Zyleris provides contract research services for topical pharmaceutical development. Established in 2010, Zyleris has been at forefront in developing technologies and providing services for topical formulation development. We aim to become your trusted service provider.
What Do We Offer Specifically?
A full suite of topical formulation development, screening, and optimization services, including tissue permeation screening (IVPT), in vitro release test (IVRT), topical formulation development and optimization, and formulation reverse-engineering/generic formulation development.
How Are We Different?
First technology developed at Zyleris is a first-in-class, proprietary high-throughput Franz Cell technology platform. This technology is fully validated against the industry standard Franz Cell technology. It revolutionizes topical formulation development and evaluation.
Zyleris believes that innovation is a key to stay competitive and deliver values to our clients. We devote significant amount of resources to improve existing technologies and develop new technologies. These proprietary and patent-protected technologies have extensively utilized in services we provide.
What Does This Mean To You?
Faster, cheaper, and better way to develop superior topical formulations.
High-throughput skin absorption and penetration screening (IVPT)
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).
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.
Any type of tissue absorption and penetration studies can be conducted on our HT Franz Cell
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.
Our high-throughput experimentation technology can be used for study of all galenic forms of
topical formulations including but not limited to:
Skin Integrity Test
Tissue barrier integrity will be measured using transepidermal electrical resistance measurement
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.
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.
With our high-throughput technology platform, we offer fast turnaround time for your projects.
Topical Formulation Development
Solubility screening and enhancement of drug candidates using high-throughput experimentation technology - solvents, pH, solubilizing agents, penetration enhancers, lipid vehicles, etc.
Dosage Form Selection
Based on physical and chemical properties of your compounds, select the dosage form most suitable for the compounds and intended indications - serums, ointments, gels, lotions, creams, etc.
Proof-of-Concept (POC) Formulation Development and Evaluation Starter Package
Based on physical and chemical property of your compound as well as its intended indication, 3-to-6 topical formulations in various dosage forms and/or concentration levels will be developed, The developed formulations will be evaluated for their skin absorption and penetration properties using our HTS technology platform. This package is specifically designed for a quick POC evaluation of your compound's suitability for topical and transdermal delivery. A typical turnaround time for this package is about four-to-six weeks (from receipt of testing materials to delivery of project report).
ADME and DMPK Studies Services
Product Development & Testing Services
High-throughput in vitro release testing (IVRT)
IVRT method development and test conducted at Zyleris are in full compliance with FDA
IVRT method development
IVRT method development process at Zyleris:
Zyleris is highly experienced in development of IVRT methods for topical products. We have successfully developed IVRT methods challenging formulations, such as, e.g., , formulations containing high API concentrations or having fast API release, ointments containing hydrophilic APIs, combination products, particularly when the API combination contains a lipophilic and hydrophilic API, and foam formulations.
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