Ø Topical drugs
Ø Transdermal drugs
Ø Personal care products
Ø Compound libraries
In Vitro Skin Model
Porcine ear skin is our standard model (why?). The skin is processed according to our SOP and industrial standards. Our technology can be used with any human or animal tissues including buccal, lung, ocular, and nasal as well as synthetic membranes.
For SUPAC-SS (U.S. FDA) studies, we also use cellulose membranes.
Mode of Study
Penetration Mode (Transdermal) – Measure active ingredient permeated across skin membrane. The cumulative amount and percent of the applied dose in receptor medium will be reported.
Absorption Mode (Absorption) - Measure active ingredient absorbed in epidermis/dermis layer. The cumulative amount and percent of the applied dose in epidermis/dermis layer will be reported.
Absorption and Penetration Mode with Mass Balance – Measure active ingredient permeated across skin membrane as well as absorbed in and on the skin membrane. The following data will be reported: amount and percent of applied dose left on skin surface, absorbed in stratum corneum, epidermis/dermis and receptor medium.
Study Protocol
Screening Protocol - Each formulation will run in three replicates. This protocol is intended for rapid formulation screening and lead generation.
Optimization Protocol - Each formulation will run in six replicates. This protocol is intended for formulation fine-tuning, optimization, and development.
Custom Protocol – Please inquire.
Data Points
Our standard procedure is to collect samples at: 2, 4, 6, 12, and 24 hour. If you need a customized collection schedule, please inquire.
Data are collected based on our SOP to ensure reliability, traceability, and reproducibility.
Galenic Forms
Our high-throughput experimentation technology can be used for screening of all galenic forms of topical and transdermal pharmaceutical and personal care product formulations including: solutions/serums, lotions, gels, creams, ointments, and pastes, etc. It can also be used for screening of transdermal patches.
Analytical Services
Method development - Develop analytical method for your active ingredient.
Analysis - We will adopt your analytical protocol or your active ingredient is well-characterized in the literature.
No-analysis - if you prefer, we can screen your formulations and send you the collected samples and you perform your own analysis.
Screening Capacity
Currently, our laboratory is set up to screen up to 60 topical and transdermal formulations per week (transdermal mode, excluding analytical service).
For added capacity, we have additional 2,200 screening cells on hand (enough to equip about 20 HTS modules). They are immediately available for use in screening experiments.
The Zyleris Pledge
Produce reliable, traceable, and reproducible data of the highest quality.
Provide fast delivery of experimental results combined with exceptional customer service and technical support.
Follow industry standards and published guidelines of various regulatory agencies (FDA, OECD, COLIPA) for skin penetration and absorption studies. |