Advancing Biorelevant Assay and the Future of USP 4 Testing

In pharmaceutical research, biorelevant in vitro experiments predict drug dissolution and absorption under physiological conditions. Dissolution testing, a key component of these assays, examines how medicines dissolve over time.

While developments in dissolution media have improved our ability to simulate in vivo circumstances, testing apparatuses must continue to improve to provide precise simulations, dependable results, and better compatibility with modern media.¹

This article introduces the ERWEKA DFZ II, a modular USP 4 dissolution testing device developed to address these challenges. With its precise control and extensive testing capabilities, the DFZ II enables researchers to achieve the best treatment outcomes.

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Challenges in Biorelevant Dissolution Testing

Modern pharmaceutical research requires dissolution experiments that closely simulate in vivo settings.

This is especially true for poorly soluble drugs, low-dose formulations, and sustained-release medications. Conventional dissolution approaches, while useful in some cases, may fail to model the intricate dynamics of drug release within the human body.

USP 4 dissolution testing addresses these gaps by utilizing flow-through cell technology, which provides a significant benefit over older procedures. It increases the versatility in mimicking various gastrointestinal conditions and enables testing of specific formulations such as implants, suppositories, and powders.²

The ERWEKA DFZ II: A Modular Approach to Dissolution Testing

The ERWEKA DFZ II provides a comprehensive solution for USP 4 dissolution testing. Its modular design and comprehensive configuration choices enable laboratories to tailor the system to their requirements, whether open, closed, offline, online, or on/offline.

Key Features of the DFZ II:

1. Improved Cell Design for Leak-Tightness and Flexibility

• The standardized cell head fits all cell bodies, resulting in faster assembly and reduced costs.
• Improved flat seals, with only three per cell, improve process safety by strengthening leak-tightness.
• Optimized cell bodies, with a leaner design, improve cell warming and accelerate test preparation.

2. Wide Range of Cell Types:

• The DFZ II can accommodate various pharmaceutical forms, including tablets, granulates, powders, implants, stents, and suppositories.
• Unique adapters, like one-way dialysis and cream application adapters, enhance testing possibilities for complex recipes.

3. Compact and Corrosion-Resistant Housing

• The space-saving design puts cells on a single line for better visual control and simplicity of usage. In addition, the tubing organizer decreases the chance of human error, enabling streamlined workflows.

4. Improved Cleaning and Maintenance:

• The water bath has a three-way valve for easy emptying and cleaning, and a color-coded water level pointer for monitoring.²

Disso.NET 3.X: Precision Control at Your Fingertips

The Disso.NET 3.X software is the best platform for the DFZ II system, providing complete control over all operational parameters. The program is designed to meet 21 CFR 11 compliance criteria, ensuring data integrity and regulatory adherence in a GMP environment.

Highlights of Disso.NET 3.X:

• USP 4 Editor: Simplifies method programming and parameter adjustments for dissolution testing.
• FTC Editor: Enables quick and exact setup of flow-through cell parameters, such as cell type, position, and filter specifications.
• Advanced Reporting: Generates extensive PDF reports and exports data in different formats for easy analysis.

This program is suitable for regular USP 4 dissolution operations and specific duties, such as long-term testing of sustained-release formulations.²

Flexible System Configurations for Varied Testing Needs

The DFZ II enables different configurations to meet unique laboratory needs, making it an adaptable tool for researchers.

1. Stand-alone System

This system is ideal for laboratories looking for an affordable way to start USP 4 testing. Thanks to the ERWEKA piston pump and a low-vibration heater, it offers manual sample capabilities and is simple to set up. This configuration is ideal for performing simple release testing without sacrificing compliance or precision.

2. Closed Offline System

This setup is designed specifically for long-term testing of low-dose, sustained-release formulations. A fixed media volume cycles through the flow cells, allowing for thorough cumulative release analysis.

3. Closed Online System

Designed for laboratories that require integrated analytics, this system combines the DFZ II with UV/VIS technology. Automated sampling and analysis at specified intervals are ideal for assessing low-dose formulations with sustained release since they streamline operations while offering real-time insights into drug release behavior.

4. Open Offline System

This setup is particularly useful for studying poorly soluble drugs that require an unlimited supply of fresh medium. Researchers can quickly change media during a test, adjusting pH and allowing for comprehensive IV/IVC (in vitro/in vivo correlation) research. Automatic sampling using the ERWEKA sample collector ensures consistency.²

Applications and Advantages of the DFZ II

The ERWEKA DFZ II meets various pharmaceutical testing requirements:

• Low-Solubility Drugs: Fresh media is continuously supplied in open systems to ensure effective dissolution.
• Sustained-Release Formulations: Enables long-term testing to analyze cumulative drug release profiles.
• Specialized Dosage Forms: Enables testing of implants, powders, and suppositories using purpose-built cells.

The DFZ II's modular design enables laboratories to perform highly specialized dissolution tests, laying the groundwork for more relevant assays and better therapeutic outcomes.²

Conclusion: A Future-Ready Solution for Biorelevant Testing

The need for advanced dissolution testing solutions has never been higher in the age of personalized medicine and complex formulations. The ERWEKA DFZ II, with its modular design, various configuration options, and precision control via Disso.NET 3.X, is a reliable solution that meets the demands of modern pharmaceutical research.

Whether conducting routine dissolution studies or investigating novel drug delivery systems, the DFZ II provides laboratories with the resources they need to push the boundaries of biorelevant testing and deliver better therapeutic analysis.

References and Further Reading

1. Lemos, H. de, Prado, L.D. and Rocha, H.V.A. (2022). Use of biorelevant dissolution media in dissolution tests as a predictive method of oral bioavailability. Brazilian Journal of Pharmaceutical Sciences, 58. https://doi.org/10.1590/s2175-97902022e19759.
2. ERWEKA. USP 4 DFZ II USP 4 Flow-Through Systems. Available at: https://www.erweka.com/files/435515/dfz-ii.pdf (Accessed 28 Feb. 2025).

About ERWEKA

ERWEKA is an international manufacturer of test equipment for the pharmaceutical industry. In addition to large pharmaceutical and life science companies, we supply development and contract laboratories as well as universities around the world with equipment for the development and testing of medicines.

ERWEKA was founded in Germany in 1951 and has been an integral part of the Verder Scientific Division since 2023. As a manufacturer with extensive experience in the testing equipment industry, ERWEKA offers the full range of tablet testing devices for solid dosage forms. Our benchmark is top quality. From development, design and production to service for our devices, we are uncompromising in our commitment to premium quality. ERWEKA stands for excellent product quality, attractive design and individual customer care. Our customers have been relying on this for over 70 years.

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