Química Nova (Jan 2010)

Análise térmica aplicada à caracterização da sinvastatina em formulações farmacêuticas Thermal analysis applied to simvastatin characterization in pharmaceutical formulations

  • Marcelo Antonio de Oliveira,
  • Maria Irene Yoshida,
  • Elionai Cassiana de Lima Gomes,
  • Wagner da Nova Mussel,
  • Cristina Duarte Vianna-Soares,
  • Gérson Antônio Pianetti

DOI
https://doi.org/10.1590/S0100-40422010000800007
Journal volume & issue
Vol. 33, no. 8
pp. 1653 – 1657

Abstract

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Thermogravimetry (TG) and differential scanning calorimetry (DSC) are used in pharmaceutical studies for drugs characterization, purity, formulations compatibility, polymorphism identification, stability evaluation, and thermal decomposition of drugs and pharmaceutical formulations. Simvastatin showed fusion at 138.5 ºC and thermal stability up to 248 ºC. Simvastatin was incompatible with preservative excipient butylhydroxyanisole (BHA) performing a process of crystal amorphization. The drug showed morphological polymorphism, where it has the same unit cell but with different crystal habits according to the recrystallization solvent.

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