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Zyleris PharmaTech - High-Throughput Franz Cell Technology for Topical Formulation Screening
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Zyleris PharmaTech - High-Throughput Franz Cell Technology for Topical Formulation Screening

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Zyleris PharmaTech specializes in innovative high-throughput experimentation technology for applications in topical pharmaceutical and personal care product industries. ...

Zyleris PharmaTech specializes in innovative high-throughput experimentation technology for applications in topical pharmaceutical and personal care product industries.

We provide high-throughput screening services for topical formulation development.

Services provided:

1. High-throughput Franz Cell skin absorption and penetration screening service.
2. High-throughput screening of compound library to identify candidates for topical and transdermal delivery.
3. High-throughput absorption depth profiling in stratum corneum layer.
4. Skin absorption and penetration enhancement development service.
5. Topical formulation development and optimization service.

For more information about the technology and our services, please visit us at www.zyleris.com.

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Zyleris PharmaTech - High-Throughput Franz Cell Technology for Topical Formulation Screening Presentation Transcript

  • 1. High-Throughput Franz Cell TechnologyPlatform For Topical Formulation Screening Best of Both Worlds – Speed and Efficiency (High Throughput ) and Data Compatibility (Standard Franz Cell) Zyleris PharmaTech (Lake Bluff, Illinois, U.S.A) 1
  • 2. Topical Formulation Development –Challenges and Opportunities• Industry standard Franz Cell technology (static and flow- through type) – low throughput and expensive.• No HTS technology in the market for topical formulation or compound library screening.• Limited number of formulations screened in topical formulation development process. Question: is the formulation slated for clinical development really best possible one to move forward?• Small number of compounds evaluated for topical and transdermal delivery. 2
  • 3. Zyleris’ High-Throughput Screening (HTS)Technology – Design Considerations• Compatibility with the standard Franz Cell (not re- inventing the wheel).• Multiple screening modes (absorption and penetration).• Galenic forms (semi-solids/liquids and transdermal patches).• Contact between tissue and receptor medium.• Efficient mixing.• Precision temperature control.• Sample collection (fast, easy, and automation-ready).• Last, but not least – high-throughput. 3
  • 4. Zyleris’ HTS Technology – Design Features• Franz Cell principle – static type with a donor and receptor chamber separated by a tissue membrane.• Each HTS station is a compact, modular 108-cell unit (size: 12x11 inches).• Diffusion area 0.5 sq. cm (8mm is in diameter.) in each HTS cell.• All glass and Teflon construction (chemically inert). 4
  • 5. Zyleris’ HTS Technology – Key DesignAdvantages• Key factors in ensuring data reliability and reproducibility (from system design point of view): mixing, sampling, and temperature control.• Unique design that eliminates potential stagnant layer or bubbles between tissue membrane and receptor medium.• Efficient mixing without vortexing.• Sampling mechanism to ensure uniformity in sample collection across all HTS cells in the screening station.• Precision temperature control. 5
  • 6. Zyleris’ HTS Schematic and Workflow Load Screen Collect = Individual Cell Analysis 6
  • 7. Zyleris’ HTS Technology – OperatingFeatures• Same operating principle as Franz Cell – process, collect, and analyze.• One tissue membrane for each cell in HTS station.• Parallel processing.• Fast and easy sample collection.• Controlled and efficient mixing.• Controlled temperature.• Fully validated against standard Franz Cell (We provide free technology comparison and validation service). 7
  • 8. Zyleris’ HTS Technology – ScreeningFeatures• Applicable to all common dosage forms – gels, lotions, creams, ointments, serums, solutions, etc.• Applicable to transdermal patches (matrix- and reservoir- type). Adaptable for iontophoretic patch.• Flexible enough for any type of skin absorption and penetration study.• Animal and human skin tissues as well as synthetic membranes.• Ocular, buccal, lung, or any other tissues, nails (with adapter).• Finite and infinite dose (occlusive or non-occlusive). 8
  • 9. Zyleris’ HTS Technology – ScreeningFeatures: The Case of Transdermal Patches• Membrane/matrix type – cut the patches into circles and carry out HTS screening as same as semi-solid/liquid dosage forms.• Reservoir type Current system: accept reservoir diameter up to 8mm (Min. diameter: 12 mm including peripheral seal). Modified system: accept reservoir diameter up to 11mm (Min. diameter: 15 mm including peripheral seal). 9
