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Storage conditions significantly impact flufenamic acid:nicotinamide (FFA:NIC) cocrystal tablet properties, revealing complex interactions missed by simple analysis. Multivariate methods uncovered dual fragmentation and plastic deformation mechanisms crucial for tablet strength.

Keywords:
Heckel equationShapiro’s equationcocrystalcompactibilitycompressibilitylatent variable modelingmultivariate statisticstablet mechanical strengthtabletability

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Solid-State Chemistry

Background:

  • Flufenamic acid:nicotinamide (FFA:NIC) cocrystals are investigated for improved drug properties.
  • Understanding the influence of storage conditions on cocrystal behavior is critical for formulation development.
  • Traditional analysis may overlook complex interactions affecting tabletability.

Purpose of the Study:

  • To investigate the effect of storage humidity (% RH) on the mechanical properties of FFA:NIC cocrystal tablets.
  • To identify the compression parameters and their relationship with tablet mechanical strength (TMS).
  • To explore the underlying deformation mechanisms during compression under varying humidity.

Main Methods:

  • Compressibility, compactibility, and tabletability profiling of FFA:NIC cocrystals.
  • Application of Shapiro and Heckel equations to determine compression parameters (porosity, f, Da, YPpl, YPel).
  • Multivariate statistical analysis including exploratory factor analysis, principal component analysis, and principal component regression.
  • Quantitative PCR modeling to assess main and interaction effects on TMS.

Main Results:

  • Multivariate analysis revealed significant effects of storage condition (% RH) on compressional profiles, contrary to visual or linear regression findings.
  • Statistically significant correlations between compression parameters (f, Da, YPel) supported the importance of fragmentation and plastic deformation mechanisms.
  • Identification of simultaneously operating dual mechanisms of fragmentation and plastic deformation, a novel finding.
  • Quantitative PCR model indicated significant main effects of f, Da, and YPel on TMS, along with a conditional interaction effect between storage condition and porosity.

Conclusions:

  • Storage conditions can have significant, yet hidden, effects on cocrystal tablet properties, necessitating advanced analytical approaches.
  • Both fragmentation and plastic deformation are key mechanisms influencing FFA:NIC cocrystal tablet mechanical strength.
  • Bivariate analysis of compression data can lead to misinterpretation; multivariate methods are essential for uncovering complex inter-relationships.