The Rainbow Dissolution SmartWare® software is a key solution for your success in the dissolution testing of pharmaceutical dosage forms. The software 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, and the software provides quality assurance features, including security levels that comply with 21 CFR Part 11 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:
- - System Administrator Privileges – designates privileges and access, as well as being the only person who can set limits and system variables for the software.
- - 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.
- - Operator Privileges – runs a method and reviews data.
- - Auditor Privileges – reviews data, cannot set up experiments, cannot write methods.
- - 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 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 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
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
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.
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.
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.
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.
Report Formats. There are two main options to review data: Export Data and Print Report.
Export Data: 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. Validated Microsoft® Excel templates are provided in the form of R&D, QC, Export and Print Report. 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.
Print Report: 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.
Additional Report Options include:
- Report Sheet: consists of a graph of the data from each probe used, time points, percent dissolved at each time point.
- Probe Data sheet: 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.
- Experiment details: has the standard mass weights 1 and 2 and System Suitability RSD and percent difference.
- System Information: calibration report, coefficients for each probe, date last calibrated.
- Method details: details written in the method.
3D 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 "3D Dissolution Surface” of a controlled-release (24 hour) formulation.
The RDDM utilizes a series of Zeiss PDA spectrometers interfaced to a dip probe to generate real time dissolution curves. Each of the probes is placed into a dissolution vessel at the start of the dissolution experiment and remains in situ during the entire dissolution test. Energy from a source lamp is split by a fiber optic furcation cable with individual fibers coupled to one of a series of dip probes. The energy thus directed, transits a calibrated gap in the probe body. The gap, which is in the dissolution bath, has a reflecting surface on the opposite side that sends the energy, which has passed through the media into a return fiber. The energy transmitted by this return fiber is then analyzed by one of the Zeiss PDA spectrometers and converted to absorbance values.
