Dissolution workstations

Fully automated workstations can automatically fill vessels with dissolution medium, drop the tablets or capsules, collect multiple samples, and clean vessels. Zymark MultiDose Automated Dissolution Workstation (Zymark Corporation, Hopkinton, MA), Sotax AT70 Smart (Sotax Corporation, Horsham, PA), and AUTO DISS systems (Pharma Test GmbH, Hainburg, Germany) are several popular automated systems used within the pharmaceutical industry. 

D Commercial COTS controlled by external computer Hybrid systems such as automated dissolution workstation with high-performance liquid chromatography (HPLC) or ultraviolet-visible (UV-Vis) interface Liquid chromatographs, gas chromatographs, UV/Vis spectrophotometers, Fourier transform infrared (FTIR) spectrophotometers, near-infrared (NIR) spectrophotometers, mass spectrometers, atomic absorption spectrometers, thermal gravimetric analyzers, COTS automation workstations... 

T. A. Steinman and E. Parente, Qualification of a Zymark MultiDose automated dissolution workstation for dissolution testing of fexofenadine HC1 capsules, Dissolut. Technol., May 2001. 

The information in this chapter applies specifically to the first element sample preparation. The sample preparation steps are usually the most tedious and labor-intensive part of an analysis. By automating the sample preparation, a significant improvement in efficiency can be achieved. It is important to make sure that (1) suitable instrument qualification has been concluded successfully before initiation of automated sample preparation validation [2], (2) the operational reliability of the automated workstation is acceptable, (3) the analyte measurement procedure has been optimized (e.g., LC run conditions), and (4) appropriate training in use of the instrument has been provided to the operator(s). The equipment used to perform automated sample preparation can be purchased as off-the-shelf units that are precustomized, or it can be built by the laboratory in conjunction with a vendor (custom-designed system). Off-the-shelf workstations for fully automated dissolution testing, automated assay, and content uniformity testing are available from a variety of suppliers, such as Zymark (www.zymark.com) and Sotax (www.sotax.com). These workstations are very well represented in the pharmaceutical industry and are all based on the same functional requirements and basic principles. 

The focus of automation is not solely on HPLC anymore (since it is automated), but also includes the sample preparation procedure for drug products since it involves many labor intensive steps (weighing, addition of sample solvent, extraction procedure, mixing, filtration, additional dilutions, second mixing, etc.). So, if the sample preparation procedures are automated and combined with HPLC, then the entire analysis is said to be fully automated whether it is for assay, CU, blend analysis, or even for dissolution testing. Such automated workstations are currently available from number of vendors (Caliper Life Science, SOTAX Inc.), but their ability to integrate with HPLC or UV spectrophotometer is left to the end users. This open-ended option depends on the end user requirements. 

Zymark has proposed simple and inexpensive workstations designed for specific tasks. Furthermore, some noncommercial systems for single tasks include a microwave digestion system for dissolution of Ti(IV) oxide and adaptations of workstations for special tasks such as the robotic-chromatographic method for the determination of glycosylated haemoglobin. 

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