IFEG   20353
INSTITUTO DE FISICA ENRIQUE GAVIOLA
Unidad Ejecutora - UE
artículos
Título:
Enalapril:beta-CD complex: stability enhancement in solid state
Autor/es:
A. ZOPPI; C. GARNERO; Y. GARRO LINCK; A.K. CHATTAH; G.A. MONTI; M.R. LONGHI
Revista:
CARBOHYDRATE POLYMERS
Editorial:
ELSEVIER SCI LTD
Referencias:
Año: 2011
ISSN:
0144-8617
Resumen:
Complexation of enalapril maleate with â-cyclodextrin was used to overcome the known enalapril maleate-excipient interaction in solid state. The complex formation was characterized by 13C solid-state nuclear magnetic resonance, X-ray powder diffraction and scanning electron microscopy. Additionally, thermogravimetric analysis (TGA) was used to evaluate the compatibility between magnesium stearate with enalapril maleate alone or in the complex form. TGA studies showed that there was compatibility between the complex and the excipient. In contrast, enalapril maleate was incompatible with magnesium stearate. Degradation under accelerated storage conditions in the presence of magnesium stearate was monitored by high pressure liquid chromatography (HPLC). Binary mixtures (1:1) of enalapril maleate or complex with magnesium stearate were stored for 6 months at 40 °C/75% relative humidity. HPLC assays demonstrated that enalapril maleate in the complex form was more stable than the drug alone, with the drug recovery after 6 month being: 95 ± 1 % and 82.1 ± 0.5 %, respectively.