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Related Concept Videos

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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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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Solid-state evaluation and polymorphic quantification of venlafaxine hydrochloride raw materials using the Rietveld

Larissa S Bernardi1, Fábio F Ferreira, Silvia L Cuffini

  • 1Programa de Pós-Graduação em Farmácia, Centro de Ciências da Saúde, Universidade Federal de Santa Catarina, Florianópolis 88040-900, SC, Brasil.

Talanta
|November 12, 2013
PubMed
Summary

This study characterized two solid-state forms of venlafaxine hydrochloride (VEN), an antidepressant. Analysis revealed commercial VEN raw materials contained either pure Form 1 or a mixture of Form 1 and Form 2.

Keywords:
PolymorphismRietveld methodVenlafaxine hydrochlorideX-ray powder diffraction

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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry

Background:

  • Venlafaxine hydrochloride (VEN) is a widely prescribed antidepressant.
  • Understanding its solid-state properties, specifically polymorphism, is crucial for drug formulation and efficacy.

Purpose of the Study:

  • To prepare and characterize pure polymorphic forms (Form 1 and Form 2) of VEN.
  • To identify and quantify the polymorphic composition of commercially available VEN raw materials.

Main Methods:

  • Polymorph preparation via different crystallization methods.
  • Solid-state characterization using X-ray Powder Diffraction (XRPD), DRIFT, Raman Spectroscopy, NMR (liquid and solid-state), DSC, and SEM.
  • Polymorphic quantification using XRPD and the Rietveld method.

Main Results:

  • Distinct differences between Form 1 and Form 2 were observed using DSC and XRPD.
  • XRPD combined with the Rietveld method was established as the standard for identification and quantification.
  • Commercial samples VEN1 and VEN2 contained only Form 1, while VEN3 and VEN4 were mixtures of Form 1 and Form 2, with quantifiable ratios.

Conclusions:

  • The study successfully prepared and characterized pure VEN polymorphs.
  • A reliable method for identifying and quantifying VEN polymorphs in commercial raw materials was established.
  • The polymorphic composition of commercial VEN samples was determined, highlighting variability among manufacturers.