Instituto de Ciencia de Materiales de Barcelona (CSIC), Campus de la UAB s/n, 08193 Bellaterra, Spain.
Anal Chim Acta. 2012 Sep 26;744:8-22. doi: 10.1016/j.aca.2012.07.010. Epub 2012 Jul 16.
The analytical characterization of drug delivery systems prepared by means of green manufacturing technologies using CO(2) as a processing fluid is here reviewed. The assessment of the performance of nanopharmaceuticals designed for controlled drug release may result in a complex analytical issue and multidisciplinary studies focused on the evaluation of physicochemical, morphological and textural properties of the products may be required. The determination of the drug content as well as the detection of impurities and solvent residues are often carried out by chromatography. Assays on solid state samples relying on X-ray, vibrational and nuclear magnetic resonance spectroscopies are of great interests to study the composition and structure of pharmaceutical forms. The morphology and size of particles are commonly checked by microscopy and complementary chemical information can be extracted in combination with spectroscopic accessories. Regarding the thermal behavior, calorimetric and thermogravimetric techniques are applied to assess the thermal transitions and stability of the samples. The evaluation of drug release profiles from the nanopharmaceuticals can be based on various experimental set-ups depending on the administration route to be considered. Kinetic curves showing the evolution of the drug concentration as a function of time in various physiological conditions (e.g., gastric, plasmatic or topical) are recorded commonly by UV-vis spectroscopy and/or chromatography. Representative examples are commented in detail to illustrate the characterization strategies.
本文综述了使用二氧化碳作为加工流体的绿色制造技术制备的药物传递系统的分析特性。为了控制药物释放而设计的纳米药物的性能评估可能会导致复杂的分析问题,需要进行多学科研究,重点评估产品的物理化学、形态和结构特性。药物含量的测定以及杂质和溶剂残留的检测通常通过色谱法进行。依靠 X 射线、振动和核磁共振光谱学的固态样品分析对于研究药物形式的组成和结构具有重要意义。颗粒的形态和大小通常通过显微镜检查进行检查,并与光谱学附件结合使用以提取补充的化学信息。关于热行为,量热法和热重分析法适用于评估样品的热转变和稳定性。纳米药物的药物释放曲线的评估可以根据所考虑的给药途径基于各种实验装置。通常通过紫外可见光谱法和/或色谱法记录在各种生理条件(例如,胃、血浆或局部)下药物浓度随时间的变化的动力学曲线。详细评论了代表性实例以说明表征策略。