benefits

In-Situ Fiber Optic UV-Vis Spectrometer for Dissolution, Absorption, Flux and Solubility Studies

The Rainbow R6, an in-situ multi-channel fiber optic spectrophotometer, combined with AuPRO software is a powerful analytical instrument that correctly and accurately measures concentration of multiple compounds in real time. It is utilized for dissolution testing, flux assays, solubility studies and other applications requiring high accuracy and repeatability in concentration measurement, even in complex media.

Real time concentration data is provided for all 8 channels.

5 different advanced mathematical approaches to deal with turbidity or other disturbances in the spectrum.

Its Green! No filters, HPLC vials, columns or eluents. Everything is done in your experiment vessel.

No separation is needed! Multiple mathematical ways to measure 2-3(-4) absorbing components in the vessel, all in real time.

Direct measurements in complex or biorelevant media, even with media conversion.

Automated data processing to find a reliable way of data refinement

Data export to common platforms or to Pion Predictor SW for data processing and reporting.

Rainbow R6 for QC and R&D

Configurations

The In-Situ UV Probe-Based Dissolution System

The Rainbow R6 provides concentration measurements in real time

Removing delays between sample draw and analysis, the Rainbow R6 produces consistent, replicable results, whatever the media.

A sample measurement can be obtained in less than 5 seconds for each vessel, enabling unattended, extended assays. This provides the enriched data for very short sampling intervals required for immediate release formulations.

The In-Situ UV Probe-Based Dissolution System
The In-Situ UV Probe-Based Dissolution System

Improve Process and Decision Making with Better In Vitro Insights.

The Rainbow R6 is the core technology in Pion’s portfolio of dissolution solutions for:

  • Dissolution testing
  • Drug solubility
  • Dissolution monitoring - just add a small volume dissolution tester to your Rainbow R6:
  • MicroDISS - small volumes of 2- 20 ml
  • MiniDISS - biorelevant volumes of 100-250 ml
  • Absorption and Flux assays - just add FLUX apparatus to your Rainbow R6:
  • MicroFLUX using only several milligrams of sample for early-stage development where sample is limited
  • BioFLUX at biorelevant  volumes (200-250mL) for late stage formulation development
  • MacroFLUX for a 900mL vessel of a USP II apparatus designed for use in formulation development based on standard USP dissolution setups
Software for the Rainbow R6
Powerful Predictive Software

Software for the Rainbow R6

AuPRO software for Rainbow for data collection and refinement in research and development:
A powerful analytical software designed specifically for the needs of early-stage compound screening, and during pre-formulation and formulation development.

DissoPRO software for Rainbow for method development and quality control (QC)
A secure, traceable software package designed to address the needs of dissolution scientists and quality groups in highly regulated environments.

Pion’s Predictor Software applies the mechanisms of the Gastrointestinal Unified Theoretical (GUT) framework to convert in vitro flux data to predictions of in vivo oral absorption and percent fraction drug absorbed (Fa%). When you apply Predictor software to flux data collected by Pion’s Rainbow Dynamic Dissolution Monitoring system, the Predictor data can help you understand the interplay between dose (Do), dissolution (Dn,) and permeability (Pn) to help you understand where to target formulation improvements. 

Predictor assigns an estimation of the rate-limiting step to absorption of the API based on the Do, Dn and Pn numbers calculated from the Fa% and defines whether the compound is subject to a permeability, dissolution, or solubility-permeability limitation.

Additionally, Predictor is able to classify the drug according to the Biopharmaceutics Classification System (BCS) based on the Do and Pn numbers determined from the Fa% result. Formulation scientists can then decide on a strategy for improving oral absorption outcome by overcoming the significant rate-limiting steps for their drug.

Common Applications

User Applications

Coupled with dissolution bath

  • Small volume dissolution testing
  • Solubility measurement
  • Dissolution rate and IDR measurements
  • Supersaturation-precipitation studies
  • Salt and polymorph selection

Coupled with dissolution-permeation (flux) system:

  • Absorption prediction
  • Prediction of the rate limiting step of absorption
  • Bioequivalence prediction
  • Formulation excipient effect screening
  • Formulation strategy selection

Coupled with Subcutaneous Injection site simulator (Scissor):

  • Biosimilar characterization
  • Injectable formulation rank ordering
  • De-risking formulation issues upon injection
User Applications
Additional Benefits
Performance Redefined

Additional Benefits

  • 5 different advanced mathematical approaches to deal with turbidity or other disturbances in the spectrum, making in situ monitoring work
  • Its Green. No filters, HPLC vials, columns or eluents. Everything is done in your experiment vessel
  • Direct measurements in complex or biorelevant media, even with media conversion is possible in small, biorelevant or USP volume
  • No separation is needed. Multiple mathematical ways to measure 2-3(-4) absorbing components in the vessel, all in real time