Sahoo Subhashree, Chakraborti Chandra Kanti, Mishra Subash Chandra
Department of Pharmaceutics, Kanak Manjari Institute of Pharmaceutical Sciences, Rourkela, Orissa, India.
J Adv Pharm Technol Res. 2011 Jul;2(3):195-204. doi: 10.4103/2231-4040.85541.
Mucoadhesive polymeric (carbopol 934) suspension of ciprofloxacin was prepared by ultrasonication and optimized with the aim of developing an oral controlled release gastro-retentive dosage form. The qualitative analysis of the formulation was performed by fourier transform infrared spectroscopy (FTIR), Raman spectroscopy, X-ray powder diffraction (XRD), and scanning electron microscopy (SEM) analyses. FTIR (400 cm(-1) to 4000 cm(-1) region) and Raman (140 to 2400 cm(-1) region) Spectroscopic studies were carried out and the spectra were used for interpretation. XRD data of pure drug, polymer and the formulation were obtained using a powder diffractometer scanned from a Bragg's angle (2θ) of 10° to 70°. The dispersion of the particle was observed using SEM techniques. The particle size distribution and aspect ratio of particles in the polymeric suspension were obtained from SEM image analysis. The results from FTIR and Raman spectroscopic analyses suggested that, in formulation, the carboxylic groups of ciprofloxacin and hydroxyl groups of C934 undergo a chemical interaction leading to esterification and hydrogen bonding. The XRD data suggested that the retention of crystalline nature of ciprofloxacin in the formulation would lead to increase in stability and drug loading; decrease in solubility; and delay in release of the drug from polymeric suspension with better bioavailability and penetration capacity. The SEM image analysis indicated that, in the formulation maximum particles were having aspect ratio from 2 to 4 and standard deviation was very less which provided supporting evidences for homogeneous, uniformly dispersed, stable controlled release ciprofloxacin suspension which would be pharmaceutically acceptable.
通过超声处理制备了环丙沙星的黏膜黏附聚合物(卡波姆934)混悬液,并进行了优化,旨在开发一种口服控释胃滞留剂型。通过傅里叶变换红外光谱(FTIR)、拉曼光谱、X射线粉末衍射(XRD)和扫描电子显微镜(SEM)分析对该制剂进行了定性分析。进行了FTIR(400 cm⁻¹至4000 cm⁻¹区域)和拉曼(140至2400 cm⁻¹区域)光谱研究,并利用光谱进行解释。使用粉末衍射仪从10°至70°的布拉格角(2θ)扫描获得纯药物、聚合物和制剂的XRD数据。使用SEM技术观察颗粒的分散情况。通过SEM图像分析获得聚合物混悬液中颗粒的粒径分布和纵横比。FTIR和拉曼光谱分析结果表明,在制剂中,环丙沙星的羧基与C934的羟基发生化学相互作用,导致酯化和氢键形成。XRD数据表明,制剂中环丙沙星结晶性质的保留将导致稳定性和载药量增加;溶解度降低;药物从聚合物混悬液中的释放延迟,具有更好的生物利用度和渗透能力。SEM图像分析表明,在制剂中,最大颗粒的纵横比为2至4,标准偏差非常小,这为均匀、均匀分散、稳定的控释环丙沙星混悬液提供了支持证据,该混悬液在药学上是可接受的。