IVPT Systems: Maximize Analytical Accuracy​​

Pharmaceutical laboratories worldwide rely on Teledyne LABS' Hanson brand of vertical diffusion cell testers for precise in vitro permeation testing (IVPT) and full compliance with regulatory mandates to bring safe, effective topical drugs to market.

Teledyne LABS' Phoenix Dry Heat Systems use dependable automation that makes diffusion cell testing faster, easier, and more economical. With decades of pharmaceutical testing expertise backing every system, our pioneering Phoenix diffusion technology eliminates bottlenecks in drug development workflows while maintaining the regulatory compliance laboratories require.

The Phoenix platform is a complete shift from cumbersome, mind-numbing manual, error-prone methods to full automation that easily handles complex IVPT protocols with minimal human intervention.

Our systems deliver measurable productivity gains while reducing operational costs through proven automation technology. Automation also frees busy lab technicians to do more complex, rewarding tasks. You'll often leave the lab and get home earlier with an automated Phoenix system.​

A foundation of firsts in automated diffusion ce​​ll testing

Our rich history of robust, precise, easy to use products began with our modified Franz cell, patented in 1980. We next released our groundbreaking Microette diffusion tester in 2000.

The Microette, a brainchild of our Hanson brand, was the first automated Vertical Diffusion Cell (VDC) available anywhere. We have since eclipsed that milestone with our automated, computer-controlled Phoenix™ RDS dry‐heat system, built on the Microette's solid foundation.

Hanson's innovative VDC was developed in collaboration with the U.S. Food and Drug
Administration and signified a tremendous stride within the scientific community. It was later
adopted into USP <1724> as the “Model A." Teledyne LABS builds on Hanson's decades of performance in pharmaceutical innovation in topical and transdermal drug delivery testing.

Today, we're well-known and well-respected worldwide, appreciated not only for the quality of our instruments, but also for our exceptional customer care and technical expertise. We are backed by 45 years of experience to fully support you before, during and long after you receive your new diffusion cell tester.

As you conduct due diligence in choosing a diffusion cell tester, consider our compact Phoenix
DB-6 six‐cell manual sampling system, or the Phoenix RDS automated system, progeny of the Microette. The Phoenix RDS is controlled by Teledyne LABS' Diffusion Master™ software, allowing you to independently operate up to two RDS systems (24 vertical diffusion cells) at once from a single computer workstation. 

IVPT: The Basis of Topical D​​rug Development

In vitro permeation testing measures how topical pharmaceutical compounds permeate through biological membranes (the skin) to evaluate performance and safety and receive data that guides drug formulation and dosing decisions. IVPT is the cornerstone of topical drug development, predicting the rate and extent of drug absorption into target tissues. This makes IVPT indispensable to pharmaceutical researchers developing creams, gels, ointments, and transdermal delivery systems.

IVPT is particularly important to bioequivalence studies for generic drug development. U.S. FDA guidelines increasingly rely on IVPT data for ANDA (Abbreviated New Drug Application) submissions, allowing pharmaceutical companies to demonstrate therapeutic equivalence without conducting expensive clinical trials. This regulatory shift has made reliable, reproducible IVPT testing more valuable than ever for companies seeking faster regulatory approval and a leg up on the competition.​​

Phoenix Diffusion Systems: Automated IVPT Ex​​cellence

The Phoenix platform delivers three integrated solutions that transform IVPT testing efficiency:

• Phoenix DB-6 Manual System: Six-cell manual sampling in a compact footprint with advanced touchscreen control over temperature, stirring speed, and sampling intervals
• Phoenix RDS Automated System: Fully automated sample collection handling of up to 24 cells simultaneously from a single workstation, managing collection and media replacement without operator intervention
• Phoenix Dry Heat Diffusion Cells: Precision borosilicate glass construction with mixer inserts engineered for instant homogenization of receptor media 
  

Visual testing with red dye demonstrates complete dispersion occurs within seconds, not minutes—a significant advantage over conventional diffusion cells that require extended mixing times. This rapid homogenization capability ensures consistent drug concentration measurements and reduces sampling errors that can compromise study validity.​

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The Phoenix platform's modular design allows laboratories to start with basic configurations and expand capabilities as testing volumes increase. This scalability makes Phoenix systems suitable for labs of all sizes, from academic research labs with moderate testing needs, to large pharmaceutical companies requiring maximum throughput.

