison of test and reference formulations (if applicable)
  • Accumulation in stratum corneum, epidermis, and dermis (if applicable)
  • Demographics of human donor

Model Description

  • Unidirectional permeability assessment of test article across frozen dermatomed human cadaver skin (male or female trunk region)
  • Skin mounted in Franz cells thermostatically controlled at 37°C
  • Test article may be dosed without formulation, or administered as a gel, cream, ointment, patch, or solution
  • Suitability experiments may include assessment of chemical stability and/or non-specifi c binding
  • Control compounds (atenolol and testosterone or caffeine) run in parallel
  • Sampling from receiver compartment at fi ve time points up to 30 hours
  • Optional determination of test article accumulation in skin
  • Optional stability assessment in skin homogenate

Benefits

  • Screen formulations in human skin before clinical PK or bioequivalence studies
  • Rank order compounds in terms of permeability
  • Evaluate locally-acting dermal formulations and quantify dermal accumulation
  • Absorption Systems provides in-house analytical and formulation services, along with consultative assistance in study design