Chitosan citrate as film former: compatibility with water-soluble anionic dyes and drug dissolution from coated tablet

Chitosan citrate solution containing 25% w/w propylene glycol was prepared and tested for its compatibility with some water soluble anionic dyes. The immiscibility between erythrosine, ponceau 4R, sunset yellow or tartrazine solutions and chitosan citrate solution was evident. The Fourier transform-infrared spectra revealed charged interaction between anionic dye and chitosan. Brilliant blue and green FS at concentration of 0.02-1.00% w/w polymer could be miscible with chitosan citrate solution due to the decrease in charge interaction by the positive charge on molecule of brilliant blue, which was also the composition in green FS. Propranolol HCl tablets coated with these colored film-coating solutions exhibited good appearance and no color migration. Drug dissolution from coated tablets was pH dependent, corresponding to the ability of chitosan to protonate in the medium. Color incorporation slightly retarded drug dissolution in acidic medium. Drug dissolved from coated tablet colored with brilliant blue was faster than from that colored with green FS. This was because brilliant blue had positive charge and more SO3H groups on its molecular structure, and exhibited higher water solubility. Accelerated condition could alter dissolution characteristics, and the Td + t(0) value from curve fitting between the dissolution profiles and Weibull equation was increased. However, drug dissolution from freshly prepared coated tablets, coated tablets after exposure to accelerated condition and after storage at room temperature for 12 months conformed to the monograph in USP XXIII. (C) 2000 Elsevier Science B.V. All rights reserved.