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High-Throughput In Vitro Drug Penetration And Release Screening Services

Pre-formulation / Formulation Development And Optimization Services

Frequently Asked Questions
 
  1. What type of services do you offer?

High-throughput screening services for topical and transdermal pharmaceutical as well as personal care product formulation development.  Specifically, we provide high-throughput in vitro skin absorption and penetration screening services. 

  1. What is the difference between your technology and Franz Cell technology?

Both our and Franz Cell technology operate on the same principle, that is, each cell contains a donor and receptor chamber separated by skin membrane.

 

However, our proprietary technology has a number of innovative features.  These features allow a large number of parallel screening experiments to be conducted rapidly and cost-effectively, thereby increasing productivity and lowering cost per formulation screened.  For more information, please refer to “Technology” page. 

  1. What factors influence cost?

Price for screening service is quoted on per formulation basis depending on type of the study.  Please refer to “Services” page for details. 

  1. What is the typical turnaround time? 

We strive to deliver highest quality of data within fastest turnaround time.

 

Currently, for up to 100 formulations in Screening Protocol (or 50 formulations in Optimization Protocol), the following is a typical guideline with assumption that we’ll adopt your analytical method or active ingredient is well-characterized.

 

If you do your own analysis, we can offer even faster turnaround time.  Generally, we can send you the collected samples within two to three weeks.

 

Receipt of contract, formulations, and screening preparation: Week one

Screening: Week two and three

Analysis: Week three and four

QC of data: Week five

Report: Week six

  1. What is your current capacity?

Currently, we have a capacity of up to 2200 screening cells, which can be used to equip 20 HTS stations.  The 20 HTS stations can be easily placed on four 6-foot standard laboratory benches.  If needed, our capacity can be easily and immediately expanded. 

  1. What type of tests do you do to ensure integrity of skin membranes used in screening experiments?

Before screening experiments, each skin membrane is examined with hand lens for any potential defects.  Only tissues of highest quality will be used.

 

After the experiments, each and every skin membrane is subject to a proprietary QC test to confirm and validate that integrity of the skin membrane is intact throughout the screening process.  Any skin membrane that fails the QC test will be flagged and the data collected from that membrane will be discarded.  A new screening experiment will be repeated using a new membrane. 

  1. Why porcine ear skin? 

Histological and biochemical properties of porcine skin have been repeatedly shown to be similar to human skin.  Porcine ear skin is particularly well-suited for absorption and penetration studies and gives comparable results to human skin.  Thickness of stratum corneum (SC) layer in pigs is about 21-26 um, which is comparable to human skin.  The viable epidermis in porcine ear skin is about 66-72 um, which is very similar to the human (shoulder) epidermal thickness of 70 um.  The follicular structure of pig skin also resembles that of humans, with hairs and infundibula extending deeply into the dermis. An average of 20 hairs is present per 1 cm2 of porcine ear skin as compared to 14–32 hairs (except the forehead area) in humans.  Moreover, the vascular anatomy and collagen fiber arrangement in the dermis, as well as the contents of SC glycosphingolipids and ceramides are similar in man and in pig.

 

Furthermore, porcine ear skin generally offers better skin uniformity and more consistent permeability than human skin.  It is particularly suitable for high-throughput screening studies for comparing topical and transdermal pharmaceutical as well as personal care product formulations and identifying formulation leads.


Zyleris has a collection of scientific literature on porcine ear skin model.  Please contact us for more information.

  1. What kind of data will I receive from a study?

For skin penetration studies, cumulative amount collected in the receptor medium at each data point will be provided (reported as weight/cm2 membrane).

 

For epidermis/dermis absorption studies, cumulative amount absorbed in the epidermis/dermis layer at each data point will be provided (reported as weight/cm2 membrane).

 

For skin absorption and penetration studies, in addition to cumulative amount collected in the receptor medium, residual dose left on skin surface, amounts absorbed in stratum corneum and epidermis/dermis will also be determined.  These data will be reported as both weight/cm2 membrane and as percent of applied dose.