Thermodynamics Research Center / ThermoML | Thermochimica Acta

Risperidone Solid-state characterization and pharmaceuticalcompatibility using thermal and non-thermal techniques

Daniel, J. S. P.[Josiane Souza Pereira], Veronez, I. P.[Isabela Pianna], Rodrigues, L. L.[Larissa Lopes], Trevisan, M. G.[Marcello G.], Garcia, J. S.[Jerusa Simone]
Thermochim. Acta 2013, 568, 148-55
ABSTRACT
A full solid-state characterization of risperidone was conducted using differential scanning calorimetry(DSC), thermogravimetry (TG), powder X-ray diffraction (PXRD), Fourier transform infrared spectroscopy(FT-IR) and scanning electron microscopy (SEM) to examine its physicochemical properties and polymor-phism. The primary aim of this work was to study the compatibility of risperidone with pharmaceuticalexcipients using DSC to obtain and compare the curves of the active pharmaceutical ingredient (API)and the excipients with their 1:1 (w/w) binary mixtures. These same binary mixtures were turned toroom temperature and analyzed by FT-IR combined with principal component analysis (PCA) to evalu-ate solid-state incompatibilities. The chemical incompatibilities of these samples were verified using astability-indicating liquid chromatography (LC) method to assay for the API and evaluate the formationof degradation products. All of these methods showed incompatibilities between risperidone and theexcipients magnesium stearate, lactose and cellulose microcrystalline.
Compounds
# Formula Name
1 C23H27FN4O2 risperidone
Datasets
The table above is generated from the ThermoML associated json file (link above). POMD and RXND refer to PureOrMixture and Reaction Datasets. The compound numbers are included in properties, variables, and phases, if specificied; the numbers refer to the table of compounds on the left.
Type Compound-# Property Variable Constraint Phase Method #Points
  • POMD
  • 1
  • Normal melting temperature, K ; Crystal
  • Crystal
  • Liquid
  • Air at 1 atmosphere
  • DTA:corrimp
  • 1
  • POMD
  • 1
  • Molar enthalpy of transition or fusion, kJ/mol ; Crystal
  • Crystal
  • Liquid
  • Air at 1 atmosphere
  • DSC
  • 1