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KMID : 0369820080380010009
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Jorunal of Korean Pharmaceutical Sciences
2008 Volume.38 No. 1 p.9 ~ p.14
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Development of New Amlodipine Complex using Ion Exchange Resin
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Jeong Sang-Young
Ahn Ki-Young
Ahn Kun-Seok
Gil Young-Sig
Hwang Sung-Joo
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Abstract
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Cation exchange resin complex of amlodipine free base has been investigated to improve the stability and dissolution profile. The complex was prepared by reacting amlodipine solution with activated cation exchange resin, and amlodipine content in the complex was 31.6% calculated by HPLC determination. Its product was not physical mixture but the complex formed by ionic bond, which was identified by microscope system, differential scanning calorimetry and X-ray diffractometry. Each tablet containing amlodipine free base(I) and its complex(II) was prepared for the accelerated stability test (, 75%RH) and dissolution test in the pH 1.2 buffer solution and purified water media. Dissolution patterns of formulation II in both media were similar to those of tablet, but the pattern of formulation I in purified water was different. After 6 months storage under stability test, amlodipine content of formulation I, II and tablet were , respectively. While amlodipine free base was unstable at the condition, its complex was not only significantly stable, but also similar in the dissolution pattern. These results suggest the usefulness of complex as a stable carrier for amlodipine free base.
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KEYWORD
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Amlodipine, Ion exchange resin, Complex, Stability
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