Understanding Dissolution Inconsistency Through In Situ Particle Characterization and Root Cause Analysis

Dissolution-Disintegration-Distek-METTLER-TOLEDO-FBRM

METTLER TOLEDO FBRM and Opt Diss Fiber Optic UV for Dissolution Testing in Distek Evolution 6100

USP tablet dissolution testing is recognized as the standard analytical method used in the pharmaceutical industry.

Traditionally, dissolution has been performed in the analytical laboratory and tests were conducted with the final product. But in recent years dissolution testing has become a development tool for Quality by Design (QbD), and testing has expanded to include dissolution and disintegration tests which screen product performance during drug product development.

These development tests require a more mechanistic understanding as to why tablets release API with varying kinetics.

This extended abstract summarizes collaborative research between
Distek, Inc.
and METTLER TOLEDO in the application of process analytical technologies (PAT) to improving Dissolution and Disintegration Testing to develop a mechanistic understanding of tablet disintegration and release of the active pharmaceutical ingredient (API).

Download the abstract – Understanding Inconsistency Through In Situ Particle Characterization and Root Cause Analysis – from the conference presentation.

Authors:
J. Seely, Distek
D. O’Grady, B. Smith, METTLER TOLEDO

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This is the third of four posters presented by my colleagues, Ian Haley and Ben Smith, at the 7th World Meeting on Pharmaceutics, Biopharmaceutics, and Pharmaceutical Technology in Malta from March 8-11, 2010.

Visit our 7th World Meeting on Pharmaceutics, Biopharmaceutics, and Pharmaceutical Technology information page for this event for more information and additional abstracts.

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