Conformational polymorphism in aripiprazole: Preparation, stability and structure of five modifications

J Pharm Sci. 2009 Jun;98(6):2010-26. doi: 10.1002/jps.21574.

Abstract

Five phase-pure modifications of the antipsychotic drug aripiprazole were prepared and characterized by thermal analysis, vibrational spectroscopy and X-ray diffractometry. All modifications can be produced from solvents, form I additionally by heating of form X degrees to approximately 120 degrees C (solid-solid transformation) and form III by crystallization from the melt. Thermodynamic relationships between the polymorphs were evaluated on the basis of thermochemical data and visualized in a semi-schematic energy/temperature diagram. At least six of the ten polymorphic pairs are enantiotropically and two monotropically related. Form X degrees is the thermodynamically stable modification at 20 degrees C, form II is stable in a window from about 62-77 degrees C, and form I above 80 degrees C (high-temperature form). Forms III and IV are triclinic ($P\overline 1$), I and X degrees are monoclinic (P2(1)) and form II orthorhombic (Pna2(1)). Each polymorph exhibits a distinct molecular conformation, and there are two fundamental N-H$\cdots$O hydrogen bond synthons (catemers and dimers). Hirshfeld surface analysis was employed to display differences in intermolecular short contacts. A high kinetic stability was observed for three metastable polymorphs which can be categorized as suitable candidates for the development of solid dosage forms.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antipsychotic Agents / chemical synthesis
  • Antipsychotic Agents / chemistry*
  • Aripiprazole
  • Calorimetry, Differential Scanning
  • Crystallization
  • Crystallography, X-Ray
  • Humans
  • Kinetics
  • Molecular Conformation
  • Piperazines / chemical synthesis
  • Piperazines / chemistry*
  • Quinolones / chemical synthesis
  • Quinolones / chemistry*
  • Solvents / chemistry
  • Spectrophotometry, Infrared
  • Spectrum Analysis, Raman
  • Thermodynamics

Substances

  • Antipsychotic Agents
  • Piperazines
  • Quinolones
  • Solvents
  • Aripiprazole