  • 10. Zyleris’ HTS Technology - Key Benefits• Franz Cell in a high-throughput fashion.• First HTS technology capable of operating at absorption and penetration mode.• Speed and efficiency (lower cost per formulation).• Data compatibility with standard Franz Cell. 10
  • 11. Services Provided• High-Throughput Skin Absorption and Permeation Screening• High-Throughput Screening of Compound Library for Topical and Transdermal Delivery• High-Throughput Absorption Depth Profiling in Stratum Corneum Layer• Percutaneous Absorption and Permeation Enhancement Development Services• Formulation Development and Optimization Services 11
  • 12. Skin Absorption and Penetration ScreeningServices• Penetration Mode API collected in receptor medium.• Absorption Mode API absorbed in epidermis and/or dermis layer.• Absorption and Penetration Mode API absorbed in epidermis and/or dermis and collected in receptor medium.• Absorption and Penetration Mode - Mass Balance Study API left on skin surface, absorbed in stratum corneum (SC) layer and epidermis and/or dermis layer, and collected in receptor medium.• Custom Mode Any type of absorption and penetration study. 12
  • 13. Skin Absorption Depth Profiling in SC Layer• HTS Formulation Screening - Absorption and release in SC layer.• High-Speed Tape-Strip Processing - Capable of processing 48 tape strips at a time. - Consistency and uniformity across all strips during each stripping cycle. - Strip pooling for depth profiling. - Solvent extraction/digestion. 13
  • 14. Formulation Screening - Schematics Topical Absorption Transdermal Penetration 14
  • 15. In Vitro Absorption and PenetrationScreening Services – Skin Model• Fresh Pig Ear Skin - Standard model• Human Cadaver Skin - Standard model• Custom - Customer may request or provide tissue membranes for specialized studies. 15
  • 16. In Vitro Absorption and PenetrationScreening Services – Skin Integrity Test• Measurement of Electrical Resistance (Impedance) - LCR meter operated at 100 – 1,000 Hz (lower frequency generally yields greater sensitivity and better differentiation) .• Electrical Resistance (Impedance, Z Value) - Dependent upon skin type, temperature, frequency, testing medium, etc.• Established Threshold Value in Our Laboratory - Fresh pig ear skin => 5 Kohms at 100 Hz. 16
  • 17. In Vitro Absorption and PenetrationScreening Services – Sample Processing• Stratum Corneum (SC) Layer Tape-stripping followed by solvent extraction.• Epidermis and/or Dermis Layer Tissue digestion/homogenization followed by solvent extraction. Separation of epidermis from dermis.• Receptor Medium - Saline, PBS or TBS buffer - Saline, PBS or TBS buffer with a non-ionic surfactant (e.g., oleth-20) or BSA for hydrophobic API. 17
  • 18. In Vitro Absorption and PenetrationScreening Services – Data and Reporting• Data Raw data as total amounts at each data point.• Reporting Project report including detailed protocol, experimental procedure, and data. 18
  • 19. In Vitro Absorption and PenetrationScreening Services – Analytical Services• Standard method of analysis LC-MS-MS.• Method development/transfer - Develop new method. - Method transfer.• DIY (Do-It-Yourself) Analysis Option Samples are returned to customers for their own analysis. 19
  • 20. Study Protocol• Screening Protocol Three replicates per formulation (N=3). Rapid formulation screening and lead generation.• Optimization Protocol Six replicates per formulation (N=6). Formulation fine-tuning and optimization.• Custom Protocol Per specification (N= any number). 20
  • 21. HTS – Current Capability• Penetration Study (Transdermal) 70 formulations per week (three replicates and 3-4 data points per formulation).• Absorption and/or Penetration Study (Topical) 35 formulations per week (three replicates and 3-4 data points per formulation).• Zyleris has the capacity (2,200 HTS cells) to equip 20 HTS stations – screening capability can be easily ramped up, when needed. 21
  • 22. Business Model• HTS Screening Service – Fee-for-Service - Clients supply formulations* to be screened. Pricing is quoted based on per formulation. - Formulations developed by Zyleris. *: Zyleris offers preformulation and formulation development services. 22
  • 23. Turnaround TimeTypical Guideline – In Transdermal Mode• Up to 70 formulations (three replicates per formulation).• Up to 4 data points at 2, 4, 8, and 24 hr.• Timeline* - Formulation screening + DIY analysis option: within 2-3 weeks. - Formulation screening + LC-MS-MS analysis + reporting: within 4-5 weeks. * Actual turnaround time is typically sooner than the above guideline. 23
  • 24. PricingFactors that affect the pricing:• Study mode (transdermal, topical absorption, depth profiling, mass balance, etc.).• Replicates per formulation.• Data points.• Number of formulations.• Number of APIs in each formulation (if analytical service is selected).• Any special handling requirements. 24
  • 25. Thank you! 25