Dissolution

MacroFLUX

In-vitro assessment of dissolution-absorption processes from full dosage forms.

benefits

In-vitro assessment of dissolution-absorption processes from full dosage forms.

Combine Dissolution and Absorption measurements into a single assay.

A stirred absorption chamber into familiar dissolution apparatus

Extend the utility of in situ UV concentration monitoring to provide an accurate assessment of transmembrane FLUX from whole dosage forms

Real-time dissolution and absorption concentration monitoring

The filter-supported artificial permeation membrane separates the dissolution (donor) compartment from the receiver compartment, containing pH 7.4 Pion Acceptor Sink Buffer.

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The dissolution compartment typically holds 900 mL of compendial or biorelevant dissolution buffer. The modified vessel cover allows fiber-optic UV probes to be positioned in both the donor and receiver compartments allowing real-time dissolution and absorption concentration monitoring in both chambers. Concentration monitoring is enabled by connecting the fiber optic UV probes from the Rainbow Dynamic Dissolution Monitor® instrument.

Real-time dissolution and absorption concentration monitoring
MacroFLUX can be used:

MacroFLUX can be used:

  • To conduct simultaneous dissolution-absorption studies
  • During formulation development for optimizing product performance and to evaluate whether certain formulation changes will affect the bio-performance of a certain drug product
  • During life-cycle management and product extensions to demonstrate bioequivalence
  • To compare brand and generic formulations to demonstrate bioequivalence
  • To compare test to reference formulations
  • To ensure continuity of product quality (batch to batch consistency) and performance of the manufacturing process (in order to differentiate bioequivalent batches from non-bioequivalent batches within a range that guarantees comparable biopharmaceutical performance in vivo).