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Buspirone Hydrochloride Polymorphism: Stability, Solubility, Flow Properties, and Manufacturing Implications.

Jéssika Adriane Janning1, Victória Guimarães Santiago2, Ederlan de Souza Ferreira2

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Advances in Pharmacological and Pharmaceutical Sciences
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PubMed
Summary

Buspirone hydrochloride exhibits two polymorphic forms impacting drug performance. Form 1 is more stable than Form 2, which converts to Form 1 under stress, necessitating formulation adjustments for optimal therapeutic efficacy.

Keywords:
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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry
  • Drug Development

Background:

  • Buspirone hydrochloride, an anxiolytic, exists in two interconvertible polymorphic forms.
  • Polymorphism significantly influences drug physicochemical properties and therapeutic efficacy.
  • Neglecting polymorphism in pharmaceutical analysis can lead to inconsistent results and compromised drug performance.

Purpose of the Study:

  • To investigate the polymorphism, stability, solubility, and flow properties of commercial buspirone hydrochloride samples.
  • To understand how polymorphic transformations affect pharmaceutical performance.
  • To identify the most effective analytical methods for distinguishing polymorphic forms.

Main Methods:

  • Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and powder X-ray diffraction (PXRD) for structural characterization.
  • Carr index and Hausner ratio for flow and density properties.
  • High-performance liquid chromatography (HPLC) for solubility evaluation in physiologically relevant pH media.

Main Results:

  • Commercial samples showed variations: one contained a mixture of Form 1 and Form 2, the other exclusively Form 2.
  • Form 2 converted to the more thermodynamically stable Form 1 under stress conditions (humidity and temperature).
  • DSC was the most effective method for distinguishing polymorphic forms and identifying mixtures; both forms exhibited poor flow properties and pH-dependent solubility.

Conclusions:

  • Buspirone hydrochloride Form 1 demonstrates greater thermodynamic stability than Form 2.
  • Polymorphic transformations and poor flow properties necessitate formulation adjustments for effective drug delivery.
  • Findings support preliminary Biopharmaceutics Classification System (BCS) Class I or III classification, pending permeability studies.