Preformulation studies of ciprofloxacin loaded PVP nanofibers

L. É. Uhljar, S. Kan, N. Radacsi, R. Ambrus
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Abstract

Ciprofloxacin is a worldwide-used, broad-spectrum antibiotic with low water-solubility [1]. To earn higher solubility, and better bioavailability, nanofibers were fabricated as an amorphous solid dispersion with the polymer, polyvinylpyrrolidone (PVP). For the production, needle and needleless electrospinning methods were used [2]. The fiber size and morphology were observed by scanning electron microscopy (SEM). Physicochemical properties were characterized by X-ray powder diffraction (XRPD), differential scanning calorimeter (DSC), and Fourier-transform infrared spectroscopy (FTIR). The results proved the amorphous state of the CIP inside the nanofibrous mats. The solubility, in vitro dissolution rate, and in vitro diffusion were remarkably higher in the case of the nanofibers compared with the CIP powder or the physical mixture of the two components. The solubility of the CIP demonstrated a significant increase both in water (pH 6.3) and phosphate buffer solution (pH 7.4). In addition, fastdissolving formulations were developed, while 94±6% of the CIP was released in the first 5 min. Moreover, in vitro diffusion from pH 6.8 to pH 7.4 also showed a notable increase. The stability of the nanofibrous samples was studied by SEM and in vitro dissolution. In conclusion, fast-dissolving formulations were built up which can be further investigated to develop appropriate pharmaceutical forms.
环丙沙星负载PVP纳米纤维的预配方研究
环丙沙星是一种广泛使用的低水溶性广谱抗生素。为了获得更高的溶解度和更好的生物利用度,纳米纤维以聚合物聚乙烯吡咯烷酮(PVP)作为无定形固体分散体制备。在生产过程中,采用了针纺丝法和无针纺丝法。用扫描电镜观察了纤维的大小和形态。采用x射线粉末衍射(XRPD)、差示扫描量热仪(DSC)和傅里叶变换红外光谱(FTIR)对其理化性质进行了表征。结果证明了纳米纤维垫内CIP的无定形状态。纳米纤维的溶解度、体外溶出率和体外扩散率均显著高于CIP粉或两者的物理混合物。CIP在水(pH 6.3)和磷酸盐缓冲溶液(pH 7.4)中的溶解度均有显著提高。此外,还开发了快速溶出配方,其中94±6%的CIP在前5 min内释放。并且,从pH 6.8到pH 7.4的体外扩散也显着增加。通过扫描电镜和体外溶出研究了纳米纤维样品的稳定性。最后,建立了快速溶出制剂,可进一步研究开发合适的药物剂型。
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