| Summary: | 碩士 === 高雄醫學大學 === 藥學研究所 === 88 === Solid dispersion is frequently used to increase the dissolution rate of poorly water-soluble drug. In this study solid dispersions containing 10 % of nifedipine were prepared with polyethylene glycol (PEG) 6000, hydroxylpropyl methylcellulose (HPMC) and nicotinamide as carrier by fusion method and solvent method, respectively. Nifedipine-PEG 6000 solid dispersions and nifedipine-nicotinamide-HPMC solid dispersions were studied for their physical properties and drug dissolution.
Dissolution studies showed that the dissolution rate was markedly increased in solid dispersion compared with physical mixtures and pure drugs. Furthermore, for the nifedipine-nicotinamide-HPMC solid dispersion system, the dissolution rate of nifedipine increased with an increase in the nicotinamide and HPMC content in the solid dispersion.
The fit factors f1 and f2 were calculated and the percentage drug dissolution per unit time between the test formulations and a reference product were then evaluated subsequently. The results showed that three out of the eleven formulations of solid dispersions were similar to the reference product, i.e. the f1 values were between 0 and 15, and the f2 values were greater than 50.
The physical characteristics of these solid dispersions were also investigated by employing differential scanning calorimetry, X-ray diffraction, Fourier-transform infrared spectroscopy and scanning electron microscopy analysis, respectively. The results indicate that amorphous nifedipine was obviously obtained and no significant intermolecular hydrogen bonds were observed for the solid dispersion system.
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