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J App Pharm Sci. 2020; 10(8): 95-104

Formulation and optimization of Enalapril Maleate-loaded floating microsphere using Box–Behnken design: in vitro study

Vijay Bahadur Kumal, Chhitij Thapa, Prakash Ghimire, Pradyumna Chaudhari, Jitendra Yadhav.


The objective was to prepare an Enalapril maleate (EnM) loaded floating microsphere with minimum particle size, maximum drug loading and drug entrapment efficiency. Formulations were prepared by varying drug-polymer ratio (A), solvent-ratio (B), and stirring time (C). Solvent evaporation method was used to prepare the microsphere. "Box-Behnken design (3-factor, 3-level)" was utilized for the optimization. The independent variables were polymer-drug ratio (A), solvent-ratio (B), and stirring time (C) while particle size (R1), drug loading (R2), and entrapment efficiency (R3) were considered as dependent variables. EnM-loaded alcohol microsphere (Formulation-A) was prepared and optimized and both Formulation-A and EnM-loaded acetonitrile microspheres (Formulation B) were subjected for the morphological, micrometric, characterization and in vitro release study. The particle size, drug loading and entrapment efficiency of Formulation-A and Formulation-B were 143±27.75µm, 37.31±5.73%, 76.89±4.97%, and 158.13±25.1µm, 40.13±6.12% and 99.19±1.14% respectively. The cumulative drug release of the Formulation-A and Formulation-B were 90.52±4.11%, and 86.23±3.81% respectively. Both formulations followed Higuchi model of drug release. EnM-floating microsphere was effectively prepared and both formulations showed excellent continuous release properties for more than 12 hours.

Key words: enalapril maleate, floating microsphere, box-behnken design, controlled release, solvent evaporation

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