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Zyleris PharmaTech

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Lake Bluff, Illinois, US

About Zyleris PharmaTech

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... Show more »

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.

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Diversity Certificates

Minority owned business Small business

Our Services (14)


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Pharmaceutical Formulation

Price on request
Request a quote for more information about this service.

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In vitro Percutaneous Absorption Studies

Price on request

High-throughput skin absorption and penetration screening (IVPT)

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... Show more »

High-throughput skin absorption and penetration screening (IVPT)

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.

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Topical Formulation

Price on request

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... Show more »

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.

  • Develop a dosage form to deliver your compound to targeted skin layer (topical) and systemic circulation (transdermal). For example, antifungals and keratolytics => controlled release into SC layer; anesthetics => controlled release in epidermis/dermis layer; transdermal delivery => achieve required flux across skin layers.
  • Select a dosage form compatible with intended indication of your compound. For example, antibacterials and products for atopic dermatitis and psoriasis => creams or ointments; acne and rosacea => aqueous gels.

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).

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Drug Delivery Systems

Price on request
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Drug Absorption Studies

Price on request
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In vitro ADME/DMPK Studies

Price on request

In vitro ADME Services

In vitro ADME Services

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
Price on request

ADME and DMPK Studies Services

ADME and DMPK Studies Services

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Pharmacology & Toxicology

Price on request

Pharmacology & Toxicology Services

Pharmacology & Toxicology Services

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Product Quality Control

Price on request

Product Quality Control Services

Product Quality Control Services

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Product Development, Testing, and Packaging

Price on request

Product Development & Testing Services

Product Development & Testing Services

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Formulation Services

Price on request

Formulation & Manufacturing Services

Formulation & Manufacturing Services

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Drug Development

Price on request

Drug Development Services

Drug Development Services

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Drug Discovery & Development

Price on request

Drug Discovery & Development Services

Drug Discovery & Development Services

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Drug Release Studies/In Vitro Release Testing (IVRT)

Price on request

High-throughput in vitro release testing (IVRT)

IVRT method development and test conducted at Zyleris are in full compliance with FDA
SUPAC-SS guidance.

IVRT method development

IVRT method development process at Zyleris:

  1. Membrane selection - membrane binding test (static and diffusion test), compatibility and... Show more »

High-throughput in vitro release testing (IVRT)

IVRT method development and test conducted at Zyleris are in full compliance with FDA
SUPAC-SS guidance.

IVRT method development

IVRT method development process at Zyleris:

  1. Membrane selection - membrane binding test (static and diffusion test), compatibility and "wettability" of membrane by the formulation. Even both hydrophobic and hydrophilic membrane pass the binding test, the membrane must be compatible and wettable by the formulation in order to achieve efficient release of an API.
  2. Receptor medium selection - API release, and solubilization (thermodynamic and kinetic), API stability, back-diffusion of receptor ingredient(s), membrane stress test in the selected receptor medium.
    More often than not, screening of API solubility alone is not enough in selecting a suitable receptor medium. API release from the formulation must be screened as well in order to achieve sufficient release.
  3. IVRT sensitivity - ability to detect concentration change.
  4. IVRT specificity - proportionality and linearity of API release.
  5. IVRT selectivity - ability to detect inequivalent product.

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.

Zyleris' advantages

  1. In our HT Franz Cell system, entire content of the receptor medium will be replaced with a fresh, pre-incubated batch at each time point. This unique sampling (shuttle-sampling) mechanism ensures that the required sink-condition can be always well-maintained. This makes selection of a receptor medium easier, which is particularly beneficial for IVRT method development of a "challenging" formulation. Since the receptor medium is only needed to solubilize the API accumulated in short time intervals (e.g., 1-2 hours), rather than throughout the entire experiment (e.g., 6-8 hours), this system allows greater freedom in selection of a receptor medium for IVRT method development.
  2. Our high-throughput Franz Cell platform makes it possible to simultaneously compare multiple prototype formulations to a reference listed drug (RLD) - accelerating your formulation and process development.
  3. We are capable of running multiple prototypes, or multiple batches of prototypes and RLDs simultaneously, minimizing inter-day data variation.
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Jerry Zhang

President

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