Enalapril:β-CD complex: Stability enhancement in solid state

被引：26

作者：

Zoppi, Ariana ^{[1
]}

Garnero, Claudia ^{[1
]}

Garro Linck, Yamila ^{[2
,3
]}

Chattah, Ana K. ^{[2
,3
]}

Monti, Gustavo A. ^{[2
,3
]}

Longhi, Marcela R. ^{[1
]}

机构：

[1] Univ Nacl Cordoba, Fac Ciencias Quim, RA-5000 Cordoba, Argentina

[2] Univ Nacl Cordoba, Fac Matemat Astron & Fis, RA-5000 Cordoba, Argentina

[3] Univ Nacl Cordoba, CONICET, IFEG, RA-5000 Cordoba, Argentina

来源：

CARBOHYDRATE POLYMERS | 2011年 / 86卷 / 02期

关键词：

Cyclodextrins; Complexation; Chemical stability; Thermogravimetric analysis; Solid state NMR; X-ray powder diffractometry; BETA-CYCLODEXTRIN; DIKETOPIPERAZINE FORMATION; TABLET FORMULATIONS; MALEATE;

D O I：

10.1016/j.carbpol.2011.05.008

中图分类号：

O69 [应用化学];

学科分类号：

081704 ;

摘要：

Complexation of enalapril maleate with beta-cyclodextrin was used to overcome the known enalapril maleate-excipient interaction in solid state. The complex formation was characterized by (13)C 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. Degradation of the drug at 40 degrees C/75% relative humidity in the presence of magnesium stearate was monitored by high performance liquid chromatography (HPLC). 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. This satisfactory high stability of the enalapril:beta-CD complex will be potentially useful for its application as solid pharmaceutical dosage products. (C) 2011 Elsevier Ltd. All rights reserved.

引用

页码：716 / 721

页数：6

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