Cutting-Edge Dissolution Systems: Pioneering Digital Advancements and Compliance Excellence

Dissolution testers have come a long way from their simple beginnings as basic stirrer units, evolving into highly advanced instruments used to assess batch-to-batch quality and predict the in vivo bioavailability of drugs.¹

As technology continues to advance, driven by increasing demands for reliability and compliance in the pharmaceutical industry, dissolution testers will continue to evolve. Leading this innovation, ERWEKA has developed a range of dissolution testers designed to not only meet but exceed industry standards, ensuring their designs are ready for the future.

Image Credit: nokwalai/Shutterstock.com

The DT 950 Series: Digitizing Dissolution Testers

ERWEKA’s DT 950 Series, the company’s first digital dissolution tester, is a software-controlled, semi-automatic system with outstanding upgrade potential. It comes in three models, each corresponding to the standard number of test stations.

• DT 956: Six test stations
• DT 957: Seven test stations
• DT 958: Eight test stations

Each model can be upgraded after purchase to encompass 8 test stations. Vessel volumes of 1000 ml and 2000 ml are also available.²

Image Credit: ERWEKA

Comprehensive Compliance with USP Methods

To ensure 100 % compliance with USP methods 1, 2, 5, and 6,³ the DT 950 Series is engineered to fulfill the strict requirements of the United States Pharmacopeia (USP). From basic paddle and basket methods to more complicated apparatus configurations, these approaches cover a wide range of dissolution testing requirements.⁴

By conforming to these globally accepted standards, the DT 950 Series ensures that its dissolution testing processes will satisfy the regulatory criteria of the pharmaceutical market worldwide.

A Flexible and Upgradeable Platform

The DT 950 Series has been designed with a high level of adaptability to accommodate the evolving needs of modern laboratories. Initially configured as a stand-alone system for basic testing tasks, each model in the series can be upgraded to either an offline or online configuration.

Users can further enhance their systems by adding features like an autosampler and fraction collector, as well as integrating advanced analytical instruments such as UV-VIS or HPLC systems.³

Advanced Digital Interface and Software Integration

The DT 950 Series features a 7" touch display with a modern, intuitive user interface designed to reduce errors and streamline the testing process.

A standout feature of this interface is the ERWEKA TestAssist, a smart assistant that helps users navigate the setup and execution of dissolution tests. TestAssist guarantees that only compliant parameters are entered, significantly enhancing the reliability of testing outcomes. Even complex testing protocols become easily manageable with real-time feasibility checks and step-by-step guidance.³

The DT 950 Series can be paired with ERWEKA’s Disso.NET software, a Windows-based platform that offers complete control over the dissolution system, including method management, test execution, and report generation. The software also ensures traceability and compliance by recording every modification through a 21 CFR Part 11 compliant audit trail.²

ERWEKA's Advanced Systems

The DT 9510 Series

With the capacity to house up to 14 test stations and maintain precise temperature control, this series allows for reliable parallel testing of two batches under identical conditions. It shares key features and compliance standards with the DT 950 Series, including the TestAssist software and an optional automatic tablet drop. Additionally, it offers enhanced capabilities such as the AirLift system, which facilitates easier operation.⁵

The DT Light Series

The DT Light Series offers a cost-effective solution for basic dissolution testing using USP methods 1, 2, 5, and 6. It features six or eight test stations and a fixed high-head design for easy vessel access, making it an ideal entry-level device for those new to dissolution testing.⁶

RoboDis II+

RoboDis II+ is a fully automated dissolution testing system managed by ERWEKA's Disso.NET software. This device can test up to 10 batches in parallel according to USP methods 1 and 2 and is fully complies with USP/EP/JP standards, providing reliable and detailed drug release profiles.⁷

BioDis RRT 10

The BioDis RRT automates dissolution testing for a range of extended and sustained-release dosage forms, replicating in vivo gastrointestinal conditions using multiple pH media. This device full complies with USP/EP/JP standards and is available in configurations for USP methods 3, 7, or both. The unit includes an external flow-through heater to minimize vibrations and a mobile touch display for user convenience.⁸

USP 4 Flow-Through Cell DFZ II

Designed for a wide range of applications, including testing poorly soluble and low-dose sustained-release products, the USP 4 Flow-Through Cell DFZ II includes improved leak-tight cell designs, an optimized tubing system, and individual cell heating. It is fully compliant with USP method 4 and is controlled via Disso.NET 3.X software.⁹

Positioning Your Lab for Success

As the pharmaceutical industry continues to evolve, the demand for precise, adaptable, and compliant dissolution testing systems grows ever more critical.

ERWEKA addresses this need by integrating advanced technology, modular design, and comprehensive USP compliance into their solutions. These systems not only meet current testing requirements but also provide the flexibility to adapt to future challenges.

By investing in one of ERWEKA’s dissolution systems, you can be confident that your lab stays at the forefront of pharmaceutical testing, fully equipped to navigate the industry's changing landscape with confidence and precision. To learn more about how these systems can benefit your lab, contact a member of the ERWEKA team today.

References and Further Reading

1. Marroum, P.J. (2014). History and Evolution of the Dissolution Test. Dissolution Technologies. doi.org/10.14227/DT210314P11
2. ERWEKA. Dissolution Guide: Our Broad Range of Dissolution Testers. Available at: https://www.erweka.com/images/downloads/specsheetsENG/Dissolution/2021/Dissolution_Guide_2021_ENG_27-07-2021_WEB_kleiner.pdf
3. ERWEKA. [Online] Digital DT 950 Series Dissolution Tester. Available at: https://www.erweka.com/products/dissolution-testers/digital-dissolution-tester.html# (Accessed on 9 August 2024).
4. Vyshnavi, K., et al. (2022). A Review Article on Dissolution Studies in Novel Drug Delivery System. Journal of Drug Delivery and Therapeutics. doi.org/10.22270/jddt.v12i3.5337
5. ERWEKA. DT 950 & DT 9510 Series. Available at: https://www.erweka.com/images/downloads/specsheetsENG/Dissolution/2022/DT950-9510_EN_1022_Web.pdf 
6. ERWEKA. [Online] The DT light Series. Available at: https://www.erweka.com/products/dissolution-testers/dissolution-testers-usp-1-2-5-6/item/dt-light-series.html (Accessed on 9 August 2024).
7. ERWEKA. [Online] Fully Automated Dissolution System. Available at: https://www.erweka.com/products/dissolution-testers/robodis-ii-fully-automated-system.html (Accessed on 9 August 2024).
8. ERWEKA. [Online] Overview: BioDis RRT 10. Available at: https://www.erweka.com/products/dissolution-testers/dissolution-tester-usp-3-7.html (Accessed on 9 August 2024).
9. ERWEKA. [Online] DFZ II Flow-Through-Cell. Available at: https://www.erweka.com/products/dissolution-testers/flow-through-cell-usp-4.html (Accessed on 9 August 2024).

About ERWEKA

ERWEKA is a leading international manufacturer of test equipment for the pharmaceutical industry. We supply tablet test equipment for large pharmaceutical and life science companies, research and test laboratories, and universities all over the world. Founded in Germany in 1951, ERWEKA is the only manufacturer to offer a product for every required test for solid dosage form drugs. ERWEKA stands for excellent product quality, attractive design and bespoke customer support. Our clients have trusted us for more than 65 years.

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