Ingredient-Specific Particle Sizing

Gateway Analytical offers a unique, patented method for ingredient-specific particle sizing (ISPS) using Raman chemical imaging. This method combines digital imaging, Raman spectroscopy, and automated particle size analysis. This method is useful for study of nasal, inhalation, semi-solid, transdermal and solid drug dosage forms.

Using this method, scientists at Gateway Analytical can provide the following types of particle measurements:

  • Drug particle size distribution
  • Particle shape
  • Agglomerated particle characterization

Working to Address Critical Path Opportunities for Generic Nasal Spray Suspensions:

Gateway Analytical scientists can provide expert support for companies developing generic nasal spray suspension products by providing accurate, reliable in vitro drug particle size distribution measurements.

Our ISPS method is performed in a cGMP laboratory environment and has the potential to address the FDA’s Critical Path Opportunity for direct measurement of particle size equivalence in nasal spray suspensions, possibly allowing for a waiver of in vivo biostudies and savings of millions of dollars in development costs and up to half of the time required for clinical studies.

Instrumentation and Techniques:

  • ChemImage Falcon II Wide-field Raman Chemical Imaging System
  • InnovaSystems NSP UA – Actuation Station