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Microfluidics in Assessing Platelet Function
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Counterintuitive compaction behavior of clopidogrel bisulfate polymorphs.

Kailas S Khomane1, Parth K More, Arvind K Bansal

  • 1Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Mohali, Punjab, India.

Journal of Pharmaceutical Sciences
|April 11, 2012
PubMed
Summary

Clopidogrel bisulfate (CLP) polymorphs I and II exhibit distinct compaction behaviors due to differences in molecular packing and crystal structure. True density, not heat of fusion, predicts bonding strength in pharmaceutical powders.

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Solid-State Chemistry

Background:

  • Clopidogrel bisulfate (CLP) exists as polymorphic forms (I and II) with varying densities, impacting compaction.
  • Understanding these differences is crucial for optimizing tablet manufacturing and drug efficacy.

Purpose of the Study:

  • To investigate the in-die and out-of-die compaction behavior of CLP polymorphs I and II.
  • To elucidate the relationship between molecular packing, true density, heat of fusion, and tabletability.
  • To identify reliable predictors of bonding strength in pharmaceutical powders.

Main Methods:

  • Compaction studies using a rotary tabletting machine with in-die and out-of-die measurements.
  • Analysis of compaction data via CTC profile, Heckel, and Walker equations.
  • Detailed examination of molecular packing, focusing on sulfate anion arrangement.

Main Results:

  • Polymorph I exhibits close cluster packing, leading to a rigid structure with poor compressibility but superior tabletability due to higher bonding strength.
  • Polymorph II shows different molecular packing, resulting in better compressibility but lower bonding strength compared to polymorph I.
  • True density was identified as a key factor influencing bonding strength, whereas heat of fusion was less predictive.

Conclusions:

  • Molecular packing, specifically the arrangement of the sulfate anion, significantly dictates the compaction behavior of CLP polymorphs.
  • True density is a more reliable predictor of bonding strength than heat of fusion for pharmaceutical powders like CLP.
  • These findings have implications for selecting appropriate polymorphs and optimizing compaction processes in pharmaceutical formulation.