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Employing Multivariate Statistics and Latent Variable Models to Identify and Quantify Complex Relationships in
William C Stagner1, Abhay Jain1, Antoine Al-Achi1
1Campbell University College of Pharmacy & Health Sciences, Buies Creek, North Carolina, 27506, USA.
AAPS Pharmscitech
|July 9, 2020
Summary
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.
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.
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