Abstract

Dissolution behavior from solid dispersion system obtained from nifedipine and enteric coating agent (hydroxypropylmethylcellulosephthalate and copolymer based on methacrylic acid and methacrylic acid methyl ester) were investigated. The X-ray diffraction data suggested that nifedipine was present in its amorphous form in these systems. Dissolved amounts of nifedipine from the system in JP X 1st fluid (pH 1.2) were poorer than that of nifedipine crystalline. But the dissolution rate of nifedipine from the system, especially nifedipine-hydroxypropylmethylcellulosephthalate, was very rapid and the system showed supersaturated concentration in JP X 2nd fluid (pH 6.8). Dissolution behavior, that is dissolution rate and amount of nifedipine dissolved in the system was better in the case of the use of hydroxypropylmethylcellulosephthalate as carrier than that using copolymer based on methacrylic acid and methacrylic acid methyl ester. The above reason was discussed from the inhibitory effect of these polymers on the crystallization of nifedipine.

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