Dissolution Testing

CE 3790 Dissolution Tester

Cecil Instruments offer complete dissolution systems as well as all the components of the system individually. The dissolution tester is common to the systems and may be used in conjunction with a choice of spectrophotometers and HPLC/IC systems. It is fully USP, EP and JP compliant.

 

The CE 3790 tester is provided with seven stirred round bottom, graduated, glass vessels; the eighth position is used for stirring the thermostatted water in the perspex bath.


The water is heated by a 1000 watt element and the temperature may be set between 30°C and 45°C with an accuracy of ±0.2°C.


Stirring speed may be set in the range 20-250 rpm. The stirring head is conveniently pneumatically counterbalanced for easy access to the vessels and paddles for adjustments. The standard paddles are of PTFE with PTFE coated spindles. Provision is made for accurate centring of vessels and paddles.

CE 3792 Software - WIN DISS


This is a comprehensive dissolution software package for control and data processing, incorporating the following features:


Storage for 100 methods; stores stirrer speed, temperature, sampling sequence, measuring wavelength etc.

A time run data store for batch number, name, operator ID, calculation details, data correction using run or pre-run blank, media evaporation etc. Calculation details include theoretical maximum Absorbance, measured standard concentration, standard measurements using linear regression and standard concentration at known testing times.


Results are printed in tabular and graphical form including Absorbance data, milligrams or % release and a 95% confidence calculation is provided. The printout may be formatted by the operator.


Double Beam Dissolution Single Beam Dissolution

Often a constant supply of an oral/anal pharmaceutical or nutraceutical preparation is required during the day and night.   Instead of the subject having to take tablets or capsules at frequent times during the day and night, controlled release tablets/capsules have been developed to provide a constant rate of release of the preparation for many hours, without the subject having to continually ingest tablets/capsules.


Controlled release tablets/capsules need to be tested to ensure that they do actually release the drug or nutraceutical, at the required rate.  Dissolution testing is an established means of testing the rate of release.


The majority of systems used in the dissolution field employ UV/Visible spectrophotometry as the chosen form of analysis.  Such systems are relatively easy to set up and run.  This sample analysis can be performed on a manual or automatic basis.


Sample concentration results can be automatically recorded by computer software and plots of active analyte concentrations over time (dissolution profile) can be generated.


In the instances were UV/Visible spectrophotometry cannot be used, perhaps because the analyte does not have a UV/Visible chromophore, there is excipient matrix and/or analyte interference, or where more than one active pharmaceutical/nutraceutical ingredient is required to be tested in the same dissolution run, HPLC/IC analysis and detection may be used.   Detection of the active pharmaceutical/nutraceutical ingredients may be on the basis of many of their properties, such as UV/Visible Absorbance, conductivity, refractive index and fluorescence.  This HPLC/IC analysis can be performed manually or on an automatic and on-line basis.


All of our dissolution systems are space saving and practical.  We offer comprehensive software packages and all of the accessories you and your regulatory authority/authorities may require.