Dissolution Testers

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DIS 6000 Dissolution Tester

The DIS 6000 has 6 stirred test vessels to measure the dissolution rate of tablets, capsules or patches. The rate at which the tablet or capsule dissolves is critical to its therapeutic efficiency and can be correlated to the bioavailability of the drug.

DIS 6000 Dissolution Tester

The DIS 6000 provides an uncluttered design with two rows of 3 vessels, which are heated in a water bath by an independent heater/circulator. The interchangeable USP-compliant paddles and baskets allow the analyst to change the method in a few seconds without any further height adjustment.

The DIS 6000 has a user friendly operating procedure that is much easier to use than other systems overladen with complex and unnecessary software functionality. It also has automatic tablet dropping features to drop tablets simultaneously into the vessels at the start of the test. The analyst can choose to use this automatic function to drop the tablets simultaneously or to manually introduce them sequentially.

The DIS 6000 can be configured according to USP:

  • Apparatus 1 (basket)
  • Apparatus 2 (paddle)
  • Apparatus 5 (paddle over disc)
  • Apparatus 6 (rotating cylinder)

The DIS 6000 is ideal for R&D studies for the bioavailability of new drugs, as well as QC testing of existing pharmaceutical drugs to evaluate the uniformity and consistency of the manufacturing process. The DIS 6000 meets USP, Ph.Eur. 2.9.3 and all the associated Pharmacopeia requirements.

The DIS 8000 is available to provide 8 stirred test vessels for higher numbers of samples. The functions and features are similar to the DIS 6000.

A high precision “Audit-Proof” version - DIS 6000 EMC - is also available with tolerances that are significantly better than FDA’s mechanical qualification requirements by a factor of 2. The DIS 6000 EMC applies the latest state of the art technologies to DIS 6000 EMC Dissolution Testerprovide a whole new level of variation control and tolerances. The DIS 6000 EMC and their associated parts are designed and manufactured differently from standard dissolution testers to ensure that the variations in dimensions and tolerances to wobble, vibration, verticality, vessel centering, height and rotation speed is reduced by more than half.

The dissolution community has long recognized that one of the major contributors to result variability is due to vessel dimensions and irregularities. Usually, dissolution vessels are individually made by manual glass blowing technique from extruded glass tubing. The DIS 6000 EMC dissolution vessels are manufactured by a more sophisticated technique that guarantees the inside diameter tolerance and blemish-free spherical radius to be only 10% of the typical tolerances.

Existing DIS 6000 units can also be upgraded with the new EMC parts. Please contact us to find out more information on the DIS 6000 EMC.

 

Online Dissolution Testing (Automated)

The introduction of extended or delayed release drugs resulted in dissolution tests that could potentially run for over 12 hours, 24 hours or even longer. These demands coupled with the rise of multi-point testing for in-vivo/in-vitro correlation led to the use of automated dissolution systems to increase efficiency and reproducibility.

‘Online’ or automated dissolution testing is essentially a continuous flow technique whereby the media from each vessel is circulated continuously through a series of flow cells in a suitable UV/Vis spectrophotometer, which will acquire the spectra of the dissolved sample. This is the more popular approach for automated dissolution testing.

However, for instances whereby a UV/Vis spectrophotometer is not suitable – such as drugs without chromophores, a HPLC system can be used instead. The HPLC system will offer better sensitivity than a UV/Vis spectrophotometer for analyzing sustained release drugs and low dosage formulations. As the HPLC detector will only accept one sample at a time, the samples are usually deposited in a sealed vial on an autosampler.

DIS 6000 Automated Dissolution Testing

The advantages of online dissolution testing are:

  • Eliminate potential errors from manual sampling and off-line analysis
  • Increased precision and accuracy
  • Higher throughput
  • Lower consumable costs
  • Saves time / Less labour intensive
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