Characterization of ternary complexes of meloxicam-HPβCD and PVP or L-arginine prepared by the spray-drying technique

Abstract

Ternary complexes of meloxicam (ME) (a poorly water soluble anti-inflammatory drug) with hydroxypropyl-beta-cyclodextrin (HPbetaCD) and either a hydrophilic polymer, namely, polyvinyl pyrrolidone (PVP) or a basic amino acid such as L-arginine, were prepared by the spray-drying technique. The solubilizing efficiency, physical properties and dissolution behaviour of each ternary system of ME-HPbetaCD with either PVP or L-arginine were compared with those of the corresponding binary system of ME-HPbetaCD. Tablets compressed from the ternary system of ME-HPbetaCD-L-arginine were compared with plain and commercial tablets. Phase solubility experiments suggested the formation of an inclusion complex of AL type. Ternary system of ME-HPbetaCD-L-arginine exhibited a stability constant 30.3 times higher than the binary system of ME-HPbetaCD, while the ternary system of ME-HPbetaCD-PVP increased the stability constant 2.2 times only. The prepared complexes were characterized by scanning electron microscopy, differential scanning calorimetry and infra red spectroscopy. Ternary solid complexes indicated the presence of strong interactions between the components. The dissolution behaviour of ME from different ternary complexes was higher than its dissolution from the binary system. Tablets compressed from ternary complexes of ME-HPbetaCD-L-arginine highly improved drug release compared to plain and commercial tablets.