powers the Rainbow Dynamic Dissolution Monitor® System.

Rainbow Dissolution SmartWare® software is a proprietary software package developed by Delphian Technology® to power the Rainbow Dynamic Dissolution Monitor® system.  The software package is stable, versatile, and user friendly.  Data is displayed in “real time,” and all data including the “raw” data is securely stored in the database.  Data cannot be deleted.

We applied some innovative patent-pending algorithms in the Rainbow SmartWare.

The software provides quality assurance features, such as security levels, that comply with regulatory requirements.

The Rainbow Dissolution SmartWare® allows you to grant end users different levels of privileges.  The software permits the scientist to write methods, set security levels, review data, and set limits on variables.

The System Administrator has access to all sections in the software.  The Rainbow Dissolution SmartWare® has the ability to restrict access, allowing only authorized scientists to create or modify a dissolution procedure.

The following list defines the privileges that can be allocated to users of the Rainbow Dissolution SmartWare®:

1. System Administrator Privileges – designates privileges and access, as well as being the only person who can set limits and system variables for the software.
    
2. Method Development Privileges – can write methods, run methods, review data, and has access to the calibration section, but cannot set limits, privileges, and system variables.
    
3. Operator Privileges – runs a method and reviews data.
    
4. Auditor Privileges – reviews data, cannot set up experiments, cannot write methods.
    
5. No Privileges – No Access – (person cannot be removed from the database; this is for audit tracking purposes).

Wavelength Calibration

The unit is calibrated for wavelength accuracy by using a low-pressure mercury lamp.  Because these values are fundamental constants, they are considered “primary standards.”

When the calibration check is performed, the Rainbow Dissolution SmartWare® software time stamps the results and resets the calibration period.

When the calibration check is performed, the Rainbow Dissolution SmartWare® software will time stamp the results and reset the calibration period.

Method Basic Page

This is a screen capture that displays the data required for developing a dissolution method.

The analyst can establish dissolution bath controls (temperature, RPM, equilibration time) and specify the type of the dissolution bath (paddle or basket).

The analyst can establish dissolution bath controls (temperature, RPM, equilibration time) and specify the type of the dissolution bath (paddle or basket).

The equilibration time entered allows the last vessel to warm up to the required temperature before you can start the experiment.  The unit also logs temperature and RPM for the vessels and indicates the date in the experiment report.

Rainbow Dissolution SmartWare® allows operation of one to all six probes in the experiment.  However, the software is capable of controlling up to 12 channels, and if two Rainbow systems are connected to a single PC, the Rainbow SmartWare will be able to employ from 1 to 12 probes simultaneously (some limitations apply), and the software detects and controls only those probes employed. 

When an analyst requires some extra time to be able to drop tablets (or other pharmaceutical forms) into individual dissolution vessels, Rainbow SmartWare provides the time delay between the start of an experiment in each vessel by employing the “Staggered Start” function. 

The analyst can also do media changeover when needed.  This option provided by the software package allows the use of a third standard when analyzing enteric coated tablets.  When this functionality is required, the analyst should enter the amount of media added, and at what time the media will be added.  The analyst can establish the frequency of scans and choose between baseline and second derivative corrections to be factored in the calculations to correct for scattering interference.  We recommend following this chart when selecting the correction algorithm:

Parameter/Equation Editor Page

The analyst can write formulas that the software will use to calculate percentage dissolved, and set variables and constants.

On this page the analyst will write formulas that the software will use to calculate percentage dissolved, and set variables and constants.  Since a variable from the formula can vary for each probe, the analyst can decide if the values are applicable to all probes or to just individual probes.

Comments Page

If the analyst needs to keep track of a LIMS Number or Stability Number, these can be defined in this page.

On this page the analyst can specify any additional parameters.  These are not included in the formula for percent dissolved which the operator fills out before starting a run.  For example, if you need to keep track of a LIMS Number or Stability Number, etc., these can be defined in this page.

