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Date and Time: February 26, 2019 – 16:00 and 19:00

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This webinar will describe the use of molecular spectroscopy techniques (Raman and IR) for solid-state analysis in drug development. Two presentations will focus on chemical imaging of polymorphs by LDIR, and the rapid quantification of low level crystalline forms using transmission Raman.

Presentation 1:

Fast Non-destructive Quantification of Low Level Crystalline Forms in Amorphous Spray Dried Dispersion using Transmission Raman Spectroscope

The enhancement of oral bioavailability of poorly water-soluble drugs is an increasingly common challenge facing the pharmaceutical industry. This may sometimes be overcome by converting the stable crystalline form to a metastable amorphous form. However, amorphous forms are still thermodynamically driven to crystallize to the less soluble forms during processing or long-term storage. Sensitive quantitation of crystallinity is critical to ensure a stable and bioavailable amorphous drug product. There are many technologies known for solid-state characterization and each technique is suitable for a particular purpose. Here we compare technologies to quantitate low levels of crystalline material in an amorphous spray-dried dispersion with a moderate 20% drug load, particularly transmission Raman spectroscopy (TRS), X-ray powder diffraction (XRPD) and solid-state NMR spectroscopy (ssNMR).

Presentation 2:

Introduction to the new 8700 LDIR IR Chemical Imaging system and its use for Polymorph Analysis  

An important aspect of drug formulation for oral dose forms is the ability to determine the presence of different polymorph forms of an API which may be present in a tablet.  This presentation will provide an overview of a new 8700 LDIR chemical imaging system based on use of quantum cascade laser technology.  This highly automated system provides high quality surface imaging of entire tablets in a few minutes and is suited to use by both expert spectroscopists and trained technicians.  Instrument use will be illustrated by analysis of different tablets with different polymorph compositions.

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 Archana Kumar, Ph.D., Scientist, Small Molecule Analytical Chemistry and Quality Control, Genentech Inc.
 Lester Taylor, Ph.D., Pharma Marketing, Agilent Technologies
 Martin Utzmann, Ph.D., Wiley moderator