Instruments

Spectra Dissolution Monitor

 

 The Spectra is the newest, next generation model in the Rainbow Dynamic Dissolution Monitor® family, which utilizes Pion's patented in situ technology and fiber optic probes.  The instrument builds upon our experi­ence in the design, development and manufacture of the Rainbow™ and µDISS Profiler™fiber optic instruments. Feedback from R&D and process control laboratories was an integral part of the development of this new instrument.

While the Spectra is price competitive with on-line sipper-based systems,  it is free of the well-known problems associated with clogged filters, kinked lines and pump maintenance. The Spectra offers real time data collection and the high data density which provides a much greater level of statistical confidence in the dissolution measurements. Since the fiber optic probe remains in the solution throughout the dissolution test, no operator involvement is required. Up to 8 dissolution vessels may be monitored simultaneously within an extended UV-Vis range between 200-700 nm.  A xenon lamp provides consistent, stable light output suitable for sustained release applications lasting many weeks or months.

As with the reliable Rainbow RDDM, the Spectra is also powered by versatile Indigo™ software, providing  users with multiple functions in one flexible, easy-to-use, integrated system for method development.  Furthermore, the IndigoSAM™ secure account manager software add-on to Indigo™ provides GMP and 21 CFR 11 compatibility for the quality control laboratory.

The Spectra is rapidly set up, requires minimal operator involvement during the run, provides real-time data display and is nearly maintenance-free.  It is used with all major dissolution baths including Pharma-Test, VanKel, Distek, Hanson, Erweka, Logan and Sotax.  Spectra will help you conduct dissolution studies faster, with lower overhead costs, and the peace of mind that in situ, fiber optic monitoring provides. 

The Spectra also easily accommodates high amounts of turbidity.  Turbidity or light scattering from excipients in dosage forms, interferes with the accurate measurement of drugs in solution.  The patented data processing algorithm effectively compensates for the spectral effects of turbidity.

video demonstration shows the dissolution of a tablet containing 200 mg caffeine in water.  When 100% of the caffeine is dissolved, non-dairy coffee creamer is successively added to increase the turbidity.  As the amount of coffee creamer increases, note that the dissolved caffeine remains at 100%.  Under these conditions, direct spectral measurement without this patented algorithm would grossly overestimate the amount of caffeine in solution.

Specifications

 Spectra

  • Up to 8 channels
  • 200-700 nm effective range
  • Long life Xe source lamp
  • Dissolution datapoints up to twice per minute
  • Durable stainless steel dip probes with variable path lengths of 1, 2, 5, 10 or 20 mm.
  • Linear range up to 1.5+ AU.

 Indigo

  • Flexible, user-friendly method development software
  • Manual or automatic scanning control
  • View all channels simultaneously in real time
  • Up to six user-programmed experiment steps
  • Data export to Excel 

IndigoSAM

  • Secure account manager add-on to Indigo™
  • Four levels of user security
  • Data audit trail and data security
  • Digital signatures
  • Easy method import and lockdown from Indigo™
  • Validation package available 

For more details on the Indigo™ and IndigoSAM™ software, click here.

Permeability


Instruments for Measuring Permeability

   
PAMPA Evolution Pion's high-throughput instrument for determining permeability in a 96-well microtiter plate format by PAMPA (Parallel Artificial Membrane Permeability Assay) method. Available on either the Tecan or Beckman robotic platforms.
   
PAMPA Explorer Pion's entry level instrument for determining permeability using the PAMPA method.
   
Gut-Box An accessory for Pion's PAMPA systems.  A stirring apparatus for 96-well plates that mimics the human jejunum.
   

Rainbow Dynamic Dissolution Monitor® Patents

The RDDM System utilizes proprietary technology to sample in situ.  These include sampling methods and data acquisition.  More information on these can be found in our patents below.

