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Related Concept Videos

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A covalently bonded heteronuclear diatomic molecule can be modeled as two vibrating masses connected by a spring. The vibrational frequency of the bond can be expressed using an equation derived from Hooke's law, which describes how the force applied to stretch or compress a spring is proportional to the displacement of the spring. In this case, the atoms behave like masses, and the bond acts like a spring.
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When electromagnetic radiation passes through a material, atoms or molecules transition from a lower to a higher energy state by absorbing radiation corresponding to the energy difference between the two states. The absorption of infrared (IR) radiation causes transitions between vibrational energy levels in a molecule. Therefore, IR spectroscopy is a useful analytical tool for determining the molecular structure of molecules.
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Related Experiment Video

Updated: Aug 18, 2025

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Development of a Near-Infrared Spectroscopy (NIRS)-Based Characterization Approach for Inherent Powder Blend

Zhenqi Shi1, Kallakuri Suparna Rao2, Prajwal Thool2

  • 1Small Molecule Pharmaceutical Sciences, Genentech Inc, 1 DNA Way, South San Francisco, California, 94080, USA. shiz16@gene.com.

The AAPS Journal
|December 9, 2022
PubMed
Summary
This summary is machine-generated.

Near infrared spectroscopy (NIRS) effectively characterizes powder blend heterogeneity in direct compression (DC) formulations at a small scale. This method complements existing tools for early research and development, supporting robust continuous manufacturing processes.

Keywords:
Classical least squaresDemixingEarly CMCNear-infrared spectroscopyPowder blendingProcess analytical technology

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Analytical Chemistry

Background:

  • Continuous direct compression (CDC) requires robust formulations with minimal powder blend heterogeneity.
  • Characterizing heterogeneity at small batch scales is crucial for developing CDC-amenable formulations.
  • Existing formulation development tools need complementary methods for early-stage characterization.

Purpose of the Study:

  • To develop and implement a near-infrared spectroscopy (NIRS)-based approach for characterizing inherent powder blend heterogeneity.
  • To complement existing formulation development tools and support early CMC data package development.
  • To enable Process Analytical Technology (PAT) method development for late-stage manufacturing.

Main Methods:

  • Utilized NIRS to collect spectral data on three fumaric acid direct compression (DC) blends with varying heterogeneity.
  • Employed both time- and angle-based triggering modes on a kg-scale batch blender.
  • Compared NIRS-based heterogeneity characterization with off-line High-Performance Liquid Chromatography (HPLC) results.

Main Results:

  • Time-triggered NIRS data showed greatest blend variability occurred between blender revolutions, not within a single revolution.
  • Angle-triggered NIRS data demonstrated a consistent trend with HPLC in characterizing blend heterogeneity across different sample sizes.
  • NIRS effectively identified blend variability patterns consistent with known powder dynamics in blenders.

Conclusions:

  • NIRS is a viable method for characterizing inherent powder blend heterogeneity in early R&D.
  • The study supports the use of NIRS for continuous characterization from gram to mini-batch CDC scales.
  • This approach aids in building early data packages for robust continuous manufacturing.