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Tissue Permeation (IVPT) – Zyleris Pharmatech

Core Platforms 

  • High-Throughput Franz Cell Platform
  • High-Throughput Tape-Tripping Platform

Skin absorption and penetration screening will be performed according to the following
guidelines: OECD TG428, OECD series on testing and assessment Nos. 28 and 156, European
Commission Guidance on Dermal Absorption Rev. 7, 2004.  Data generated by Zyleris have
been accepted by major regulatory agencies around the world.
Zyleris is licensed to handle DEA Schedule II-V controlled substances.

In Vitro Skin Model

Human cadaver skin - Zyleris maintains a large inventory of human cadaver skin tissues. No
leadtime for tissue delivery. Human cadaver skin tissues can be collected from many anatomical
sites, including abdominal, thigh, knee, feet, scalp (section or entire scalp).

Fresh human skin - Collected from elective surgery. Most tissues are from lower abdomen. Some are
from breast. Few are from thigh. Leadtime for tissue delivery varies.

Fresh pig skin – Harvested from pig ears, back, or flank.

Gottingen or other minipig - Harvested from pig ears, back, or flank area.

Mouse, rat, and hamster - Harvested from back and flank area.

In Vitro Nail Model

Human cadaver nail - Middle three digits of human cadaver finger or toe nails.

In Vitro Ocular Model

Bovine eye tissue – Collected from animals of 6-to-18 months old.

In Vitro Buccal Model

Pig buccal tissue – Collected from pig tongues.

Human cadaver buccal tissue.

Other In Vitro Tissue Model

Your own tissue model - Our technology platform can be used with any human or animal tissue
including but not limited to vaginal, lung, otic, cat, dog and bovine skin, etc.

Study Protocol

Any type of tissue absorption and penetration studies can be conducted on our HT Franz Cell
platform.

Examples of the study protocols include:
Tissue permeation flux (Transdermal) – Measure active ingredient collected in receptor medium.

Tissue permeation retention and flux – Measure active ingredient absorbed and retained in
epidermis and/or dermis layer as well as collected in receptor medium at each data point.
Epidermis and dermis can be separated and individually analyzed.

Mass Balance Study – Measure active ingredient permeated through skin layers into receptor
medium as well as absorbed in skin layers and left on the skin surface.  The following data will
be reported at each data point: amount of applied dose remained on skin surface (i.e.,
unabsorbed/unpenetrated), absorbed into stratum corneum, epidermis and dermis layer, and
collected in receptor medium.  Epidermis and dermis can be separated and individually analyzed.

Mass balance study can be performed in standard or fully validated fashion.  Validated mass
balance study includes validation of surface wash, tape stripping, and skin extraction as well as
analytical method validation.

Galenic Forms

Our high-throughput experimentation technology can be used for study of all galenic forms of
topical formulations including but not limited to:
- Solutions/serums, lotions, gels, creams, ointments, sprays, and pastes, etc.
- Foams. A foam collapsing method will be developed. The foam will be collapsed into a
typical topical dosage form depending on nature of the foam.
- Transdermal patches (matrix- and reservoir-type).

Skin Integrity Test

Tissue barrier integrity will be measured using transepidermal electrical resistance measurement
(TEER).

Analytical Services

Our standard method of analysis for IVPT is LC-MS/MS.
A client has the option to perform its own analysis.  After an IVPT study, the collected samples
can be sent to any laboratory of client’s designation for analysis.

Screening Capacity

Zyleris has an inventory of 2,200+ Franz Cells.  They are ready for use.
Currently, our laboratory is equipped to screen up to 70 topical and transdermal formulations per
week (analytical service is extra).  Additional capacity can be easily added.

Turnaround Time

With our high-throughput technology platform, we offer fast turnaround time for your projects.