Dissolution Testing and Physical Testing

Dissolution tests are used in the pharma industry in order to characterize 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 a very interesting method that 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. In addition to dissolution testing, solid dosage forms are tested to determine the compliance of physical characteristics: disintegration, friability, hardness, flowability, etc. All instruments for these tests can operate as stand alone units, but they are also ready for easy integration with data management software and reporting - in full compliance with requirement 21 CFR 11.

FAQ: Dissolution Testing and Physical Testing

What dissolution systems does SOTAX offer?

USP 1/2/5/6 and USP4

Are SOTAX dissolution systems upgradeable?

Yes, SOTAX has a basic, manual, model of the dissolution apparatus: AT Xtend, which can be upgraded to a semi-automatic or automatic system by adding modules.

What level of automation do SOTAX dissolution systems have?

AT Xtend Manual, Semi-Automatic ATS Xtend Offline, Semi-Automatic ATS Xtend Online, Semi-Automatic ATS Xtend On-Offline, ATF Xtend Automatic System

What type of pump do SOTAX dissolution systems use?

SOTAX most often uses piston pumps in its configurations, as they are the most reliable and robust. In addition to them, the offer also includes syringe pumps, and it is up to the user to choose the one that suits him best

Can SOTAX dissolution systems work with or without software?

SOTAX AT Xtend dissolution systems can work without software (as stand alone) or with dedicated q-doc software

Does SOTAX offer devices for the preparation of dissolution media?

SOTAX offers an apparatus for media preparation (mixing, degassing, heating) – model MP

What level of automation do SOTAX tablet hardness testers have?

SOTAX offers machines for manual testing MT50, semi-automatic testing ST50 and automatic testing AT50. All devices, in addition to hardness, can also measure tablet dimensions and, optionally, weight

Does SOTAX offer instruments for disintegration test?

Yes, SOTAX offers disintegration test devices: model DT50 (automatic and without water bath) and model DT2 (manual and with water bath)

Does SOTAX offer devices for sample preparation?

Yes, SOTAX offers JetX MultiFlow and SigleFlow automated sample preparation systems that enable simple and reproducible sample preparation

What devices can be controlled by the q-doc software?

q-doc is software for data management that can control 1 device (single workstation) or work as network solution for multiple devices and systems (dissolution systems, devices for testing the physical characteristics of solid forms, balances, etc…)