Solid State Analysis and In-Vitro Dissolution Behavior of MeloxicamHydroxy Propyl Beta Cyclodextrin-Ethanolamines Ternary Complexes

Abstract

The present study was aimed to improve the aqueous solubility and dissolution rate of an NSAID meloxicam by hydroxy propyl β-cyclodextrin ternary complexes employing ethanolamines. Initially, meloxicam (MLX) binary complexes with Hydroxy propyl β-Cyclodextrin (HPβCD) were formulated by kneading and solvent evaporation techniques which was followed by ternary complex preparation of selected MLX-HPβCD binary complex employing different ethanolamines by solvent evaporation method. The solvent evaporationwas used in preparing ternary complexes of MLX, because it was proved to be the best method comparatively in yielding promising binary complexes of meloxicam in the initial stage of this study. MLX formed 1:1 M stoichiometric binary and ternary inclusion complexes as demonstrated by the AL-type of phase solubility curve. An increment in the stability constant value (Kc) of MLX- HPβCD complex in the presence of ethanolamines conceded higher complexation efficiency. Solid state analysis (FTIR, TGA, and SEM studies) of ternary compounds evidenced the perfect inclusion complex formation. Ternary complexes showed significant improvement in drug dissolution compared topure MLX and MLX-HPβCD binary complex. The ternary complex containing 1:1:1 molar ratio of MLX-HPβCD-DEA exhibited 86.91% drug dissolution in 1 hour, which was significantly high in relation to ternary complexes containing mono and tri ethanolamines, and it was found to follow imperatively matrix order release mechanism. On aging studied complexes showed no significant change in physical appearance, drug content and drug dissolution attributes, which clearly shows high in-vitro stability of the complexes.