Dynamic Data Acquisition and Presentation.
p
ION has acquired a US patent protecting the RDDM real-time display of dissolution curves during data collection. This technology gives the user instant feedback on the progress of the dissolution test. This allows the user to quickly spot potential errors in the setup of the experiment or equipment rather than having to wait for results from off-line HPLC analyzers.(US Patent Number 6,558,957)

Hollow Shaft Measurement
pION has acquired a US patent protecting the RDDM method for placing the UV dip probe within the hollow shaft of a USP paddle stirrer. This enables the Rainbow to acquire data without creating hydrodynamic artifacts that may negatively influence dissolution measurements.(US Patent Number 6,174,497)

Rainbow Dynamic Dissolution Monitor® Software

Indigo™ and IndigoSAM™ represent the latest software innovation fort the Rainbow Dynamic Dissolution Monitor® System.  Combining UV with the technology built into the Rainbow, these software platforms give formulation and dvelopment chemists the ultimate in flexibility for in situ dissolution analysis. 

Indigo™
This is a flexible software tool for the Rainbow for use in the R&D and formulation laboratory.  The Indigo™ user interface is simple and intuitive to navigate because it uses one screen interface to handle all tasks. Simply clicking tabs on the Indigo™ desktop takes the user from activity to activity with full access to every step at any time. Setting up a dissolution experiment or UV measurements is straightforward. No longer will it take more time to setup than to run the experiment.

IndigoSAM™
This secure account manager has a full suite of security tools to Indigo for GMP and QC environments.* These include digital signatures, data audit trails and more. IndigoSAM™ provides Indigo users with a full suite of  security tools commonly used in GMP and QC environments. Methods developed in Indigo™ may be imported, locked down, and run in the secure environment of IndigoSAM™.  Four levels of user access and security are provided for user-creation and control, data audit, method creation and experimentation.

Customizable Data Sampling Rates
Indigo™ allows you to customize the sample rate of your experiment. In seven steps, the sample rate can be adjusted to suit the dissolution rate. Collecting more data on the steep parts and less on the flat regions, reduces the amount of unnecessary data.

Complete Data Collection
Using the Rainbow’s built in photodiode array, Indigo™ collects data throughout the wavelength range. This provides far richer data sets than those obtained by single or multiple wavelength spectrometers. On the fly, calibrated conversion of absorption vs. photodiode number to absorption vs. wavelength in 2 nm steps ensures that data files are kept as small as possible. Because full spectra data sets are saved, data analysis can be performed in different ways after data collection. The multithreaded design of Indigo allows viewing and changing data sets already saved in parallel during data collection. 

Data Processing
Indigo™ features both baseline subtraction and 2nd derivative correction for sloping baselines of especially turbid solutions. In case of 2nd derivative spectra, Indigo allows the selection of different levels of curve smoothing. Both single wavelength and Area Under the Curve (AUC) may be used in calculation of % dissolved using either single wavelength, wavelength range, or full range spectra. Spectra for standards are saved and can be made available to more than one dissolution run, further saving time and effort.

*GMP and 21 CFR 11 compliance in any given IT environment is the sole responsibility of the user.

Rainbow Dynamic Dissolution Monitor® Details

The Rainbow is a powerful tool for highly accurate dissolution analysis without the high cost, extensive maintenance, operator involvement, and slow turnaround time of conventional methods. UV-based spectroscopy has been adopted for dissolution testing by R&D, manufacturing, and QC laboratories worldwide. 

The Rainbow employs a patented process for data acquisition and presents it in real-time. This enables the user to view the collection of data points from each probe as the data are collected.  No need for external programs or calculations after the experiment.  When the data collection is done, you’re done!

The in situ UV monitoring supersedes traditional HPLC or flow-injection systems by eliminating the problems of operator error, complicated mechanical sipping devices, clogged filters, sample adhesion to tubing walls, wasted bench space, expensive consumables and clean-up. We pipe the light, not the liquid!  Equipped to collect data from the very start of the experiment to several days later, the Rainbow monitor is ideal for both rapid-release and extended release solid dosage forms.

