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Understanding Dynamics of Polymorphic Conversion during the Tableting Process Using In Situ Mechanical Raman

Heejun Park1, Haichen Nie2, Abhijeet Dhiman3

  • 1Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana 47907, United States.

Molecular Pharmaceutics
|July 8, 2020
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Summary

This study reveals how pharmaceutical powders change solid-state forms during tableting. Using in situ mechanical Raman spectroscopy, we observed polymorphic interconversion in chlorpropamide (CPA) under compaction stress and elastic recovery.

Keywords:
chlorpropamidedeformationin situ mechanical Raman spectroscopypolymorphic interconversiontableting

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Polymorphic interconversion is critical in pharmaceutical manufacturing.
  • Understanding solid-state transformations during tableting is essential for drug product quality.
  • Chlorpropamide (CPA) is known to undergo mechanical shear-induced polymorphic conversions.

Purpose of the Study:

  • To fundamentally understand polymorphic interconversion during the tableting process.
  • To develop and utilize in situ mechanical Raman spectroscopy for simultaneous measurement of Raman spectra and densification.
  • To investigate the dynamics of polymorphic interconversion in chlorpropamide (CPA) during compaction, dwell, decompression, and ejection.

Main Methods:

  • Development of a fit-for-purpose in situ mechanical Raman spectroscopy technique.
  • Simultaneous measurement of Raman spectra and powder compact densification.
  • Utilizing chlorpropamide (CPA) as a model pharmaceutical compound with known polymorphic conversions.

Main Results:

  • Confirmed transformation of CPA polymorph A (CPA-A) to CPA polymorph C (CPA-C) under compaction stress.
  • Observed reversion of CPA-C to CPA-A during dwelling and unloading due to elastic recovery.
  • Demonstrated a correlation between powder compact relative density changes and polymorphic interconversion.

Conclusions:

  • Process-induced polymorph conversion is a dynamic process influenced by compaction pressure, material properties, elastic recovery, and stress dissipation.
  • In situ mechanical Raman spectroscopy enables simultaneous detection of mechanical and chemical information during tableting.
  • The study provides the first dynamic depiction of CPA polymorphic interconversion throughout the tableting cycle.