Ingredient-Specific Particle Sizing


Example: Nasal Spray Suspension

Optical Image of Nasal Srpay Particles
Optical Image
Raman Chemical Image of Nasal Spray Particles
Raman Chemical Image Overlay

 

API and Excipient #1 PSD histogram based on 15x15 chemical image montage from a nasal spray suspension.

ChemImage chemical imaging instrumentation can provide you with ingredient-specific particle sizing (ISPS) for your drug development projects. Our ISPS method provides simultaneous spatial information (size, distribution, shape) and spectral information (chemical identification of particles) that is key to measuring the drug particle size distribution within nasal, inhalable, semi-solid, transdermal drug delivery systems.  This technique addresses the need for a fundamental understanding of API particles in the presence of other undissolved excipients in the formulation and can be used to study ISPS, aggregation and dispersion characteristics.

Raman Chemical Imaging (RCI) Provides:

  • Drug particle size distribution (PSD)
  • Drug PSD measurements faster than optical microscopy and other methods combined
  • Easy identification and analysis of aggregates
  • Automated identification of drug substance
  • Critical support for in vitro bioequivalence testing


Traditionally it has been a challenge to determine drug particle size distribution (PSD) in a nasal spray suspension or inhalation drug products containing more than one drug substance. Using ChemImage (ISPS) this information is now easily attainable.


Nasal sprays formulated as suspensions typically contain micronized drug substance within large droplets, and in the presence of multiple excipient materials. Formulators and researchers can use RCI to can obtain drug-specific PSD (or other ingredient-specific particle size) information of pharmaceutical nasal spray suspensions, aerosols and other metered-dose inhalers. This measurement gives you critical information to compare the specific size, shape and distribution of one or more active ingredients.

ChemImage RCI provides an in vitro test method which saves time, increases reproducibility and precision in addition to being cost-effective. Now, you can reduce development costs, speed up the approvals of abbreviated and new drug applications, and enter  in vivo biostudies with greater confidence in your pre-clinical data, effectively lowering risk of failure.