 Small, Clean, Quiet

The Rainbow fits nicely on your lab bench right next to the dissolution bath. Since the Rainbow pipes the light and not the liquid, it does not generate any waste of its own.  RDDM UV transflectance probe  In fact, the only cleaning required is a quick rinse of the probes. Using the accompanying Indigo™ software, the Rainbow is easy to operate, requiring almost no maintenance, as there are no moving parts in the system.

UV in situ Dip Probes

The Rainbow utilizes dip-type UV probes (6 to 8 per monitor) to measure the amount of active pharmaceutical ingredient (API) released from a solid dosage form.  These probes are suspended at the USP sampling position in the dissolution vessels and reside in situ for the duration of the test.  RDDM dip type UV probe Constructed of stainless steel, the probes have interchangeable quartz mirror tips offering path lengths of 1, 2, 5, 10, and 20 mm. The probes are sturdy, durable, and may be used in most dissolution media and all baths.

 Security in the QC Environment

For GMP and QC environments, the optional IndigoSAM™ software adds a full suite of security tools commonly employed in GMP and 21 CFR Part 11 laboratories.* These include secure user access, audit trails, digital signatures, data security and secure reporting.

Photo Diode Array Spectrometers

The system uses a bank of Zeiss UV spectrometers interfaced to the dip probes for optical sampling; no material is removed from the bath. RDDM Zeiss PDA spectrometers  This allows very rapid acquisition of a full UV spectrum from 200 nm to 720 nm, in steps of 2 nm, from all vessels. In the case of a controlled-release formulation, a typical system configuration might sample every 20 minutes for 24 hours. For an immediate-release formulation, samples may be taken as frequent as every second. Watch the compound dissolve in real time.

The precision of the Rainbow exhibits excellent analytical performance in the range of 0.001 to 2.0+ absorbance units. The low thermal expansion properties of the titanium body virtually eliminate drift due to ambient temperature fluctuations. The patented design of the MMS-UV spectrometer eliminates moving parts and ensures high wavelength accuracy and precision (observed annual drift of less than 0.1 nm).

Easy to Use Interface

Rainbow’s software interface, Indigo™ is simple and intuitive to navigate because it uses one screen interface to handle all tasks. Simply clicking tabs on the Indigo desktop takes the user from activity to activity with full access to every step at any time. Setting up a dissolution experiment or any spectral measurement is straightforward.

GMP and QC Environments

IndigoSAM™ software offers a full suite of security tools for the GMP and QC environments.* These include digital signatures, data audit trails and more. IndigoSAM, a secure account manager, provides Indigo users with a full suite of security tools commonly used in GMP and QC laboratories. Methods developed in Indigo may be imported into, locked down, and run in your secure environment.  

* GMP and 21 CFR 11 compliance in any given IT environment is solely the responsibility of the user.

  Dissolution Baths
 

 
 The Rainbow Dynamic Dissolution Monitor® System works with all dissolution baths, including the following:
Sotax - www.sotax.com
Logan Instruments - www.loganinstruments.com
Erweka - www.erweka.com
Varian - www.varian.com
Hanson Research - www.hansonresearch.com

Distek - www.distekinc.com

Pharma-Test - www.pharma-test.com

 

 

Evolution Library Manager

Data management software for µSOL Evolution™ and PAMPA Evolution™

 

Evolution Library Manager

Evolution Library Manager (ELM™) provides a single interface to reference data for every assay performed on your Evolution instrument.

Rather than searching through hundreds of data files to find historical data, ELM puts every aspect of every experiment right at your fingertips, including:

  • Compound Name
  • pH
  • Avg Pe
  • % Membrane Retention
  • Pion Index (data quality ranking)
  • Assay Date
  • File Location

ELM makes your uSol and PAMPA Evolution instruments more powerful than ever.

More information on the Evolution Library Manager is available from your local distributor or representative.