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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Chemometrics-assisted solid-state characterization of pharmaceutically relevant materials. Polymorphic substances.

Natalia L Calvo1, Rubén M Maggio1, Teodoro S Kaufman1

  • 1Instituto de Química Rosario (IQUIR, CONICET-UNR) and Área Análisis de Medicamentos, Facultad de Ciencias Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario, Suipacha 531, Rosario (S2002LRK), Argentina.

Journal of Pharmaceutical and Biomedical Analysis
|July 3, 2017
PubMed
Summary
This summary is machine-generated.

Chemometrics and analytical techniques help characterize drug solid-state properties, particularly drug polymorphism. This review details methods for identifying and quantifying polymorphs in pharmaceutical systems.

Keywords:
ChemometricsMCR-ALSMIRNIRPCAPLSPolymorph identificationPolymorphic transitionsRaman and ssNMR spectroscopiesSolid-state characterizationXRPD

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Physical Chemistry

Background:

  • Current regulations mandate thorough characterization of pharmaceutical solid systems.
  • Chemometrics offers powerful tools for analyzing complex data and uncovering hidden information.
  • Understanding drug polymorphism is crucial for solid-state drug characterization.

Purpose of the Study:

  • To review the integration of analytical techniques and chemometrics for studying drug polymorphism.
  • To highlight methods for gaining insights into the solid-state characteristics of drugs.
  • To examine the application of chemometrics in pharmaceutical solid-state analysis.

Main Methods:

  • Combination of spectroscopic techniques (Raman, terahertz, IR) with chemometrics.
  • Integration of X-ray powder diffraction, 13C solid-state NMR, and thermal methods with chemometrics.
  • Application of qualitative and quantitative chemometrics methodologies.

Main Results:

  • Chemometrics-based approaches enable polymorph classification and identity assignment.
  • Methods allow for the determination of specific polymorphs in simple and complex mixtures.
  • Discussion of solvation, phase transformations, crystallinity, and recrystallization processes.

Conclusions:

  • The synergy between analytical techniques and chemometrics provides valuable insights into drug polymorphism.
  • These combined approaches are essential for meeting regulatory requirements in pharmaceutical solid-state characterization.
  • Future perspectives highlight advancements in instrumentation and chemometrics methodologies.