DIS 6000 / DIS 8000 - Dissolution testers
Efficient and compact, the tablet dissolution testers DIS 8000 and DIS 6000 are rugged "no-nonsense" units with eight, respectively six stirred test vessels and simple, easy-to-use controls. Dissolutions testers of the DIS series meet the latest specifications as laid down in the European, United States and associated Pharmacopoeia. Particular emphasis has been placed on those factors affecting the eccentricity, alignment and centring of the stirring elements in order to reduce the number of parts used and hence keep the machine variables at a minimum.
The term "dissolution test" is normally used to describe the testing of those forms such as immediate release oral tablets or capsules intended to dissolve rapidly in the test medium.
For non-oral dosage forms such as suppositories, topical and transdermal systems, the term "drug release" is normally employed.
From a regulatory perspective, the Food and Drug Administration (FDA) has published four Guidances for Industy relating to dissolution. A similar function is provided by the European Medicines Agency (EMEA) in the form the Committee for Medicinal Products for Human Use (CHMP).
Baskets, paddles and rotating cylinders
All of the DIS series are equipped with precision ground drive shafts that will accept any of the baskets, paddles or rotating cylinders described in the respective Pharmacopoeia.
- Basket stirring elements (USP Method 1 / EP)
- Paddle stirring elements (USP Method 2 / EP)
- Transdermal patches (USP Method 5 / EP Chapter 2.9.4)
- Rotating cylinder (USP Method 6 / EP Chapter 2.9.4 Method 3)
- Special baskets and mini-paddle systems
All stirring elements can be laser numbered and certified on request. All of the elements can be supplied with a 2.5 micron coating of gold for additional protection against aggressive media, if required.
Vessels, centring and lids
All DIS models are supplied with USP / EP compliant vessels and feature an "Easy Centre" system to ensure that the vessels are perfectly centered every time. The fixture is designed such that once secured, the vessels will not become loose or float, even when empty.
All vessels are supplied as standard with clear view acrylic lids. Special membrane-sealed two-part lids are available on request, where losses caused by evaporation may be an issue.
Control and monitoring of speed and temperature
All of the DIS series of dissolution testers have a speed range of 0 - 200 rpm. The electronic speed control is provided with its own digital closed loop circuitry which guarantees an accuracy of +/- 2% by automatically checking and compensating for any drift from the nominal speed.
The heater/circulator has an accuracy of +/- 0.1 degrees C, thus ensuring a constant and even distribution of heat throughout the bath. It is fitted with an adjustable over-temperature cut-out and alarm indicator, in addition to a priming warning indicator if there is insufficient water available.
Automatic tablet drop
The first procedure at the start of any dissolution test is to drop the samples into the individual vessels. This function can be performed manually if desired. However, this approach does mean employing a staggered start since it is very difficult to introduce all the samples simultaneously. For this reason, a correction factor has to be applied to the final results in order to take into account the time-lag between introducing the samples.
In order to obviate this problem, the DIS dissolution tester can be fitted with an automatic tablet drop system. With this system, the tablets are placed in a series of chambers on the dissolution vessel lids and ejected into the vessels simultaneously at the start of the test.
Routine calibration is an essential part of your operation. Therefore a special calibration menu guides the user through the various functions and provides a printed report at the end of the operation.
A unique feature is the electronic temperature calibration kit. Available as an option, the electronic temperature calibration kit comprises two UKAS certified test keys (0 and 37 degrees C) which are simply plugged into the temperature probe socket to perform the calibration.