pH-independent release of a basic drug from pellets coated with the extended release polymer dispersion Kollicoat® SR 30 D and the enteric polymer dispersion Kollicoat® MAE 30 DP

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Abstract

The objective of this study was to obtain pH-independent release profiles from coated pellets containing drugs with pH-dependent solubility. pH-independent release of the basic model drug verapamil HCl was achieved by coating with a combination of the neutral polymer dispersions Kollicoat® SR 30 D (aqueous dispersion of polyvinyl acetate) and the enteric polymer dispersion Kollicoat® MAE 30 DP (aqueous dispersion of methacrylic acid and ethyl acrylate copolymer; methacrylic acid copolymer type C). The two polymers where applied either as separate layers (enteric polymer+extended release polymer or vice versa) or as a polymer blend. A careful balance of the ratios of the polymers allowed the achievement of a pH-independent release. Higher amounts of the enteric polymer in the polymer blend resulted in a reversal of the pH-dependency, e.g. a faster release at pH 6.8 than in 0.1 N HCl.

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