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High-Throughput Absorption Depth Profiling in Stratum Corneum

High-Throughput Corneal/Scleral Absorption and Pentration Screening

High-Throughput In Vitro Release Testing (HT-IVRT)

High-Throughput Nail Penetration Screening

High-Throughput Screening of Compound Library for Topical and Transdermal Delivery

High-Throughput Skin Absorption and Penetration Screening

In Vitro Skin Barrier Integrity and Skin Irritation/Corrosion Test

Ophthalmic Formulation Development and Optimization

Preformulation, design, Development, and Screening

Skin Absorption and Penetration Enhancement and Retardation Development

Topical Formulation Development And Optimization

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High-Throughput Skin Absorption and Penetration Screening


Core Platforms


Ø      High-Throughput Franz Cell Platform

 

Ø      High-Throughput Tape-Tripping Setup

 

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 - Standard model.  Zyleris maintains a large inventory of human cadaver skin tissues.  Fresh human skin tissues from elective surgery are also available.  Human cadaver skin tissues can be collected from many anatomical sites, including abdominal, thigh, knee and arm, buccal, scalp (section or entire scalp), etc.

Fresh pig ear skin - Standard model (why?).

Other animal species - Gottingen minipig, rat, mouse, etc.  We have also done studies using cat, dog, and cattle skin tissues.

Your own skin model - Our technology platform can be used with any human or animal tissue including but not limited to buccal, lung, ocular, or synthetic membrane.

Mode of Study

 

Penetration Mode (Transdermal) – Measure active ingredient collected in receptor medium at each data point.

 

Absorption Depth Profiling Mode - Measure absorption depth profile of active ingredient in stratum corneum layer using our proprietary high-speed tape-stripping technique from tape-strip pooling.

 

Absorption Mode (Absorption) - Measure active ingredient absorbed and retained in epidermis and/or dermis layer at each data point.

 

Absorption and Penetration Mode – Measure active ingredient absorbed and retained in epidermis and/or dermis layer as well as collected in receptor medium at each data point.

 

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.

 

Study Protocol

 

Our HT Franz Cell platform is very flexible so you can specify any study protocol that fits your requirements.

  

Galenic Forms

 

Our high-throughput experimentation technology can be used for study of all galenic forms of topical and transdermal pharmaceutical and personal care products including but not limited to:


- Solutions/serums, lotions, gels, creams, ointments, sprays, and pastes, etc.


- Transdermal patches (matrix- and reservoir-type).

 

Skin Integrity Test

 

Measurement of transepidermal electrical resistance (TEER, Z value) across skin membranes using a LCR meter.

 

For human cadaver skin, due to lot-to-lot variation in donor age, gender, race, and anatomical site, skin integrity test will be conducted for each individual lot to establish the threshold value for the lot.


For fresh pig ear skin, the threshold value for intact pig ear skin is 5 Kohms at 100 Hz under our laboratory conditions based on a large amount of internal data. 


Analytical Services

 

Our standard method of analysis is LC-MS/MS.


Sample analysis  - Develop a new LC-MS/MS method for your active ingredient(s) or transfer/validate your analytical method.  Conduct analysis of collected samples. 

 

Do-it-yourself (DIY) analysis - this option allows a customer to perform its own analysis.  We screen your formulations and send the collected samples back to you.

 

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.


For projects with DIY analysis option  - Typically, within two-to-three weeks.

 

For projects with standard sample analysis option - Typically, within four-to-five weeks.


Actual turnaround time, in most of cases, is faster than the "typical" turnaround time listed above.