The Flexibility to Optimize Your IVPT Protocols

Phoenix systems use the Franz diffusion method, a two-chamber setup where drug formulations are applied to the top chamber and permeate through a membrane into the bottom chamber for measurement. This approach provides reliable data on how well drugs will absorb into the body.

Phoenix automation handles timing, temperature control, and sample collection through programmable protocols. The systems maintain consistent sampling intervals and environmental conditions while reducing manual intervention requirements. Laboratory technicians can manage multiple studies simultaneously without compromising data quality.

Most IVPT testing focuses on skin permeation for topical and transdermal formulations. Phoenix systems accommodate both biological samples (human or animal skin) for regulatory studies and synthetic membranes for preliminary screening. This flexibility allows researchers to conduct cost-effective formulation screening before advancing to more expensive biological testing.

Sampling methodology depends on study requirements and analytical objectives. Aliquot sampling collects small fluid volumes at each time point, enabling frequent measurements while conserving receptor media. Full media replacement prevents concentration buildup that could affect permeation measurements. Phoenix systems support both approaches through configurable protocols.​

From Small Molecules to Complex For​​mulations

Phoenix systems accommodate the spectrum of pharmaceutical testing requirements through versatile configurations that adapt to diverse study protocols. Whether testing conventional creams or innovative nanoparticle formulations, Phoenix systems provide the adaptability needed for contemporary pharmaceutical development.

Testing capabilities include multiple categories of pharmaceutical compounds:

• Small molecules with straightforward diffusion kinetics requiring standard protocols
• Peptides and proteins that may need specialized receptor solutions or extended testing periods
• Macromolecules presenting unique analytical challenges and longer permeation timelines
• Nanoparticle formulations requiring specialized handling and measurement techniques 

Temperature control is an important factor in IVPT testing, as even small temperature variations can affect permeation rates. Phoenix systems maintain precise temperature control throughout testing periods, with a dry heat system that ensure consistent conditions across all diffusion cells. This environmental consistency proves particularly important for comparative studies where temperature variations could introduce confounding variables.​

Eliminate Testing Errors Through Smart Automation

Manual sampling and collection procedures introduce sources of error in IVPT testing, from timing inconsistencies to contamination risks. Phoenix automation transforms laboratory operations through programmable protocols that execute with mechanical precision while freeing personnel for higher-value activities.

Phoenix systems deliver measurable productivity improvements through:

• Multi-cell testing capabilities that multiply throughput without proportional labor increases
• Automated sampling protocols that eliminate human timing errors and contamination risks
• Protocol Manager software creating complete audit trails while reducing manual documentation
• Data integrity features preventing post-collection modifications with secure multi-user access controls to satisfy 21 CFR Part 11 requirements. 

The Phoenix RDS system's ability to handle 24 cells simultaneously means laboratories can conduct multiple studies or increase statistical power within individual studies. This throughput advantage becomes particularly valuable for contract laboratories serving multiple clients or pharmaceutical companies evaluating numerous formulation variants.​

Navigate Regulatory Requirements with Con​​fidence

FDA compliance for topical drug bioequivalence studies requires specific testing protocols and documentation standards. Phoenix systems include built-in temperature monitoring, automated data logging, and protocol management features that align with these regulatory requirements. The systems generate the documentation trails and data integrity features that regulators demand.

Regulatory alignment means Phoenix systems meet established pharmacopeial standards for pharmaceutical testing equipment. This standardization helps laboratories maintain consistent testing approaches across different studies and simplifies method transfer when working with multiple sites or contract organizations. Pharmacopeial-compliant systems also reduce the validation work required when implementing established testing protocols.

High-quality IVPT data supports predictive modeling that can identify promising formulations before clinical testing begins. Permeation measurements help formulators understand which delivery approaches will work and which won't, allowing teams to focus development resources on the most viable candidates. This screening approach helps pharmaceutical companies make informed decisions about formulation development priorities.​​

Industry-Specific I​​VPT Solutions That Work

Phoenix IVPT systems serve multiple pharmaceutical sectors across diverse laboratory environments that have specialized requirements. Each market segment benefits from the automation and precision that Phoenix technology delivers, though specific applications vary based on testing objectives and regulatory requirements.

