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KMID : 0369820130430010055
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Jorunal of Korean Pharmaceutical Sciences
2013 Volume.43 No. 1 p.55 ~ p.61
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Improvement of photostability and dissolution profile of isradipine using inclusion complex
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Park Jun-Bom
Lee Gun-Hee
Kang Ji-Won
Jeon Ik-Sung
Kim Jung-Mi
Kim Ki-Beom
Kang Chin-Yang
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Abstract
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Inclusion complexes using β-cyclodextrin were manufactured by solvent evaporation method. Then, sustained release (SR) hydroxypropylmethylcellulose (HPMC) matrix tablets containing inclusion complex were prepared via direct compression. Isradipine was chosen as a model drug due to its low solubility, photo-instability and short elimination half-life. The physicochemical properties of the inclusion complexes were examined using differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FT-IR). The solubility test and dissolution behaviours were also investigated. Based on the solubility experiments, a 1:2 molar ratio (isradipine:β-Cyclodextrin) was best and chosen to prepare inclusion complexes. In addition, the crystal structure of isradipine was converted to an amorphous structure, as confirmed by Fourier transform infrared spectroscopy (FT-IR) and DSC. The photostability of isradipine in the inclusion complex was more stable than pure isradipine after 4 days radiation. By using hypromellose as the hydrophilic sustained release material, the dissolution rate was retarded during 24 h. A combined method of inclusion complex and SR technology showed increased and sustained release profile above that of Dynacirc® SR Cap. 5 mg.
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KEYWORD
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Isradipine, Inclusion complex, Photo-stability, Sustained release, β-Cyclodextrin
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