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Raman Spectroscopy: Overview01:20

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The underlying principle of Raman spectroscopy is based on the interaction between light and matter, specifically molecules' inelastic scattering of photons. When a monochromatic beam of light, typically from a laser source, interacts with a sample, most scattered light has the same frequency as the incident light. This is known as Rayleigh scattering.
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Kinetic Energy

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Kinetic energy is the ability of an object in motion to do work or enact change. It can take on many forms. For instance, water flowing down a waterfall has kinetic energy. In biological systems, particles of light travel and are absorbed by plants to create chemical energy. Animals consume the chemical energy and give off molecules that carry their scent through the air. They also generate kinetic energy when they run away from predators. Entire systems also possess kinetic energy, like the...
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Optical Trapping of Plasmonic Nanoparticles for In Situ Surface-Enhanced Raman Spectroscopy Characterizations
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Kinetics Study of Cocrystal Formation Between Indomethacin and Saccharin Using High-Shear Granulation With In Situ

Ryoma Tanaka1, Yusuke Hattori2, Kazuhide Ashizawa3

  • 1Graduate School of Pharmaceutical Sciences, Musashino University, 1-1-20 Shin-machi, Nishi-Tokyo, Tokyo 202-8585, Japan; Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota 55455.

Journal of Pharmaceutical Sciences
|July 8, 2019
PubMed
Summary

High-shear wet granulation enables cocrystal formation, simplifying pharmaceutical manufacturing. The initial state of indomethacin significantly impacts cocrystal formation kinetics during this process.

Keywords:
Raman spectroscopychemometricscocrystalcontinuous processingcrystal engineeringcrystal structurecrystallizationgranulationkineticsprocess analytical technology

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Area of Science:

  • Pharmaceutical Science
  • Chemical Engineering
  • Materials Science

Background:

  • Pharmaceutical manufacturing requires robust processes for solid dosage forms, including cocrystals.
  • Reducing unit operations in pharmaceutical manufacturing is a key goal for efficiency.
  • Cocrystal formation is a strategy to improve drug properties and manufacturing.

Purpose of the Study:

  • To investigate the kinetics of indomethacin-saccharin cocrystal formation during high-shear wet granulation.
  • To explore the influence of different initial indomethacin crystal forms on cocrystal formation kinetics.
  • To evaluate the feasibility of high-shear wet granulation as a scalable pharmaceutical manufacturing method.

Main Methods:

  • High-shear wet granulation was employed for cocrystal formation using indomethacin-saccharin as a model.
  • In situ Raman spectroscopy coupled with multivariate curve resolution by alternating least-squares (MCR-ALS) was used to monitor cocrystal formation kinetics.
  • Initial indomethacin states (gamma-form, alpha-form, amorphous) were systematically varied.
  • Granules were characterized using X-ray diffraction (XRD) and tablet dissolution testing.
  • Kinetic data were analyzed using Avrami-Erofeev and Ginstling-Brounshtein models.

Main Results:

  • Indomethacin-saccharin cocrystal formation was confirmed during high-shear wet granulation with ethanol as a binding solvent, evidenced by increased Raman peaks.
  • The kinetics of cocrystal formation varied significantly depending on the initial crystalline form (gamma, alpha, or amorphous) of indomethacin.
  • Different crystallization mechanisms for cocrystal formation were observed based on the initial thermodynamic state of indomethacin.
  • Tablet dissolution testing indicated successful granule formation suitable for pharmaceutical applications.

Conclusions:

  • High-shear wet granulation is a viable and scalable method for pharmaceutical cocrystal manufacturing.
  • The initial physical form of the active pharmaceutical ingredient critically influences cocrystal formation kinetics.
  • Understanding these kinetics is essential for optimizing pharmaceutical manufacturing processes and ensuring product quality.