Market applications include:

• Pharmaceutical companies: Generic drug development, formulation optimization, and bioequivalence studies throughout the drug development lifecycle
• Contract laboratories: High-throughput testing services for multiple pharmaceutical clients requiring rapid turnaround and consistent quality
• Academic institutions: Method development studies and fundamental permeation research with modular configurations optimized for specific research objectives
• Personal care companies: Cosmetic formulation permeation studies requiring the same analytical rigor as pharmaceutical applications​ 

Generic drug manufacturers particularly benefit from automated IVPT capabilities that support multiple ANDA submissions simultaneously. The Phoenix RDS system's 24-cell capacity and automated operation make it particularly suitable for contract testing environments where commercial success depends on rapid turnaround times and consistent quality across diverse testing protocols.​

Complete Support from Installation to I​​nnovation

Teledyne LABS application notes provide step-by-step guidance for method development and validation procedures based on Teledyne's pharmaceutical testing experience. These documents help laboratories set up testing protocols for specific compounds and formulations while meeting regulatory requirements. Laboratories establishing new IVPT capabilities or expanding their testing scope can use these resources to avoid common setup issues.

Teledyne LABS training programs cover both theoretical background and hands-on operation of Phoenix systems. The programs address common operational challenges and help laboratory personnel understand proper testing techniques. Training support continues after initial installation to help laboratories maintain consistent testin​g quality when staff changes, or testing requirements shift.

Equipment qualification and installation support covers performance verification testing, environmental setup, and integration with existing laboratory systems. Technical representatives work with laboratories to validate system performance and establish proper operating procedures. Method transfer assistance helps laboratories move from other diffusion systems to Phoenix platforms while maintaining data continuity between testing methods.​​

Our C​​ompany​

Teledyne LABS represents a collection of established laboratory instrumentation brands with decades of proven expertise in pharmaceutical testing automation. We have assembled industry-leading specialists under one roof—CETAC Technologies, Hanson, ISCO chromatography and pumps, Leeman Labs, and Tekmar—creating an unparalleled breadth of analytical solutions for modern laboratories.

The Teledyne LABS philosophy centers on laboratory automation that increases productivity while eliminating human error. Every solution we develop addresses the fundamental challenge facing pharmaceutical laboratories: how to generate reliable, regulatory-compliant data more efficiently than manual methods allow. Our automation approach helps laboratory professionals focus on scientific interpretation rather than repetitive manual tasks.

Teledyne LABS continues the innovation tradition that has defined our constituent brands for decades. We invest in advancing diffusion cell technology, developing new automation capabilities, and expanding our analytical portfolio to meet the changing requirements of pharmaceutical development. This commitment to innovation ensures our customers stay ahead of regulatory changes and market demands while maintaining the scientific rigor their work requires.​

Frequently Asked Qu​​estions

What is IVPT and how does it diff​​er from IVRT?

IVPT (In Vitro Permeation Testing) measures drug permeation through biological membranes or skin to assess absorption and bioavailability. IVRT (In Vitro Release Testing) measures drug release from formulations into receptor media. IVPT focuses on barrier penetration while IVRT evaluates formulation release characteristics.​ 

Can Phoenix systems handle high-throughput testi​ng for contract laboratories?

The Phoenix RDS system processes up to 24 diffusion cells simultaneously with fully automated sampling and collection. This capacity, combined with programmable protocols, makes it ideal for contract laboratories serving multiple pharmaceutical clients with diverse testing requirements. 

What training and support does Teledyne LABS provide ​for IVPT method development?

Teledyne LABS provides training programs covering theoretical principles and practical operation techniques. Application notes and case studies guide method development and validation, while in-house technical experts assists with equipment qualification, installation, and method transfer from other diffusion systems.

Where can I find regulatory guidance​ documents?

• Draft Guidance for Industry: In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs
• Draft Guidance: In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs
  
• United States Pharmacopeia, General Chapter <1724> Semisolid drug products-Performance Test
• European Medicines Agency guidance