December 2012: High Performance Liquid Chromatography (HPLC) has been and continues to be a workhorse of the pharmaceutical laboratory. Throughout the product life cycle from Pre-Formulation to Quality Control, HPLC coupled to Dissolution and Content Uniformity/Assay testing are some of the biggest sample sources for HPLC analysis. SOTAX, the leader in automated solutions for Dissolution testing and Automated Sample Prep has developed a variety of “Off-line” autosampler solutions over the decades. ”Off-line” samples are withdrawn from our instruments, immediately filtered and collected in a variety of formats. To further automate the analytical workflow and to avoid costly manual transfer mistakes, SOTAX is now pleased to announce the newest addition to their line of autosamplers: the SAM Sample Manager.

The SAM guarantees a seamless flow from Dissolution samples to analytical results. Totally flexible and scalable, the system is available in three different capacities to connect to semi-automated single, double, and fully-automated systems: SAM S (small; for up to 240 samples), SAM M (medium; for up to 480 samples), and SAM L (large; for up to 720 samples). The SAM acts as a transfer platform keeping samples protected and injecting them one by one into HPLC, all without any vial transfer. The system works with any HPLC instrument with ready signal functionality and can be integrated with a variety of different injection valves. SAM is driven by the WinSOTAXplus Advanced Dissolution Software while the LC data is processed with the existing chromatography software. SAM will take care of the samples seamlessly from start, to analytical finish.

For more information about the new HPLC On-line solution with SAM, please contact us.
To download the press release in English, click here.
To download the press release in German, click here.
To download the press release in French, click here.

SOTAX AG
Press contact: Petra Silbereisen
E-mail: petra.silbereisen@sotax.com 

Phone:  +41 61 487 54 54 
Fax:      +41 61 482 13 31
 
 

March 2012: To strengthen its existing UV-Vis portfolio, SOTAX is pleased to announce a new UV-Vis option: the SOTAX SPECORD® PLUS, powered by Analytik Jena.

The SPECORD® PLUS conforms to all international pharmacopeias and fulfills the requirements for equipment qualification in the pharmaceutical industry. A dual-beam system equipped with symmetrical double eight position cell changers, the SPECORD® PLUS is the ideal spectrophotometer for double on-line systems, allowing users to test up to twelve samples simultaneously.

Today, driven by the WinSOTAXplus Advanced Dissolution Software, on-line UV systems are able to withdraw, transfer, and measure the absorbance of dissolution samples. Data can be compared to an entered standard value, a standard curve, or a measured standard value before, during, and after the test.

The compliant dissolution software calculates concentration and finally % dissolved from raw absorbance values at one wavelength or on the whole wavelength spectra for single or multi-active components.

For customers who prefer to integrate their existing UV-Vis into a semi-automated SOTAX AT 7smart UV-Vis online system, SOTAX also has an answer: the WinSOTAXplus software includes UV-Vis drivers for most UV-Vis brands, including Thermo, Perkin Elmer, Shimadzu, Agilent, Analytik Jena, and more.

SOTAX integrated UV-VIS solutions for dissolution – flexible solutions for the global market.

For more information about SOTAX' new UV-Vis solution, please contact us.
To download the press release, please click here!

SOTAX AG
Binningerstrasse 106
4123 Allschwil 1
Switzerland

E-mail: info@sotax.com  

Phone:  +41 61 487 54 54 
Fax:      +41 61 482 13 31

August 2011:  The SOTAX Group, the market leader and pioneer in USP Apparatus 4 Flow announce the introduction of the lipidic cell for soft gelatin capsule testing into the latest release of USP <2040> Disintegration and Dissolution of Dietary Supplements. This flow cell was first introduced in Eur. Ph. chapter 2.9.42 and has been official since 2006.

Designed specifically for use with lipidic products such as fat-based suppositories and oil-filled soft gelatin capsules, this flow cell solves the problem of floating and the formation of a lipidic layer on the surface of the dissolution medium seen in USP Apparatus 2 methods. The cell consists of three compartments. The lower part (1) is made up of two adjacent chambers connected to an overflow device. The dissolution medium passes through chamber A and is subjected to an upward flow. The flow in chamber B is directed downward to an exit that then leads upward to a filtering assembly. The middle part (2) of the cell has a cavity designed to collect lipophilic excipients that float on the dissolution medium. A metal mesh is used as a rough filter. The upper part (3) holds the filter in place. The sample is then collected and analyzed for drug release content.

For more information about the Soft Gelatin Capsule Flow Through Cell and USP Apparatus 4, please contact us.

Download the Press Release in pdf with pictures here!

SOTAX AG
Binningerstrasse 106
4123 Allschwil 1
Switzerland

E-mail: info@sotax.com  

Phone:  +41 61 487 54 54 
Fax:      +41 61 482 13 31

August 2011:  The SOTAX Group, the market leader and pioneer in USP Apparatus 4 announce the release of a new Dialysis Adapter for use with the SOTAX CE7smart Flow Through Dissolution System.

The patented A4D was designed and tested in collaboration with Professor Diane Burgess of the School of Pharmacy at The University of Connecticut. The adapter was designed to fulfill a growing application requirement for drug release testing from controlled-release parenteral products such as liposomes and nanoparticle formulations (1). Dr. Burgess’s work on in-vitro drug release testing using USP Apparatus 4 began several years ago with the study of microsphere formulations (2).

The challenges with monitoring drug release from these formulations are sample containment, filtration, and method standardization. Traditional small scale drug release testing on liposomes began with non-compendial sample and separate, dialysis sac, and diffusion cell techniques. In order to incorporate this into the USP 4 method, an adapter was designed which uses dialysis tubing fit over a compartment within the standard 22.6 mm flow cell. This new adapter allows researchers to accurately discriminate different liposome formulations and defines a standardized approach to dialysis testing. SOTAX is a proud sponsor of The School of Pharmacy at the University of Connecticut. In late 2009, the University of Connecticut honored SOTAX with the dedication of the “SOTAX Dissolution and Drug Release Testing Laboratory” at UCONN.

For more information about the A4D Dialysis Insert and USP Apparatus 4, please contact us.

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(1) Bhardwaj, U., Burgess, D.J., 2010. A novel USP apparatus 4 based release testing method for dispersed systems. Int. J. Pharm. 388, 1-2, pp. 287-294.
(2) Rawat A, Stippler E, Shah VP, Burgess DJ. 2011. Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal(®) Consta(®). Int J Pharm. 2011 Aug 24

Download the Press Release in pdf with pictures here!

SOTAX AG
Binningerstrasse 106
4123 Allschwil 1
Switzerland

E-mail: info@sotax.com  

Phone:  +41 61 487 54 54 
Fax:      +41 61 482 13 31