View Energy

The Rainbow Dissolution SmartWare® allows the operator to view the energy transmitted by the light source to each probe.

The Rainbow Dissolution SmartWare® allows the operator to view the energy transmitted by the light source to each probe.

Normalize Energy

When viewing the energy, the operator will notice that the relative energies in the individual probes are not the same.  If multiple probes are employed, the energy of each probe might be different.  This is due to the varying amounts of light through each probe.  Rainbow SmartWare allows the operator to normalize all probes to the same relative energy employed by adjusting the integrating times.  This is easily done by simply clicking on the “Normalize Energy” button displayed on the PC monitor screen.  The operator will notice how the integration times are automatically adjusted to the correct setting.  The graph will show that all probes are normalized at 80% relative energy. 

By adjusting the integrating times, Rainbow SmartWare allows the normalization of all probes to the same relative energy.

Collect Dark Spectra

After the probes are done adjusting integration times, the operator will need to close the lamp shutter and collect dark spectra.  Again, this is easy to do, just click on the “Collect Dark Spectra” button.  When the dark spectra have been taken, a graph of the relative energy of the dark spectra will appear.

When the dark spectra have been taken, a graph of the relative energy of the dark spectra will appear.

Collect 100% Transmittance

Finally to complete the Rainbow setup for experiment, the operator will need to press the button marked “Collect 100% Transmittance” to obtain system suitability.

Reports

The Rainbow Dissolution SmartWare® software automatically collects all data and stores it on the validated computer without analyst intervention.  All results and user actions are time stamped to demonstrate data integrity.  All data is available for viewing after a dissolution experiment, but cannot be deleted by anybody including the analyst who performed the experiment, or even a person who has System Administrator Privilege.  All of the calculations (fully validated) are safely locked away in the software, and cannot be altered or tampered with.  This completely eliminates the many errors associated with post-experiment manual calculations.

Report Formats

There are two options to review data:  Export Data or Print Report.

The “Export Data” function allows you to take collected data and use it in a Microsoft^® Excel spreadsheet.  You will need to set up a template in Microsoft^® Excel prior to exporting data to organize the analysis and further graphical representation.  Delphian Technology provides default validated Microsoft^® Excel templates in the form of R&D, QC, Export and Print Report. Each template consists of the following:

1. Report Sheet – consists of a graph of the data from each probe used, time points, percent dissolved at each time point.
    
2. Probe Data sheet # 1-12 – each probe has its own sheet which displays the absorbance at each wavelength for each time point, dark reference, light reference, standard 1 and 2 absorbance.
    
3. Experiment details – has the standard mass weights 1 and 2 and System Suitability RSD and percent difference.
    
4. System Information – calibration report, coefficients for each probe, date last calibrated.
    
5. Method details – details written in the method.

The use of Microsoft^® Excel allows for great flexibility and efficiency in analyzing compound properties, and comparing rates of dissolution.  It also allows for data presentation for up to 12 probes at once with immediate visible results and graphical representation of dissolution curves.

These templates can be used as is or modified as desired. 

The “Print Report” function allows you to generate a report with the data collected.  This feature uses the same template as the export feature with no visualization of data in Excel.

3-D Contour Plot – “Dissolution Surface”

Rainbow Dissolution SmartWare® allows you to create a unique “dissolution surface” by plotting wavelength vs. time vs. absorbance on a 3-D coordinate system. 

The 3-D surface shows every individual spectrum collected during the dissolution experiment. This is a very efficient tool for demonstrating spectral purity of the sample over a given period of time. It also shows if any interfering compounds were released from the formulation over time.

A "3-D Dissolution Surface” of a controlled-release (24 hour) formulation:

The 3-D surface shows every individual spectrum collected during the dissolution experiment.

Rainbow Dissolution SmartWare® software is a key solution for your success in the dissolution testing of pharmaceutical dosage forms.