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Multi-dimensional visualization for the morphology of lubricant stearic acid particles and their distribution in tablets

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Asian Journal of Pharmaceutical Sciences 2020年第1期15卷 60-68页

作者： Liu Zhang shailendra shakya Li Wu Jiangtao Wang Guanghui Jin Huimin Sun Xianzhen Yin Lixin Sun Jiwen Zhang School of Pharmacy Shenyang Pharmaceutical UniversityShenyang 110016China Center for Drug Delivery Systems Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghai 201203China Weihai Disu Pharmaceutical Manufacturer Weihai 264200China National Institutes for Food and Drug Control Beijing 100050China

The shapes of particles and their distribution in tablets, controlled by pretreatment and tableting process, determine the pharmaceutical performance of excipient like lubricant. This study aims to provide deeper insights to the relationship of the morphology and spatial distribution of stearic acid(SA) with the lubrication efficiency, as well as the resulting tablet property. Unmodified SA particles as flat sheet-like particles were firstly reprocessed by emulsification in hot water to obtain the reprocessed SA particles with spherical morphology. The three-dimensional(3 D) information of SA particles in tablets was detected by a quantitative and non-invasive 3 D structure elucidation technique, namely, synchrotron radiation X-ray micro-computed tomography(SR-μCT). SA particles in glipizide tablets prepared by using unmodified SA(GUT), reprocessed SA(GRT), as well as reference listed drug(RLD) of glipizide tablets were analyzed by SR-μCT. The results showed that the reprocessed SA with better flowability contributed to similarity of breaking forces between that of GRT and RLD. SA particles in GRT were very similar to those in RLD with uniform morphology and particle size, while SA particles in GUT were not evenly distributed. These findings not only demonstrated the feasibility of SR-μCT as a new method in revealing the morphology and spatial distribution of excipient in drug delivery system, but also deepened insights of solid dosage form design into a new scale by powder engineering.

关键词： Stearic acid Morphology Spatial distribution SR-μCT Glipizide tablets

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Optimization of taste-masking on ibuprofen microspheres with selected structure features

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Asian Journal of Pharmaceutical Sciences 2019年第2期14卷 174-182页

作者： Wei Qin Yuanzhi He Zhen Guo Liu Zhang Li Wu Xianzhen Yin shailendra shakya Abi Maharjan Yan Tang Weifeng Zhu Jiwen Zhang Ministry of Education Jiangxi University of Traditional Chinese Medicine Shanghai Institute of Materia Medica Chinese Academy of Sciences School of Pharmacy Shenyang Pharmaceutical University School of Pharmacy University of Chinese Academy of Sciences

The microsphere was a primary particulate system for taste-masking with unique structural features defined by production process. In this article, ibuprofen lipid microspheres of octadecanol and glycerin monostearate were prepared to mask the undesirable taste of ibuprofen via three kinds of spray congealing processes, namely, air-cooling, water-cooling and citric acid solution-cooling. The stereoscopic and internal structures of ibuprofen microspheres were quantitatively analyzed by synchrotron radiation X-ray micro-computed tomography(SR-μCT) to establish the relationship between the preparation process and microsphere architectures. It was found that the microstructure and morphology of the microspheres were significantly influenced by preparation processes as the primary factors to determine the release profiles and taste-masking effects. The sphericity of ibuprofen microspheres congealed in citric acid solution was higher than that of other two and its morphology was more regular than that being congealed in air or distilled water, and the contact angles between congealing media and melted ibuprofen in octadecanol and glycerin monostearate well demonstrated the structure differences among microspheres of three processes which controlled the release characteristics of the microspheres. The structure parameters like porosity, sphericity, and radius ratio from quantitative analysis were correlated well with drug release behaviors. The results demonstrated that the exterior morphology and internal structure of microspheres had considerable influences on the drug release behaviors as well as taste-masking effects.

关键词： Ibuprofen microsphere Spray congealing Internal structure Synchrotron radiation X-ray micro-computed tomography

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HPLC-MS法测定氯吡格雷酸人体尿药浓度及氯吡格雷酸经尿排泄研究

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药学进展 2010年第10期34卷 463-467页

作者：刘园园唐立超沙克亚丁黎文爱东杨林中国药科大学药物分析教研室江苏南京210009 第四军医大学西京医院国家药品临床研究机构Ⅰ期临床试验研究室陕西西安710032

目的:建立测定氯吡格雷酸人体尿药浓度的高效液相色谱-质谱联用方法,并通过监测硫酸氢氯吡格雷片经健康受试者口服后其主要Ⅰ相代谢物氯吡格雷酸尿药浓度的经时变化过程,考察氯吡格雷酸经尿排泄特征。方法:色谱采用Lichrospher C18柱(15... 详细信息

目的:建立测定氯吡格雷酸人体尿药浓度的高效液相色谱-质谱联用方法,并通过监测硫酸氢氯吡格雷片经健康受试者口服后其主要Ⅰ相代谢物氯吡格雷酸尿药浓度的经时变化过程,考察氯吡格雷酸经尿排泄特征。方法:色谱采用Lichrospher C18柱(150 mm×2.1 mm,5μm),以甲醇-10 mmol.L-1醋酸铵水溶液(含0.1%甲酸)(42∶58)为流动相。质谱采用电喷雾离子源四级杆质谱,以选择性离子监测方式进行正离子检测。6名健康受试者单次口服硫酸氢氯吡格雷片75 mg后,定时收集尿样。采用甲醇直接稀释法处理尿样后,评价氯吡格雷酸经尿排泄特征。结果:氯吡格雷酸在4.780～9 559μg.L-1质量浓度范围内线性关系良好,平均回收率大于93.4%。受试者服药后0～2小时间,氯吡格雷酸经尿排泄速率最大;36小时内有(1.1±0.5)%的氯吡格雷以氯吡格雷酸形式从尿中排出。结论:该测定方法符合生物样品分析要求;氯吡格雷在体内以氯吡格雷酸形式经尿排泄迅速,24小时内基本排泄完全。

关键词：氯吡格雷氯吡格雷酸尿药浓度高效液相色谱-质谱联用经尿排泄特征

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