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Abstract

ENHANCEMENT OF SOLUBILITY OF ACECLOFENAC BY RECRYSTALLIZATION METHOD USING POLAR SOLVENTS

*Gajanan V. Pulgamwar, Ram S. Pentewar, M. A. Saleem, R. V. Sugave, A.V. Moholkar and M. S. Digge

Abstract

Aceclofenac crystals were prepared by Recrystallization from selected solvents such as ethanol and methanol under different working conditions and using different additives like HPMC, PVP, PEG 4000 Sodium CMC, Chitosan, Gelatin, and Sodium Alginate. Obtained crystals were characterized by photomicrography, scanning electron microscopy, X-ray powder diffractometry, FT-IR spectrometry, differential scanning calorimetery, thermogravimetric analysis and Karl Fischer titration. The crystals were evaluated for melting point, LOD, particle size, solubility and dissolution. It was found that the newly developed crystals were different from each other with respect to physical properties, but they are chemically identical. The crystals obtained from ethanol produced prismatic and rod shaped and that obtained from methanol produced hexagonal and thin pole shaped crystals. But the crystals obtained with alcoholic (ethanolic / methanolic) solution of drug in the presence of produced smooth needle shaped crystals. X-ray diffraction spectra of pure drug and prepared crystals indicate that existence of four distinct crystal modifications of orthorhombic for pure drug, triclinic, monoclinic and hexagonal when modified with different solvents, methods and additives. Hence, both X-ray diffraction spectra and differential scanning calorimeter study of the newly developed crystals, clearly indicate that Aceclofenac exist in different crystal modifications. The solubility of newly developed crystals was about 1.5 to 1.9 times higher in distilled water than that of untreated Aceclofenac. The flow properties as angle of repose, car’s compressibility index and Hausner’s ratio suggested that there was slight variation for obtained crystals due to change in crystal shape and particle size.

Keywords: Aceclofenac; Recrystallization; Crystal shape; Solubility; Invitro dissolution


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