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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 In Vitro Release Testing (HT-IVRT)

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

Patent-Pending Technology for Difficult Formulations such as ointments containing hydrophilic APIs or combination APIs.

High-throughput 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 (thermodynamics vs. kinetics), API stability, back-diffusion of receptor component(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.

For challenging formulations such as e.g., ointment formulation containing a hydrophilic API, Zyleris has developed a rapid-screening method based on our HT Franz Cell platform to identify a receptor medium and membrane that can both promote efficient release of the API from a highly lipophilic ointment vehicle AND ensure sufficient solubilization of the released API in the receptor medium.  This requires a fine balance in screening and selecting lipophilic and hydrophilic components for the receptor medium.  Selection of such a receptor medium is critical in successful development of the IVRT method - Highly experienced in development of IVRT method for "difficult" topical 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 "difficult" formulation.  Since the receptor medium is only needed to solubilize the API accumulated in short time intervals (1 -2 hours), rather than throughout the entire experiment (6-8 hours), this system allows greater freedom to select 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.