Abstract
The aim of the present investigation was to develop an oral formulation with decreased gastrotoxicity for niflumic acid (NIF), a non-steroidal anti-inflammatory drug, through cyclodextrin associations. Due to the amphoteric nature of the drug, phase solubility studies were performed at pH values representative of in vivo conditions where the drug produces untoward effects (pH 1.2 and 4.5) and close to protonation macroconstants of NIF (pK = 4.44 and pK 2 = 2.26). Equimolar NIF/CD solid systems prepared by freeze-drying and spray-drying were amorphous and able to dissolve a higher amount of NIF than pure drug can at acidic pH as a function of cyclodextrin type and physicochemical properties of the solid system. In a pharmacological study performed on rats, the freeze-driedproducts showed a remarkably reduced gastrolesivity in comparison with pure NIF.
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