SOTAX – Pharmaceutical Testing

Dissolution tests are used in the pharmaceutical industry in order to characterize the dissolution properties of the active drug, the active drug’s release, as well as the dissolution from a dosage formulation. While standard tablets are typically tested using the paddle method (USP 2), swelling or floating dosage forms e.g. capsules are tested according to the basket method (USP 1), whereas paddle-over-disk (USP 5) and rotating cylinder (USP 6) methods are utilized for transdermal dosage forms.
The flow-through dissolution method (USP 4 / EP Flow-through cell) is very interesting method which offers complete flexibility on media volumes and allows repeatable positioning of virtually all dosage forms: powders, suspensions, suppositories, APIs, lipophilic forms, liposomes, microspheres, semi-solids, implants, as well as medical devices including drug eluting stents.

SOTAX AG is a world leader in the production of dissolution systems. They can be configured from the simplest, manual, to highly sophisticated, fully automatic. Since 2013, Analysis has been authorized as an exclusive representative of SOTAX in Serbia, Bosnia and Herzegovina, Montenegro and Northern Macedonia.

AT Xtend Manual is an easy-to-operate, manual dissolution tester with advanced monitoring options. The system incorporates SOTAX’s proven HollowShaft technology, which provides world’s most simple and repeatable manual sampling process. This system enables programming individual vessel temperatures before pulling samples. What is more, your dissolution bath can be turned into a semi-automated tester anytime, by simply adding dedicated Xtend modules. The AT Xtend Manual allows performing dissolution tests for all USP 1/2/5/6 methods, as well as other non-compendial methods.

ATS Xtend Offline or Online is a semi-automated dissolution tester that automatically withdraws, filters, and collects samples in tubes, capped LC vials or well plates, or direct read on UV-Vis Spectrophotometers. The automation of essential steps of your dissolution test makes them highly repeatable, improves accuracy, and simplifies method transfer. Samples are simultaneously taken from 6 to 8 vessels. Built on the success of preceding SOTAX dissolution testers, the ATS Xtend system can be flexibly configured for Apparatus 1/2/5/6 methods with different style baskets, paddles, rotating cylinders, etc.

CE7 Smart, the flow-through dissolution method (USP 4 / EP Flow-through cell) offers complete flexibility on media volumes and allows repeatable positioning of virtually all dosage forms. Dissolution and drug release testing using a flow-through cell is proven to characterize the active drug release in terms of bioequivalence and in-vitro / in-vivo correlation (IVIVC) in clinical studies, as well as daily QC routines alike. With 30 years of experience, SOTAX was the first manufacturer to develop a standardized flow-through dissolution unit.

In addition to dissolution testing, solid dosage forms are tested to determine the compliance of physical characteristics: disintegration, friability, hardness, flowability … All instruments for these tests can operate as stand alone units, but are ready for easy integration with data management software and reporting – in full compliance with requirement 21 CFR 11.
SOTAX in the program portfolio has the following devices for measuring physical characteristics:

  • Hardness testers (manual MT50, semi-automated ST50, automatic AT50)
  • Disintegration testers (DT50 and DT2)
  • Friability tester (FT2)
  • Tap density tester (TD1)
  • Powder flow tester (PF1)
  • Cap Torque tester (TM200)

Special products in SOTAX portfolio perform Automatic Sample Preparation of solid or liquid oral dosage forms, API, creams and pastes, which requires accurate execution of multiple laborious steps.
SOTAX is providing full data management software that addresses different aspects of data collection, analysis, approval & evaluation, as well as reporting. From single workstations to multiple networked instruments, SOTAX software solutions help your organization comply with current FDA data integrity guidelines and 21 CFR part 11 regulations on electronic records.